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The unhinged abortion pill lawsuit hearing

What a shitshow.

The future of medication abortion in the United States remains up in the air after a federal judge heard arguments Wednesday in a suit challenging the Food and Drug Administration’s long-standing approval of mifepristone.

U.S. District Judge Matthew Kacsmaryk said he would rule “as soon as possible” on the challenge brought by the Alliance Defending Freedom, a conservative, anti-abortion law firm.

ADF is asking Kacsmaryk to suspend — and ultimately withdraw — the FDA’s approval of the medication, which would have nationwide implications, especially in states where abortion remains legal. In the hearing, a lawyer for ADF conceded that this would be unprecedented, but argued that the court had the authority to intervene to prevent harm.

Lawyers for the Department of Justice and Danco Laboratories, the pharmaceutical company that produces generic mifepristone, argued that the lawsuit is meritless.

Granting a preliminary injunction would be “depriving patients and doctors of a safe and effective drug,” argued Julie Straus Harris, with the DOJ.

Since it was initially approved in 2000, mifepristone has been found to be overwhelmingly safe and effective for terminating pregnancies. Citing that body of evidence, the FDA has recently relaxed restrictions on the medication, which is used in the majority of the abortions in the United States.

In the suit, ADF is representing anti-abortion medical organizations and doctors who argue they have been harmed by having to treat patients who have experienced adverse effects from the medications — and that they anticipate increased harm as a result of these loosened restrictions.

They also argue the drug was initially approved improperly under an FDA regulation that fast-tracks drugs that treat serious illnesses.

“Pregnancy is not an illness,” said Erik Baptist, a lawyer for ADF, in Wednesday’s hearing. “Mifepristone doesn’t treat anything.”

Kacsmaryk, appearing to give weight to that argument, listed off all the drugs that were approved under this regulation before mifepristone, most of which treat HIV and cancer. Separately, he summarized Baptist’s argument as asking the court to “deem one of these not like the others.”

The hearing, which ran more than four hours in Kacsmaryk’s Amarillo courtroom, covered a wide range of arguments. But the central question before Kacsmaryk is not as much about abortion as it is about administrative procedure — and whether the plaintiffs have any right to bring this lawsuit at all.

See here and here for the background. I can’t overstate how ridiculous this all is, and that includes the extreme restrictions on coverage of the hearing, for which you literally had to be there or at a single courthouse in Dallas, but only a handful of people were allowed at the courtroom, and cellphones were banned, so no live-tweeting. All for a hearing at which one hand-picked judge could severely curtail access to abortion for millions of women across the country, based on vibes. I really hope I’m wrong, but I don’t see anything in the coverage I’ve read to suggest this guy will do anything other than what he clearly wants to do. We’ll find out soon. Jezebel, the Associated Press, Slate, Daily Kos, and NBC News have more.

UPDATE: From Slate, “If Kacsmaryk rewrites the history of mifepristone’s approval as grounds to pull it from the market, his decision should command no respect or acquiescence from anyone—not the FDA, not abortion providers, and certainly not the public at large.”

The hearing for that unhinged abortion pill lawsuit is today

Like I said, brace yourselves.

A federal judge in Texas will hear arguments Wednesday in a closely watched dispute that could halt distribution of a key drug used for medication abortion and disrupt access nationwide, even in states where reproductive rights are protected.

The case before U.S. District Judge Matthew Kacsmaryk was brought in November by a conservative legal organization on behalf of anti-abortion rights medical associations and targets the Food and Drug Administration’s (FDA) decades-old approval of the drug mifepristone, one of two medications used to terminate an early pregnancy.

The associations have requested Kacsmaryk order the FDA to withdraw its 2000 approval of mifepristone, arguing the agency erred when it gave the green-light to the drug under a regulation that allows accelerated approval of medications for “serious or life-threatening illnesses.”

But the Biden administration has warned that such a step would harm patients who rely on abortion pills and further strain state health care systems, particularly in places with clinics already grappling with overcrowding as a result of abortion restrictions in neighboring states.

The parties will have two hours apiece to press their arguments before Kacsmaryk, and the judge laid out a host of issues for them to discuss Wednesday, including whether the associations have the legal standing to sue, whether an injunction would serve the public interest and the regulation under which mifepristone was approved.

Kacsmaryk could issue his decision on the associations’ request for a preliminary injunction any time after the hearing, though a quick appeal to the U.S. Circuit Court of Appeals for the 5th Circuit is expected.

[…]

In papers filed with the court, the anti-abortion rights groups claimed the FDA exceeded its regulatory authority to approve mifepristone and has over the years removed safeguards by changing the dosage and route of administration in 2016, and lifting an in-person dispensing requirement to allow the pills to be mailed in 2021.

“The FDA took these actions by running roughshod over the laws and regulations that govern the agency and, more importantly, protect the public from harmful drugs,” they argued.

The Biden administration countered that the challengers’ request for the court to withdraw approval of mifepristone is “extraordinary and unprecedented.” Administration lawyers said they have been unable to find any case where a court has “second-guessed FDA’s safety and efficacy determination and ordered a widely available FDA-approved drug to be removed from the market — much less an example that includes a two-decade delay.”

Taking aim at the associations’ claim that the FDA improperly accelerated approval of mifepristone without substantial evidence of its safety, Justice Department lawyers noted that the 2000 approval of the drug came more than four years after manufacturer Danco submitted its application.

The drug maker, too, told the court that forcing the FDA to withdraw its long standing approval of mifepristone would not only “seismically disrupt the agency’s governing authority as to whether drugs are safe and effective,” but also put Danco out of business.

“The public has no interest in a hastily cobbled together, and overtly political, attempt by private parties to wrest control of the drug approval process from the United States agency responsible for it — an agency that has acted deliberately, thoughtfully, and consistent with its authorizing statute and implementing regulations,” the company said.

See here for the background. Plenty of legal types have written at length about how specious and flimsy the plaintiffs’ arguments are, and how utterly lacking their claim of standing is, so I’ll just note that and move on. Whether any of that matters to this wingnut judge or not will only be known after his ruling. As for the coverage of this ridiculous lawsuit, TPM among others provided insight:

TPM has obtained, and is first to report, the transcript from the status conference, which was conducted over the phone.

The case centers on the Food and Drug Administration’s 20-year-old approval of mifepristone, a drug often prescribed with misoprostol to induce abortions. Anti-abortion groups are trying to get that approval revoked, which could send the drug’s availability into flux.

After some typical housekeeping, Kacsmaryk leans on the lawyers to keep the hearing quiet.

“Because of limited security resources and staffing, I will ask that the parties avoid further publicizing the date of the hearing,” he said. “This is not a gag order but just a request for courtesy given the death threats and harassing phone calls and voicemails that this division has received. We want a fluid hearing with all parties being heard. I think less advertisement of this hearing is better.”

He said that the case so far has brought “a barrage of death threats and protesters and the rest.”

“So we will have standard security protocols in place, but I’ll just ask as a courtesy that you not further advertise or Tweet any of the details of this hearing so that all parties can be heard and we don’t have any unnecessary circus-like atmosphere of what should be more of an appellate-style proceeding,” he added.

He then told the lawyers that he was going to purposefully keep the hearing off the docket until the day before the hearing, to keep it as under the radar as possible — a move that prompted questions and objections by observers when discovered. A Department of Justice lawyer on the call sought clarification about whether the hearing would be made public at some point Tuesday.

“To minimize some of the unnecessary death threats and voicemails and harassment that this division has received from the start of the case, we’re going to post that later in the day,” Kacsmaryk replied. “So it may even be after business hours, but that will be publicly filed.”

The absolute best case scenario here is that in the end this was all a massive waste of time and energy. Here’s hoping. CNN, ABC News, and CNBC have more.

The unhinged abortion pills lawsuit will take place in darkness

Nothing about this is good.

The Texas judge who could undo government approval of a key abortion drug has scheduled the first hearing in the case for Wednesday but took unusual steps to keep it from being publicized, according to people familiar with the plans.

The hearing will be an opportunity for lawyers for the Justice Department, the company that makes the drug and the conservative group that is challenging it to argue their positions before U.S. District Court Judge Matthew Kacsmaryk. After they do, the judge could rule at any time.

Kacsmaryk scheduled the hearing during a call with attorneys Friday, said multiple people familiar with the call, who spoke on the condition of anonymity because they were not authorized to discuss it. Kacsmaryk said he would delay putting the hearing on the public docket until late Tuesday to try to minimize disruptions and possible protests, and asked the lawyers on the call not to share information about it before then, the people said.

Public access to federal court proceedings is a key principle of the American judicial system, and Kacsmaryk’s apparent delay in placing the hearing on the docket is highly unusual. The judge and his staff did not respond to emails requesting comment on Saturday evening.

The lawsuit seeks to revoke Food and Drug Administration approval of mifepristone, one of two drugs used in a medication abortion. The case has garnered widespread attention and protests.

A decision by Kacsmaryk to suspend FDA approval of mifepristone would immediately prompt major changes in how many abortion clinics across the country provide care. Some are planning to immediately switch to a misoprostol-only protocol, while others are planning to offer only surgical abortions. Any decision would likely be appealed to the conservative U.S. Court of Appeals for the 5th Circuit, and possibly to the Supreme Court.

[…]

Kacsmaryk told the attorneys that he also wanted to delay publicizing the hearing because courthouse members have received threats in the wake of the lawsuit, according to the people familiar with the call. Several people close to Kacsmaryk say the judge and his family have faced security threats since he ascended to the federal bench in 2019, and those threats have intensified ahead of the abortion pill ruling.

Before and after the Friday phone call with lawyers, The Washington Post repeatedly called and emailed Kacsmaryk’s chambers seeking information about it, but received no response. Kacsmaryk’s chambers also did not respond to a request that reporters be allowed to join the call.

Kacsmaryk was nominated by President Donald Trump and is known for his conservative views on issues like same-sex marriage and abortion.

By waiting to publicize the time of the hearing, Kacsmaryk and his staff could make it difficult for the public, the media and others to travel to the courthouse in Amarillo. The remote, deeply conservative city has few direct flights except from Dallas or San Antonio and is at least a four-hour drive from any of the state’s major, heavily-Democratic cities. Still, over 150 abortion rights advocates gathered there on a Saturday in mid-February to voice their support for abortion pills.

I noted this lawsuit when it was filed. There’s been a metric crap-ton of analysis and punditry and increasingly dire warnings about this lawsuit and the pernicious effect of court-shopping, and I’ll leave it to you to google around for all the screaming into the void you can handle. It’s possible that this maneuver means that Kacsmaryk has at least a dim idea that his actions have the potential to cause a massive shitstorm. It also may just be that he doesn’t care to deal with the media and he has the power to make his wishes come true. Either way, brace yourselves.

UPDATE: Chris Geidner has more.

Democratic AGs file lawsuit to ease access to mifepristone

Good, albeit a bit confusing at this point in time.

A dozen Democratic state attorneys general have opened a new front in the legal war over mifepristone, the “gold standard” medication used in the majority of all US abortions. In a federal lawsuit filed Thursday, the AGs—from states including Arizona, Illinois, and Washington—accuse the Food and Drug Administration of imposing unnecessarily “onerous” restrictions on mifepristone, which is used in combination with the anti-ulcer drug misoprostol to end pregnancies in the first 10 weeks.

The drug has a sterling safety record and has been used by an estimated 5.6 million people since it was approved by the FDA more than 22 years ago. Nevertheless, the FDA has long subjected mifepristone to a set of unusual restrictions known as a “Risk Evaluation and Mitigation Strategy” (REMS). The agency only applies these extra rules, such as a requirement that prescribers receive a special certification, to a few dozen drugs—typically high-risk medications like opioids, or injectable anti-psychotic sedatives. The inclusion of mifepristone on this list has long been controversial. “Many people believe that the strict restrictions on mifepristone reflect political concerns more so than concerns around the safety of the drug itself,” Temple University law dean Rachel Rebouché told me in June, the day the Supreme Court overturned Roe v. Wade.

Since then, a dozen states have outlawed abortion almost entirely. Medication abortion has only grown in importance as people who want to end their pregnancies in abortion-hostile states source the pills through telehealth, mail-forwarding services, and overseas pharmacies.

Yet while the FDA has recently loosened some of its rules on mifepristone—for instance, by allowing certified pharmacies to dispense it—the REMS remains in place. “FDA’s decision to continue these burdensome restrictions in January 2023 on a drug that has been on the market for more than two decades with only ‘exceedingly rare’ adverse events has no basis in science,” argues the complaint from the attorneys general. “It only serves to make mifepristone harder for doctors to prescribe, harder for pharmacies to fill, harder for patients to access, and more burdensome for the Plaintiff States and their health care providers to dispense.”

