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FDA says shots that target new variants won’t need large clinical trials to win approval

Erick Vazquez receives the Pfizer vaccine during an event to inoculate about 500 health care workers and adults over the age of 65 against COVID-19 put on by the Labor Community Services, the Los Angeles Federation of Labor and St. Johns Well Child and Family Center coined Labor of Love, in Pico Union, Feb. 13, 2021 in Los Angeles, CA.

Dania Maxwell | Los Angeles Times | Getty Images

The Food and Drug Administration said Monday that modified Covid-19 vaccines against new, emerging variants may be authorized without the need for lengthy clinical trials.

The new guidance, released in a 24-page document on the FDA’s website, would clear the new vaccines as an amendment to a company’s originally approved emergency use application, according to the FDA.

“Preliminary reports from clinical trials evaluating COVID-19 vaccine candidates in multiple countries including South Africa have added to concerns that vaccine efficacy against the B.1.351 variant may be lower than against the original virus,” the agency wrote in the document. “Thus, there is an urgent need to initiate development and evaluation of vaccines against these SARSCoV-2 variants.”

This is a developing story. Please check back for updates.


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