FDA addresses coronavirus variants in updated guidance for medical developers

February 22, 2021 at 19:13

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.
We need to arm health care providers with the best available diagnostics, therapeutics and vaccines to fight this virus.
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.
FOR CORONAVIRUS SURVIVORS, ONE VACCINE DOSE MAY BE ENOUGH, EARLY STUDIES SHOWSeveral 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.
The FDA also encourages manufacturers to study the vaccine in non-vaccinated individuals and in those previously vaccinated with an authorized vaccine.
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.
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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