Key Findings
The European Medicines Agency’s (EMA) third Periodic Safety Update Report (PSUR #3) for the Pfizer-BioNTech COVID-19 vaccine, covering December 2021 through June 2022, has revealed significant data about adverse events following vaccination, particularly among young recipients.
Overview of General Safety Data
The report documented 508,351 individuals experiencing 1,597,673 adverse events following vaccination. Notable patterns emerged:
- Women reported three times more cases than men
- One-third of cases were classified as serious
- 3,280 deaths were reported overall
- 60% of cases had unknown outcomes or showed no recovery
- Most cases occurred in people aged 31-50
- Germany led reporting with 22.5% of worldwide cases
Pediatric Cases: A Concerning Increase
The number of adverse events reported in children (age 17 and under) showed a dramatic rise:
- Total pediatric cases increased from 1,643 in early 2021 to 31,930 in early 2022
- This coincided with EMA’s approval of the vaccine for ages 12-15 (May 2021) and 5-11 (November 2021)
Analysis of Cases in Young Children (Ages 5-11)
Among children aged 5-11:
- 9,605 individual cases reported adverse events
- 17% of events were classified as serious
- Over 40% had unknown outcomes
- 14.5% showed no resolution
- 20 deaths were recorded, including two confirmed cases of myocarditis
Disturbingly, there were 20 deaths recorded for this age group. A screenshot below shows the most frequently reported preferred terms (PTs) in the fatal cases.
Out of the 20 deaths, 2 were attributed to myocarditis (inflammation of the heart muscle). Their cases are detailed in the screenshot below.
Both these children suffered from cardio-respiratory arrest which resulted in their death and both developed myocarditis soon after vaccine dose 1 or 2 was administered
In the case of the 6-year-old boy who died, ‘the reporter concluded that the death “had nothing to do” with the administration of BNT162b2 and was due to natural causes.’
Adolescent Cases (Ages 12-17)
The report documented:
- 21,945 individual cases with 61,071 adverse events
- 32% classified as serious
- One-third had unknown outcomes
- 20% remained unresolved
- 62 fatal cases reported
The screenshot below shows the details of the remaining 39 cases. The list of fatal adverse events is extensive.
According to Pfizer’s 83-page report of fatal cases, a total of 13,659 deaths (all age groups) were retrieved from 21 December 2020 through to 18 June 2022.
It’s noteworthy that the highest number of fatal cases, reported across all age groups, were classified under Cardiac and Nervous system disorders.
Expert Commentary
Dr. Clare Craig, a diagnostic pathologist, highlighted systemic issues in investigating post-vaccination deaths: “Any unexpected death, especially in a child, should have a post-mortem… The situation is not helped by a culture of not investigating deaths by post-mortem.”
Regulatory Response
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) raised concerns about:
- Insufficient investigation of fatal cases
- Limited documentation of myocarditis cases
- Lack of comprehensive autopsy data
- Inadequate follow-up on cases with unknown outcomes
Data Monitoring Challenges
The report reveals significant gaps in post-vaccination monitoring:
- Many autopsies were either not performed or results were not provided
- Numerous cases were dismissed due to “limited information”
- Follow-up investigations were often incomplete
- Causality assessments were frequently inconclusive
Implications for Public Health
These findings raise important questions about:
- The thoroughness of post-vaccination safety monitoring
- The need for more rigorous investigation of adverse events
- The importance of comprehensive follow-up in pediatric cases
- The necessity of improved reporting systems
