Pfizer has confirmed it stopped its clinical trial analyzing COVID-19 vaccine safety and efficacy in pregnant women early.
The company said that enrollment in the study stopped in the fourth quarter of 2021 after health experts, including the U.S. Advisory Committee on Immunization Practices, began recommending the Pfizer-BioNTech vaccine for pregnant women.
“With the declining enrollment, the study had insufficient sample size to assess the primary immunogenicity objective and continuation of this placebo controlled study could no longer be justified due to global recommendations,” Pfizer told journalist Maryanne Demasi.
The U.S. Food and Drug Administration and European Medicines Agency both agreed to the proposal to halt the study, according to Pfizer. The regulatory agencies did not respond to requests for comment.
An internal email, disclosed in a court case, previously indicated Pfizer had stopped enrollment early.
“The study enrolment was stopped with incomplete ...
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