When President Donald Trump huddled with vaccine makers last spring, the CEO of Regeneron – who landed an audience with the President after a private call to a well-placed White House adviser – made the most of the chance to plug his company’s coronavirus treatment.
During that face-to-face meeting at the White House in March, Trump appeared taken with Dr. Len Schleifer’s promise of a treatment that could speed up the recovery for sick coronavirus patients and prevent others from becoming infected.
At least one top government scientist was also convinced. Dr. Rick Bright, former head of biomedical research at the Department of Health and Human Services, had witnessed Schleifer’s phone pitch for the right to make his case to Trump directly. He, too, believed that monoclonal antibodies held huge potential for combating the pandemic.
But in the months that followed, Trump’s focus drifted toward other unproven treatments such as hydroxychloroquine and the bigger prize of developing a vaccine. Scientists inside and outside the government tried to prod the administration to aggressively invest in antibody treatments such as Regeneron’s, but the Trump team waited months to ink a deal to invest in their manufacturing.
“It was very disappointing that the administration was only focusing on leaning forward on vaccines and not really choosing to do the same for antibodies,” said Bright, who has since left the administration. “There should have been no hesitation on leaning forward to address the supply chain and the volumes that we knew that we would need.”
Ironically, the antibody cocktail Schleifer pitched in March is now Trump’s miracle “cure” of choice. After taking a large dose of Regeneron’s dual-antibody cocktail during his recent hospitalization for coronavirus, Trump has touted the treatment and pledged to expedite its approval.
“I was very sick, and I took this medicine and it was incredible, it was incredible,” Trump said in a video shortly after he got out of the hospital. “You’re gonna get the same medicine and you’re gonna get it free, no charge and we’re gonna get it to you soon.”
Experts say that’s probably not going to happen. Even if Regeneron’s treatment or another antibody cocktail is authorized by the Food and Drug Administration, there certainly won’t be enough to treat anyone who falls ill with coronavirus. Concerns are already arising about how that limited supply will be distributed. Some worry that after the government’s initial distribution, the treatment could wind up with such a high price tag that is serves only the most privileged patients.
“Since the very start of the pandemic, scientists have predicted monoclonal antibodies would be a very effective treatment as well as preventative measure against Covid-19 and yet the Trump administration seems to have focused its Operation Warp Speed almost entirely on vaccines,” said Rep. Bill Foster, an Illinois Democrat and member of the House coronavirus subcommittee. “How do they intend to allocate this life-saving treatment? Will it be dispensed on the basis to save the most human lives or will they…allow a market-based allocation where those were able to afford it would get treatments unavailable to ordinary Americans?”
While the Trump administration launched Operation Warp Speed to invest hundreds of millions of dollars in developing and manufacturing yet unproven vaccine candidates, the government’s efforts to invest in promising therapeutics weren’t as aggressive. And though the antibody therapies appear promising and seem to reduce levels of the virus and improve patients’ symptoms, they have not yet been proven effective in for coronavirus patients and there is not yet evidence to support the notion that they could be a life-saving treatment.
“If we knew that something was going to work as confidently as we knew that a vaccine was going to work, we should’ve done it much sooner,” a senior federal health official said. “But therapies are always a second stepson to what goes on with vaccines.”
To be sure, antibody cocktails were just one of many unproven treatments Trump was hearing about back in March and the administration inevitably had to choose to gamble on some and not on others. And there are plenty of experts both inside and outside the administration believe the government made the right choice by focusing more of its energy and investment on vaccines. Still, the Regeneron case reveals how the Trump administration went about setting such consequential priorities, often against the backdrop of Trump’s vacillating attention.
Paul Mango, the deputy chief of staff for policy at the Department of Health and Human Services, disputed the idea that the administration was slow to invest in manufacturing for antibody treatments, saying the science simply wasn’t there yet to justify such an investment.