This isn’t the only legal battle over mifepristone. For the few weeks, abortion rights advocates have been waiting and watching as an anti-abortion, Trump-appointed judge in Texas considers issuing a nationwide ban on the drug. That case—brought by the religious-right legal group Alliance Defending Freedom—claims that the FDA “exceeded its regulatory authority” when it approved mifepristone in 2000; that the agency had overlooked potentially harmful side effects; and that a 19th-century anti-obscenity law forbids the mailing of abortion drugs. If the judge agrees and issues a temporary injunction, which he could do any day, mifepristone could be taken off the market everywhere from New York to California.

That case, about which I’m sure you’ve already read at least two alarmist articles, is the reason I’m a little confused by this. Who even knows what happens if that whackjob judge in Texas decides to make medication abortion illegal across the country? That said, I do appreciate an effort to go on the offensive. Daily Kos adds on.

The suit is spearheaded by Oregon Attorney General Ellen Rosenblum and Washington Attorney General Bob Ferguson. In January, the FDA updated the risk evaluation and mitigation strategy (REMS) for mifepristone to life the requirement that patients pick the medicine up in person from a pharmacy, making it simpler for pharmacies to fill the prescriptions online and through the mail. But the FDA kept a requirement under REMS that forces prescribers to obtain specific certifications, and requires extensive documentation that the AGs say could endanger both providers and patients.

The paper trail “puts both patients and providers in danger of violence, harassment, and threats of liability amid the growing criminalization and outlawing of abortion in other states,” the complaint states. That paperwork puts an unnecessary burden on healthcare providers and on patients, the AGs say in the suit.

Under the REMS, both doctor and patient are required to sign an agreement saying that the drug is being prescribed and the patient intends to take it to end a pregnancy. It doesn’t distinguish between an abortion or treatment for a miscarriage, and that agreement stays in a patient’s medical record.

The lawsuit also points out that there are just 60 drugs among more than 20,000 regulated by the FDA that it has imposed REMS on, that “cover dangerous drugs such as fentanyl and other opioids, certain risky cancer drugs, and highdose sedatives used for patients with psychosis.” It is “improper and discriminatory for FDA to relegate mifepristone … to the very limited class of dangerous drugs that are subject to a REMS.”

“FDA’s decision to continue these burdensome restrictions in January 2023 on a drug that has been on the market for more than two decades with only ‘exceedingly rare’ adverse events has no basis in science,” the AGs lawsuit says. “It only serves to make mifepristone harder for doctors to prescribe, harder for pharmacies to fill, harder for patients to access, and more burdensome for the Plaintiff States and their health care providers to dispense.”

“In this time when reproductive healthcare is under attack, our coalition of 12 states seeks to ensure that access to mifepristone—the predominant method of safe and effective abortion in the U.S.—is not unduly restricted,” Rosenblum said in a statement. “Our coalition stands by our belief that abortion is healthcare, and healthcare is a human right.” The other states joining the suit, filed in the Eastern District of Washington state, are Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island, and Vermont.

The suit was filed in the Eastern District of Washington. I’d like to think that if the plaintiffs gets a favorable ruling, the FDA will not appeal. We’ll see where we even are when that happens.

The fentanyl vaccine

This is not actually new, but this story just came out and I hadn’t noticed the coverage before, so I’m catching up.

To combat the fentanyl epidemic in the United States, researchers at the University of Houston have created a fentanyl vaccine that could help prevent overdoses. They aim to test the vaccine in a human trial within the next year.

Fentanyl is a synthetic opioid drug that kills hundreds of Texans every year, according to the Texas Health and Human Services Commission.

The vaccine will need FDA approval before people can use it. According to Johns Hopkins University, that process can take five to 15 years, and sometimes longer. The process can be sped up during a public health emergency where no alternate treatments exist. The first COVID-19 vaccines were created, tested and given emergency use authorization by the FDA in under a year.

In a study published last year in the journal Pharmaceutics, the Houston researchers reported that their vaccine triggered production of antibodies against fentanyl in rats and decreased the amount of fentanyl in rats’ brains. The researchers’ vaccine received praise from Governor Greg Abbott, who visited the University of Houston last year to congratulate the team.

[…]

Doctors can prescribe maintenance medications like methadone and buprenorphine for those recovering from opioid addiction. These drugs are opioids, but they can reduce opioid cravings and withdrawal symptoms.

The effectiveness of these medications depends on how they’re made, the opioid being misused and access to the medications. Recovering patients can relapse after they leave treatment and are especially vulnerable to overdose deaths, said Colin Haile, a research associate professor at the University of Houston.

“Clearly, the medications that we have to address opioid use disorder and overdose are not working,” said Haile, who led the team that created the vaccine.

Haile’s team created a vaccine that could tell the human body to produce antibodies against fentanyl. If a vaccinated person consumes fentanyl, the antibodies could attach to the drug, preventing it from getting to the brain and inducing a “high” or potential overdose. The fentanyl would remain in the blood, eventually passing through the kidneys and out the body.

In the published study, Haile’s team said the vaccine successfully produced antibodies against fentanyl in rats. The vaccine also blocked one of the effects of fentanyl: pain relief. Compared to unvaccinated rats, vaccinated rats also had decreased fentanyl levels in their brains when fentanyl was administered 20 weeks after their first vaccination.

“The effect was pretty incredible,” Haile said. “I’ve never seen anything like this, ever.”

The vaccine produced antibodies that attached to fentanyl but not to methadone or buprenorphine, meaning that vaccinated people could potentially still take those medications to treat opioid addiction. The antibodies also did not bind to morphine or oxycodone, two other opioids.

Like I said, this isn’t new – UH put out a press release last November to tout the accomplishment. There are other vaccines in the research pipeline – this one wasn’t the first to be discovered, but it has some differences from the others out there. Researchers are going to put it into phase 1 human trials soon, with the goal of making the vaccine available to the public in the hopefully not-too-distant future. It sure has the potential to do a lot of good when it’s ready. Kudos to all for the work.

FDA suggests annual COVID booster

I like the idea of this, which is to make COVID shots simpler and thus hopefully more likely to be taken, but it seems to be more nuanced than that.

The US Food and Drug Administration wants to simplify the Covid-19 vaccine process to look more like what happens with the flu vaccine, according to documents posted online on Monday. That could include streamlining the vaccine composition, immunization schedules and periodic updates of Covid-19 vaccines.

The FDA said it expects to assess circulating strains of the coronavirus at least annually and decide in June which strains to select for the fall season, much like the process to update annual flu vaccines.

Moving forward, the agency said, most people may need only one dose of the latest Covid-19 shot to restore protection, regardless of how many shots they’ve gotten before. Two doses may be needed for people who are very young and haven’t been exposed, who are elderly or who have weakened immune systems, according to the FDA’s briefing document for its vaccine advisers.

The agency is urging a shift toward only one vaccine composition rather than a combination of monovalent vaccines – which are currently used for primary shots and target only one strain – and bivalent vaccines – which are currently used for booster doses and target more than one strain.

The FDA briefing documents do not say whether the annual shot would contain a single strain, two strains or more. The annual influenza vaccine immunizes against four strains.

“This simplification of vaccine composition should reduce complexity, decrease vaccine administration errors due to the complexity of the number of different vial presentations, and potentially increase vaccine compliance by allowing clearer communication,” the FDA said.

The agency’s independent vaccine advisers, the Vaccines and Related Biological Products Advisory Committee, are scheduled to meet Thursday to discuss the future of Covid-19 vaccine regimens and will be asked to vote on whether they recommend parts of the FDA’s plan.

Vaccine experts had mixed responses.

[…]

Dr. Peter Hotez, dean of the National School of Tropical Medicine at the Baylor College of Medicine, said he sees the plan for an annual update as a balance between what science says is needed to fight the virus and what’s actually practical.

“I think it’s a balance, trying to do what the science says, which is the need for adaptability and flexibility. Yet the practicality that’s unlikely the companies can probably make that switch more than once a year,” he said.

But this plan also has some weaknesses, he notes. Annual updates are fine as long as the virus continues to evolve incrementally, based on previously circulating viruses. But he questions whether the world has enough genomic surveillance to catch a radically different variant that pops out of left field, as Omicron did.

“We don’t have the surveillance mechanisms in place globally. We don’t have the genomic sequencing in place globally. We don’t have the carefully orchestrated dance that took decades to build for influenza surveillance in place for coronavirus surveillance,” Hotez said.

The NYT has more from the scientists.

The proposal took some scientists by surprise, including a few of the F.D.A.’s own advisers. They are scheduled to meet on Thursday to discuss the country’s vaccine strategy, including which doses should be offered and on what schedule.

“I’m choosing to believe that they are open to advice, and that they haven’t already made up their minds as to exactly what they’re going to do,” Dr. Paul Offit, one of the advisers and director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said of F.D.A. officials.

There was little research to support the suggested plan, some advisers said.

“I’d like to see some data on the effect of dosing interval, at least observational data,” said Dr. Eric Rubin, one of the advisers and editor in chief of the New England Journal of Medicine. “And going forward, I’d like to see data collected to try to tell if we’re doing the right thing.”

Still, Dr. Rubin added, “I’d definitely be in favor of something simpler, as it would make it more likely that people might take it.”

Only about 40 percent of adults aged 65 and older, and only 16 percent of those 5 and older, have received the latest Covid booster shot. Many experts, including federal officials, have said that the doses are most important for Americans at high risk of severe disease and death from Covid: older adults, immunocompromised people, pregnant women and those with multiple underlying conditions.

In its briefing documents, the F.D.A. addressed the varying risks to people of different ages and health status.

“Most individuals may only need to receive one dose of an approved or authorized Covid-19 vaccine to restore protective immunity for a period of time,” the agency said. Very young children who may not already have been infected with the virus, as well as older adults and immunocompromised people, may need two shots, the documents said.

But some scientists said there was little to suggest that Americans at low risk needed even a single annual shot. The original vaccines continue to protect young and healthy people from severe disease, and the benefit of annual boosters is unclear.

Most people are “well protected against severe Covid disease with a primary series and without yearly boosters,” said Dr. Céline Gounder, an infectious disease physician and senior fellow at the Kaiser Family Foundation.

The F.D.A. advisers said they would like to see detailed information regarding who is most vulnerable to the virus and to make decisions about future vaccination strategy based on those data.

“How old are they? What are their comorbidities? When was the last dose of vaccine they got? Did they take antiviral medicines?” Dr. Offit said. At the moment, the national strategy seems to be, “‘OK, well, let’s just dose everybody all the time,’” he said. “And that’s just not a good reason.”

I am obviously not remotely qualified to weigh in on the merits. I like the idea of yearly boosters, because I already get a yearly flu shot and this is appealing as a neat and orderly risk-mitigation device. I’d like to think it might help increase the number of people who get boosted, but I’m not quite that optimistic. It would be nice to say that the science should prevail over the politics in this debate, but you can’t take the politics out of it, and you still need people to buy into whatever eventually gets recommended. Just try to make a good decision and don’t draw it out to the point where the only thing people hear about is the argument over the decision. StatNews has more.

Mifepristone can now be offered at retail pharmacies

Good news, for at least some of the country.

For the first time, retail pharmacies, from corner drugstores to major chains like CVS and Walgreens, will be allowed to offer abortion pills in the United States under a regulatory change made Tuesday by the Food and Drug Administration. The action could significantly expand access to abortion through medication.

Until now, mifepristone — the first pill used in the two-drug medication abortion regimen — could be dispensed only by a few mail-order pharmacies or by specially certified doctors or clinics. Under the new F.D.A. rules, patients will still need a prescription from a certified health care provider, but any pharmacy that agrees to accept those prescriptions and abide by certain other criteria can dispense the pills in its stores and by mail order.

The change comes as abortion pills, already used in more than half of pregnancy terminations in the U.S., are becoming even more sought after in the aftermath of last year’s Supreme Court decision overturning the federal right to abortion. With conservative states banning or sharply restricting abortion, the pills have increasingly become the focus of political and legal battles, which may influence a pharmacy’s decision about whether or not to dispense the medication.

The F.D.A. did not issue an announcement but planned to update its website to reflect the decision. The two makers of the pill, Danco Laboratories and GenBioPro, released statements saying the agency had informed them of the action.

The action is the latest step taken by the federal government to expand access to abortion pills by easing some of the restrictions that have applied to mifepristone since it was approved in 2000.

In December 2021, the F.D.A. said it would permanently lift the requirement that patients obtain mifepristone in person from a health provider, a step that paved the way for telemedicine abortion services which conduct medical consultations with patients by video, phone or online questionnaires and then arrange for them to receive the prescribed pills by mail.

On Tuesday, the F.D.A. officially removed the in-person requirement from its regulatory rule book for mifepristone, leaving in place the remaining two requirements: that health providers be certified to show they have the knowledge and ability to treat abortion patients and that patients complete a consent form.

See here for some background. My understanding of the action taken in 2021 was that it allowed mifepristone to be prescribed via telehealth. I’m a little fuzzy on how much of a difference-maker this announcement is, but whatever it is, every little bit helps. Just, you know, not everywhere.

