HHS, Operation Warp Speed tout benefits of monoclonal antibody therapeutics for COVID-19

Hospitals and health systems have been stretched almost to their breaking points during the COVID-19 pandemic, leading many to rest their hopes on the widespread administration of a vaccine. But while the vaccine is the most powerful tool yet for containing the coronavirus, it won't prevent infections entirely.

With that in mind, the Department of Health and Human Services has promoted the benefits of monoclonal antibody therapeutics, which it says have proven effective in those already infected with the virus.

Two monoclonal antibody therapeutics have been granted emergency use authorization from the U.S. Food and Drug Administration to treat non-hospitalized patients with mild to moderate confirmed cases of COVID-19. HHS, which partners with the Department of Defense on the Operation Warp Speed initiative, said greater understanding of the uses and potential benefits of these treatments is needed among health systems.

"There is growing light at the end of the tunnel," said Vice Admiral Dr. Jerome Adams, U.S. Surgeon General, during a press conference Thursday. "But we all have to stay vigilant and prevent overcrowding in our hospitals."

Adams said there's been an uptick in the pace of vaccinations, with more than 700,000 occurring each day during the past week. But since vaccines cannot prevent every infection, monoclonal antibody therapeutics come highly recommended for keeping people out of the hospital, shortening their stay if they are hospitalized, and generally improving outcomes among those infected. Adams said the benefits far outweigh the risks.

"We aren't seeing them utilized as widely as they should be," he said. "I want people to know they have options to improve their chances of a successful and full recovery from COVID even after falling ill. These medications work best when given early. If you have COVID symptoms or have had a high-risk exposure, we need you to get tested right away."

Adams also has a message for clinicians, saying they should be willing to prescribe these treatments much more frequently.

WHAT'S THE IMPACT?

According to Dr. Janet Woodcock, therapeutics lead for Operation Warp Speed, OWS has doled out about two million doses of monoclonal antibody treatments to date, but the country is not yet seeing full utilization. This is due to a couple of factors, she said: public awareness, but also the difficulty inherent in giving infusions to people when they're highly infectious. OWS is engaging in efforts to improve awareness and promote increased administration of the treatments, she said.

"The government has purchased them and they're available, but we have a shortage of ability to administer these to patients," said Woodcock. "This is important because we want to keep people out of the hospital."

OWS data shows that monoclonal antibody therapies decrease the prevalence of the coronavirus in peoples' bodies, shorten the length of symptoms and lower hospital admission rates, and the agency believes better awareness will translate to better administration of the antibodies.

"Hospitals are stressed, but if we don't do this they'll be even more overwhelmed," said Woodcock. "It's definitely worth it, we believe."

Dr. William Fales, medical director of the Michigan Department of Health and Human Services, said OWS gave each state a baseline supply of monoclonal antibody therapeutics and then distributed more as needed. Michigan has been allocated 21,000 courses of the treatment, but to date fewer than 2,000 patients have been treated, which in Fales' opinion supports the case for a more aggressive effort in administering the treatments.

Wes Hoyt, chief of operations at Hutchinson Regional Medical Center in Kansas, aid his state received monoclonal antibody treatments in the middle of the early fall surge and anecdotally it has helped Kansas turn the tide.

"Our goal was to take the fight to COVID rather than waiting for it to overwhelm us," said Hoyt. "Once these monoclonals became an option, our philosophy was to accept these as treatments, period. We created a process that can be used by anybody, and we fostered an ability to become a hub of infusion of monoclonals with relative ease.

"We didn't keep anything on the shelf," he said. "If it was available on the shelf, we were going to use it until it was gone and then we'd call for more. We approached this as a community benefit, which eliminated a lot of silos."

THE LARGER TREND

Operation Warp Speed has been busy these past few months. To further its efforts, HHS and the Centers for Disease Control and Prevention announced last week they're releasing more than $22 billion in funding to help states, territories and localities provide testing and vaccinations. The money is part of the Coronavirus Response and Relief Supplemental Appropriations Act recently passed by Congress.

More than $19 billion will be allocated to jurisdictions through the existing CDC Epidemiology and Laboratory Capacity cooperative agreement to support testing, contract tracing, surveillance, containment and mitigation to monitor and suppress the spread of COVID-19. More than $3 billion will be made available in an initial award to jurisdictions through the existing CDC Immunization and Vaccines for Children cooperative agreement.
 

Twitter: @JELagasse
Email the writer: jeff.lagasse@himssmedia.com