104 miscarriages before 20 weeks in 127 women, blood clots and myocarditis, claims impeding the process of obtaining informed consent, deeply irresponsible and unprofessional, Dr Brenda Kelly, No data is available regarding potential effects on the foetus or other pregnancy outcomes, no evidence at all that Covid-19 vaccines will prevent SARS-CoV-2 infection, polyethylene glycol (PEG), pregnant women were not included in the regulatory trials, the Covid-19 vaccine safety profile
Obstetrician’s safety claims on Covid vaccine in pregnancy ‘were misleading and biased’
By Sally Beck
July 21, 2021
THE UK Medical Freedom Alliance has sent an open letter to Dr Brenda Kelly, consultant obstetrician at Oxford University Hospitals, detailing ‘serious concerns’ about statements she made in videos on the hospitals’ website about Covid-19 vaccination in pregnancy.
The alliance, a group of medical professionals, scientists and lawyers, says it is concerned about several ‘simplified, misleading and biased’ claims Dr Kelly made about the safety and efficacy of the Covid-19 vaccines. It says these claims are not supported by the available evidence, and ‘may seriously impede the process of obtaining fully informed consent from pregnant women’.
This is the text of the letter:
We would like to share with you our Open Letters to the RCOG / RCM dated 29 March 2021 and to the JCVI dated 19 April 2021 vaccines-should-be-offered-to-all-pregnant-women regarding Covid-19 vaccines for pregnant women.
This is in response to your recent appearance in a series of short videos, published on the Oxford University Hospitals website, where you made several statements conveying simplified and biased messages that are not supported by the available evidence.
Concerns are mainly related, but not limited to, your representation of the Covid-19 vaccine safety profile.
1. You state that Covid-19 vaccines are safer for pregnant women than contracting Covid-19 disease, when there is no evidence at all that Covid-19 vaccines will prevent SARS-CoV-2 infection or any of the complications you refer to (stillbirths / premature delivery / long Covid).
2. Your statement that Covid-19 vaccines are ‘safe and effective’ stands completely unqualified, resulting in the suggestion that nobody will come to any serious harm as a result of the vaccine.
As a medical practitioner, we are sure that you will be aware that such a statement does not apply to any medical intervention, and cannot possibly apply to a product that is based on a completely novel technology whilst remaining in Phase 3 trial stages, not due to be completed till 2023.
3. You indicate it to be reassuring that Covid-19 vaccines do not contain any live virus, but completely fail to mention that the gene technology using mRNA and lipid nanoparticles has never previously received full regulatory approval for humans on a large scale.
As pregnant women were not included in the regulatory trials, the effect of this technology on a pregnancy, a developing foetus and on a breastfeeding baby cannot possibly be known and declared safe at this stage.
4. You categorically state that there are no harmful ingredients in the Covid-19 vaccines, specifically the Pfizer and Moderna vaccines, which you recommend for pregnant women. May we refer you to the Government documents for a full list of ingredients of the Pfizer and Moderna vaccines.
Both mRNA vaccines contain polyethylene glycol (PEG). PEG is a known allergen which carries a risk of serious, potentially fatal allergic reactions. The US Centre for Disease Control (CDC) has issued advice that anyone allergic to PEG or its close relative, Polysorbate, should not receive either of the currently available mRNA vaccines.
This has also been reflected in advice from the NHS, which states: ‘Since the Pfizer-BioNTech COVID-19 vaccine contains PEG, individuals with PEG allergy should not receive this vaccine.’
5. You state that side-effects to be expected after a Covid-19 vaccine would be mild and self-limiting. However, since the start of Covid-19 vaccine rollout to the population in December 2020, thousands of vaccine-related illnesses and deaths have been reported through databases in the US, Europe and the UK, raising serious concerns about safety.
In the report published by the MHRA on June 30, 2021, there were over one million adverse reactions in the UK, some of them very serious, including seizures, paralysis, blindness, strokes, blood clots and acute cardiac events. This report includes 1,440 fatalities.
Some life-threatening effects, such as blood clots and myocarditis, have been reported specifically in young people, which will be particularly relevant for women of childbearing age.
We strongly suggest that any published information regarding Covid-19 vaccine should include reference to risks of serious morbidity, which you completely fail to mention.
In this context, it is also essential to note that Covid-19 vaccine manufacturers demanded and were granted exemption from any liability for adverse effects of injury or death caused by their products.
6. You claim that safety of Covid-19 vaccines in pregnancy may be inferred from monitoring over 130,000 pregnant women in the US, which has not raised any safety concerns.
Whilst this suggests robust reassurance, this assertion completely fails to acknowledge that this ‘study’ refers to the CDC’s V-safe Covid-19 Vaccine Pregnancy Registry, which is a voluntary reporting system, collecting observational data of over 130,000 women, who happened to be pregnant at the time of vaccination. It is notable that only just over 5,000 of these women have been formally enrolled.
This is not comparable to robust, thorough, scientific evaluation and peer-reviewed evidence.
No data is available regarding potential effects on the foetus or other pregnancy outcomes, as the length of time Covid-19 vaccines have been tested and administered does not even equal the length of a single pregnancy at this point.
Published data from June 2021 in the New England Journal of Medicine only refer to ‘preliminary findings’ regarding safety of mRNA Covid-19 vaccines in pregnancy, also mostly based on the V-safe pregnancy registry.
This study reports 104 miscarriages before 20 weeks in 127 women, who had received a Covid-19 vaccine before the third trimester and completed their pregnancy. As of 30 June 2021, 314 miscarriages and 12 stillbirths / foetal deaths have been reported to the MHRA via the Yellow Card system.
7. We would like to draw your attention to a recent report from the MHRA regarding the Pfizer Covid-19 vaccine, dated June 4, 2021, which states under toxicology conclusions: ‘In the context of supply under Regulation 174, it is considered that sufficient reassurance of safe use of the vaccine in pregnant women cannot be provided at the present time: However, use in women of childbearing potential could be supported provided healthcare professionals are advised to rule out known or suspected pregnancy prior to vaccination. Women who are breastfeeding should also not be vaccinated.’
8. We further would like to draw your attention to the Summary of Product Characteristics for Covid-19 Vaccine Moderna by the MHRA updated 25 June 2021, which states: ‘Administration of COVID-19 Vaccine Moderna in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus. It is unknown whether COVID-19 Vaccine Moderna is excreted in human milk.’
This is not consistent with your message that the mRNA Covid-19 vaccines are suitable for every pregnant woman without further considerations.
In the current situation, which is fraught with uncertainty and fear, the public is looking to professionals for balanced advice. We suggest that anyone stepping forward with a purpose of conveying information relevant to Covid-19 vaccination bears the responsibility to do so comprehensively and based on all available evidence.
We further suggest that presenting such a simplified and biased message as in your series aimed at pregnant women, is deeply irresponsible and even unprofessional.
We find it incomprehensible how you would justify omitting all the information we have presented in this letter, which is freely available and essential to assimilate for anyone deliberating whether to accept a Covid-19 vaccine, especially when two lives are potentially affected at once, as during pregnancy.
We therefore strongly recommend that you immediately retract your videos or issue a corrected version including comprehensive and balanced information regarding the available evidence about Covid-19 vaccine safety in pregnancy.
We thank you for reading this letter and sincerely hope you consider its contents in full.