Covid Vaccines in Pregnancy
The current geological age is anthropocene, meaning human activity is dominant in shaping the climate and environment. The future historians might refer to this post pandemic era as vaccinnocene, though. We are witnessing a time when every genuine concern for medical science and humanity is being pushed into the vortex of vaccine orthodoxy.
Why should we vaccinate the majority of world population to prevent a disease that has nearly 98% natural recovery rate? Why should we terrify people with number theatrics when the infection fatality rate is just 0.23% [1] which is comparable to other respiratory viral diseases? Why do we need to move heaven and earth to eradicate a disease that has negligible and inconsequential fatality compared to its predecessors like SARS (10%) and MERS (30%) [1A]?
Prof. John Ioannidis, the most brilliant epidemiological scientist of our time took a jibe at this unscientific idea in one of his latest lectures, “ I love zero covid just as I love zero cancer, zero tuberculosis, but can we achieve this?, will our efforts reduce or increase the death and disease burden? ”. Many experts around the world echoed Prof. Iaonnidis and asked a legitimate question, is this idea not a reckless one? The MIT scientist Dr. Stephanie Seneff has cautioned that the vaccines based on novel mRNA technology is being heavily promoted with its long term effects remaining largely unknown. She argued in her research paper [2] that there will be an increase in auto immune and neurodegenerative diseases which may take 10 to 15 years to manifest themselves. Prof. Ioannidis and Prof. Seneff have been talking science. But science loses its relevance when it does not fit into the agenda of maximizing profit. Science gets replaced by speculations and prophecies. Before the Covid 19 broke out, the billionaire prophet predicted that 30 million people would die from it, and now he wanted 7 billion people around the world to be vaccinated against Covid 19. His whims and fancies matter a lot in shaping our lives and our future too. He is believed to be the emperor of vaccine market across the world. The advocacy and policy arm of Bill and Melinda Gates Foundation in collaboration with world economic forum (WEF) has raised most concerted and strident voice in favour of mass vaccination against Covid 19.
WEF has no qualms about saying, “Public health officials could use advertising theory to achieve herd immunity to COVID 19”. In their latest statement titled “3 tactics to overcome vaccine hesitancy” [3] they estimated 60-70% of world population needs to be vaccinated and this makes overcoming vaccine hesitancy is the greatest marketing challenge of our life time.”
Unlike the celebrity vaccine exponents of our country and abroad, WEF appears more candid in saying that they are “ moving from a supply problem to a demand problem.” They also prescribed marketing solutions to do away with the vaccine hesitancy by incentives and coercion under the guise of persuasion. It is understandable even to a common man that hesitancy to a poorly tested gene based technology which is used in humans for the first time is quite natural and legitimate. Any restrictions, reservations, exclusions or even cautions mentioned in the fact-sheets of the covid vaccines narrow down the demand side and hence marketing strategists need to get rid of them. But erasing the disclaimer and precautions will be a difficult job for the drug regulators like Food and Drug Administration (FDA), European Medicines Agency (EMA), and their Indian counterpart Central Drugs Standard Control Organisation (CDSCO). Naturally, the burden was shifted to the Ministry of Health who wield more sweeping power with less accountability to move things at faster pace. This is exactly what happened in speeding up the approval of Covid vaccines for pregnant and lactating mothers in India. Faster approval was hailed by the media as the symbol of efficiency and responsibility, not the epitome of recklessness and disregard for long term adverse effects. Moreover, many uncomfortable truths could be swept away in the heat and dust of fast-tracking.
