Moderna will begin studying its COVID-19 vaccine in pregnant women, according to a posting on ClinicalTrials.gov. The trial, which has not yet begun recruiting, is aiming to enroll about 1,000 females over 18 who will be studied over a 21-month period.
Women who have been exposed to the Moderna COVID-19 vaccine during the 28 days prior to their last menstrual period, or at any time during pregnancy are eligible.
Moderna shares rose over 3% during Monday's session.
The brief summary of the trial states that the main goal is "to evaluate the outcomes of pregnancy in females exposed to the Moderna COVID-19 vaccine (mRNA-1273) during pregnancy." The study will measure the number of participants who have infants with suspected major and minor congenital malformations, the number of participants with any pregnancy complications, the number of participants with any pregnancy outcomes and the number of participants with infant outcomes.
The study’s estimated start time is July 22, with an estimated primary completion date of Dec. 9, 2023.
Currently, the Centers for Disease Control and Prevention states that pregnant women can get a COVID-19 vaccine, but clinical trials specifically studying the jabs among this population were not done when the Food and Drug Administration granted any of the vaccines' emergency use authorization. Since then, several trials have either gotten underway or have been planned.
Current data collected from the CDC and FDA safety monitoring systems "did not identify any safety concerns for pregnant people who were vaccinated or their babies," but the agencies stress that the findings are preliminary.
Moderna did not issue a press release regarding the trial prior to the posting. Inquiries to Moderna by FOX Business were not immediately returned.