Posted BY: Daily Sceptic

There follows an open letter from 66 doctors, scientists

and clinical practitioners to the Royal College of Obstetricians and Gynaecologists (RCOG), the Royal College of Midwives (RCM), and the U.K. Health Security Agency (UKHSA) regarding safety concerns about COVID-19 vaccinations in pregnancy. Where is the evidence, they ask. Obstetricians and gynecologists in the U.K. have put their faith in and adjusted their practice according to guidance from their Royal College (RCOG). However, recent advice from the RCOG has been in complete contradiction to everything that it itself and academic institutions have been teaching about evidence-based medicine. This advice is that: COVID-19 vaccines are not only safe but strongly recommended for pregnant women. 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. 

Ethics of clinical research

Clinical 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. 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 have all happened in the COVID-19 vaccine 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. It is unethical to extrapolate the conclusions of a prematurely ended trial to vulnerable groups not represented in the trial – such as pregnant women.

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For obvious reasons, pregnant women are usually excluded from clinical trials. The British National Formulary frequently advises against the use of a pharmaceutical product in pregnancy as a precaution due to a lack of data. In pregnancy, a lack of data is sufficient to be hesitant. 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. It was indeed the thalidomide scandal that led to the establishment of the U.K. Yellow Card system for adverse event reporting. But suddenly all of this seems to be forgotten.

Lack of robust and reliable safety data

A recent public controversy focused on MHRA advice updated on August 16th, 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”. The Government and the RCOG were very quick to express their concerns about the circulation of this apparent misinformation and to reinforce their advice that pregnant women should get vaccinated. This document was originally from December 2020, so the claim is that this section is outdated. The question remains why this section was not amended if this document was recently updated. The answer is of course because there is nothing to update it with: studies regarding genotoxicity, carcinogenicity, reproductive and developmental toxicity, and prenatal and postnatal development have still not been conducted.

It cannot possibly be known whether it is safe to give these products to pregnant and breastfeeding women. Clinical research standards dictate close and prolonged observation of trial subjects, documenting any and all observed clinical effects following the administration of the trial compound. This has not been done. There are no trials that last even the duration of a pregnancy. COVID-19 vaccines were on the market for a mere four months when the initial advice to avoid them in pregnancy changed by 180 degrees and they were declared safe. Potential adverse effects for the offspring have not even been considered.

It is profoundly unethical to give a completely novel compound to pregnant women on a mass scale without the strict protocols of clinical research to just see what happens and then pretend that this is science. Yet this is exactly what has been happening.

Incorrect interpretation of available data

Safety data are largely based on retrospective and observational cohort analyses and registries, such as the CDC’s V-Safe COVID-19 Vaccine Pregnancy Registry. Voluntary registries are not equivalent to well-designed prospective clinical trials, as follow-up is inconsistent and incomplete with no standardization or systematization and no tracking of participants.

Other data are from short-term studies where outcomes are determined in post hoc analyses, with little or no stratification of gestational age at the time of vaccination. A large Canadian study published in the Lancet concluded that “COVID-19 vaccines have a good safety profile in pregnancy” based on a follow-up period of a whole seven days. Conflicts of interest status on this paper is notable. Publications are clearly biased toward reaching the conclusions of affirming safety and effectiveness of COVID-19 vaccines in pregnancy even when their study data do not allow such conclusions. The U.K. Medical Freedom Alliance (UKMFA) has published on its website open letters to the U.K.-based authors of two such studies with a critique of their conclusions. Both papers were widely propagated to the public.

The systematic review and meta-analysis of the effectiveness and perinatal outcomes of COVID-19 vaccination in pregnancy was co-authored by the current president of the RCOG, who shared this headline with the RCOG membership: “COVID-19 vaccination associated with 15% reduction in stillbirths in pregnant women.” The prompt within the message to “Find out more” linked not to the original paper for everyone to scrutinize and recognize the flawed methodology, but to the Guardian propagating the same headline. The work of Professor Norman Fenton (Professor of Risk Information Management) on the “statistical illusion of better pregnancy outcomes for vaccinated women” is worth considering for a comprehensive analysis of the available data.

Currently, any quantitative assessment of the risks of adverse events in pregnancy is mostly stymied by the lack of reliable denominators, prohibiting accurate interpretation of existing data.

