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FDA Authorizes Novavax’s Covid-19 Vaccine For Adults

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Topline

The Food and Drug Administration on Wednesday issued an emergency use authorization for the Novavax Covid-19 vaccine, giving Americans 18 and older a fourth vaccine choice as the U.S. moves to expand inoculations as the BA.5 omicron subvariant spreads.

Key Facts

The Novavax vaccine schedule consists of two doses three weeks apart, and contains a small Covid-19 “spike protein” that teaches the immune system to recognize and fight off future infections utilizing older technology used in shingles and hepatitis B vaccines.

Trials show the vaccine is 90.4% effective in preventing mild, moderate or severe Covid-19 infections, and no cases of moderate or severe COVID-19 were reported in the 17,200 participants who received the vaccine.

Officials hope the protein-based Novavax vaccine will be an attractive option for Americans who are resistant or unable to receive the vaccines manufactured by Pfizer-BioNTech and Moderna, which utilize a new mRNA technology (About one in five Americans have not received a first Covid-19 vaccine, according to the Centers for Disease Control and Prevention).

Key Background

The Novavax vaccine has already been approved for use and administered in dozens of countries and the European Union. The Biden administration announced Monday it had secured 3.2 million Novavax doses to distribute nationwide upon FDA authorization. In development for two years, the vaccine was plagued by manufacturing issues. Last week, the CDC announced that the new BA.5 omicron subvariant was the dominant form of Covid-19 circulating in the U.S. and driving an increase of new infections and hospitalizations.

Further Reading

U.S. Secures 3.2 Million Novavax Covid Vaccines — Offering Alternative To MRNA Shots As New Variant Spreads (Forbes)

Highly Contagious BA.5 Variant Becomes Dominant In U.S. As Covid Cases Rise (Forbes)

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