PFIZER AND BIONTECH COMMENCE GLOBAL CLINICAL TRIAL TO EVALUATE COVID-19 VACCINE IN PREGNANT WOMEN

[PeteS in CA]

PFIZER AND BIONTECH COMMENCE GLOBAL CLINICAL TRIAL TO EVALUATE COVID-19 VACCINE IN PREGNANT WOMEN

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-commence-global-clinical-trial-evaluate

New York, USA and Mainz, Germany, February 18, 2021 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that 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 18 years of age and older.

“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., Senior Vice President of Vaccine Clinical Research and Development, Pfizer. “Pregnant women have an increased risk of complications and developing severe COVID-19, which is why it is critical that we develop a vaccine that is safe and effective for this population. We are deeply thankful to the volunteers who are enrolling in the trial, and site investigators who are leading this work.” 

“Enabling broad access to our highly effective COVID-19 vaccine is an important goal for us. Now that we are seeing 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, to potentially protect both them and future generations,” said Özlem Türeci, M.D., Chief Medical Officer of BioNTech.

The Phase 2/3 trial is designed as a randomized, placebo-controlled, observer-blind study in approximately 4,000 healthy pregnant women 18 years of age or older vaccinated during 24 to 34 weeks of gestation. ...

Several types of people were excluded from the original Phase 3 Pfizer test. Youths under age 16 were excluded, as were pregnant women. While I haven't see word of the Pfizer vaccine being tested on younger people, I do know Moderna's is being tested with youths age 12-17 (Moderna's protocol excluded youths under age 18).