- The FDA chief outlined plans to deal with problematic variants of the coronavirus.
- Some vaccines and COVID-19 treatments may not work as well against new forms of the virus.
- Regulators will allow developers to adjust their vaccines, similar to updates made to flu vaccines to deal with strain variations.
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In an attempt to stay ahead of the coronavirus pandemic, US regulators are looking at decades of research on influenza vaccines.
Dr. Janet Woodcock, acting head of the United States Food and Drug Administration, said on Thursday night that the agency will build its structure to deal with the flu to find out how to track the evolution of the coronavirus. She spoke on a phone call with reporters and said that more complete guidance for pharmacists would come soon.
The goal is to allow pharmaceutical companies to quickly adjust their vaccines and treatments to combat new forms of the coronavirus, while ensuring that these new products are safe and effective.
For pharmaceutical companies that have already developed an authorized vaccine, for example, the FDA aims to allow them to adjust their vaccines without repeating massive clinical trials involving tens of thousands of volunteers.
Read More: Leading vaccine developers are updating COVID-19 vaccines as mutations threaten our progress in reducing the pandemic
The agency’s leader also emphasized that she believes current coronavirus vaccines will work against the identified variants.
“Number one, we believe that the currently authorized vaccines will be effective against the strains that we know of,” said Woodcock. “Number two, we don’t know what is going to happen. We do not know whether different strains will become prevalent in the United States and we do not know what their characteristics may be in relation to vaccines. our point is that we must prepare for all eventualities. “
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The increase in virus variants has raised concerns among scientists. Public health leaders recently described this as an “alert”. A collection of recent clinical and laboratory results suggests that current COVID-19 vaccines may not work as well against certain variants of the virus, particularly B.1.351, which was first identified in South Africa. work so well.
No details are yet available on the exact type of research that vaccine developers will be required to do to prove that their updated vaccines work, such as how many additional volunteers will be needed for the tests and what those studies would have to show. Woodcock said the FDA will release details for its proposals in the coming weeks.
In the past 10 days, leading developers of modern vaccines, Pfizer, Johnson & Johnson and Novavax announced research related to variants. Moderna and Novavax are working on experimental reinforcement shots tailored to variant B.1.351.
Modern and at least one other vaccine developer are working with researchers at the National Institutes of Health to start human testing of these variant-specific vaccines in March, reported Sarah Owermohle and David Lim of Politico.