The mRNA vaccines were released globally in early 2021 with the slogan ‘safe and effective’. Unusually for a new class of medicine, they were soon recommended by public health authorities for pregnant women. By late 2021, working-age women, including those who were pregnant, were being thrown out of employment for not agreeing to be injected. Those who took the mRNA vaccines did so based on trust in health authorities – the assumption being that they would not have been approved had the evidence not been absolutely clear. The role of regulatory agencies is to protect the public and, therefore, if they were approved, it was assumed that the ‘vaccines’ were safe.
Recently, a lengthy vaccine evaluation report dated January 2021, sponsored by Pfizer and submitted to the Australian regulator, the Therapeutic Goods Administration (TGA), was released under a Freedom of Information (FOI) request. The report contains significant new information that had been suppressed by the TGA and by Pfizer itself. Much of this relates directly to the issue of safety in pregnancy, and to impacts on the fertility of women of child-bearing age. The whole report is important, but four key data points stand out:
- The rapid decline in antibody levels and T cells in monkeys following the second dose
- Biodistribution studies (previously released in 2021 through an FOI request in Japan)
- Data on the impact of fertility outcomes for rats
- Data on foetal abnormalities in rats.
We shall focus on the last three items as, regarding the first point, it is enough to quote from the report itself: “Antibodies and T cells in monkeys declined quickly over 5 weeks after the second dose of BNT162b2 (V9), raising concerns over long term immunity …”. This point indicates that the regulators should have anticipated the rapid decline in efficacy of the vaccine, and must have known from the outset that the initial two-dose ‘course’ was unlikely to confer lasting immunity and would therefore require multiple repeat doses. This expectation of failure was recently highlighted by Dr Anthony Fauci, the former Director of NIAID in the USA.
The three remaining points should be a major cause for alarm for the pharmaceutical regulatory system. The first, as revealed in 2021, involved biodistribution studies of the lipid nanoparticle carrier in rats, using a luciferase enzyme to substitute for the mRNA vaccine. The study demonstrated that the lipid nanoparticles, and hence the vaccine, travel throughout the body after injection, and are found not only at the injection site but in all organs tested, with high concentration in the ovaries, liver, adrenal glands and spleen. Authorities who assured vaccinated people in early 2021 that the vaccine stays in the arm were, as we have known for two years, lying.
As with the increased pregnancy losses, Pfizer simply ignored the trend and compared the results with historical data from other rat populations.
Lipid concentration per gram, recalculated as a percentage of that administered at the injection site.
| ORGAN | 28 HOURS µg lipid equiv/g | TOTAL | CONC VS INJECTION SITE |
| ADRENAL GLANDS | 18.21 | 164.9 | 11.04% |
| BONE MARROW | 3.77 | 164.9 | 2.29% |
| INJECTION SITE | 164.9 | 164.9 | 100.00% |
| LIVER | 24.29 | 164.9 | 14.73% |
| OVARIES | 12.26 | 164.9 | 7.43% |
| SPLEEN | 23.35 | 164.9 | 14.16% |
In terms of the impact on fertility and foetal abnormalities, the report includes a study of 44 rats. It describes two main metrics, namely the pre-implantation loss rate, and the number of abnormalities per foetus (also expressed per litter). In both cases the metrics were significantly higher for vaccinated rats than for unvaccinated rats.
Roughly speaking, the pre-implantation loss ratio compares the estimated number of fertilised ova with the ova implanted in the uterus. The table below is taken from the report itself and clearly shows that the loss rate for rats vaccinated with BNT162b2 is more than double that in the unvaccinated control group.
In a case-control study, a doubling of pregnancy loss in the intervention group would represent a serious safety signal. Rather than taking this seriously, however, the authors of the report then compared the outcomes with historical data from 27 studies of 568 rats from other rat populations. They then ignored the outcome because other populations had recorded higher overall losses. This range is shown in the right-hand column as 2.6% to 13.8%. This analysis is alarming as remaining below the highest previously recorded pregnancy loss levels in populations elsewhere is not evidence of safety, especially when the intervention resulted in double the harm experienced by the control group.
A similar pattern is observed for foetal malformations, with a higher abnormality rate in each of the 12 categories studied. Of the 11 categories for which Pfizer confirmed the data was reliable, only two total abnormalities were reported in the control group, versus 28 in the group receiving the mRNA vaccine (BNT162b2). In the category which Pfizer labelled as unreliable (supernumerary lumbar ribs), there were three abnormalities in the control group and 12 in the vaccinated group.
As with the increased pregnancy losses, Pfizer simply ignored the trend and compared the results with historical data from other rat populations. This is very significant as it is seen across every malformation category. The case-control nature of the study design was again ignored, apparently in order to hide the negative outcomes demonstrated.
These data indicate that there is NO basis for saying that the vaccine is safe in pregnancy. Concentration of LNPs in the ovaries, a doubled pregnancy loss rate, and a raised foetal abnormality rate across all measured categories indicate that designating a safe-in-pregnancy label (B1 category in Australia) was contrary to the available evidence. The data implies that not only was the Government’s ‘safe and effective’ sloganeering inaccurate, it was totally misleading with respect to the safety data available.
Known unknowns and missing data:
Despite the negative nature of these outcomes, the classification of this medicine as a vaccine appears to have precluded further animal trials. Historically, new medicines, especially those in classes never used before in humans, would require a very rigorous assessment. Vaccines, however, require a lower burden of proof than ordinary medicines. As the TGA itself notes, classifying mRNA injections as ‘vaccines’ ensured regulatory approval with significantly less stringent safety requirements. In fact, mRNA gene therapies function more like medicines than vaccines, in that they modify the internal functioning of cells, rather than stimulating an immune response to the presence of an antigen. Labelling these gene therapy products as vaccines means that, as far as we are aware, no genotoxicity or carcinogenicity studies have yet been carried out.
This report, which was only released after a FOI request, is extremely disturbing as it shows that the authorities knew that there were major risks associated with mRNA Covid-19 vaccination while simultaneously assuring populations that it was safe. The fact that mainstream media has (as far as we are aware) completely ignored the newly released data should reinforce the need for caution when listening to the advice of public health messaging regarding Covid-19 vaccination.
In conclusion, it is clear that regulators, drug companies and the government would have known that vaccine-induced immunity tails off very rapidly, having observed efficacy against infection falling to zero in real-world data. Accordingly, the single point in time figures of 95% and 62% efficacy against cases quoted for Pfizer and ChAdOx1 (AstraZeneca) respectively meant almost nothing, since a rapid decline was to be expected. Similarly, the concept of a two-dose ‘course’ was inaccurate, as endless boosters would likely have been required given the rapid decline in antibodies and T cells observed in the monkeys.
Furthermore, and possibly most importantly, the data does not in any way support the “safe” conclusion with respect to pregnancy; a conclusion of ‘dangerous’ would be more accurate. The assurances of safety were completely misleading given the data disclosures in the recent FOI release. Regulatory authorities knew that animal studies had revealed major red flags regarding both pregnancy loss and foetal abnormalities, consistent with the systemic distribution of the mRNA, a fact that they had been hiding from the public. Even in March 2023, it is impossible to offer these assurances, given that important studies have not, to the best of our knowledge, been carried out. Pfizer elected not to follow up the vast majority of pregnancies in the original human trials, despite high miscarriage rates in the minority they did follow. Given all of the problems with efficacy and safety, the administration of these products to women of childbearing age, and administration to healthy pregnant women, can only be regarded as extremely high risk and unjustifiable.
