FDA may limit future Covid-19 shots to older people and those at risk of serious infection

By Brenda Goodman, Sarah Owermohle, Meg Tirrell, CNN

(CNN) — The US Food and Drug Administration is changing the way it approves Covid-19 vaccines for Americans, a move that may limit future shots to older Americans and people at higher risk of serious Covid-19 infection.

The agency is changing the type of evidence it will accept from vaccine manufacturers to approve updated Covid-19 shots, Dr. Vinay Prasad, the new director of the FDA’s Center for Biologics Evaluation and Research, and FDA Commissioner Dr. Marty Makary said in an editorial published Tuesday in the New England Journal of Medicine.

The change means the updated shots will probably be available this fall for adults 65 and older and those with underlying conditions that may put them at higher risk of a severe Covid-19 infection, but they may not be for everyone who was previously eligible. Nearly three-quarters of Americans 6 months and older have at least one of these underlying medical conditions, according to the US Centers for Disease Control and Prevention.

The change, which was already being studied by experts who advise the CDC on its vaccine recommendations, will more closely align the United States with guidelines in the UK, Canada and Australia.

But millions of healthy adults and kids stand to lose access to updated vaccines under the new criteria. Prasad and Makary say there’s not enough evidence that healthy children and adults get clinically meaningful benefit from regular Covid-19 shots, and they want to see more placebo-controlled trials, particularly in adults 50 to 64, before recommending the shots for other groups.

It’s not clear whether Covid-19 vaccine manufacturers, including Pfizer, Moderna and Novavax, will decide to conduct the randomized controlled trials the FDA is seeking for certain age groups. These kinds of studies are expensive and typically take months or even years.

Moderna said in a statement Tuesday, “We appreciate the FDA’s clear guidance and remain committed to working with the Agency to provide the data they need to ensure access for Americans.”

Pfizer and Novavax did not respond to requests for comment on the FDA’s new regulatory framework.

Just days before the FDA’s announcement, it approved the Novavax Covid-19 vaccine, which was six weeks past its planned approval deadline. The FDA restricted the use of the vaccine to people 65 and older and those 12 and up with underlying health conditions.

“Market research and US C.D.C. statistics indicate that older individuals and those with underlying conditions are the populations most likely to seek out COVID-19 vaccination seasonally,” Novavax President and CEO John Jacobs said at the time. “This significant milestone demonstrates our commitment to these populations and is a significant step towards availability of our protein-based vaccine option.”

‘We will consider the results’

In a discussion shared online Tuesday, Prasad answered some questions about the new requirements that were posed to him by Makary.

“This is a free country, and companies are, of course, free to conduct their own randomized studies in younger populations, in people without risk factors for severe Covid-19,” Prasad said. “They can run the research agenda they see fit, and we will consider the results of those studies.”

Prasad also sought to flesh out why the FDA settled on these age groups and risk factors for vaccine recommendations. For the 50-to-65 age group, “we are genuinely uncertain, globally, if those patients benefit,” he said, with some countries recommending Covid vaccination for people 65 and older and others as young as 40.

“Fifty to 65, we feel, is an area where there’s disagreement among our peer nations. It’s a place [where] we can bring data to this question,” he added.

Dr. Noel Brewer, a professor of public health and health behavior at the University of North Carolina at Chapel Hill, said he supports the change.

“The proposed policy moves the US in line with other countries. This global view of public health is a welcome development,” said Brewer, who sits on the CDC’s Advisory Committee on Immunization Practices and was part of the working group mulling the change to Covid vaccine recommendations.

But he and other experts say they’re still worried about the youngest children, those under age 2, who have higher rates of hospitalizations from Covid-19 compared with some other age groups.

Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia and a member of the FDA’s independent advisory group on vaccines, says he disagrees with the underlying premise of the new framework, which is that previous Covid-19 vaccine recommendations haven’t been based on good evidence.

