Manufacturer is seeking blanket authorization for all adults

Moderna announced it is requesting that the FDA expand the emergency use authorization (EUA) for its Covid-19 vaccine, mRNA-1273, to include boosters for all adults 18 and older.

The vaccine manufacturer announced its new filing in a brief statement on Nov. 17, making mRNA-1273 the second Covid-19 shot lined up to receive an expanded booster authorization—rumors that Pfizer and BioNTech planned to request a similar EUA revision began swirling earlier this month, and the FDA is expected to grant the request before the week is out.

Booster doses of mRNA-1273—consisting of a single 50 μg shot, half of a primary series dose—were originally cleared by the FDA on Oct. 20, but like Pfizer-BioNTech’s BNT162b2 before it, the booster indication was limited to individuals ages 65 and older and individuals ages 18 and older who are either at risk of severe Covid-19 illness or complications due to underlying medical conditions or face high work or institution-related exposure. Booster doses of Johnson & Johnson’s adenovirus-vectored Covid vaccine gained FDA authorization for use in all adults on the same day.

Moderna’s request comes as a growing number of U.S. states have begun attempting to circumvent current FDA and CDC guidelines and offer Covid boosters to all adults in hopes of fending off a new Covid spike during the holidays, according to reporting in the Washington Post.

If Pfizer and Moderna’s new EUA applications are approved, then soon all U.S. individuals age 18 or older may be eligible to receive a booster dose of either mRNA-based Covid-19 vaccine—and patients can choose which of the vaccines they prefer, due to the authorization of heterologous booster dosing for all currently authorized Covid-19 vaccines.

John McKenna, Associate Editor, BreakingMED™

Cat ID: 31

Topic ID: 79,31,730,933,31,926,561,927,725,928,925,934