FDA Prepares To Escalate Covid Strategies To Counter Variants
More booster shots of vaccine as well as additional testing and treatment drug capacity will be needed if the spread of new coronavirus strains picks up, as experts worry will happen. The FDA will release new guidance in the coming weeks to respond.
Biden Health Team Hatches New Vaccine Strategy As Variant Threat Builds
The Food and Drug Administration is preparing to release new standards for Covid-19 vaccine booster shots, tests and drugs in the coming weeks — all aimed at preparing the country to beat back fast-spreading virus variants that are less susceptible to existing shots. The agency confirmed Thursday that it plans to release draft guidance. It could come in two to three weeks, according to four people familiar with the discussion. In the meantime, federal and state officials are scrambling to track how widely the coronavirus variants first found in South Africa, Brazil and the United Kingdom are spreading in the United States. (Owermohle and Lim, 2/4)
U.S. FDA Gearing Up For Rapid Review Of Potential COVID-19 Booster Shots
The U.S. Food and Drug Administration is planning a rapid review process for quick turnaround of new COVID-19 booster shots if variants of the coronavirus emerge against which the vaccines do not provide protection, the agency’s top official said on Thursday. Dr. Janet Woodcock, acting commissioner of the FDA, said that if new variants of the coronavirus emerge that require booster shots or changes to vaccines, the agency will not require the type of large trials that were required for emergency use authorization or approval. (2/4)
FDA Announces Plan To Draft Guidance To Contend With COVID-19 Variants
Concerned about new variants of the virus that causes COVID-19, the U.S. Food and Drug Administration announced late Thursday that it is developing guidance to help vaccine, drug and testing manufacturers adapt. Existing vaccines, treatments and tests still work well, emphasized the FDA's acting commissioner Janet Woodcock. But now is the time to get ready for a future when they may not. "We must prepare for all eventualities," she said in a call with reporters. Within the next few weeks, the FDA will provide draft guidance to manufacturers on how to adapt their products as needed, Woodcock said. Feedback from companies and others will help refine that guidance. (Weintraub, 2/4)