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FDA Plans New Rules for COVID-19 Boosters: Annual Shots May Soon Be Limited to High-Risk Americans

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the staff of the Ridgewood blog

Ridgewood NJ, the U.S. Food and Drug Administration (FDA) has announced major changes to how annual COVID-19 boosters are approved in the U.S., signaling a shift in vaccination policy that could limit eligibility to older adults and high-risk individuals. The new guidance, published in the New England Journal of Medicine, emphasizes the need for new clinical trials before extending yearly COVID-19 vaccines to healthy Americans under age 65.

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Novavax COVID-19 Vaccine Demonstrates Near 90% Efficacy in UK Phase 3 Trial

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the staff of the Ridgewood blog

GAITHERSBURG MD,  Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that NVX-CoV2373, its protein-based COVID-19 vaccine candidate, met the primary endpoint, with a vaccine efficacy of 89.3%, in its Phase 3 clinical trial conducted in the United Kingdom (UK). The study assessed efficacy during a period with high transmission and with a new UK variant strain of the virus emerging and circulating widely. It was conducted in partnership with the UK Government’s Vaccines Taskforce. Novavax also announced successful results of its Phase 2b study conducted in South Africa.

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