By DR. STEPHANIE WIDMER, ABC News
(NEW YORK) — Pfizer and BioNTech have announced a new trial to evaluate their COVID-19 vaccine in pregnant women.
Their vaccine, along with Moderna’s, are the two mRNA vaccines currently available in the United States after being granted Emergency Use Authorization by the Food and Drug Administration.
Pregnant women were excluded from the first clinical trials, meaning there’s limited data in this group. The Centers for Disease Control and Prevention says getting vaccinated is a personal choice for anyone who is pregnant, and recommends people speak to their health care providers if they have questions about relative risks.
Pfizer’s trial will help offer more conclusive data about the vaccine’s safety and effectiveness in pregnant women.
The phase 2/3 trial will enroll approximately 4,000 women within weeks 24-34 of their pregnancy, Pfizer announced in a press release.
Half will get the vaccine, and half will get a placebo
The study will include healthy, pregnant woman age 18 and older in the U.S., Canada, Argentina, Brazil, Chile, Mozambique, South Africa, the United Kingdom and Spain.
Participants in the vaccine group will receive two doses at 21 days apart — and each woman will be followed for at least 7-10 months in order to continuously assess for safety in both participants and their infants.
Infants will also be assessed, up until 6 months of age, for transfer of protective antibodies from their vaccinated mother.
Women enrolled in the trial will be made aware of their vaccine status shortly after giving birth to allow those women who originally received placebo to be vaccinated while staying in the study.
“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,” Dr. William Gruber, senior vice president of Vaccine Clinical Research and Development for Pfizer, stated in the release.
Dr. Stephanie Widmer is an emergency medicine physician and medical toxicology fellow in New York and a contributor to the ABC News Medical Unit.
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