Feds to distribute 30K doses of new Regeneron COVID-19 antibody cocktail just approved by FDA

Regeneron
The Trump administration's Operation Warp Speed announced Monday it will distribute 30,000 doses of Regeneron's new COVID-19 antibody cocktail within 24 hours. (Regeneron)

The Trump administration announced plans to distribute on Tuesday 30,000 doses of a newly approved antibody cocktail designed to fight mild and moderate cases of COVID-19.

Administration officials shared details Monday of the initial distribution of a monoclonal antibody cocktail made by Regeneron that got emergency approval from the Food and Drug Administration on Saturday.

“We expect to distribute 30,000 doses tomorrow with more to come in the ensuing weeks,” said Department of Health and Human Services Secretary Alex Azar during a call with reporters Monday.

Regeneron’s cocktail is the second of its kind to get emergency approval, after a cocktail from Eli Lilly was approved a few weeks ago. Azar said 85,000 doses of that drug have since been delivered.

“As with Lilly, we will be working with state, local and territorial health departments so patients can get Regeneron infusions for hospitals, and outpatient clinics,” Azar said.

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The distribution process will be similar to that used for remdesivir, the first FDA-approved treatment to fight COVID-19.

However, Regeneron’s product is not to be used in severe cases like remdesivir is.

Instead, the cocktail is approved to treat mild to moderate COVID-19 cases in adults and children ages 12 years or older. The cocktail must be administered intravenously and is intended to curb or reduce hospitalizations.

Officials said they understand intravenous administration can present unique challenges for outpatient clinics, and there needs to be training and equipment for the infusions.

The administration’s Operation Warp Speed, which has been funding research and initial doses of COVID-19 vaccines and treatments, is handling the allocation of the drug.

The administration will look at COVID-19 total cases and hospitalizations in a state to determine where to send the most doses of the cocktail.

“We look at hospitalizations because that is what we are trying to avoid for these medications,” a senior administration official said. “We want to make sure that we use a measure of acuity of severity of illness.”

The officials added that providers are being asked to assess patients and their histories to determine whether they are at a high risk of hospitalization, such as if they are in a high-risk category for complications from the virus.