11.18.20

Despite Impressive Data, FDA’s Coronavirus Vaccine Reviews Will Take Weeks, Not Days, Official Says

Source: FiercePharma

As leading COVID-19 vaccines post positive phase 3 data and near FDA submissions, the agency official in charge of reviewing vaccines is emphasizing transparency and patience during the high-stakes process, according to a FiercePharma report.

Americans should expect reviews to take weeks rather than days, Peter Marks, head of the FDA’s Center for Biologics Evaluation and Research, told Business Insider. While the dire COVID-19 pandemic naturally creates urgency, Marks and his team “have to take the amount of time that we need to take,” he said. The FDA is said to be discussing potential committee meetings for December 8 to 10, CNBC’s Meg Tirrell reports.

Read the full article.

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