FDA Aims To Be Nimble On COVID-19 Vaccine Changes For Varian
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With two COVID-19 vaccines available in the United States and more on the way, things are starting to look up. But virus mutations being detected around the world mean the vaccines may one day need updates to ensure they stay effective. The FDA is already working on a playbook for how it could greenlight vaccine changes.

The agency is aiming to be nimble when it comes to evaluating COVID-19 vaccine tweaks to make them effective against the coronavirus mutations, says Marks, who heads the FDA's Center for Biologics Evaluation and Research. That means the agency will require some small studies, but not the large clinical trials that took companies months to recruit and complete the first time around.

Available data show the Pfizer and Moderna vaccines are still quite effective against the U.K. variant. Continuing to follow public health guidelines like social distancing and mask-wearing as well as vaccinating as many people as possible is the best defense against the evolution of variance. Vaccines in the pipeline also appear to work against the variant strains, but they may not work as well.

It's actually very common for the FDA to approve supplements for changes to drugs and vaccines. Changes can include things like new or expanded populations, new active, new inactive ingredients, which they call excipients in manufacturing processes, or new diseases that the drug treats.

At least three scenarios that could play out for updates to the COVID-19 vaccine, an economist says. The FDA could require an entirely new emergency use authorization. The original vaccines could have enough follow-up data to have achieved full FDA approval by the time an update is needed. The updates would go through a standard supplemental approval process for changes in viral strains.

Source:
https://www.michiganradio.org/post/fda-aims-be-nimble-covid-19-vaccine-changes-variants
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