FDA Issues Updated Guidance on Tailoring Covid-19 Vaccines, Testing, and Therapeutics for Coronavirus Variants


The agency said in an announcement Monday that it expects “manufacturing information to remain generally the same” for licensed Covid-19 vaccines that can be updated for target variants. The agency recommended that data from clinical immunogenicity studies be used to support any changes or updates to vaccines.

Such studies would be smaller and could take less time than large-scale clinical trials.

“It’s going to be on the order of a few hundred people in terms of size and we hope that will take a few months,” said Dr. Peter Marks, director of the FDA’s Center for Biological Research and Evaluation, during a Call to Reporters. Monday.

“For clinical data, the guideline recommends that the determination of effectiveness be supported by data from clinical immunogenicity studies, which would compare the immune response of a recipient with the variants of the virus induced by the modified vaccine against the immune response to the vaccine. authorized, “the agency noted. in your ad.

According to FDA guidance, studies to evaluate the effectiveness of the primary injection and booster dose of a Covid-19 vaccine must compare the immune response induced by the modified version of the vaccine with the original vaccine, and researchers must conduct a “booster study” in which the modified vaccine is administered to those who previously received the original vaccine.

“Each of the studies described above can be performed in only one age group,” the guide said. These results can then be extrapolated to other age groups for which the original vaccine has been licensed, and to previously infected individuals in those age groups.

The agency also published a separate guide for Covid-19 testing and therapeutics.

“The FDA is committed to identifying efficient ways to modify medical products that are in the pipeline or have been authorized for emergency use to address emerging variants,” said FDA Acting Commissioner Dr. Janet Woodcock in the announcement on Monday.

“We know that the country is eager to return to a new normal and the emergence of virus variants raises new concerns about the performance of these products,” Woodcock said in part. “By issuing these guidelines, we want the American public to know that we are using every tool in our toolbox to fight this pandemic, including rotation as the virus adapts.”

FDA officials said during Monday’s call that some of the updated guidelines for Covid-19 vaccines build on what has already been done for the development of seasonal flu vaccines.

“We have experience with the fact that viruses change over time and seasonal influenza changes very frequently,” Woodcock said during the call.

Marks added: “What we are doing here that is similar is trying to take advantage of the change with the minimum amount of additional data that we need to make things easier. We are trying to prepare in advance, as we would for influenza.”

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