Two recombinant vaccines, Arexvy (GSK) and Abrysvo (Pfizer), have been approved by the FDA for prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults ≥60 years old. They are the first RSV vaccines to be approved in the US. Abrysvo is also approved for use in pregnant women at 32-36 weeks' gestation to prevent LRTD caused by RSV in their infants from birth through 6 months of age.
RSV DISEASE ― RSV typically causes a mild upper respiratory tract infection, but infants <6 months old and older adults, particularly those with...
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RELEASE
New 2023-2024 formulations of the mRNA COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) that more closely target currently circulating variants have been licensed by the FDA for use in persons ≥12 years old and made available under FDA Emergency Use Authorizations (EUAs) for use in persons 6 months to 11 years old. The bivalent (original and Omicron BA.4/5) formulations of the Pfizer and Moderna vaccines are no longer authorized for use in the US.1-3
THE NEW VACCINES – The new formulations are monovalent vaccines that code for the spike protein of the XBB.1.5 Omicron strain of SARS-CoV-2.
EFFICACY – No clinical studies evaluating the effectiveness of the new vaccine formulations are available. Licensure and authorization of both vaccines were based on safety and efficacy data …