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 and Centers for Disease Control and Prevention decided 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 CDC signed off on the booster shots several hours after the FDA authorized them.
A second booster dose improves protection against severe COVID-19 and is not associated with new safety concerns, the FDA said.
Second boosters are “especially important for those 65 and older and those 50 and older with underlying medical conditions that increase their risk for severe disease from COVID-19 as they are the most likely to benefit from receiving an additional booster dose at this time,” CDC Director Rochelle Walensky said in a statement.
Medical conditions that increase risk for severe disease include obesity, diabetes, chronic lung, kidney or liver disease, heart disease, smoking, pregnancy and many mental health conditions.
Both agencies authorized a fifth shot for anyone with a weakened immune system, often because of treatment for cancer, organ transplantation or autoimmune disease.
Anyone immunocompromised and age 12 or older is eligible for another dose of the Pfizer-BioNTech vaccine, and immunocompromised adults can also receive the Moderna vaccine.
For the immunocompromised, the initial vaccination is three doses. They have been allowed since last fall to get a first booster, or fourth dose, and are now entitled to a fifth, CDC spokeswoman Kristen Nordlund confirmed.
People who received initial doses of the Johnson & Johnson vaccine can receive a second booster dose, Nordlund said. The J&J vaccine was initially a one-shot vaccine, though studies suggested that two doses were needed to provide the same protection as the other two authorized vaccines.
J&J recipients have been eligible since last fall to get a second shot, and the CDC recommended that they receive a Pfizer-BioNTech or Moderna vaccine for their second dose. They can receive a third shot, with either Pfizer-BioNTech or Moderna, Nordlund said.
All of the boosters are available at no cost, although the Biden administration said it needs more funding from Congress to keep providing the shots for free.
When and whether individuals get 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, former director of the CDC, who heads Resolve to Save Lives, an initiative to prevent epidemics and cardiovascular disease.
Frieden said if he had a healthy 55-year-old patient who was 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? Some experts disagree that everyone 50 and older needs another shot.
For the Pfizer-BioNTech vaccine, the booster will be identical to all previous shots. The Moderna booster contains half the original 100-microgram dose.
Although the initial shots provide 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 officially peer-reviewed and published, show vaccine effectiveness declines three to six months after the initial booster, and 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.
The CDC made similar points in its own statement, and emphasized the importance of initial shots and a first booster dose.
“Data continue to show the importance of vaccination and booster doses to protect individuals both from infection and severe outcomes of COVID-19,” the statement said.
Some experts raised concerns that an additional booster does not provide much benefit to healthy people.
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 offers only a little extra protection against 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.”
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 USA, 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.
