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Three Pharmaceutical Companies Announce U.S. FDA Approval for Updated COVID-19 Vaccinations.
Pfizer and BioNTech’s COMIRNATY® has been approved for adults 65 and older and individuals ages 5-64 with underlying conditions that increase risk for severe COVID-19. Moderna received approval for updated COVID-19 vaccines targeting the LP.8.1 variant of SARS-CoV-2. The updated formulas for Spikevax and mNEXSPIKEare approved for people 64 years of age and older, and individuals 6 months and older who have underlying conditions that may increase their risk for severe COVID-19. And Novavax's Nuvaxovid™ 2025-2026 formula COVID-19 vaccine is approved for individuals 65 years of age and older, or 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.
FDA Update on the Safety of Ixchiq Chikungunya Vaccine
The U.S. FDA’s Center for Biologics Evaluation and Research has suspended the biologics license for Valneva Austria GmbH’s live-attenuated IXCHIQ vaccine. This vaccine was initially approved by the FDA under the accelerated approval pathway in November of 2023 for the prevention of disease caused by the chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV. CBER’s decision is based on serious safety concerns related to the vaccine, which appears to be causing chikungunya-like illness in vaccine recipients. There has been one death from encephalitis directly attributable to the vaccine (CSF PCR was + for the vaccine strain of the virus), and over 20 reported serious adverse events that were consistent with chikungunya-like illness
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