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Pfizer and BioNTech Announced Start of Trial of COVID-19 Vaccine in Pregnant Women



Pfizer and BioNTech, through a press release published on Thursday, February 18, 2021, announced the start of their global clinical trial to evaluate COVID-19 vaccine in pregnant women.

“We are proud to start this study in pregnant women and continue to gather the evidence on safety and efficacy to potentially support the use of the vaccine by important subpopulations,” said William Gruber M.D., the Senior Vice President of Vaccine Clinical Research and Development of Pfizer.


According to Gruber, pregnant women have an increased risk of complications and developing severe COVID-19. “…it is critical that we develop a vaccine that is safe and effective for this population,” he added.

Meanwhile, Özlem Türeci, M.D., the Chief Medical Officer of BioNTech, said, “Now that we are seeing the successful initial implementation of vaccine campaigns with BNT162b2 across the globe, it is time to take the next step and extend our clinical program to other vulnerable populations, such as pregnant women.”

The Clinical Trial in Pregnant Women

Part of the trial are approximately 4,000 healthy pregnant women 18 years of age or older. “…the first participants have been dosed in a global Phase 2/3 study to further evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) in preventing COVID-19 in healthy pregnant women…” stated Pfizer.


“We are deeply thankful to the volunteers who are enrolling in the trial,” said the Senior Vice President of Vaccine Clinical Research and Development of Pfizer.

It was said that Pfizer and BioNTech completed a developmental and reproductive toxicity (DART) study with BNT162b2 prior to conducting the clinical trial in pregnant women.

The Pfizer-BioNTech COVID-19 Vaccine

Note that Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA). However, it has been authorized by the FDA for emergency use under an Emergency Use Authorization (EUA).

Related Articles:

Pfizer and BioNTech Vaccine Authorized for Use in UK

PH Approves Pfizer-BioNTech Vaccine

Pfizer’s Vaccine Shows Promising Results in Israel, Says Report

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Source: Pfizer| Press Release, Pfizer| Official Facebook



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