FDA Eases Path For Quicker Covid Vaccine Booster Approvals
With virus variants posing a threat to vaccination efforts, the Food and Drug Administration issued new guidance for manufacturers on a streamlined authorization process for covid booster shots.
The Wall Street Journal:
FDA Looks To Quickly Authorize Covid-19 Vaccine Booster Shots As New Variants Emerge
The Food and Drug Administration said Monday it will quickly analyze any vaccine booster shots against Covid-19 variants such as those from South Africa and the U.K., and won’t require further large clinical trials of the new shots’ effectiveness. The agency issued new guidance for vaccine manufacturers as it looks to establish speedier procedures to deal with virus mutations that could worsen the pandemic. Acting FDA Commissioner Janet Woodcock said in a statement the agency is seeking “efficient ways to modify medical products that either are in the pipeline or have been authorized for emergency use to address emerging variants.” (Burton, 2/22)
Los Angeles Times:
Modified COVID-19 Vaccines May Get Nod From FDA Without Repeating Full Trials
The U.S. Food and Drug Administration issued new guidance Monday that streamlines the vetting process for COVID-19 vaccines that are modified to target new coronavirus variants. The recommendations, detailed in a 24-page document on the FDA’s website, are intended to speed up the review process amid worries that the new variants — some more contagious, some more able to evade current vaccines — will undermine efforts to halt the virus’ spread. (Khan, 2/22)
Bloomberg:
FDA Outlines Faster Path For Shots Against New Covid Variants
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. (Langreth and Fay Cortez, 2/22)
The New York Times:
Vaccines Adapted For Variants Will Not Need Lengthy Testing, F.D.A. Says
The guidance was part of a slate of new documents the agency released on Monday, including others addressing how antibody treatments and diagnostic tests might need to be retooled to respond to the virus variants. Together, they amounted to the federal government’s most detailed acknowledgment of the threat the variants pose to existing vaccines, treatments and tests for the coronavirus, and came weeks after the F.D.A.’s acting commissioner, Dr. Janet Woodcock, said the agency was developing a plan. (Weiland, Thomas and Zimmer, 2/22)
