Lack of robust and reliable safety dataĪ recent public controversy focused on MHRA advice updated on 16 August 2022 stating in the toxicity conclusions that “ sufficient reassurance of safe use of the vaccine (mRNA BNT162b2 / Pfizer/BioNTech) cannot be provided at the present time” and “ women who are breastfeeding should also not be vaccinated”. But suddenly all of this seems to be forgotten. It was indeed the thalidomide scandal which led to the establishment of the UK Yellow Card system for adverse event reporting. Two examples in the not-too- distant past remind us how disastrously wrong it can go when a new product is given to pregnant women: thalidomide caused severe limb defects in the fetus, and diethylstilbestrol (DES) increased the risk of certain cancers after exposure in utero, requiring life-long surveillance for more than one generation. In pregnancy, lack of data is sufficient to be hesitant. The British National Formulary frequently advises against the use of a pharmaceutical product in pregnancy as a precaution due to lack of data. It is unethical to extrapolate the conclusions of a prematurely ended trial to vulnerable groups not represented in the trial − such as pregnant women.įor obvious reasons, pregnant women are usually excluded from clinical trials. It is unethical to prevent the public from accessing raw trial data for 75 years and to only release some of it for independent scrutiny after a lawsuit. According to those principles, it is unethical to violate a study protocol by under-reporting adverse events, by removing subjects with adverse events from the study, and by unblinding study participants prematurely with the purpose of administering the product under investigation to everyone and therefore effectively ending the trial − as has all happened in the COVID-19 vaccine trials. Such advice is not grounded in robust data based on ethically conducted research − and anyone who is medically and academically trained should take serious issue with this.Ĭlinical researchers, especially when conducting trials to investigate pharmaceutical products, are required to update themselves every two years on the principles of Good Clinical Practice, which incorporate the Nuremberg Code and the Declaration of Helsinki. This advice is that: COVID-19 vaccines are not only safe but strongly recommended for pregnant women. However, recent advice from the RCOG has been in complete contradiction to everything that they themselves and academic institutions have been teaching about evidence-based medicine. Obstetricians and gynaecologists in the UK have put their faith in and adjusted their practice according to guidance from their Royal College (RCOG). To: The Royal College of Obstetricians and Gynaecologists (RCOG) Royal College of Midwives (RCM) UK Health Security Agency (UKHSA) Re: Safety Concerns re: Covid-19 Vaccinations In PregnancyĬOVID-19 Inoculations in pregnancy – where is the evidence?
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