Erick Vazquez receives the Pfizer vaccine at an event to inoculate about 500 health professionals and adults over the age of 65 against COVID-19 from the Labor Community Services, the Los Angeles Federation of Labor and St. Johns Well Child and Family Center devised Labor of Love, at 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 could be approved against new, emerging variants without the need for lengthy clinical trials.
The new guideline, 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, the FDA said. The company should submit new data showing that the modified vaccine provides a similar immune response and is safe, similar to the process for annual flu vaccines.
“Preliminary reports from clinical trials evaluating COVID-19 vaccine candidates in multiple countries, including South Africa, have raised concerns that the vaccine efficacy against the B.1.351 variant may be lower than against the parent virus”, the agency wrote in the document, referring to the species found in South Africa. “There is thus an urgent need for the development and evaluation of vaccines against these SARSCoV-2 variants.”
The updated guidelines come because US health officials, including White House chief medical adviser Dr. Anthony Fauci, are concerned that the virus may be mutating enough to bypass the protections of current vaccines and reverse the pandemic’s progress.
In recent weeks, officials have been urging 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 have identified 1,661 cases of the B.1.1.7 variant for the first time identified in the UK. The agency has 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 vaccines for emergency use in December, and the two drug manufacturers have since announced plans to adapt their injections to new variants. The guideline could speed up the regulatory review process for the vaccines.
Public health officials and infectious disease experts have said Covid-19 is likely to become an endemic disease, meaning it will never disappear completely, although it will likely spread at lower levels than it does today. Health officials will have to constantly be on the lookout for new variants of the virus so scientists can produce vaccines to combat them, medical experts say.
Richard Webby, who leads a World Health Organization flu center at St. Jude Children’s Research Hospital, said the approval process for modified Covid-19 vaccines is ultimately very similar to the process for annual flu shots.
The US and other countries will have to step up their surveillance of new species and then make periodic recommendations on which varieties to target the shots, he said in a recent publication. “It’s not there for Covid now.”