“It’s the same principle we use for vaccines, which is we didn’t want to make any investments in manufacturing until we saw early results from trials,” Mango said.
‘I call that a cure’
After his diagnosis with coronavirus and a brief stint in the hospital, the President emerged as an evangelist for Regeneron’s treatment and others like it.
“I wasn’t feeling so hot, and within a very short period of time they gave me Regeneron, it’s called Regeneron and other things, too, but I think this was the key,” Trump said in a propaganda-style video recorded last week. “They gave me Regeneron and it was like unbelievable. I felt good immediately.”
It wasn’t just a therapeutic, the President insisted, “it just made me better. I call that a cure.”
But the President’s “cure” is currently available to virtually no one else in the US. Regeneron and Eli Lilly are both in the midst of clinical trials to test their antibody treatments in coronavirus patients and both companies have requested emergency use authorization from the FDA, which are pending.
“He tends to be somewhat childlike in understanding how pharmaceuticals work,” said Dr. Peter Hotez, director of the Center for Vaccine Development at Texas Children’s Hospital. “He’s always had this magical thinking about biomedical interventions, starting with hydroxychloroquine.”
The President received a special dispensation – commonly known as “compassionate use” – in order to get a dose of Regeneron’s antibody cocktail. His spotlight on the treatment has renewed concerns that there won’t be adequate supplies and raised questions about how those supplies will be distributed.
“This is all very complicated because it’s real lives at stake,” Regeneron’s CEO told CNBC after Trump touted the treatment he received. “But, of course, we want to get definitive evidence, so it’s a tough act to balance.”
Monoclonal antibody treatments are developed in a lab to kickstart the immune response. Regeneron had effectively used the technology to develop a trio of antibodies that helped treat patients sick with the Ebola virus, which gave scientists hope that antibody treatments may work in the fight against coronavirus as well.
While they haven’t been proven effective yet, the President has been bullish about getting them to the American people.
“We’re going to be providing Regeneron all over the country very shortly at no cost,” Trump said Thursday, providing no other details.
Privately, Health and Human Services Secretary Alex Azar has also assured lawmakers that the administration is confident it has put enough manufacturing might behind antibody treatments. The government believes it will have “well over a million doses” of antibodies available to the public before the end of the year, HHS’s Mango said.
“Now, that’s not all going to happen tomorrow,” he cautioned.
The US is only likely to have sufficient doses of the antibody treatments, if they are approved, for a small sliver of patients. If the FDA only authorizes them for a narrow set of high-risk coronavirus patients, Mango said the government feels “comfortable” it will have enough doses available. But if the FDA were to authorize them for a broader set of coronavirus patients or for people living in close quarters with someone who has Covid-19, supplies will fall short.
In a recent interview on CBS’ Face the Nation, Schleifer acknowledged that there wouldn’t be enough antibody treatments such as Regeneron’s for everyone who might benefit. “We have to figure out ways to ration this,” he said.
Regeneron has been pushing the federal government for years to expand its investment in antibody manufacturing capacity in order to prepare for future pandemics. The company also recently partnered with Roche to significantly expand the doses it can manufacture going forward.
“We are doing everything we can,” said Hala Mirza, Regeneron’s senior vice president for Corporate Communications and Citizenship. “It really will take a village beyond Regeneron.”
If the treatments are approved, the administration plans to take a similar approach to distribution as it did with remdesivir, Mango said. The administration will determine how many doses are allocated per state – based on infection rates and other population data – and then it will be up to each state to determine where those doses go.
The government’s distribution of doses is expected to be provided to patients free of charge. Mango said they are committed to trying to keep the treatment affordable once it is available commercially, although some experts still worry it could wind up being too costly for many Americans.
“I also just want to reiterate that we are going to make sure the most vulnerable people get these first and we think that’s a very important role,” Mango said.
While the development and production of these coronavirus-fighting therapies has moved at an accelerated pace, pandemic preparedness experts still believe there were missed opportunities along the way.
