Pfizer/BioNTech Evaluate COVID-19 Vaccine in Pregnant Women

Pfizer and BioNTech announced that they have dosed the first patients in a global study evaluating their COVID-19 vaccine in pregnant women 18 years and over.

The phase 2/3 trial, which aims to address the lack of data for this population, will enroll 4,000 pregnant volunteers to assess the vaccine’s safety, tolerability and immunogenicity profile. The study is slated to last between seven to 10 months.

The World Health Organization (WHO) has recommended against pregnant women getting the vaccine, unless the benefits outweigh the risks and/or they are at high risk of infection (DID, Jan. 28).

The Pfizer/BioNtech study will also attempt to determine if the women transfer protective antibodies to their babies, who will be monitored until six months of age. According to the trial protocol, once a participant gives birth, she will become unblinded and, for those in the placebo group, they will then receive the vaccine.

“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,” said William Gruber, Pfizer’s senior vice president of vaccine clinical research and development.

Pfizer and BioNTech also plan to launch more studies assessing their vaccine in children between five and 11 years old within the next few months, and in children younger than five sometime later this year. The vaccine is currently being evaluated in children between 12 to 15 in an ongoing global phase 3 study. ― Jason Scott