A clinical trial volunteer participates in Johnson & Johnson's study to test a coronavirus vaccine candidateAn 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.
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. 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.
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. 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."1. Concerns on the speed of the process4.
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.
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