Adverse Events Rise in Babies Breastfed by Vaccinated Mothers
Adverse Events Rise in Babies Breastfed by Vaccinated Mothers
MRNA VACCINES, PREGNANCY AND LACTATION:
Is COVID-19 vaccination safe for pregnancy and breast feeding?
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Pfizer Documents Research Volunteers – Team 3
PART 1: BREAST FEEDING AND COVID VACCINATION
In pregnancy and breast-feeding, any substance is guilty until proven innocent. The COVID-19 vaccines are declared safe for pregnancy and breast-feeding by authorities in their field, such as the ABM ( (Academy of Breast Feeding Medicine., 2021). Is this recommendation based on science or fantasy? Is the COVID-19 vaccine safe for pregnancy and breast-feeding? I do not know the answers to these questions. We look to “The Science” to find out. And we find that the authorities in medicine and medical sciences don’t know the answers because no one has done the evaluation. But those who adhere to the known science have a strong foundation to question safety because “Before a product is declared safe for breast feeding or pregnancy, the answer be known”. The great tragedy of thalidomide in the 1950’s and disaster of widespread smallpox vaccination during an epidemic in the late 1870’s taught us the bitter lesson.
Our journey to understand the safety or lack of safety will be based on the strict science. We will begin with what is known. If some cases, we will need to bring in some foundational information. If a recommendation by an authority is based on opinion and not science, this will be pointed out. If the recommendation goes contrary to the known science, that will be pointed out.
Before we start, we need to emphasize that there are 3 vaccines on the market in the US. Two of them are mRNA vaccines (made by Pfizer/Biontech and Moderna, respectively) and one is adenovirus vaccine (made by JNJ but now pulled from the market).
When we talk about a COVID-19 vaccine being safe for breastfeeding or pregnancy, it is not clear that one size fits all and we should not lump all COVID-19 vaccines together. Nor can we look as pregnancy and breast-feeding as a single entity and assume if on is safe or harmful for one it is the same for the other. That said, we will lump the mRNA vaccines together to an extent as they are similarly constructed and look at the adverse effects from their individual components and if the adverse reaction is due to the spike protein.
The mRNA vaccine is a composite product consisting of an mRNA core wrapped in a lipid blanket. Lipid is the scientific term for fat.
The core of vaccine is the mRNA which will code for the spike protein. The core is surrounded by 3 layers of lipid to facilitate entry into cells. The first layer is the lipid nanoparticle. The second layer is PEG. PEG is polyethylene glycol. PEG is similar to anti-freeze and there are many different types of PEGs. The vaccines use ALC 0159. A third lipid is added called an emulsifier along with cholesterol. The vaccine is unstable at room temperature requiring it to be kept at very cold temperatures. Wrapping the mRNA core in these lipid layers allows it to merge with cells. The lipid nanoparticle penetrates the blood brain barrier (Christensen, 2014), the placental barrier (Huang et al., 2015), (Wick, 2010), fatty breast tissue (Golan Y. e., 2021) and breast milk. The lipid nanoparticle, even without the mRNA component, is highly inflammatory. (Ndeupin, 2021). The mRNA vaccine induces a potent immunological response in the breast and in the breast milk. (Narayanaswamy et al., 2022)
Before we delve into the adverse reactions and the actual science as to why these occur, it behooves us to examine the misleading advice given by prominent medical societies.
The Academy of Breastfeeding Medicine. ABA M Statement tells us that the vaccine is made of lipid nanoparticles that contain mRNA (which will code) for the SARS-CoV-2 spike protein (once it is in the cells). (Parenthesis added for clarification). These particles are injected into muscle. Here the nanoparticles are taken up by muscle cells. These muscle cells then transcribe the mRNA to produce spike protein. The spike protein made by the cell stimulates an immune response. (Academy of Breast Feeding Medicine., 2021). Note: All of these statements are true but are not relevant as to the safety of the vaccine for breast-feeding.
