Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

COVID-19 Vaccines: The Impact on Pregnancy Outcomes and Menstrual Function

Version 1 : Received: 24 September 2022 / Approved: 28 September 2022 / Online: 28 September 2022 (03:50:35 CEST)
Version 2 : Received: 30 December 2022 / Approved: 30 December 2022 / Online: 30 December 2022 (09:39:28 CET)

How to cite: Thorp, J.A.; Rogers, C.; Deskevich, M.P.; Tankersley, S.; Benavides, A.; Redshaw, M.D.; McCullough, P.A. COVID-19 Vaccines: The Impact on Pregnancy Outcomes and Menstrual Function. Preprints.org 2022, 2022090430. https://doi.org/10.20944/preprints202209.0430.v1. Thorp, J.A.; Rogers, C.; Deskevich, M.P.; Tankersley, S.; Benavides, A.; Redshaw, M.D.; McCullough, P.A. COVID-19 Vaccines: The Impact on Pregnancy Outcomes and Menstrual Function. Preprints.org 2022, 2022090430. https://doi.org/10.20944/preprints202209.0430.v1.

Abstract

Objectives: Assess rates of adverse events (AE) after COVID-19 vaccines experienced by women of reproductive age, focusing on pregnancy and menstruation, using data collected by the US Centers for Disease Control and Prevention (CDC) Vaccine Adverse Events Reporting System (VAERS) database. Design: Population based retrospective cohort study. Setting: US and global entries in US Centers for Disease Control and Prevention (CDC) Vaccine Adverse Events Reporting System (VAERS). Participants CDC VAERS entries from January 1, 1998 to June 30, 2022. Interventions: None. Main Outcome and Measures: A proportional reporting ratio analysis is performed using data in the VAERS system comparing adverse events (AE) reported post COVID-19 vaccines with that of post-Influenza vaccines. Results: COVID-19 vaccines, when compared to the Influenza vaccines are associated with a significant increase in AE with all proportional reporting ratios of > 2.0: menstrual abnormality, miscarriage, fetal chromosomal abnormalities, fetal malformation, fetal cystic hygroma, fetal cardiac disorders, fetal arrhythmia, fetal cardiac arrest, fetal vascular mal-perfusion, fetal growth abnormalities, fetal abnormal surveillance, fetal placental thrombosis, low amniotic fluid, and fetal death/stillbirth (all p values were much smaller than 0.05). When normalized by time-available, doses-given, or persons-received, all COVID-19 vaccine AE far exceed the safety signal on all recognized thresholds. Conclusions: Pregnancy and menstrual abnormalities are significantly more frequent following COVID-19 vaccinations than that of Influenza vaccinations. A worldwide moratorium on the use of COVID-19 vaccines in pregnancy is advised until randomized prospective trials document safety in pregnancy and long-term follow-up in offspring.

Keywords

COVID-19 vaccines; menstruation; pregnancy outcomes; Influenza vaccines; VAERS

Subject

Medicine and Pharmacology, Obstetrics and Gynaecology

Comments (5)

Comment 1
Received: 18 January 2023
Commenter: Rachel Gail White
The commenter has declared there is no conflict of interests.
Comment: I’m curious as to why there are no comments displayed, especially since there are so many views and downloads.
Additionally, why is the population of pregnancies in non-covid-vaccinated women of reproductive age, (throughout the same time period as those vaccinated) left out of this study?
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Response 1 to Comment 1
Received: 24 February 2023
Commenter: Kelly Hansen
The commenter has declared there is no conflict of interests.
Comment: Because it analyzed reported data from the system that system that collects reports on adverse events on vaccinations. The data of the same issues for non jabbed women is not collected nor collated.
Comment 2
Received: 27 February 2023
Commenter:
The commenter has declared there is no conflict of interests.
Comment: As the authors acknowledge in the limitations section, their conclusions absolutely rely upon: 1. Their estimates of the number of doses given; 2. The assumption that the reporting rate to VAERS is the same for flu vaccination between 1998 and 2022 and COVID vaccination between 2020 and 2022. They conclude that the miscarriage rate for COVID vaccination is 57x that for flu vaccination, in which case every pregnancy miscarries approximately 8 times – clearly impossible [1]. This strongly suggests that the author’s modelling assumptions are not reasonable.

