Pfizer and BioNTech launched a global clinical trial to evaluate the effects of their coronavirus vaccine on pregnant women

Pfizer and BioNTech announced that they have administered the doses of their coronavirus vaccine to the first healthy pregnant participants in a global phase 2/3 study to further assess the Safety, Tolerability, and Immunogenicity of Their Trial Against COVID-19 Disease in Expecting Women.

“We are proud to begin this study in pregnant women and to continue to gather the evidence for safety and efficacy to potentially support the use of the vaccine by important subpopulations. Pregnant women are at increased risk of complications and of developing severe COVID-19, so it is critical that we develop a vaccine that is safe and effective for this population. We are deeply grateful to the volunteers who are signing up for the trial and to the researchers at the center who are leading this work, ”said Pfizer Senior Vice President of Clinical Vaccine Research and Development, William Gruber.

“Enabling wide access to our highly effective COVID-19 vaccine is an important goal for us. Now that we are seeing the success of the initial implementation of vaccination campaigns around the world, it is time to take the next step and expand our clinical program to other vulnerable populations, such as pregnant women, to potentially protect both themselves and future generations”Added BioNTech’s medical director, Ozlem Türeci.

Pfizer and BioNTech coronavirus vaccine.

The phase 2/3 trial is designed as a randomized, placebo-controlled, observer-blind study of approximately 4,000 healthy pregnant women aged 18 years or older vaccinated during 24 to 34 weeks of gestation. The study will evaluate the safety, tolerability, and immunogenicity of two doses of the vaccine or placebo administered 21 days apart. Each woman will participate in the study for about 7 to 10 months, depending on whether she was randomized to receive the vaccine or the placebo.

The study will evaluate the safety in infants of vaccinated pregnant women and the transfer of potentially protective antibodies to their children. Babies will be monitored until approximately six months old. As stated in the study protocol, after a participant’s baby is born, the volunteers in the maternal trial will be unmasked and those in the placebo group will receive the vaccine.

Before conducting your clinical trial in pregnant women, Pfizer and BioNTech completed a toxicity investigation required by regulatory authorities before starting this new study, which showed no evidence of toxicity for fertility or reproduction in animals.

Pfizer and BioNTech hope to initiate additional studies in children between 5 and 11 years old “in the next few months”, and in children under 5 years old “later in 2021”. Safety and efficacy in 12-15-year-olds are already being evaluated in a global phase 3 study and the relevant data is planned to be submitted to regulatory authorities “in the second quarter of 2021”. The companies are also planning studies to further evaluate the vaccine in people with compromised immune systems.