The FDA's new COVID-19 vaccine policy is clear as mud

Japan Times

26-05-2025

When news broke that the U.S. Food and Drug Administration was rolling out a new plan for COVID-19 vaccine approvals, my phone instantly started buzzing. Friends, family members and colleagues all had the same question: Does this mean I can't get a fall booster?
I wish I had a straightforward answer for them.
Despite an explanation of the new strategy published last week from FDA Commissioner Marty Makary and Vinay Prasad, who oversees vaccines at the agency, public health experts were left guessing about basic details such as how it will affect access to COVID-19 shots. Do healthy people have a choice or not? What is the status of shots for kids? For an agency that has vowed to build the public's trust by offering transparency and an open dialogue, it was a frustrating start.
Here's what we know: The FDA is adopting a risk-based strategy for approving new COVID-19 vaccines that will limit their use to people 65 and older or anyone with a health condition that puts them at risk for severe disease — a group Prasad and Makary estimate accounts for about 100 million Americans. The new policy keeps the current standards for greenlighting vaccines, meaning pharmaceutical companies need only to produce data showing theirs prompts people to produce antibodies against the virus.
For healthy adults and children, new vaccines, including boosters updated to match circulating strains of the virus, seem to be on ice. FDA officials will require drug manufacturers to run studies proving their vaccines are better than a placebo in preventing symptomatic infections in people ages 50 to 64 — a group Prasad said was chosen because health agencies around the world express the most disagreement over the benefits of vaccination for the demographic. They said companies can choose to pursue studies that demonstrate their drugs effects in other groups. The future of pediatric COVID-19 vaccines seems particularly foggy, since updated shots also function as the primary series for unvaccinated children.
While billed as "a balance of regulatory flexibility and a commitment to gold-standard science,' the policy seems designed to put the vaccines out of reach.
Let's start with the feasibility and ethics of running the trials. Who would volunteer for such a study? COVID-19 skeptics or anyone hesitant about the safety of the vaccine seem unlikely to participate. Why would anyone who trusts the evidence that the vaccine is safe and effective — and that the risks from COVID-19 are real — want to take a chance on getting a placebo, says Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia. "This is a low-risk group, but it's not a no-risk group,' he says.
Although we are no longer in an emergency, COVID-19 hasn't gone away. Nearly 1,400 Americans died of the disease last month — and we're in a lull. During last year's late-summer wave, more than 1,000 people were dying each week, according to data from the Centers for Disease Control and Prevention.
The required trials would also be expensive. Thousands of people would need to be enrolled and, according to the FDA's plan, followed for six months. With few people opting for COVID-19 boosters these days, companies might decide the investment isn't worth it. If FDA's advisers, who meet this week to choose a formula for fall shots, ask drug companies to change the vaccine, millions of Americans could be left without a booster this fall.
Vaccines are a public good. I am at low risk of a serious COVID-19 infection, but my motivation to get a booster is about more than my own health. When I roll up my sleeve, I am thinking about my elderly parents, a dear family member undergoing chemotherapy and all the other people in my life who are more vulnerable to this virus than I am. I know a booster can't guarantee that I won't get sick and pass that infection onto others, but the evidence that it lowers the chances of both, at least for a few months, is sufficient for me to believe it's worth getting. I should have that option.
Prasad dismisses that argument, noting in a town hall (an event where only Makary was allowed to ask questions) that there's "no high-quality evidence' to suggest getting a booster to "go visit grandma' is helpful. He and Makary argue that without data to support that claim, people are operating under a false sense of security.
However, the CDC and others have offered evidence showing that higher vaccination rates in a community result in fewer infections and fewer people ending up hospitalized. It's true that finding comes from mining real-world data rather than randomized, placebo-controlled trials, but that doesn't mean people can't factor it into their choice to vaccinate.
And Americans have spent the last several years making personal decisions with the knowledge that some information is murky, says Georgetown University professor Jesse Goodman, who previously served as the FDA's chief scientist. "I would argue that people, just as they are now, can make up their mind about whether with the imperfect data they'd like to get the vaccine,' he says. "I'd rather give people the choice.'
Anyone worried about losing that choice should be just as concerned about how all of this is unfolding. The FDA's realm is evaluating the evidence about vaccines, while the CDC is charged with making recommendations about how they should be used. In nearly all cases, those decisions are based on advice from the CDC's Advisory Committee on Immunization Practices (ACIP), independent experts who carefully and publicly debate the evidence.
"I'm very concerned that this really is the first step towards neutering ACIP,' says Michael Osterholm, director of the Center for Infectious Disease Research and Policy in Minnesota. "ACIP should be involved with this. This is not FDA's role to be making recommendations on vaccine for risk groups.'
That committee will meet in June to discuss COVID-19 boosters. Ironically, they are likely to arrive at guidelines that largely align with Makary and Prasad's focus on the elderly and high-risk groups. Yet public health experts note the panel's recommendations are likely to differ in one notable way: Given the safety of the vaccine, they're likely to leave the door open for everyone to decide for themselves.
Makary and Prasad argue that generating better data will drive more people to follow them — and that it's the lack of confidence that's holding individuals back. Public health experts have a different view. Many people simply don't see COVID-19 as the threat it once was and so are opting out. Others have been deterred by the intense rhetoric and misinformation about the shots — much of it coming from current health agency leadership.
In an ideal world, we'd have perfect data that allows people to make easy decisions about their health. And while continuing to study our vaccines and adapt our recommendations to fit the evolving state of the outbreak is perfectly reasonable, it should be done through the normal channels — and communicated in terms that everyone can understand.
Lisa Jarvis is a Bloomberg Opinion columnist covering biotech, health care and the pharmaceutical industry. Previously, she was executive editor of Chemical & Engineering News.