Pfizer has confirmed it stopped its clinical trial analyzing COVID-19 vaccine safety and efficacy in pregnant women early.
S. Advisory Committee on Immunization Practices, began recommending the Pfizer-BioNTech vaccine for pregnant women.
“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,” Jelena Vojicic, vaccines medical lead at Pfizer Canada, wrote in the 2022 email.
The randomized, placebo-controlled study in question was launched in early 2021 after pregnant women were excluded from the phase three trial that led to the authorization of the vaccine in the United States and a number of other countries.
Pfizer and BioNTech said they expected to enroll some 4,000 pregnant women but actually enrolled just 349, according to the trial record.
Pfizer told Demasi that it still does not have “a complete data set” from the study and did not say when it expected to receive it.
” Pfizer officials told CDC advisers in September 2022 that the study was completed.
“We will be generating data from that study despite the difficulties in enrollment … due to the wide recommendations for pregnant women to be vaccinated, but we will generate those data for sure,” Nicholas Kitchen, a senior Pfizer vaccine official, told the panel.
Malone said that the “premature” recommendations from bodies such as the CDC “basically killed” Pfizer`s trial.
The FDA only required Pfizer to conduct one study on vaccination in pregnant women when it approved the company`s vaccine two weeks after the CDC`s recommendation.
Pfizer was scheduled to complete the study by June 30, 2025, and submit a final report on the results by the end of 2025, according to the FDA, which has allowed the company to delay at least one critical postmarketing study.
Dozens of women reported pregnancies and some suffered miscarriages, according to documents released under court order by the FDA.
The CDC says COVID-19 vaccination in pregnant women is safe and effective, pointing to data from its monitoring systems.
He said that the CDC would present data on vaccine safety during pregnancy at a future meeting, but it has not done so to date.
The company said it expected to enroll 1,000 women in the observational study.
A second observational study, examining vaccine safety among pregnant women in five European countries, was also listed, with a completion date of March 31, 2023.
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