People age 50 and older are now eligible for a second booster dose of the COVID-19 vaccine at least four months after their first, the Food and Drug Administration and the Centers for Disease Control and Prevention decided on Tuesday.
“Based on an analysis of emerging data, a second booster dose of the Pfizer-BioNTech or Moderna COVID-19 vaccine could help increase levels of protection for these high-risk individuals,” said Dr Peter Marks, who directs the FDA’s Center for Biologics. Assessment and Research, said in a statement.
The CDC approved the booster shots several hours after the FDA cleared them.
A second booster dose improves protection against severe COVID-19 and is not associated with new safety concerns, the FDA said.
The second boosters are “particularly important for people 65 and older and those 50 and older with underlying medical conditions that increase their risk of serious illness from COVID-19, as they are most likely to benefit. an additional booster dose at this time,” CDC Director Dr. Rochelle Walensky said in a statement.
Medical conditions that increase the risk of serious illness include obesity, diabetes, chronic lung, kidney or liver disease, heart disease, smoking, pregnancy and many mental health conditions.
The two agencies also authorized a fifth vaccine for anyone with a weakened immune system, often due to cancer treatment, an organ transplant or an autoimmune disease.
Anyone who is immunocompromised and aged 12 or older is now eligible for another dose of the Pfizer-BioNTech vaccine, while immunocompromised adults can also receive the Moderna vaccine.
For immunocompromised individuals, the initial vaccination is considered to be three doses. They have been allowed since last fall to receive 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 now receive a second booster dose, Nordlund said. The J&J vaccine was initially considered a single-shot vaccine, although studies have suggested that two doses were needed to provide the same protection as the other two licensed vaccines.
J&J recipients have been eligible since last fall to receive a second vaccine, with the CDC recommending that they receive a Pfizer-BioNTech or Moderna vaccine for their second dose. Now they can get a third hit, again with Pfizer-BioNTech or Moderna, Nordlund said.
All boosters are available for free, although the Biden administration has said it needs more funding from Congress to continue providing the injections for free.
When and if individuals get one remains a personal decision that should be based on age, health status and the evolution 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 CDC director, who leads 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 would be less concerned about giving him another shot. “If you want to get one, fine. If you don’t, it’s really up to you,” Frieden said he would tell this patient.
Another booster? Some experts disagree that anyone over 50 needs another injection.
For the Pfizer-BioNTech vaccine, the booster will be identical to all previous vaccines. The Moderna booster contains half of the original 100 microgram dose.
Although initial injections provide protection against hospitalization and death from COVID-19, a booster injection was more effective in preventing serious infection with the omicron variant that emerged late last year.
There is some evidence to suggest that a second booster shot would help fight the fading of immunity after the third shot.
The FDA cited an ongoing study among Israeli healthcare 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 antibody levels capable of fighting COVID-19, while antibody levels continued to decline among those who did not receive a booster. additional. No new safety issues were raised in either group.
Other studies, some of which have not been formally peer-reviewed and published, show that vaccine effectiveness declines three to six months after the initial booster, and that a second booster may improve protection against disease. serious.
“The FDA has determined that the known and potential benefits of a second booster dose of the COVID-19 vaccine with either of these vaccines outweigh their known and potential risks in these populations,” said the agency in a press release.
The CDC made similar points in its own statement, and particularly emphasized the importance of initial injections and a first booster dose.
“Data continue to show the importance of vaccination and booster doses in protecting individuals from both infection and severe consequences of COVID-19,” the statement said.
Some experts have expressed concern that an additional booster may not bring much benefit to healthy people.
The same Israeli study presented as evidence in favor of a fourth vaccine concludes that “a fourth vaccination of healthy young healthcare workers may have only marginal benefits. Older and vulnerable populations have not been evaluated”.
Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said he hadn’t seen any convincing evidence that healthy people need extra protection against serious illnesses above. beyond the initial vaccines.
A second booster provides only a small additional protection against COVID-19 infection and it’s unclear how long that benefit lasts, he said.
Stephane 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 brink of another potential wave driven by the BA.2 variant,” he said. “Now healthcare providers have the ability to advise high-risk people on when and how to get boosted and boost their immunity ahead of future outbreaks.”
Megan Ranney, an emergency physician at Rhode Island Hospital and a public health expert at Brown University’s Alpert Medical School, said if she was in her 50s or 60s and healthy, she would wait to get the shot.
The pandemic is at a low point in the United States, so there is relatively little risk of infection. She prefers to get a booster closer to the time of an outbreak, when it would be more likely to protect against infection.
“I wouldn’t rush to get a callback today,” she said. “If you get it too early, that won’t help either.”
Weintraub can be contacted at [email protected]
Coverage of patient health and safety 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 contributions.
USA Today
