Whatever Happened to Pfizer’s Covid Vaccine Trial in Pregnant Women?
February 24th, 2023Via: Maryanne Demasi:
In the absence of any human data, Pfizer announced it would begin recruiting volunteers for a clinical trial to examine the safety and efficacy of its mRNA vaccine in pregnant women and their newborns.
The trial, which began in Feb 2021, originally intended to enroll 4,000 women, but enrollment stopped in late 2021 with just 349 participants.
There has been no explanation for why they stopped recruiting participants, nor have the data been published in a conference abstract, preprint or medical journal.
It has been over a year since the last woman was enrolled in the trial, and all of them would have given birth by now.
Recently, Marty Makary, a public policy researcher at Johns Hopkins University, objected to the secrecy. “They should say something. They have a moral duty to speak up. Here we are 18 months later, the results of those 349 women have never been made public,” said Makary.
“They just recommended it for pregnant women with zero data. And maybe that’s why [Pfizer] stopped the study….running a study runs the risk of showing that there may not be a benefit in pregnant women,” he added.
Pfizer’s response
In response to my questions, today I can reveal the reason why Pfizer hasn’t published the study — the company admitted it does not have the data.
In an email, Pfizer said the trial’s “enrollment rate declined significantly” towards the end of 2021, because authorities had already widely recommended the vaccine to pregnant women.
Declining enrollments meant that there were insufficient numbers of participants in the trial to carry out the intended analysis.
