Pregnant Women to Be Included in COVID-19 Vaccine Trials, Pfizer Says
According to the statement, around 4,000 healthy women, older than 18 and between 24 and 34 weeks pregnant, will be enrolled in the trial. The participants are from the United States, Argentina, Brazil, Canada, Chile, Mozambique, South Africa, Spain and the United Kingdom, ABC News reports.
In the trial, participants will get two doses of the vaccine spaced out between 21 days. Both mom and baby will be monitored for seven to 10 months afterward, until baby is around 6 months old. While half the participants will get the vaccine, the other half will get a placebo. Anyone given the placebo will also have the chance to get vaccinated later on, the statement says.
“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,” William Gruber M.D., senior vice president of Vaccine Clinical Research and Development for Pfizer, said in the statement. "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. We are deeply thankful to the volunteers who are enrolling in the trial, and site investigators who are leading this work.”
Pregnant women were left out of the first round of trials. According to Daniel Roshan, M.D., F.A.C.O.G, F.A.C.S and director of ROSH Maternal-Fetal Medicine, for ethical reasons, pregnant and breastfeeding women are almost never part of vaccine or medication trials. Earlier this month, experts at the National Institutes of Health called out the need for pregnant women to be included in the trials. In a recent article published in the Journal of the American Medical Association they pointed out, “Pregnant and lactating persons should not be protected from participating in research, but rather should be protected through research.”
The ACOG recommends pregnant women get the COVID-19 vaccine, but, with the lack of research and uncertainty that has surrounded the novel virus all year, it’s understandable that many women still have questions. Hopefully, these new trials will be able to help provide more clarity on the relationship between pregnancy and the vaccine.
Pfizer and BioNTech have also already started trials for kids aged between 12 and 15. They plan to start evaluating the vaccine for kids aged 5 to 11 in the next couple of months and kids aged younger than 5 later on in 2021.