“We have been using an evidence-based approach to Covid-19 vaccination, but they kind of swoop in and believe that for the first time, we’re going to get, as they say, ‘gold standard’ data, robust data, for the first time, because according to them, we don’t have that. But we do have that,” Offit said.

“That’s why we’ve made good decisions about the vaccine. That’s why that vaccine is remarkably safe. The mRNA vaccines are remarkably safe.”

Dr. Jodie Guest, senior vice chair of epidemiology at Emory University’s Rollins School of Public Health, said that restricting access to Covid-19 vaccines is a mistake.

“This policy change will increase likelihood of variant emergence and worsen health inequities. Broad vaccination protects more people, reduces disruptions, and is essential for community-wide immunity and pandemic control. It is also likely to make these vaccines less insurable,” Guest said in an email to CNN.

Longer-term risks

The editorial says that going forward, Covid-19 vaccines for people 65 and older and those 6 months and older with underlying health conditions that put them at higher risk from Covid-19 infections will be approved after pharmaceutical companies can demonstrate that they create protective antibody concentrations.

These types of studies are called immunobridging studies. They’re typically done in a smaller number of people or even in animals, and they can be done quickly so vaccine manufacturing can ramp up in time to have large numbers of shots ready for an expected wave of illness, usually over the fall and winter.

This is largely how seasonal flu vaccinations are approved each year in the US, and it’s the way the FDA has been approving Covid-19 vaccines for the past few years.

For everyone else, the FDA says it will approve vaccines only after studies that prove the shots can prevent symptomatic Covid-19 better than a placebo. The agency will also consider several secondary outcomes, including severe illness, hospitalization and death.

The new plan doesn’t take into account other effects of Covid-19 infections, such as long Covid. Studies have shown that vaccination may cut the risk of long Covid between 25% and 60%. Covid-19 infections also increase the risk of heart attacks and strokes, and vaccines can help prevent those complications, said Dr. Peter Hotez, director of the Center for Vaccine Development at Texas Children’s Hospital in Houston.

The FDA is focusing on the short-term impacts of Covid-19 infections but not the long-term ones, he said.

“The reason that’s relevant is because that’s a major reason why we vaccinate otherwise healthy, younger adults and adolescents, maybe even kids,” Hotez said. “It’s almost as though they forgot about that.”

It also doesn’t consider whether vaccination may be a good idea for healthy people who want to safeguard vulnerable friends and loved ones who may have depleted immune function.

Prasad and Makary say the new policy balances the need to swiftly approve vaccines to have them ready by the fall for the most vulnerable adults and children against the need for more evidence before offering them to others.

Additionally, they say, millions of Americans under the age of 65 will still qualify to get a Covid-19 vaccine if they want one if they have any of the health conditions identified by the CDC as raising someone’s risk of severe disease from Covid-19.

“Estimates suggest that 100 million to 200 million Americans will have access to vaccines in this manner,” the FDA officials wrote.

However, many Americans now get their vaccinations from pharmacies or other settings outside the doctor’s office. It’s not clear who might be determining or checking to see whether someone is at high risk.

“Do you have to tell the pharmacist why you’re at high risk?” Offit asked. “They’re not going to supervise that.”

Prasad and Makary say their goal in requiring more evidence for other groups is to restore public trust in vaccines.

They noted that for the past two respiratory virus seasons, less than 25% of Americans have received a Covid-19 shot, including less than 10% of kids and less than 50% of adults over the age of 75.

They say broad Covid-19 vaccine recommendations and mandates during the pandemic eroded public trust and caused falling vaccination rates for other types of shots too, such as the measles, mumps and rubella vaccine.

“I don’t think that’s why rates are down. I think rates were down because people don’t fear the disease anymore,” Offit said. There’s also “booster fatigue,” public health shorthand for the burnout some people may feel after a steady stream of Covid-19 vaccine recommendations in recent years.

“It has nothing to do with the loss of trust,” Offit added. “I think the premise is wrong.”

CNN’s Katherine Dillinger contributed to this report.

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