“It was insanely fast”, observed a professor of medical ethics in view of by-passing of animal trials in the development of covid vaccines. She was quoted in an article, “Researchers rush to test coronavirus vaccine in people without knowing how well it works in animals”[4], which was published in both STAT and the Scientific American. FDA swung into action by giving emergency use authorization to Pfizer and Moderna Vaccines. EMA gave limited commercial marketing license to Astra Zeneca Vaccine. Our very own CDSCO approved Covishield (the Indian version of Astra Zeneca vaccine) and Covaxin for emergency and restricted use on 3 Jan, 2021. There was no clarification on what is meant by “restricted”. The company fact- sheets suggested that it referred to the prioritized group. Strangely, the elderly population above 60 was included with front line workers, though EMA clearly announced that only people of age between 18 and 55 were included in the over-seas trial of Astra Zeneca Vaccine.
The pregnant and lactating women were excluded from vaccination due to lack of trial data.
The original Covishield fact-sheet published by Serum Institute of India said, “Preliminary animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo-fetal development, parturition or postnatal development; definitive animal studies have not been completed yet. The full relevance of animal studies to human risk with vaccines for COVID-19 remains to be established.” [5]
“It is unknown whether COVISHIELD is excreted in human milk.” [5]
Purportedly to inform the public, CDSCO posted a copy of this fact-sheet on their website which appears to be somewhat redacted and revised version of the earlier one. On the issue of pregnancy and lactation, it just instructed the recipient to consult the health care provider. [5A] But, whom will the health care provider consult? A grey area was deliberately left unanswered. The Covaxin fact-sheet was amply clear on this issue. They said, “you should not take Bharat Biotech Covaxin if you are pregnant or breast feeding” [6]
On 19 May, 2021, the Union Ministry of Health recommended [7] the covid vaccines for all lactating women on the basis of their discussion with NEGVAC, the euphemism for National Expert Group on Vaccine Administration. NEGVAC had made their recommendations “based on evolving situation and emerging global scientific evidence & experience.” The purported evidence was understood by the wise men of union health ministry. Therefore the role of CDSCO became redundant. Taking public into confidence was no longer needed because media has perfected the art of making hype and manipulating public perception. Since the early week of March 2021, most of the leading dailies, both national and regional almost in unison began publishing information on the new studies that claimed to have busted the fear of vaccine induced placental damage.
This was in spite of the fact that there is no definitive data with the government concerning safety of Covid vaccines in pregnancy.[8] Anecdotal reports of severe complications in pregnant women with positive Covid 19 are common and needs further investigation. The media was rife with dubious claim of some doctors including celebrity gynecologist and obstetricians that the vaccine will save many lives of pregnant women. No real life study was there to back the claim.
On 8 June, 2021, we came to know from the press release[9] posted by Press Information Bureau (PIB) on behalf of MoHFW, that “vaccination should not be given to pregnant women. The reason for this is that a decision recommending vaccination to pregnant women could not be taken by doctors and the scientific community based on available data from vaccine trials. However, the Government of India will clarify this situation in a few days, based on new scientific inputs”, said Dr. V.K.Paul (NITIAyog). Dr. Guleria, Director AIIMS, New Delhi, said, “Data regarding COVAXIN and COVISHIELD will also come soon; some data is already available, and we hope that in a few days, we hope to get the full required data and grant approval for vaccinating pregnant women in India too.”
Data however, are still elusive in public domain. Within 3 weeks, the “No” response has been replaced by emphatic “Yes”. CDSCO approved restrictive use but restrictions have been merrily lifted by MoHMW. The regulator’s place was usurped by administrators of MoHFW. Decision on a medical intervention was conveniently transformed into a mere administrative one. Nevertheless, the members of MoHFW were wise enough to hold an engaging discussion with national experts to brush up their knowledge on current scientific inputs. On 2 July, 2021, the press release[10] of MoHFW that claimed to have empowered pregnant women by including them in vaccination spree, said -
“The National Technical Advisory Group on Immunization (NTAGI) has recommended vaccination for pregnant women. The National Expert Group on Vaccine Administration for COVID-19(NEGVAC) too has unanimously recommended it. Further, a national level Consultation on COVID-19 vaccination for pregnant women was also convened by the Union Ministry of Health and Family Welfare to build consensus on COVID Vaccination of pregnant women. The consultation unanimously welcomed the recommendation of NTAGI to vaccinate pregnant women. The consultation included professional bodies like FOGSI, representatives of State Governments, CSOs, NGOs, Development Partner agencies, technical experts etc.”
