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FDA Approves Updated COVID-19 Vaccines from Pfizer and Moderna Targeting XBB.1.5 Omicron Variant

• The FDA has approved updated COVID-19 vaccines from Pfizer and Moderna, targeting the Omicron subvariant XBB.1.5, for individuals 12 years and older, with emergency use authorization for children aged 6 months to 11 years. • These updated vaccines are poised for imminent distribution across the U.S. following a CDC advisory panel recommendation, amidst rising COVID-19 hospitalizations, offering reassurance as cases increase. • While the updated vaccines do not specifically target currently dominant variants like EG.5 (Eris), manufacturers assert they will still provide protection against these strains as the school year commences and temperatures drop. • Health officials are encouraging individuals to receive the updated COVID-19 vaccine alongside their annual flu shot, as hospitalizations have increased for seven consecutive weeks, rising over 15% in late August.

The Food and Drug Administration (FDA) has approved updated COVID-19 vaccines from Pfizer and Moderna, setting the stage for distribution across the United States as hospitalizations due to the virus are on the rise. These updated vaccines target the XBB.1.5 omicron subvariant and are approved for individuals 12 years and older, with emergency use authorization for children aged 6 months through 11 years.

Vaccine Availability and Recommendations

While the updated vaccines from Pfizer and Moderna are approved, their immediate availability hinges on the Centers for Disease Control and Prevention (CDC). A CDC advisory panel is scheduled to convene and vote on recommendations for the use of these vaccines. Following the CDC director's endorsement, the vaccines will be accessible at pharmacies, health clinics, and other vaccine distribution sites.
The Biden administration had previously indicated that the new single-strain vaccines from Pfizer, Moderna, and Novavax, all targeting XBB.1.5, were expected to be available to the public by mid-September. Pfizer CEO Albert Bourla stated, "We expect this season's vaccine to be available in the coming days, pending recommendation from public health authorities." Both Bourla and Moderna CEO Stéphane Bancel have advocated for individuals to receive their updated COVID-19 shot concurrently with their annual flu shot.

Novavax Vaccine Review

The FDA has not yet announced a decision regarding Novavax's updated COVID-19 shot. Novavax reported that the agency is still in the process of reviewing its vaccine. Novavax's vaccine employs protein-based technology, a well-established method used in routine vaccinations against diseases like hepatitis B and shingles. In contrast, the Pfizer and Moderna vaccines utilize messenger RNA (mRNA) technology, which instructs cells to produce proteins that trigger an immune response against COVID-19.

Impact on Rising COVID-19 Cases

The arrival of updated vaccines provides a degree of reassurance as the nation experiences an increase in COVID-19 cases and hospitalizations. Hospitalizations have been on the rise for seven consecutive weeks, with a more than 15% increase for the week ending August 26, reaching 17,418, according to the latest CDC data. However, this figure remains below the surge observed in the summer of 2022, when hospitalizations exceeded 40,000.
The increase in cases is driven by newer strains of the virus, closely related to XBB.1.5, such as EG.5, also known as Eris. As of September 2, the CDC reported that this omicron strain accounted for 21.5% of all cases. Meanwhile, the prevalence of XBB.1.5 is declining in the U.S.

Protection Against Current Strains

Although the updated vaccines do not specifically target the currently dominant variants, vaccine manufacturers assert that the shots will still offer protection against these strains as children return to school and the weather cools down.
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[1]
FDA approves updated Covid vaccines from Pfizer and Moderna as ...
cnbc.com · Sep 11, 2023

FDA approved updated Pfizer and Moderna Covid vaccines targeting XBB.1.5 for ages 12+, with emergency use for younger ch...

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