Azar touts mAb COVID-19 therapies but NIH isn’t convinced
The Trump administration sent mixed messages about mAbs for COVID-19 Wednesday as HHS Secretary Alex Azar urged the media to encourage Americans to seek the therapies and an NIH panel said there aren’t enough data to recommend their use. Instead of treating their patients with a mAb that has been authorized by FDA, the panel encouraged physicians to refer their patients to placebo-controlled trials of the therapies.
FDA has granted emergency use authorizations for mAb therapies from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and partners Eli Lilly and Co. (NYSE:LLY) and AbCellera Biologics Inc. Operation Warp Speed has purchased the mAbs and is distributing them to state and territorial health departments.
“As of this week, we’ve distributed more than 157,000-patient courses of two authorized antibody products across the United States and allocated a total of 205,000 courses for delivery to states,” Azar said.
He added that more than 3,000 sites are signed up to offer bamlanivimab from AbCellera and Lilly and Regeneron’s casirivimab/imdevimab (REGN-COV2). In addition, HHS has “launched a pilot program that will explore how to reach vulnerable populations with these treatments and offer the treatments at even more convenient locations,” he said.
“Americans need to know that this treatment is a possible option.”
Emphasizing the role of mAbs in preventing progression of mild COVID-19, Azar said, “Americans need to know that this treatment is a possible option for patients who are at high risk for severe COVID-19 but who have not been hospitalized. That includes all Americans over the age of 65 — that’s the definition we’re using in this case for risk of severe COVID-19.”
For high-risk COVID-19 patients, mAbs “could help keep you out of the hospital, potentially helping to save your life. So, we want to encourage the news media and all Americans to spread the word about the availability of COVID-19 treatments,” Azar said.
The panel concluded that “there are insufficient data to recommend either for or against the use” of either mAb to treat outpatients with mild to moderate COVID-19.
The NIH panel recommended that the mAb therapies “should not be considered the standard of care for the treatment of patients with COVID-19.”
Rather than treating patients with a mAb authorized under the EUA, “health care providers are encouraged to discuss participation in SARS-CoV-2 neutralizing antibody clinical trials with patients,” the panel stated. Trials of the mAbs are placebo-controlled, so patients who enroll in a trial would have to accept the risk that they would not receive an active treatment.
The panel noted the possibility of limited supplies of the mAbs, as well as challenges distributing and administering the therapies, and recommended prioritizing their use for “patients at highest risk for COVID-19 progression” and taking steps to “ensure that communities most affected by COVID-19 have equitable access.”