Is Covid vaccination a health hazard for pregnant and breastfeeding mothers – and their babies?

July 7, 2021

The sole Covid-19 vaccine that has been in use in NZ since late February 2021 is the Pfizer/BioNTech mRNA vaccine known as “Comirnaty”.   

Below news releases on Pfizer’s website, under the heading “IMPORTANT SAFETY INFORMATION FROM U.S. FDA EMERGENCY USE AUTHORIZATION PRESCRIBING INFORMATION” the company provides information about some of the “adverse reactions” that affected people who participated in the clinical trials of the vaccine as well as some adverse effects reported after the vaccine began to be used in the general population.

Pfizer’s website makes the following statements in relation to the use of the vaccine during pregnancy and by breastfeeding mothers:

Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy”.  [1]

The likely reason for the inclusion of the above statement is that pregnant women were excluded from the major trial of the Pfizer-BioNTech COVID-19 vaccine (NCT04368728) [2] and while a trial of the vaccine in healthy pregnant women has since been initiated, it is not due for completion until June 27, 2022.  Pregnant women who participate in this clinical trial will be given the vaccine (or a saline solution as a placebo injection) when they are between 24 and 34 weeks pregnant. [3]

In relation to the use of the vaccine by breastfeeding mothers the Pfizer website states: 

Data are not available to assess the effects of Pfizer-BioNTech COVID-19 Vaccine on the breastfed infant or on milk production/excretion”. [1]

Despite the statement on Pfizer’s website that the data are “insufficient to inform vaccine-associated risks in pregnancy” the NZ Ministry of Health is promoting Covid vaccination for pregnant women “at any stage of … pregnancy”. [4] 

The NZ Ministry of Health is also promoting Covid vaccination to breastfeeding women even though the Pfizer’s website states: “(d)ata are not available to assess the effects [of the vaccine] on the breastfed infant or on milk production/excretion”. [1]

Promotion of a vaccine to pregnant and breastfeeding women by the Ministry of Health would not be a concern if there was compelling evidence that the vaccine is both safe and effective.  However the Pfizer-BioNTech Covid-19 vaccine uses mRNA technology that has never before been used in a mass vaccination campaign prior to the development of the Pfizer/BioNTech (and Moderna) Covid-19 vaccines and Pfizer admits data in relation to the Pfizer/BioNTech vaccine data about “vaccine-associated risks” during pregnancy is “insufficient”.

In the real world, where pregnant women have been injected with Covid vaccines at varying stages of pregnancy, there have been concerning reports of adverse events after these injections including cases of miscarriage and stillbirth, as discussed at the following link: https://therealnews.nz/2021/02/28/are-covid-10-vaccines-safe-for-pregnant-women/

Since this article was written, a new analysis of data from the United Sates “v-safe” Covid vaccination monitoring programme has shown a miscarriage rate of more than 80% when the vaccine is administered in the first half of pregnancy.

https://impf-info.de/pdfs/Coronoia/Shimabukuro_LE_MacLeod.pdf

Covid vaccination of breastfeeding mothers may cause adverse effects in their babies

In NZ, Comirnaty is being promoted to breastfeeding women. A page on the NZ Ministry of Health website (last updated June 4, 2021) states in relation to breastfeeding:

“If you’re breastfeeding … there are no safety concerns about getting the Pfizer vaccine (Comirnaty).” [4]  

This statement seems to be false.

A search of the United States Vaccine Adverse Events Reporting System (VAERS) website for adverse events following to Covid vaccination in children aged under 3 years yields a number of reports in relation to symptoms suffered by babies and toddlers after they have been breastfed by their vaccinated mothers.

Some of these reports are of babies exposed to the Pfizer/BioNTech mRNA Covid-19 vaccine via their mother’s breastmilk experiencing relatively mild symptoms that are of short duration such as a rash, fretfulness and fever.  (One baby’s rash was described as “Red rash comprised of small bumps and skin discoloration was observed 4 days after vaccine was administered, though infant does not appear to scratch or react to the rash.” – VAERS ID 1182232)

In one case (VAERS ID 921052) a mother was breastfeeding twins aged 14 months and after her Pfizer/BioNTech Covid-19 vaccination her baby girl developed symptoms (fever and “fussiness”) but her baby boy’s health was unchanged (“he was completely fine”).  The mother was advised to give her daughter paracetamol (acetaminophen) and did this.  The baby girl’s symptoms resolved by the next day. (This little girl had had also had a fever and rash following multiple vaccinations (“4 to 5 shots”) that were administered to her when she was 12 months old.   It was reported in the write up in this report that the mother had related that “her son doesn’t usually get vaccine reactions, her daughter does”.)  The twins’ mother did not experience any adverse reaction herself.

