The FDA could authorize the use of Moderna (NSDQ:MRNA) COVID-19 vaccine boosters at a half-dose level, according to a report from Bloomberg.
Each primary series dose of the Moderna vaccine contains 100 µg of mRNA. By contrast, the Pfizer-BioNTech vaccine uses a 30-µg dose level for the primary series and boosters.
Earlier this month, Moderna CEO Stéphane Bancel said that recent data from its Phase 3 COVD study “supports the need for a booster to maintain high levels of protection.”
E.U. authorities are also reviewing data related to booster doses of the Moderna vaccine.
In addition, the European Medicines Agency is considering authorizing a booster dose of the Pfizer-BioNTech vaccine. The agency said it hopes to announce its decision in early October.
NIAID Director Dr. Anthony Fauci ultimately predicts that regulatory authorities will view mRNA vaccines as requiring three doses.
While U.S. authorities now recommend matching boosters to the same type used in the primary series, NIH is studying so-called mix-and-match vaccine regimens.
Filed Under: clinical trials, Drug Discovery, Infectious Disease