“You don’t have enough for everybody to do post-exposure prophylaxis,” said Luciana Borio, the former director for medical and biodefense preparedness policy at the National Security Council. “But imagine the good you could do.”
She added, “We will get there eventually. I just find it tragic that it has taken so long.”
Stuck on vaccines, short on therapeutics
If the Trump administration had hoped to make antibody cocktails available for their widest possible set of people who might benefit – anyone fighting Covid-19 or anyone living in close quarters with someone infected – the administration would have had to pour money into the manufacturing process months earlier, experts said.
“It would’ve been nice retrospectively,” the senior federal health official said, noting that there are limited supplies of Regeneron’s antibody cocktail today. “But I don’t think that there was enough known yet,” to warrant large-scale government investment, the official said.
In the early phases of the pandemic, the White House coronavirus task force was primarily focused on existing drugs that could help sick patients fight off the worst symptoms of coronavirus. While remdesivir showed some early promise with patients, the President was fixated on hydroxychloroquine.
“There was a huge push for hydroxychloroquine where the task force ended up going in circles on it,” said a former administration official. Outside of discussions on remdesivir and hydroxychloroquine, the task force didn’t focus much of its time on up-and-coming therapeutics.
Bright, who alleged in a whistleblower complaint that he was removed from his post in biomedical research in part because he resisted efforts to widen the availability of hydroxychloroquine, said the administration was “distracted by hydroxychloroquine.”
“I think there’s numerous therapies that warranted investigation that were just not given the prioritization,” he added.
While developing therapeutics may not have been top of mind for the task force, health agencies were already eyeing emerging technologies.
Bright had been in contact with Schleifer since January about the potential for antibodies to combat the coronavirus. But after securing an initial partnership with Regeneron in February to develop a coronavirus antibody treatment, Bright could not secure more government funds in the following months. A $2 billion budget request he submitted in late March to support the large-scale production of monoclonal antibodies by Regeneron and other companies was denied.
Schleifer had lobbied to attend that March White House meeting because he knew the company already had a successful track record in responding to outbreaks like Ebola. “Regeneron viewed the meeting as an opportunity to educate on the potential of monoclonal antibodies to respond to the Covid-19 threat,” said Regeneron’s Mirza.
As Bright pushed for the funding, he stayed in touch with Regeneron’s CEO, who expressed frustration that he couldn’t get more enthusiastic buy-in from the federal government.
“I was pretty confident that if a monoclonal antibody would work for this virus that Regeneron would know how to make it,” Bright said.
At that point, the President was still busy touting hydroxychloroquine.
“We think it has a very serious, a very good impact on what we’re talking about with respect to the virus,” Trump said in a March visit to FEMA headquarters. “I think, to me, that’s a game changer.”
The race for a vaccine was also overshadowing the interest in investing aggressively in potential therapeutics like antibodies, the senior health official said, but added that was natural during a pandemic and in a fight against a virus like the coronavirus, where the odds of developing an effective vaccine are high.
Ultimately, the Trump administration did clear the way for drug companies developing antibody treatments to talk to each other about manufacturing issues without running the risk of violating antitrust laws. In July, the administration signed its $450 million deal with Regeneron to expand its manufacturing and buy the initial 70,000 to 300,000 doses stemming from that deal. This month, the administration also announced a $486 million deal with AstraZeneca to manufacture and purchases doses of its antibody therapy. HHS said altogether it has invested in six monoclonal antibody candidates.
Meanwhile, the President’s glowing language once reserved for hydroxychloroquine has now drifted over to his cure du jour: antibody treatments.
“I said let me take it and it was incredible the way it worked, incredible. And I think if I didn’t catch it, we’d be looking at that like a number of other drugs,” Trump said in a video last week. “I think this was a blessing from God that I caught it.”
CNN’s Elizabeth Cohen contributed to this report.