The agency said in an announcement Monday that it expects “manufacturing information will generally remain the same” for authorized Covid-19 vaccines that can be updated to target the variant. The agency recommended that data from clinical immunogenicity studies be used to support any changes or updates to vaccines.
Such studies will be smaller and may take less time than large-scale clinical trials.
“It’s going to be in the order of a few hundred individuals in terms of size, and we would expect it to take a few months,” said Dr. Peter Marks, director of the FDA’s center for evaluation and research on biology, during a link Monday with reporters.
“For clinical data, the guidance recommends that a determination of efficacy be supported by data from clinical immunogenicity studies, comparing the immune response of a recipient with virus variants induced by the modified vaccine with the immune response to the authorized vaccine,” he said. the agency noted. in his announcement.
“Each of the studies described above can be done in a single age group,” the guidance said. These results can then be extrapolated to other age groups for which the original vaccine was approved – and to people previously infected in the age groups.
The agency also released separate clues for Covid-19 tests and therapeutic agents.
“The FDA is committed to identifying effective ways to alter medical products that are in the pipeline or authorized for emergency use to address emerging variants,” said Dr. Janet Woodcock, acting commissioner of the FDA, said in the announcement on Monday.
“We know the country is eager to return to a new normal, and the rise of the virus variant 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 the twist as the virus adjusts.”
FDA officials said during Monday’s call that some of the updated clues for Covid-19 vaccines are based on what is already being done for the development of seasonal flu vaccines.
“We have experience with the fact that viruses change over time and that seasonal flu changes very frequently,” Woodcock said during the call.
Marks added: “What we’re doing similarly here is trying to take advantage of the change with the minimal amount of extra data we need to make things easier. We’re trying to prepare in advance, like for flu.”