Pfizer, BioNTech Begin Global Clinical Study Of COVID-19 Vaccine In Pregnant Women

Pfizer Inc. PFE and BioNTech BNTX have started a clinical trial to determine the efficacy of the companies' COVID-19 vaccine with pregnant women.

What Happened:The Phase 2/3 trial is designed as a randomized, placebo-controlled, observer-blind study in approximately 4,000 healthy pregnant women 18 and older in nine countries (the U.S., Canada, Argentina, Brazil, Chile, Mozambique, South Africa, U.K. and Spain).

The trial’s participants will be vaccinated during 24 to 34 weeks of gestation, and the first participants have been dosed in the U.S.

The study will evaluate the safety, tolerability, and immunogenicity of two doses of either the vaccine or the placebo administered 21 days apart.

Each woman will participate in the study for approximately seven to 10 months, depending on whether she was randomized to receive the vaccine or placebo.

Furthermore, the study will assess the vaccine’s safety in infants and whether there can be a transfer of potentially protective antibodies from vaccinated mothers to their infants. Infants will be monitored through approximately six months of age.

What Happens Next: The companies said that maternal trial participants will be unblinded after the birth of their infants and those who were in the placebo group will receive the vaccine.

Separately, Pfizer and BioNTech plan to commence additional studies in children between the ages of five and 11 over the next few months, and in children younger than 5 later in 2021.

Safety and efficacy studies in subjects 12-15 years of age are underway. While the companies’ vaccine has not been approved or licensed by the U.S. Food and Drug Administration, it has been authorized for emergency use in the U.S. in individuals 16 years of age and older.