Family members who have weaker immunities and have yet to receive their vaccination have another option if they become exposed to the deadly virus. The U.S. Food and Drug Administration (FDA) has granted a COVID-19 antibody treatment, developed by Regeneron Pharmacy, for emergency use.
The COVID-19 antibody treatment, also termed as a monoclonal antibody treatment, will work best for about three percent of America's immunocompromised, such as patients who have cancer, HIV, or organ transplant.
Reports cited that this is the first injectable medication approved for emergency use for patients exposed to the virus. The injectable is ideally administered when the virus infection is still in the person's nose and throat and would work to protect the lungs and the rest of the body's organs from damage.
However, the FDA clarified that this injection is not a replacement for the vaccine. The agency is still urging all eligible individuals to get their vaccination.
Monoclonal Antibody Treatments Defined
The new treatment was initially allowed for limited use and administered as an IV infusion cocktail, alongside medications like casirivimab and imdevimab, within ten days of the patient's symptoms manifestation. However, with the FDA's newest approval, the treatment may now be administered within 96 hours after the exposure.
To gain clearance from the FDA, the pharmaceutical company had a clinical trial among a larger group composed of families exposed to contacts with COVID-19 in the U.S. Moldova and Romania. Of the 1,505 participants, 81 percent who took the cocktail had reduced risks of hospitalization and severe symptoms from the virus. The affected patients also had shorter symptoms of the virus clearing faster than if they did not get the IV infusion.
FDA said that while there were few immunocompromised participants in the study, it covered a demographic that required preventive treatment and involved people who work in high-risk environments that could expose weaker family members to the virus. The clinical trial also showed that the COVID-19 antibody treatment is safe for patients who may need it every month if they are repeatedly exposed to COVID-19.
Infectious disease expert Dr. Katharine Bar of the University of Pennsylvania said that this infusion would provide a highly efficacious treatment option for patients. However, as with the FDA, she stressed that the best defense against COVID-19 is still vaccination.
Approved for Kids As Well
In November 2020, the FDA also approved Regeneron's casirivimab and imdevimab IV infusion cocktail for children above 12 years old who have symptoms of COVID-19, except if they need oxygen therapy. The agency was confident of the clinical trials showing that kids who weigh at least 88 pounds had better outcomes against the virus during their emergency room visit.
However, kids above 12 years old are already eligible for Pfizer-BioNTech vaccine shots in the U.S. The pharmaceutical company is also waiting for approval on their vaccines for younger kids by October. Trials are currently underway involving children from six to 11 years old, while another clinical trial for those under five years old will be conducted shortly.
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