President Donald Trump, former New Jersey Gov. Chris Christie and former New York City Mayor Rudy Giuliani all received monoclonal antibodies when they were treated for COVID-19.
And despite having risk factors such as age and weight that put them at risk of getting really sick, they recovered quickly, although Christie spent a week in intensive care.
They all credit monoclonal antibodies.
But only a fraction of those doses have reached the people who could benefit from them, Health and Human Services Secretary Alex Azar said Monday.
The reason is a mix of science and politics, with some logistical and staffing challenges thrown in.
Monoclonal antibodies mimic the natural process of the immune system, providing it with molecules the body normally manufactures to fight disease. They are specific to each disease, but have been shown highly effective against other conditions, including Ebola, rheumatoid arthritis and some types ofcancer.
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Trump was so impressed with monoclonal antibodies, he promised to make them freely available to everyone in the United States. The government has since bought and delivered more than 250,000 doses of two therapies to hospitals across the country.
Butresearch isn’t clear that monoclonal antibodies help patients recover faster. 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.
Most hospitalized patients are too sick to benefit from the drugs, and it’s challenging to deliver drugs to COVID-19 patients who aren’t sick enough to be hospitalized, Gandhi said.
Hospitals have limited staff available to deliver monoclonal antibodies because COVID-19 has filled their beds and are busy delivering the first vaccinations.
The drugs are hard to deliver, requiring a one-hour infusion followed by one to two hours of observation. And the people who need monoclonal antibodies 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.
As of last week, about 20% of the 250,000 doses of monoclonal antibodies delivered to states have been used, according to a Health and Human Services spokesperson.
To improve usage,Azar said the federal Operation Warp Speed has begun delivering doses to retail pharmacies that have infusion centers, to skilled nursing facilities, and to at-home infusion services.
Azar said people at high risk for serious disease should ask their doctors for the monoclonal antibodies as soon as they’re diagnosed with COVID-19.
“We simply can’t have this very valuable tool sitting on the shelves,” Azar said.
Former FDA Commissioner Scott Gottlieb said the only people getting monoclonal antibodies now are those like Trump and his friends who have the right doctor or know what to ask for.
“Patients who already face obstacles to getting good care run the risk of having a hard time finding doctors and centers that are able to infuse these drugs, while those connected to better sites of service are able to seek out these medicines,” he said. “This runs the risk of widening the disparities we already see in COVID outcomes.”
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When Trump received the therapy made by Regeneron Pharmaceuticals of New York, he was among fewer than 10 people to receive the drug outside of a trial, under a “compassionate use” exemption. Christie also received the treatment that way, although the combination of two antibodies, casirivimab and imdevimab, had been FDA authorized by the time Giuliani fell ill.
A similar treatment, bamlanivimab, made by Eli Lilly and Co. of Indianapolis, Indiana, has also received emergency use authorization, which requires a lower standard of effectiveness than full approval.
Monoclonal antibodies were deemed ‘very exciting’ early in COVID-19 fight
Since the earliest days of the pandemic, health officials have promised monoclonal antibodies would be a game-changer in the fight against COVID-19.
On March 2, in a White House meeting with drug company executives, Dr. Deborah Birx, who had recently taken the job of Coronavirus Response Coordinator for the White House Coronavirus Task Force, touted the combination of monoclonal antibodies, therapeutics and vaccines to fight COVID-19. “It’s very encouraging,” she said.
“It is very exciting. And the speed is very exciting, too,” Trump replied.
Two months later, the administration announced the creation of Operation Warp Speed, a $10 billion government effort to rapidly develop vaccines, therapeutics and diagnostics to fight COVID-19.
Vaccines were developed in record time. But Gottlieb, the former FDA commissioner, said the administration did not work quickly enough to expand the manufacturing capacity of monoclonal antibodies.
Millions of doses could be available and in use today, if the government had done more early on, Gottlieb said. He said officials should have used the government’s authority to get other drug companies to manufacture these monoclonals.
The government also could have invested in special sites to administer monoclonals, said Gottlieb, who also sits on the board of Pfizer, the pharmaceutical giant behind one of the two COVID-19 vaccines authorized so far.
“Many of us, including myself, were writing and advocating back in April and May that we should start trying to requisition biologics manufacturing capacity, recognizing that the antibodies were going to be available at some point in the fall,’ Gottlieb said.
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. “We just didn’t do it.”
Gandhi, at Massachusetts General, said clinical trials of monoclonal antibodies could have moved faster, too.
“These antibodies are going to give us an answer relatively soon,” Gandhi said. “It would have been nice if the answer was months ago.”
One hard lesson learned during the pandemic: The U.S needs a better system for conducting clinical trials during a disease outbreak, when the need for information is urgent but studies are more difficult, Gandhi said.
Lilly, Regeneron antibodies could be ‘lifesaving and prevent hospitalizations’
Although the data remains limited, monoclonal antibodies do seem generally safe.
“I do believe these two monoclonal antibodies can be lifesaving and prevent hospitalizations,” Moncef Slaoui, the scientific chief of Operation Warp Speed, said Monday.
“They are effective at either eliminating the virus and giving time to the patient’s own immune response to eliminate whatever (virus remains),” he said, “and on the other hand are very good at decreasing the virus load, which is very likely to translate into clinical benefit, but that benefit hasn’t been confirmed.”
In small clinical trials, both the Lilly and Regeneron antibodies — both of which have been FDA-authorized for emergency use — seemed to help people stay out of the hospital. Both drugs were authorized for use in non-hospitalized patients.
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Among a high-risk group of people recently diagnosed with COVID-19, approximately 10% who received a placebo ended up needing hospital care to treat their disease, compared to only 3% of those who received Lilly’s monoclonal antibody. Regeneron’s results were similar.
Regeneron, in a 275-person study published last week in the New England Journal of Medicine, showed that its monoclonal antibodies reduced the amount of virus in people diagnosed with COVID-19, particularly those who were carrying particularly high levels of virus and those whose bodies hadn’t yet begun to fight it.
Gandhi said it is not yet clear whether reducing someone’s viral load can help them recover faster or save their life.
And the studies were so small “that it’s hard to be extremely confident in those results,” Gandhi said.
That’s why the Infectious Disease Society of American and the National Institutes of Health guidelines, which practitioners often use to direct the care they provide, declined to support the use of monoclonal antibodies, he said.
Azar complained Monday that both groups should be willing to accept less conclusive data during a global pandemic, when thousands of Americans are dying every day.
“We’ve been very disappointed that this incredibly important tool that should be getting used more frequently, that should be getting used to keep people out of the hospital” isn’t reaching more patients, Azar said.
Both Regeneron and Lilly are continuing their monoclonal antibody trials, hoping to make more data available soon. Slaoui said Lilly is also investigating three cases in which the virus appeared to mutate to evade the drug, although all three trial participants recovered.