Therefore, the MoHFW was able to reach consensus through consultation plus recommendation and thus obviated the need of promised trial data.
Backed by marketing solution for overcoming vaccine hesitancy, the theatre of absurd has nicely been staged. However, the question of credible scientific inputs begs some plausible answers. Predictably, the media jumped into the fray by chanting the cliché, “benefits far outweigh the risks”.[11] They also churned out a host of study results which were neither new nor had anything to do with safety data of vaccines in pregnancy.
One such study [12] was published by American Journal of Obsterics & Gyenaecology. Period of publication was said to be unspecified month of 2021. Out of total 131 participants, 84 were vaccinated pregnant and 16 were vaccinated non pregnant. It concluded that mRNA vaccines generated robust immunity in pregnant compared to nonpregnant. The study was designed to show the evidence of identical immunogenicity and reactogenecity among pregnant and nonpregnant women. No attempt was made to record the adverse effects of mRNA vaccines and the spike proteins in pregnancy and rule out teratogenic effects of the constituents of vaccines.
An old CDC report[13] published on Nov 2, 2020 frequently mentioned by them suggested that women might be at increased risk of severe illness due to covid 19. It was an observational study with data collected from NNDSS, a govt-run data source. It did not try to answer the question whether vaccination alters the outcome.
Another frequently cited study report[14] was published by JAMA (Paediatrics). It was also an old study dated March, 2020 with cohorts of 706 pregnant and 1424 non pregnant women. The study was supported by Covid 19 Research Response Fund from Oxford University, the birth place of Astra Zeneca Vaccine. Predictably they advocated what the marketing strategists would love to hear.
The most devastating fiasco was committed by the authors of the study “Preliminary Findings of mRNA Covid19 vaccine Safety in Pregnant Persons”[15] published in April 21, 2021 issue of New England Journal of Medicine. They concluded that “Preliminary findings did not show obvious safety signals among pregnant women who received mRNA Covid vaccines”. Their fabricated claims fell flat on the face of their own findings which include “among 3958 participants enrolled, 827 had a completed pregnancy, of which 115 (13.9%) resulted in pregnancy loss (miscarriage) (mostly when given in third trimester), adverse neonatal outcomes included preterm birth (9.4%), small size for gestational age (3.2%)”. They also admitted, “among 221 pregnancy-related adverse events reported to the VEARS, the most frequently reported event was spontaneous abortion (46 cases).”
As of May 22, 2021, there are a total of 283 adverse reports in VAERS [16] where the symptoms is either spontaneous abortion or fetal death. Of these 9.54% are attributed to Janssen, 36.75 % to Moderna, and 53.71% to Pfizer vaccines. Nearly 30% of these adverse events took place within 0-2 days after vaccination. The actual scale of the damage caused by Covid vaccines in pregnant woman would be much more appalling, if we consider the fact that only 1% of total adverse events are recorded in VAERS.
The secret Japanese Pfizer document (translated into English) is alleged to have admitted that animal study confirmed the presence of spike proteins in circulation and evidence of getting them deposited in vital organs. There is a constituent in Covishield Vaccine named L-Histidine Hydrochloride Monohydrate which is widely known as a nanoparticle. Some research papers mentioned that this chemical compound being attached to nucleic acid can bind with DNA of the host cell. In genetic technology this function is known as transfection. To rule out mutagenicity and genetic contamination the likelihood of transfection should have been studied, but till date no such study result is available to us.
Sometimes data are scary. Sometimes they are alarming and eloquent. Here the VAERS data and findings of NEJM speak volumes in favour of warnings made by Dr. Peter McCullough, the highly cited professor of Medicine. He said, ““These vaccines are directly killing babies in the first trimester and it is absolutely atrocious, horrible. No woman should ever take the risk with the Covid-19 vaccine during pregnancy period.”
