Pfizer Halted Clinical Trial to Test Safety and Efficacy of COVID-19 Vaccine in Pregnant Women
New internal documents disclosed as part of a court case reveal Pfizer discontinued its clinical trial designed to evaluate the safety and efficacy of its COVID-19 vaccine in pregnant women.
According to The Epoch Times, Dr. Eliana Castillo, a professor of medicine at the University of Calgary sent an email on April 1 to Pfizer Canada asking about the status of a clinical trial announced by the company in February 2021.
“I represent the Society of Obstetricians and Gynaecologists of Canada @ NACI [National Advisory Committee for Immunization],” Castillo wrote.
She then stated she had two questions for Pfizer to “continue to support our providers and patients with our guidelines.”
Castillo wanted to know why Pfizer stopped enrolling subjects in its clinical trial for pregnant women and if enrollment was complete. She then asked for data from the Development and Reproductive Toxicity (DART) study on the Pfizer-BioNTech COVID-19 vaccine.
The DART study, “Lack of effects on female fertility and prenatal and postnatal offspring development in rats with BNT162b2, an mRNA-based COVID-19 vaccine” was published on August 2021 in the journal of Reproductive Toxicology.
Jelena Vojicic, medical lead on vaccines at Pfizer Canada, said in an April 4 email:
“The study enrolment was stopped with incomplete numbers because recruitment was slow and it became unreasonable/inappropriate to randomise pregnant women to placebo given the amount of observational evidence that the vaccine is safe and effective, coupled with increasing number of technical committees supporting immunization of pregnant women.”
In other words, Pfizer stopped its clinical trial and said the limited data it already had on safety and efficacy was enough to justify vaccinating pregnant and breastfeeding women with an experimental vaccine.
The emails came out as part of a lawsuit initiated in Canada challenging the government’s COVID vaccine mandate for travelers. During expert testimony on behalf of the government imposing the mandate, expert Vanessa Poliquin, an associate professor at the Department of Obstetrics, Gynecology, and Reproductive science at the University of Manitoba, used the email to defend the government’s position Pfizer’s vaccine is “safe and effective.”
Opposing counsel then requested the full email chain leading to the email admitting the trial was never completed.
During her testimony, Poloquin said Pfizer’s medical experts believe retrospective data was sufficient to determine the safety and efficacy of its vaccine for pregnant women.
In a press release on Feb. 18, 2021, Pfizer said its first participant in its global clinical trial for pregnant women was vaccinated to evaluate the “safety, tolerability, and immunogenicity” of the BNT162b2 vaccine in pregnant women.
In September 2021, Pfizer told the Wall Street Journal that despite having trouble getting women to enroll in the trial, it would be completed.
No further press releases were ever published on the clinical trial.
To date, neither Pfizer nor Moderna have conducted studies to show their products are safe for women who are pregnant or breastfeeding.