Shimabukuro et al. published their preliminary findings of mRNA COVID-19 vaccine safety in pregnancy in the NEJM based on the V-Safe registry, reporting a miscarriage rate of 12.6% – consistent with the general population. This was based on a denominator of 827 completed pregnancies. The conclusion was incorrect as only 127 women had been vaccinated in the first or second trimester, and so by definition, the remaining 700 women could not possibly have had an early pregnancy loss.

According to post-marketing data from Pfizer, 42,086 adverse events were reported to the manufacturer during the first three months of the vaccination program. Amongst these were reports from 270 pregnant women. Only 32 pregnancy outcomes were recorded. This should have been but indeed was not a study with dedicated follow-up. These data were collected as part of post-marketing surveillance and are insufficient for comprehensive analysis.

Therefore, there are no reliable statistics at this time – but there are plausible mechanisms of potential harm and there are glaring safety signals.

Mechanisms of potential harm

Even if pregnant women were at increased risk from COVID-19, there are no conclusive data demonstrating that those risks are mitigated by vaccination. Regarding effectiveness, it is worth considering the data tracking COVID-19 vaccination and infection in pregnancy in Scotland, which do not indicate vaccination to have been beneficial, indeed they suggest quite the opposite (Figure 1).

Figure 1

Independent of the potential risks to the pregnancy itself, there are now well-acknowledged risks of COVID-19 vaccines for women of childbearing age in general, including risks of cardiac and cardiovascular morbidities, which may well affect a pregnancy.

Pfizer’s own pharmacokinetics studies showed that the lipid nanoparticles used to carry the mRNA are distributed to and accumulate in the ovaries at significant concentrations (Table 1).

Table 1

A recent research letter in JAMA Pediatrics highlighted that COVID-19 vaccine mRNA could be detected in breast milk. The clinical significance of this has not been investigated, but the conclusion advises caution against breastfeeding for the first 48 hours after vaccination, and previous studies have described adverse events in 7.1% of breastfed infants.

A study published in PLOS Pathogens showed that in mice “the mRNA-LNP vaccine platform induces long-term immunological changes, some of which can be inherited by the offspring”. The effect on the immune system in human offspring – including defense against infections as well as the propensity to allergies and autoimmune disorders – is at this stage completely unknown.

Concern regarding potential autoimmunity is also based on molecular mimicry. mRNA vaccines induce human cells to produce antigens (spike proteins) in order to elicit an immune response. Similarities between spike proteins and human proteins may lead to an adverse autoimmune reaction. It is potentially relevant for pregnant women that the SARS-CoV-2 spike glycoprotein was found to share similarities with 27 human proteins that relate to oogenesis, uterine receptivity, decidualization and placentation in a study published in the American Journal of Reproductive Immunology.

Safety Signals

Most concerning are the accumulating safety signals – and the apparent reluctance to fully investigate them. All four major databases for adverse event reporting (VAERSMHRA Yellow CardsEudraVigilanceWHO Vigiaccess) contain significant numbers of pregnancy-related adverse outcomes, including miscarriages and stillbirths (Table 2).

Table 2: Pregnancy-related adverse events on international databases

A study – currently in preprint – by Dr. James Thorp (U.S. specialist in fetal-maternal medicine) compares pregnancy-related adverse outcomes reported after COVID-19 vaccination to those reported after influenza vaccinations. Even considering the limitations of the study and the perhaps questionable validity of this comparison, the number of reports following COVID-19 vaccines of miscarriages, fetal chromosomal abnormalities, fetal malformation, fetal cystic hygroma, fetal cardiac disorders, foetal arrhythmia, fetal cardiac arrest, fetal vascular mal-perfusion, fetal growth abnormalities, foetal abnormal surveillance, foetal placental thrombosis, low amniotic fluid, and fetal death and stillbirth are extremely concerning.

In addition, there are reports of unexplained phenomena. Birth rates in the first half of 2022 appear to have fallen significantly in highly vaccinated countries in Europe based on official figures, with a decline of more than 4% in 15 countries and more than 10% in seven countries. The rates of cumulative annualized infant mortality in Scotland show 2021 as a significant outlier (Figure 2). As the data are cumulative, the variation usually evens out towards the end of the year, but not so in 2021. The rise mostly relates to spikes in neonatal deaths, which have occurred in temporal association with COVID-19 vaccination (Figure 3). This correlation is especially remarkable considering not all pregnant women were vaccinated.