The most likely assumption to have been violated is that the reporting rate for the two vaccines is the same. Before 2003, it was only possible to report to VAERS by mail or fax, with online reporting introduced in 2013 [2]. The change in the ease of reporting is likely to mean that the reporting rate is greater for more-recently developed vaccines – in this case, COVID vaccines. It is also important to note that reporting rates decline over time, so the reporting rate is likely to be higher for the newer vaccine – again COVID vaccines [3].

Peer-reviewed analyses of this same dataset have found no signals suggesting an increased risk of pregnancy complications associated with COVID vaccination [4-6], and this is in line with findings from studies in which vaccinated cohorts are actively tracked to assess pregnancy outcomes [7].

References
1. Quenby, 2021, The Lancet. DOI: 10.1016/S0140-6736(21)00682-6
2. Shimabukuro, 2015, Vaccine. DOI: 10.1016/j.vaccine.2015.07.035
3. Stokley, 2013, MMWR. https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6229a4.htm
4. Shimabukuro, 2021, NEJM. DOI: 10.1056/NEJMoa2104983
5. Moro, 2022, Vaccine. DOI: 10.1016/j.vaccine.2022.04.031
6. Moro, 2022, Obstet Gynecol. DOI: 10.1097/AOG.0000000000004889
7. Prasad, 2022, Nat Comms. DOI: 10.1038/s41467-022-30052-w
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Response 1 to Comment 2
Received: 2 March 2023
Commenter: Faith Arnold
The commenter has declared there is no conflict of interests.
Comment: What "studies in which vaccinated cohorts are actively tracked to assess pregnancy outcomes"? A search for that citation returned no results. It has alreadt been well establushed, including from the FOI-released internal documents that massive fraud was committed during the drug trials for the COVID shots. Participants experiencing adverse events were dropped and/or their symptoms lied about to make the drugs appear safer than they actually are. AND all pregnant women and women of childbearing age likely to get pregnant were excluded from the trials, so there was no assesment whatsoever of safety to pregnant mothers or their fetuses!
Response 2 to Comment 2
Received: 3 March 2023
Commenter:
The commenter has declared there is no conflict of interests.
Comment: The meta-analysis referred to in footnote [7] is available at the stated DOI, but has serious problems that may possibly invalidate the findings referred to. Issues were raised on PubPeer in June of 2021, including that data from a study, correctly interpreted, indicated a spontaneous abortion incidence of 82% (104 of 127). Corrections were published in October of 2021, but the 82% was not directly challenged. Instead I find some unexplained corrections to Table 4, such as replacing “104/827 (12.6)" with “104”, (To me, the former makes sense, while the latter does not.) The authors implicitly retracted their own spontaneous abortion incidence and add the comment:

  • “No denominator was available to calculate a risk estimate for spontaneous abortions, because at the time of this report, follow-up through 20 weeks was not yet available for 905 of the 1224 participants vaccinated within 30 days before the first day of the last menstrual period or in the first trimester. Furthermore, any risk estimate would need to account for gestational week–specific risk of spontaneous abortion.”



  • Regarding:

  • "[T]here was no [assessment] whatsoever of safety to pregnant mothers or their fetuses!"

  • It's worse than that. The Pfizer/BioNTech vaccine was trialed in pregnant women starting in February 2021, and the RCT was completed on July 15, 2022, but there have been NO RESULTS reported.
    The study record was updated nineteen times:clinicaltrials.gov/ct2/history/NCT04754594.
    But all updating ceased after the study was completed. No interim or final results. By contrast, interim results of the main BNT162b2 RCT were put out by press release years BEFORE the trial was complete.

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