FACT CHECK: Did Pfizer Recommend Against Unprotected Sex After The Second Dose Of Its COVID-19 Vaccine Due To Reproductive Risks?
A post shared on Instagram alleges Pfizer advised against unprotected sex up to 28 days after receiving the second dose of its COVID-19 vaccine due to potential reproductive risks.
View this post on Instagram
The document featured in the post is part of Pfizer’s 2020 vaccine clinical trial guidelines. There is no evidence that Pfizer’s COVID-19 vaccine has any negative effects on reproduction.
The post shows what appears to be a hyperlink to a Pfizer document along with text that reads, “Page 132 of Pfizer vaccine… basically says no unprotected sex up to 28 days after 2nd dose due to reproductive safety risks.. this is for males and females… births (sic) defects due to genetic manipulation.”
The provided URL, however, does not lead to a recent document discussing the Food and Drug Administration-approved Pfizer-BioNTech COVID-19 vaccine. Rather, the 146-page document linked relates to the protocol for the company’s 2020 clinical trials of its COVID-19 vaccine. The document states it seeks to “evaluate the safety, tolerability, immunogenicity, and efficacy of SARS-CoV-2 RNA vaccine candidates against COVID-19 in healthy individuals.”
Page 132, which is referenced in the post, discusses “Contraceptive Guidance.” It states that throughout the trial male participants must refrain from donating sperm and be abstinent, or use protection when having intercourse with a female. It also stipulates that female participants must not be pregnant or breastfeeding and must use contraception if engaging in sex. Birth defects are not discussed in the document’s contraceptive guidance section.
The Regulatory Support Committee (RSC), which provides support for all clinical trials from the National Institute of Allergy and Infectious Diseases (NIAID), notes that similar contraceptive rules are required for clinical trials that pose a known or unknown level of reproductive risk, according to its Therapeutics Research Guidance.
“Clinical trials of investigational products—those that have not yet been approved or authorized by the FDA—always include a contraceptive requirement unless the same product has been used extensively for a different purpose with a proven safety record in pregnancy,” said the NIAID in a statement sent via email to Check Your Fact. The institute explained the contraceptive requirements are simply a “safety precaution” and do not indicate that reproductive harm is known or anticipated.
“The requirements in the Pfizer protocol do not reflect those typically implemented for a known higher reproductive risk, as described in the Therapeutics Research Program (TRP) guidelines,” said the NIAID. (RELATED: Did Pfizer Scientists Warn Weekly COVID-19 Vaccinations May Be Needed To Prevent Lockdowns?)
The Centers for Disease Control and Prevention (CDC) states on its website that there is no proven risk of fertility problems associated with any of the COVID-19 vaccines. The agency recommends all people anticipating pregnancy, along with their partners, receive a COVID-19 vaccination.
A Pfizer spokesperson stated in an email to Check Your Fact that “There is no evidence that the vaccine causes reproductive risks.”