En español | Americans ages 65 and older, health care workers and others whose jobs put them at risk for severe COVID-19 would be authorized to get a vaccine booster under recommendations made Sept. 17 by an advisory committee of the U.S. Food and Drug Administration (FDA). The panel resoundingly rejected a proposal to suggest that all those 16 and older get another shot of the vaccine at this time.
The recommendation applies only to the Pfizer-BioNTech vaccine, the only COVID-19 vaccine that so far has received full FDA approval. The maker of Moderna has asked the agency to review its booster request, and Johnson & Johnson is expected to do so as well.
The committee's recommendation doesn't mean people age 65 and over and others at risk who have already been vaccinated should flock to their pharmacies or doctors' offices for another shot yet.
First, FDA officials need to decide whether to accept the panel's recommendation, which the agency typically does. Then the decision goes to the Centers for Disease Control and Prevention (CDC), whose top official would rule on whether to suggest the public get the booster. A CDC advisory committee is expected to meet the week of September 20 to suggest to CDC Administrator Rochelle Walensky how — and exactly to whom — a booster shot should be administered.
New research shows that while the vaccines continue to provide strong protection against hospitalization and death from COVID-19, their effectiveness may wane faster in older adults. A recent CDC study found that overall, the vaccines have been 86 percent effective in preventing hospitalization during the emergence of the delta variant. In adults age 75 and older, however, vaccine effectiveness dropped to 76 percent. And though severe breakthrough infections are extremely rare, most of those are happening in adults 65 and older.
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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.