Prognosis
FDA Outlines Fast Path for Shots Against New Virus Variants
- Variants are already causing problems for testing, treatment
- Agency’s moves intended to speed reaction to virus mutations
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Drugmakers won’t have to perform massive trials for new vaccines or booster shots developed to combat worrisome new variants of the coronavirus, the U.S. Food and Drug Administration said.
In documents released by the agency Monday, it said immunizations that protect against the variants could receive clearance based on so-called immunogenicity studies, where researchers vaccinate people and then conduct laboratory tests to measure the strength of their immune response. These tests, similar to what is done for annual flu shots, are far simpler than the standard efficacy studies used for clearance of the initial vaccines, which involved thousands of volunteers and took months of work.