The U.S. Food and Drug Administration (FDA) announced Tuesday that it has authorized a “second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people and certain immunocompromised individuals.”
FDA’s authorization comes just two weeks after Pfizer and Moderna asked the agency to permit a second booster shot based on data from Israel.
The FDA authorized fourth doses of Pfizer and Moderna for everyone age 50 and older “at least four months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine.”
The approval also extends to certain immunocompromised people 12 years of age and older, including recipients of organ transplants, with the Pfizer vaccine being approved for anyone over 12 while Moderna’s vaccine is approved for those 18 and older.
“Current evidence suggests some waning of protection over time against serious outcomes from Covid-19 in older and immunocompromised individuals,” said Peter Marks, director of the FDA Center for Biologics Evaluation and Research.
The Centers for Disease Control and Prevention (CDC) was fast to sign off on the decision, repeating the recommendation the same day as FDA.
It also recommended that “adults who received a primary vaccine and booster dose of Johnson & Johnson’s Janssen COVID-19 vaccine at least four months ago may now receive a second booster dose using an mRNA COVID-19 vaccine.”
“Both the FDA and CDC made the decision without calling meetings of their vaccine advisory committees”, CNBC wrote, noting it is “a rare move the agencies have made more frequently over the course of the pandemic to expand uses of already-approved COVID vaccines.”