Whether large pharmacy chains and local drugstores would opt to make the pills available was not immediately clear Tuesday. The steps for pharmacies to become certified to dispense mifepristone are not difficult, but they involve some administrative requirements that go beyond the process pharmacies use with most other medications, such as designating an employee to ensure compliance. Given the time and resources required by those steps, some pharmacies may not consider it worthwhile to offer a medication that only a small percentage of their customers may use.

But while abortion pills may constitute a small percentage of a pharmacy’s sales, they could have a big impact on its public profile. Calculations about public perception and the highly polarized political landscape are also likely to influence a pharmacy’s decision.

In about half the states, abortion bans or restrictions would make it illegal or very difficult for pharmacies to provide abortion pills.

In states where abortion remains legal, pharmacies may face customer demand for the medication or public pressure from abortion rights advocates and health providers. National chains could decide to offer the medication in those states while not providing it in their stores in restrictive states.

I can say with 100% certainty that you won’t be able to walk into your local CVS here in Texas and find any mifepristone. The real question is what the Lege will try to do to prevent people from going out of state to get any kind of abortion care, or to punish people not in Texas who provide that care; the corollary questions will be about what the courts will do with the resulting litigation. We’re still a few months out from that, but it’s coming. In the meantime, at least some people will get to benefit from this.

A non-prescription pill

This sounds like a good idea.

If you’re one of the estimated 10 million people in the United States taking oral contraception, you probably needed a prescription to get it. But that could soon change: In July, a Paris-based company, HRA Pharma, announced it asked the US Food and Drug Administration for permission to sell its progestin-only birth control pill over the counter. For the first time since its approval in 1960, the Pill may be available with no requirement to consult a health care professional—a significant hurdle for those most in need of the medication.

The US wouldn’t be the first country to #FreeThePill; in fact, oral contraceptives are available without a prescription in more than 100 countries. That’s because the Pill is nearly 100 percent effective when taken regularly, and safe for most people. Blood clots, a risk associated with the drug, are serious, but rare in today’s formulations: Every year, between one and five out of 10,000 women who are not on hormonal birth control or pregnant experience a blood clot; for people on the combination (estrogen and progestin) pill, the risk rises to between three and nine out of 10,000 people. And there’s no increased risk of clots for those on a progestin-only pill. In recent years, dozens of US medical organizations have declared support for a nonprescription pill, and an overwhelming majority of voters appear to be in favor of making the change.

[…]

An FDA approval would be a “step forward,” California Latinas for Reproductive Justice Communications Director Susy Chávez Herrera says, “in terms of expanding health care access, and folks in our community having bodily autonomy.”

A decision from the FDA is likely several months away: A panel of independent experts was set to meet on November 18 to discuss HRA Pharma’s proposal, but the meeting was postponed, reportedly to accommodate more data. Now, the agency is expected to weigh in on over-the-counter birth control sometime next year.

In any case, the fight for access won’t end at the pharmacy. For one, the FDA typically only considers one product at a time; a green light for HRA Pharma’s pill won’t automatically free up other options. (So far, just one other company, Cadence Health, has said it plans to ask the FDA for approval to sell its combination pill over the counter, but has yet to complete the necessary research trials.) And just because a drug is available doesn’t mean it will be affordable. “Having the FDA approve an over-the-counter birth control pill would be a huge win,” Chávez Herrera says, “but it would not be complete if it was not accessible to the people that really need it.”

Research underscores the need to keep costs low. A 2018 study from Ibis found that generally, adults are willing to pay up to $15 for a one-month supply. “If the price goes up much more than that,” says Daniel Grossman, a professor in the department of obstetrics, gynecology and reproductive sciences at the University of California, San Francisco, and an author of the study, “then interest really kind of bottoms out.” When I asked HRA Pharma how much its pill would cost, their Chief Strategic Operations and Innovation Officer Frederique Welgryn told me in an emailed statement that the company would “set an acceptable price tested with consumers” and is working on developing a financial assistance program.

I’m in favor of anything that increasing reproductive freedom and gives women more control over their lives. I feel confident that the forced birth fanatics will fight back, via state laws that put restrictions on pill access and lawsuits that seek out friendly judges, but that’s a fight we should be willing to have. Whether this would blunt their already ongoing environmental attack is not known to me. Be that as it may, the important thing is finding ways to move the ball forward in whatever way we can.

The environmental attack on abortion

It’s ridiculous.

Abortion opponents and their allies in elected office are seizing on an unusual strategy after suffering a wave of election defeats — using environmental laws to try to block the distribution of abortion pills.

The new approach comes as the pills mifepristone and misoprostol, which people can take at home during the first 10 weeks of pregnancy, have become the most common method of abortion in the U.S. and virtually the only option for millions of people in states with laws that have forced clinics to close since the fall of Roe v. Wade.

The first salvo started last week with a petition asking the Food and Drug Administration to require any doctor who prescribes the pills to be responsible for disposing of the fetal tissue — which anti-abortion advocates want to be bagged and treated as medical waste rather than flushed down the toilet and into the wastewater.

If the FDA ignores or rejects the petition, as is expected, the group Students for Life of America plans to sue.

The new push is the culmination of years of brainstorming around how to restrict access to the pills — particularly since their use surged following the outbreak of Covid-19 and the FDA’s ruling in 2021 that they are safe to take at home without a doctor present.

[…]

With Leonard Leo, the Federalist Society president who has been influential in putting more conservative judges on the bench, co-chairing its board and the conservative legal powerhouse Alliance Defending Freedom, whose attorneys helped draft and defend the Mississippi anti-abortion law that eventually toppled Roe v. Wade, advising them on the campaign, Students for Life is also pushing conservative state attorneys general to bring enforcement actions against doctors and abortion pill manufacturers, and is planning a tour of college campuses to advocate on the issue.

Should they prevail in any jurisdiction, the rules would be so burdensome that use of the drugs could be effectively cut off, several groups representing abortion providers told POLITICO. And even if they are unsuccessful in court, the effort aims to sway public opinion at a time voters have become increasingly accepting of abortions early in pregnancy.

“It’s hard for me to imagine even a Trump-friendly judge going for an argument about wastewater regulation, but you never know. Anytime you deal with abortion, judges get weird,” said Mary Ziegler, a law professor at the University of California, Davis and author of “Abortion and the Law in America.” “And we know that the more the anti-abortion movement can get people to think about fetal remains and other concrete details about what abortion entails, the more uncomfortable Americans become. So, it could be helpful for them even if it doesn’t go anywhere legally.”

The group’s FDA petition argues that the high number of people using pills to terminate pregnancies at home and flushing fetal remains down the toilet — which has increased in part due to the same group’s efforts to overturn Roe v. Wade and restrict access to surgical abortions — poses risks to the environment.

It claims without direct evidence that trace amounts of the drug in wastewater could threaten livestock and wildlife as well as humans, citing some studies in which the drug was given directly to animals rather than ingested from groundwater, and others where drugs flushed directly down the toilet contaminated the water supply.

“Pharmaceutical contamination of water is a serious issue that can have serious impacts on the environment, but trying to say that one drug out of thousands is having an outsized effect is based on ideology not evidence,” said Nathan Donley, the Environmental Health Science director for the Center for Biological Diversity, who has written citizen petitions to the FDA. “Of all the drugs and synthetic chemicals we shed that can potentially contaminate water, abortifacients are a fraction of a fraction of a percent. It’s nothing.”

Also referenced repeatedly in the petition are studies about the environmental impact of hormonal contraception, leading some experts to ask whether conservative groups will apply the strategy to other drugs in the future.

“It seems like they’re laying the groundwork for considering contraception itself as medical waste,” said Susan Wood, the former FDA assistant commissioner for Women’s Health and a professor of health policy at George Washington University.

The bad faith here is thick enough to blot out the sun, but shame has never been a limiting factor for this crowd. Use of abortion pills is already pretty restricted in Texas so I’m not sure if a bill to impose this kind of requirement is likely in the forthcoming legislative session, but it wouldn’t surprise me. There will be a bill for this in the Republican-controlled US House, which at least should make the campaign case for flipping that chamber back that much easier. This is the world that SCOTUS has forced us to live in. The bad guys are going to keep coming. We can’t let up.

Forced birther lawsuit targets abortion pills

Did you think you were going to have a nice, peaceful Thanksgiving week? Sorry, no can do.

Abortion opponents who helped challenge Roe v. Wade filed a lawsuit Friday that takes aim at medication abortions, asking a federal judge in Texas to undo decades-old approval of the drugs that have become the preferred method of ending pregnancy in the U.S.

Even before the Supreme Court struck down the constitutional right to an abortion earlier this year, the use of abortion pills had been increasing in the U.S. and demand is expected to grow as more states seek abortion limits.

The lawsuit was filed by the Alliance for Defending Freedom, which was also involved in the Mississippi case that led to Roe v. Wade being overturned. The lawsuit argues the U.S. Food and Drug Administration erred in approving the drugs mifepristone and misoprostol and overstepped its authority in doing so.

Reached for comment, the FDA said it does not comment on pending or ongoing litigation.

The lawsuit was filed in federal court in Amarillo, Texas. The state banned abortion after the Roe decision and is among the states where GOP lawmakers have banned mail delivery of the pills.

The number of medication abortions has increased since regulators started allowing them and now account for roughly 40% of U.S. abortions. The medication can cost as little as $110 to get by mail, compared with at least $300 for a surgical abortion. Research has shown the pills are safe.

However, people seeking abortion pills often must navigate differing state laws, including bans on delivery of the drugs and on telemedicine consultations to discuss the medication with a health care provider. And until Democrat Joe Biden became president, U.S. government policy banned mail delivery nationwide.

Axios has a copy of the lawsuit. And before you ask the answer is yes, of course this is about sheer opportunism, not anything resembling facts.

Medication abortion accounts for more than half of abortions in the U.S. In response to the pandemic, the FDA allowed abortion pills to be mailed, which contributed to a significant jump in its use. For decades now, it has been used safely and effectively up to 10 weeks of pregnancy. It has been extensively researched for decades, and has proven safe, effective, and convenient for doctors and patients alike.

There is absolutely no scientific or medical basis for the assertions in this case. It is “an incredibly safe medication,” Loren Colson, a family medicine physician in Idaho and fellow with Physicians for Reproductive Health, told The Washington Post. “It’s been well-studied and much safer than a lot of things you can find over the counter,” Colson said. “If they are trying to argue the safety, they have very little ground to stand on. It’s just a clear and blatant attack on abortion.”

One legal expert who has written extensively about the pill calls the safety claims in the suit “ridiculous.” Greer Donley, associate professor of law at the University of Pittsburgh School of Law, said, “Mifepristone is one of the safest drugs on the market, safer than Viagra and penicillin,” citing the decades of research: “We have a lot of studies and a lot of data on it.” This case, she said, is “really weak.”

Which is why the group chose Texas, where they could find a friendly federal district judge. They did. The case is going to Trump appointee Matthew Kacsmaryk, one of the young extremists the Federalist Society handpicked. He is vehemently anti-LGBTQ and misogynistic, and so extreme in his anti-LGBTQ writings that Sen. Susan Collins, a Republican, voted against him.

His hostility to abortion is no secret. He has described Roe v. Wade as wrongly decided. “On January 22, 1973, seven justices of the Supreme Court found an unwritten ‘fundamental right’ to abortion hiding in the due process clause of the Fourteenth Amendment and the shadowy ‘penumbras’ of the Bill of Rights, a celestial phenomenon invisible to the non-lawyer eye.”

It’s a junk case with no basis in science or medical research. But we’ve been here before with junk cases, this federal court district, and the 5th Circuit in which it operates. Kacsmaryk will rule for the plaintiffs and possibly even try to put a national injunction on the use of medication abortion. The administration will appeal and it will go to the abortion-hostile 5th Circuit, from where it will be fast-tracked to the Supreme Court.

So yeah, this is bad, not because of the law or anything like that but because of numbers and court-shopping. I don’t know how long it will take to get to a hearing and then to a preliminary ruling, but it’s out there. Be prepared for it. Bloomberg Law and Kaiser Health News have more.

Get your kids vaccinated (I’m saying it again)

We have a long way to go.

In the two weeks since the federal government allowed emergency use of COVID-19 vaccines for children younger than 5, nearly 32,000 Texas kids in that age group have been vaccinated.

That accounts for just over 1% of the state’s youngest residents, a lower rate than doctors had hoped, but faster than the national rate for kids that age — even as Texas deals with a lower-than-average vaccination rate across the state.

[…]

Vaccine acceptance by parents of Texas babies and toddlers is slower than the medical community had hoped it would be after COVID-19 vaccines were approved for use in children ages 6 months to 4 years old in late June.

