EMA’s failure to pull COVID 19 jabs even though risk-benefit balance nullified (I)

 

The first ever 286-page EU Periodic Safety Update Report (PSUR #1), covering the 6 month period from 19 December 2020 through 18 June 2021 reveals damning safety signals for the Pfizer-BioNTech Covid-19 vaccine (COMIRNATY). It was released via FOIA request from an anonymous reader and provided to the Austrian science and political blog, TKP.

According to the European Medicines Agency definition: ‘PSURs are pharmacovigilance documents intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points after its authorisation. The objective of the PSUR is to present a comprehensive and critical analysis of the risk-benefit balance of the product, taking into account new or emerging safety information in the context of cumulative information on risk and benefits.’

It is the MAH (Marketing Authorisation Holder) in this case, BioNTech SE, who are legally required to submit PSURs to the EMA, along with an application fee. The EMA then assesses the information found in the report to determine if any new risks are identified or if the risk-benefit balance has changed.

I have extensively gone through voluminous Pfizer-BioNTech vaccine-related documents, this report was one of the most eyebrow-raising, not just in relation to the damning data but its conclusion that the ‘benefit-risk profile of BNT162b2 remains favourable.’

The damning data

The following is an overview of the total number of cases (post-marketing and clinical trial data) of the 6-month reporting period: 

 

The table below (extracted from the document) shows the number of cases broken down by: gender, age, country, case seriousness, outcome and presence of comorbidities.

What’s noteworthy is that similar findings relating to: gender-specific vaccine safety risks for  females; individuals (cases) suffering from an average of 3-4 adverse events; high number of reports with either unknown and/or unresolved outcomes; high number of cases with gender unknown and the unusual grouping together of resolved/resolving cases were found when I analysed the Pfizer prepared document for the FDA, entitled, “Cumulative Analysis of Post-Authorization Adverse Event Reports of PF-07302048 (BNT162B2) received through 28 February 2021”. 

However, a striking difference between the two reports, is the explosion in the number of cases and events recorded in the EU’s PSUR, which is a staggering seven times higher compared to Pfizer’s submission to the FDA, which covered half the period.

The document states that during the reporting interval, 635,763,682 doses were estimated to have been administered worldwide and adds: “It is not possible to determine with certainty the number of individuals who received BNT162b2 during the period of this review.” Therefore, extrapolating accurate incidence rates is not feasible.

However, an important point to factor in when assessing the data, is the magnitude of underreporting of cases. A Harvard study concluded that only 1-13% of serious adverse events are ever reported. Furthermore, a systematic review by Hazell et al., provided ‘evidence of significant and widespread under-reporting of ADRs to spontaneous reporting systems including serious or severe ADRs.’ Therefore, it’s concerning that although the number of cases and events in the reporting interval seem high, the actual numbers may have been far higher. 

 

 

The table above shows the most frequently reported lot numbers in case reports. Notice the frequency of cases reported for certain lot numbers, such as lot number EL1484, which was reported in 16,077 cases. Yet, PSUR goes on to state ‘overall, there were no related quality issues identified during investigations of these lot/batch numbers..and any potential signals indicating a potential relationship between a safety issue and a particular batch lots, and that was not already evaluated as part of other signal activities, would undergo evaluation and escalation as per standard procedures.’

This statement is evasive- even the term “overall” implies there could have been issues related to quality that were identified across different batches. In fact, it was known that they were. I have written extensively on the leaked EMA emails and other Pfizer-BioNTech related documents which revealed that the regulators had  concerns about the batch-to-batch variation in vaccine quality  right up to the time emergency use authorisation was granted. Significantly higher proportions of truncated mRNA species (not intact) were identified in the commercial lots of the vaccine, compared to those used in the clinical trials. These truncated species were classified as “product-related impurities.”