The Food and Drug Administration (FDA) has released new guidelines on how CVD-19 vaccines, tests, and adapted treatments with new variants should test. These recommendations designed to keep the process safe and fast and ensure that humanity is ahead of the virus. While currently approved vaccines are effective in protecting against variants derived from the United Kingdom, South Africa, Brazil, and California, it is important to prepare for the worst. This wills a new variant that is moderate or completely resistant to the current vaccine.
The guidelines explain how approved vaccine modifications should test and this is similar to how the annual flu vaccine is tested. Smaller trials will compare the updated vaccine with the original approved one, test it for both non-vaccinated and previous vaccines, and evaluate the safety of this vaccine even after testing. The FDA also said it had no plans to approve a COVID-19 vaccine modification without clinical studies, but that it would be important to discuss it in the end.
When it comes to testing, some variants are soft on avoiding detection. Testing is crucial in our fight against epidemics, and the FDA recommends that test developers consider the possibility of viral genetic mutations in test design. These manufacturers should monitor their products regularly to ensure that they continue to work as well as possible. For treatment, the new guideline (updated on what published in May 2020) discusses how much we now know about SARS-Cavi-2 and the different variations of the virus that have appeared around the world.
FDA Commissioner Janet Woodcock, MD, said in a statement, “The FDA is committed to identifying effective ways to change the treatment products that are in the pipeline or have been approved for emergency use to resolve emergencies,” FDA Acting Commissioner Janet Woodcock said in a statement. “We know that the country is keen to return to a new normal and the emergence of a variant of the virus raises new concerns about the effectiveness of these products. By issuing these guidelines, we want the American public to know that we are using every tool in our toolbox to fight this epidemic, including pivoting as virus adapters. To fight this virus we need to arm healthcare providers with the best available diagnostics, therapeutics and vaccines. We are committed to bringing these life-saving products to the forefront.”
Moderna and Pfizer/BioNTech vaccines can be adapted to a new form in just six weeks, although testing and production will take longer. Moderna is already looking at a modified booster shot to be more effective against the South African alternative. There is no expectation that new vaccines or modified old vaccines will submit for approval any time soon, but it is better to have an official structure for this.
