The Food and Drug Administration issued a new guideline on Monday amid the emergence of new variants of the coronavirus for medical product developers. The regulatory agency said it was “committed to identifying efficient ways to modify medical products” that are in progress or have already been authorized for emergency use to deal with the variants.
“We know that the country is eager to return to a new normal and the emergence of variants of the virus raises new concerns about the performance of these products,” said Dr. Jane Woodcock, interim FDA commissioner, in a press release. “In 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 pivoting as the virus adapts. We need to provide healthcare professionals with the best diagnostics, therapies and vaccines. to fight 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), had previously warned that variants could hinder progress made in the fight against the coronavirus. Dr. Anthony Fauci, the country’s leading infectious disease specialist, said the emerging mutations should serve as a wake-up call for those in vaccine development to remain agile.
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Several companies have already started exploring adjustments to vaccine formulas or potential booster doses, if the variants affect effectiveness.
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 deal with the variant, the guidance recommends that a determination of efficacy be supported by data from clinical immunogenicity studies, which would compare the immune response. of a recipient 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 unvaccinated and previously vaccinated individuals with an authorized vaccine.
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“Finally, the guidance states that further discussions will be needed to decide whether, in the future, modified COVID-19 vaccines can be authorized without the need for clinical studies,” said the FDA.
Dr. Greg Poland, an infectious disease specialist at the Mayo Clinic, emphasized to Fox News that the guidance is not binding, meaning it is still subject to change.
“I like it [the FDA] made efforts to ensure that people understood it was a non-binding guideline, “said Poland, adding:” What I would like to see flagged is that we do not yet have enough information about the immunology of these variants and we have people who fall under immunological classifications different because of illness or vaccine and we may need to be more subtle in our requirements for reinforcements in these situations. “
Meanwhile, for testing, the agency has already issued a safety alert to warn that genetic mutations can affect test performance, and has already identified several tests that could be affected.
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“The guidance also provides recommendations for test developers, how to consider the potential for future viral genetic mutations when designing their test and conducting their own routine monitoring to assess the potential impact of new emerging viral genetic mutations, which may be the basis for variants in the performance of SARS-CoV-2 molecular, antigen and serological tests, “said the FDA.
With regard to therapy, the agency said it was aware that some of the monoclonal antibodies authorized for patients with COVID-19 are less active against variants. The updated guidance “provides recommendations on effective approaches for generating non-clinical, clinical and chemical, manufacturing and control data that could potentially support a USA for monoclonal antibody products that may be effective against emerging variants.”