Experts urge transparency, advisory committee review for COVID-19 vaccines

Regulatory NewsRegulatory News | 14 July 2020 |  By 

At a virtual briefing on Tuesday, several experts told members of the House Committee on Oversight and Reform Subcommittee on Economic and Consumer Policy that a transparent process and advisory committee review will be key to the effective rollout of a vaccine to prevent coronavirus disease (COVID-19).
The briefing comes just two weeks after the US Food and Drug Administration (FDA) issued guidance on the development and licensure of vaccines against SARS-CoV-2, the virus that causes COVID-19, and at a time when some of the most advanced vaccine candidates are moving into Phase 3 trials. (RELATED: FDA issues COVID-19 vaccine guidance, setting 50% effectiveness threshold, Regulatory Focus 30 June 2020; Marks on COVID-19 vaccine efficacy, EUAs and challenge trials, Regulatory Focus 9 July 2020).
During the briefing, Bruce Gellin, MD, president, global immunization at the Sabin Vaccine Institute, said that FDA’s recent guidance helps provide transparency about its decision-making process for an eventual COVID-19 vaccine.
“Guidances like these, while directed to industry, are really for all to see, so all know the considerations that go into the process,” Gellin said, warning that cutting corners in the race to approve a vaccine would be a “misstep” with “serious implications,” such as fueling vaccine skepticism and eroding the public’s trust in FDA’s approval process.
“I strongly recommend that any vaccine that’s being considered for any type of approval by the FDA be reviewed in an open public meeting by FDA’s Vaccine and Related Biological Products Advisory Committee [VRBPAC],” Gellin said, noting his past participation on the committee.
“Without such a public review, I have no doubt that stories will appear about vaccine approvals made behind closed doors because the government didn’t want the public to see what or who may have influenced those decisions,” he said.
Two other experts, Ruth Karron, MD, director of the Center for Immunization Research at Johns Hopkins Bloomberg School of Public Health, and Jason Schwartz, PhD, assistant professor of health policy at the Yale School of Public Health, concurred.
Karron, who previously chaired the committee, said that VRBPAC’s “advice will be critical as the FDA reviews vaccine trial data and makes decisions about emergency use authorizations (EUAs) and licensure.”
Schwartz added that both VRBPAC and the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) have helped to support the government’s regulatory and policymaking work for vaccines for decades.
“The closer that our government health agencies adhere to their well-established, time tested processes for evaluating the safety and effectiveness of COVID-19 vaccines and developing evidence-based approaches for their deployment, the more confidence the public can have in the integrity and quality of those decisions and those vaccines,” Schwartz said.
Approvals and EUAs
Jesse Goodman, MD, director of the Center on Medical Product Access, Safety and Stewardship at Georgetown University and former chief scientist at FDA, said he thinks the 50% effectiveness threshold set in FDA’s guidance is “a reasonable starting point.”
Goodman also said that with adequate caution, an EUA or expanded access protocol could provide early access to a vaccine.
“We need to be very thoughtful about any vaccine access prior to approval. There may be circumstances where use of an unapproved vaccine could be appropriate in a severe outbreak. For example, if a vaccine with documented safety and promising effectiveness were available, but all the data needed [was] not yet submitted, FDA could provide access through an expanded access program or through an emergency use authorization,” Goodman said.
Both Goodman and Schwartz raised concerns that the public might not understand the difference between an EUA and full approval.
“I would be concerned … that an emergency use authorization would not be understood among the public to be different from the full approval with all the details from the FDA,” Schwartz said, before adding that issuing an EUA prior to having Phase 3 data in hand would be a “very serious gamble.”
Goodman suggested that FDA require informed consent as part of the process for administering a vaccine under an EUA and said that such use should be “targeted to those at highest risk of infection and complications.”


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