The United States FDA has released a renewed guideline for the development of Covid variant vaccines. Drawing its relevance from the emerging need for vaccines capable of immunizing against SARS Covid variants, the guidelines could ‘Fastlane’ the development of new vaccines to prevent Covid-19 virus variants.
FDA Decides To Forgo Lengthy Clinical Trials For Covid Vaccines For Virus Variants
The Food and Drug Administration on Monday said that it believes there is no need for lengthy clinical trials to approve variant vaccines. At present, the vaccine development for these variants is being overwhelmed by fast-changing mutants of the virus. The new guidelines released by the FDA states that there is an evident and immediate need for the development of vaccines capable of fighting these variants. Hence, the FDA is looking to adapt the clinical trials to suit current needs.
This involves using small clinical trials to identify if the vaccine is effective. Such tests have been formerly used to test flu vaccines. The Acting Commissioner of FDA Janet Woodcock, MD, in a statement, guaranteed the commitment of the FDA to find effective ways to adapt existing vaccines to the emerging variants of the virus.
She said that by issuing the renewed guidances the FDA looks to assure the general public that they are using all at their disposal to overcome the pandemic. This includes adaptations based on the virus mutations, she said.
Meanwhile, on a similar trend, the vaccine manufacturers such as Pfizer and BioNTech have expressed their intent to modify existing Covid-19 vaccines to be more effective against the variants.
The Center for Disease Control and Prevention has reported 1661 cases of B.1.17 variant from the UK, and 22 cases of the B.1.351 variant first identified in South Africa. Also, there are five active patients of the P.1 variant that was found in Brazil, according to the agency. According to the New York Times, the agency is ready to skip the long clinical trials of modified vaccines and replace them with short-term trials. This will entail smaller volunteer groups and the analysis of the effects of the vaccine on them.
Researchers will draw blood samples from these volunteers and observe whether the vaccine is triggering a response from the immune system. They will also look into the percentage and nature of these responses. This should help them identify if the vaccine is fit for the mainstream public.
The new guidelines have already drawn several opinions from researchers and scientists. Some scientists are quick to dismiss the thought of such accelerated approvals. They say that this could drive the commercialization of vaccines in a dire time of need. While others are hopeful that this development could, essentially, hasten the development of variant vaccines, seeking a respite from the onslaught of the SARS Covid-19 virus.