As the coronavirus becomes a stubborn and unpredictable aspect of daily life, scientists and federal health officials are moving closer to a new strategy to immunize Americans: vaccination campaigns this fall, perhaps with doses well-tuned to fight the expected version of the virus. be in circulation.
The plan will be largely borrowed from a textbook on the spread of annual flu shots and could become a template for Americans to arm against the coronavirus in the coming years.
But some experts question how well the pandemic-weary public will respond to the resumed vaccination, whether doses can be deployed quickly enough to reach the people who need them most – and whether most Americans need additional vaccinations.
On June 28, scientific advisers from the Food and Drug Administration will meet to determine a variant of the coronavirus that is likely to spread in the United States as the temperature drops. This should leave manufacturers time to decide whether to review the composition of vaccines and increase production, hopefully enough to release hundreds of millions of doses by October.
FDA scientific advisers have said they will support the transition to a new version of the vaccine only if there is convincing evidence that the current version is no longer effective and the modified version will be better.
The idea is that Americans who are eligible will be encouraged to be immunized against coronavirus and influenza at the same time this fall and in the same places: pharmacies, doctors’ offices, clinics and the like. Some important details – such as who will be eligible – will be discussed next month at meetings of FDA scientific advisers and the Centers for Disease Control and Prevention.
The plan will mean moving away from current consecutive vaccination permits for different age groups. But the shortcomings of the annual approach have been apparent to influenza researchers for years.
Scientists and federal health officials typically decide to develop a flu vaccine in the spring, six months before the flu season. They are guessing which version of the flu virus will arrive in the United States, given what is already circulating in the Southern Hemisphere, among other factors.
But a few years later, “by the time the vaccine was produced, the strains had changed, and then you might not have a good match,” said Dr. Ofer Levy, director of precision vaccines at Boston Children’s Hospital and an FDA adviser.
Among the candidates for the fall of Covid – a booster designed for Omicron, an amazing new avatar of the coronavirus, and combinations that include it. The main booster candidate from Moderna contains 25 micrograms of each original vaccine and one developed for Omicron, said Dr Paul Burton, the company’s chief medical officer.
Pfizer is also testing a specific Omicron vaccine, but will not decide on its fall candidate until June, according to Jerry Pitts, a company spokeswoman.
Even if the vaccine match is not perfect, boosting immunity should provide some protection against any new fall options, as the flu vaccine does.
The number of Americans who chose to receive the recommended doses decreased with each new recommended injection. While 90 percent of American adults received at least one dose of the Covid vaccine, 76 percent chose the second dose and only 50 percent the third.
“Considering extra doses for less and less returns gives the impression that we don’t have a very effective vaccination program,” said Dr. Matthew Daly, senior researcher at Kaiser Permanente Colorado, who heads the CDC Vaccine Working Group.
A nationwide campaign for regular vaccinations will unnecessarily deplete pharmacists, suppliers and healthcare personnel, warned Dr. Daly and other advisers at a meeting of their committee last month.
And experts are concerned that the push for additional doses this fall, when the risks of serious illness and death are likely to be low for most Americans, could cut collective readiness for immunization later when a new option emerges and the public urgently demands it.
Re-immunization may even blunt the effectiveness of the vaccine. For example, people who have been vaccinated against the flu for one year develop stronger immunity than those who have been vaccinated for two years in a row, said Florian Kramer, an immunologist at Icona Medical School on Mount Sinai in New York City.
Despite the fears, federal officials are preparing for the fall campaign. The annual combination of the Covid vaccine with the flu is the easiest way to persuade Americans to queue for vaccines, said Peter Marx, director of the FDA’s Center for the Evaluation and Research of Biologicals.
“It saves people time,” said Dr. Marx. “And that could mean more people will get both vaccines, which would be good.”
The agency’s scientists are actively discussing the best composition for the fall vaccine with the World Health Organization, the National Institutes of Health and vaccine manufacturers, Dr Marx said.
The FDA is in favor of proposing roughly the same composition of Pfizer-BioNTech and Moderna vaccines to avoid misleading people. Otherwise, “I’m worried it could paralyze the vaccination campaign, if the most important thing is that people get an incentive at all,” Dr. Marx said.
However, if the flu vaccine is some sign, many Americans will give up the next Covid vaccine. The Omicron option makes it clear that preventing all infections is an unattainable goal, and many believe the risk of serious illness or death in them is very low.
However, Dr. Marx noted that anti-influenza campaigns also aim to prevent loss of performance, not just medical consequences.
Prior to the arrival of the Omicron version, administration officials said Covid vaccines were designed to prevent all symptomatic infections, but they have since abandoned the position.
While Covid vaccines have blunted the spread of previous versions by 70 percent, “with Omicron this is clearly not the case,” he said. “It would be good to have something that would do better.”
Some experts said that instead of another cycle of injections, the best candidate to limit infections would be a nasal spray that would cover the nose and throat with antibodies to block the virus right at the entrance. But these sprays will not be available in the United States for at least two to three years.
Until Omicron appeared, FDA scientists were so excited about mRNA vaccines that they did not consider alternative boosters, Dr. Marx added: “We may have been temporarily blinded by light.”
However, minimizing the number of infections, if possible, is “obviously a very, very important secondary goal,” said Dr. Sarah Oliver, who represents the CDC in the working group on Covid-19 vaccines.
In addition to curtailing the spread of the virus and disruptions in society, reducing the number of infections should reduce the incidence of prolonged covid, a set of symptoms that can persist for months, she said.
The new plan could revive some long-standing tensions. Disagreements over who and to whom vaccines should be recommended have troubled these agencies for months.
Typically, FDA scientific advisors review the safety and efficacy of vaccines and recommend obtaining permission or approval. Experts who advise the CDC then issue instructions on who and when should be vaccinated.
During the pandemic, the boundaries between the White House, the FDA and the CDC were often blurred. “Now one of the problems is that we have a lot of voices that express immunization policies, and historically we only have one vote,” Dr. Daly said.
When the FDA authorized a second booster, for example, it did so only for adults 50 years and older – a distinction that would normally occur from CDC vaccine consultants.
The CDC also made a subtle distinction that was lost by many Americans: it recommended that adults over 50 could get a booster if they wanted to, not what they should do. But the new King Kovid of the White House, Dr. Ashish Ja, supported the second additional injections.
“It’s not entirely clear that the White House is able to make recommendations on vaccines, but, nonetheless, he said he recommended it,” said Dr. Camille Cotton, an infectious disease doctor at Massachusetts Hospital and CDC research advisor, Dr. Ja.
It is unclear who will pay for the autumn vaccination campaign. The stalemate in Congress over Covid-19 funding is jeopardizing the government’s ability to procure and provide vaccines to people who need it most.
“Without urgent additional funding, we can’t provide enough extra vaccinations for every American who wants when they’re needed in the fall, and we can’t provide newer, more effective vaccines that protect against new options,” Sarah Lowenheim, assistant said the Secretary of Public Relations of the Ministry of Health and Social Services.