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A key advisory committee to the Food and Drug Administration met on Thursday to discuss the future of COVID-19 vaccination in the United States.
The FDA is reversing course on its COVID vaccine guidance: Rather than having a vaccine that targets the older JN.1 variant, the FDA said fall 2024 vaccines should target a newer strain of the virus.
All RMPs for COVID‑19 vaccines will be published on the EMA's website. [136] The EMA published guidance for developers of potential COVID‑19 vaccines on the clinical evidence to include in marketing authorization applications. [137] In November 2020, the CHMP started a rolling review of the Moderna vaccine for COVID‑19 known as mRNA-1273 ...
The FDA advised drugmakers to update Covid vaccines to target the KP.2 strain, a descendant of the highly contagious JN.1 variant that spread widely in the U.S. this winter.
As early as March 2020, the World Health Organization (WHO), [2] European Medicines Agency (EMA), [3] US Food and Drug Administration (FDA), [4] and the Chinese government and drug manufacturers [5] [6] were coordinating with academic and industry researchers to speed development of vaccines, antiviral drugs, and post-infection therapies.
The Bureau was transferred from the NIH to the FDA in 1972, where it was renamed Bureau of Biologics and focused on vaccines, serums for allergy shots, and blood products. [8] Ten years later, with the beginning of the biotechnology revolution, the line between a drug and a biologic, or a device and a biologic, became blurred. [8]
In June 2024, the FDA advised manufacturers of licensed and authorized COVID-19 vaccines that the COVID-19 vaccines (2024-2025 formula) should be monovalent JN.1 vaccines. [78] Based on the further evolution of SARS-CoV-2 and a rise in cases of COVID-19, the agency subsequently determined and advised manufacturers that the preferred JN.1 ...
The Food and Drug Administration's change in recommendation, in an update dated Thursday, comes even as Moderna and Novavax — makers of two of the three COVID vaccines — submitted their ...