Figure 2: Infant mortality in Scotland 2015-2022
 Figure 3: Neonatal deaths and COVID-19 vaccination (Dose 1-3) in pregnancy in Scotland

These spikes in neonatal deaths have been publicly acknowledged as concerning. Dr. Sarah Stock, an expert in maternal and fetal medicine at the University of Edinburgh, commented in May 2022: “The numbers are really troubling, and I don’t think we know the reasons why yet”, but “stressed the Covid vaccine, which studies have consistently shown to be safe in pregnancy, was not a factor”. This cannot possibly be known unless it is investigated without the bias that has afflicted most publications on this subject to date. The need for investigation is urgent, and whilst this should have been with clinical trials, there should now be a moratorium on COVID-19 vaccines to allow for meticulous retrospective analysis and re-evaluation.

If we continue to ignore these safety signals, we are not doing our due diligence to protect patients from harm. According to the principles of Good Medical Practice outlined by the General Medical Council, we are supposed to take action when we are concerned about compromised patient safety.

We are not just concerned but deeply disturbed and alarmed at the widespread distortion of science and the blatant omissions in the process of bringing a newly developed pharmaceutical product to market.

We have a collective duty to restore the principles of medical ethics to our practice and to clinical research to protect the most vulnerable groups from harm, and this includes pregnant women and their babies.

In the absence of data on long-term outcomes of mRNA COVID-19 vaccination in pregnancy for either women or their infants, vaccination of pregnant women should be paused while a full safety inquiry is conducted and until results of long-term studies on animals as well as pregnant women and their offspring firmly and unequivocally establish that the benefits of vaccination clearly outweigh the risks to both mothers and babies.

We look forward to an early response to our concerns.

