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.
