IVF BIOLOGIST MADE SUBMISSION TO THE USA VACCINE ADVISORY COMMITTEE - mRNA SAFETY SIGNAL SEEN IN IVF CLINICS...
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My name is Hanna Parikka. I’m writing to you as a former academic reproductive health professional with 20 years’ experience as an IVF biologist (equivalent to embryologist) in Finland. Since the gene-based Covid vaccines rollout, I have had extreme concerns about the lack of safety data, pharmacovigilance, transparency, precautionary principle, accountability, informed consent, professional ethics & competence as well as free speech in scientific and ethical issues in our society and amongst us professionals.
We were told by the authorities that the safety signals have been closely monitored and nothing of concern has been found. I would like to ask: who is monitoring, where are the written guidelines and who is responsible for the collected data? I know as a professional that concerning the Covid vaccines, there were no instructions or requirements for traceability from the authorities.
The IVF field could have been the perfect early-warning system - why wasn't it implemented?
This is not a question of IVF, but possible safety signals which could be seen especially in the IVF laboratory, and which possibly could explain the decline in global fertility & birth rates. IVF field could have been able to detect some biological disturbances long before they become visible as reduced fertility outcomes. Known risks associated with gene-based Covid vaccines (e.g. lipid nanoparticles, spike protein, modified mRNA, residual DNA, SV40 promoter/enhancer sequences) may also affect fertility at a very early stage, which can lead to problems with cell or early embryo quality, implantation issues, or very early miscarriage. Also, we cannot think in a way that we aren’t seeing any safety signal if the child is born alive. IVF outcome tracking should have been mandatory from 2021 onward. Failing to do so was not only a complete scientific failure, but especially a moral failure born of haste, political pressure and institutional capture.
Since the introduction of Covid vaccines some professionals (me included) in the IVF field have shared their concerning observations in the IVF clinics, e.g. less mature oocytes (MII), degenerating oocytes and embryos, lower blastocyst formation, impaired quality of eggs, sperm and embryos, unusual findings in PGT (pre-implantation genetic testing), implantation failures, increased miscarriages and impaired sperm quality. The fundamental problem is that there are no requirements or guidelines provided by the authorities for the monitoring of safety signals, and the information of patients’ vaccination status is not provided – this makes it very difficult to find any safety signals linked to the gene-based Covid vaccines in the IVF lab. Thus, you won’t probably find anything.
The data collected by authorities from IVF clinics is far too generalized, and detecting safety signals in these datasets may be impossible or delayed by years. We need much more detailed data from IVF clinics to really find any safety signal sooner than decades too late. The parameters in the IVF laboratory that should be compared before and after the introduction of Covid vaccines are e.g. mature eggs (MII %), degenerated / weak eggs, egg survival after ICSI, normal fertilization (2 PN), fragmentation, timing delays in embryo cleavage, multinucleation, blastocyst formation rate, high quality blastocysts, re expansion after freezing, early cleavage arrest, sperm quality, sperm DNA fragmentation, PGT genetic testing results (aneuploid / mosaic /chaotic embryos) - this is not a complete list. We must also make use of all possible independent knowledge and currently developed test methods that can detect Covid vaccine derived disruptions in e.g. gametes, embryos, gonads, endometrium, placenta, foetus and newborn child. At this time, at the latest, no conflicts of interest must interfere with these investigations.
The only ethical step forward now is independent retrospective analysis: combining national reproductive health registries, IVF clinic data, miscarriage statistics, ovarian reserve data and gamete bank data – and making anonymous data fully available to the public.
IVF professionals make daily observations in their work, which is why it is completely absurd to close your eyes in your own laboratory as if there is no right and obligation to apply your knowledge and experience - and instead, without examining conflicts of interest, read in a scientific publication that "no safety signal has emerged in our large dataset". Professional ethics and moral responsibility have been made impossible if the only permissible way to carry out one's work is to blindly follow the instructions coming from above. As professionals, we must all act in a manner that makes us worthy of the trust of our patients, children, young people, and future generations.
Sincerely, Hanna Parikka, MSc, fmr IVF biologist
@YellowHideaway
regulations.gov/comment/CDC-…
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