The state of coronavirus vaccine development in the U.S.

The discovery of an effective coronavirus vaccine is among the most pressing international public health concerns humans face as the number of COVID-19 cases continues to climb, with more than 35 million cases and 1 million deaths globally. But the speed at which these vaccines are being developed raises important questions about the scientific integrity of the process and the safety of the final product—questions that the experts at a symposium co-hosted by Johns Hopkins University and the University of Washington on Tuesday sought to disentangle from political spin and public misinformation.

"Our clinical trials' infrastructure is a model to the world, and making sure we maintain the scientific integrity of the programs is critical for us to continue our scientific leadership globally," said Larry Corey, co-lead of the Vaccine Clinical Trials subgroup for Operation Warp Speed, the U.S. federal effort to devise, test, and distribute a coronavirus vaccine.

Corey was among more than two dozen of the nation's leading experts on vaccine development and public health to speak at the symposium.

"We must not relax our guidelines for efficacy," he added, "and we must insist these trials be allowed to provide the scientific underpinnings of our COVID-19 vaccination strategy."

At least eight coronavirus vaccine candidates are currently in development by Operation Warp Speed. Most of these vaccines—selected for their potential effectiveness and safety, as well as their speed of development and ability to be manufactured at scale—have already reached Phases 2 and 3 of clinical trials, and the U.S. government has begun stockpiling millions of doses in the event that they are approved for public use. Experts are hopeful that for two of these vaccine candidates, evidence of their efficacy will be available in November or December. The prospect of reaching the efficacy endpoint, combined with the stockpiling effort, means that with an emergency use authorization from the U.S. Food and Drug Administration, public health experts could begin vaccinating large portions of the American population at the beginning of 2021, said Moncef Slaoui, chief adviser for Operation Warp Speed.

"I'm amazed, actually, to take a step back and to realize that this virus was described on Jan. 23, 2020, which was less than 10 months ago," he said. "And well before a year has gone by, we are likely to have an effective, safe, and available vaccine. That really speaks to the enormous commitment that all the players have had behind this crisis, and also the great advancements in science and technology that underpin vaccine design and development."

To meet the urgent timeline while adhering to the highest standards of scientific inquiry and clinical evaluation, Operation Warp Speed expanded the recruitment for its Phase 3 clinical trials, enrolling far more participants than is typically required. The large number of trial participants means researchers can more easily identify adverse reactions among vulnerable patient populations such as the elderly, Corey said.

During the symposium, Peter Marks, director of the Center for Biologics Evaluation and Research for the FDA, explained new guidelines issued Tuesday outlining how the agency would evaluate emergency use authorization applications, or EUAs, for coronavirus vaccines. Typically EUAs are required to meet a lower standard of demonstrated effectiveness, he said, because there is often not enough time in emergency scenarios to create and deploy adequate clinical trials. In the case of the coronavirus vaccine, however, the FDA would review applications with a higher standard and look for "clear and compelling evidence of effectiveness." He added that the FDA's review of the EUA application will be conducted by independent advisers and carried out publicly and transparently.

There's more at stake here than speed, he suggested.

"Our process must end up ultimately increasing trust in vaccines because without that vaccine confidence, we're not going to get to where we need to [with herd immunity]," Marks said. "Our regulatory mandate is for quality, safety, and efficacy of vaccines, but all of that is for naught if people don't roll up their sleeves and take those vaccines. Without a large fraction of the population vaccinated with a reasonably effective vaccine, we're going to continue to be in [the grips of this pandemic]."

Johns Hopkins University President Ronald J. Daniels gave opening remarks during the symposium and introduced speaker Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and a member of President Donald Trump's White House Coronavirus Task Force. During his remarks, Daniels emphasized the importance of maintaining the highest scientific standards during vaccine development, testing, and distribution.

"Our current search for a vaccine is and must be built on a firm foundation of efforts that have established efficient, effective, and ethically sound approaches to such development," he said. "In a pandemic such as this one, we cannot abide abandoning such approaches but must double and redouble our efforts to adhere to them ever more assiduously."

There is still a long way to go before a coronavirus vaccine is available and accessible to those who need it, experts advised, and the urgency of a viable and ethically distributed vaccine only increases as time passes. University of Washington Professor Christopher Murray, an expert in health metrics, warned that his models suggest the coming winter months could herald a deadly rise in coronavirus cases in the Northern Hemisphere.

But still, experts said, the progress that has been made to date is heartening.

"Despite a lot of the political noise, the science is really going well. In fact it's going extremely well if you compare it to anything that we've ever tried to do before," said Francis Collins, director of the National Institutes of Health, which helps coordinate Operation Warp Speed. "I am guardedly optimistic that come 2021, we're going to be on a path—over many months, let's not talk about this as a quick solution—to where we can eventually put COVID-19 in the rearview mirror."

Other speakers at the event included:

• Michele Andrasik, University of Washington
• Nancy Bennett, University of Rochester School of Medicine and Dentistry
• Chris Beyrer, Johns Hopkins Bloomberg School of Public Health
• Mike Bloomberg, Bloomberg Philanthropies
• Ana Mari Cauce, University of Washington president
• Ruth Faden, Johns Hopkins Bloomberg School of Public Health
• Helene Gayle, The Chicago Community Trust
• Scott Gottlieb, formerly of the U.S. Food and Drug Administration
• Tom Inglesby, Johns Hopkins Bloomberg School of Public Health
• Keith Jerome, University of Washington
• Ruth Karron, Johns Hopkins Bloomberg School of Public Health
• Ellen MacKenzie, Johns Hopkins Bloomberg School of Public Health
• Apoorva Mandavilli, The New York Times
• Bill Moss, Johns Hopkins Bloomberg School of Public Health
• Kathleen Neuzil, University of Maryland School of Medicine
• Joshua Sharfstein, Johns Hopkins Bloomberg School of Public Health
• Will Stone, NPR
• Sarah Zhang, The Atlantic