The Food and Drug Administration has laid the groundwork for pharmacists to react quickly to emerging variants of the coronavirus and make modified products available to the public without the need for extensive clinical trials.
“We are using all the tools in our toolbox to combat this pandemic, including rotation as the virus adapts,” said Dr. Janet Woodcock, interim FDA commissioner, in a statement on Monday.
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The FDA guidance issued on Monday is for companies that manufacture vaccines, therapies and diagnostic tests for Covid-19 as they work to track evolving variants of SARS-CoV-2.
Evidence so far suggests that the two Covid-19 vaccines authorized in the US, from Moderna and Pfizer-BioNTech, appear to offer good protection against new variants.
But the fact that the virus continues to mutate means that drug makers will need to keep up, adapting quickly if necessary. The FDA’s guidance suggests that companies may step back in lengthy clinical trials to prove safety and effectiveness each time a new variant appears.
This is no different than how the flu vaccine changes from year to year.
“For the flu, we are very used to doing this,” said Dr. Peter Marks, director of the FDA’s Center for Biological Research and Evaluation, in a call with reporters on Monday. Because the flu vaccine is so well studied, clinical studies in humans are unnecessary each year. Manufacturers simply modify shots based on the strains that are expected to circulate.
Until experts have more data on Covid-19 vaccines, however, the FDA will continue to require drug manufacturers to study the effectiveness of their vaccines against emerging strains.
“We need to understand whether the new strain of the vaccine is capable of covering both the new and the old strain,” said Marks. Additional security data, at least in the meantime, will be required.
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“After doing this three or four times, we will see everything and, if everything looks consistent, we can move more towards the influenza-like model,” said Marks.
The FDA guidance also recommends that Covid-19 diagnostic test developers and manufacturers of monoclonal antibody treatments monitor how emerging variants may affect their effectiveness.
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