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ARTICLE | Product Development

FDA’s Marks admonishes U.K. regulators for discussing COVID vaccine adverse events as MHRA updates guidance

Plus: BNT162b2 data hacked at EMA; Canada approves BioNTech, Pfizer vaccine

December 9, 2020 10:38 PM UTC

FDA’s Peter Marks has criticized U.K. regulators for releasing incomplete information about serious adverse events experienced by two individuals following administration of the BNT162b2 COVID-19 vaccine from Pfizer and BioNTech. MHRA updated its guidance to include new details about the management of anaphylaxis.

Marks’ comments come on a day that also saw news of a security breach at EMA and Canada’s first approval of a COVID-19 vaccine...

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