The Food And Drug Administration (FDA) has published new guidelines on how COVID-19 vaccines, tests, and treatments adapted to new variants should be tested. These recommendations are designed to keep the process safe and fast, and make sure humanity stays ahead of the virus.
While currently authorized vaccines remain effective in protecting against the emergent variants from the UK, South Africa, Brazil, and California, it is important to prep for the worst. That would be a new variant that is moderately or fully resistant to the current vaccine.
The guidelines explain how the authorized vaccine modifications should be tested, and it is similar to how the annual flu vaccine is tested. Smaller trials will compare the updated vaccine to the original authorized one, testing it in both non-vaccinated and previously vaccinated people, and the trial will still have to assess the safety of the vaccine.
The FDA also states that there are no plans to authorize a COVID-19 vaccine modification without clinical studies, but that a discussion on it will eventually be necessary.
When it comes to testing, some of the variants are sneakier at avoiding detection. Testing is crucial in our fight against the pandemic, and the FDA recommends that test developers take into consideration the potential for viral genetic mutations in the designing of tests. These manufacturers should also have routine monitoring of their products to make sure they continue to work as best as they can.
For treatments, the new guidance (updating on what was released in May 2020) discusses how much we know of SARS-CoV-2 now and the various variations of the virus that have emerged across the world.
“The FDA is committed to identifying efficient ways to modify medical products that either are in the pipeline or have been authorized for emergency use to address emerging variants,” Acting FDA Commissioner Janet Woodcock, MD, said in a statement.
“We know the country is eager to return to a new normal and the emergence of the virus variants raises new concerns about the performance of these products. 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. We need to arm health care providers with the best available diagnostics, therapeutics and vaccines to fight this virus. We remain committed to getting these life-saving products to the frontlines.”
The Moderna and Pfizer/BioNTech vaccines could be adapted to a new variant in just six weeks, although testing and manufacturing would take longer. Moderna is already looking at a modified booster shot to be more effective against the South African variant.
There are no expectations that new vaccines or modified old vaccines are going to be submitted for approval any time soon, but it is good to have an official framework in place.
For more information about COVID-19, check out the IFLScience COVID-19 hub where you can follow the current state of the pandemic, the progress of vaccine development, and further insights into the disease.
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