On June 17, the U.S. Food and Drug Administration granted emergency use authorization, after frequent delays over several months, to Pfizer’s COVID-19 vaccine for children ages 6 months to 5 years, as well as to Moderna’s vaccine for kids ages 6 months to 6 years. The Centers for Disease Control and Prevention recommended their use the following day.

So far, just over 1% of the estimated 1.8 million Texans under 5 have gotten at least one dose. Nationwide, the number is slightly lower, with less than 1% of the country’s 29 million kids under 5 having their first doses.

Hesitancy with the vaccine rises among parents of younger kids because they tend to be more skeptical about the need for them, said Dr. Jaime E. Fergie, director of pediatric infectious diseases and hospital epidemiologist at Driscoll Children’s Hospital in Corpus Christi.

When the vaccine was made available to Texas kids ages 5 to 11 in November, nearly 6% of the population was vaccinated in the first two weeks. For children ages 12-15, when they were approved for the vaccine a year ago, more than 11% were vaccinated in the same time frame, according to the Texas Department of State Health Services.

During that time, the delta variant was making an alarming and devastating impact on the nation’s children, killing twice as many Texas kids in August through October 2021 than COVID-19 did the entire first year of the pandemic. That likely fueled early interest in the vaccine for children ages 5 and up, while recent months with lower community spread have likely bred what Fergie called “complacency” among the parents of the state’s tiniest residents.

“The uptake [for younger children] has been low; it’s been pathetic,” Fergie said. “I think the misconception is that COVID-19 in children is not important. But even though the impact on children is much less than on adults, there is still death for children, and hospitalizations are rising. There are still very powerful reasons to vaccinate children.”

Children accounted for nearly 20% of all COVID-19 cases reported in the U.S. throughout the pandemic. But they are less likely to develop serious illness or die than are patients who are decades older, and the mortality rate has been relatively low compared with adults.

Still, at least 155 Texans age 19 or younger have died from COVID-19 since the beginning of the pandemic, according to state health data. One-third of them were younger than 10.

Some 61% of Texans are fully vaccinated, compared with 67% nationwide.

See here for some background, and go read the rest, it’s a long story. I do think that the earlier authorizations came during the delta period made for a faster initial rollout, though the overall vax rate for kids remains bafflingly low. The fact that with current variants, the shots now are about preventing bad outcomes rather than preventing infection has probably changed the risk calculus for some folks. Add in the lack of any coordinated push for people to get the shots, the continued resistance by numerous Republican factions, and the general weariness with the pandemic, and this is what you get. I don’t know what else to say.

Get your kids vaccinated

A good start, but we can do a lot more.

Texas Children’s Hospital has administered COVID-19 vaccines to nearly 6,000 children ages 6 months through 4 years old since the youngest age group became eligible to receive the shots last week, the hospital said Thursday.

“We’ve been waiting for a long time to be able to protect our youngest children,” said Dr. Stan Spinner, the chief medical officer and vice president of Texas Children’s Pediatrics. “We’ve had families asking for a long time ‘When is this vaccine going to be available for our kids?’ And now it is.”

Still, the overall share of children younger than 5 who have received the shot is incredibly low — hovering around 1 percent statewide.

Another 3,000 children are scheduled for vaccine appointments at Texas Children’s Hospital or more than 60 Texas Children’s Pediatrics locations in the Houston, Austin and College Station areas, hospital spokeswoman Natasha Barrett said during a news conference.

Vaccines are also available to kids under 5 at other hospitals, including Children’s Memorial Hermann, as well as pediatrician’s offices, pharmacies and other locations.

Across Texas,the overall interest in vaccines for children has been lagging. Just 26 percent of Texas residents aged 5 to 11 and 59 percent of residents aged 12 to 17 are fully v accinated, according to data from The New York Times. Just 4 percent of Texas residents under 18 years old have received a booster.

However, Texas Children’s doctors said they have also been encouraged by that fact that families with children 5 to 11 years old have been signing up for booster shots of the Pfizer-BioNTech vaccine. The U.S. Food and Drug Administration approved booster shots for that age group last month.

My kids are older and got vaxxed and boosted at their first opportunities. If there’s an omicron-specific booster this fall, they’ll get that, too. I’ve definitely been disappointed by the low vaccination rate among younger kids, but maybe that will turn around now. Even with the lower hospitalization and mortality rates, so many people have gotten an infection lately that perhaps the ongoing threat of this pandemic is sinking in again. We all still need to do our part to try to keep this under some control.

COVID vaccines for kids under 5 are now available

It’s been a long wait.

On Saturday, the Centers for Disease Control and Prevention Director Dr. Rochelle Walensky signed off on Covid vaccines for the youngest Americans. Her endorsement means shots can begin immediately, finally ending the two-and-a-half year wait on the part of parents of children under 5.

Walenksy accepted the recommendation within hours after the CDC advisory committee voted unanimously in favor of the Pfizer-BioNTech and Moderna vaccines for children as young as 6 months. A Centers for Disease Control and Prevention advisory committee on Saturday endorsed Pfizer-BioNTech and Moderna’s Covid-19 vaccines for the youngest children, the last step before CDC Director Dr. Rochelle Walensky could issue her final sign-off.

The unanimous recommendations from the CDC’s Advisory Committee on Immunization Practices followed the Food and Drug Administration’s authorization of the shots on Friday.

President Biden responded to the announcement Saturday hailing it as a “monumental step forward.”

“For parents all over the country, this is a day of relief and celebration,” Biden said. “As the first country to protect our youngest children with COVID-19 vaccines, my Administration has been planning and preparing for this moment for months, effectively securing doses and offering safe and highly effective mRNA vaccines for all children as young as six months old.”

Shortly before Saturday’s votes — one for Moderna and a separate one for Pfizer — many panel members celebrated the milestone, noting that parents will soon have two effective tools to protect their youngest children from Covid after more than two years of living with the virus.

“We want to say today that if you’re not going to immunize your children, we think that’s a misplaced concern and that you should immunize your children to save their lives,” said committee member Dr. Sarah Long, a pediatrician at St. Christopher’s Hospital for Children in Philadelphia.

While young children are generally less likely than adults to experience the most serious outcomes of the virus, some do. Among children 6 months old through age 4, there have been more than 2 million confirmed cases of Covid, more than 20,000 hospitalizations and more than 200 deaths, according to CDC data. Covid is the fifth most common cause of death in children younger than 5.

“This is an opportunity, which one doesn’t get very often, to participate in preventing the death of young children,” said committee member Dr. Beth Bell, a clinical professor in the department of global health at the University of Washington. “A death of a young child is an incredible tragedy, and we know that this disease is killing children.”

It’s a function of where we are now in this pandemic that this isn’t bigger and more exciting news than it is. The vaccination rate for kids in the 5 to 11 year old range remains disappointingly low, and the estimates I’ve seen suggest that maybe 20% of the under-five crowd will get their shots. We could of course mandate COVID vaccines for enrollment in schools, but, well, I think you know what would happen then. The best way forward, as even a modest number of kids getting their shots will help save lives, is for those of us who have kids in that age range to get them vaccinated, and for the rest of us to help persuade our family and friends who do to do the same. Your Local Epidemiologist, who has two young kids of her own, has some ideas on that front. COVID is still out there killing people, y’all. We should try to remember that.

The coming fight over medical abortion

Sure is a good thing SCOTUS will leave this up to the states, isn’t it?

Republican-led states are moving swiftly to restrict access to medication abortion.

The efforts so far have focused on regulations around the pills, such as banning them from being shipped or prescribed. But can states ban the actual abortion pill itself, even though the Food and Drug Administration has approved it? That question could be the next frontier in the abortion wars.

The short answer comes down to this: The issue isn’t settled law and will likely be litigated in the courts. Some argue states may be hard-pressed to ban the federally approved medication, though antiabortion advocates disagree.

[…]

Some states have introduced bills focused on banning abortion pills, but they haven’t gotten a lot of traction, per Elizabeth Nash, an interim associate director at Guttmacher Institute, a research group that supports abortion rights. (A recent exception is Oklahoma, whose Republican governor is poised to sign legislation banning abortions – including medication abortions – from the moment of “fertilization.”)

Rather, states are banning the practice of medicine around the pills. For instance: At least 19 states ban the use of telehealth for medication abortion, and some states have additional restrictions, like prohibiting pills from being mailed.

Yet, if Roe v. Wade is overturned, some states may try to ban the actual medication. And states already have gestational limits and other abortion bans on the books that could kick in quickly if Roe is overturned — and those likely encompass limitations on the pills, experts said.

Can states ban a medication the FDA has signed off on?

There’s no clear precedent here.

Some states may argue they can ban medication abortion because states have the authority to regulate the practice of medicine. The FDA, on the other hand, is the acknowledged authority on medical products, such as the abortion pill. But the line between medical practice and medical products is not always clear.

And if a state squared off against the federal government over an FDA-approved drug … “We don’t know how the court would rule. It’s an open question,” Patti Zettler, an associate professor of law at Ohio State University and former associate chief counsel in the FDA’s Office of the Chief Counsel.

See here for some background. Reminder #1: The state of Texas has made it a felony to provide abortion medication after seven weeks, after having already banned anyone but doctors from dispensing such medication, and only via an in-person office visit – no telemedicine. You can be sure that Texas will take this to the next level in the next legislative session if it is in position to do so.

Reminder #2: The same medicine that is used for abortion is also used to treat miscarriages. Needless to say, women who are suffering through a miscarriage will face – and as that story notes, are already facing – barriers to medical care that could threaten their health, their future ability to get pregnant and carry a child to term, and even their lives. That’s our future, and if you think I’m being alarmist, go back and read all those soothing articles about how this Supreme Court was never ever going to overturn Roe v Wade because it would cause too much upheaval.

Here comes BA.2 in Houston

But don’t panic, it’s just a change in the virus composition, not an increase in viral load.

Houston is seeing an uptick in the number of BA.2 cases, with genome sequencing and wastewater testing picking up higher levels this week compared to last week.

The more contagious omicron subvariant was identified in 24 percent of patients who were sequenced at Houston Methodist, a jump from the 1 to 3 percent previously reported. BA.2 was also detected at six wastewater treatment plants on March 21 — the most recent day for which data is available — after the Houston Health Department last week said it had not been detected at any plants.

“Previously, we saw some indications of mutations consistent with BA.2 but were not confident in the determination at the time,” health department spokesman Scott Packard said in an email. “Retrospective analysis indicates BA.2 was likely in the wastewater in low levels starting in mid-to-late January.”

The recent data is the first indication of a significant rise in BA.2 in the Houston-area. Eventually, the subvariant is expected to become the dominant strain here, lining up with the nationwide rate, according to the health department.

[…]

In Houston, the average positivity rate over the last two weeks is 1.8 percent, down from the high 30s in the early January. Wastewater testing shows an increasing viral load at nine wastewater plants, while the remaining 30 are plateaued or decreasing.

“Although BA.2 appears to be more contagious than BA.1, the good news is that countries experiencing a spike in cases are not seeing a proportionate spikes in hospitalizations,” Packard said. “That means being up to date on vaccines (initial shots plus boosters) remains highly effective against serious illness, even with BA.2.”

As a reminder, you can see the Houston wastewater dashboard here. I don’t know how long we will be in this trough, but at least in the short term our vax level plus the sheer number of people who contracted the BA.1 version of omicron should help.

In the longer term, as immunity wanes and new variants pop up, it will be time for more shots. A fourth shot has now been authorized by the FDA for us old folks.

A second round of booster shots was greenlighted for everyone over the age of 50 by public health officials on Tuesday, kicking off the regulatory process for shots to likely be available in pharmacies this week.

Everyone 12 and older is already eligible for a booster shot five months after their initial vaccine series if they received an mRNA vaccine like Pfizer or Moderna, or two months after getting the Johnson & Johnson vaccine.

But for those over 50, determined to be a vulnerable age group, officials at the Food and Drug Administration and Centers for Disease Control and Prevention have decided the data on waning immunity justifies making another shot available four months after the first boost. And while anyone who meets that criteria can now get another booster, CDC Director Rochelle Walensky said it was “especially important” for those 65 and older and those 50 and older with underlying medical conditions.

“This is especially important for those 65 and older and those 50 and older with underlying medical conditions that increase their risk for severe disease from COVID-19 as they are the most likely to benefit from receiving an additional booster dose at this time,” Walensky said in a statement on Tuesday.

My niece is getting married in June in Washington state. I expect all of us who will be there for it and who are eligible for that booster will have gotten it by then. I ain’t messing around.

More people are choosing the medical abortion option

It’s not like there are good alternatives right now in Texas.

The demand for abortion-inducing medication spiked in the month after Texas significantly limited abortion access and has remained high since, according to new data from a researcher at the University of Texas at Austin.

The study reviewed requests for abortion-inducing medication made to Aid Access, an international nonprofit that provides the medication via the internet to people who cannot otherwise legally access the procedure. Prior to September 2021, the organization typically received an average of 10.8 requests a day from Texans.

