Erick Vazquez receives the Pfizer vaccine during an inoculation event for about 500 health care workers and adults over the age of 65 against COVID-19, put by Labor Community Services, the Los Angeles Federation of Labor and St. The Johns Well Child and Family Center invented Labor of Love in 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 guideline, published in a 24-page document on the FDA’s website, would remove the new vaccines as a change to a company’s initially approved emergency application, according to the FDA. The company should present new data showing that the modified vaccine produces a similar immune response and is safe, similar to the process for annual influenza vaccines.
“Preliminary reports from clinical trials evaluating COVID-19 vaccine candidates in several countries, including South Africa, have raised concerns that the vaccine’s effectiveness against variant B.1.351 may be lower than against the original virus,” the agency wrote in document, referring to the strain found in South Africa. “Thus, it is urgent to initiate the development and evaluation of vaccines against these SARSCoV-2 variants.”
The updated guide comes as U.S. health officials, including White House chief medical adviser Dr. Anthony Fauci, are worried that the virus could move enough to evade current vaccine protection and reverse progress in vaccination. pandemic.
In recent weeks, officials have pushed Americans to get vaccinated as soon as possible before potentially new and even more dangerous variants of the virus appear.
As of Sunday, the Centers for Disease Control and Prevention identified 1,661 cases of variant B.1.1.7, identified for the first time in the United Kingdom. The agency identified 22 cases of strain B.1.351 in 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 change the photos to target new variants. The guidelines could speed up the process of revising vaccine regulations.
Public health officials and infectious disease experts say Covid-19 is highly likely to become an endemic disease, meaning it will never disappear completely, although it is likely to spread to lower levels than it is now. . Health officials will have to keep an eye on new variants of the virus so scientists can produce vaccines to fight them, say medical experts.
Richard Webby, who runs a World Health Organization flu center at St. Louis Children’s Research Hospital. Jude said the process for eliminating the modified Covid-19 vaccines could be very similar to the process for annual flu vaccines.
The United States and other nations will need to step up their surveillance of new strains and then make regular recommendations on what options fire should target, he said in a recent interview. “For Covid, it doesn’t exist right now.”