On Saturday, November 27, 2021, a Facebook user, Sipho Shezi posted a graphic with the inscription that Pfizer has warned both males and females to avoid unprotected sex for 28 days after taking the second dose due to reproductive safety risks.
The Facebook post reads: page 132 of Pfizer vaccine basically says no unprotected sex up to 28 days after the second dose due to reproductive safety risk…this is for males and females. Births defects due to genetic manipulation.
The post generated 1 comment, 4 shares, and 8 reactions from various users since it was published in November 2021.
POTENTIAL IMPACT OF THE CLAIM
It is important to fact-check this claim due to the various news surrounding COVID-19 vaccines.
Also, there have been claims of people getting infected by COVID-19, even after taking the vaccine, and also there are cases where people were injected with fake or expired vaccines.
N-VA extracted the claim, “Pfizer vaccine causes births defects due to genetic manipulation” and went on to fact-check and verify its authenticity.
What is The Pfizer vaccine?
According to Centers for Diseases Control and Prevention, CDC, Pfizer-BioNTech (COMIRNATY) received U.S. Food and Drug Administration (FDA) approval on August 23, 2021, for individuals ages 16 years and older. Once vaccines are approved by the FDA, companies can market the vaccines under brand names. COMIRNATY is the brand name for the Pfizer-BioNTech COVID-19 vaccine. After FDA approval, the FDA-authorized Pfizer-BioNTech COVID-19 vaccine for individuals ages 16 years and older was marketed as COMIRNATY. No change was made to the vaccine’s formula with the name change.
The Pfizer-BioNTech vaccine label remains for individuals ages 5–15 years since the vaccine is authorized but not yet approved for this age group.
DID “PAGE 132 OF PFIZER VACCINE” WARNS BOTH MALE AND FEMALE TO AVOID UNPROTECTED SEX FOR 28 DAYS AFTER TAKING THE SECOND DOSE DUE TO REPRODUCTIVE SAFETY RISK?”
Below after the boldly written text, is a blurry reproduction of part of a document that seems to read “Appendix 4: Contraceptive Guidance” and then “Male Participant Reproductive Inclusion Criteria”. It also provides a link to the document.
In a quest to know if truly if the “page 132 of Pfizer vaccine” really warns that both men and women would have to practice safe sex for 28 days after the second Comirnaty shot because of the “reproductive safety risk” caused by “genetic manipulation”, the researcher makes use of the keywords from the blurry text to access a document published on Pfizer website in November 2020.
The document was titled, “A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS” which is against the medical side effect warnings to both male and female.
For clarity, the researcher flip to page 132 to get the full details of what has been written there. It contains details on the contraceptives guidance for males and females.
It stated that the male participants are eligible to participate if they agree to the following requirements during the intervention period and for at least 28 days after the last dose of study intervention, which corresponds to the time needed to eliminate the reproductive safety risk of the study intervention(s). But participants must follow these guidelines:
- Refrain from donating sperm.
- Be abstinent from heterosexual intercourse with a female of childbearing potential as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent.
Must agree to use a male condom when engaging in any activity that allows for the passage of ejaculate to another person.
- In addition to male condom use, a highly effective method of contraception may be considered in WOCBP partners of male participants.
The female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:
- Is not a WOCBP
- Is a WOCBP and using an acceptable contraceptive method as described below during the intervention period (for a minimum of 28 days after the last dose of study intervention).
It advised that the investigator should evaluate the effectiveness of the contraceptive method in relation to the first dose of the study intervention. The investigator is responsible for the review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with early undetected pregnancy.
The claim with the headline “Pfizer vaccine causes births defects due to genetic manipulation” is FALSE as the document referenced in the viral image was during test trials for vaccine efficacy.