The Trump administration is imposing new clinical trial requirements on Novavax's COVID-19 vaccine, causing uncertainty for updates to other vaccines. The FDA has suggested Novavax conduct a new trial post-approval, raising doubts about the timely adjustment of vaccines amid ongoing virus mutations. Experts express concern that if strain changes necessitate new trials, vaccine updates could be delayed indefinitely. This shift follows the ousting of the FDA's vaccine chief, aligning with Health Secretary Robert F. Kennedy Jr.'s controversial approach towards vaccine regulation and oversight.
The FDA's new requirement for a fresh clinical trial for Novavax's vaccine raises uncertainty about potential updates to other COVID-19 vaccines, spurring worries.
Dr. Jesse Goodman suggests that requiring new trials for every strain change would ultimately hinder the timely availability of updated vaccines.
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