Pfizer-BioNTech said on Thursday that it is beginning clinical trials of its Covid-19 vaccine in pregnant women, the first such studies to include expectant mothers in the United States.
The drug manufacturer aims to register about 4,000 pregnant women in the trials, which will include participants in the US as well as Argentina, Brazil, Canada, Chile, Mozambique, South Africa, Spain and the UK Women over 18 and who are 24 to 34 weeks pregnant will be justified.
The first doses will be administered in the United States, says Pfizer.
Dr. Brenna Hughes, a maternal-fetal medicine specialist at Duke Health in Durham, North Carolina, said she “absolutely applauds” Pfizer’s study of its vaccine in pregnant women.
“Any information that helps assure pregnant patients that the vaccine is safe for them is desperately needed,” said Hughes, a member of the American College of Obstetricians and Gynecologists.
“We are proud to launch this study on pregnant women and continue to gather evidence of 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 at Pfizer, in a statement.
Some of the women get the real pictures, while others get the placebo. They do not know what type they got until after the birth. At that time, women who received placebo will be offered the vaccine.
Researchers will monitor for any adverse side effects in women, including miscarriage. There are some preliminary data on safety during pregnancy, as some women in previous studies of the Covid-19 vaccine became pregnant while participating in clinical trials.
“From everything we see so far from pregnant women who have received the vaccine, there are no red flags,” said Stacey Stewart, president of the March of Dimes.
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However, there is evidence that Covid-19 itself may be harmful to expectant mothers.
According to Centers for Disease Control and Prevention, pregnant women infected with SARS-CoV-2, the virus that causes Covid-19, have an increased risk of complications, including premature birth and the need to be put in a ventilator.
“We are in a pandemic,” Hughes said. “We are not in a situation where we can take the risk and in my opinion not offer the vaccine to all potential individuals who can benefit from it.”
There is currently no clear guidance from the CDC on whether pregnant women should receive Covid-19 vaccination. The agency says women “may choose to be vaccinated.”
Pfizer’s study will also follow newborns for six months after birth to see if antibodies from the mother are transmitted to the infant.
There is a precedent for such protection. Infants born to women who got the flu shot have a level of protection against the flu for at least six months until they can also get the vaccine.
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