- The head of the FDA has outlined plans to deal with problems with coronavirus variants.
- Some COVID-19 vaccines and treatments may not work as well against new forms of the virus.
- Regulators will allow developers to customize their shots, similar to updates made to flu vaccines to deal with the changing strains.
- Visit the Insider Business Department for more stories.
In an effort to stem the coronavirus pandemic, U.S. regulators are taking a page from decades of research on flu vaccines.
Dr. Janet Woodcock, acting head of the U.S. Food and Drug Administration, said Thursday night that the agency will expand its flu management framework to find out how it is keeping pace with the changing coronavirus. She spoke to reporters on a call, saying more complete guidance for drugmakers would come soon.
The goal is to enable pharmaceutical companies to quickly adapt their vaccines and treatments to fight new forms of the coronavirus while keeping the new products safe and effective.
For drug companies that have already developed an authorized vaccine, the FDA intends to enable them to modify their vaccines without repeating massive clinical trials with tens of thousands of volunteers.
Read more: Top vaccine developers are upgrading COVID-19 shots as mutations threaten our progress in reducing the pandemic
The agency’s leader also stressed that she believes the current coronavirus vaccinations will work against the identified variants.
“Number one, we think the current vaccines will be effective against the strains we know of,” Woodcock said. “Number two, we do not know what is going to happen. We do not know if different strains in the US will be predominant, and we do not know then what their characteristics may be regarding the vaccines. But our point is that we must prepare for all events. ‘
Read more: What comes next for COVID-19 vaccines? Here’s the latest on 11 leading programs.
The rise of virus variants has expressed concern among scientists. Public health leaders recently described it as a “wake-up call”. 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. Some antibody treatments also do not work as well.
Details are not yet available on exactly what kind of research vaccine developers will have to do to prove that their upgraded shots are working, such as how many additional volunteers are needed for trials and what the studies will have to show. Woodcock said the FDA will release details on its proposals in the coming weeks.
Over the past ten days, leading vaccine developers Moderna, Pfizer, Johnson & Johnson and Novavax have all announced research related to variants. Moderna and Novavax are both working on experimental booster shots adapted for the B.1.351 variant.
Modern and at least one other vaccine developer are working with the National Institutes of Health researchers to begin human testing of these variety-specific shots in March, report Sarah Owermohle and David Lim of Politico.