Erick Vázquez receives the Pfizer vaccine during an event to inoculate about 500 health workers and adults over the age of 65 against COVID-19 presented by Labor Community Services, the Los Angeles Federation of Labor and St. Johns Well Child and Family Center coined Labor of Love, at Pico Union, on 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 against new emerging variants could be authorized without the need for lengthy clinical trials.
The new guide, published in a 24-page document on the FDA website, would remove the new vaccines as an amendment to the emergency use application originally approved by a company, according to the FDA. The company should present new data showing that the modified vaccine produces a similar and safe immune response, similar to the annual flu vaccine process.
“Preliminary reports from clinical trials evaluating candidates for COVID-19 vaccines in several countries, including South Africa, have added to the concern that the efficacy of the vaccine against variant B.1.351 may be lower than that of the original virus. “, wrote the agency in the document. the strain found in South Africa. “Therefore, it is urgent to begin the development and evaluation of vaccines against these SARSCoV-2 variants.”
The updated guidance comes when U.S. health officials, including Dr. Anthony Fauci, chief medical adviser to the White House, is concerned that the virus may mutate enough to evade protection from current vaccines and reverse the progress made in the pandemic.
In recent weeks, officials have pushed Americans to get vaccinated as quickly as possible before potentially new and even more dangerous variants of the virus appear.
Since Sunday, the Centers for Disease Control and Prevention has identified 1,661 cases of variant B.1.1.7 first identified in the UK. The agency has identified 22 cases of strain B.1.351 from South Africa, as well as five cases of P .1, a variant first identified in Brazil.
The FDA authorized Pfizer and Moderna vaccines for emergency use in December, and the two drug manufacturers have since announced plans to modify their features to target new variants. The guide could speed up the process of regulatory review of vaccines.
Public health officials and experts in infectious diseases have said that there is a high probability that Covid-19 will become an endemic disease, meaning that it will never disappear completely, although it is likely to spread to lower levels than now. . Health officials will need to continuously monitor new variants of the virus so that scientists can produce vaccines to fight them, medical experts say.
Richard Webby, who runs a World Health Organization influenza center at St. Louis Children’s Research Hospital. Jude said the process for removing modified Covid-19 vaccines may end up being very similar to the process for annual flu vaccines.
The United States and other nations will need to step up surveillance of new strains and then make periodic recommendations on which variants the shots should target, he said in a recent post. “For Covid, he’s not there right now.”