FDA Outlines Data Required for Modifying COVID-19 Vaccines Against Viral Variants
Following through on its statement that it doesn’t expect COVID-19 vaccine sponsors to conduct separate large-scale trials to address variants of the virus, the FDA has outlined additional information the agency needs to amend current Emergency Use Authorizations (EUA).
The agency said it expects trials for modified vaccines will take approximately two to three months and consist of “a few hundred individuals.” The guidance, which replaces a guidance of the same name issued in October 2020, also encourages vaccine-makers to include both nonvaccinated participants and those previously vaccinated with the authorized vaccine in trials for amended EUAs.
However, the agency’s new guidance says that evaluating the modified version in a larger safety database than initially planned for immunogenicity studies may be necessary. The FDA also released a guidance last week on monoclonal antibody variant trials.
In addition, the FDA put out a revised guidance, first issued in May 2020, that outlines in a broader sense its recommendations for phase 2 and 3 clinical trials for drugs and biological products being developed for treating COVID-19 variants.
Read the COVID-19 vaccine guidance here: https://bit.ly/2O26BN7.
Read the COVID-19 monoclonal antibody guidance here: https://bit.ly/3b0oyVh.
Read the COVID-19 drugs and biological products guidance here: https://bit.ly/3ktkKyU.