Then, the Texas Legislature passed Senate Bill 8, which prohibits abortions after about six weeks of pregnancy, a point at which many people do not know they are pregnant. In the first week after the law went into effect on Sept. 1, Aid Access received an average of 137.7 daily requests from Texas, an increase of over 1000%.

“That big of a spike in requests shows us the uncertainty and chaos created by Senate Bill 8 going into effect,” said Abigail Aiken, the lead researcher on the study. “If it’s not certain that you can go to a clinic and get the care that you need, people will be looking around for what other options they have.”

The demand for the medication has remained higher than normal in the months since, Aiken found.

Medical abortion is typically a two-drug regimen of mifepristone and misoprostol that has been shown to be effective at terminating a pregnancy through the first 10 weeks of pregnancy. In December, the federal government lifted a requirement that the medication be dispensed in person, allowing it to be prescribed by telemedicine and sent through the mail.

But Texas law does not allow the medication to be prescribed through telemedicine or mailed and has limited its use to the first seven weeks of pregnancy.

[…]

Aiken, the researcher behind the study, said it’s impossible to know how and when patients use the medication they access through Aid Access — or how many patients are terminating pregnancies through other means.

But as the U.S. Supreme Court considers whether to overturn the constitutional protection for abortion, Aiken said this Texas data serves as a snapshot of what whole swaths of the country may be facing.

“It’s clear from this research and many studies that just because you make abortion harder to get, it doesn’t mean the need for abortion goes away,” she said. “And many people, they will look for other ways of doing that.”

See here and here for some background. The forced-birth contingent is of course not happy with this and murmuring about ways to pursue “legal action” against international and out of state groups like Aid Access. Not sure how they could do that without being extremely invasive, but I have no doubt that such a thought does not bother them at all. On the assumption that SCOTUS is going to gut Roe v Wade in some significant way, the main question is whether people will mostly still be able to get abortion pills freely, or whether they will have to rely on more evasive options. Both seem very much in play. The Chron has more.

Simply having a COVIDful Christmastime

Sorry not sorry.

Houston has surpassed 300,000 COVID-19 cases, just days after the highly contagious omicron variant leapfrogged delta to become the dominant viral strain circulating in the region and around the United States.

The staggering milestone reached Thursday, when the Houston Health Department reported 2,397 new cases for a cumulative total of 302,460, underscores the virus’s ability to evade all attempts at containment nearly two years into a global pandemic few predicted would be this persistent or deadly.

“Twenty-one months ago I never imagined our cases would get anywhere close to this big,” Houston’s Chief Medical Officer Dr. David Persse said. “If you had told me 300,000 I would have politely told you, ‘I think you’re crazy.”

Yet the easily transmitted omicron variant, first detected last month in South Africa, appears poised to sweep the Houston area and is already fueling outbreaks and scuttling holiday plans across the region.

The milestone is almost certainly an undercount, Persse said. Prevalence studies have found between 20 and 25 percent of Houston residents carry the antibodies that indicated a previous COVID infection. Accounting for those who contracted the virus but were never tested could put the city’s true COVID case count closer to half a million people.

“It’s a lot of suffering,” Persse said.

Extrapolating out to Harris County, that’s something like 1.2 million people who have had COVID, maybe a bit more. Obviously, for a lot of those people the consequences have been fairly small so far, but who knows what the longer term effect may be. And of course, we’re in the early stages of the omicron surge. So check back again later to see where these numbers go.

This says a lot, too.

As the omicron variant of COVID-19 threatens to fuel another surge of infections this winter, the state’s vaccination data shows demand for booster shots has outpaced the demand for first doses of the vaccine in the last few months — even as millions of Texans remain unvaccinated.

The average number of people getting boosters in Texas every day has surpassed those getting their first shots since late September, according to the state’s data. As of Dec. 21, the daily average of Texans who received their booster shots over the last week was about 52,000 — compared with the approximately 20,000 who received their first doses.

So far this month, at least 1.2 million Texans have gotten booster shots — nearly triple the number of people who received their first doses of the vaccine during the same time.

Meanwhile, the number of people getting their first shot of the vaccine over the last few months has remained far below people getting boosters, though the rate of first shots slightly increased in November and December.

[…]

Booster rates have gone up as the Food and Drug Administration has gradually authorized their use among different age groups. Adults 18 and older are allowed to get booster shots, and this month, the FDA authorized emergency use for 16- and 17-year-olds who had the Pfizer vaccine as their initial two-dose treatment, making them eligible to receive the same vaccine as a booster.

Meanwhile, the amount of people getting their first vaccine doses has waned in the last few months as vaccines have become more widely available and more people take the next steps in their vaccination regime. The state’s data shows a slight bump in first doses in November as Thanksgiving approached.

Even so, 10 million Texans remain unvaccinated.

And while there isn’t one specific reason why first-dose rates lag behind booster shots, Dr. Emily Briggs, who specializes in family medicine and has seen the split in the demand for the vaccine from a private practice in New Braunfels, largely credits ideology.

“We are at that point of anybody who believes in science acknowledges that we have had benefit from this vaccine. Those who are politically motivated or have been given fear and are focused on that fear are not vaccinated,” she said.

The people who have taken this pandemic seriously and have done what they can to minimize their risk and protect their communities are continuing to do so. The people who have not done so are still not doing so. Same as it ever was.

Same as it ever was.

As other states are mobilizing to respond to the rapidly spreading omicron variant, Gov. Greg Abbott is not budging on his hands-off approach to the coronavirus pandemic that was cemented months ago.

In March, Abbott ended the statewide mask mandate, marking the beginning of a sharp shift toward preaching “personal responsibility” and an outright rejection of any government mandate — whether state or local — to curb the pandemic. That philosophy carried the state through the delta variant this fall, even as hospitals were overrun and deaths climbed. Now as the state stares down the latest variant, Abbott remains unmoved, continuing to rule out any mask or vaccine mandates and business shutdowns.

“We’re moving forward with life as we know it,” Abbott said Tuesday in a radio interview when asked about omicron.

[…]

Asked Tuesday what the state is doing to address omicron, Abbott’s spokesperson Renae Eze said in a statement that the governor recently got a briefing on the state response to the variant by John Hellerstedt, the commissioner of the Department of State Health Services, and Nim Kidd, chief of the Texas Division of Emergency Management. Eze otherwise gave no indication the state was doing anything differently, saying it was continuing to respond to the pandemic by “setting up therapeutic infusion centers, ramping up COVID vaccination efforts, and providing surge staffing and medical equipment to hospitals and nursing homes.”

Eze ended by calling vaccination the “best defense” against COVID-19 and encouraging Texans to get immunized.

Even as Abbott’s office says it’s prioritizing vaccines as the best defense against COVID-19, the state’s vaccination rate lags nationally. As of Monday, 56% of Texans were fully vaccinated, placing Texas in the back half of the 50 states when ranked by vaccination rates.

Abbott got vaccinated on camera late last year and has encouraged Texans to get the shot. But he does not go out of his way to promote vaccinations and he has expended much more energy in recent months fighting vaccine requirements by local and federal officials.

Abbott has been virtually silent on the booster, which the U.S. Centers for Disease Control and Prevention said last month every qualifying adult should receive. The word “booster” has never appeared on Abbott’s personal Twitter account, and a spokesperson did not respond when asked whether the governor has received a booster.

I’m sure he has been boosted. Abbott is not an idiot. He’s a coward, but he’s not going to risk his own health and well-being. Same as it ever was.

FDA lifts restrictions on medical abortion

Long overdue

The Biden administration on Thursday ended a long-standing restriction on a medication used to terminate early stage pregnancies, even as politicians across the United States intensified efforts that represent the most serious challenge to abortion rights in decades.

The elimination of the rule by the Food and Drug Administration means abortion pills can be prescribed through telehealth consultations with providers and mailed to patients in states where permitted by law. Previously, the pills could not be mailed, though that regulation had been temporarily suspended by the FDA.

In large swaths of the nation, however, strict state rules will dampen the impact. Several states ban sending abortion pills by mail and impose other restrictions.

The medication, mifepristone, was approved by the FDA in 2000 for what’s known as medication abortion. It is used with a second drug, misoprostol. The FDA required patients to pick up mifepristone in person at a hospital, clinic or medical office. There is no FDA requirement that the medication, also known as RU-486, be taken in a clinical setting, and most patients take it at home.

In April, the FDA waived the in-person dispensing requirement during the pandemic, saying research showed the action did not raise “serious safety concerns.” It then launched a scientific review to see whether restrictions on mifepristone should be lifted permanently, with Thursday as the deadline.

The agency, writing to a medical group that had sued the FDA over the rule, said it was dropping the in-person dispensing requirement “to minimize the burden on the health care delivery system” and “to ensure that the benefits of the drug outweigh the risks.” The FDA did not give an effective date for the change.

[…]

Loosening the federal restrictions will not change abortion access in many states with stricter regulations on the pills. Nineteen states have banned receiving the drugs through telehealth appointments, making the relaxed FDA rules irrelevant in places including Alabama, Arizona and Missouri. Some states impose other limitations on medication abortion, including allowing only physicians to prescribe the drug and mandating that patients take the pills under a doctor’s supervision rather than at home.

As federal officials have moved to ease restrictions on the drug, many states have tightened access. At least 16 states have proposed new restrictions on medication abortions this year, said Elizabeth Nash, state policy analyst for the Guttmacher Institute.

“State legislatures have been watching very carefully what happens at the federal level,” Nash said.

The highest-profile limitations were enacted in Texas, where lawmakers made it a felony to provide abortion pills after seven weeks of pregnancy and outlawed sending the drugs through the mail. Texas also banned nearly all abortion within the state by making any form of abortion illegal after about six weeks of pregnancy, though that law is being challenged in the courts.

The differing rules have the potential to widen disparities in abortion access, Nash said.

“Access looks very different depending on where you live,” Nash said. “Abortion access will continue to be very limited in states in the South, in the Plains and in the Midwest, and more accessible in states along the West Coast and the Northeast. … That’s problematic in and of itself, and could become an even bigger divide.”

Yeah, it sure is an issue here in Texas. The main question I have is how effectively will Texas be able to enforce its restrictions. It seems to me that there will be a lot of effort put into avoidance, and as such the only way to really make that law work as intended is to be pretty darned invasive. I don’t know how that will work.

Restrictive state laws are spurring an increase in some areas of what’s known as “self-managed abortions” in which patients buy illegal medication on the Internet and terminate pregnancies without interacting with the health-care system.

While some see this as a dangerous trend, others say the situation is sharply improved from decades earlier — because of the abortion pills.

Abigail Aiken, assistant professor of public affairs at the University of Texas at Austin, said she is often asked whether the country is headed to “back-alley abortions and infections” if Roe v. Wade is struck down.

“One of the things we have that we didn’t have in the ’60s and ’70s is access to abortion pills that are very safe, very effective if you have the right instructions,” Aiken said. “Self management is a safety net. And it’s also an ability to take your health care into your own hands when the state legislature is trying to block access.”

That sounds logical to me. And it should be known, this way around the law has been in use for some time. Again, the question to me is how vigorously Texas will try to crack down on that, and how heavy-handed such enforcement will be. I feel very confident saying that the zealots who pushed the bounty hunter law will not be satisfied by anything other than an all-out crackdown, whatever the consequences. If you think I’m being alarmist, look at where we are now and tell me honestly it’s not far worse than you thought it would be. The 19th and Mother Jones have more.

By the way, medical abortion is now more tightly restricted in Texas, too

Another piece of crap from the special session.

Misoprostol

A new law limiting the use of abortion-inducing medication in Texas goes into effect Thursday.

The law makes it a felony to provide the medication after seven weeks of pregnancy, putting Texas at odds with federal regulations. It also makes it a crime to send the medication through the mail.

Medical abortion is the most common way women in Texas terminate their pregnancies, according to state data.

These new restrictions reflect a growing concern among abortion opponents about the rise of “self-managed” abortions, in which pregnant people obtain the medications from out-of-state or international providers, with or without a prescription.

There’s evidence that more women turn to self-managed abortions when legal abortion is restricted. Texans have been unable to access abortions after about six weeks of pregnancy since Sept. 1, when a controversial new ban went into effect.

“Texas is looking at the ways that people are navigating around restrictions and trying to essentially make that as unsafe and as frightening for people as possible in order to deter them,” said Farah Diaz-Tello, senior legal counsel for If/When/How, a reproductive justice legal group.

Diaz-Tello and other advocates worry that the new criminal penalties may make pregnant Texans fearful of seeking medical care after a self-managed abortion.

[…]

Texas’ new law also specifies that no one may provide abortion medication “by courier, delivery or mail service.”

Texas already required the medication to be provided by a physician in person. But this specific clause addresses a growing concern among abortion opponents that patients are trying to circumvent the required doctor visit by getting the drugs by mail, especially with the state’s new restrictions that bans abortions after around six weeks.

