pfizer, a case in conflict
FDA case narrative of a 16-year-old boy being hospitalised with myopericarditis
First posted online: 30 May 2022
I challenge anyone to reconcile the FDA’s case narrative of a 16-year-old boy’s myopericarditis during Pfizer’s clinical trial with case narratives Pfizer later reported to the EMA. I await a credible defence of the following discrepancies.
This boy was hospitalised. That’s an instant qualifying condition for a Serious Adverse Event (SAE). This ensures his injury must have been entered into Pfizer’s Safety Database. It’ll be in the Clinical Trial (CT) subset.
Importantly, myopericarditis is the joint diagnosis of both myocarditis and pericarditis. At best, after 2 months, the boy’s adverse event could be described as "resolved with sequalae", as it necessitated the cardiologist to recommend “limited activity”.
In the view of the trial investigator, Pfizer’s drug caused the injury with "reasonable possibility". The FDA agreed. They too could not rule out causality. A 16-year-old boy being hospitalised 3 days after taking Dose 2 of a new drug is reasonable grounds for suspicion.
Now pericarditis cannot simply be erased from the boy’s case narrative, nor the joint assessment of causality with “reasonable possibility”, nor the unresolved nature of his injury after 2 months. Because that would be wrong on 3 counts. Unless something foul is at play.
But that’s exactly what we see Pfizer report to the EMA’s pharmacovigilance body, PRAC. A quick aside on a non-CT SAE. EU Member States MS1/MS3 express concern about a separate “medically confirmed” myocarditis SAE hospitalising <12-year-old prior to the FDA’s approval.
The document records a SAE from the clinical trial in <18-year-old who crossed over to the open-label study prior to the cut-off date, 31 August. Myocarditis developed 3 days after Dose 2, resolved 2 days later, “not related” to treatment according to the investigator.
In the EMA’s latest Risk Management Plan (RMP), Pfizer likewise report a single case of myocarditis. This case narrative is entirely consistent with what Pfizer reported to the PRAC and entirely inconsistent with what the FDA reported back in October 2021. Irreconcilable.
So what if, somehow, these represent two different case reports in 2 different boys during the open-label study period? Good luck trying to justify how these two case reports never appear in the same summary in any document.
The EMA's pharmacovigilance body, PRAC, reported on a case of myocarditis in a child <12 years of age prior to the FDA's approval in the age range
PRAC's case narrative conflicts with the FDA's
VRBPAC FDA Briefing Document (29 October 2021)
EU Risk Management Plan
EMA PRAC Signal Assessment Report on myocarditis/pericarditis