Fact Check

No, European Medicines Agency Did Not Say COVID-19 Vaccines Adversely Affect Female Fertility

In a statement, the EMA told us that this rumor was false, calling the effort to promote it "a deliberate disinformation campaign."

Published Jun 2, 2023

Vials of the Pfizer-BioNTech Covid-19 vaccine, Comirnaty on Nov. 19, 2021 in Bari, Italy. (Photo by Donato Fasano/Getty Images) (Donato Fasano/Getty Images)
Vials of the Pfizer-BioNTech Covid-19 vaccine, Comirnaty on Nov. 19, 2021 in Bari, Italy. (Photo by Donato Fasano/Getty Images)
Claim:
The European Medicines Agency (EMA) said that COVID-19 vaccines could have an adverse effect on female fertility.

On May 31, 2023, Dr. Simone Gold, the founder of the anti-vaccine group America's Frontline Doctors, tweeted, "BREAKING: The European Medicines Agency (EMA) has admitted that COVID-19 jab can have an adverse effect on female fertility."

BBC Verify journalist Shayan Sardarizadeh replied to the tweet, writing, "The European Medicines Agency has said no such thing."

Gold ended her tweet with a dramatic bit about, "I fear we've only touched the surface," adding, "The American people were lied to."

However, according to the data, the only people being misled here were the users who believed Gold's tweet.

We previously reported that it's false to claim that COVID-19 vaccines threaten a person's fertility. To come to this conclusion, we referenced a number of authoritative sources. All of those sources were listed for readers to view at the end of the article.

Gold's tweet contained no links or sourcing of any kind. One would assume that if an organization the size of the EMA (roughly 4,500 contributors) had made such an admission, this supposed news would be available on many websites online. It wasn't.

It wasn't that the so-called admission was unavailable because the news media, both national and local, was trying to cover anything up, as a handful of social media users sometimes baselessly claim about these sorts of rumors. Rather, it's simply because it never happened.

By email, a spokesperson for the EMA told us, in part, "The claims circulating online alleging that EMA is advising pregnant women not to receive COVID-19 vaccines as these would 'cause infertility' are false," and added, "These statements appear to be part of a deliberate disinformation campaign."

The organization also provided a full explanation of what they referred to as a "misinterpretation" of its product information:

These allegations are a misinterpretation of the decision of EMA's safety committee (PRAC) to add heavy menstrual bleeding as a side effect of unknown frequency in the product information for the mRNA COVID-19 vaccines Comirnaty and Spikevax.

The PRAC's recommendation was based on a review of all the available evidence, including cases reported during clinical trials, cases spontaneously reported in Eudravigilance and findings from the medical literature.

A review of cases showed that heavy menstrual bleeding can occur after the administration of the first or second dose of the primary course and after administration of a booster.

The Committee concluded that all the evidence together indicated that there is at least a reasonable possibility that heavy menstrual bleeding is causally associated with vaccination. The PRAC also noted that most cases assessed were short-lived. 

In the second part of the EMA's statement, the organization linked to highlights from an October 2022 meeting. They also cited documentation from several studies that reportedly "did not find any sign of an increased risk of pregnancy complications, miscarriages, preterm births, or adverse effects in the unborn babies following mRNA COVID-19 vaccination."

The Committee specified, in the communication issued at the time of the recommendation, that there is no evidence or plausible mechanism to suggest that menstrual changes experienced by some women following vaccination have any impact on fertility.

With regard to the effects of COVID-19 vaccination on pregnancy in general, several studies involving around 65,000 pregnancies at different stages did not find any sign of an increased risk of pregnancy complications, miscarriages, preterm births or adverse effects in the unborn babies following mRNA COVID-19 vaccination.

In fact, COVID-19 vaccination may also be more beneficial to pregnant women as pregnancy has been associated with a higher risk of severe COVID-19, particularly in the second and third trimesters.

We previously reported that Gold has a history of amplifying false or unsupported claims about the COVID-19 pandemic. We also documented that she had participated in the U.S. Capitol riot on Jan. 6, 2021, an act that led to her serving a brief term in jail.

This story will be updated should any further developments come to light.

Snopes is still fighting an "infodemic" of rumors and misinformation surrounding the COVID-19 pandemic, and you can help. Find out what we've learned and how to inoculate yourself against COVID-19 misinformation. Read the latest fact checks about the vaccines. Submit any questionable rumors and "advice" you encounter. Become a Founding Member to help us hire more fact-checkers. And, please, follow the CDC or WHO for guidance on protecting your community from the disease.

Sources

"Capitol Breach Cases: Simone Melissa Gold (Case Number: 1:21-Cr-85)." The United States Attorney's Office: District of Columbia, https://www.justice.gov/usao-dc/defendants/gold-simone-melissa.

Clark, Cheryl. "Simone Gold of America's Frontline Doctors Released From Prison Early." Medpage Today, 9 Sept. 2022, https://www.medpagetoday.com/special-reports/exclusives/100624.

Dapcevich, Madison. "Who Are 'America's Frontline Doctors' and Dr. Stella Immanuel?" Snopes, 30 July 2020, https://www.snopes.com/news/2020/07/30/americas-frontline-doctors/.

EMA. "COVID-19: Latest Safety Data Provide Reassurance about Use of mRNA Vaccines during Pregnancy." European Medicines Agency, https://www.ema.europa.eu/en/news/covid-19-latest-safety-data-provide-reassurance-about-use-mrna-vaccines-during-pregnancy.

---. "Meeting Highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 24 - 27 October 2022." European Medicines Agency, 28 Oct. 2022, https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-24-27-october-2022.

Kunzelman, Michael. "Anti-Vaccine Doctor Sentenced to Prison for Capitol Riot." The Associated Press, 16 June 2022, https://apnews.com/article/capitol-siege-covid-health-california-government-and-politics-e0e72e384e0d01ff9ce1aff7173a369b.

Palma, Bethania. "Was 'America's Frontline Doctor' Simone Gold at US Capitol Attack?" Snopes, 13 Jan. 2021, https://www.snopes.com/fact-check/simone-gold-capitol-riot/.

The European Medicines Agency (PDF Presentation). European Medicines Agency, https://www.ema.europa.eu/en/documents/presentation/presentation-european-medicines-agency_en.pdf.

United States of America v. John Herbert Strand, Simone Melissa Gold. Court Listener, 13 Jan. 2021, storage.courtlistener.com/recap/gov.uscourts.dcd.227166/gov.uscourts.dcd.227166.1.1.pdf.

Jordan Liles is a Senior Reporter who has been with Snopes since 2016.

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