Amid emerging variants of the coronavirus, the Food and Drug Administration (FDA) is developing guidelines to help companies adjust vaccines, therapies and tests, if necessary.
“We are committed to identifying efficient processes for authorized products that may need to be modified, based on information about emerging variants,” said Dr. Janet Woodcock, interim FDA commissioner, in a statement published on Thursday. “We don’t believe there is a need to start from scratch with any of these products.”
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The recently approved vaccines appear to remain effective against strains circulating in the United States. Moderna is moving forward with plans to advance a booster candidate specifically against a variant first identified in South Africa, and Pfizer and BioNTech are working to develop a booster injection against worrying strains as well, Bloomberg reported. Pfizer previously praised the flexibility in the mRNA vaccine platform to make rapid changes if needed.
Woodcock told reporters on a call on Thursday that the FDA will not require the considerable clinical trials necessary for emergency approvals to assess booster doses, Reuters reported. A future proposal on the assessment process could arrive in a few weeks and would likely require security data and a review by outside experts.
Meanwhile, growing data suggest that the South African variant almost escapes treatment with convalescent plasma and antibody drugs.
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“For therapy, particularly monoclonal antibodies to the virus, we are considering approaches to help accelerate drug development in this key area, including the discussion of appropriate regulatory flexibilities,” said Woodcock.
However, the variants do not pose a significant threat to the molecular tests of COVID-19. The FDA said it would update the public with the plans as soon as they became available amid the evolving situation.