In line with the FDA, pictures focusing on new variants do not require giant medical trials to achieve approval
Erick Vazquez receives the Pfizer vaccine during an event to vaccinate approximately 500 healthcare workers and adults over 65 years of age against COVID-19 organized by Labor Community Services, the Los Angeles Federation of Labor, and the St. Johns Well Child and Family Center shaped work of love, in Pico Union, February 13, 2021 in Los Angeles, CA.
Dania Maxwell | Los Angeles Times | Getty Images
The Food and Drug Administration announced Monday that modified Covid-19 vaccines against new, emerging variants can be approved without the need for lengthy clinical trials.
The new guidelines, published in a 24-page document on the FDA’s website, would release the new vaccines as an amendment to a company’s originally approved emergency application, according to the FDA. The company would have to submit new data showing the modified vaccine elicits a similar immune response and is safe, similar to annual flu vaccines.
“Preliminary reports from clinical trials evaluating COVID-19 vaccine candidates in several countries, including South Africa, have contributed to concerns that the vaccine may be less effective against variant B.1.351 than against the original virus,” the wrote Agency found in the document with reference to the strain in South Africa. “Therefore, there is an urgent need to initiate the development and evaluation of vaccines against these SARSCoV-2 variants.”
The updated guidelines come because U.S. health officials, including White House Chief Medical Officer Dr. Anthony Fauci, fear the virus could potentially mutate enough to evade the protection of current vaccines and reverse advances in the pandemic.
For the past few weeks, officials have urged Americans to get vaccinated as soon as possible before potentially new and even more dangerous variants of the virus emerge.
As of Sunday, the Centers for Disease Control and Prevention had identified 1,661 cases of the B.1.1.7 variant, which were first identified in the UK. The agency has identified 22 cases of the B.1.351 strain from South Africa and five cases of P .1, a variant identified for the first time in Brazil.
The FDA approved Pfizer and Moderna’s emergency vaccines in December, and the two drug makers have since announced plans to change their vaccines to target new variants. The guidelines could speed up the regulatory review process for the vaccines.
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