There are also some very concerning reports:

VAERS ID 1124474

“MOTHER OF 12 MONTH OLD BOY RECEIVED FIRST DOSE OF COVID 19 VACCINE AT 9:15 AM SHE BREASTFED HER 12 MONTH OLD SON 3 HOURS LATER AND WHILE BREASTFEEDING THE CHILD DEVELOPED ACUTE ANAPHYLAXIS. TO BE CLEAR: MOTHER HAD THE VACCINE AND THE CHILD HAD THE REACTION.”

Fortunately the other details provided with this case show that the child had “recovered”.  Acute anaphylaxis (a life threatening allergic reaction) can usually be treated successfully but it can occasionally be fatal even with prompt treatment.

VAERS ID 1313912

“I received the Pfizer COVID-19 vaccination, and experience injection site soreness. My nursing toddler (22 months old) experienced the following adverse side effects: loose stool (days 2-4 post vaccine), vomiting (72hrs post vaccine), 102 -103 degree fever for several days/nights (beginning 72hrs post vaccine), wet cough (beginning 24-48hrs post vaccine, and ongoing), extreme congestion (immediately after first nursing session post vaccine and ongoing), exhaustion (72hrs post vaccine and ongoing), sensitivity to lights/brightness (24hrs post vaccine and ongoing), and irritability (beginning 24hrs posts vaccine and ongoing).”

This baby had not recovered at the time the report was made on May 13, 2021.

In relation to the baby’s light sensitivity, the person (presumably a health professional) who made the report obviously suspects some sort of (hopefully temporary) adverse impact on the toddler’s brain as among the terms used to categorise the child’s symptoms are 

“Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad)” which relate to inflammation of the brain.

The VAERS system includes one report of a fatal outcome in a breastfeeding baby of a mother who had received the Pfizer-BioNTech mRNA Covid-19 vaccine:

The write up for this case (VAERS ID 1166062) is as follows:

“Patient received second dose of Pfizer vaccine on March 17, 2020 while at work. March 18, 2020 her 5 month old breastfed infant developed a rash and within 24 hours was inconsolable, refusing to eat, and developed a fever. Patient brought baby to local ER where assessments were performed, blood analysis revealed elevated liver enzymes. Infant was hospitalized but continued to decline and passed away. Diagnosis of TTP. No known allergies. No new exposures aside from the mother’s vaccination the previous day.”

The baby boy died on March 20, 2021.  His diagnosis “TTP” refers to a condition known as “Thrombotic Thrombocytopenic Purpura”. TTP is characterised by a tendency of the blood to form clots in small blood vessels in the body as well as problems with bleeding (due to a low platelet count, known as thrombocytopaenia). The “purpura” in the name of the illness refers to a purplish rash caused by bleeding beneath the skin.

Another condition known as TTS (thrombosis with thrombocytopaenia syndrome) that involves a dangerous combination of unusual blood clots plus bleeding due to a low platelet count has been linked to the Oxford-AstraZeneca and Janssen (Johnson & Johnson) Covid-19 vaccines. [5]   

Reports of Babies in NZ Becoming Ill After Breastfeeding From Recently Vaccinated Mothers

There have now been cases reported of adverse reactions in babies in NZ whose mothers had recently been vaccinated.

A small amount of information about these is available on Medsafe’ss 10th “safety report” on the use of Comirnaty in NZ.  The report includes the following sentences:  “There were also two reports of breastfed infants becoming unwell after their mother received the vaccine. One of the infants had an allergic reaction and the other infant had flu-like symptoms. Note that because these infants did not receive the vaccine, they are not included in the AEFI tables below.” See: https://www.medsafe.govt.nz/COVID-19/safety-report-10.asp

Concluding Thoughts

In light of recent research that has shown that the spike protein from the Moderna mRNA Covid-19 vaccine can be detected in the plasma of recently vaccinated people [6], it seems likely that the spike protein from the Pfizer/BioNTech vaccine makes its way into the bloodstream of vaccine recipients and thereafter into the milk of nursing mothers.

