FDA authorizes second bivalent COVID booster for older adults

FDA authorizes second bivalent COVID booster for older adults

April 18 (Reuters) – The U.S. Food and Drug Administration on Tuesday authorized a second dose of Omicron-targeting COVID-19 vaccines for older adults as well as those with a weak immune system.

The agency also said the updated shots from Pfizer-BioNTech (PFE.N)/(22UAy.DE) and Moderna (MRNA.O) would become the new primary COVID vaccine, and withdrew its emergency-use authorization for the older messenger RNA vaccines that target only the original version of coronavirus.

People aged 65 years and older can now receive a second dose of updated booster four months after the first, while immunocompromised people can get an additional shot of the updated vaccine after two months, the agency said.

FDA’s decision comes a day before the Centers for Disease Control and Prevention’s (CDC) panel of expert advisers’ meeting on updating COVID-19 vaccination guidelines.

The CDC would have to recommend the second Omicron-tailored shots from Pfizer-BioNTech and Moderna for them to become widely available.

The FDA authorized the bivalent COVID boosters in August that target the BA.4 and BA.5 Omicron subvariants, along with the original strain of the coronavirus.

Only around 17% of the U.S. population has received the bivalent boosters, but among people aged 65 years and older, the uptake is higher, about 42.6% of them have received their first shot of the updated vaccines. The authorization withdrawal for Moderna Inc and Pfizer-BioNTech’s older vaccines, comes at a time when the FDA plans to shift to an annual COVID booster campaign with an updated strain, similar to the way Americans get their flu shots.

The FDA also said it will hold another meeting of its advisers in June to discuss the strain composition of the COVID-19 vaccines for the fall season, with mRNA vaccine manufacturers expected to update their shots once the specific strains are selected.