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The Food and Drug Administration released new guidelines on Monday amid the emergence of new coronavirus variants for developers of medical products. The regulatory agency said it was “committed to identifying effective ways to modify medical products” that are either under development or have already been cleared for emergency use to treat variants.
“We know the country is eager to return to a new normal and that the urgency of virus variants raises new concerns about the performance of these products,” said Dr. Jane Woodcock, acting commissioner of the FDA, in A press release. “By posting these guidelines, we want the American public to know what we are using each tool in our toolkit to combat this pandemic, including the rotation as the virus adapts. We must equip health care providers with the best diagnostics, therapies and vaccines to fight this virus. We remain committed to bringing these vital products to the forefront. “
Dr Rochelle Walensky, the director of the Centers for Disease Control and Prevention (CDC) had previously warned that the variants could jeopardize progress in the fight against the coronavirus. Dr Anthony Fauci, the country’s leading infectious disease specialist, said emerging mutations should serve as a wake-up call to keep those developing vaccines nimble.
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Several companies have already started exploring adjustments to vaccine formulas or potential booster shots if 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 to be modified to treat the variant, the guidelines recommend that a determination of efficacy be supported by data from the vaccine. ‘clinical immunogenicity studies, which would compare a recipient’s immune response to viral 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 in those previously vaccinated with an authorized vaccine.
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“Finally, the guidelines indicate 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,” the FDA said.
Dr Greg Poland, an infectious disease expert at the Mayo Clinic, told Fox News that the guidelines are non-binding, which means they are always subject to change.
“I like this [the FDA] made an effort to make sure people understand that this was a non-binding directive, “Poland said, adding:” what I would have liked to have seen reported is that we did not not yet enough information on the immunology of these variants and that we have people who fall into immunologically different classifications. due to an illness or a vaccine and we may need to be more nuanced in our need for reminders in these situations. “
Meanwhile, for the tests, the agency has already issued a safety alert to warn that genetic mutations could potentially impact test performance, and has already identified several tests that could be impacted.
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“The guidance also provides recommendations to test developers, such as examining the potential for future viral genetic mutations when designing their test, and conducting their own routine surveillance to assess the potential impact of the mutations.” new and emerging viral genetics, which may underlie viral variants, on the performance of molecular, antigenic and serological tests for SARS-CoV-2, ”the FDA said.
Regarding therapeutics, the agency said it is aware that some of the monoclonal antibodies allowed for COVID-19 patients are less active against the variants. Updated guidance “provides recommendations on effective approaches for the generation of non-clinical, clinical and chemical, manufacturing, and control data that could potentially support EUA for monoclonal antibody products that could be effective against variants. emerging. “
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