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IDSA Response to Pfizer Request for COVID-19 Vaccine EUA


Barbara D. Alexander, M.D., MHS, FIDSA – President, Infectious Diseases Society of America on today’s Pfizer/BioNTech application for Emergency Use Authorization of its COVID-19 vaccine candidate:

While encouraging data from the Pfizer/BioNTech COVID-19 vaccine trial indicates the welcome possibility of a critical new tool against the pandemic, a comprehensive, transparent review of data, including evidence that the vaccine has been studied in diverse populations, remains essential to ensure its safety, effectiveness and acceptance. A positive recommendation from the independent scientific experts on FDA’s Vaccines and Related Biological Products Advisory Committee should be required before granting an authorization. Any vaccine’s distribution should be informed by priorities and practices recommended by the Centers for Disease Control Advisory Committee on Immunization Practices. If Emergency Use Authorization is granted, clinical trials and data collection must continue. Measures that include wearing masks, frequent hand-washing, maintaining physical distance and restricting the size of gatherings will remain crucial. Finally, new federal funding must be provided for widespread, fair and equitable vaccine distribution in addition to campaigns to build vaccine confidence.


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