Novavax’s COVID Vaccine Finally Receives FDA Authorization for Use Without Vaccination

in great shape , Novavax Inc. Empty vials of Nuvaxovid COVID-19 vaccine are arranged at the Tegel Vaccine Center on Monday, March 7, 2022 in Berlin, Germany.

The US Food and Drug Administration on Wednesday issued the long-awaited authorization for Novavax’s COVID-19 vaccine. It is the fourth COVID-19 vaccine to receive authorization in the US, but it is the first to use a more traditional protein-subunit design.

For now, the two-dose vaccine is primarily targeted at the approximately 72 million Americans who have not yet received a single dose of a COVID-19 vaccine. The FDA’s emergency use authorization only allows its use as a primary series, not a booster for those already vaccinated. Although Novavax is expected to receive booster authorization later, the company and the FDA expect the vaccine’s conventional formulation now to tempt vaccination holdouts, especially as BA.5 is widespread in the country.

Some regard the vaccine’s protein-subunit design as a more tried-and-true design relative to the new mRNA-based platform used in major COVID-19 vaccines made by Pfizer-BioNtech and Moderna. While mRNA-based vaccines made their public debut during the pandemic, protein-subunit-based vaccines were already in use against a variety of diseases, including hepatitis B, flu, pertussis (whooping cough) and meningococcal infection.

To fight COVID-19, the Novavax vaccine directly delivers the SARS-CoV-2 spike protein, which is manufactured largely in insect cells. The vaccine also contains an adjuvant, which is an additive that enhances the immune response. In this case, adjuvants include an extract of saponins from the Chilean soap tree previously used in FDA-approved vaccines.

long awaited option

At a meeting of FDA advisors last month, the agency’s top vaccine regulator Peter Marks expressed the need for more vaccine options in the US. “We have a problem with getting a vaccine that is very serious in the United States, and everything we can do to get people to be able to accept these potentially life-saving medical products is something that we think we can do. are forced to,” Marx said. As such, many experts were eager to see the Novavax vaccine authorized. However, the vaccine, which has been in development for two years, was significantly delayed due to a string of manufacturing failures that have recently been cleared up.

Still, at the June meeting, FDA advisers voted almost unanimously in favor of the FDA authorizing the vaccine. In a large trial of more than 25,000, the vaccine appeared to be 90.4 percent effective against COVID-19, although the testing was done before the Delta and Omicron variants emerged. The vaccine also appears generally safe, although it does come with an increased risk of myocarditis and pericarditis (inflammation of the heart and surrounding tissue). Ultimately, 21 of 22 FDA advisors voted in favor of the authorization, while one expert did not participate, citing a lack of version-specific efficacy data.

“Today’s authorization provides adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s strict standards for safety, effectiveness, and manufacturing quality necessary to support emergency use authorization. meets the standards. COVID-19 vaccines remain the best preventive measure against the serious disease caused by COVID-19,” FDA Commissioner Robert Calif said in a statement Wednesday. I encourage anyone who is eligible, but has not yet received a COVID-19 vaccine, to consider doing so.”

Authorities as federal officials are renewing efforts to raise land vaccination rates, which have largely stagnated. Last week, Novavax announced that the US government had signed an agreement to buy 3.2 million doses. But, before the Novavax shots can start going up in arms, the Centers for Disease Control and Prevention will need to sign off. CDC advisers are expected to convene next week to discuss the vaccine.

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