CDC distribution roadmap, safety oversight plans, and other takeaways from FDA’s big COVID-19 vaccine meeting

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, however, and, against this backdrop, senior government experts took over Thursday to discuss vaccine safety and efficacy requirements, distribution plans and confidence.

In a day virtual hearing, experts reviewed progress in the COVID-19 vaccine field so far and talked about plans to get the vaccines to the arms of Americans. The Centers for Disease Control and Prevention (CDC) worked with Operation Warp Speed ​​and the localities on a phased distribution approach, Janell Routh, MD, CDC viral disease manager, said at the event.

During the first few weeks of vaccination, when doses are limited, health care providers and other first responders will be given priority for vaccinations. Also during the early stages of vaccination, the government will target people at high risk of severe COVID-19, those who live nearby, teachers and those with limited access to vaccines, Routh said.

In the second phase, more doses should be available for larger vaccination efforts in pharmacies, doctor’s offices and clinics. The third phase moves into a time when supply outweighs demand, and the aim is to ensure access for anyone who wants to be vaccinated, Routh said.

Federal officials plan to leverage partnerships with local governments because they are more familiar with local needs and have key partnerships with health organizations. The CDC released a handbook on distribution strategies last month, and in mid-October, jurisdictions returned their own strategies to the agency. The CDC is reviewing its plans, she said.

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

In addition, the topic of vaccine skepticism was brought up several times during the one-day discussion. Susan Winckler, CEO of the Reagan-Udall Foundation, and researcher Chris Wilks shared some of their lessons from listening groups on confidence in vaccination. The concerns they heard were about the speed of the process, mistrust of government, mistrust of health systems, etc.

An anonymous person told researchers they don’t believe the FDA can trust people’s safety. Another said the White Houses’ involvement in the FDA review process had damaged their confidence.

The one-day meeting featured many other actions to take, including severalHighlightedby Politico. For example, experts said pivotal trials will need to continue even after emergency use approvals so investigators can continue to collect data. Prior to the event, Johnson & Johnson and Pfizer urged the FDA to clarify how trials can go smoothly, even when a vaccine is available, Reuters reports.

And previous emergency use authorizations from the FDA during the pandemic could come back to bite the agency, Paul Offit of the University of Pennsylvania said during the hearing. Following the EUAs for hydroxychloroquine and convalescent plasma based on limited evidence, the public may not have confidence 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 passes through the FDA, the agency will hold a separate public meeting, officials said.

So far, vaccines from Pfizer, Moderna, Johnson & Johnson, AstraZeneca and Novavax are in late testing, and officials said the first doses could be available in late 2020 or early 2021. This week, Moncef said. Slaoui, responsible for Operation Warp Speed ​​that Moderna and Pfizer’s COVID-19 vaccines could reach all Americans by June 2021 if policy doesn’t slow adoption.