  1. Dr. Julia Wilkens, FRCOG, MD, Consultant in Obstetrics & Gynaecology
  2. Dr. John Williams, FRCOG, retired Consultant in Obstetrics & Gynaecology
  3. Professor Angus Dalgleish, MD, FRCP, FRACP, FRCPath, FMed Sci, Principal, Institute for Cancer Vaccines & Immunotherapy (ICVI)
  4. Professor Richard Ennos, MA, Ph.D., Honorary Professorial Fellow, University of Edinburgh
  5. Professor John Fairclough, FRCS, FFSEM, retired Honorary Consultant Surgeon
  6. Professor Dennis McGonagle, Ph.D., FRCPI, Consultant Rheumatologist, University of Leeds
  7. Professor Karol Sikora, MA, MBBChir, Ph.D., FRCR, FRCP, FFPM, Honorary Professor of Professional Practice, Buckingham University
  8. Lord Moonie, MBChB, MRCPsych, MFCM, MSc, a retired member of the House of Lords, former parliamentary under-secretary of state 2001-2003, former Consultant in Public Health Medicine
  9. Dr Victoria Anderson, MBChB, MRCGP, MRCPCH, DRCOG, General Practitioner
  10. Julie Annakin, RN, Immunisation Specialist Nurse
  11. Helen Auburn, Dip ION MBANT NTCC CNHC RNT, registered Nutritional Therapist
  12. Dr David Bell, MBBS, PhD, FRCP(UK), Public Health Physician
  13. Dr Mark A Bell, MBChB, MRCP(UK), FRCEM, Consultant in Emergency Medicine
  14. Dr Michael D Bell, MBChB, MRCGP, retired General Practitioner
  15. Dr Alan Black, MBBS, MSc, DipPharmMed, retired Pharmaceutical Physician
  16. Dr Gillian Breese, BSc, MB ChB, DFFP, DTM&H, General Practitioner
  17. Dr H Burger, MRCGP, DRCOG, General Practitioner
  18. Dr David Cartland, MBChB, BMedSci, General Practitioner
  19. Caroline Cartledge, RM, BA (hons), Midwife
  20. Angela Chamberlain, BSc (hons), Midwife
  21. Dr Peter Chan, BM, MRCS, MRCGP, NLP, General Practitioner, Functional Medicine Practitioner
  22. Michael Cockayne, MSc, PGDip, SCPHNOH, BA, RN, Occupational Health Practitioner
  23. James Cook, NHS Registered Nurse, Bachelor of Nursing (Hons), Master of Public Health (MPH)
  24. Dr Clare Craig, BMBCh, FRCPath, Pathologist
  25. Dr David Critchley, BSc, PhD in Pharmacology, 32 years’ experience in Pharmaceutical R&D
  26. Dr Sue de Lacy, MBBS, MRCGP, AFMCP, UK Integrative Medicine Doctor
  27. Dr Jayne LM Donegan, MBBS, DRCOG, DCH, DFFP, MRCGP, General Practitioner
  28. Dr Jonathan Eastwood, BSc, MBChB, MRCGP, General Practitioner
  29. Dr Elizabeth Evans, MA(Cantab), MBBS, DRCOG, Co-founder UKMFA
  30. Dr Christopher Exley, Ph.D. FRSB, retired Professor in Bioinorganic Chemistry
  31. Dr John Flack, BPharm, Ph.D., retired Director of Safety Evaluation, Beecham Pharmaceuticals, Senior Vice-president for Drug Discovery SmithKline Beecham
  32. Sophie Gidet, RM, Midwife
  33. Dr Ali Haggett, Mental health community work, 3rd sector, former Lecturer in the history of medicine
  34. Dr Keith Johnson, BA, D.Phil (Oxon), IP Consultant for Diagnostic Testing
  35. Dr Rosamond Jones, MBBS, DRCOG, MD, FRCPCH, retired Consultant Paediatrician
  36. Dr Tanya Klymenko, PhD, FHEA, FIBMS, Senior Lecturer in Biomedical Sciences
  37. Dr Caroline Lapworth, General Practitioner
  38. Dr Branko Latinkic, BSc, PhD, Reader in Biosciences
  39. Dr Theresa Lawrie, MBBCh, PhD, Director, Evidence-Based Medicine Consultancy Ltd, Bath
  40. Dr Felicity Lillingstone, IMD, DHS, PhD, ANP, Doctor, Urgent Care, Research Fellow 
  41. Dr Geoffrey Maidment, MBBS, DRCOG, MD, FRCP, retired Consultant Physician
  42. Dr Ayiesha Malik, MBChB, General Practitioner
  43. Dr Kulvinder S. Manik, MBChB, MRCGP, MA(Cantab), LLM, Gray’s Inn
  44. Dr Franziska Meuschel, MD, ND, PhD, LFHom, BSEM, Nutritional, Environmental and Integrated Medicine
  45. Dr Graham Milne, MBChB, DRCOG, MRCGP, General Practitioner
  46. Dr David Morris, MBChB, MRCP(UK), General Practitioner
  47. Margaret Moss, MA(Cantab), CBiol, MRSB, Director, The Nutrition and Allergy Clinic, Cheshire
  48. Theresa Ann Mounsey, BSc (hons) in midwifery studies
  49. Dr Sarah Myhill, MBBS, Naturopathic Physician, retired General Practitioner
  50. Dr Chris Newton, PhD, Biochemist working in immuno-metabolism
  51. Dr Rachel Nicholl, PhD, Medical Researcher
  52. Sue Parker Hall, certified transactional analyst (CTA, psychotherapy), MSc (Counselling & Supervision), MBACP (senior accredited practitioner), EMDR practitioner, Psychotherapist
  53. Rev Dr William J U Philip, MBChB, MRCP, BD, Senior Minister The Tron Church, Glasgow, formerly doctor working in cardiology
  54. Anna Phillips, RSCN, BSc Hons, Clinical Lead Trainer Clinical Systems (Paediatric Intensive Care)
  55. Dr Angharad Powell, MBChB, General Practitioner
  56. Dr Jessica Righart, MSc, MIBMS, Senior Biomedical Scientist
  57. Mr James Royle, MBChB, FRCS, MMedEd, Colorectal Surgeon
  58. Dr Salmaan Saleem, General Practitioner
  59. Dr Rohaan Seth, BSc (hons), MBChB (hons), MRCGP, retired General Practitioner
  60. Dr Noel Thomas, MA, MBChB, DObsRCOG, DTM&H, MFHom, retired Doctor
  61. Dr Livia Tossici-Bolt, PhD, Clinical Scientist
  62. Tanya Wardle, RM, Registered Midwife
  63. Dr Helen Westwood, MBChB, MRCGP, DCH, DRCOG, General Practitioner
  64. Dr Carmen Wheatley, DPhil, Orthomolecular Oncology
  65. Mr Lasantha Wijesinghe, FRCS, Consultant Vascular Surgeon
  66. Dr Lucie Wilk, MD, Consultant Rheumatologist

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