Erick Vazquez received the Pfizer vaccine at a rally to vaccinate about 500 health workers and adults over the age of 65 against COVID-19, which was provided by Labor Community Services, the Los Angeles Federation of Labor and St. Johns Well Child and Family Center. created Labor of Love, in Pico Union, February 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 may be approved against new, emerging variants without the need for lengthy clinical trials.
The new guidelines, published in a 24-page document on the FDA’s website, will, according to the FDA, clear the new vaccines as an amendment to the originally approved emergency use application. The company needs to submit new data showing that the modified vaccine produces a similar immune response and is safe, similar to the process for annual flu vaccines.
“Preliminary reports of clinical trials evaluating the candidates of COVID-19 vaccine in several countries including South Africa have raised concerns that the efficacy of the vaccine against the B.1.351 variant may be lower than against the original virus,” “the agency wrote in the document, referring to the tribe found in South Africa. “There is therefore an urgent need to start the development and evaluation of vaccines against these SARSCoV-2 variants.”
The updated guidelines come because U.S. health officials, including White House medical adviser Dr. Anthony Fauci, is concerned that the virus could possibly mutate enough to evade the protection of current vaccines and reverse the progress of the pandemic.
In recent weeks, officials have urged Americans to be vaccinated as soon as possible before potentially new and even more dangerous variants of the virus emerge.
The Centers for Disease Control and Prevention has identified as of Sunday 1 661 cases of the B.1.1.7 variant, which was first identified in the United Kingdom. The agency identified 22 cases of the B.1.351 strain, from South Africa, as well as five. cases of P.1, a variant first identified in Brazil.
The FDA approved Pfizer and Moderna’s emergency vaccinations in December, and the two drugmakers have since announced plans to modify their shots to target new variants. The guidance could speed up the review process for the vaccines.
Public health officials and infectious disease experts said there is a high probability that Covid-19 will become an endemic disease, meaning it will never completely disappear, although it is likely to spread to lower levels than now. Health officials will have to constantly look at new variants of the virus so that scientists can manufacture vaccines to combat them, medical experts say.
Richard Webby, who runs a World Health Organization’s flu center at St. Jude Children’s Research Hospital, said the clearance process for modified Covid-19 vaccines could ultimately be very similar to the annual flu shot process.
The U.S. and other countries need to step up their oversight of new tribes and then make regular recommendations on what variants the shots should focus on, he said in a recent interview. “For Covid, it’s not there.”