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

“We know that the country is eager to return to a new normal and the emergence of virus variants gives rise to new concerns about the performance of these products,” Dr. Jane Woodcock, FDA Commissioner, Acting, Said in a news release. “By issuing these guidelines, we want the American public to know what we are using each tool in our toolbox to fight this epidemic, including adapting the virus. The best available trostics, There is a need to share healthcare providers with therapies and vaccines to fight the virus. We are committed to bringing these life-saving products to the forefront. “

Director of the Centers for Disease Control and Prevention (CDC) Drs. Rochelle Wallensky has previously warned that variants may jeopardize the progress made in the fight against Coronavirus. The country’s leading infectious disease specialist, Dr. Anthony Fauci states that emerging mutations should be an agile call for those in vaccine development to remain agile.

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Many companies have already begun searching for vaccines for vaccine formulas or potential booster shots.

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

The FDA encourages vaccines to be studied in non-vaccinated individuals and those previously vaccinated with authorized vaccines.


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

Infectious Disease Specialist Dr. at Mayo Clinic Greg Poland emphasized to Granthshala News that the guidance is nonbinding, meaning it is still subject to change.

“I like it [the FDA] Poland said that it was people’s effort to make sure that it was nonbinding guidance, “Poland said,” What I would have liked to see is that we have as yet insufficient information about the immunology of these variants and We have people who fit into different classifications of immunologically. Causes of disease or vaccine and we may need more subtlety in our requirements for boosters in those situations. “

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

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

As far as therapeutics are concerned, the agency stated that it is aware that some monoclonal antibodies authorized for COVID-19 patients are less active than the variants. The updated guidance provides recommendations on “efficient approaches to the generation of non-clinical, clinical and chemistry, manufacturing and control data that may potentially support EUA for monoclonal antibody products that are effective against emerging variants Can. “