The agency said in an announcement on Monday that it expects “manufacturing information to generally remain the same” for authorized 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.
These studies would be smaller and take less time than large-scale clinical trials.
“It will be in the order of a few hundred individuals in terms of size and we hope it will take a few months,” said Dr. Peter Marks, director of the FDA’s Center for Biological Research and Evaluation, during a call with reporters on Monday.
“For clinical data, the guidance recommends that a determination of efficacy be supported by data from clinical immunogenicity studies, which would compare a recipient’s immune response to variants of the virus induced by the modified vaccine against the immune response to the authorized vaccine,” noted the agency in your ad.
“Each of the studies described above can be conducted in a single age group,” said the guide. These results can then be extrapolated to other age groups for which the original vaccine was authorized – and to people previously infected in those age groups.
The agency released separate guidelines for testing and therapies for Covid-19 as well.
“The FDA is committed to identifying efficient ways to modify medical products that are in development or have been authorized for emergency use to deal with emerging variants,” said Dr. Janet Woodcock, interim FDA commissioner, in the announcement on Monday.
“We know that the country is eager to return to a new normality and the emergence of variants of the virus raises new concerns about the performance of these products,” said Woodcock in part. “In issuing these guidelines, we want the American public to know that we are using all the tools in our toolbox to combat this pandemic, including rotation as the virus adapts.”
FDA officials said during Monday’s call that some of the updated Covid-19 vaccine guidelines are modeled after what is already done for the development of seasonal flu vaccines.
“We have experience with the fact that viruses change over time and seasonal influenza changes very often,” said Woodcock during the call.
Marks added: “What we are doing here that is similar is trying to leverage change with the minimum amount of extra data we need to make things easier. We are trying to prepare in advance, as we would do for the flu.”