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HomeNewsFDA Authorizes Novavax Covid-19 Shot as Booster for Adults

FDA Authorizes Novavax Covid-19 Shot as Booster for Adults


The Food and Drug Administration granted emergency authorization to

Novavax Inc.’s

Covid-19 shot as a booster for adults.

The shot targets the original strain of the virus, whereas the updated booster shots from

Moderna Inc.


Pfizer Inc.

and its partner

BioNTech SE,

authorized in August by the FDA, target both the original strain and newer Omicron strains. The Novavax shot also uses a protein platform, whereas the other two companies’ boosters use messenger RNA, a newer technology.

The Novavax booster was authorized on Wednesday for adults who received a primary series of vaccines at least six months prior and who don’t want or can’t access or might have medical reasons to avoid the dual-target booster shots from Pfizer or Moderna.

Centers for Disease Control and Prevention Director

Rochelle Walensky

then signed off on the Novavax shot, the last step before the booster is available to patients.

“According to CDC data, almost 50% of adults who received their primary series have yet to receive their first booster dose,” said

Stanley Erck,

Novavax’s president. “Offering another vaccine choice may help increase Covid-19 booster vaccination rates for these adults.”

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The FDA’s decision was based on clinical trial data showing that Novavax’s booster increased antibodies both in patients who earlier received Novavax primary shots or who received messenger RNA shots.

Novavax recommended patients use to find available doses of its shots.

The shot was already authorized as a booster in the European Union, Japan, Australia, New Zealand, Switzerland and Israel, the company said.

More than 35,000 doses of the Novavax vaccine have been administered in the U.S. so far, according to CDC data, whereas more than 600 million doses of primary messenger RNA vaccines have been administered.

Similar to other Covid-19 vaccines, Novavax’s shot comes with rare risks of allergic reaction and heart-inflammation conditions myocarditis and pericarditis, the FDA said.

Also on Wednesday, a key committee for the European Medicines Agency, Europe’s top health regulator, recommended authorization of Moderna’s dual-target booster.

Write to Liz Essley Whyte at [email protected]

Copyright ©2022 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8

Appeared in the October 20, 2022, print edition as ‘Novavax Covid Booster Shot Authorized for Use by Adults.’


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