According to the ABM, during lactation it is unlikely that the vaccine lipid would enter the blood stream and reach breast tissue. (Note: This is speculation unsupported by experimental evidence. It is irresponsible for an authority figure to make such a speculation in the absence of evidence. Additional evidence showed this statement to be false). If it does, it is even less likely that either the intact nanoparticle or mRNA transfer into milk. (Note: This is speculation proved to be false). In the unlikely event that mRNA is present in milk, it would be expected to be digested by the child and would be unlikely to have any biological effects. (Note: This is speculation and given the asymmetrical risk of being wrong, it is not worthy of any who has had training in medicine, who first oath is to do no harm. It is a question of the utmost importance. Preliminary evidence indicates that this is a false statement, and the immunological effects are profound (Narayanaswamy et al., 2022)).
Compare the above statements to the actual experimental evidence. In every case the speculation is proved wrong by experimental evidence. Experimental evidence is the foundation of the science that we are to follow.
While there is little plausible risk for the breast-fed infant (Note: the lack of plausible risk is speculation), there is a biologically plausible benefit. Antibodies and T-cells stimulated by the vaccine may passively transfer into milk. (Note: This is a true statement). Following vaccination against other viruses, IgA antibodies are detectable in milk within 5 to 7 days. (Note: This is a true statement but there is speculation that antibodies produced by vaccination are equivalent to IgA antibodies of natural infection. It is assumed that passive transfer of activated T cells is a good thing. This is spectacularly wrong). Antibodies transferred into milk may therefore protect the infant from infection with SARS-CoV-2. Although the biology is reassuring, for definitive information, we will have to wait for data on outcomes once the vaccine is used in lactating individuals and their children. (Note: this is the only valid statement).
It is essential to note that the ABM assumes, without evidence, that the vaccine and transfer of antibodies and other inflammatory cytokines are beneficial to the breast feeding infant and fails to consider the question as to whether they are harmful. They are only concerned with ability to protect from SARSCOV-2. This tunnel vision is reprehensible as SARSCOV-2 offers little harms to the infant, but initiation of an inflammatory response may prove fatal as explained below.
The ABM does not stand alone. The American College of Obstetrics and Gynecology and The Society for Maternal Fetal Medicine have recommended that these mRNA vaccines be made available for lactating women, despite acknowledging that initial trials excluded breastfeeding women and no assessment could be made concerning their safety. (Bertand, 2021-04-25). The World Health Organization recommends that breastfeeding individuals be vaccinated and does not advise cessation of breastfeeding following vaccine administration. (Golan Y. e., 2021). The Academy of Breastfeeding Medicine states that there is little plausible risk that vaccine nanoparticles or mRNA would enter breast tissue or be transferred to milk. (Golan Y. e., 2021). The ABM notes that if the mRNA vaccine entered the breast milk there is a theoretical possibility of priming the infant immune system. (Golan Y. e., 2021).
Let’s compare this to the actual science: the mRNA does enter the breast, does initiate an immune response (Narayanaswamy et al., 2022) and Is highly inflammatory. (Ndeupin, 2021)
As the original trials did not look at breast feeding, two studies at breast-feeding were done. One evaluated breast-fed children for a 4 to 48 hr. period following vaccination. (Golan Y. e., 2021). The second found approximately 10% of breast-fed children had adverse events, the events were worse after the second dose and with Moderna but concluded that the adverse events were not serious (Bertand, 2021-04-25). Little comfort can be drawn from these studies as the studies are small, underpowered, non-randomized and not blinded. One of the studies used self-reporting. We have been lectured ad nauseum by Dr. Anthony Fauci that only randomized, controlled, double blind studies count.
Underpowered studies mean that is not enough data to draw valid conclusions. Not only is the conclusion not valid, it is often opposite of the true effect.
