A stricter FDA policy for COVID vaccines could limit future access

The Food and Drug Administration is taking a new approach to COVID-19 vaccines that would prioritize immunizations for people at highest risk for serious complications from the disease but could make it harder for many other people to get the shots.

The new strategy would continue the current vaccine approval process for people ages 65 and older and younger people with health problems that put them at high risk, according to an article published Tuesday in The New England Journal of Medicine. But the FDA will now require vaccine manufacturers to conduct additional large studies to evaluate the safety and effectiveness of the vaccines for children and younger healthy adults.

“We have launched down this multiyear campaign of booster after booster after booster and distrust of the American public. And we do not have gold-standard science to support this for average-risk, low-risk Americans,” Dr. Vinay Prasad, the new director of the FDA’s Center for Biologics Evaluation and Research, said during a briefing to explain the new policy.

The federal health officials say the steps will bring the U.S. in line with the approach that other high-income countries take towards the vaccines and are necessary to restore trust in the vaccines.

For consumers the changes could mean that annual boosters wouldn’t be automatically recommended for everyone. Instead, they would be aimed at older people and younger people with health risks. For other adults and children additional studies would have to show the benefits of vaccination outweigh risks.

From 100 million to 200 million Americans would be eligible for COVID vaccines under the new approach, according to an estimate cited in the journal article. That’s a change from the current approach, which recommends vaccines for almost everyone.

FDA says the new approach balances flexibility and rigor

“The FDA’s new Covid-19 philosophy represents a balance of regulatory flexibility and a commitment to gold-standard science,” wrote Prasad and FDA Commissioner Dr. Martin Makary, in the journal article. “The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk.”

The move was welcomed by some independent public health experts.

“I find it refreshing to see the clarity in these guidelines,” says Rick Bright, a former federal vaccine official. “The FDA is signaling a major departure from the one-size-fits-all approach that’s largely defined the U.S. vaccination policy until now. Not everyone is at equal risk and public policy should reflect that reality.”

But critics say the new requirements bypass the usual input from independent outside advisers and are unnecessary given the overwhelming evidence that COVID vaccines are safe and effective.

They also worry the regulatory move sends the misleading message that the vaccines have not been adequately evaluated and that it would limit the availability of the vaccines because insurers would no longer pay for the shots for everyone.

Insurers may no longer pay for some vaccinations

“Secretary Kennedy had made it clear that he would never take vaccines away from anyone,”  Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, said in an interview with NPR, referring to Health and Human Services Secretary Robert F. Kennedy Jr., who oversees the FDA. “This violates that in every way possible” because if insurance companies won’t pay for the vaccine many people simply won’t be able to afford it.”

Others also note that the new approach doesn’t take other issues into account, such as the fact that even younger, healthier people can get long COVID and that immunization can reduce that risk.

“That’s very important because long COVID occurs in all age groups and even children and therefore I think COVID vaccines should be made available to all age groups,” says Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine.

Others at low risk themselves may want to get vaccinated to protect other people, such as older family members and those with weak immune systems, Hotez says.

Many experts also argue that it would be unethical to perform a clinical study that involves giving some people a placebo instead of a vaccine, given that the virus can be a major threat to anyone and COVID vaccines have been shown to be effective.

“I don’t think it’s ethical, given that we have a vaccine that works, given that we know that SARS-CoV2 continues to circulate and cause hospitalizations and death, and there’s no group that has no risk,” says Dr. Paul Offit, director of the Vaccine Education Center at the University of Pennsylvania.

But Prasad argues that more evidence is needed to prove that additional vaccinations would provide a benefit to most young, healthy people.

“The truth is that for many Americans we simply do not know the answer to whether or they should be getting a seventh or eighth or ninth or 10th COVID-19 booster,” Prasad says.

Later this week an independent FDA advisory committee will meet to discuss the composition of new COVID boosters for next fall and winter.