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Federal officials say monoclonal antibodies are in full supply, but patients and providers are not taking advantage of them to treat COVID-19.
In a briefing Thursday, the Department of Health and Human Services and Operation Warp Speed urged Americans to ask their doctors about the treatment to prevent severe illness and help ease the crushing burden of the pandemic on hospitals.
“We now have all the tools we need to both prevent and fight back against COVID-19,” said U.S. Surgeon General Dr. Jerome Adams. “But tools that never leave the toolbox don’t get the work done.”
The Food and Drug Administration has authorized antibodies from Eli Lilly and Regeneron for emergency use in non-hospitalized patients with mild or moderate COVID-19 who are at high risk of developing severe symptoms.
Dr. Janet Woodcock, therapeutics lead for Operation Warp Speed, said the federal government has shipped more than half a million doses to more than 3,700 locations across the country.
HHS agreed to purchase approximately 300,000 additional doses from Regeneron and has the option of buying three million doses from Lilly, if needed.
“And yet, we’re not seeing full utilization,” said Woodcock, who placed partial blame on a lack of public awareness.
To increase that awareness and public access, HHS launched a website that allows patients and providers to find potential locations for treatment with monoclonal antibodies. As of Thursday, several states did not show treatment locations. Woodcock said states have until next week to update data on available locations.
Since the earliest days of the pandemic, health officials have promised monoclonal antibodies would be a game-changer in the fight against COVID-19. However, a host of logistical issues and political decisions have prevented large numbers of Americans from benefiting from them, experts say.
Hospitals have limited staff available to deliver monoclonal antibodies because COVID-19 has filled their beds, and health care workers are busy delivering the first vaccinations.
Antibodies are hard to deliver, requiring a one-hour infusion followed by one to two hours of observation. And the people who need them are at the most contagious stage of disease, making it tricky to deliver the drugs in facilities like cancer or dialysis centers that commonly deliver medication by infusion.
Monoclonal antibodies could have helped prevent severely sick patients from overwhelming hospitals if federal officials had made them a priority from the start, health experts argue.
President Donald Trump, former New Jersey Gov. Chris Christie and former New York City Mayor Rudy Giuliani all were able to receive the treatment when they tested positive for COVID-19.
But former FDA Commissioner Scott Gottlieb said the administration did not work quickly enough to expand the manufacturing capacity and invest in special sites to administer the monoclonals when average Americans needed them.
If they had started making the drugs earlier, and if people had understood their potential, we might not be in the current situation, he said.
The science is also is not as definitive as the government asserts. Two key panels that recommend how doctors should treat COVID-19 patients declined to support monoclonal antibodies. Until they do, doctors may be hesitant to prescribe the treatment.
"Although these look promising, there's not enough conclusive evidence to know that these are having a clinical benefit," said Dr. Rajesh Gandhi, an infectious diseases doctor at Massachusetts General Hospital and Harvard Medical School, who sits on both guideline panels.
In small clinical trials, both the Lilly and Regeneron antibodies seemed to help people stay out of the hospital.
Among a high-risk group of people recently diagnosed with COVID-19, approximately 10% of those who received a placebo ended up needing hospital care to treat their disease, compared with only 3% of those who received Lilly's monoclonal antibody. Regeneron's results were similar.
But studies were so small “that it’s hard to be extremely confident in those results,” Gandhi said.
Both Regeneron and Eli Lilly are continuing their monoclonal antibody trials, hoping to make more data available soon.
Scientists are also concerned that changes in the virus – though so far not substantial enough to make vaccines ineffective – could render more targeted monoclonal antibodies useless.
Regeneron's antibody includes two monoclonals, which makes it more likely to remain effective, but changes to the target of Lilly's antibody could limit its usefulness, just as the federal government pushes make it available.
"The monoclonal antibodies, their days are numbered," said Dr. W. Ian Lipkin, an epidemiologist at Columbia.
Karen Weintraub contributed to this report.
Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.
This article originally appeared on USA TODAY: Monoclonal antibodies for COVID in full supply, but lack demand: HHS