FDA Tells Doctors In 8 States To Stop Using COVID Treatment

BA.2 (a subvariant of omicron) was liable for 12.6 percent of COVID-19 infections in the United States in the week ending March 5. As such, the FDA has told doctors in 8 states to stop using COVID treatment.

FDA Tells Doctors in 8 States to Stop Using COVID-19 Treatment

Health care professionals in eight states have been advised to avoid using a COVID-19 medication as it may not be helpful against an Omicron coronavirus subvariant that is becoming more common.

Sotrovimab, a monoclonal antibody given to treat COVID-19, is no longer approved for use in Connecticut, Maine, Massachusetts, New Hampshire, New Jersey, New York, Rhode Island, and Vermont, according to the Food and Drug Administration.

Stotrovimab is no longer being used by suppliers in Puerto Rico and the Virgin Islands either.

The FDA declared in a statement that the medication, which was granted emergency use authorization in May 2021, “is unlikely to be effective against the BA.2 subvariant.”

BA.2 is a subvariant of Omicron, which is a strain of the coronavirus, which causes COVID-19.

BA.2 was liable for 12.6 percent of COVID-19 infections in the United States in the week ending March 5, as per genomic surveillance done by the Centers for Disease Control and Prevention. However, the agency predicted a 35 percent spike in the week ending March 19, and the subvariant was said to be widespread in the northeast.

According to estimations, BA.2 is culpable for the bulk of instances in states where sotrovimab prescription is now restricted.

The FDA had stated in February that the treatment would be limited.

Several investigations, and even one released in Nature Medicine (read below), have found that sotrovimab is ineffective against BA.2.

However, the drug’s creators, GlaxoSmithKline and Vir Biotechnology, have stated that tests revealed the treatment’s ability to neutralize BA.2.

The businesses responded on March 25 that they were notified of the FDA’s action and that they have been planning to provide the agency and other regulatory bodies an information package showing that a larger dosage of sotrovimab appears to work against BA.2.

According to the FDA, COVID-19 treatments that seem to be impactful against BA.2 comprise Pfizer’s paxlovid tablet, Gilead Sciences’ remdesivir antiviral, and Eli Lilly’s recently approved bebtelovimab monoclonal.

“We will continue to monitor BA.2 in all U.S. regions and may revise the authorization further to ensure that patients with COVID-19 have effective treatments available. Health care providers should also monitor the frequency of BA.2 in their region as they choose appropriate treatment options for patients,” the agency said.

The FDA previously revoked approval for REGEN-COV, a Regeneron monoclonal, and a different Eli Lilly medication after lab research revealed that they were not effective against Omicron.

Read the full document below:

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