Any study that examines the safety of breast-feeding following vaccination needs to evaluate the recipient infant. The breast-feeding infant is taking the breast milk by mouth and so the GI tract is the target organ. This means that studies looking at adverse vaccination events from intra-muscular injections cannot be used. A better model is from natural infection. In natural infection, the virus infects the upper respiratory tract and then is swallowed into the GI tract where it initiates a systemic, IgG based immunological response. A newborn infant and up to about 6 months has an immature immune system. The key question is how the immature immune system of the breast-feeding infant reacts the inflammatory cytokines and chemokines found in breast milk. We don’t know the answer as it was not evaluated. But we do know this. The breast immune response produces potent chemicals called chemokines and cytokines that have profound immunological effect. One that is of particular concern is interferon gamma and the very high levels of interferon gamma that are produced. (Narayanaswamy et al., 2022) These are transferred to the infant in the breast milk. High dose interferon gamma is a liver toxin. The other cytokines may change the infant’s immune response from Th2 mediated, that leads to antibody protection, to Th1 response that increases interferon gamma even more.
The mRNA vaccine induces the mother’s cells to produce spike protein. This protein is cleaved with the S1 subunit discarded into the circulation. This S1 component of the vaccine lasts for weeks and produces far higher S1 protein subunits than natural infection. (Röltgen et al., 2022) This means that which each breast-feeding, the amount of spike protein and S1 sub-unit protein is building in the infant’s gastrointestinal tract. Even if the first exposure is miniscule, continued feeding increases the dose. The level of spike and S1 protein is likely builds over time in the infants GI tract and may be find entrance into circulation.
The lipid nanoparticle, without the mRNA payload, is highly inflammatory by itself. (Ndeupin, 2021). The lipid nanoparticle can cross the placenta and induce trophoblast to undergo apoptosis (programmed cellular death of a damaged cell). (Huang et al., 2015)
The other component of the mRNA vaccine is PEG. Assessment of likelihood of adverse reaction needs to evaluate whether PEG or PEG antibodies are transferred from mother to the infant and results in sensitization and potential of initiating a severe allergic adverse reaction.
PEG Allergy and the Vaccine
One of major components of the mRNA vaccine is PEG. PEG is polyethylene glycol. It comes in many variants and each variant has its own chemical properties. The PEG used for mRNA vaccine is known by the chemical identifier ALC 0159. It is used in many medications, cosmetics, and food products. The widespread use of PEG has sensitized many in the population to PEG and this sensitization is often unknown or unsuspected. (Hypersensitivity to Polyethylene Glycols & Polysorbates – Physician’s Weekly, n.d.)
The seriousness of the allergic response is not only dependent on the dose of the PEG but also whether the immune system is primed to react towards PEG. The amount of PEG in a vaccine is qualitatively minute, bordering on undetectable (Golan Y. e., 2021) but the amount of PEG present can induce anaphylaxis or a serious allergic response. ( (Golan Y. e., 2021). (Sellaturay, 2021) , (Hypersensitivity to Polyethylene Glycols & Polysorbates – Physician’s Weekly, n.d.) Many normal individuals also have pre-existing antibodies against PEG in their circulation and are primed to react against PEG. (Chen, 2021). When a mother is immunized her breast milk carries many cytokines and chemokines. (Narayanaswamy et al., 2022) These chemokines and cytokines are the same chemicals that are released in an anaphylactic reaction to PEG. (Janeway, 2001)
The gut reaction to PEG is different than the intradermal or skin reaction. The amount of PEG in breast milk is negligible (Golan Y. e., 2021) and below detection ( (Golan et al., 2021)) but still present. If the mother has been sensitized and passes on this sensitization in her breast milk to the infant, even if she is not showing signs of sensitization, then the immature immune system of the infant may be triggered and undergo a reaction even to a minute amount of PEG.
In a separate issue, the breast-feeding infant may initiate an immune response independent of PEG. This is dependent on the amount of interferon gamma that the mother is passing to the breast-feeding infant. The mother is also passing the S1 subunit of the spike protein. The S1 subunit is produced in abundance by the vaccinated mother, and it is likely that this excess is distributes into the breast milk. In the presence of excessive interferon and S1 subfraction, a non-specific hyperactivation of the cell immune response result. (University of Pittsburgh, 2022). (Brodin, 2022)
We are back at our beginning question: Is it safe to vaccinate a breast-feeding mother? The science raises many questions that precludes a blanket statement of safety. Wisdom paid for by the unmeasurable disasters of the past answers decisively: No, as the risk to the infant from COVID-19 is virtually zero, but the potential risk of adverse reactions from the vaccine are real and measurable.