Pfizer-BioNTech said on Thursday that it is starting clinical trials of its Covid-19 vaccine on pregnant women, the first to include pregnant women in the United States.
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The pharmaceutical company plans to enroll about 4,000 pregnant women in the trials, which will include participants in the United States, as well as in Argentina, Brazil, Canada, Chile, Mozambique, South Africa, Spain and the United Kingdom. Women over the age of 18 and 24 to 34 weeks pregnant are 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 “fully applauds” Pfizer’s study of her vaccine in pregnant women.
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“Any data to help reassure pregnant patients that the vaccine is safe for them is sorely needed,” said Hughes, a member of the American College of Obstetricians and Gynecologists.
“We are proud to initiate this study in pregnant women and continue to gather evidence on safety and efficacy to potentially support the use of the vaccine by important subpopulations,” said Dr. William Gruber, senior vice president of Clinical Vaccine Research at Pfizer. in a statement.
Some women will receive real injections, while others will receive a placebo. They will not know what type they received until after delivery. At that point, women who received the placebo will receive the vaccine.
The researchers will monitor any negative side effects in women, including miscarriage. There are some preliminary data on safety during pregnancy, because some women in previous studies of the Covid-19 vaccine became pregnant while participating in clinical trials.
“From everything we’ve seen so far from pregnant women who received the vaccine, there are no warning signs,” said Stacey Stewart, president of the March of Dimes.
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There is, however, evidence that Covid-19 itself can be harmful to pregnant women.
According to the 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 for ventilation.
“We are in a pandemic,” said Hughes. “We are not really in a situation where we can take the risk and, in my opinion, not offer the vaccine to all potential individuals who could benefit.”
Currently, there is no clear guidance from the CDC on whether pregnant women should receive Covid-19 vaccination. The agency says women “can choose to be vaccinated”.
The Pfizer study will also monitor newborns for six months after birth to see if the mother’s antibodies are transferred to the babies.
There are precedents for such protection. Babies born to women who received the flu vaccine have a level of protection against the flu for at least six months, until they can also receive the vaccine.
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