The Food and Drug Administration (FDA) announced that vaccines for new Covid prepared for new variants don’t require long clinical trials to get emergency approval.
Drugmakers are supposed to submit the new data that the revised vaccine provides a similar immune response. This data should confirm the vaccine is safe and related to the process for annual flu vaccines.
Vaccines for New COVID Can Proceed with Small Clinical Trials
As per the FDA’s updated guidelines, there is “an urgent need to initiate development and evaluation of vaccines against these SARSCoV-2 variants.” The recent guidance authorizes scientists to perform small trials, similar to flu vaccines’ trials, in modifying vaccines for new Covid variants.
In December 2020, the FDA approved Pfizer and Moderna’s vaccines for emergency treatment. These two drug producers declared their plans to modify their shots to fight against new variants.
Acting FDA Commissioner Janet Woodcock, MD, stated, “The FDA is committed to identifying efficient ways to modify medical products that are either in the pipeline or have been authorized for emergency use to address emerging variants.” He continued, “By issuing these guidances, we want the American public to know that we are using every tool in our toolbox to fight this pandemic, including pivoting as the virus adapts.”
Scientists who produced the Moderna and Pfizer-BioNTech vaccines are used in the USA. They decided to modify their vaccines to be more effective in fighting the variants.
According to the CDC, three Coronavirus variants were found in the United States. 1,661 cases of the B.1.1.7 variant (which was the first variant)found in the UK. The B.1.351 variant was found in South Africa with 22 cases. 5 cases of the P.1 variant found in Brazil are called Brazil(ian) variants.
The agency wrote on a 24-page document on the FDA’s website about the strain discovered in South Africa. It stated, “Preliminary reports from clinical trials evaluating COVID-19 vaccine candidates in multiple countries including South Africa have added to concerns that vaccine efficacy against the B.1.351 variant may be lower than against the original virus.”
“Thus, there is an urgent need to initiate the development and evaluation of vaccines against these SARSCoV-2 variants.”
According to The New York Times, “An updated Covid-19 vaccine can skip the monthslong process of a randomized clinical trial that would compare it with a placebo, the agency said.”
“But a tweaked vaccine will still need to go undergo some testing. In trials proposed by the F.D.A., researchers will draw blood from a relatively small group of volunteers who have been given the adapted vaccine.”
“Scientists will then observe what percentage of volunteers’ samples produce an immune response to the variants in the lab and how large that response is. The vaccines will be judged acceptable if they produce an immune response.”
FDA’s recent guidance proposes that U.S health officials, including White House Chief Medical Advisor, Dr. Anthony Fauci, are concerned that Covid-19 virus could evolve enough to evade the latest vaccines’ protection and are capable of reversing the progress that is made for the pandemic.
In the last few weeks, officials have urged Americans to get vaccinated as soon as possible before the new and more critical variants of the Covid-19 virus infect them.
Richard Webby, a director at WHO’s flu center at St. Jude Children’s Research Hospital, demonstrated that the United States and other countries must ramp up their efforts to protect from the new strains and then create periodic suggestions variants the shots should focus on. “For Covid, that’s not there right now.”