TUCSON, Ariz., March 21, 2023 (GLOBE NEWSWIRE) -- The COVID-19 vaccine was developed and distributed with unprecedented speed, including to pregnant women. Maternal-fetal medicine specialist James A. Thorp, M.D., and colleagues analyzed reports to the Vaccine Adverse Events Reporting System (VAERS) of events most relevant to fertility and reproductive physiology. Their summary is published in the spring issue of the peer-reviewed Journal of American Physicians and Surgeons.
The events included menstrual abnormality, miscarriage (spontaneous abortion), fetal death (stillbirth), premature delivery, and premature baby death.
The method was a retrospective analysis of the adverse event (AE) reports post-COVID-19 vaccines and post-influenza vaccines in the VAERS database maintained by the U.S. Centers for Disease Control and Prevention (CDC) 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. The study period provides 282 months of data for the influenza vaccine and 18 months of data for the COVID-19 vaccines.
The method is comparable to the method used by the CDC to give a proportional reporting ratio (PRR). According to CDC’s Standard Operating Procedures for COVID-19, a two-fold increase in the PRR is of concern.
For all AEs, the report rates post-COVID-19 vaccination are higher than post-influenza vaccination across all three normalization methods: by unit time, by dose given, and by number of persons vaccinated. Almost all were higher by a factor of two or more.
Although the occurrence of an AE post vaccination does not prove causality, the Food and Drug Administration (FDA) considers VAERS to be a valuable tool for post-marketing safety surveillance. Vaccine manufacturers and medical professionals are historically the primary sources of VAERS reporting, but consumers are also able to submit reports. It is a federal offense punishable by fine and imprisonment to falsify VAERS reports.
The authors conclude: “Administration of COVID-19 vaccines in pregnancy and women of reproductive age should be halted immediately until these safety signals can be fully investigated.”
The Journal of American Physicians and Surgeons is published by the Association of American Physicians and Surgeons (AAPS), a national organization representing physicians in all specialties since 1943.
