Moderna Asks FDA to Authorize COVID-19 Vaccine Boosters for All Adults

By Zachary Stieber
Zachary Stieber
Zachary Stieber
Reporter
Zachary Stieber covers U.S. news, including politics and court cases. He started at The Epoch Times as a New York City metro reporter.
November 17, 2021 Updated: November 17, 2021

Moderna on Wednesday asked U.S. drug regulators to widen authorization for additional doses of its COVID-19 vaccine.

The Massachusetts-based biotechnology firm wants every American 18 or older to be able to get a booster.

The Food and Drug Administration (FDA) recently allowed boosters of the Moderna and Pfizer COVID-19 vaccines, which both have two-shot primary regimens, but only for select groups.

In a brief statement issued Wednesday afternoon, Moderna said it submitted an application for emergency use authorization at the 50 microgram dose level for all adults 18 or older.

The FDA has told The Epoch Times it cannot comment on timelines for responding to such filings. “We are committed to quickly and thoroughly reviewing all submitted applications, including requests for emergency use authorization, to speed patient access to medicines to prevent or treat COVID-19 provided they meet the agency’s rigorous standards,” a spokesperson said in an email this week.

Pfizer already filed for authorization for boosters of its shot for every American 16 and older.

The FDA confirmed earlier Wednesday it will decide on that filing without input from its expert advisory panel.

The Advisory Committee on Immunization Practices, which advises the Centers for Disease Control and Prevention (CDC) on vaccine recommendations, is set to meet Friday. The meeting agenda has not yet been released.

The FDA decides whether to authorize vaccines and drugs. If authorization is granted, the CDC decides which populations can get the authorized products.

Biden administration officials announced over the summer that all adults should get a booster due to waning vaccine effectiveness, but they made their announcement while regulators were weighing authorizing boosters and were challenged by top FDA scientists and the expert advisory panel.

Utimately, the Moderna and Pfizer boosters were limited to everybody 65 or older and those younger who have serious underlying health conditions or can be deemed at high risk of COVID-19 exposure due to their jobs or living situations.

Johnson & Johnson’s booster was authorized and allowed for everybody who got the jab because its effectiveness dropped so much.

Moderna’s vaccine is considered to be the most powerful of the three but also the one that leads to the most side effects.

Multiple European countries have paused use of the jab in recent weeks because of concerns about post-vaccination effects, principally heart inflammation.

Moderna last week acknowledged the higher heart inflammation risk but said that its vaccine also offers better protection. The company continues to insist the benefits of its jab outweigh the risks.

The FDA has publicly affirmed its confidence in the vaccine but also last month pushed back a decision on letting 12- to 17-year-olds get it.

Zachary Stieber
Zachary Stieber covers U.S. news, including politics and court cases. He started at The Epoch Times as a New York City metro reporter.