As the coronavirus morphs into a stubborn and unpredictable facet of everyday life, scientists and federal health officials are coming together on a new strategy for immunizing Americans: a vaccination campaign this fall, perhaps with doses fine-tuned to deliver the expected version of the virus. to combat are in circulation.
The plan would borrow much from the script for distributing annual flu shots, and could become the template for arming Americans against the coronavirus in the coming years.
But some experts question how well a booster vaccination push would be received by a pandemic-weary population, whether the doses could be rolled out quickly enough to reach the people who need them most — or whether most Americans need additional injections at all. .
On June 28, scientific advisors to the Food and Drug Administration will meet to identify the coronavirus variant most likely to seep into the United States as temperatures cool. That should give manufacturers time to decide whether to overhaul the vaccine formulations and ramp up production, hopefully enough to produce hundreds of millions of doses by October.
Scientific advisors to the FDA have said they would prefer to switch to a new version of the vaccines only if there was convincing evidence that the current one was no longer effective and a modified version would be better.
The idea is that eligible Americans would be urged to get vaccinated against the coronavirus and the flu this fall at the same time, and in the same places: drugstores, doctor’s offices, walk-in clinics, and the like. Some key details — such as eligibility — will be settled next month at scientific advisor meetings from the FDA and the Centers for Disease Control and Prevention.
The plan would be a departure from the current sequential authorizations of booster shots for different age groups. But the shortcomings of the annual approach have been apparent to flu researchers for years.
Scientists and federal health officials usually decide the formulation of the flu vaccine in the spring, six months before flu season. They guess which version of the flu virus will arrive in the United States by, among other things, looking at what’s already circulating in the Southern Hemisphere.
But in some years, “by the time the vaccine is produced, the strains have changed, and then you may not have a good match,” Dr. Ofer Levy, director of the precision vaccines program at Boston Children’s Hospital and an FDA advisor, said.
Among the candidates for a Covid shot for the fall is a booster designed for Omicron, the strange new avatar of the coronavirus, and combinations containing it. Moderna’s lead booster candidate contains 25 micrograms each of the original vaccine and one tailored from Omicron, said Dr. Paul Burton, the company’s medical director.
Pfizer is also testing an Omicron-specific vaccine, but won’t make a decision on the fall candidate until June, according to Jerica Pitts, a company spokeswoman.
Even if the vaccine match isn’t perfect, boosting immunity should provide some protection against any new variant in the fall, like the flu vaccine does.
The number of Americans who have chosen to receive booster doses has decreased with each newly recommended injection. While 90 percent of American adults have received at least one dose of a Covid vaccine, 76 percent opted for a second dose and only 50 percent for a third.
“Considering extra doses for smaller and smaller yields gives the impression that we don’t have a very effective vaccination program,” said Dr. Matthew Daley, a senior investigator at Kaiser Permanente Colorado who heads the CDC’s vaccine working group.
A nationwide campaign for a new vaccine would unnecessarily exhaust pharmacists, suppliers and public health personnel, warned Dr. Daley and other advisers at a meeting of their committee last month.
And the experts worry that a push for additional doses this fall, when the risks of serious illness and death for most Americans are likely to be low, could reduce the collective willingness to be vaccinated later if a new variant emerges and it becomes more common. public desperately needs it.
Repeated immunizations can even weaken the effectiveness of a vaccine. For example, people vaccinated against the flu in one year develop stronger immunity than those vaccinated two years in a row, noted Florian Krammer, an immunologist at the Icahn School of Medicine at Mount Sinai in New York.
Despite the doubts, federal officials are gearing up for a fall campaign. Linking the Covid vaccine to flu annually is the easiest way to convince Americans to queue for the vaccines, said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
“It saves people time,” said Dr. Marks. “And it could mean more people getting both vaccines, which would be a good thing.”
Agency scientists are actively debating the best composition for a fall vaccine with the World Health Organization, the National Institutes of Health and the vaccine manufacturers, said Dr. Marks.
The FDA prefers to offer similar formulations of the Pfizer-BioNTech and Moderna vaccines, to avoid confusion in people. Anders: “I worry that a vaccine campaign could even be paralyzed, when the most important thing is that people get a boost at all,” said Dr. Marks.
However, if the flu vaccine is any indication, many Americans will forgo another Covid shot. The Omicron variant has made it clear that preventing all infections is an unattainable goal, and many consider themselves to be at low risk of serious illness or death.
Still, Dr. Marks notes that flu campaigns also focus on preventing productivity loss, not just medical consequences.
Before the arrival of the Omicron variant, government officials said the Covid vaccines were intended to prevent all symptomatic infections, but they have since retracted that position.
While the Covid vaccines have slackened the spread of previous variants by up to 70 percent, “that’s clearly not true with Omicron,” he said. “It would be nice to have something that does it better.”
Some experts said that instead of another round of injections, the best candidate for limiting infections would have been a nasal spray that would coat the nose and throat with antibodies to block the virus right at its entrance. But those sprays won’t be available in the United States for two or three years.
Until Omicron came along, FDA scientists were so excited about mRNA vaccines that they didn’t consider alternative boosters, added Dr. Marks added: “We may be temporarily blinded by the light.”
Still, minimizing the number of infections as much as possible is “obviously a very, very important secondary goal,” said Dr. Sara Oliver, who represents the CDC on the Covid-19 vaccination working group.
Aside from curbing the spread of the virus and societal disruption, reduced infections should reduce the number of long-term Covid cases, the constellation of symptoms that can last for months, she said.
The new plan could revive some long-standing tensions. Disagreements over who should recommend vaccines and for whom have kept these bodies preoccupied for months.
In general, the FDA’s scientific advisors review the safety and effectiveness of vaccines and recommend authorization or approval. Experts advising the CDC then provide guidance on who should get the vaccines and when.
During the pandemic, the lines between the White House, the FDA and the CDC have often blurred. “Right now one of the challenges is that we have a lot of voices talking about immunization policy, and historically we’ve only had one vote,” said Dr. daley.
For example, when the FDA approved a second booster, it only did it for adults 50 and older — a distinction that would normally come from the CDC’s vaccine advisors.
The CDC also made a subtle distinction that many Americans were lost: It advised adults over 50 get a booster if they wanted to, not that they should. But the White House’s new Covid czar, Dr. Ashish Jha, approved the second booster shots.
“It’s not entirely clear whether the White House is in a position to make vaccine recommendations per se, but he said he recommended it nonetheless,” Dr. Camille Kotton, an infectious disease physician at Massachusetts General Hospital and a scientific advisor to the CDC, said of Dr. yah.
It’s unclear who would pay for a fall vaccination campaign. The stalemate in Congress over funding for Covid-19 is jeopardizing the government’s ability to buy and deliver the vaccines to those who need them most.
“Without urgent additional funding, we won’t be able to get enough booster shots for every American who wants one when they’re needed in the fall, and we won’t be able to get newer, more effective vaccines that protect against new variants.” Sarah Lovenheim, assistant secretary for public affairs at the Department of Health and Human Services, said.