The trials mark the first to include pregnant people in the U.S.
Remember nearly one month ago, when the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC) just could not agree on whether pregnant people should get the COVID-19 vaccine? At the time, they were frustratingly offering different recommendations, leaving pregnant people left scratching their heads, wondering what the hell they should do.
Well, today, we finally have an update on the COVID-19 vaccine for pregnant people: Pfizer and BioNTech, specifically, started testing the COVID-19 vaccine in pregnant women. This marks the first such trials to include pregnant people in the United States.
According to Reuters, Pfizer and BioNTech have started an international study comprised of 4,000 volunteers, including pregnant people aged 18 and older in the U.S., Canada, Argentina, Brazil, Chile, Mozambique, South Africa, the U.K. and Spain.
The first doses will be administered in the U.S., according to Pfizer; and pregnant people will receive the vaccine during weeks 24 through 34 of gestation and will get two shots 21 days apart, which, according to Reuters, is the same process used in the larger clinical trial. Then, shortly after giving birth, participants who got a placebo in the trial will be given an opportunity to get the actual vaccine, while remaining part of the study.
The new study will evaluate the safety and effectiveness of their COVID-19 vaccine in healthy pregnant people, including whether antibodies are transferred to babies. And because pregnant people are at higher risk of developing respiratory complications that require intensive care versus those who aren’t pregnant, the CDC reports — and because pregnant people are also more likely to be placed on a ventilator — this is big, important news.
“We are proud to start this study in pregnant women and continue to gather the evidence on safety and efficacy to potentially support the use of the vaccine by important subpopulations,” Dr. William Gruber, senior vice president of Vaccine Clinical Research at Pfizer, says in a statement, per NBC News.
The announcement of the study follows the U.S. National Institutes of Health (NIH)’s call for greater inclusion of pregnant and lactating people in COVID-19 vaccine research.
It also follows the CDC stating, again last month, that “studies in pregnant people are planned.”
“… and the vaccine manufacturers are following outcomes in people in the clinical trials who became pregnant,” the CDC continues. “Based on current knowledge, experts believe that mRNA vaccines are unlikely to pose a risk to the pregnant person or the fetus because mRNA vaccines are not live vaccines.”
After the expectant mothers receive the vaccine and deliver their respective babies, Pfizer will follow newborns for six months to see if antibodies from the mother transfer to the infants.
In the meantime, in the coming months, AstraZeneca Plc. and Johnson & Johnson are also planning to run trials on pregnant people.
Information about COVID-19 is rapidly changing, and Scary Mommy is committed to providing the most recent data in our coverage. With news being updated so frequently, some of the information in this story may have changed after publication. For this reason, we are encouraging readers to use online resources from local public health departments, the Centers for Disease Control, and the World Health Organization to remain as informed as possible.