Pharmaceutical firms such as Pfizer and Moderna have started adjusting their existing COVID19 vaccines for other strains of coronavirus. In the wake of surging cases of other variants, the US Food and Drug Administration (FDA) has said that health experts do not require to go for lengthy randomized trials for vaccines, which are being adapted to offer immunity against other strains of the virus. The FDA has suggested that these adapted vaccines might need small trials much like those, which are needed for annual flu vaccines. The officials from the FDA have said that it will speed up the review process at a time when scientists are worried that new variants might slow or reverse the efforts, which have been taken so far in the fight against the virus. This guideline is a part of new recommendations, which have been released by the agency recently. New recommendations of the agency include how diagnostic tests and other antibody treatments can be repurposed to prevent the spread of the virus. With the new guidelines, the government has taken the most detailed acknowledgment of the threat posed by the new strains of the virus to already existing vaccines. The officials have noted that the new variants of the virus pose a serious threat to treatments and tests for the SARS-CoV-2 virus. New guidelines have come weeks after the acting commissioner of the FDA Dr. Janet Woodcock has assured that the agency will be coming up with a plan to tackle fast-spreading new variants of the virus.
Dr. Janet Woodcock has said that the appearance of the new variants of coronavirus might interfere with the performance of vaccines, antibody therapies, and diagnostic tests. She has assured that the agency is not leaving any stone unturned to use every tool available to fight against the pandemic. The Majority of vaccine makers with approved vaccines or candidates in late-stage trials have announced their plans to modify their vaccines to fight against the new strains. The mRNA technology has been used in Moderna and Pfizer-BioNtech vaccines that can be used to change existing vaccines within six weeks. However, manufacturing and testing might take a little longer. As per the report, Moderna has already started making a new version of its COVID19 vaccine, which can be used as a booster vaccine to fight against the variant known as B.1.351, which has been found in South Africa. This variant seems to reduce the effectiveness of the COVID19 vaccines. Experts have said that a variant, which has been found in the UK, which has been spreading rapidly, has gained a troubling mutation that can make it hard to control the pandemic with vaccines. This strain with a worrisome mutation has been found in the US last week. However, the new guidelines do not seem to be written with the assumption that new vaccines are required. Despite the indication that some variants of the virus might hamper the efficiency of the existing vaccines, the agency has noted that currently available vaccines still provide immunity against the severity of the disease, hospitalization, and death due to the disease. It is uncertain that how long people will have to wait for these new vaccines.
The officials of the agency have said that new vaccines can leave out the long process of a randomized clinical trial, which compares it with a placebo. Nevertheless, the tweaked vaccines need to undergo some testing before being approved by the authorities. The FDA has said that experts will have to take blood samples from a small group of participants who will be given the tweaked vaccines. After that, experts will see how many volunteers are able to generate an immune response to the new variants of the virus in the lab. The officials have said that these new vaccines will be accepted if they are able to trigger an immune response, which is fairly close to the one produced by the original vaccines. These volunteers will be closely monitored for any side effects. The FDA has said that testing of the tweaked vaccines can be done on a single age group and later can be extrapolated to other age groups as well. New guidelines have supported the use of animal testing as well to determine the efficacy of modified vaccines.