FDA urges makers of COVID-19 vaccines, tests, treatments to adapt to coronavirus variants
LAUSD Medical assistant Kristi Gomez, prepares a COVID-19 vaccination as Los Angeles Unified employees received their first dose of the vaccine.(Al Seib / Los Angeles Times via Getty Images).
WASHINGTON - The U.S. Food and Drug Administration has issued new guidelines for medical companies developing COVID-19 vaccines, tests and antibody treatments as coronavirus variants become prevalent.
The agency said it has already been in talks with vaccine makers, but decided to make its guidelines public for the sake of transparency and to seek public input.
The FDA said it believes that authorized vaccines are effective against the current strains of COVID-19, but the agency said pharmaceutical companies must be prepared to modify or upgrade their vaccines if a new, more-resistant COVID-19 strain appears.
Before approving any modified vaccines, the FDA said it wants vaccine makers, in their clinical studies, to compare a participant’s immune response to the modified vaccine with the participant’s immune response to the original, already authorized, vaccine.
The FDA also said modified vaccines should be tested in participants who haven’t received the original vaccine.
For COVID-19 test manufacturers, the FDA said future mutations of the coronavirus should be considered in product development. COVID-19 tests should be routinely monitored to evaluate their effectiveness, the FDA said.
The FDA also updated its guidance for medical companies which create laboratory-made antibodies, or proteins, to fight off the coronavirus. The agency said some authorized antibody treatments are less effective against newer strains of the coronavirus.
The FDA said treatment developers should continue to study the genetic makeup of COVID-19 variants and determine which variants are becoming prevalent.
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"The FDA is committed to identifying efficient ways to modify medical products that either are in the pipeline or have be authorized for emergency use to address emerging variants," Acting FDA Commissioner Janet Woodcock said in a news release.
"By issuing these guidances, 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."
According to the U.S. Centers for Disease Control and Prevention, nearly 20 million Americans have been vaccinated against the coronavirus. This, as the country’s death toll approaches 500,000 since the pandemic began nearly a year ago.
More than 28 million Americans have contracted the virus within the past year.
FDA officials said they’re committed to monitoring COVID-19 and its variants. The agency encourages people to get tested, vaccinated and follow other safety protocols.
This story was reported from Los Angeles.