FDA authorizes second COVID booster for Americans 50 and older

People age 50 and up are eligible for a second booster dose of COVID-19 vaccine at least four months after their first, the Food and Drug Administration said Tuesday.

“Based on an analysis of emerging data, a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine could help increase protection levels for these higher-risk individuals,” Dr. Peter Marks, who directs the FDA’s Center for Biologics Evaluation and Research, said in a statement.

The Centers for Disease Control and Prevention has to sign off on the booster before it becomes available. It’s not clear how soon that may happen.

A second booster dose of an improves protection against severe COVID-19 and is not associated with new safety concerns, the FDA said.

But when and whether individuals gets one remains a personal decision that should be based on age, health status and the course of the pandemic, experts said.

“Obviously, the older you are, the higher the risk; and the more underlying conditions the higher the risk,” said Dr. Tom Frieden, the former director of the Centers for Disease Control and Prevention, who now heads Resolve to Save Lives, an initiative to prevent epidemics and cardiovascular disease.

But Frieden said if he had a healthy 55-year-old patient who was already vaccinated and boosted, he’d be less concerned about getting that person another shot. “If you want to get one, fine. If you don’t, it’s really up to you,” Frieden said he’d tell that patient.

Another booster?: Not all experts agree everyone 50 and older need another shot.

According to the FDA’s decision, people 50 and over who received a booster shot of the Pfizer-BioNTech or Moderna vaccine more than four months ago can now get another booster at no cost.

Anyone 12 or older with a weakened immune system because of medical treatment or conditions, has been eligible for an additional shot aimed to provide them the same level of protection someone with a healthy immune system received after three doses. Immunocompromised adults can receive a Moderna booster, though it is not authorized for use in minors.

For the Pfizer-BioNTech vaccine, the booster will be identical to all previous shots, while with Moderna, a booster contains half the original 100-microgram dose.

Although the initial shots provide good protection against hospitalization and death from COVID-19, a booster shot was better at preventing severe infection from the omicron variant that emerged near the end of last year.

Some data suggests a second booster shot would help combat fading immunity after the third shot.

The FDA cited an ongoing study among Israeli health care workers, 154 of whom received a fourth shot with the Pfizer-BioNTech vaccine and 120 who were boosted a second time with Moderna.

Two weeks later, both groups saw at least a 10-fold increase in levels of antibodies capable of fighting off COVID-19, while antibody levels continued to fall among those who didn’t receive an additional booster. No new safety concerns were raised in either group.

Other studies, some not yet officially peer reviewed and published, also show a decline in vaccine effectiveness three to six months after the initial booster, and that a second booster can improve protection against severe disease.

“The FDA has determined that the known and potential benefits of a second COVID-19 vaccine booster dose with either of these vaccines outweigh their known and potential risks in these populations,” the agency said in a statement.

Some experts have raised concerns that an extra booster does not provide enough benefit to healthy people to justify its use.

The same Israeli study offered as evidence in favor of a fourth shot concludes that “a fourth vaccination of healthy young health care workers may have only marginal benefits. Older and vulnerable populations were not assessed.”

Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, said he has seen no convincing evidence that healthy people need extra protection against severe disease beyond the initial vaccines.

A second booster only offers a little extra protection against any infection with COVID-19 and it’s not clear how long that benefit lasts, he said.

Stéphane Bancel, CEO of Moderna said in a statement that boosters are needed to provide continued protection against COVID-19.

“The virus continues to evolve, and we are currently on the verge of another potential wave driven by the BA.2 variant,” he said. “Now, healthcare providers have the opportunity to advise higher-risk people about when and how to get boosted and build immunity in advance of future outbreaks.”

Dr. Megan Ranney, an emergency physician at Rhode Island Hospital and a public health expert at the Alpert Medical School of Brown University, said if she were in her 50s or 60s and healthy, she’d wait to get another shot.

The pandemic is at a low point in the United States right now, so there’s relatively little risk of infection. She’d rather get a booster closer to the time of an outbreak, when it would be more likely to protect against infection.

“I would not be rushing out to get a booster today,” she said. “If you get it too early, that’s not going to help, either.”

Weintraub can be reached at kweintraub@usatoday.com.

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

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FDA authorizes second COVID booster for Americans 50 and older

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