Story at a glance
- Monoclonal antibody treatment Evusheld has emergency use authorization from the FDA.
- It is meant to be given pre-exposure for immunocompromised people or people who have had adverse reactions to the COVID-19 vaccines.
- The FDA revised its guidance to double the dosage for the treatment.
Evusheld from AstraZeneca is a pre-exposure prophylaxis treatment meant to be taken by immunocompromised individuals to help prevent illness from COVID-19. It was authorized for emergency use by the U.S. Food and Drug Administration (FDA) on Dec. 8, 2021. Since then, it’s been shipped out to health care providers around the U.S., but data suggests that many of the doses are not getting used.
Evusheld is a treatment that involves two compounds that act as a “long-acting antibody combination,” according to the company’s website. Patients are meant to get this treatment before exposure to the SARS-CoV-2 coronavirus, and may need the shots every six months.
These antibodies were developed from immune cells from coronavirus patients early in the pandemic and were improved upon by AstraZeneca so that they would last longer in the body. The initial dosage consisted of 150 mg of tixagevimab and 150 mg of cilgavimab administered, given as two separate consecutive intramuscular injections.
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Last month on Feb. 24, the FDA revised its guidance for the dosing regimen. Newly available data suggests that a higher dose of 300 mg of each drug should be given. The FDA suggests that people who have already received the initial injections of 150 mg of each drug should get additional shots with 150 mg for each drug.
In January, doctors were reporting that they had to put people into a lottery or rank patients by medical need in order to determine who should get the first doses of Evusheld because they did not have enough to cover all of their immunocompromised patients.
Availability may vary by state and shipments may have caught up to demand. On Sunday, the New York Times reported that 80 percent of Evusheld doses are sitting on shelves in warehouses and in hospitals. There have been cases where people will travel out of their way to find these shots, and cases where health workers don’t know what it is even if they do have it in stock.
Many people, including doctors, still may not know about it or feel that they know enough to prescribe it to their patients. “The biggest problem is that there is absolutely no guidance or prioritization or any rollout in place at all, and it’s been a mess,” says Dorry Segev, who is a transplant surgeon at N.Y.U. Langone Health, to the Times. “Without formal guidelines, you really can’t do anything.”
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