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...