How safe are the mRNA vaccines for pregnant women and breastfeeding? Pretty safe, so said CDC, and the rest of the world goes along. You might want to do a double take.
The basis for guideline of vaccine use for pregnant women:
Following the use of Johnson & Johnson's covid-19 vaccine in US, 6 women suffered a rare type of blood clot called cerebral venous sinus thrombosis after vaccination. The CDC conducted a review and relied on the conclusions of the Shimabukuro et al study, which supported the use of the mRNA vaccine in early pregnancy. This has formed the basis for international guidelines for vaccine use in many countries.
Singapore recommendation of vaccine use for pregnant women:
The College of Obstetricians & Gynaecologists, Singapore and the Obstetrical & Gynaecological Society of Singapore issued a joint guideline (June 2021) "Covid-19 vaccination for pregnant women, breastfeeding women and women planning to conceive". The risk-benefits are explained and conclusions are in accord with the CDC. Their review took into consideration various studies including Shimabukuro et el.
Ministry of Health statements on use of vaccine by pregnant women :
* The Expert Committee on COVID-19 Vaccination (EC19V) has examined studies done to monitor women who were vaccinated when they were pregnant, as well as their babies.
* These studies were done on women at different trimesters of pregnancy and there is no evidence to suggest that the Pfizer-BioNTech/Comirnaty or Moderna COVID-19 vaccine may cause harm to pregnant women or their babies.
* Both Pfizer-BioNTech/Comirnaty and Moderna COVID-19 vaccines are mRNA vaccines. As mRNA vaccines are not live vaccines, they are biologically unlikely to adversely affect breastfed babies.
* In addition, the breast milk of vaccinated mothers may help to protect their babies from COVID-19 due to antibodies in breast milk. There have also been no vaccine-related side effects reported in the babies who were breastfed by mothers who received the vaccine while breastfeeding.
The MP for Jurong GRC Dr Tan Wu Meng had a parliamentary question in Sep 2021. (I'm not quite sure whether this is tabled, or has been discussed in parliament). The question raised and the written answer :
Question: To ask the Minister for Health (a) to date, how many and what proportion of medically eligible pregnant women in Singapore have received an mRNA vaccination against COVID-19; (b) what are the types and frequencies of side effects that have been observed so far; and (c) how does this compare with the experience of other countries.
Answer: The Health Sciences Authority (HSA) has received a small number of non-serious adverse event (AE) reports with the Pfizer-BioNTech/Comirnaty vaccine in pregnant women. These include rash, syncope (fainting), dizziness and one report of Bell’s Palsy (temporary weakness of the facial muscles). These AEs are similar to those reported in the general population. There is currently no evidence of safety concerns when mRNA vaccines are used in pregnant women, based on real-world clinical data. MOH and HSA will continue to monitor both the local and international safety data.
Criticism of Shimabukuro et al:
Study on "Spontaneous Abortions and Policies on COVID-19 mRNA Vaccine Use During Pregnancy" published Nov 2021 by:
Dr Aleisha Brock Ph.D., MVS, BSc. Whanganui, New Zealand
Dr Simon Thornley Ph.D., MPH(Hons), MBChB. Senior Lecturer, Section of Epidemiology and Biostatistics, The University of Auckland
Brock and Thornley reassessed the report of Shimabukuro et al and determined that "The study presents falsely reassuring statistics related to the risk of spontaneous abortion in early pregnancy, since the majority of women in the calculation were exposed to the mRNA product after the outcome period was defined (20 weeks’ gestation)."
They recalculated the risk of the outcome based on the cohort that was exposed to the vaccine before 20 weeks’ gestation. Their re-analysis indicates a cumulative incidence of spontaneous abortion 7 to 8 times higher than the original authors’ results. Which means :
Pregnant women who had mRNA vaccination had an incredibly high rate of spontaneous miscarriage -- 92% in the first 13 weeks, 81.9% in the first 20 weeks!!!
On the safety of breastfeeding, the authors recommended great caution as the transmission of mRNA and spike protein across the placenta and through breast milk has never been tested and the effects unknown.
