JACKSONVILLE, Fla. – Pfizer and BioNTech have begun a clinical trial of their COVID-19 vaccine on pregnant women as they aim to examine the vaccine’s safety and effectiveness among expecting mothers.
The drugmakers announced the trials Thursday, saying about 4,000 healthy pregnant women will be part of the months-long study. Besides testing the vaccine’s effects on pregnant women, the study will also evaluate how it affects infants and whether antibodies are passed along from mother to child.
“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,” said Dr. William Gruber, senior vice president of vaccine clinical research and development for Pfizer. “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.”
The risks of COVID-19 infection for expectant mothers aren’t lost on Dr. Priyanka Vijapura, a Jacksonville internist who received her first dose of the Pfizer-BioNTech vaccine when she was 16 weeks pregnant back in December.
At first, Dr. Vijapura admitted, she was a bit hesitant to get the vaccine.
“Then around early December, ACOG (American College of Obstetrics and Gynecology) put out a statement basically totally eradicating any concerns I had, saying: ‘This is how an MRNA vaccine works, there is no way it can be incorporated into human DNA or cause any sort of side effect or harm to a fetus or a pregnant woman,’” she said.
“So even though we don’t have evidence in pregnant woman at this point, that was very reassuring to me. Especially trying to weigh my risk and benefit seeing patients in the hospital with COVID every day.”
Vijapura, who is due in May, has since gotten her second dose. While she said the first came with expected side effects, such as a fever and soreness in her arm, they passed in 24 hours. She didn’t experience any side effects from the second dose.
“The other thing is, I have plenty of colleagues and friends from medical school, so many people in my network who are my age and expecting and at similar or greater risk than me in terms of their COVID exposure,” Vijapura said. “And I haven’t heard of a single or lactating physician who declined the COVID vaccine.”
Dr. Mohammed Reza, an infectious disease specialist and medical director of CAN Community Health, said the vaccine contains zero live or dead components of the novel coronavirus, meaning it cannot cause you to get sick.
“The reality is, you want that protection throughout the whole pregnancy period,” Dr. Reza said.
He said pregnant women should speak with their primary doctor and OBGYN about their risk and exposure to the virus.
“The heightened state of the immune system lasts for the first 12 weeks of pregnancy to allow for the fetus to get fully established,” he said. “Over the following 15 weeks, the mother’s immune system is repressed. During that time period, women have a higher risk for having a viral, bacterial or any sort of infection because their immune system is a bit weaker. We have data showing people who are pregnant have a worse outcome and a lot higher rate of death when infected with this virus.”
Dr. Reza said we can anticipate results and evidence from this clinical trial within the next six to 12 months.