The Food and Drug Administration said this week that vaccine developers no need for long randomized controlled trials for vaccines which have been adapted to protect against the relevant coronavirus variants. From a report: The recommendations, which call for small trials more like those required for annual influenza vaccines, would speed up the review process significantly at a time when scientists are increasingly concerned about how variants might slow down or reverse. progress against the virus. The guidelines were part of a list of new documents the agency released on Monday, including others dealing with how antibody treatments and diagnostic tests may need to be rearranged to respond to variants of the virus. Together, they represented the most detailed recognition by the federal government of the threat the variants pose to existing vaccines, treatments and tests for the coronavirus, and came weeks after Acting FDA Commissioner Dr. Janet Woodcock said the agency was making a plan.
“The emergence of variants of the virus raises new concerns about the performance of these products,” Dr Woodcock said in a statement Monday. “We want the American public to know that we are using every tool in our toolkit to fight this pandemic, including the pivot as the virus adapts.” Most vaccine manufacturers with licensed vaccines or candidates in late stage trials have already announced their intention to adjust their products to accommodate vaccine variants. Moderna and Pfizer-BioNTech vaccines use mRNA technology that the companies say can be used to modify existing vaccines within six weeks, although testing and manufacturing take longer. Moderna has already started developing a new version of its vaccine that could be used as a booster shot against a variant of the virus native to South Africa known as B.1.351, which appears to weaken the effectiveness of existing vaccines. . A rapidly spreading coronavirus variant first seen in Britain has also acquired a disturbing mutation that could make it more difficult to control with vaccines. This variant with the mutation was found in the United States last week.
Variant-friendly vaccines won’t require lengthy testing, FDA says
Source link Variant-friendly vaccines won’t require lengthy testing, FDA says