Some of America’s top vaccine experts met with federal health authorities on Thursday to discuss the urgent effort to develop, produce, distribute, and administer a vaccine for the coronavirus ravaging the United States.
The online meeting of the 18-member Vaccines and Related Biological Products Advisory Committee (VRBPAC) didn’t result in a sudden green light for any of the top candidates to ward off infection. The committee, overseen by the U.S. Food and Drug Administration (FDA), plans to reconvene in the coming weeks—or months—in order to endorse, or nix, potential vaccines. And yet the six-hour meeting, plagued by the usual connectivity problems and webcam gaffes, offered a window into scientists’ top concerns as the country hurtles toward an unprecedented mass-vaccination program.
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Among other things, experts repeatedly asked government officials about representation—that is, among demographic groups—in testing, quality control at vaccine factories, and regional bias in vaccination plans.
The queries point to simmering concerns that the feds might ignore safety problems at pharmaceutical production facilities, neglect rural communities, or release a vaccine without first testing it on children and pregnant mothers.
“They are very intelligent questions,” Lawrence Gostin, a Georgetown University global health expert, told The Daily Beast of the grilling on Thursday.
But there are other issues that the FDA should consider, experts said. In particular, they highlighted the importance of transparency and a possible need for more, and more flexible, ways to administer a vaccine, even after a decent one rears its head.
The Vaccines and Related Biological Products Advisory Committee, established by law in the 1970s, is one of several independent boards that weigh in every time the pharmaceutical industry develops a new vaccine and the FDA considers approving it for widespread use.
The VRBPAC usually convenes before the FDA signs off on a vaccine. The committee hears presentations from government health officials and then decides, by a majority vote, whether to endorse the vaccine. The FDA is under no legal obligation to follow the committee’s recommendation, the agency confirmed to The Daily Beast. But in practice, it usually does.
There was some concern this summer that the FDA, under Commissioner Stephen Hahn, might cave to pressure from Donald Trump and his administration—and push out an untested vaccine over the objections of the VRBPAC and other advisory boards.
But the FDA in recent weeks has signaled its intention to adhere to the usual conventions. Most notably, the agency in early October stiffened the requirements for granting emergency approval to a new vaccine before it has completed large-scale Phase 3 trials. “I don’t think any vaccine is going to be put in the hands of the American public without a robust safety portfolio,” Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia and a VRBPAC member, told The Daily Beast last month.
At the final presidential debate on Thursday, Trump at one point said a vaccine was “ready” before immediately backtracking, in what was arguably a reflection of his inability to move the process forward artificially. In fact, the VRBPAC’s online meeting was itself a part of the FDA’s retrenchment against political interference, Irwin Redlener, the founding director of Columbia University’s National Center for Disaster Preparedness, told The Daily Beast. “It immediately makes me suspect we’ve got a different kind of leadership at the FDA,” he said.
The VRBPAC has convened 161 times in its roughly 50-year history. Thursday’s meeting was the first to be open to the public.
The meeting’s six hours of briefings and discussions were heavy with technical details about vaccine development, data management, and bureaucratic procedure. But pointed questions and frank admissions from officials and committee members occasionally cut through the jargon.
Several committee members questioned the FDA’s process for inspecting the factories that are already churning out millions of vaccine doses in anticipation of agency approval for pharmaceutical companies to distribute them. FDA regulations require inspectors to check out production facilities prior to the agency fully approving a vaccine.
But the quality-control standards are more lax when it comes to emergency-approval—a process some therapies have received in recent months, and that a vaccine could theoretically get before being fully sanctioned by the feds.
The FDA could even sign off on limited emergency distribution of a vaccine without actually inspecting the factory that makes the doses. But that could risk a repeat of a 1955 incident in which Cutter Laboratories in California accidentally introduced live virus into doses of a polio vaccine. As a result, 40,000 people got sick, and five died.
Jerry Weir, an FDA microbiologist, assured the committee that, when it comes to emergency approval of a vaccine, the FDA would hold manufacturers to the same standards that the agency requires for full approval. “Expectations for manufacturers will be similar to that of licensure,” Weir said.
Committee members also asked about the demographic makeup of the trial groups for the six vaccine candidates that have received major financial support from Operation Warp Speed, the federal government’s $13 billion vaccine-accelerator. The pharma industry has come under fire for enrolling test subjects who, as a group, are younger, healthier, and whiter than the general public.
The VRBPAC seemed especially worried about the lack of children and pregnant women in the trial groups, and those fears were not exactly wiped away. “Safety questions will remain post-Phase 3 trials,” Stephanie Schrag, an epidemiologist with the U.S. Centers for Disease Control and Prevention, told the committee. “Pregnant women and children are not included in initial trials.”
This is not a new problem. Researchers are often reluctant to include minors (who cannot consent to testing) and pregnant mothers (who are at high risk for complications) in drug and vaccine trials. That might not be a huge problem with a drug that kids and expectant mothers don’t usually take. But health authorities expect that millions of minors and mothers will get a coronavirus vaccine.
CDC officials at Thursday’s meeting outlined plans to carefully monitor millions of Americans after they get vaccinated for COVID-19, scrutinizing medical records in order to detect any emerging adverse effects from the vaccine. That monitoring will include kids and moms, officials explained.
But the monitoring plan raised other questions from committee members. Hayley Altman-Gans, a Stanford University pediatrician, noted that the government’s health-monitoring system is concentrated on the West Coast—in California, especially. The government risks missing out on complications that crop up in communities farther east—some of which, such as Native Americans on sprawling Midwest reservations, are uniquely vulnerable to the SARS-CoV-2 pathogen.
“I’m worried it doesn’t fully capture the geography of disease,” Altman-Gans said of the CDC’s monitoring plan. Her statement inspired a lively discussion of government health-monitoring systems that ended only as the online meeting strayed well off its published schedule.
There are potential problems that the VRBPAC committee barely addressed at all on Thursday, Jeffrey Klausner, a professor of medicine and public health at UCLA who previously worked at the CDC, told The Daily Beast. “We need to focus on distribution and make sure there is a range of providers and sites where people can get vaccinated,” Klausner said. He proposed the government train dentists to administer vaccines and fund pop-up vaccination sites at county offices, libraries, and other government buildings.
Gostin said the government should double down on transparency efforts. It was a good thing that the FDA made Thursday’s committee meeting open to the public, he said. But what plans do authorities have to reassure the public that any vaccine the FDA approves—especially any vaccine that gets approval for emergency use before the end of Phase 3 trials—is safe and effective? “Will all the data that go into the [emergency-use authorization] decision be publicly transparent?” he asked.
Even a six-hour wonkfest of a meeting wasn’t long enough for the experts to fully express all their concerns as the United States—and indeed the whole world—barrels toward one of the most wide-ranging vaccination efforts in history.
