Why do some people think that the Pfizer COVID vaccine trials warned men to stay away from pregnant women?
The usual suspects…
Did the Pfizer COVID Trials Warn Men to Stay Away from Pregnant Women?
Of course it isn’t true.
There is no warning in the Pfizer COVID-19 vaccine trials that men should stay away from pregnant women and no documentation referencing “knowledge of shedding.”
Instead, the Pfizer clinical trial documentation talks about what happens if any of the participants in the study have any “exposure to the study intervention.”
What is the study intervention?
The Pfizer COVID-19 vaccine or placebo!
How might you get exposed to the study intervention?
“A female participant is found to be pregnant while receiving or after discontinuing study intervention.”
8.3.5.1 Exposure During Pregnancy
Well, you might have gotten vaccinated before you knew you were pregnant.
“A female is found to be pregnant while being exposed or having been exposed to study intervention due to environmental exposure.”
8.3.5.1 Exposure During Pregnancy
Or you might be vaccinating folks in the study and one of the vials broke or a syringe with vaccine squirted on your skin, leading to exposure by “by inhalation or skin contact.”
“An occupational exposure occurs when, during the performance of job duties, a person (whether a healthcare professional or otherwise) gets in unplanned direct contact with the product, which may or may not lead to the occurrence of an AE.”
PF-06930164 (Crisaborole) Protocol C3291028
Reviewing other Pfizer study protocols which uses very similar language should help everyone understand that these are standard protocols in their clinical trials.
What about the part that mention exposing a female partner?
“A male participant who is receiving or has discontinued study intervention exposes a female partner prior to or around the time of conception.”
8.3.5.1 Exposure During Pregnancy
While that might sound like they are evaluating the vaccine for shedding, it is certainly not a warning to stay away from pregnant women and it goes along with the requirements found on page 132 that male participants must either “be abstinent from heterosexual intercourse with a female of childbearing potential” or “must agree to use a male condom.”
But no, this is not about vaccine shedding. These protocols are in the study for the simple reason that the primary focus of the studies were not pregnancy.
“Details of all pregnancies in female partners of male participants will be collected after the start of study intervention and until 3 weeks after the last dose.”
Dacomitinib Trial 8.3.5.1 Exposure During Pregnancy
And again, this is routine language found in many of their clinical trials.
Pfizer COVID Trials Exposure During Pregnancy Fact Check
It is not true that men in the Pfizer COVID vaccine trials were warned to stay away from pregnant women or that the trials included any warning about shedding.
More on COVID Vaccines and Pregnancy
- Who are America’s Frontline Doctors?
- Infertility and COVID Vaccines
- The Truth About COVID-19 Vaccines
- Vaccines and the HAZMAT Team Myth
- It was inevitable that antivaxxers would claim that COVID-19 vaccines make females infertile
- COVID-19 mRNA vaccines and infertility
- A Phase 1/2/3, Placebo-Controlled, Randomized, Observer-Blind, Dose-Finding Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of Sars-Cov-2rna Vaccine Candidates Against Covid-19 in Healthy Individuals
- Guideline for collection, analysis and presentation of safety data in clinical trials of vaccines in pregnant women
- EMA – Guideline On the Exposure to Medicinal Products During Pregnancy: Need for Post-Authorisation Data
- COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER)
- Fact check: No, interacting with a vaccinated person won’t cause miscarriage or menstrual changes
- Fact check: Pregnant women do receive vaccines, but more study needed on COVID-19 shot
- A Phase 1, Open-Label, Single-Dose, Parallel-Group Study to Evaluate the Plasma Pharmacokinetics and Safety of Dacomitinib in Participants With Severely Impaired Hepatic Function Relative to Participants With Normal Hepatic Function
- Video misrepresents Pfizer’s COVID-19 vaccine clinical trial protocol
- What page 132 of the Pfizer “vaccine report” actually says about infertility
- FactCheck: No, Pfizer did not say unprotected sex should be avoided after the vaccine because of risk from ‘genetic manipulation’
- Therapeutics Research Program Guidance for the Development of Protocol Procedures to Address Reproductive Risk
Last Updated on May 1, 2021