The 20-member committee is a mix of physicians, statistics, vaccines and infectious disease specialists along with two drug company representatives and a consumer representative, in this case a lawyer. A five-year cluster came from the FDA, the Center for Disease Control and Prevention and the National Institutes of Health, but the rest works outside the government.
The vaccine team is one of a dozen expert panels called by the FDA to review data or discuss a hot button issue in a specific field – others for food, tobacco and drugs, for example – and advise the agency what they should do.
Although the FDA does not have to follow the advice of advisory committees, it generally follows. Commissioner Stephen Hahn and other agency officials including vaccine chief Peter Marks were repeatedly instructed at the vaccine meeting on October 22 as evidence that the agency was led by science and data, not politics.
“It is critical for the FDA to raise public awareness of our expectations of data requirements to support safety and effectiveness,”; Hahn tweeted Thursday with a link to the forthcoming meeting, adding that a discussion on between scientific and public health experts will help the public understand the vaccine testing process.
The biggest issue at the table – and the subject of recent disputes between the FDA and the White House – is when a vaccine manufacturer can declare their shot safe and effective. POLITICO committee members also said they hope to discuss the variation in volunteer enrollment and the impact that emergency consent may have on ongoing trials for other shots.
“We want to assure American citizens that the process and testing for the development of the Covid-19 vaccine will be as open and transparent as possible,” Marks, director of the Center for Biologics Evaluation and Research, told a statement in POLITICO.
While a specific vaccine is not on the table for October 22, the discussion about enrollment, safety monitoring and the bar for effectiveness could have implications for all manufacturers in the final testing tests.
Pfizer, considered as a frontrunner as it works through Phase III tests, told POLITICO last week that they did not plan to submit data prior to the meeting. AstraZeneca and Johnson & Johnson, two other sweeping manufacturers in the final stages of trials, paused each of those studies because of the serious effects on a patient. AstraZeneca, which announced the cessation in September, has yet to restart tests in the US.
Workers refused to commit to filing within a specific timeframe, noting that their speed would be dictated by the data they collected – and unexpected factors, such as pausing a study for safety factors, can slow them down.
The FDA also reaffirmed its expectations for vaccine makers earlier this month, saying everyone must follow at least half of the participants in their Phase III trials within two months before apply for an emergency use permit. The new standards all but close the window on any company filing before Election Day, urging the president to accuse career scientists of stifling development for political reasons.
“We do not live in a bubble. We hear and see what is happening around the world and the concern that many people have expressed to the public, in their words, is rushing the vaccine [and] cutting corners, “said Archana Chatterjee, dean of Chicago Medical School of Rosalind Franklin University and committee member.
The intense public scrutiny and widespread demand for a coronavirus vaccine, along with the record speed at which shots were generated – many using untested technologies – made the FDA panel meeting in October unique previously, Chatterjee said.
“Part of our job is to make sure we act like we always do,” he said. “To the best of our ability, assure the public that we are doing our job free from any kind of interference from anyone with regard to the safety and effectiveness of those vaccines.”
Through functionality, FDA advisory committees meet on topical topics. Recent hot-button issues before include other e-cigarette panels, breast implants linked to cancer and how to adjust opioid approvals amid the addiction crisis. But nothing has caught the president’s attention more than finding a vaccine to help end the pandemic that killed nearly 220,000 people in the US and stalled the economy.
“I think this upcoming meeting will be important to establish the basic guidelines for the safety and effectiveness of the vaccine, in the hope of [emergency use authorization] applications that may come from many manufacturers in the coming year, “ Paul Spearman, a professor and director for infectious diseases at Cincinnati Children’s Hospital, said. He usually sits on the FDA vaccine advisory committee but will not participate on October 22 because he is involved in the Covid-19 vaccine trials.
Panel chairman Hana El Sahly, a virologist and microbiologist at Baylor University, and Fred Hutchinson Cancer Research Center biostatistician Holly Janes, were also removed from the October 22 panel due to potential conflicts. He and Spearman could be excluded from future meetings on specific vaccines depending on their research, leading the FDA to temporarily draw other experts on the committee.
An FDA spokesman said the committee’s full list, including possible temporary replacements, would be published 48 hours before the October 22 meeting.
Emergency use permits, one bar less than the entire FDA approval, has become a controversial issue in the Trump administration. The White House has pushed the FDA to approve the malaria drug hydroxychloroquine for coronavirus, a charge the FDA has denied. The agency finally revoked the authorization after studies showed no positive side effects from the pills. Other emergency permits, such as one for the convalescent plasma, was roiled into rotten rollouts that were also colored by the president’s calls for the FDA to expedite its review.
HHS urges the FDA to re-brand the authorization of any coronavirus vaccine as a “pre-licensure” to boost public confidence – something that the drug agency is still fighting for political reasons for its scientific decisions, POLITICO revealed this week.
The advisory committee is likely to discuss how awarding a vaccine to an emergency permit may make it more difficult for other companies to find participants for clinical trials of their own shots, Spearman said, because those shots are unproven and some volunteers will receive a placebo.
Another hot topic is whether the tests are recorded sufficiently diverse groups of participants. Coronavirus was unevenly infected, hospitalized and killed Black and Latinx populations, but the two groups were no longer representative of the trials. Legislators like Sen. Maggie Hassan (DN.H.) also raised concerns that the tests did not include enough adults to determine if the shots were safe and effective in the elderly, as the immune system weakened with aging.
Broadly, members of the POLITICO committee said they were deeply aware of balancing the need for vaccines against the potential disaster of greenlighting something dangerous or ineffective because regulators were moving so soon.
“We’re in a very good time,” Chatterjee said. “Usually I take this role seriously somehow, but I think under these circumstances I think of it in a somewhat strange way.”