Health & Fitness

FDA addresses coronavirus variants in updated guidance for medical developers


The Food and Drug Administration issued new guidance on Monday amid the emergence of new coronavirus variants for medical product developers. The regulatory agency said it is “committed to identifying efficient ways to modify medical products” that either are in the works or have already been authorized for emergency use to address the variants.

“We know the country is eager to return to a new normal and the emergency of the virus variants raises new concerns about the performance of these products,” Dr. Jane Woodcock, acting FDA commissioner, said in a news release. “By issuing these guidances, we want the American public to know what that we are using every tool in our toolbox to fight this pandemic, including pivoting as the virus adapts. We need to arm health care providers with the best available diagnostics, therapeutics and vaccines to fight this virus. We remain committed to getting these life-saving products to the frontlines.”

Dr. Rochelle Walensky, the director of the Centers for Disease Control and Prevention (CDC) has previously warned that the variants could jeopardize the progress made in the fight against coronavirus. Dr. Anthony Fauci, the nation’s leading infectious disease expert, has said the emerging mutations should serve as a wakeup call for those in vaccine development to remain nimble.


Several companies have already started exploring tweaks to vaccine formulas or potential booster shots should the variants impact efficacy.

The FDA said it will continue to monitor the situation and update plans as more information becomes available. For vaccines, the agency said that if a product that has already received emergency use authorization needs modification to address the variant, guidance recommends that a determination of efficacy be supported by data from clinical immunogenicity studies, which would compare a recipient’s immune response to virus variants induced by the modified vaccine against the immune response to the authorized vaccine.

The FDA also encourages manufacturers to study the vaccine in non-vaccinated individuals and in those previously vaccinated with an authorized vaccine.


“Finally, the guidance states that further discussions will be necessary to decide whether in the future, modified COVID-19 vaccines may be authorized without the need for clinical studies,” the FDA said.  

Dr. Greg Poland, infectious disease expert at Mayo Clinic, emphasized to Fox News that the guidance is nonbinding, meaning it is still subject to change. 

“I like that [the FDA] made efforts to ensure people understood it was nonbinding guidance,” Poland said, adding, “what I would’ve liked to see signaled is that we have insufficient information yet about the immunology of these variants and we have people who fit into immunologically different classifications because of disease or vaccine and we may need to be more nuanced in our requirements for boosters in those situations.”

Meanwhile for testing, the agency already issued a safety alert to caution that the genetic mutations could potentially impact test performance, and has already identified several tests that may be impacted.


“The guidance also provides recommendations to test developers, such as considering the potential for future viral genetic mutations when designing their test, and conducting their own routine monitoring to evaluate the potential impact of new and emerging viral genetic mutations, which may be the basis of viral variants, on the performance for molecular, antigen and serology SARS-CoV-2 tests,” the FDA said.

As far as therapeutics is concerned, the agency said it’s aware that some of the monoclonal antibodies authorized for COVID-19 patients are less active against variants. Updated guidance “provides recommendations on efficient approaches to the generation of non-clinical, clinical and chemistry, manufacturing and controls data that could potentially support an EUA for monoclonal antibody products that may be effective against emerging variants.”


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