Called a “self-managed abortion,” this usually entails ordering abortion-inducing drugs online, with or without a prescription, from doctors, pharmacies and other providers out of state or overseas.

The FDA has attempted to crack down on some providers, including AidAccess, a group founded in 2018 by Dr. Rebecca Gomperts, a European doctor. AidAccess provides abortion-inducing medications to women in areas that have restricted access to the procedure.

Gomperts has said she will continue prescribing to patients in Texas. She told CBS News in September that she believes she is on solid legal ground since it is legal to prescribe this medication where she is based.

See here for the backgroun; I didn’t blog it at the time for whatever the reason. A bit more than half of all abortions in Texas are medical abortions, which the FDA says are safe up to ten weeks. I suspect Dr. Gomperts and others like her if they exist will get more business now, despite the prohibition on sending the medication via mail. It’s really a matter of enforcement, and it’s not clear to me how Texas will be able to do that. That FDA action against her was from 2019, by the way. It would be nice for the current FDA to maybe revisit that now. I don’t have anything positive to end with. This is where we are right now.

The Pfizer pill

This would be a big step forward.

Pfizer Inc. said [recently] that its experimental antiviral pill for COVID-19 cut rates of hospitalization and death by nearly 90% in high-risk adults, as the drugmaker joined the race for an easy-to-use medication to treat the coronavirus.

Currently most COVID-19 treatments require an IV or injection. Competitor Merck’s COVID-19 pill is already under review at the Food and Drug Administration after showing strong initial results, and on Thursday the United Kingdom became the first country to OK it.

Pfizer said it will ask the FDA and international regulators to authorize its pill as soon as possible, after independent experts recommended halting the company’s study based on the strength of its results. Once Pfizer applies, the FDA could make a decision within weeks or months.

Since the beginning of the pandemic last year, researchers worldwide have been racing to find a pill to treat COVID-19 that can be taken at home to ease symptoms, speed recovery and keep people out of the hospital.

Having pills to treat early COVID-19 “would be a very important advance,” said Dr. John Mellors, chief of infectious diseases at the University of Pittsburgh, who was not involved in the Pfizer study.

“If someone developed symptoms and tested positive we could call in a prescription to the local pharmacy as we do for many, many infectious diseases,” he said.

[…]

Study participants were unvaccinated, with mild-to-moderate COVID-19, and were considered high risk for hospitalization due to health problems like obesity, diabetes or heart disease. Treatment began within three to five days of initial symptoms, and lasted for five days. Patients who received the drug earlier showed slightly better results, underscoring the need for speedy testing and treatment.

Pfizer reported few details on side effects but said rates of problems were similar between the groups at about 20%.

It’s much better to prevent COVID than to treat it, in the same way that it’s much better to prevent malware from getting on your computer than to clean up after it. As such, getting vaccinated is still far and away the best thing to do to mitigate the risk of COVID. But if I want to extend the cybersecurity analogy, you must have multiple layers of defense to truly have good security practices, and so having a safe and reliable treatment to COVID that can keep people out of the hospital is crucial. I look forward to both the Pfizer and Merck pills getting approved by the FDA.

More kids are getting their COVID shots

So good to see.

The possibility of the parties, vacations and family gatherings energized six families who attended the COVID-19 vaccination event on Wednesday inside Memorial Hermann, the morning after the Centers for Disease Control and Prevention officially expanded eligibility to kids from 5- to 11-years-old. Eager parents are clamoring for an opportunity to vaccinate their children after an especially challenging wave of infections, which hit a peak in late August just as kids returned to school.

Texas Children’s Hospital administered its first dose of the vaccine at 6:15 a.m., and is expected to administer thousands more throughout the week to children with an appointment, which are now only available as soon as Nov. 18. Memorial Hermann is making the vaccine available to walk-ins at its hospital campuses, beginning Thursday morning.

Parents, many of whom were affiliated with the Memorial Hermann system, shared their own harrowing experiences with the virus at Thursday’s vaccine event. Chris Lange, the father of 8-year-old and 5-year-old girls, said he is still dealing with brain fog after an aggressive bout with COVID during the February winter freeze.

The kids caught a less severe infection, but the experience raised the urgency of vaccination, he said.

“This whole (pandemic) is just such a drain on everyone,” he said. “Knowing that now maybe we don’t have to worry about schools closing. We don’t have to worry about kids staying home. I mean, that’s a big win.”

I’ve seen plenty of celebrating, on Facebook and Twitter, by friends who have kids in the 5-11 age range, much as I did when the shots were cleared for ages 12 and up. I figure we’ll see a big spike in vax rates in the first couple of weeks, then it will settle at a much lower level as the eager folks all get it done and what’s left are the more hesitant and resistant. Every little bit helps, that much is for sure.

Get your kids ready for their COVID shots

At long last.

The U.S. Food and Drug Administration on Friday authorized the emergency use of the Pfizer-BioNTech COVID-19 vaccine on children ages 5-11, marking a long-awaited milestone in the nearly two-year fight against the deadly virus that experts say has likely already infected nearly half the population in that age group.

In Texas, that makes up to 2.9 million children eligible for the vaccine.

The federal regulatory agency said the vaccine is safe and effective for children in that age group. The Pfizer test results shared with the FDA show that its vaccine prevents symptoms in most children and causes no side effects more serious than those already seen in older age groups. FDA panelists decided that the benefits of the vaccine for children ages 5-11 — many of whom have suffered isolation, depression and learning loss throughout the course of the pandemic — outweigh the risks associated with the Pfizer shot.

“As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today’s authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” said Dr. Janet Woodcock, acting FDA commissioner. “Our comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards.”

Still uncertain, however, is whether the U.S. Centers for Disease Control and Prevention will limit the shots to only children with preconditions that put them at high risk of serious disease from COVID-19 — a decision expected next week.

The FDA’s announcement, which follows a recommendation by its vaccine advisory panel earlier this week, triggers an initial federal allocation of more than a million doses destined for children ages 5-11 to providers in nearly half of Texas counties. Those will start landing in Texas pharmacies, pediatrics offices, health clinics and hospitals within a few days, state health officials said.

After the first federal shipment, others will continue on a weekly basis. The amounts will vary based on providers’ requests, officials said.

Most of the parents I know nowadays have older kids who are already vaccinated, and yet I know plenty more who will be ready and eager to get their kids vaxxed. As with every other instance of this vaccine, I expect there will be a big surge up front as all of the willing people stampede to get it done, followed by a long fallow period in which the reluctant, the folks with access issues, and eventually some of the holdouts who meet up with mandates of one form or another get around to it. The boost to the overall vaccination rate in the state should help keep things under control, more or less, through the winter. It’s good news for many, and we have been waiting for it. The Chron has more.

More on the Abbott max anti-vaxx order

Businesses will face a choice that they would rather not have to face.

Companies doing business in Texas face new and complicated challenges after Gov. Greg Abbott this week banned COVID-19 vaccine mandates for all entities in the state — including private businesses — for employees or customers.

The ramifications for businesses could begin as soon as Friday, when companies that enter into contract work with the federal government will be required to have all employees vaccinated under orders from the White House.

This conflicts with Abbott’s ban on vaccine mandates, putting the many Texas businesses that receive federal contracts in a tough position: Comply with federal law and violate Abbott’s ban, or comply with Abbott and turn down business from the federal government.

[…]

“This harms Texans directly,” Karen Vladeck, an employment lawyer in Austin, said of the new order from Abbott. “I just think it wasn’t well thought out.”

Abbott’s office did not reply to a request for comment.

On top of prohibiting any entity in Texas from requiring vaccinations, Abbott’s order also lists several expanded exemptions. Vladeck and other employment lawyers said that this adds to the vaccine dilemma facing businesses in Texas. Under Abbott’s new rule, people may opt out of a vaccine requirement for medical reasons, including if they prove they have had COVID-19 in the past, despite scientists widely agreeing that this does not protect people against contracting the virus.

“The executive order’s medical reason language is a bit strange because usually you exempt people for medical reasons if they have a severe allergic reaction to a vaccine,” said Elizabeth Sepper, a law professor at the University of Texas at Austin. Abbott’s order is “meant to cover people who don’t want to get the vaccine because they believe, quite wrongly, that they’re completely protected by already having COVID.”

Abbott’s rule also allows people to opt out of a vaccine requirement if they prove they hold a deep personal belief against getting jabbed.

Any entity that fails to comply with Abbott’s rule could receive up to a $1,000 fine.

Abbott’s Monday order is a reversal from his position in August, when the Pfizer vaccine received final approval from the U.S. Food and Drug Administration. At the time, Abbott’s spokesperson said that businesses had the option of mandating vaccination for employees and “private businesses don’t need government running their business.”

“It’s all about company choice in Texas, except now it’s come to something that they don’t like what the companies are choosing,” Vladeck said. “It puts a big burden on employers.”

See here for the background. So far, businesses that are also federal contractors, including airlines and companies like IBM, will ignore Abbott’s order, while others are awaiting the OSHA rules before making a decision. Multiple business groups, the same organizations that often turn to the state for a legislative solution to local ordinances they don’t like, harshly criticized Abbott’s order for making their lives more difficult. Harris County Attorney Christian Menefee released a statement encouraging businesses that want to be able to get their employees vaccinated to file a lawsuit against Abbott over the order. And in the end, even wingnut talk radio hosts weren’t impressed by Abbott’s order. It’s almost as if he were a weak, gutless leader.

More on the San Antonio ISD vaccination mandate litigation

I’m a little confused at this point, but I’ll cope.

Judge Mary Lou Alvarez of the 45th District Court denied the state of Texas’ request for a temporary injunction Friday, allowing the San Antonio Independent School District to continue requiring its employees to be vaccinated against the coronavirus.

Former SAISD Superintendent Pedro Martinez, who has since left the district to take a job in Chicago, issued the vaccine mandate on Aug. 16, requiring all staff members to be vaccinated by Oct. 15. SAISD board President Christina Martinez said Thursday that about 90% of SAISD staff has been vaccinated.

Alvarez’s decision came after a hearing on the state’s request for temporary relief against the vaccine mandate was delayed. Another state district judge denied the school district’s challenge on Sept. 23 that the state and Gov. Greg Abbott did not have jurisdiction to sue. SAISD then appealed that ruling, pushing back the original hearing for the state’s lawsuit; the appeal was dropped earlier this week.

After Alvarez’s ruling, the state’s legal team said they planned to appeal. A trial for the lawsuit is set for Jan. 19, 2022.

[…]

Attorney Steve Chiscano, who represented SAISD, dismissed the state’s lawsuit as a political ploy.

“We are sitting in an injunction hearing that the AG is hoping to win so he can spin off another press release on how proud he is that he beat up on this district,” Chiscano said. “It is so obvious and so clear that this is happening that I believe at the end of the day, you’ll see that what the governor is doing is not supported by any law.”

See here and here for the background. I’ve decided that we had a motion by SAISD to dismiss the lawsuit, which was denied, and then the state asked for a temporary restraining order against SAISD, which was also denied. The source of my initial confusion was the change in judges between the two, but I think that may just be how Bexar County rolls. In any event, true to form and as the story notes, Paxton – who was not present for the hearing – did indeed tweet about it and how he’s fighting for the freedom of people who want to get sick and die and take others with them. Ultimately, this judge did not buy the state’s argument that the Abbott executive order was enough on its own to prevent SAISD from responding to the pandemic in this fashion. A higher court may intervene before the hearing for an injunction, but in the meantime I sure hope that SAISD is making progress in getting shots into arms. That is what really matters. The Current has more.

SAISD vaccine mandate update

Still in place for now, but clearly on shaky ground.

Best mugshot ever

San Antonio Independent School District can continue requiring its staff to get vaccinated against COVID-19, despite a judge ruling against the district Thursday in a case filed by the Texas attorney general.

Judge Angelica Jimenez of the 408th District Court denied SAISD’s plea on Thursday that state Attorney General Ken Paxton lacks the legal authority to enforce Gov. Greg Abbott’s Aug. 25 executive order, which banned public entities, such as school districts, from mandating COVID-19 vaccines. Steve Chiscano, the attorney representing SAISD, immediately appealed the ruling.

Appealing Jimenez’s jurisdiction ruling delayed a hearing requested by the state to stop SAISD’s vaccine mandate with a temporary restraining order. The school district and attorney general’s office will make their arguments again before the 4th Court of Appeals. Case information is due at the court Oct. 4, according to online court records. The lawyers will file briefs, and justices will make a decision at an undetermined date.

[…]

In a statement, the district said Jimenez’s ruling does not enforce Abbott’s executive order prohibiting vaccine mandates and that SAISD would continue its vaccine protocols.

