What’s the news: The Food and Drug Administration (FDA) authorized a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 mRNA vaccines for people over 50 and for certain people with compromised immune systems, which may be administered four months after receiving an initial booster dose. The Centers for Disease Control and Prevention (CDC) followed suit with a recommendation that these people may receive a second booster dose.
The CDC is recommending that adults who got the J&J vaccine for their primary series and booster dose at least four months ago may now receive a second booster dose of an mRNA COVID-19 vaccine.
The move is based on newly published data from its tracking network of COVID-19 related emergency department visits and hospitalizations in 10 states. For COVID-19 patients in the network hospitals, vaccine effectiveness against COVID-19 related hospitalization was 54% after two Janssen doses. That compares with 79% for one Janssen and one mRNA dose, and 83% for three mRNA doses.
The CDC’s action is commonly known as a “permissive recommendation,” meaning that certain people may get the second booster if they wish to get it, though the agency itself is not yet officially urging them to do so.
The news comes as the CDC reported that the highly transmissible SARS-CoV-2 BA.2 Omicron subvariant now accounts for more than half of cases in the U.S. The FDA said it had 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.
Why it’s important: The agencies’ actions were driven by Biden administration concern that the waning immunity in older Americans as well as protection for those with compromised immune systems needed to be bolstered before an expected new wave of COVID-19 hits in the fall, Andrea Garcia, MPH, director of science, medicine and public health at the AMA, said during an episode of the “AMA COVID-19 Update” about FDA authorization for a second booster shot.
“At that point, federal health officials say they expect that everyone is going to need another shot,” Garcia added.
During the recent COVID-19 surge driven by SARS-CoV-2 Omicron variant, people receiving a booster dose were 21 times less likely to die from COVID-19, compared with patients who were unvaccinated. They were seven times less likely to be hospitalized, according to the CDC. The updated recommendations acknowledge the increased risk of severe disease in certain populations including seniors and those 50 or older with multiple underlying conditions, the CDC added.
The FDA noted that it was basing its action on safety and immune response information reported to the agency, information on effectiveness reported by vaccine manufacturers, and a summary of safety data provided by the Israeli health ministry on the administration of a fourth dose to 700,000 people—the vast majority of whom were between 60 and 100 years old.
“That study found that older adults who received that second booster of the Pfizer vaccine, specifically, had a 78% lower mortality rate than those who only had one booster,” the AMA’s Garcia said, offering a note of a caution about the results, which have not yet gone through peer review.
Learn more: In a statement, CDC Director Rochelle P. Walensky, MD, MPH, said the agency would collaborate with the FDA and others to continue evaluating the “the need for additional booster doses for all Americans.”
To stay informed on the latest COVID-19 news on vaccines, treatments and guidance, visit the AMA COVID-19 resource center for physicians.
And read why now is definitely not the time to skimp on the COVID-19 funding that’s needed to pay for vaccines, testing and therapies.
The AMA has also developed frequently-asked-questions documents on COVID-19 vaccination covering safety, allocation and distribution, administration and more. There are two FAQs, one designed to answer patients’ questions (PDF), and another to address physicians’ COVID-19 vaccine questions (PDF).
