- An influential advisory group to the US Food and Drug Administration discussed a wide range of hot-button issues surrounding a potential COVID-19 vaccine on Thursday.
- Over the course of a virtual meeting that ran for more than eight hours, the group discussed public distrust in the process, using an emergency authorization on a vaccine, inoculating children, and the distribution plan for the shots.
- Here are five key takeaways from Thursday’s meeting of doctors, scientists, and other experts.
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An influential advisory group to the US Food and Drug Administration met on Thursday to discuss coronavirus vaccines for the first time.
The committee contemplated a wide range of hypotheticals before any actual data from the final stage of clinical trials of experimental vaccines has been divulged. The group is expected to meet again to vet each COVID-19 vaccine later on, if a vaccine-maker applies for either full approval or emergency authorization.
While uncertainty still reigns over the prospects and timeline for a COVID-19 vaccine, the group’s eight-hour-plus meeting did shed some light on how the US is progressing on vaccination plans, with the ultimate goal of eventually ending the pandemic.
Here are five key takeaways from Thursday’s meeting, including details on the distribution plan, public distrust in the process, using an emergency approval, and eventually vaccinating children.
1. Science, not politics, will drive the vaccine review process
If there was one theme that emerged throughout Thursday, it was government scientists emphasizing that COVID-19 shots will be vetted in the same review system as other experimental vaccines.
Drug companies reached the brink of producing a vaccine in less than a year by doing research and manufacturing in parallel instead of in a typically sequential process, government scientists said. Some of the financial risk has been footed by the US government.
“Vaccine development can be expedited. However, I want to stress that it cannot, and must not, be rushed,” Dr. Marion Gruber, director of the agency’s vaccine research office, said in a presentation to the group.
Even the biggest hiccups to date are evidence of the process playing out as it should, experts said at the meeting. These include disruptions to the final stage of clinical trials for two vaccine candidates developed by AstraZeneca and Johnson & Johnson’s subsidiary Janssen. The US-based phase-three studies for both vaccines are now paused, as scientists investigate potential safety issues.
“The recent regulatory hold for AstraZeneca and the clinical pause for Janssen are signs the system is working as expected,” said Dr. Hilary Marston, a medical officer and policy advisor for global health and pandemic preparedness at the National Institutes of Health’s infectious-disease unit. “We’re finding these cases, we are working them up thoroughly and working in close partnership with the regulators at FDA.”
2. A distribution plan starts to form, and it involves ‘vaccine cards’
Details have been scarce on how exactly the US government plans to distribute a coronavirus vaccine.
There are many wrinkles that will make it difficult, such as the fact that the vaccines closest to being authorized will need to be kept in freezers or refrigerators and require two doses given several weeks apart.
Dr. Janell Routh, a medical officer at the Centers for Disease Control and Prevention, shared a few thoughts on the distribution plan, which will include leaning on pharmacies. “Almost 90% of Americans live within a 10-mile radius of a pharmacy,” she said.
Given the fact there are multiple vaccine candidates in the final stage of testing, Routh said the CDC does have plans in the works to ensure people get a second dose of the same vaccine they received first.
“We are going to have both electronic systems and also a fail-safe backup system to ensure we get that correct second dose to the right person,” she said.
The US plans to use “vaccine cards” that have info filled out on which vaccine a person gets and when, she said. Routh did not provide detailed information on the electronic systems, but did mention a text-messaging program to remind people to get the booster shot later on.
“We are asking that they keep and return that card when they come back for the second dose,” Routh said.
3. A “sobering” reality around public distrust in COVID-19 vaccines
Hand-in-hand with distancing vaccines from politics is the challenge of convincing the public to trust the scientific and regulatory process and ultimately feel comfortable about getting the shots.
The leaders of the Reagan-Udall Foundation, a nonprofit that supports the FDA, presented their findings from hosting several listening sessions with the general public over the past few months to get a sense of what people are thinking. The nonprofit’s CEO, Susan Winckler, called some of the direct quotes from these sessions “sobering.”
Overall, the group distilled six major themes driving distrust in coronavirus vaccines:
1. Concerns on the speed of the process
2. Distrust of government
3. Distrust of the healthcare system
4. Concern that politics and economics will be prioritized over science
5. Fear the vaccine will not work for me or my community
6. Fear based on past experiences
Some of the direct quotes were jarring and show the work that still needs to be done to shore up public trust. “I firmly believe that this is another Tuskegee project,” one said.
“The more they study me, the more they know how to get rid of me,” another participant said.
4. What is an emergency use authorization anyway?
Experts also discussed how to describe the standards the FDA is using to evaluate coronavirus vaccines for emergency use.
Dr. Paul Offit raised issue with the regulatory term emergency use authorization, or EUA. The committee is widely expected to debate issuing an EUA for a vaccine first, with full regulatory approvals coming several months down the line supported by additional follow-up data.
“I think we have a language problem,” said Offit, who sits on the advisory committee and is director of the University of Pennsylvania’s Vaccine Education Center.
Offit said that people associate an EUA with “a very low bar,” which doesn’t align with the level of data the FDA wants before considering any potential emergency authorization.
Offit said the group has to make it clearer to the public that an emergency authorization would be much closer to a typical FDA approval than in previous cases, such as when the FDA gave an emergency authorization for hydroxychloroquine.
The FDA withdrew that EUA after more data emerged showing the hydroxychloroquine isn’t a useful COVID-19 treatment.
“I wish we could get rid of the word EUA,” Offit quipped.
Other members later expressed reservations about the potential downsides of issuing an EUA.
Sheldon Toubman, a lawyer who serves on the FDA’s expert group as the lone consumer representative, emphasized the importance of public trust in a COVID-19 vaccine and said an EUA could undermine those efforts, particularly if the vaccine isn’t very effective. “EUA probably should not be used here,” he added.
5. The plan for kids is still hazy
So far, coronavirus vaccine trials have focused almost entirely on adults, meaning the vaccines probably won’t initially be available for children.
Pfizer has been the only frontrunner to expand research to include children, enrolling people as young as 12.
Robert Johnson, a director at the US Biological Advanced Research and Development Authority, said “discussions are ongoing right now” between vaccine-makers and regulators on what is needed to start enrolling younger populations.
One idea to speed up pediatric studies would be to lean on the adult results. The idea is that if a COVID-19 vaccine succeeds in adults, there could be a lower bar for extending that approval to kids. One idea is to measure immune responses in children, and see if they’re similar to those measured in adults.
But some committee members raised concerns with the idea.
“I’m very concerned about extending the immuno-bridging from adults to children,” said Dr. Luigi Notarangelo, a NIH immunology researcher who is a temporary voting member on the committee. “I think children at this point should not be considered for use of this vaccine until there is sufficient evidence. What we’ve been presented today does not provide that.”
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