قالب وردپرس درنا توس
Home / Health / The FDA says that injections for the new variant do not require large clinical trials

The FDA says that injections for the new variant do not require large clinical trials



Erick Vazquez received a Pfizer vaccine at an event that was vaccinated against COVID-19 proposed by the Department of Labor Community Services, the Los Angeles Federation of Labor and the St. Johnsville Children and Family Center. Inoculating about 500 medical staff and adults over 65 years of age to create a labor of love in the Pico Alliance in Los Angeles, USA on February 1

3, 2021.

Dania Maxwell | Los Angeles Times | Getty Images

The U.S. Food and Drug Administration said on Monday that a modified Covid-19 vaccine for the emerging variant may be approved without a lengthy clinical trial.

According to the FDA, the new guidance has been published in a 24-page document on the FDA website. The new guidance will clear the new vaccine as an amendment to the company’s initial emergency use application. The company will need to submit new data to prove that the improved vaccine produces a similar immune response and is safe, similar to the annual flu vaccine production process.

The agency wrote in the document: “Preliminary reports of clinical trials evaluating COVID-19 vaccine candidates from many countries, including South Africa, have raised concerns that the vaccine against the B.1.351 variant may be less effective than the original Virus potency.” A strain found in South Africa. “Therefore, there is an urgent need to initiate the development and evaluation of vaccines against these SARSCoV-2 variants.”

As the updated guidelines are released, US health officials, including Dr. Anthony Fauci, Chief Medical Advisor to the White House, are concerned that the virus may mutate to evade the protection of current vaccines and reverse the progress of the pandemic.

In recent weeks, officials have urged Americans to get vaccinated as soon as possible before new and even more dangerous variants of the virus may emerge.

As of Sunday, the Centers for Disease Control and Prevention has identified 1,661 cases of the B.1.1.7 variant first discovered in the UK. The agency has identified 22 cases of B.1.351 strains from South Africa and 5 cases of P.1, the first variant found in Brazil.

The FDA authorized Pfizer and Moderna’s vaccines for emergency use in December, and the two drugmakers have since announced plans to modify their injections to target new variants. The guidelines can speed up the regulatory review process for vaccines.

Public health officials and infectious disease experts said that it is highly likely that Covid-19 will become an endemic disease, which means it will never completely disappear, although its level of transmission may be lower than it is now. Medical experts say that health officials will have to constantly pay attention to new variants of the virus so that scientists can produce vaccines against them.

Richard Whitby, who directs the World Health Organization Influenza Center at St. Jude Children’s Research Hospital, said that the removal process of the improved Covid-19 vaccine may eventually be very similar to the removal process of the annual flu vaccine.

He recently stated that the United States and other countries will need to strengthen surveillance of new strains and then make regular recommendations on which variants of these guns should be targeted. “For Covid, it doesn’t exist yet.”


Source link