https://www.wsj.com/articles/a-fast-coronavirus-vaccine-without-cutting-corners-11590954444?mod=opinion_lead_pos8Can America reopen without a major resurgence of Covid-19? We’ve learned a great deal about controlling the virus. In the summer people will spend time outdoors, which can reduce the risk. Yet a second wave could come in the fall as schools open and businesses try to return to normal. Americans will feel more confident—or simply tired—and may take fewer precautions.
Getting the threat behind us will require a vaccine cleared for general use. There are ways to accelerate that process, but it is important not to cut corners, lest the public lose confidence and refuse a vaccine. The urgent public-health need demands speed. But that doesn’t mean compromising robust data to prove safety and efficacy.
Almost a dozen vaccine candidates are in early clinical trials, with more on the way. Each of the six major drug makers with vaccine programs is developing a Covid-19 candidate. These efforts are moving at an unprecedented pace, thanks to innovative but often unproven vaccine-making technologies, many of which have never been used to make a licensed vaccine. These include gene-based vaccines that deliver parts of the coronavirus gene to the body.
Once vaccine candidates complete Phase 1 clinical studies, which assess their safety and ability to stimulate an immune response, promising candidates should move quickly to Phase 2, or even larger trials that look at efficacy. A vaccine’s ability to generate an immune response doesn’t always indicate that it can prevent infection—and preventing infection and disease are the endpoints that matter.
There are innovative ways to conduct these trials, including what’s known as an adaptive randomized-controlled trial. These trials can be structured to evaluate multiple vaccine candidates against a common control group and can shift enrollment based on which vaccines are most promising. Vaccines would be selected based on their promise in early studies and how quickly their manufacturing can be scaled. With so many patients developing mild or no symptoms, clinical trials will need to be large. But this is the best shot at quickly identifying safe and effective vaccines.
This fall there may be an urge to give a vaccine early to protect certain groups, such as health-care workers and nursing-home residents. There will be pressure to deploy vaccines based on the antibody response, without confirming that they confer immunity. Yet not all antibodies confer equal protection. It also isn’t clear what antibody levels are needed to provide immunity, or how long protection lasts.
Moreover, there are practical concerns about safety. One risk is that a vaccine could make a small number of patients more susceptible to Covid. There’s also a theoretical risk that the coronavirus proteins vaccines use to stimulate immune response—known as the spike protein—may be the trigger for some rare symptoms of Covid illness. These dangers are probably remote, but clinical trials are necessary to detect them.
It’s also time to plan for collecting safety data on the vaccine even after it is made widely available. During the 2009 H1N1 influenza pandemic, the government relied on the Vaccine Adverse Event Reporting System, a national surveillance program managed by the Food and Drug Administration, and the Vaccine Safety Datalink, which is able to monitor electronic health data on millions of patients. FDA is investing in a real-time system for tracking Covid vaccine safety. Such a system, which can track rare side effects, will be essential for faster and broader distribution.
Covid will likely re-emerge in the fall and winter before it can be vanquished. The fastest way to get effective vaccines, and make sure the public is willing to take them, is through a development plan that earns the trust of Americans.
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.
