What is the Truth?
Debunking the Claim: European Medicines Agency (EMA) Denies COVID Vaccine Causes Infertility
Conclusion: No Evidence of Infertility
Contrary to social media claims, there is no evidence to suggest that menstrual disturbances caused by the COVID vaccine have any impact on female reproduction and fertility.
EFE Madrid |
The European Medicines Agency (EMA) has categorically denied the false claim circulating on social networks that the COVID vaccine causes infertility. While the EMA acknowledges a potential link between heavy menstrual bleeding and the vaccines, it emphasizes that there is no scientific evidence to support the notion that menstrual disturbances affect female reproduction and fertility.
Several Facebook and Twitter users have been sharing information recently, citing an alleged report from the European Medicines Agency in October 2022, to support the claim that “The EMA admits that the COVID vaccine causes infertility“.
These posts have garnered various comments from users, with some asserting, “Once again, we were right; they intended to reduce the population“, while others argue, “If that were true, pregnant women and maternity wards would be empty“, and a few caution, “It seems like a conspiracy theory“.
Possible Link to Heavy Menstrual Bleeding
Despite the misinformation circulating on social media, the EMA has not admitted that the COVID vaccine causes infertility. However, it does acknowledge a potential association between the vaccines and heavy menstrual bleeding. Nevertheless, the EMA reiterates that there is no evidence to suggest that menstrual disturbances impact female reproduction and fertility.
The European Pharmacovigilance Risk Assessment Committee (PRAC) of the EMA, in the aforementioned report, recommends including heavy menstrual bleeding as a “side effect of unknown frequency of COVID-19 mRNA vaccines Comirnaty and Spikevax“.
The report also states that cases of heavy menstrual bleeding have been reported after the first, second, and booster doses of both vaccines, and there is “a reasonable chance that such bleeding is causally associated with these vaccines“.
However, the EMA clarifies that the available data primarily involve cases “that appear to be non-serious and temporary in nature“.
9,000 Non-Serious Cases Worldwide
The 18th Pharmacovigilance report on COVID-19 vaccines, published by the Spanish Ministry of Health in December 2022, shortly after the EMA report, reveals that approximately 9,000 cases of heavy menstrual bleeding have been reported worldwide following the administration of any dose of Comirnaty and Spikevax vaccines (first, second, or booster dose).
According to the data, the analysis of these cases indicates that the majority of them are transient and self-limited, without any serious consequences.
In January 2023, after the spread of false information on social media, the 19th Pharmacovigilance report on COVID-19 vaccines was published by Health authorities. Interestingly, heavy bleeding was not among the most frequent adverse events reported, which mainly included fever, dizziness, and myalgia.
The Spanish Medicines Agency also reminds us that “menstrual disorders, including those affecting the amount and duration of bleeding, have been monitored by European medicines agencies since the first cases were identified in 2021“. However, “the benefit-risk balance of Comirnaty and Spikevax remains favorable“.
No Evidence of Impact on Fertility
Contrary to the misrepresented claims, the EMA report does not affirm or acknowledge that menstrual bleeding alterations affect women’s fertility or cause complications during pregnancy. In fact, the document concludes that “there is no evidence to suggest that menstrual disorders experienced by some individuals have any impact on reproduction and fertility“.
On its website, the European Medicines Agency provides updated information on the safety and effectiveness of COVID vaccines, stating that “several studies have shown that mRNA COVID-19 vaccines do not pose any risks to pregnancy, neither for mothers nor their babies; on the contrary, they offer protection to expectant mothers and their babies“.
The United States Center for Disease Control and Prevention (CDC) also recommended COVID-19 vaccination for all individuals aged 6 months and above, including pregnant women, those breastfeeding, those trying to conceive, and those planning to have children in the future.
The CDC confirms that “vaccination against COVID-19 during pregnancy is safe and effective“, and “COVID-19 vaccines do not cause fertility problems in women or men“.
On its updated website in February 2023, the CDC addresses various myths and facts related to COVID-19 vaccines, and medical professionals in the United States and Europe strongly recommend vaccination, even for those planning to have children.
Fighting COVID Misinformation
The institutions of the European Union have launched several initiatives since the beginning of the pandemic to combat the spread of false information regarding COVID-19. These efforts aim to raise awareness about the dangers of misinformation and promote the use of reliable sources.
One such measure is the creation of a dedicated webpage providing real-time information about the virus and the EU’s response. Additionally, the EU regularly publishes rebuttals in all EU languages to debunk the most prevalent myths surrounding the coronavirus.
The European Commission encourages the dissemination of information from reputable sources such as the World Health Organization and the European Center for Disease Prevention and Control.
In the case of this fact check, many profiles spreading the false claim that the EMA admits the COVID vaccine causes infertility are sharing an article from the British website “The Expose“, known for spreading vaccine and coronavirus-related misinformation.
EFE Verifies has