​FDA Panel Recommends COVID-19 Vaccine Booster for Older Americans

This latest guidance to the public in combatting COVID-19 will take the form of an emergency use authorization (EUA), which is used during public health emergencies. The authorization recommendation simply calls for people age 65 and older and others at high risk for getting severe COVID to get the added shot. But during its deliberations, the panel took a poll and informally asked FDA officials to add health care workers and others who occupationally are at risk for COVID to the new EUA language. FDA officials assured the members of its committee that the CDC's Advisory Committee on Immunization Practices can refine exactly who should get the third shot.

During its debate, panel members wondered whether people with such underlying conditions as obesity and diabetes should also be told to get a booster, regardless of age. Those whose immune systems are compromised were already cleared in August to receive a third vaccine dose.

The White House had announced several weeks ago that a COVID-19 booster campaign for all Americans who had already been fully vaccinated would begin the week of Sept. 20. But the scope of that effort is likely to change given the outcome of the FDA meeting, and the start date could slip depending on when the CDC acts.

Data lacking on boosters for all

The vast majority of the experts on the FDA advisory committee were concerned about both the safety and the effectiveness of a booster shot and bemoaned the lack of data available to help them make a decision.

"It's not clear to me that the data we're seeing right now is applicable and necessary for the general population," said Michael Kurilla, an FDA committee member from the National Institutes of Health. Another committee member, Cody Meissner from Tufts University School of Medicine, said he didn't think the "booster dose is going to significantly contribute to controlling the pandemic. The main message we need to transmit is that everyone needs to get two doses."

The members spent much of the time Friday listening to officials from Israel whose research indicates these boosters have been effective in bringing down what they say is the fourth wave of the COVID infection. But concerns about a potential heart inflammation issue — myocarditis — and the lack of U.S. data overrode the testimony from Israeli health officials and from executives at Pfizer.

Dena Bunis covers Medicare, health care, health policy and Congress. She also writes the “Medicare Made Easy” column for the AARP Bulletin. An award-winning journalist, Bunis spent decades working for metropolitan daily newspapers, including as Washington bureau chief for the Orange County Register and as a health policy and workplace writer for Newsday.