The Food and Drug Administration (FDA) under the US Department of Health and Human Services has allowed manufacturers of vaccines against the new coronavirus not to conduct long-term tests of drugs designed for new strains of infection. The relevant recommendations were published on the regulator’s website on Monday.
The FDA stressed that the coronavirus vaccines that have received their approval now “retain their effectiveness <…> against the currently spreading variants” of the infection. “However, if one or more variants of the SARS-CoV-2 virus arise in the United States that are fully or partially resistant to antibodies formed as a result of the use of existing COVID-19 vaccines, it may be necessary to refine them,” the regulator said in a statement.
At the same time, the FDA experts expect that the general information about the vaccine will remain unchanged even if it is finalized. In this regard, the regulator requires that manufacturers conduct only brief clinical studies of the immunogenicity of these drugs before applying for registration of an updated version of the vaccine.
As The New York Times explains, we are talking about laboratory testing of blood samples of a small group of volunteers for the appearance of antibodies to new variants of the coronavirus. In fact, this means that manufacturers will be able to rapidly refine their existing drugs without conducting lengthy, multi-step studies, similar to those they were forced to resort to for the initial registration of vaccines.
The FDA in December approved a coronavirus vaccine developed by the US Company Pfizer and its German partner BioNTech. The drug, which Moderna produces, was also certified. These vaccines are already being used to immunize the population.
According to Johns Hopkins University, which counts based on information from international organizations, federal and local authorities, since the beginning of the pandemic in the United States, more than 28.1 million cases of coronavirus infection have been registered, more than 499.3 thousand people have died. The country ranks first in the world in both indicators.