Business

In accordance with the FDA, recordings for brand spanking new variants don’t require massive medical research

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 produces 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 Chief White House Advisor Dr. Anthony Fauci, fear the virus could potentially mutate enough to evade current vaccines protection 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 variant B.1.1.7, 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 first identified in Brazil.

The FDA approved Pfizer and Moderna’s emergency vaccines in December, and the two drug makers have since announced plans to modify their vaccines to target new variants. The guidelines could speed up the regulatory review process for the vaccines.

Public health officials and infectious disease experts have indicated that there is a high probability that Covid-19 will become an endemic disease, meaning it will never go away completely, although it will likely spread at lower levels than it does now. Health officials must constantly look for new variants of the virus so scientists can make vaccines against them, medical experts say.

Richard Webby, director of a World Health Organization flu center at St. Jude Children’s Research Hospital, said the approval process for modified Covid-19 vaccines may be very similar to the procedure for annual flu shots.

The U.S. and other nations need to step up their surveillance of new tribes and then make regular recommendations as to which variants the shots should target, he said in a recent interview. “It’s not there for Covid at the moment.”

Leave your vote

0 points
Upvote Downvote

Related Articles

Log In

Forgot password?

Don't have an account? Register

Forgot password?

Enter your account data and we will send you a link to reset your password.

Your password reset link appears to be invalid or expired.

Log in

Privacy Policy

Add to Collection

No Collections

Here you'll find all collections you've created before.