Don't Shortchange COVID-19 Vax Approval Process, House Panel Told
— Experts urge large-scale clinical trials, FDA advisory committees
by Molly Walker, Associate Editor, MedPage Today July 14, 2020
Any vaccine against COVID-19 should undergo a transparent approval process and the FDA should not "cut corners" in order to rush a vaccine to market without being assured of its safety and efficacy, experts told a House subcommittee on Tuesday.
To that end, vaccine manufacturers need large-scale clinical trials of at least 30,000 participants, as well as a fully transparent process buttressed by input from independent academic and scientific experts through the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC).
At a virtual briefing of the House Subcommittee on Economic and Consumer Policy, Chairman Raja Krishnamoorthi (D-Ill.) characterized these as "guardrails" to a safe and effective vaccine. He said a letter was sent to FDA Commissioner Stephen Hahn, MD, about committing to them in the COVID-19 decision-making process; as of Tuesday, the FDA had not responded.
"An impending election, the stock market and ... a return to normalcy must not distort the decision about whether or not to approve a vaccine," he said. "We must expedite development ... but we cannot cut corners in the process."
The panel of assembled experts were nearly universal in their endorsement of VRBPAC, and cautioned that Operation Warp Speed, the Trump administration's plan to streamline the process of developing and manufacturing COVID-19 vaccine candidates, could lead to more questions about public trust in vaccines without proper review.
Without the input of VRBPAC, vaccine decisions "would be made behind closed doors," said Bruce Gellin, MD, MPH, who heads the Sabin Vaccine Institute's global immunization division.
Americans want to understand "what the process is and be assured the process is being followed and not short-circuited," he said.
Jesse Goodman, MD, of Georgetown University, emphasized the importance of a safety database to track any potential vaccine safety signals. He also warned if the FDA approves a COVID-19 vaccine under emergency use authorization (EUA), the public may interpret that as an approval, and without plans in place to assure safety, "a crisis could occur, undermining confidence in all vaccines," he said.
Krishnamoorthi seized on that point, wondering if the FDA "may prematurely grant an EUA to a COVID-19 vaccine, like it did for hydroxychloroquine, a decision the FDA later revoked."
"We've heard about Operation Warp Speed, but I'm concerned about EUAs being handed out at warp speed," he said.
Jason Schwartz, PhD, of the Yale School of Public Health, said moving forward with an EUA would be "moving forward with less evidence than we typically have" and expressed his hope that VRBPAC would be included in such conversations.
Rep. Glenn Grothman (R-Wis.), on the other hand, channeled some of the skepticism toward "experts" now current in conservative circles. "I think the public health establishment has screwed up a lot in this right now," he said.
He then asked if "somebody who thinks we're over-vaccinating America and shouldn't be gung-ho in vaccinating everybody" should be on a vaccine safety panel.
"Intelligent people who read a lot are a little jaded on the vaccine thing," Grothman added.
Gellin responded that researchers "are concerned about vaccine safety and we want to be sure that when vaccines are available ... there's a process in place that ensures they are safe and effective."
Rep. Ayanna Pressley (D-Mass.) stressed the importance of "health equity" when developing a vaccine, and the need for "a deliberate process that values equity and inclusion." She discussed the fear from "historically underrepresented groups," who have little reason to trust the medical establishment based on "past history."
"We are engaging now with community leaders and members of faith organizations ... potential volunteers themselves that can help allay those concerns," responded Ruth Karron, MD, of Johns Hopkins Bloomberg School of Public Health. "People need to be approached ... by people who look like them."
Karron is on the Data Safety and Monitoring Board of the ongoing phase II trial of Moderna's COVID-19 vaccine -- soon to enter phase III -- and will serve as co-investigator for two other vaccine trials scheduled to begin this summer. She said many individuals have wanted assurance they and their families will have access to the vaccine once it's developed.
"We must ensure that Black, Latinx, and Native American populations who are far more likely to be infected by the virus ... are not only offered the opportunity to participate, but choose to participate," she said.
Rep. Katie Porter (D-Calif.) emphasized the importance of trust in public health measures, and brought up the debate over face masks in public as an example of an "aggressive debate" even though the science is there, because of a lack of clear message from the federal government.
"We cannot risk the same thing happening with a vaccine," she said.
Gellin said it is important to communicate this information about the vaccine approval process to the public, including clinicians, who will be fielding questions from their patients.
"People are tired of building the ship as we're sailing it. Let's build it, then sail it. Nobody wants it to sink," he said.
Molly Walker is an associate editor, who covers infectious diseases for MedPage Today. She has a passion for evidence, data and public health. Follow