FDA authorizes second COVID-19 booster shot for adults aged 50 years or older
The FDA on Tuesday authorized a second booster dose of COVID-19 vaccine for people aged 50 years or older and certain immunocompromised patients, citing evidence that it improves protection against severe disease.
The authorization applies to the messenger RNA vaccines made by Pfizer-BioNTech and Moderna.
The FDA previously authorized a booster shot for older adults in September. They are now eligible for a fourth shot. Immunocompromised adults who received a recommended three-dose primary series of either vaccine have been eligible for a fourth dose since October and may now receive a fifth dose.
Following the authorization, the CDC updated its recommendations to include an additional dose for these populations, adding that adults who received a primary vaccine and booster dose of Johnson & Johnson’s vaccine at least 4 months ago may now receive a second booster dose of an mRNA vaccine.
“Current evidence suggests some waning of protection over time against serious outcomes from COVID-19 in older and immunocompromised individuals,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “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.”
The FDA specified that a second booster dose of either mRNA vaccine may be administered to people aged 50 years or older at least 4 months after they received their first booster dose of any authorized or approved COVID-19 vaccine.
Anyone aged 12 years or older with certain kinds of immunocompromise can receive a second booster dose of the Pfizer-BioNTech COVID-19 vaccine at least 4 months after a first booster of any authorized or approved COVID-19 vaccine. A second booster dose of the Moderna COVID-19 vaccine is available only to adults because it is not yet authorized or approved for anyone younger than age 18 years.
The FDA said that it 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.”
It cited surveillance data from Israel from around 700,000 people who received a fourth dose of the Pfizer-BioNTech vaccine that revealed no new safety concerns. The FDA said an ongoing study among Israeli health care workers demonstrated increased antibody levels 2 weeks after the second booster shot compared with 5 months after the first, including against the delta and omicron variants of SARS-CoV-2.
Both the FDA and CDC made their decisions without calling a meeting of their respective vaccine advisory committees, though the FDA’s Vaccines and Related Biological Products Advisory Committee plans to meet next week. In the meantime, the FDA said it will continue to evaluate data and information as it becomes available when considering the potential of a second booster dose in other age groups.
According to CDC data, 89% of people aged 65 years or older in the U.S. are fully vaccinated against COVID-19 but less than 70% have received a booster shot.
“Boosters are safe, and people over the age of 50 can now get an additional booster 4 months after their prior dose to increase their protection further,” CDC Director Rochelle P. Walensky, MD, MPH, said in statement. “This is 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.”