As the coronavirus morphs into a stubborn and unpredictable facet of everyday life, scientists and federal health officials are converting on a new strategy for immunizing Americans: a vaccination campaign this fall, with doses that are finely tuned to combat the version of the virus expected to be in circulation.
The plan would be to heavily distribute the playbook for the annual flu shots, and possibly become the template for arming Americans against the coronavirus in the years to come.
But some experts question how well a renewed vaccination push would have received by a pandemic-weary public, even if the doses could be rolled out quickly enough to reach the people who need them most – and even most Americans need additional shots at all.
On June 28, scientific advisers to the Food and Drug Administration will meet to identify the coronavirus variant most likely to be percolating in the United States as temperatures cool. That should leave manufacturers time to decide if the vaccines’ composition needs to be revised and ramp up production, hopefully enough to churn out hundreds of millions of doses by October.
Scientific advisers to the FDA have said they would favor switching to a new version of the vaccines if there were compelling evidence that current ones were no longer effective and a modified version would be better.
The idea is that eligible Americans will be urged to seek immunization against the coronavirus and the flu at the same time this fall, and in the same places: drugstores, doctors’ offices, walk-in clinics, and the like. Some important details – like who would qualify – will be sorted out next month at scientific advisors to the FDA and the Centers for Disease Control and Prevention.
The plan would mark a departure from the current sequential authorizations of booster shots for various age groups. But the annual approach to shortcomings has been apparent to flu researchers for years.
Scientists and federal health officials usually decide on the formulation of the flu vaccine in the spring, six months before the flu season. They are guessing at which version of the flu virus will arrive in the United States by looking at what is already circulating in the southern hemisphere, among other factors.
But in some years, “by the time the vaccine is manufactured, the strains have changed, and then you may not be good matching,” Dr. Ofer Levy, director of the precision vaccines program at Boston Children’s Hospital and an adviser to the FDA, said.
Among the candidates for a fall Covid shot is a booster designed for Omicron, the odd new avatar of the coronavirus, and combinations that include it. Moderna’s lead booster candidate contains 25 micrograms each of its original vaccine and one tailored to Omicron, Dr. Said Paul Burton, the company’s chief medical officer.
Pfizer is also testing an Omicron-specific vaccine, but will not make a decision on its fall candidate until June, according to Jerica Pitts, a spokeswoman for the company.
Even if the vaccine match is not perfect, the boost to immunity should offer some protection against any new variant in the fall, as the flu vaccine does.
The number of Americans who have opted to get booster doses has dwindled with each newly recommended shot. While 90 percent of American adults have received at least one dose of covid vaccine, 76 percent have opted for a second dose and just 50 percent for a third.
“Considering additional doses for smaller and smaller returns is creating an impression that we do not have a very effective vaccination program,” Dr. Matthew Daley, a senior investigator at Kaiser Permanente Colorado who heads the CDC’s vaccine working group, said.
A nationwide campaign for another vaccination would needlessly exhaust pharmacists, providers and public health staff, Dr. Daley and other advisers were warned at a meeting of their committee last month.
And the experts worry that a push for extra doses this fall, while the risks of severe illness and death are likely to be lower for most Americans, may cut the collective willingness to be immunized later if a new variant surfaces and the public urgently requires it.
Repeated immunizations may even blunt a vaccine’s effectiveness. For example, people who are vaccinated against the flu in a single year develop stronger immunity than those who have been vaccinated for two years in a row, said Florian Krammer, an immunologist at the Icahn School of Medicine at Mount Sinai in New York.
Among the misgivings, federal officials are gearing up for a fall campaign. Flu is the simplest way to convince Americans to line up for vaccines every year, said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
“It saves people time,” Dr. Marks said. “And that might 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. Marks said.
The FDA favors offering roughly the same formulations of the Pfizer-BioNTech and Moderna vaccines, in order to avoid befuddling people. Otherwise, “I was worried that could actually paralyze a vaccine campaign, when the most important thing is that people get boosted at all,” Dr. Marks said.
If the flu vaccine is any indication, however, 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 only at a low risk of serious illness or death.
Still, Dr. Marks noted that influenza campaigns also aim to prevent loss of productivity, not just medical consequences.
Before the arrival of the Omicron variant, administration officials said the Covid vaccines were intended to prevent all symptomatic infections, but they have since backed off that stance.
While the Covid vaccines blunted the spread of earlier variants by up to 70 percent, “that’s clearly not true with Omicron,” he said. “It would be nice to have something that did a better job.”
Some experts said that instead of injections of another round, the best candidate for limiting infections would be a nasal spray that would coat the nose and throat with antibodies to block the virus right at its entryway. But those sprays will not be available in the United States for at least two or three years.
Until Omicron came around, the FDA’s scientists were so excited about mRNA vaccines that they didn’t consider alternative boosters, Dr. Marks added: “We may have been temporarily blinded by the light.”
Still, minimizing the number of infections whenever possible is “obviously a very, very important secondary goal,” Dr. Sara Oliver, who represents the Covid-19 vaccine working group on the CDC, said.
Apart from curtailing the spread of the virus and societal disruption, reduced infections should reduce cases of long covid, the symptoms of constellation that can persist for months, she said.
The new plan may revive some longstanding tensions. Disagreements about who should recommend vaccines, and for whom, have roiled these agencies for months.
Generally, the FDA’s scientific advisers review the safety and efficacy of vaccines, and recommend authorization or approval. Experts who advise the CDC then issue guidelines on who should get the vaccines and when.
During the pandemic, the lines between the White House, the FDA and the CDC have often been blurred. “Right now, one of the challenges is that we have a lot of voices who are speaking immunization policy, and historically we just had a voice,” said Dr. Daley said.
When the FDA authorized a second booster, for example, it did so only 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 was lost on many Americans: It recommended that adults older than 50 get a booster if they wished, that they should do so. But the White House’s new Covid czar, Dr. Ashish Jha, endorsed the second booster shots.
“It’s not entirely clear that the White House is in the position of making vaccine recommendations per se, but nonetheless, he said he recommended it,” Dr. Camille Kotton, an infectious disease physician at the Massachusetts General Hospital and a scientific adviser to the CDC, said. Jha.
It’s unclear who will pay for a fall vaccination campaign. The stalemate in Congress on Covid-19 funding jeopardizes the government’s ability to buy and provide vaccines to the people who are most in need.
“Without urgent additional funding, we’re unable to secure enough booster shots for every American who wants one in the fall, and we’re unable to secure newer, more effective vaccines that protect against new variants,” Sarah Lovenheim, assistant The Secretary for Public Affairs at the Department of Health and Human Services said.