Moderna Seeks FDA’s Emergency Use Authorization Of COVID-19 Booster Shots
Drug maker Moderna Inc. (MRNA) Wednesday announced that it has filed an application with the U.S. Food and Drug Administration seeking emergency use authorization of its Covid-19 booster vaccine shots for all adults ages 18 and up.
The company’s booster vaccine for adults “regardless of occupational risk factors” is already authorized in many international markets, Moderna said in a statement.
The FDA had last month approved a third Moderna vaccine booster shot for everyone 65 years and older as well as other adults who are at higher risk of catching the virus and received their second dose more than six months prior.
If approved, the authorization would allow tens of millions of Americans to get a third vaccine dose, as data shows that the vaccine loses efficacy over the time.
Meanwhile, a panel of Centers for Disease Control and Prevention is set to meet this Friday to discuss data regarding Pfizer-BioNTech’s request for approval of the booster shots. According to New York Times, the FDA might authorize booster doses of the Pfizer-BioNTech vaccine as early as Thursday.
Pfizer’s booster dose, like Moderna’s, were previously approved by FDA for older people as well as others with high-risk. Meanwhile, people ages 18 and older who have received Johnson & Jonson’s single-dose vaccine are eligible for a booster.
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