What Does the FDA Halt on Certain COVID Antibody Treatments Mean for Patients?

The Food and Drug Administration (FDA) has told eight states to stop using a COVID-19 antibody treatment as it is not effective against the new Omicron variant.

U.S. drug regulators warned doctors in Connecticut, Maine, Massachusetts, New Hampshire, New Jersey, New York, Rhode Island, and Vermont that sotrovimab, a monoclonal antibody, can no longer be used.

The FDA said this treatment, which was given the green light back in May 2021, is not effective in the rising BA.2 subvariant. This new variant currently accounts for 73% of COVID cases in New England, according to the CDC.

The FDA began limiting treatment of this specific monoclonal antibody in February 2021.

“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.

How will this affect patients in Massachusetts?

In this week's COVID Q&A, three Boston doctors discussed the change. Boston Medical Center's Dr. Sabrina Assoumou there are other treatment options for high-risk patients, including Pfizer’s pill, paxlovid, the antiviral from Gilead Sciences known as remdesivir, and Eli Lilly and Company’s bebtelovimab, a monoclonal antibody treatment, and molnupiravir, Merck's oral treatment.

She said one of the key uses of sotrovimab was for patients who tested positive for the virus, were not yet hospitalized but were at high-risk for serious complications from COVID-19.

“It’s not good that we’re losing a monoclonal antibody (option) but what I want to also emphasize is that we have thankfully other tools in our toolbox," she said.

Brigham and Women's Hospital's Chief of Infectious Disease Dr. Daniel Kuritzkes said that doctors already make calls about what treatment options will be most effective, a concept dating back 100 years.

"There are all kinds of antibiotics we don’t use because we know bacteria are resistant," Kuritzkes said.

"The challenge here is that we don’t have readily available testing to tell us which variant an individual patient is infected with so that in the necessary time frame, meaning a day or two, you could know which strain the patient has and whether sotrovimab would or wouldn’t be useful or whether some other agent would be useful," he added.

He also noted that right now there are still very few treatment options with full FDA approval, and emergency use authorization comes with a certain set of restrictions and a lack of flexibility that full approval allows.

“We don’t have antibodies that are currently fully approved. Only remdesivir is fully approved and then only for people in the hospital, not outpatients," he said.

Dr. Shira Doron of Tufts Medical Center said that the FDA announcement did not feel particularly restricting because doctors were already pulling back on using the treatment because they weren't finding it as effective. However, she pointed out the FDA made its decision based on mostly lab data, not clinical data, and reassured patients who may have received sotrovimab that it may not be totally ineffective.

All three stressed that the public should get tested as soon as they experience any symptoms that could be COVID-19, and that if they test positive, they should contact their health care provider immediately.

For more information for treatment options, and to find out of you qualify as high risk, click here.

What happens next?

The makers of sotrovimab, GlaxoSmithKline and Vir Biotechnology, pushed back on the FDA's claim. They said a higher dose of their treatment works for the BA.2. The drug makers sent the FDA a data package that backs up their claim.

Currently, the FDA says the only treatment that works for the rising BA.2. variant are Pfizer’s pill, paxlovid, the antiviral from Gilead Sciences known as remdesivir, and Eli Lilly and Company’s bebtelovimab, a monoclonal antibody treatment.