Pfizer To Begin Coronavirus Vaccine Trial For Pregnant Women
PITTSBURGH (KDKA) -- Christine Fabrizio is a health care worker who got the Pfizer COVID-19 vaccine.
At the time of her second dose in January, she was 21 weeks pregnant.
"I wish there were some studies. It was definitely a level of uncertainty, but I was actually more worried about getting COVID," she said. "I had seen multiple pregnant patients come in positive for COVID. I saw the toll it took on them."
Had there been a clinical trial, she would have participated. Pregnant women are at risk for severe complications with COVID-19, which is why many obstetricians advise them to get vaccinated.
But because studies have not included pregnant women, doctors have a dilemma.
"Should we give patients this vaccine where we only have limited information?" said Dr. Michael Aziz with Allegheny Health Network.
Now Pfizer is starting clinical trials in pregnant women to evaluate the safety, tolerability and immune response to its vaccine. The company is recruiting 4,000 women later in pregnancy, between 24 and 34 weeks gestation.
After the baby is born, if the mother got the placebo, she will be offered a vaccine. The babies will be followed, as well, for six months to see if they have protective antibodies, transferred from mom.
Dr. Aziz is glad the study is moving forward.
"Very important and very necessary."
But he had hoped it would include women in early pregnancy to determine any risks for birth defects and miscarriage. Now at 26 weeks, Fabrizio is relieved she's been immunized.
"Knowing that I'm not putting my life or my unborn baby's life on the line," she said.
Moderna did pregnancy studies on animals, which showed no problems in baby rats.
Johnson & Johnson has a different type of vaccine that uses a non-infectious cold virus as a carrier. Johnson & Johnson plans on studying the vaccine in pregnant women. It is still awaiting emergency use authorization from the FDA.
About 20,000 pregnant women have received the coronavirus vaccine in the U.S. With informal analysis, no red flags have popped up. The data has yet to be systemically reviewed and published.
