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

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

ABSTRACT

This population-based retrospective cohort study assesses 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 Vaccine Adverse Events Reporting System (VAERS) database from Jan 1, 1998, to Jun 30, 2022.

The proportional reporting ratio comparing AEs reported after COVID-19 vaccines with those reported after influenza vaccines is significantly increased (≥ 2.0) for COVID-19 vaccine for menstrual abnormality, miscarriage, fetal chromosomal abnormalities, fetal malformation, fetal cystic hygroma, fetal cardiac disorders, fetal cardiac arrest, fetal arrhythmias, fetal vascular malperfusion, fetal growth abnormalities, fetal abnormal surveillance, placental thrombosis, fetal death/stillbirth, low amniotic fluid, preeclampsia, premature delivery, preterm premature rupture of membrane, and premature baby death.

When normalized by time-available, doses-given, or number of persons vaccinated, all COVID-19 vaccine AEs far exceed the safety signal on all recognized thresholds. These results necessitate a worldwide moratorium on the use of COVID-19 vaccines in pregnancy.

Introduction

Historically, a vaccine is subjected to an average of 10-12 years in clinical trials before it is authorized to be administered to the general population. The response to the COVID-19 pandemic, organized under Operation Warp Speed, rolled out novel SARS-CoV-2 vaccines in record time. Under an Emergency Use Authorization (EUA), these vaccines were available to the public as early as 10 months after development. The sentiment at the onset of the pandemic was that early treatment strategies for COVID-19 were ineffective, and these novel vaccines were promoted as the sole solution to the pandemic.

The rapid rollout of the COVID-19 vaccines meant that long-term safety studies had not been conducted by the time the vaccines were made available to the general population. COVID-19 vaccines were immediately authorized for use in pregnant women, which is unprecedented in the history of medicine. The influenza vaccine underwent continuous development and testing for nearly 60 years before being authorized in 1997 for use during pregnancy. The rapid development of COVID-19 vaccines, very limited safety data, and subsequent clinical observations prompt urgent inquiry into the safety of the COVID-19 vaccines in pregnancy.

Methods

A retrospective analysis was conducted of the adverse event (AE) reports post-COVID-19 vaccines and post-influenza vaccines in the U.S. Centers for Disease Control and Prevention (CDC) Vaccine Adverse Events Reporting System (VAERS) database between Jan 1, 1998, and Jun 30, 2022. Influenza vaccines were chosen as the control group because the CDC first approved influenza vaccines for pregnant women in 1997. Reports in VAERS after Jan 1, 1998, would count AEs due to onlabel use of the vaccines. The study period ending on Jun 30, 2022, provides 282 months of data for the Influenza vaccine and 18 months of data for the COVID-19 vaccines.

AE Report Counts

Based on a high-volume obstetrical practice over 43 years, a board-certified obstetrician-gynecologist and maternalfetal medicine physician (JAT) chose AEs of interest from the VAERS database that are most relevant to fertility and reproductive physiology. A query of the VAERS database was made for each AE: menstrual abnormality, miscarriage (spontaneous abortion), fetal chromosomal abnormalities, fetal malformation, fetal cystic hygroma, fetal cardiac disorders, fetal cardiac arrest, fetal arrhythmia, fetal vascular malperfusion, fetal growth abnormalities, fetal abnormal surveillance, placental thrombosis, fetal death (stillbirth), low amniotic fluid, preeclampsia, preterm premature rupture of membranes (PPROM), premature delivery/baby (PTD), and premature baby death. AE reports were counted globally and within the U.S. for both the COVID-19 and the influenza vaccines. The global counts for these events, which include U.S. counts, are listed in Table 1. U.S. counts only are in Table 1 Supplement, available at https://jpands.org/vol28no1/thorpsupplement.pdf.

Doses Given

The AE report count data is normalized by doses of each vaccine administered during the study period. Using Our World in Data,1 we estimate that 12.07 billion doses of the COVID-19 vaccine were given globally. Using CDC data, we estimate that 66 billion doses of the influenza vaccine were given globally, and 3.3 billion doses were given in the U.S.(2-6)

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James A. Thorp, MD
Board Certified ObGyn
Board Certified Maternal Fetal Medicine

REFERENCES

1. Our World in Data. Coronavirus (COVID-19) Vaccinations. Available at: https://ourworldindata.org/covid-vaccinations. Accessed Feb 2, 2023.

2. US Census Bureau. US Population by year. Available at: https://www. multpl.com/united-states-population/table/by-year. Accessed Feb 24, 2023.

3. CDC. Flu Vaccination Coverage, United States, 2018-19 Influenza Season. Available at: https://www.cdc.gov/flu/weekly/FluViewInteractive.htm. Accessed Feb 24, 2023.

4. CDC. Historical Reference of Seasonal Influenza Vaccine Doses Distributed. Available at: https://www.cdc.gov/flu/prevent/vaccine-supply-historical.htm. Accessed Feb 24, 2023.

5. CDC. Flu Vaccination Dashboard. Available at: https://www.cdc.gov. Accessed Feb 24, 2023.

6. UN Population Data. Available at: https://population.un.org/. Accessed Feb 24, 2023.