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EMA head grilled over damning data from EU’s 1st Pfizer/BioNTech vaccine safety report at the European Parliament

On March 27, a 3-hour session held by the ‘Special Committee on COVID-19 pandemic’ took place at the European Parliament.

The last memorable session was when Pfizer’s President of International Developed Markets- “working at the speed of science”-Janine Smalls (who stood in for company CEO Albert Bourla because he failed to show) faced a grilling from certain MEPs. This time it was Emer Cooke’s (former Big Pharma lobbyist, now Executive Director of the European Medicines Agency) turn to be questioned.

Michele Rivasi, MEP and Vice-Chair of the Special Committee on the COVID-19 pandemic: lessons learned and recommendations for the future dropped damning COVID-19 vaccine adverse event data on the floor of the parliament culminating in the fundamental question aimed at Ms Cooke and her agency:

How could the EMA conclude a favourable safety profile of the vaccine given the troubling data found in the first-ever EU Pfizer/BioNTech vaccine safety report?

Rivasi’s office informed me that her questions to the EMA head, were drawn from my analysis (first published in Children’s Health Defense Europe) of the bombshell EU report, which contained damning data reported during the first 6 months of 2021.

Below is my overview of the alarming data found in the 286-page report.

Rivasi made a point of highlighting the alarming pregnancy outcome data from the clinical trials, referenced in my analysis. During the 6 month reporting period, 26 pregnancy outcomes from the 149 unique pregnancy cases, were recorded. Of those 26 outcomes, 15 resulted in spontaneous abortion (miscarriage) and 5 of the pregnancy outcomes resulted in live births with congenital anomalies. 

In Cooke’s dismissive response, she stated:

“ We reviewed several studies on 65,000 pregnant women at different stages in pregnancy and didn’t see a risk in pregnant women.”

Her remark stems from an early 2022 EMA news report:

‘The task force undertook a detailed review of several studies involving around 65,000 pregnancies at different stages. The review did not find any sign of an increased risk of pregnancy complications, miscarriages, preterm births or adverse effects in the unborn babies following mRNA COVID-19 vaccination. Despite some limitations in the data, the results appear consistent across studies looking at these outcomes.’

Firstly, Cooke should have been aware, if she read any of the EMA referenced studies, that a small proportion of the 65,000 women actually took a COVID-19 vaccine, so her comment was misleading. In addition, the studies had many limitations and in certain cases multiple authors declared significant conflicts of interest. For example, in the Lipkind et al. study, Heather Lipkind is on the Pfizer COVID-19 Vaccine in Pregnancy Data Safety Monitoring Board. Kimberly Vesco, disclosed she receives institutional support from Pfizer. Candace Fuller disclosed she receives institutional research funding from Pfizer and Johnson & Johnson. Vesco and Lipkind, happened to also be authors of the Kharbanda et al. EMA referenced study, along with another author, Allison Naleway, who reported receiving research funding from Pfizer for an unrelated study.

A common limitation shared among many of the studies was the fact that the majority of pregnant women were administered a COVID-19 vaccine in their third trimesterThis is a confounding factor, because 80% of miscarriages (spontaneous abortions) occur in the first trimester. In the Lipkind et al. study, only 1.7% of women were in their first trimester compared to 61.8% in the third.

Furthermore, in the limitations section of the Shimabukuro et al. study, the authors wrote:

We also do not know the total number of Covid-19 vaccine doses administered to pregnant persons, which further limits our ability to estimate rates of reported adverse events from VAERS data. Among pregnancy-specific conditions reported to the VAERS after Covid-19 vaccination, miscarriage was the most common. This is similar to what was observed during the influenza A (H1N1) pandemic in 2009 after the introduction of the 2009 H1N1 inactivated influenza vaccine, where miscarriage was the most common adverse event reported by pregnant persons who received that vaccine.’

substack by Dr Ah Kahn Syed (a pseudonym) offers a critical analysis of some of these pregnancy studies. Moreover, in a follow-up piece from Arkmedic’s blog a disturbing revelation is explored in great detail: how the miscarriage rate in a healthy population is actually around 5-6%. However, for years, rates have been misrepresented at 15-20% so when new drugs are tested in pregnancy, a doubling of the miscarriage rate will effectively be obscured.

I have also written an in-depth report for Trial Site News entitled: ‘On what basis are pregnant women being encouraged to take the Pfizer vaccine? The follow-up report can be read here.

For Emer Cooke, to state that “we didn’t see a risk for pregnant women”, when miscarriage is a common pregnancy-specific adverse event after COVID-19 vaccination, seen across multiple surveillance systems- is a slap in the face to those who’ve suffered from miscarriage or still birth resulting from their vaccination. As of March 17, 2023, from VAERS data, 4,955 miscarriages have been reported, post COVID-19 vaccination.

Throughout the long session, Emer Cooke cited that the COVID-19 vaccines are “safe and effective” and that “we looked critically at the data” and “based our decisions on expert evaluation.” However, she did state one truth – “the EMA relies on fees from private industry”- the very industry they’re supposed to regulate.

Turning to the 2022 annual EudraVigilance report for the European Parliament, surely as Executive Director of the EMA, Cooke would have been aware that:

‘A large proportion of the reports were related to COVID-19 vaccines, which accounted for 39% (1,140,583) of all the ICSRs, and 61% (885,216) of the ICSRs originating in the EEA.’

* ICSR stands for Individual Case Safety Report

Surely, she would have known that ‘reporting to EudraVigilance in 2021 was the highest annual total ever recorded, mainly driven by COVID-19 vaccine reports.

Certainly, Cooke would have read the first-ever crucial EU PSUR (Periodic Safety Update Report) crammed with disturbing data. So, how was it that as head of the agency, she allowed the EMA to conclude in the report the Pfizer-BioNTech mRNA vaccine safety profile “remains favourable.” The report was published in the summer of 2021 (but not made publicly available until a recent FOIA request). It would have been a crucial time for the EMA to halt the experimental mRNA vaccine programme but the opposite happened, the agency simply rolled it out to younger and younger age groups and encouraged its use for pregnant and lactating women.

This begs the question: is Cooke just ignorant or wilfully so?

Originally published on Substack: Sonia Elijah Investigates

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