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Vaccines Adapted for New Variants won’t need Lengthy Trials, says FDA

Evaluation of vaccines has been adapted to target the concerning coronavirus variants. On Monday, the Food and Drug Administration (FDA) said lengthy randomized controlled trials would not be required this time. As necessary for annual flu vaccines, small tests are more than enough to accelerate the review process of these vaccines. With the increasing anxiety of scientists regarding how the variants might slow the process, this might speed things up.

On Monday, a part of the new documents was released by the agency. Guidance, including addressing the treatment of antibodies and diagnostic tests that need retooling, was issued in the release. The federal government made the most detailed acknowledgment regarding the threats the variants pose to existing vaccines.

Dr. Janet Woodcock, FDA’s acting commissioner, said that the agency was developing a plan. In a statement on Monday, Woodcock said, “We want the American public to know that we are using every tool in our toolbox to fight this pandemic, including pivoting as the virus adapts.”

According to the new variants, several authorized vaccine producers or candidates in the last stage trials have announced to make adjustments in their products. The mRNA technology used by The Moderna and Pfizer-BioNTech vaccines would take about six weeks to alter, say the companies. However, the testing and manufacturing would require more time after the alteration.

With the rise of the South African variant, Moderna has already started developing a vaccine booster. The new version of the vaccine will be given as a booster shot to the public.

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