Many accomplished and highly respected practioners of gynaecology and obstetrics, many of whom have outstanding track records in their field, are accepting the recommendation of Covid vaccines in pregnancy uncritically without raising pertinent questions. It will be the darkest time in practice of modern medicine if the physicians conveniently forget the first principle, Primum non nocere (first, do no harm). It will be tantamount to endorsing an unpardonable misadventure.
SOURCES :
[1] Infection fatality rate of COVID 19 inferred fromsero-prevalence data, John P A Ioannidis, Bulletin of WHO, 2020
https://www.who.int › BLT.20.265892.pdf
Note: Best estimate of prof. Ioannidis is global IFR 0.15% and for Asia/Africa 0.05 to 0.1%
COVID- 19: An overview of systematic evaluations. Eur J Clin Invest. 2021;51:e13554. European Journal of Clinical Investigation, https://doi.org/10.1111/eci.13554
[1A] Sucharit Bhakdi, Corona False Alarm ? Facts & Figures , pages 8,9,70
[2] Worse than the disease? Reviewing some possible Unintended Consequences of the mRNA vaccines against COVID 19, Stephanie Seneff & Greg Nigh
[3] Tactics to overcome COVID-19 vaccine hesitancy, 28 June, 2021, WEF
https://www.weforum.org/agenda/2021/06/3-tactics-to-overcome-covid-19-vaccine-hesitancy/
[4] https://www.statnews.com/2020/03/11/researchers-rush-to-start-moderna-coronavirus-vaccine-trial-without-usual-animal-testing/
[5] COVISHIELD FAQs - Serum Institute Of India.https://www.seruminstitute.com › health_faq_covishield
[5A] https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/en/Factsheetof-ChAdSerum.pdf
[6] Covaxin Fact sheet
[7] New Recommendations of NEGVAC accepted by Union Ministry of Health, https://pib.gov.in/PressReleasePage.aspx?PRID=1719925
[8] Why pregnant women in India still are not eligible for COVID-19vaccines, National Geographic, 23 June 2021 https://www.nationalgeographic.com/science/article/why-pregnant-women-in-india-still-are-not-eligible-for-covid-19-vaccines
[9] Can pregnant women take Covid 19 vaccine? FAQ https://pib.gov.in/PressReleasePage.aspx?PRID=1725244
[10] Pregnant Women now eligible for COVID-19Vaccination, MoHFW https://pib.gov.in/PressReleasePage.aspx?PRID=1732312
[11] Covid-19 vaccine and pregnancy: Expectant mothers now eligible for the jab, Indian Express , July2, 2021 https://indianexpress.com/article/lifestyle/health/covid-vaccine-pregnant-women-guidelines-7377125/
[12] Coronavirus disease 2019 vaccine response in pregnant and lactating women: a cohort study, MONTH 2021 American Journal of Obstetrics & Gynecology
https://www.ajog.org › article › fulltext
[13] Update: Characteristics of Symptomatic Women of Reproductive Age with Laboratory-Confirmed SARS-CoV-2 Infection by Pregnancy Status — United States, January 22–October 3, 2020, MMWR / November 6, 2020 / Vol. 69 / No. 44 https://www.cdc.gov › 69 › pdfs › mm6944e3-H
[14] Maternal and Neonatal Morbidity and Mortality Among PregnantWomen With and Without COVID-19 Infection The INTERCOVID Multinational Cohort Study, JAMA Pediatr. doi:10.1001/jamapediatrics.2021.1050
[15] Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons, April21,2021, NEJM https://www.nejm.org/doi/full/10.1056/NEJMoa2104983
[16] VAERS Report Regarding Spontaneous Abortion & Fetal Death, https://needtoknow.news/2021/05/covid-vaccine-animal-trials-reveal-threat-to-life-in-the-womb/
