Washington, Feb 19 (Agency) Pfizer and BioNTech launched a new clinical trial in nine countries including the United States, Canada, South Africa, the United Kingdom (UK) and Brazil to test their Corona vaccine in pregnant women, the companies said in a statement. “Phase 2/3 trial will enroll approximately 4,000 healthy pregnant women in the US, Canada, Argentina, Brazil, Chile, Mozambique, South Africa, UK, and Spain,” the release said. “Women enrolled in the trial will be unblinded shortly after giving birth to allow those women who originally received placebo to be vaccinated while staying in the study.”
The study will 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, the release said. “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,” Pfizer Senior Vice President of Vaccine Clinical Research and Development William Gruber said in the release. 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, BioNTech said.