“We do not believe the Governor and Attorney General have the legal authority to continue this lawsuit, and we respectfully disagree with the judge’s ruling,” the district said in the statement. “We know that following the executive order and not requiring vaccination of our employees is potentially deadly, and we will do what is necessary to protect the children and staff of the district.”

See here for the previous update. I’ve always thought that the vaccine mandate was a heavier lift than the mask mandates, so I won’t be surprised if Paxton eventually wins this one. But as long as that mandate remains in place, SAISD can move closer to a goal of maximizing the number of its employees who have been vaccinated. No matter the odds, that’s worth fighting for.

The COVID shot for kids is coming

Not a moment too soon.

On Monday, Pfizer released the initial trial results, showing that its vaccine is safe and effective for the 5-11 age group. The findings are a key step toward inoculating a younger population that so far has been unprotected from the virus.

“It’s good to hear the studies are paying off,” García said. “We are happy to be part of the process to help other people get more trust in the vaccine, so we can start getting back to normal as soon as possible.”

The announcement summarized results from 2,268 trial participants. The findings show that children develop an antibody response similar to the 16- to 25-year-old age group when given a lower dosage of the vaccine.

Pfizer and BioNTech, the company’s German partner, plan to include the data in a “near-term submission for Emergency Use Authorization” while safety research is ongoing. Dr. Bill Gruber, a Pfizer senior vice president, told The Associated Press that the company plans to apply for emergency use by the end of the month.

My kids are thankfully old enough to already be vaccinated, but I know a lot of people who have been eagerly awaiting this announcement. I expect there will be a surge of new vaccinations in the weeks following the emergency use grant, and while it will surely fall well short of the full total of eligible kids, it will make a decent dent in the overall vaccination rate. We’re going to need every bit of this. The 19th and Daily Kos have more.

Paxton sues again over SAISD’s vaccine mandate

Yes, vaccine mandate. For teachers and staff.

Best mugshot ever

For the second time in a month, Texas Attorney General Ken Paxton sued San Antonio Independent School District and Superintendent Pedro Martinez for requiring all staff to be vaccinated against COVID-19.

Martinez issued a staff vaccine mandate and mask mandate Aug. 16 for everyone inside school buildings. Three days later, Paxton sued Martinez and SAISD over both mandates, stating in the lawsuit that the superintendent and the district were “deliberately violating state law,” as a July executive order from Gov. Greg Abbott prohibits any entity that receives public funds from mandating COVID-19 vaccines that had received only emergency approval from the federal government.

But the federal Food and Drug Administration granted full approval for the Pfizer COVID-19 vaccine on Aug. 23, and the lawsuit was dropped. Two days later, Abbott issued a new executive order, banning governmental entities from requiring any COVID-19 vaccine, regardless of FDA approval status.

Paxton filed the second lawsuit against SAISD in Bexar County on Sept. 9, seeking a temporary restraining order barring the school district from mandating vaccines. In the petition, Paxton claims SAISD and Martinez are again violating state law by “flouting” the August executive order.

“The decision to openly violate state law and devote district resources to defending Superintendent Martinez’s unlawful actions is irresponsible,” Paxton said in a statement. “But if school districts decide to use their limited funding to try to get away with breaking the law, my office will oppose them and uphold the rule of law in Texas.”

See here and here for some background. My reaction when Paxton filed the first lawsuit was that he was likely to prevail, and despite the FDA approval and Biden mandate (which has been announced but not yet fully implemented), I don’t see any reason why that would change. I will of course be happy to be wrong, and if it is the case that some people have gotten vaccinated as a result of the SAISD mandate then it’s a win no matter what happens in court. The main thing to remember here is that Ken Paxton, like Greg Abbott, is objectively pro-COVID, and we need to make them pay at the ballot box for it.

Hospital systems have no excuse for not mandating COVID vaccines now

So get on with it already.

Local hospitals reacted Friday to President Joseph Biden’s sweeping vaccine mandates directed at the health care workers, who make up much of the Houston workforce.

In a move that overrides Gov. Greg Abbott’s executive order barring public institutions from issuing their own COVID-19 restrictions, the administration said it would require vaccinations for employees at health care facilities that accept Medicare and Medicaid reimbursement.

Baylor College of Medicine’s dean of clinical affairs, Dr. James McDeavitt, said Thursday he supported the new measures.

“It is the right thing to do,” he said.

Still, he wished the plan had come sooner. “It is not going to help us with the current delta surge,” he added.

[…]

Five Houston hospital systems already require a vaccine. In June, Houston Methodist became the first hospital in the nation to announce it would require its staff to be fully vaccinated, a move that met months of resistance, including a lawsuit by some employees. Memorial Hermann and Baylor College of Medicine enacted their own vaccine mandates in July; St. Luke’s Health and Texas Children’s Hospital announced similar plans in August.

Thursday’s executive order will bring similar mandates to the city’s remaining health systems.

Until now, Harris Health System and UTHealth had encouraged worker vaccinations but were unable to require it under the governor’s order.

But on Friday, Harris Health System said it “fully intends to embrace the vaccine mandate” for workers at its two hospitals, 18 community health centers and 10 clinics serving the greater Houston area. The system has not yet set a date.

UT Health said it would wait for guidance from the Centers for Medicare & Medicaid Service, expected in October. It had not instituted a mandate as of Friday afternoon.

St. Joseph Medical Center and UTMB Galveston said they are still evaluating Biden’s plan.

While Kelsey-Seybold Clinic said in August it was waiting for full vaccine approval from the U.S. Food and Drug Administration before asking employees to provide proof of immunization, the clinic has not announced a mandate since the Pfizer-BioNTech vaccine gained full U.S. Food and Drug Administration approval late last month.

See here for the background. I agree that the mandate coming out now will have little to no effect on the current surge, given that it takes a few weeks to get both shots and the full effect of them, and that it will take time for these hospital systems to get their programs going. It would still be nice if some of them had more of a sense of urgency about it. This is still by far the best thing we can do for the medium to longer term, and at the very least these hospital systems should be setting a better example. Get it done already, y’all. The Trib has more.

The legal situation with the heartbeat bill

I’m writing this at eight PM, and will very likely be asleep before SCOTUS takes any action, if they do take action. So let’s start with what we have as of now:

That was in reply to this:

See here for the previous entry. If I see that SCOTUS has taken action when I get up in the morning, I’ll update this post. If not, you can assume that there’s basically no such thing as abortion in Texas until further notice. And that will include medical abortion.

Two days before one of the strictest abortion laws in the country is set to go into effect in Texas, the state Legislature tentatively approved another bill Monday evening that would restrict the procedure during the first term of pregnancy.

Senate Bill 4 remains identical to the version of the bill passed by the Texas Senate. Texas Democrats were unable to attach amendments to the bill, despite more than a dozen attempts, which means the bill will head straight to Gov. Greg Abbott’s desk if it is finally approved with no changes.

The legislation would limit patients’ access to abortion-inducing pills, preventing physicians or providers from giving abortion-inducing medication to patients who are more than seven weeks pregnant. Current law allows practitioners to give these pills to patients who are up to 10 weeks pregnant.

Notably, the U.S. Food and Drug Administration set its guidelines in 2016 advising that abortion-inducing pills are safe to use up to 70 days, or 10 weeks, after initial conception.

These pills have increasingly become the most common method for women to terminate a pregnancy if they are aware of their pregnancy early enough. According to the Guttmacher Institute, a reproductive health research institute that supports abortion rights, 60% of women elect to take a pill over having surgery.

It’s grim. This bill might have a chance of being knocked down by litigation, but who can even say at this point.

It should be noted that there is some state litigation happening, but that will not have the effect of blocking SB8.

Travis County District Judge Amy Clark Meachum issued a temporary restraining order barring the anti-abortion organization Texas Right To Life; John Seago, its legislative director, and others from “instituting any private enforcement lawsuits” under SB 8 against the plaintiff, a Dallas attorney, according to the order.

But the full scope of the order was narrow, and does not apply to a majority of providers or Texans.

“While the temporary restraining order issued by the Texas state court in Austin provides some relief to the two individuals and one nonprofit organization against lawsuits from the Texas Right to Life, it does not provide the full relief needed to ensure all Texans can access their constitutional right to an abortion,” said Julie Murray, staff attorney for Planned Parenthood Federation of America.

Here’s a bit more on that litigation from KXAN:

District Judge Amy Clark Meachum considered three cases on Tuesday morning: one, brought by an attorney and sexual assault victim’s advocate named Michelle Tuegel; another brought by Bridge Collective, a resource group for people seeking an abortion; and another brought by Allie Van Stean, a woman who regularly donates to women’s health clinics.

On Tuesday morning, the judge granted temporary restraining orders (TROs) in all three instances, against the group Texas Right to Life. According to attorneys for these three plaintiffs, the TRO’s prevent Texas Right to Life from filing lawsuits under the new fetal heartbeat law, until the court can conduct a full-scale temporary injunction hearing later in September.

Their attorneys say the ruling is significant for their clients because they had to prove “probable right to relief” to get the TRO — meaning they were able to show the judge evidence supporting their challenge to the law’s constitutionality.

KXAN spoke to Van Stean earlier this month, who explained, “Simply donating to places like Planned Parenthood count as aiding and abetting an abortion… If I’m donating to Planned Parenthood, I’m not necessarily giving with the intent to assist women in getting an abortion. Planned Parenthood and other places provide necessary and needed services like birth control at a lower cost, affordable option for women who can’t afford it.”

A spokesperson for Texas Right to Life told KXAN on Tuesday, the judge’s ruling was “narrow” and does not block the Texas Heartbeat Act from being broadly enforced at midnight.

Rewire wrote a story about Michelle Tuegel, who had filed a lawsuit in Dallas. In that one she sued a whole lot of people, mostly legislators. I don’t know what happened to that suit or if it is related in some way to this one. You should read that story, which links to this one about how Tuegel won a big judgment against US Gymnastics over the Larry Nassar case. If nothing else, I’m glad to have someone like that fighting the good fight.

And that’s all I know right now. If there’s any news in the morning, I’ll include it here. Daily Kos has more.

UPDATE: No word from SCOTUS, so SB8 officially became law at midnight last night. They can – and some people think they will – still act today. But SB8 is in effect until and unless they do.

The financial incentive

At this point, whatever works.

A week after public health officials in Texas’ most populous county started handing out $100 cash cards to locals getting their first COVID-19 shot, the number of daily vaccinations has shot up to six times its previous rate, Harris County Judge Lina Hidalgo said Tuesday.

“We had an inkling that something was going right when I started my announcement [about the incentive] at noon, and by the time I was done, 30 minutes later, there was a line of cars waiting to receive the vaccine,” Hidalgo said. “We haven’t seen those lines for months.”

To accommodate and encourage the increased demand, the county will be opening an additional mass vaccination site and expanding its mobile vaccine program, Hidalgo said.

“You have to be creative, and we’re seeing the results and we’re doubling down on it,” Hidalgo said.

Harris County officials began the incentive program last Tuesday in a bid to jumpstart stalled vaccinations in Houston and surrounding areas, and to provide relief to the region’s stressed hospitals during what health officials say is the worst surge of infections the area has seen since the pandemic began last year.

For the three weeks before the program started, Hidalgo said, Harris County Public Health was administering an average of 431 first doses per day. The day the announcement was made, the number jumped to 914. The next day, 1,596 people sought the first doses from public health providers.

On Saturday, four days into the program, some 2,700 people got their first injection, Hidalgo said.

“This is an incredible achievement,” she said.

As the story notes, more vaccination sites are being opened to accommodate what I hope will be a sharp uptick in demand. The FDA approval of the Pfizer shot, and more companies telling their employees to get vaxxed may help push the numbers up as well. I honestly don’t care what the cause is, as long as it happens. And it needs to happen at a higher rate than this – even with the uptick statewide, we’re at less than 30% of the shots-per-day peak in April. Let’s get closer to that, and then we’ll really have something.

Greg Abbott remains COVID’s best friend

It’s hard to even know what to say.

Gov. Greg Abbott on Wednesday announced an executive order banning COVID-19 vaccine mandates regardless of a vaccine’s approval status with the U.S. Food and Drug Administration.

He also said he was adding the issue to the agenda for the current special session of the Texas Legislature.

The order comes two days after the FDA granted full approval to the Pfizer vaccine. That raised questions about the fate of a previous Abbott order that prohibited vaccine mandates, but only for those under emergency authorization.

Abbott’s latest order is simple, saying “no governmental entity can compel any individual to receive a COVID-19 vaccine.” The order preserves exceptions for places like nursing homes and state-supported living centers.

At the same time, Abbott asked lawmakers to consider legislation addressing whether state or local governments could issue vaccine mandates and, if so, which exemptions should apply.

“Vaccine requirements and exemptions have historically been determined by the legislature, and their involvement is particularly important to avoid a patchwork of vaccine mandates across Texas,” Abbott said in a statement.