In addition to synthetic mRNA (known as “BNT162b2” which is designed to trick vaccine recipients’ bodies into producing the toxic spike protein from the SARS-CoV-2 virus) the Pfizer/BioNTech vaccine also contains novels lipids that have never before been used in other vaccines including a PEG-based lipid.  The polyethylene glycol (PEG) component of the Pfizer/BioNTech Covid vaccine is suspected to be the reason for the high rate of severe allergic reactions to the Pfizer/BioNTech vaccine compared to some other vaccines [7].

It should come as no surprise to anyone with medical training that substances injected into a muscle can end up in the bloodstream considering that some medications, such as penicillin, are administered as intramuscular injections for some conditions as the muscle acts as a “depot” for the medication and can release it slowly to provide a long-acting treatment from a single injection.

It seems sensible to assume when breastfeeding mothers are vaccinated with an mRNA vaccine, their babies are being indirectly vaccinated via their mothers’ breastmilk. In the case of a vaccine like Comirnaty, for which the major clinical trial of the vaccine in adults will not be completed until 2023 [1], promotion of this vaccine to breastfeeding mothers appears to be not only premature but foolhardy based on the potential for tragic outcomes, such as the death of the breastfeeding baby boy.

REFERENCES AND NOTES

[1] https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-receive-first-authorization-european

[2] https://clinicaltrials.gov/ct2/show/NCT04368728

[3] https://clinicaltrials.gov/ct2/show/NCT04754594

[4] https://www.health.govt.nz/our-work/diseases-and-conditions/covid-19-novel-coronavirus/covid-19-vaccines/covid-19-vaccine-advice-specific-groups-and-health-conditions#pregnant   (Since the above page was updated on June 4, Medsafe has published its 10th “safety report” on the use of Comirnaty in NZ.  The report includes the following sentences:  “There were also two reports of breastfed infants becoming unwell after their mother received the vaccine. One of the infants had an allergic reaction and the other infant had flu-like symptoms. Note that because these infants did not receive the vaccine, they are not included in the AEFI tables below.” https://www.medsafe.govt.nz/COVID-19/safety-report-10.asp )

NB:  The decision by the NZ Ministry of Health to promote the Pfizer/BioNtech mRNA Covid-19 vaccine to pregnant women regardless of the stage of pregnancy, meaning that some women might receive the vaccine in the first trimester of their pregnancies when their babies’ organs are still forming.  The decision to allow the use of the vaccine at this critical time in pregnancy seems particularly irresponsible given that, as part of the vaccine gaining provisional consent to be distributed in NZ, Medsafe asked Pfizer to supply information relating to the control of possible genotoxic contaminants that may be present in materials used to manufacture the lipids (known as ALC-0315 and ALC-0159) used in the vaccine formulation. The deadline for a response to these questions is July 2021. https://gazette.govt.nz/notice/id/2021-go338  

A document on a UK government website describes ALC-0315 and ALC-0159 as “novel” because have never before been used in a medicinal product in the UK prior to their use in the  Pfizer/BioNtech mRNA Covid-19 “Comirnaty”.  https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/944544/COVID-19_mRNA_Vaccine_BNT162b2__UKPAR___PFIZER_BIONTECH__15Dec2020.pdf  

[5]  https://mvec.mcri.edu.au/references/thrombosis-with-thrombocytopenia-syndrome/ Medsafe’s website does seem to have been updated on the topic of TTS since 27 April 2021.  On that date Medsafe (the business unit of the NZ Ministry of Health which is supposed to regulate pharmaceuticals for the benefit of the public) claimed to have “completed a review of the risk of rare cases of blood clots with bleeding [TTS] reported internationally with some COVID-19 vaccines” and declared that “there is no evidence of a risk of TTS with the Comirnaty (Pfizer/BioNTech) vaccine”. (A search of the VAERS online database for the similar condition TTP reveals other cases of people developing this condition after Covid vaccination.)

[6] https://voicesforfreedom.co.nz/new-study-shows-potential-for-serious-harm/

[7]  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7999280/ ; https://jamanetwork.com/journals/jama/fullarticle/2777417 and https://www.fox5ny.com/news/japan-sees-high-rates-of-anaphylaxis-with-pfizer-vaccine

End note:  It is possible to use the search tool developed by the National Vaccine Information Center at the link below to search the VAERS database for specific conditions of interest:   

https://medalerts.org/vaersdb/index.php