The report calls for the immediate withdrawal of mRNA vaccine use in pregnancy and those breastfeeding, alongside the withdrawal of mRNA vaccines to children or those of child-bearing age, until more convincing data relating to the safety and long-term impacts on fertility, pregnancy and reproduction are established.
Vaccine labels Pfizer-BNT162b2 and Comirnaty :
They are both of the same formulation and manufactured by Pfizer. BNT162b2 is sold under EUA (emergency use authorisation) and Comirnaty is FDA approved. Comirnaty is a political scam. It exists in name only, created for the purpose of receiving an official FDA approval to help dispel fear and vaccine hesitancy to drive the US vaccination mandate. Comirnaty is not marketed at the moment for 2 reasons. (1) By law, once there is an approved drug for a disease, all other EUA drugs must be withdrawn. This has not happened. (2) Pfizer makes billions selling BNT162b2 under EUA where there is a waiver or liability. Why on Earth would they want to sell the approved label Comirnaty and face the possibility of multi-billion dollar suits?
On 23 Jun 2021 Straits Times reported the MOH is expecting to receive a batch of Comirnaty for use in Singapore. A google search is all about Singapore "to receive", there is no news about arrival of the shipment. Surely there would have been some huha if MOH received the approved vaccine, publicity milked to the limit to allay the fears of the vaccine hesitant. Afterall, that was the very purpose. I am deeply skeptical MOH actually received the shipment. MOH has now gone for registration purposes to record anyone taking the Pfizer vaccine under a common category "Pfizer BNT162b2 / Comirnaty". In other words, MOH sees no difference between the two. Physically they are the same formulation, but legally they are not. BNT162b2 carries no manufacturer liability, Comirnaty has liabilities for Pfizer. This imposes a legal issue, a contingency MOH does not consider. Post fact, there will be no basis to establish which label one actually had the jab.
Comirnaty carries this caveat with regards to pregnant women and breast-fed babies :
"..available data on Comirnaty administered to pregnant women are insufficient to inform vaccine- associated risks in pregnancy”, and “it is not known whether Comirnaty is excreted in human milk” as “data are not available to assess the effects of Comirnaty on the breastfed infant”
This is totally in contradiction to CDC and MOH statements on the use of the vaccine.
Big Pharmas all have a dedicated website for each drug they produce. This is where they put out their fact sheet -- how to use the drug, the ingredients, warnings, etc. Here's the curious case of Comirnaty. Pfizer put up Comirnaty.com when it was approved by FDA. In an earlier blog I mentioned the Corminaty website did not recommend use of the approved label for age 15 and below. They don't want the liability, just as for pregnant women. That website has been totally revamped and it is now basically carrying statements of the CDC or FDA regarding their product. Hands washed off all liabilities, that's what it's all about.
Fudging data and nuanced presentation of statistics:
Trust of information from positions of power and governance is now a big issue. We have seen how NIH, CDC, FDA, Doctors Fauci and Francis Collins, who has now stepped down from NIH, practically lied, concealed, and fabricated information relating to the vaccine and the virus. We have seen how a Lancet report was contrived to support Fauci in his appearance at the Senate inquiry where he lied under oath that the virus was zoonotic. This CDC-supported Shimabukuro et al report now appears to be a similar sham show.
Facebook commenter Goh Meng Seng is a statistician, I am not. My only claim to this crazy numbers world is a statistics paper I sat in my younger days and which I had to resit 3 times because it bored me to sleep at the study table. On Facebook chats, both GMS and myself have consistently warned of how data can be easily misinterpreted, due to bias selection or not taking into account critical context. It could be innocent mistakes, or intentionally nuanced to suit a particular narrative.
For example this pictograph showing 60% un-vaxxed in the ICU was propaganda to warn of the dangers of not getting the jab, had many people easily convinced, including critical minds like hotshot social commentator 'Critical Spectator'. The fatal flaw lies in the population of the un-vaxx in the ICU. They are mostly the old and with comorbidities who had to avoid vaccination in the first place. The fatal flaws in the Shimabukuro et al report just shows how dangerous it can be to get the statistics wrong.
