5.3.6 Cumulative Analysis of Post-Authorization Adverse Event Reports of PF-07302048 (BNT162B2) Received Through 28-FEB-2021 – Pfizer

Reference is made to the Request for Comments and Advice submitted 04 February 2021 regarding Pfizer/BioNTech’s proposal for the clinical and post-authorization safety data package for the Biologics License Application (BLA) for our investigational COVID-19 Vaccine (BNT162b2). Further reference is made to the Agency’s 09 March 2021 response to this request, and specifically, the following request from the Agency.

The download link is available from Public Health and Medical Professionals for Transparency.

Important points from this report include:

  • A seven-year-old experienced a stroke.
  • One child and one infant suffered facial paralysis.
  • One infant had a kidney adverse event, either kidney injury or failure.
  • Of the 34 cases, 24 (71%) were classified as serious.
  • Predominantly female patients were affected — at least 25 of 34 (73.5%) patients.
  • Table 6 reports 34 cases of use in pediatric individuals. However, 28 additional cases were excluded because details such as height and weight were “not consistent with pediatric subjects.”
  • Ages ranged from two months to nine years, with median 4.0 years, which means half the children were under four years of age.
  • 132 adverse events were reported in the 34 children – i.e., an average of 3.88 AEs per child.

Summary from Daily Clout journalists: