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FDA Approves Novavax’s Enhanced COVID-19 Vaccine Update

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The Food and Drug Administration (FDA) has granted emergency use authorization for Novavax’s updated COVID-19 vaccine for individuals aged 12 and above. This authorization paves the way for the vaccine to be rolled out shortly after the recent authorizations for new jabs from Pfizer and Moderna. Novavax’s vaccine is specifically designed to target the omicron subvariant XBB.1.5 and requires an updated recommendation from the Centers for Disease Control and Prevention (CDC) before it can be accessed by patients at various distribution sites. Novavax expects the CDC’s recommendation to be given soon, with doses of the vaccine becoming available in the coming days.

Novavax’s authorization offers people the option of a protein-based non-mRNA vaccine to protect against COVID-19. This alternative may appeal to individuals who are hesitant to receive messenger RNA shots from Pfizer and Moderna. The Novavax vaccine utilizes protein-based technology, which has been used in routine vaccinations against illnesses like hepatitis B and shingles for many years. The FDA and CDC previously greenlit XBB.1.5 shots from Pfizer and Moderna for all Americans aged six months and older, and it is expected that the same eligibility guidelines will apply to Novavax’s updated vaccine.

The rollout of Novavax’s vaccine is occurring during a surge in COVID-19 cases and hospitalizations in the US. While the current levels are lower than previous waves, they mark the first significant increase since last winter and have prompted the revival of mask mandates in some businesses and schools. The rise in cases is driven by newer strains of the virus, such as the EG.5 or Eris variant. Novavax’s vaccine has shown a broad immune response against these newer strains, but it remains uncertain whether it will be effective against the highly mutated BA.2.86 strain. The launch of Novavax’s vaccine also coincides with the end of the US COVID-19 public health emergency, meaning that all three manufacturers—Novavax, Pfizer, and Moderna—will now sell their vaccines directly to healthcare providers and compete in the commercial market.

Overall, Novavax’s authorization provides another option for individuals seeking protection against COVID-19, particularly those who may be hesitant to receive mRNA vaccines. With the expected availability of Novavax’s vaccine in the coming days, it is hoped that the combination of vaccines from Novavax, Pfizer, and Moderna will help combat the spread of the virus in the US during the fall and winter seasons, when infection rates typically rise.

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