WASHINGTON — Drugmaker Pfizer and German partner BioNTech have begun a nine-country study of the safety and effectiveness of their COVID-19 vaccine in pregnant women.
The companies said Thursday that the first volunteers have received shots in the study, which is to enroll about 4,000 healthy pregnant women aged 18 and older.
Women in the United States, Canada, Argentina, Brazil, Chile, Mozambique, South Africa, Spain and the UK will be included.
Dr. William Gruber, Pfizer’s head of vaccine clinical research and development, said in a statement that “pregnant women have an increased risk of complications and developing severe COVID-19,” and “it is critical that we develop a vaccine that is safe and effective” for them.
The study will vaccinate pregnant women during the 24 to 34 weeks of pregnancy. Throughout the study, researchers will evaluate the safety, tolerability, and immunogenicity of the two doses of the vaccine or the placebo.
It will assess effects on the infants for about six months, checking whether or not they received potentially protective antibodies from their mothers.
“Enabling broad access to our highly effective COVID-19 vaccine is an important goal for us," said Özlem Türeci, M.D., Chief Medical Officer of BioNTech. "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."
Pfizer said in a statement that it plans to start studies of the vaccine in children between the ages of 5 and 11 over the next few months.
The Pfizer-BioNTech's COVID-19 vaccine has not been approved or licensed by the U.S. Food and Drug Administration, but it has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent the spread of the virus.
For most people, the coronavirus causes mild or moderate symptoms. For some, especially older adults and people with existing health problems, it can cause more severe illness, including pneumonia and death.
The United States has more than 27 million confirmed cases of COVID-19, according to data from Johns Hopkins University.
As of Friday, the U.S. had more nearly 500,000 deaths from the virus. Worldwide, there are more than 110 million confirmed cases with more than 2.4 million deaths.