Public furor has arisen over the FDA-release of Pfizer’s documents, not simply because the FDA and Pfizer wanted to keep them confidential until 2096 but what the trove of data has exposed.

My analysis on the first wave of released documents was published in Trial Site News at the end of last year, long before any other media outlet reported on it. Since then, I’ve written several reports for Trial Site on subsequent Pfizer data dumps, which have highlighted numerous anomalies and alarming revelations. In my December 2021 report, I made reference to the missing information associated with the ‘Use in pregnancy and lactation which was somehow excluded from Pfizer’s original Cumulative Analysis of Post-Authorization Adverse Event Reports, submitted to the FDA. In the Pfizer amended version and in the subsequent reissue, 413 adverse cases were reported with 84 classified as serious.

Pregnancy outcomes for the 270 pregnancies were reported as spontaneous abortion (23), outcome pending (5), premature birth with neonatal death, spontaneous abortion with intrauterine death (2 each), spontaneous abortion with neonatal death, and normal outcome (1 each). No outcome was provided for 238 pregnancies.

The fact that out of the 270 pregnancies, 23 were reported as spontaneous abortion (miscarriage) is disturbing but equally so is the further revelation that for the remaining 238 pregnancies ‘no outcome was provided.’

The data in the post-authorization report referenced above, was collected after emergency use authorization (EUA) was given in December 2020 for the Pfizer-BioNTech COVID-19 vaccine (BNT162b2).

Pregnant women were officially excluded from Pfizer’s clinical trial

The elephant in the room appears to be the fact that Pfizer’s pivotal Phase 1/2/3 trial (which the FDA based their EUA upon) did not include pregnant women. This subpopulation was listed under Pfizer’s clinical trial protocol’s exclusion criteria, clearly stated in both the Nov 2020 version (on page 42) and in the updated March 2021 version (on page 81). The latter document was released by the FDA a year later on March 2022, thanks to the plaintiff group, PHMPT (Public Health and Medical Professionals for Transparency) which filed a lawsuit against the FDA for failing to comply with their FOIA request for access to all the data the FDA relied upon to grant EUA for the Pfizer-BNTech COVID-19 vaccine.

It’s also worth noting (see screenshot below) that on page 52 of the FDA’s EUA document it states there’s ‘insufficient data to make conclusion about the safety of the vaccine in..children less than 16 years of age, pregnant and lactating individuals..’

Also on page 6 in a document from the UK, entitled, ‘REG 174 Information for UK Healthcare Professionals,’ released around the same time as the FDA’s EUA in the US, it states, ‘There is limited experience with use of COVID-19 mRNA Vaccine BNT162b2 in pregnant women..It is unknown whether COVID-19 mRNA Vaccine BNT162b2 is excreted in human milk.’ (See screenshot below)

COMIRNATY (the marketing name given to Pfizer’s BNT162B2 vaccine) was approved on August 23, 2021 for individuals aged 16 years and above. Buried within the package insert for COMIRNATY (that was last revised in December 2021) states, ‘Available data on COMIRNATY administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.’ (See screenshot below)

 

Shockingly, by spring of 2021, pregnant and lactating women were encouraged to the have this vaccine in the US (promoted by the CDC and other medical authorities) even when the FDA’s label (package insert) stated there was insufficient safety data.

What data did the US authorities rely on to say it was safe for pregnant women?

In February 2021, Pfizer began conducting their COVID-19 vaccine clinical trial in pregnant women, prior to that Pfizer and BioNTech completed a developmental and reproductive toxicity (DART) study on rats (44 female rats in both the vaccine and placebo group) with BNT162b2, which was required by the FDA before starting the study in pregnant women. In Part 2 of my Trial Site News report on the Pfizer documents, I analysed the non-clinical overview report, which was released on the PHMPT website on March 1, 2022. Shockingly, it revealed no safety pharmacology, pharmacokinetic, genotoxicity or carcinogenicity studies were done by Pfizer because they were not deemed ‘necessary.’

In early summer of 2021, a study (the DART study I make reference to above) entitled, ‘Lack of effects on female fertility and prenatal and postnatal offspring development in rats with BNT162b2, a mRNA-based COVID-19 vaccine’ was published in Elsevier and its online partner, Science Direct. The results of the DART study conducted on rats stated, ‘No adverse effects of BNT162b2 on rat offspring following maternal vaccination.’

Further statement was made:

‘Together with the safety profile in nonpregnant people, this ICH-compliant nonclinical safety data supports study of BNT162b2 in women of childbearing potential and pregnant and lactating women’.

It’s worth noting that all the authors of that study were Pfizer employees and that ‘Funding for this work came from BioNTech and Pfizer, Inc.’

This Pfizer-funded study done on rats, which was later used as evidence in paving the way that it was safe for pregnant women, starkly contradicts the alarming results seen in the ‘Cumulative Analysis of Post-Authorization Adverse Event Reports.’

The biased data the CDC relied on

In April 2021, the CDC recommended the Pfizer and Moderna’s COVID-19 vaccine for pregnant women, based on a preliminary report from a retrospective cohort of  >40,000 pregnant women. Of the total number, 36,015 were unvaccinated and a much smaller group of 10,064 received a COVID-19 vaccine (Pfizer, Moderna and Janssen) at eight health care organization sites from Dec 15,2020- July 22, 2021. The report stated that ‘COVID-19 vaccination during pregnancy was not associated with preterm birth or small-for-gestational-age at birth overall, stratified by trimester of vaccination, or number of vaccine doses received during pregnancy, compared with unvaccinated pregnant women.’

The lead author of that report, 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.

If you look at the table 2 of the vaccinated women, the majority were administered the vaccine in their third trimester!

 

This would have injected a significant confounding factor effecting the study results. This is because 80% of miscarriages (spontaneous abortions) occur in the first trimester. From the table above, only 1.7% of the 10,064 pregnant women were given the vaccine in their first trimester compared to 61.8% who were in their third. By the simple fact that COVID-19 vaccine was given to 61.8% of women in their third trimester renders this study limited and subject to significant bias.

This limitation was referenced in the report by the authors stating, ‘because of the timing of COVID-19 vaccine availability and the timing of the births in this cohort, few first-trimester vaccinations were observed.’

It’s interesting to note that the FDA still has not authorised any COVID-19 vaccine to pregnant women. They have also only fully approved the Pfizer-BioNTech vaccine (under the marketing name COMIRNATY) for people aged 16 years and above but granted emergency use authorization only for 12-15 year olds and from October 29, 2021 for 5-11 year olds. The FDA packaging insert to this day, still states that there’s insufficient available safety data for pregnant women. Yet, despite the alarming results found in Pfizer’s cumulative adverse events report and the findings in the non-clinical review, which revealed that many safety studies were not done, the CDC continues to recommend this vaccine (with an estimated clinical trial completion date of February 2024 and no long term safety data) to pregnant women and not just to that subgroup but much younger age-groups of the population, which the FDA is just as guilty of.