At the April 6 meeting, FDA is asking its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to not only lay out parameters for how to determine when it might be necessary to update the composition of COVID boosters, but how often and how it might be applied to both approved and authorized vaccines.
In the documents released on [April 5], FDA staff appear to be nudging VRBPAC toward a structure similar to that of influenza vaccines, “an approach where strain modifications could be supported by manufacturing information alone,” which would be supported by clinical immunogenicity and safety data, as opposed to the current policy that requires clinical data.
The most important difference is that unlike influenza, COVID does not have “predictable winter seasonality,” where manufacturers can implement recommendations based on flu patterns in the Northern or Southern hemispheres. By contrast, “a predictable pattern for SARS-CoV-2 has yet to emerge,” FDA staff noted.
Related on the SLP
“At this time, it is not clear if or when the epidemiology of SARS-CoV-2 will fall into a pattern that will make a global recommendation for an updated COVID-19 vaccine composition obvious or needed,” they wrote.
