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August 15, 2022

Novavax asks FDA to authorize its COVID-19 booster shot

To generate an immune response, the vaccine uses more traditional technology than those utilized by Moderna and Pfizer

Novavax is asking the U.S. Food and Drug Administration to authorize its COVID-19 booster shot, pitching its more traditional formulation as an asset in the U.S. vaccination push.  

The two most common booster shots available, made by Moderna and Pfizer-BioNTech, utilize a newer technology to develop an immune response. The Novavax vaccine relies on a protein-based approach that has been used for decades in vaccines against hepatitis B and HPV.

"It's important for people to have a choice as they evaluate how to stay protected against COVID-19, and boosters are an invaluable tool to build upon immunity obtained from previous vaccinations," Novavax CEO Stanley C. Erck said Monday.

In July, the Novavax vaccine was authorized as a primary vaccine series, joining those made by Moderna, Pfizer and Johnson & Johnson. Any adults eligible for a booster, regardless of their primary series, would be able to get a Novavax shot. 

Novavax's submission comes as the public awaits omicron-specific boosters from Moderna and Pfizer. Those vaccines will target the original coronavirus and the two most recent omicron subvariants, BA.4 and BA.5. 

The Novavax booster only targets the original virus, but its vaccine has been billed as an option for people who have been reluctant to utilize the other vaccines. 

The vaccines made by Pfizer and Moderna use similar mRNA technology that uses the genetic code of the coronavirus to trigger an immune response. The J&J vaccine uses a genetically-modified virus, but the U.S. Centers for Disease Control and Prevention has recommended it only be used in limited circumstances due to safety concerns. 

The Novavax vaccine contains a full-length spike protein of the coronavirus mixed with an adjuvant to boost immune response. The protein cannot replicate or cause disease. This technology also has been used to develop an influenza vaccine that has been available in the U.S. for almost a decade.

The CDC recommends everyone ages 6 months and older get vaccinated against COVID-19. Those ages 5 and older are eligible for booster shots, but children only can receive the Moderna or Pfizer boosters. Adults ages 50 and older, and people who are immunocompromised, can get a second booster dose. 

Novavax based its application for a booster on data in a pair of trials. In one study, healthy adults received the booster dose at least 6 months after their primary two-dose vaccination series of the Novavax vaccine. In the other, their primary series was from another COVID-19 vaccine.

According to study findings, all participants experienced a robust antibody response. Major adverse side effects were rare. 

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