Responding to the rise of variants, the US FDA has issued new guidance for pharmaceutical companies on adapting COVID-19 vaccines, tests, and treatments such as monoclonal antibodies.
New vaccines that protect against variants will not have to go through large, randomized controlled trials required for initial versions of the vaccines, The New York Times reports.
Instead: The agency called for smaller, speedier clinical immunogenicity studies that would compare the immune response induced by modified vaccines to the original version, CNN reports.
“Booster studies” would need to be done for administering modified vaccines to those who have already received first-generation COVID-19 vaccines.
The vaccine guidance is likened to the process of updating seasonal flu vaccines. It may eventually be possible to move closer to a flu vaccine model in which vaccine updates are tested in a lab, rather than in clinical trials.
Still Up in the Air: The FDA says current vaccines are effective against the strains now circulating. What’s not yet known, the Times reported, is exactly what data would point to the need for producing a new vaccine version--or who would make the call.
For treatment trials, the agency called on drugmakers to adopt a more inclusive approach, MedPage Today reports:
- Prioritize enrolling racial and ethnic minority groups hardest-hit by the pandemic
- Enroll pregnant and lactating women in Phase III trials where appropriate
- Not categorically exclude children from experimental treatment trials