Sunday, April 14, 2024

Novavax Receives FDA Approval for Updated COVID-19 Vaccine Targeting XBB.1.5 Variant

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The US Food and Drug Administration (FDA) has granted approval for Novavax to release an updated version of its COVID-19 vaccine specifically designed to combat the XBB.1.5 variant of the coronavirus. This protein-based vaccine joins the ranks of Pfizer/BioNTech and Moderna’s mRNA-based vaccines, offering an additional option for the upcoming US immunization campaign.

Novavax’s vaccine is approved for individuals aged 12 and over, while the mRNA vaccines from Pfizer and Moderna are authorized for those aged six months and older. The Centers for Disease Control and Prevention (CDC) will accept the FDA’s decision, making it easier for Novavax to enter the market.

This approval marks a significant turnaround for Novavax, which had faced manufacturing complications with its first-generation product during the pandemic. The company’s recent success includes $424 million in sales in the second quarter, bolstering its prospects for the fourth quarter as it develops other vaccine candidates, such as a combination influenza/COVID-19 shot.

The FDA emphasized that Novavax’s vaccine meets its safety, effectiveness, and manufacturing quality standards and encourages eligible individuals to consider getting updated COVID-19 vaccines for better protection against evolving variants. As infections begin to rise with the approach of colder months, the availability of vaccines targeting specific variants is crucial in curbing the spread of the virus and reducing severe COVID-19 cases.

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