CDC's distribution road map, safety monitoring plans plus other takeaways from FDA's big COVID-19 vaccine meeting

FDA Building
Officials from a range of government agencies updated on the progress for COVID-19 vaccines Thursday. (FDA)

In less than a year, scientists around the world have rallied against COVID-19 and developed promising vaccines that could stem the pandemic. Concerns remain, though, and, amid that backdrop, top government experts took the chance Thursday to discuss safety and efficacy requirements, distribution plans and vaccine confidence—plus more.

In a daylong virtual hearing, experts reviewed COVID-19 vaccine progress so far and talked about plans to get the immunizations to the arms of Americans. The Centers for Disease Control and Prevention (CDC) has been working with Operation Warp Speed and localities on a phased distribution approach, CDC viral diseases official Janell Routh, M.D., said during the event.

During the first few weeks of vaccinations, while doses are limited, healthcare providers and other first responders will be prioritized for immunizations. Also during the early vaccination stages, the government will target people at high risk for severe COVID-19, those who live in close quarters, teachers and those with limited access to vaccines, Routh said.  

In the second phase, more doses are expected to be available for broader vaccination efforts through pharmacies, doctors' offices and clinics. The third phase moves to a period when supply outweighs demand, and the goal there is to ensure access “for anybody who wants to be vaccinated,” Routh said.

Federal officials plan to leverage partnerships with local jurisdictions because they know best about local needs and have key partnerships with health organizations. The CDC released a “playbook” covering distribution strategies last month, and, in mid-October, jurisdictions returned their own strategies to the agency. The CDC is now reviewing its plans, she said.

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Aside from distribution, FDA biologics official Steven Anderson, Ph.D., talked about the agency’s plans for safety reviews after vaccines are authorized. The agency plans to track 10 to 20 “safety outcomes of interest” based on developer safety data, experience with similar vaccines and more, he said. The FDA will work with federal partners and use Centers for Medicare & Medicaid Services data to stay on top of any potential safety concerns when the vaccines are widely available.

Further, the topic of vaccine skepticism came up several times during the daylong discussion. Reagan-Udall Foundation CEO Susan Winckler and researcher Chris Wilks shared some of their learnings from listening groups about vaccine confidence. Concerns they heard focused on speed of the process, distrust of the government, distrust of healthcare systems and more. 

One unnamed person told the researchers that they “don’t think the FDA can be trusted to keep people safe.” Another said the White House’s involvement in the FDA’s review process hurt their confidence.

The daylong meeting featured plenty of other takeaways, including several highlighted by Politico. For instance, experts said the pivotal trials will need to keep going even after emergency use authorizations so that investigators can continue to collect data. Ahead of the event, Johnson & Johnson and Pfizer urged the FDA to provide clarity on how trials can proceed smoothly even when a vaccine is available, Reuters reports.

And earlier emergency use authorizations by the FDA during the pandemic could come back to bite the agency, University of Pennsylvania's Paul Offit said during the hearing. Following the EUAs for hydroxychloroquine and convalescent plasma based on limited evidence, the public may not have faith in a vaccine that is granted an EUA, Offit said.

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Thursday’s hearing was just the first in a series of expected public meetings on COVID-19 vaccines. For each potential vaccine application that comes through the FDA, the agency will host a separate public meeting, officials have said.

So far, vaccines from Pfizer, Moderna, Johnson & Johnson, AstraZeneca and Novavax are in late-stage testing, and officials have said the first doses could be available in late 2020 or early 2021. This week, Operation Warp Speed head Moncef Slaoui said that COVID-19 vaccines from Moderna and Pfizer could reach all Americans by June 2021 if politics don’t slow uptake.