Hospital staff work at an intensive care unit in Houston, June 29.
Photo: callaghan o'hare/ReutersAmerica’s coronavirus epidemic has taken a turn for the worse, with many more states showing sharp increases in daily cases compared with two weeks ago. How long will it take for researchers to catch up and develop more effective therapies against Covid-19?
The federal government’s Operation Warp Speed is working with drugmakers to accelerate the development and manufacturing of vaccines. Five candidates are in clinical trials, including one from Pfizer (on whose board one of us, Dr. Gottlieb, sits). More vaccines are expected to enter such trials soon. A safe and effective vaccine is the best hope for ending the pandemic and fully restoring the economy. Everyone is hoping for success—and quickly.
But the path to a vaccine can be long and complex. Enrolling patients in clinical trials, ramping up factories, and producing sufficient supply is an intricate process that can take many months. Distributing vaccines also takes time, and so does encouraging Americans to take them. With so many uncertainties, vaccines aren’t likely to be available widely until next year. That means we need to pursue other potential antidotes.
One promising option is monoclonal antibodies—lab-produced molecules engineered to mimic antibodies that occur naturally in response to an infection or vaccine. Like natural antibodies, the lab versions bind to the virus and prevent its spread. Regeneron, Vir, Eli Lilly and others are developing this class of drugs for Covid. Several are in clinical trials.
The trick will be producing them at scale. For a cautionary tale, consider the antiviral drug remdesivir, which has shown benefits against Covid and is authorized for use by the Food and Drug Administration. Supply wasn’t ramped up enough in advance, so there may be shortages as the epidemic worsens. It’s important not to repeat that mistake with antibodies.
Antibody drugs have a record of treating viral diseases such as Ebola and might be a bridge to a vaccine. These treatments can be administered to those exposed to coronavirus and used as a prophylaxis to prevent them from developing the disease. Antibodies can also reduce the severity of the disease in infected patients.
Moreover, antibodies are a hedge against the risk that the virus mutates in ways that evade other drugs or vaccines. Antibodies can be administered as a mixture of different molecules that target different parts of the virus. Drugmakers can engineer the antibodies to stay in the body for months, which offers lasting protection the way a vaccine does. As important, antibodies can protect the elderly and the immunocompromised, whose immune systems often fail to mount an effective response to vaccines. Best of all, these drugs can be available as soon as this fall.
The problem is the limited capacity to make enough product to meet demand during a pandemic. A recent report by the Duke Margolis Center for Health Policy estimates that it would take at least 25 million doses of antibodies to give the therapies to symptomatic people and their close contacts over the next year, assuming the number of cases holds roughly steady to the levels of mid-June. That’s about half as many antibodies as the U.S. produces each year in supplying the 100 different antibody products approved for a range of other diseases.
Operation Warp Speed focuses on finding and making vaccines. The government should set up a parallel effort for antibodies, as even a limited supply could save many lives. Government should work with drugmakers to free up domestic manufacturing plants to start making more of these antibody drugs even before the FDA approves them. That way America can have a large supply on hand if one or more prove safe and effective. To avoid disruption to the supply of other antibody drugs, companies could be asked to quickly make and stockpile extra doses of their existing medicines.
Ultimately, the hope is crushing Covid-19 with a vaccine. But the epidemics raging in the Sun Belt suggest that the virus’s wrath will be a threat through the summer, fall and winter. Combining public-health measures, such as face masks and distancing, with technology like monoclonal antibodies is the best hope for faster progress.
Dr. Borio is a vice president at In-Q-Tel and was director for medical and biodefense preparedness policy at the National Security Council, 2017-19. Dr. Gottlieb is a resident fellow at the American Enterprise Institute and a board member of Pfizer and Illumina. He was commissioner of the Food and Drug Administration, 2017-19.
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