How long will it take to develop a vaccine for COVID-19? And how quickly can it be scaled up to inoculate everyone?
With lives and livelihoods on pause, Cornell’s Institute of Politics and Global Affairs hosted a TeleTown Hall April 8 to explore these questions.
Featured speakers were Dr. Leonard Schleifer ’73, founder, president and CEO of biotechnology firm Regeneron; and Sean Nicholson, professor of policy analysis and management in the College of Human Ecology and director of the Sloan Program in Health Administration.
More than 300 listeners tuned in, including several current and former members of Congress and the New York State Legislature, along with Cornell students and alumni.
Schleifer, Cornell’s 2019 Entrepreneur of the Year, shared his expertise from more than 30 years of working to develop effective treatments for diseases ranging from Alzheimer’s to Ebola. Nicholson shared his insights on how to mobilize the public and private sectors to work together – at the scale necessary to address the pandemic.
Steve Israel, director of the institute and a member of Congress from 2001-17, and Douglas Kriner, faculty director of the institute and the Clinton Rossiter Professor in American Institutions in the College of Arts and Sciences, moderated the discussion.
According to Schleifer, we should follow a three-step approach to deal with the pandemic.
The first step: Identify the treatments we have on the shelf now, ready to go. These include drugs that have already been approved by the FDA. He said he has received thousands of phone calls regarding the efficacy of various interventions, from infusions of vitamin C to anti-malarial drugs.
“We believe you should follow the recommendations of science,” and to take only those pharmaceuticals that have already been proven to work or those being evaluated as part of a scientific study, he said.
Schleifer said the process of identifying and testing drugs does not produce instant results. “It took Regeneron 25 years to make a profit,” he said.
According to Schleifer, the only reason his company survived was that his investors believed that “we would get there, and that there would be some reward at the back end.”
The second step, he said, involves repurposing innovative solutions. Schleifer estimated that it could take months to develop, test, and produce a vaccine to protect people against COVID-19. Until an effective and safe vaccine is available, he said, Regeneron is focusing on how to use the “technologies we’ve been developing for decades to deal with other diseases to come up with a short-term solution for COVID-19.”
Schleifer said drug development costs are modest when compared to the lifetime costs of caring for those inflicted with disease.
“Think of Alzheimer’s disease,” he said. “The cost of caring for patients is way more than the cost of providing drugs to treat the disease. But everyone who needs them should have access to drugs – we all agree on that.”
The third step is the long-term solution to the pandemic – what Schleifer called an “antibody cocktail,” developed specifically to protect the body against the novel coronavirus.
“When the body is attacked by a foreign virus, the immune system kicks into high gear – turning the body into a factory for producing antibodies to attack the virus,” he said. A vaccine works by “tricking” the body into making the right antibodies before the virus attacks.
Regeneron uses mice that have been bred to mimic the human immune system to test various combinations of antibodies. These “magical mice” were used successfully to produce antibodies to protect humans against the Ebola virus; the vaccine Regeneron developed using this approach was “overwhelmingly effective,” Schleifer said, when deployed in the Congo in 2018-19.
Since the new virus was identified in January, the company has tested thousands of antibodies and identified hundreds that are effective. Regeneron will test the most promising of these antibody combinations on mice through the summer.
There are significant advantages to using artificially developed antibodies versus drawing antibodies from the blood of those who have recovered from COVID-19.
“Maybe you can use plasma [from someone who has recovered] to treat one person,” Schleifer said. “Through the miracle of biotechnology, we can make thousands of these antibodies and treat many people, without the risks of transferring other illnesses.”
Nicholson said the health care system in the U.S. incentivizes pharmaceutical companies to innovate, by allowing them to recoup their R&D investment through drug sales.
“[W]hat we’re about to observe over the next 12 to 18 months,” he said, “is the upside of an unregulated economy. Our kitchen sink is full of already approved drugs that can be channeled to treat COVID-19.”
He cautioned, however, that the marketplace does not account for “positive externalities,” such as how all citizens benefit if the country is able to return to normal economic activity quickly. In order for us to feel confident about returning to work, he said, “we need to believe that there’s a treatment for higher-risk individuals.”
Nicholson said that the government can facilitate “our willingness to recover quickly” through several actions. He cited several examples, including authorizing the FDA to conduct “real-time review” of promising drugs to shorten the approval time.
“The government could also commit to purchasing a large quantity of the drug once it is approved,” he said, “and sell it at marginal cost or give it away for free.” He believes that these policies could help Americans become more willing to go back to work.
Schleifer noted that in the U.S., a major roadblock remains: “We do not have the capacity right now to manufacture enough antibody cocktail to treat everyone.”
He estimated that Regeneron can scale up to manufacture enough vaccines to treat, at most, 1 million people a month – far fewer than our nation’s population of roughly 330 million people.
“We have to have a stockpile of capacity to manufacture drugs,” Schleifer said. “When the red phone rings, we need these factories ready to go to manufacture what the country needs.”
Nicholson agreed that the U.S. needs to increase its capacity to produce these biologics.
“We need to allow other companies to manufacture the vaccine to ensure there’s enough supply,” he said. “Normally in capitalism we have a horse race. In this case, we need to pay the second, third and fourth companies to produce the vaccine.”
TeleTown Halls are a series of conversations with national and global thought leaders. The next event will feature Sen. Amy Klobuchar on April 15, discussing her proposed legislation to broaden access to voting.
Linda Copman is a writer for Alumni Affairs and Development.