I have written to the 7 co-authors of the "Covid-19 vaccination for pregnant women, breastfeeding women and women planning to conceive" for their comments on the Broch and Thornley report but have not yet received any response.
The report calls for the immediate withdrawal of mRNA vaccine use in pregnancy and those breastfeeding, alongside the withdrawal of mRNA vaccines to children or those of child-bearing age, until more convincing data relating to the safety and long-term impacts on fertility, pregnancy and reproduction are established.
Vaccine labels Pfizer-BNT162b2 and Comirnaty :
They are both of the same formulation and manufactured by Pfizer. BNT162b2 is sold under EUA (emergency use authorisation) and Comirnaty is FDA approved. Comirnaty is a political scam. It exists in name only, created for the purpose of receiving an official FDA approval to help dispel fear and vaccine hesitancy to drive the US vaccination mandate. Comirnaty is not marketed at the moment for 2 reasons. (1) By law, once there is an approved drug for a disease, all other EUA drugs must be withdrawn. This has not happened. (2) Pfizer makes billions selling BNT162b2 under EUA where there is a waiver or liability. Why on Earth would they want to sell the approved label Comirnaty and face the possibility of multi-billion dollar suits?
On 23 Jun 2021 Straits Times reported the MOH is expecting to receive a batch of Comirnaty for use in Singapore. A google search is all about Singapore "to receive", there is no news about arrival of the shipment. Surely there would have been some huha if MOH received the approved vaccine, publicity milked to the limit to allay the fears of the vaccine hesitant. Afterall, that was the very purpose. I am deeply skeptical MOH actually received the shipment. MOH has now gone for registration purposes to record anyone taking the Pfizer vaccine under a common category "Pfizer BNT162b2 / Comirnaty". In other words, MOH sees no difference between the two. Physically they are the same formulation, but legally they are not. BNT162b2 carries no manufacturer liability, Comirnaty has liabilities for Pfizer. This imposes a legal issue, a contingency MOH does not consider. Post fact, there will be no basis to establish which label one actually had the jab.
Comirnaty carries this caveat with regards to pregnant women and breast-fed babies :
"..available data on Comirnaty administered to pregnant women are insufficient to inform vaccine- associated risks in pregnancy”, and “it is not known whether Comirnaty is excreted in human milk” as “data are not available to assess the effects of Comirnaty on the breastfed infant”
This is totally in contradiction to CDC and MOH statements on the use of the vaccine.
Big Pharmas all have a dedicated website for each drug they produce. This is where they put out their fact sheet -- how to use the drug, the ingredients, warnings, etc. Here's the curious case of Comirnaty. Pfizer put up Comirnaty.com when it was approved by FDA. In an earlier blog I mentioned the Corminaty website did not recommend use of the approved label for age 15 and below. They don't want the liability, just as for pregnant women. That website has been totally revamped and it is now basically carrying statements of the CDC or FDA regarding their product. Hands washed off all liabilities, that's what it's all about.
Fudging data and nuanced presentation of statistics:
Trust of information from positions of power and governance is now a big issue. We have seen how NIH, CDC, FDA, Doctors Fauci and Francis Collins, who has now stepped down from NIH, practically lied, concealed, and fabricated information relating to the vaccine and the virus. We have seen how a Lancet report was contrived to support Fauci in his appearance at the Senate inquiry where he lied under oath that the virus was zoonotic. This CDC-supported Shimabukuro et al report now appears to be a similar sham show.
Facebook commenter Goh Meng Seng is a statistician, I am not. My only claim to this crazy numbers world is a statistics paper I sat in my younger days and which I had to resit 3 times because it bored me to sleep at the study table. On Facebook chats, both GMS and myself have consistently warned of how data can be easily misinterpreted, due to bias selection or not taking into account critical context. It could be innocent mistakes, or intentionally nuanced to suit a particular narrative.
I have written to the 7 co-authors of the "Covid-19 vaccination for pregnant women, breastfeeding women and women planning to conceive" for their comments on the Broch and Thornley report but have not yet received any response.
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Thank you for your continued vigilance and keeping us informed.
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