[…]

There specifically appeared to be the fresh potential for cities, counties and school districts to require their employees to get vaccinated against COVID-19. San Antonio Independent School District had already announced mandatory employee vaccinations, prompting a lawsuit from Attorney General Ken Paxton.

District officials said Wednesday they will move forward with the mandate — despite Abbott’s latest order.

“We strongly believe that the safest path forward as a school district is for all staff to become vaccinated against COVID-19,” the district said in a statement.

See here for some background, and here for a copy of the order. As the story notes, this would prevent government entities from ordering their employees from getting COVID shots, though as you can see that’s already being challenged. Private employers are not affected by this, so if you work for one of the increasing number of them that are imposing COVID vax mandates, you’re out of luck. A bill passed during the regular session forbids businesses from requiring proof of vaccination from their customers, though that doesn’t take effect until September 1 so Harry Styles can still do what he wants.

I don’t think this is anywhere near the end of it. The same arguments being made about mask mandate bans – successfully, so far – by multiple counties and school districts is that the Disaster Act of 1975 doesn’t actually give Abbott this power. That would be equally true for vaccine mandate bans, I would think. That doesn’t mean the courts, by which I mostly mean the Supreme Court, will eventually accept that argument, just that these same entities will give it a try. The federal government will have a say as well, and let’s not forget the federal lawsuit, too. We’re also going to have an election next year, and we have the option of electing a Governor who wants to fight against the COVID virus instead of fighting for it. There’s a lot more of this story to be written. The Current and the Chron have more.

The approval and the mandates

As I’m sure you’ve heard by now, the FDA has given its final approval to the Pfizer vaccine for COVID-19. That should mean a lot of good things, but among them it should mean broader vaccine mandates are now in play.

The U.S. Food and Drug Administration’s full approval of the Pfizer vaccine Monday is cracking open the door for Texas cities, counties and school districts to compel their employees to get vaccinated against COVID-19 — moves previously blocked by Gov. Greg Abbott.

Abbott had banned public schools and local governments from enacting their own vaccine mandates. But the governor’s executive order specifies that the ban on mandates applies to COVID-19 vaccines that are under emergency authorization — a designation that no longer applies to the Pfizer two-dose vaccination.

Already, one major school district is pressing forward with its plan to require vaccinations for teachers and staff.

Pedro Martinez, superintendent for San Antonio Independent School District, called for mandatory employee vaccinations last week — drawing a lawsuit from Attorney General Ken Paxton, who accused the district and Martinez of breaching Abbott’s ban on vaccine mandates.

But with the FDA’s approval, San Antonio school officials are moving forward with their vaccine requirement for district employees.

In a statement, Martinez called the FDA approval “a positive step forward in the fight against COVID-19 nationwide and a step forward in helping keep schools safe for learning here at home.”

Here’s Superintendent Martinez on CNN discussing his fight against Greg Abbott over this. Most of the fights so far have been about mask mandates, but as we noted recently, San Antonio ISD has notified its employees that they must get vaccinated, which has drawn a lawsuit from Ken Paxton. Which, apparently, has been withdrawn now, as the executive order against vaccine mandates only covered “vaccines administered under an emergency use authorization”.

Here’s more from the Chron.

The Pfizer vaccine’s change in status appears to give cities, school districts and universities a way around the governor’s ban.

“Receiving a COVID-19 vaccine under an emergency use authorization is always voluntary in Texas and will never be mandated by the government, but it is strongly encouraged for those eligible to receive one,” Abbott’s most recent executive order reads.

A spokeswoman for Abbott did not immediately respond to a request for comment on Monday.

The update means San Antonio Independent School District, which was sued by the state after requiring its employees to get the shots by Oct. 15, is still moving forward with its mandate. The district had clarified late last week that it would not compel workers to get a vaccine that wasn’t fully approved by the FDA.

Attorney General Ken Paxton touted that as a win in a news release Monday, distributed less than an hour after the FDA granted full approval.

“State law could not be clearer: ‘No governmental entity can compel any individual to receive a COVID-19 vaccine administered under an emergency use authorization,’” Paxton said in the release. “But San Antonio ISD tried to play by its own set of rules. Thankfully, we stopped them.”

San Antonio school officials say the full authorization now allows the district to go ahead with its requirement that all employees get the shots by mid-October, they say. In his clarification statement last week, Superintendent Pedro Martinez had stipulated that the timeline would only change if the FDA hadn’t fully authorized the vaccine by Sept. 10.

Hey, if you want to declare victory while you’re surrendering and retreating, it’s fine by me. Just keep on surrendering and retreating, that’s all I ask.

The remaining questions are 1) What about Moderna and J&J; 2) What will other government entities do about this new ability; and 3) What about the mask mandates? In short,

1) “In May, Pfizer and BioNTech submitted their license application. Moderna began its application in June, and Johnson & Johnson said it will begin the process later this year.” As such, I’d assume the Moderna approval will come sometime in September or October, and J&J will be later than that. But most people have Pfizer or Moderna shots, so that’s the main thing.

2) My guess is they will move more slowly, but once the first domino falls I’d expect others to follow quickly. Note that this will be about mandates for local government employees, not residents. It’ll help, but it won’t apply to everyone.

3) Not the same thing, so we’re still waiting for the lawsuits to play out.

In the meantime, go tell all your vax-hesitant family, friends, neighbors, co-workers, acquaintances, and whoever else that now is the time for them to get their shots. It’s all officially approved, there’s no need to wait any longer.

“Universal masking” for school children recommended

Seems like a sensible idea, especially given that children under the age of 12 can’t get the vaccine yet.

The American Academy of Pediatrics on Monday recommended that all children over the age of 2 wear masks when returning to school this year, regardless of vaccination status.

The AAP, which said its important for children to return to in-person learning this year, recommends that school staff also wear masks. The AAP is calling the new guidance a “layered approach.”

“We need to prioritize getting children back into schools alongside their friends and their teachers — and we all play a role in making sure it happens safely,” said Sonja O’Leary, chair of the AAP Council on School Health. “Combining layers of protection that include vaccinations, masking and clean hands hygiene will make in-person learning safe and possible for everyone.”

The AAP said universal masking is necessary because much of the student population is not vaccinated, and it’s hard for schools to determine who is as new variants emerge that might spread more easily among children.

Children 12 and over are eligible for Covid-19 vaccinations in the U.S. And the FDA said last week that emergency authorization for vaccines for children under 12 could come in early to midwinter.

[…]

Universal masking will also protect students and staff from other respiratory illnesses that could keep kids out of school, the AAP said.

The Centers for Disease Control and Prevention recommended this month that vaccinated students do not have to wear masks in classrooms.

Dr. Francis Collins, director of the National Institutes of Health, said on MSNBC that the CDC may have been trying to be a little more lenient, allowing people to make judgment calls “depending on the circumstances in your school and your community.”

But he said he understands where the AAP is coming from.

“They will not be popular amongst parents and kids who are sick of masks, but you know what? The virus doesn’t care that we’re sick of masks,” Collins said. “The virus is having another version of its wonderful party for itself. And to the degree that we can squash that by doing something that maybe is a little uncomfortable, a little inconvenient … if it looks like it’s going to help, put the mask back on for a while.”

That was from last week. Yesterday, the CDC caught up.

To prevent further spread of the Delta variant, the US Centers for Disease Control and Prevention updated its mask guidance on Tuesday to recommend that fully vaccinated people wear masks indoors when in areas with “substantial” and “high” transmission of Covid-19, which includes nearly two-thirds of all US counties.

“In recent days I have seen new scientific data from recent outbreak investigations showing that the Delta variant behaves uniquely differently from past strains of the virus that cause Covid-19,” CDC Director Dr. Rochelle Walensky told a media briefing on Tuesday.

“This new science is worrisome and unfortunately warrants an update to our recommendations,” she said. “This is not a decision that we or CDC has made lightly.”

[…]

Earlier this month, the CDC’s Covid-19 school guidance noted that fully vaccinated people do not need to wear masks, and then about a week later the American Academy of Pediatrics issued stricter guidance recommending that everyone older than 2 wear a mask in schools, regardless of vaccination their status.

Now the updated CDC guidance recommends everyone in schools wear masks.

“CDC recommends that everyone in K through 12 schools wear a mask indoors, including teachers, staff, students and visitors, regardless of vaccination status. Children should return to full-time, in-person learning in the fall with proper prevention strategies in place,” Walensky said. “Finally, CDC recommends community leaders encourage vaccination and universal masking to prevent further outbreaks in areas of substantial and high transmission. With the Delta variant, vaccinating more Americans now is more urgent than ever.”

The updated CDC guidance makes “excellent sense,” Dr. David Weber, professor at the University of North Carolina School of Medicine in Chapel Hill and board member of the Society of Healthcare Epidemiology, told CNN on Tuesday.

“Breakthrough disease clearly occurs, and for those cases, we know they’re much more mild in vaccinated people, but we don’t know how infectious vaccinated people are,” he said. “But clearly, if you want to protect your children under 12 or grandchildren, or protect immunocompromised people, as well as protect your own health — from even mild disease — then you should be wearing a mask, particularly in areas of high transmission when indoors.”

My kids have been vaccinated, but they’re still regular mask-wearers, especially the younger one. I fully expect them to continue to do so in school, at least for the fall. I’ve been wearing a mask again for indoor spaces as well. I will admit it’s kind of annoying, as we have been vaccinated for months now and have been pretty damn careful all along, but it is what it is. That said, I have a lot of sympathy for this position:

Some of that is happening in other states, but who knows, maybe we’ll get it for federal buildings and air travel, too. And who knows, maybe this will work.

As leaders in other parts of the country require government employees to get COVID-19 vaccinations, San Antonio and Bexar County are considering following suit, the Express-News reports.

Such a step would come as vaccination rates plateau and the highly contagious delta variant leads to a rise in infections, hospitalizations and deaths in Texas. California and New York City this week said they will make employees get the vaccine or submit to weekly coronavirus tests. Veterans Affairs became the first federal agency to mandate COVID vaccinations for frontline staff.

“We are supportive of the efforts of New York and California,” San Antonio Mayor Ron Nirenberg and County Judge Nelson Wolff said in a joint statement supplied to Express-News. “We will be reviewing the legalities and practicalities of requiring a COVID-19 vaccine and/or weekly testing in conformity with CDC guidelines in order to protect the health and well-being of city/county workforce.”

A city and county vaccine mandate would apply to roughly 18,000 workers, according to the daily, which reports that both Nirenberg and Wolff are unsure whether the requirement would be allowable under state law.

I think we can say with extreme confidence that the state would bring all its fight against such a move. That doesn’t mean it’s not worth the effort, but it’s not a move to be made lightly. Be prepared to hire a bunch of expensive lawyers, and have a solid communication strategy in place, that would be my advice.

As for masks in schools, well…

What did you expect? Greg Abbott has already said there won’t be any mask mandate in schools, and it’s impossible to imagine him changing his mind. It’s all up to the parents and school staff. I would not feel safe having my not-yet-vaccinated kids in school without a full-mask situation, which by the way is what we did in this past spring semester. I don’t even know what the argument against is. Doesn’t much matter when the power is on that side. The Trib and Daily Kos have more.

Pfizer shot approved for younger kids

Yes!

The Food and Drug Administration cleared the first coronavirus vaccine for emergency use in children as young as 12 on Monday, expanding access to the Pfizer-BioNTech shot to adolescents ahead of the next school year and marking another milestone in the nation’s battle with the virus.

The decision that the two-shot regimen is safe and effective for younger adolescents had been highly anticipated by many parents and pediatricians, particularly with the growing gap between what vaccinated and unvaccinated people may do safely. Evidence suggests that schools can function at low risk with prevention measures, such as masks and social distancing. But vaccines are poised to increase confidence in resuming in-person activities and are regarded as pivotal to returning to normalcy.

“Adolescents, especially, have suffered tremendously from the covid pandemic. Even though they’re less likely than adults to be hospitalized or have severe illness, their lives really have been curtailed in many parts of the country,” said Kawsar R. Talaat, an assistant professor of international health at the Johns Hopkins Bloomberg School of Public Health. “A vaccine gives them an extra layer of protection and allows them to go back to being kids.”

Expert advisers to the Centers for Disease Control and Prevention are scheduled to meet Wednesday to recommend how the vaccine should be used in that age group, and the vaccine can be administered as soon as the CDC director signs off on the recommendation.

In a news briefing Monday evening after the announcement, FDA officials said the Pfizer authorization for 12- to 15-year-olds was a straightforward decision because the data showed that the vaccine was safe and that the response to the vaccine was even better than among the 18- to 25-year-olds who got the shots.

Our almost-17-year-old has had her shots. We’ll be getting the 14-year-old signed up as soon as we can. “Herd immunity” may never be a thing we achieve with COVID, but having a greater share of the population vaxed is a good thing, and adding this group to the eligible list moves towards that goal. I’m ready for this.