FDA Addresses Coronavirus Variants in Updated Guide 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 are in process or that have already been authorized for emergency use to address the variants.

“We know that the country is eager to return to a new normal and the emergence of virus variants raises new concerns about the performance of these products,” said FDA Acting Commissioner Dr. Jane Woodcock in a press release. . “By issuing these guidelines, we want the American public to know that we are using all the tools in our toolbox to combat this pandemic, including the twist as the virus adapts. We need to arm healthcare providers with the best. diagnostics, therapies and vaccines to combat this virus. We remain committed to bringing these life-saving products to the forefront. “

Dr. Rochelle Walensky, 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 emerging mutations should serve as a wake-up call for those involved in vaccine development to remain nimble.


Several companies have already started exploring adjustments to vaccine formulas or possible booster injections if the variants affect 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 an emergency use authorization needs modification to address the variant, the guidance recommends that an efficacy determination be supported by data from clinical immunogenicity studies, which would compare the immune response of a receptor with virus variants. induced by the modified vaccine against the immune response to the licensed vaccine.

The FDA also encourages manufacturers to study the vaccine in unvaccinated individuals and those previously vaccinated with a licensed vaccine.


“Ultimately, the guidance states that further discussion will be necessary to decide whether in the future, modified COVID-19 vaccines can be licensed without the need for clinical studies,” the FDA said.

Dr. Greg Poland, an infectious disease expert at Mayo Clinic, emphasized to Fox News that the guide is non-binding, which means it is still subject to change.

“I like that [the FDA] made efforts to ensure that people understood that it was a non-binding guide, “Poland said, adding,” What I would have liked to see pointed out is that we still don’t have enough information about the immunology of these variants and we have people who fit the classifications immunologically different due to disease or vaccine and we may need to be more nuanced on our booster requirements in those situations. “

Meanwhile, for testing, the agency has already issued a safety alert to warn that genetic mutations could affect test performance, and has already identified several tests that may be affected.


“The guide also provides recommendations for test developers, such as considering the potential of future viral gene mutations when designing your test and conducting your own routine monitoring to assess the potential impact of new and emerging viral gene mutations, which may underlie of viral variants, on the performance of molecular, antigenic and serological tests for SARS-CoV-2, “said the FDA.

When it comes to therapeutics, the agency said it is aware that some of the monoclonal antibodies licensed for COVID-19 patients are less active against the variants. The updated guidance “provides recommendations on efficient approaches for the generation of non-clinical, clinical and chemical data, manufacturing and controls that could support an AUS for monoclonal antibody products that may be effective against emerging variants.”

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