The Food and Drug Administration (FDA) has indicated that updates to COVID vaccines aimed at virus variants will not need lengthy testing.
As governments around the world roll out COVID vaccines, a pressing concern is the emergence of variants, such as the UK strain and the South African strain. Experts are concerned that some strains may be more contagious and possibly resistant to existing vaccines.
To successfully combat existing and emerging strains, it will be important for vaccine manufacturers to be able to quickly bring updated versions of their vaccines, or boosters, to market. The FDA has removed a big hurdle, indicating that vaccine boosters will not require the same lengthy testing as the original vaccine. Instead, manufacturers will be able to adopt a similar approach as that used with flu vaccines.
“The FDA is committed to identifying efficient ways to modify medical products that either are in the pipeline or have been authorized for emergency use to address emerging variants,” said Acting FDA Commissioner Janet Woodcock, M.D. “We know the country is eager to return to a new normal and the emergence of the virus variants raises new concerns about the performance of these products. By issuing these guidances, we want the American public to know that we are using every tool in our toolbox to fight this pandemic, including pivoting as the virus adapts. We need to arm health care providers with the best available diagnostics, therapeutics and vaccines to fight this virus. We remain committed to getting these life-saving products to the frontlines.”
The FDA’s new guidance is good news for vaccine manufacturers and citizens alike.