FDA COVID-19 Treatment Development Update
By Dr. Kevin Barber, PhD, RAC, PMP, Vice President of Regulatory Strategy & Submissions, Dr. Monica Frazier, PhD, RAC, Research Scientist, Dr. Theresa Zucchero Scocca, PhD, RAC, Research Scientist
With the recent emergency authorizations of the Pfizer-BioNTech COVID-19 vaccine by the regulatory authorities in the United Kingdom, Canada, and United States (after a positive FDA advisory committee meeting on December 10, 2020), and with FDA holding a second advisory committee meeting to review the Moderna vaccine on December 17, 2020, we are on the verge of a significant breakthrough in coping with the COVID-19 global pandemic. Assuming FDA grants an emergency use authorization for the Moderna vaccine in addition to the authorization for the Pfizer-BioNTech vaccine, both will gradually become available in the United States over the next several months to vaccinate high-priority workers and high-risk individuals.
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