Vaccine makers won't have to conduct monthslong, randomized clinical trials to gain authorization for COVID-19 vaccines altered to combat virus variants, the FDA said Feb. 22, according to The New York Times.
The FDA is recommending that vaccines adjusted for virus variants undergo smaller trials, similar to the annual flu vaccines.
Instead of the longer trials, researchers would draw blood from a relatively small group of volunteers who have been given the updated vaccine. They would then observe what percentage of the volunteers' samples produce an immune response to the virus variants and the size of that response, according to the Times.
The vaccines would be authorized if they produce an immune response relatively close to that of the original vaccines. Volunteers would also be monitored for side effects, the Times reported. The FDA would authorize the updated vaccines under an amendment to the original vaccine's emergency authorization, the agency said.
"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," acting FDA commissioner Janet Woodcock, MD, said in a statement to the Times.
Most drugmakers that have vaccines authorized or in late-stage trials have said they plan to adjust their vaccines to protect against virus variants. Moderna and Pfizer said their vaccines could be updated against the virus variants within six weeks, but testing and manufacturing would take longer, according to the Times.
The FDA said that existing COVID-19 vaccines offer protection against virus variants and appear to greatly reduce the severity of illness, preventing hospitalizations and death, the Times reported.
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