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Pfizer-BioNTech said on Thursday it was beginning clinical trials of its Covid-19 vaccine in pregnant women, the first such trials to include pregnant women in the United States.
The drugmaker aims to enroll around 4,000 pregnant women in the trials, which will include participants in the United States as well as Argentina, Brazil, Canada, Chile, Mozambique, South Africa, Spain and the United States. United Kingdom Women over 18 and aged 24 to 34 weeks during their pregnancy will be eligible.
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The first doses will be administered in the United States, Pfizer said.
Dr Brenna Hughes, a maternal and fetal medicine specialist at Duke Health in Durham, North Carolina, said she “absolutely applauded” Pfizer’s study of its vaccine in pregnant women.
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“Any data to help reassure pregnant patients that the vaccine is safe for them is desperately needed,” said Hughes, a fellow of the American College of Obstetricians and Gynecologists.
“We are proud to begin this study in pregnant women and to continue to gather evidence on the safety and efficacy to potentially support the use of the vaccine by large subpopulations,” said Dr William Gruber, senior vice president of clinical vaccine research at Pfizer. in a report.
Some women will receive the real injections, while others will receive a placebo. They will not know what type they received before delivery. At this point, women who have received the placebo will be offered the vaccine.
Researchers will watch for negative side effects in women, including miscarriages. There is some preliminary data on safety during pregnancy, as some women participating 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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There is, however, some evidence that Covid-19 itself could be harmful to pregnant women.
According to the Centers for Disease Control and Prevention, pregnant women who are infected with SARS-CoV-2, the virus that causes Covid-19, have an increased risk of complications, including premature labor and the need to be put on a ventilator.
“We are in a pandemic,” said Hughes. “We’re not really in a situation where we can take the risk and, in my opinion, not offer the vaccine to all the potential individuals who might benefit from it.”
There is currently no clear guidance from the CDC on whether pregnant women should be vaccinated against Covid-19. The agency says women “can choose to be vaccinated.”
The Pfizer study will also follow newborns for six months after birth to see if the mother’s antibodies are passed to the infants.
There is precedent for such protection. Babies born to women who have received the influenza vaccine have a level of protection against the flu for at least six months, until they too can receive the vaccine.
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