Two front runners for COVID-19 vaccines from Pfizer and Moderna pharmaceutical companies await authorization from the Food and Drug Administration. However, since pregnant women were not included in the clinical trials, the Centers for Disease Control and Prevention’s advisory committee announced on Tuesday it would not recommend the vaccine for this population.
According to ABC News, Dr. Rashmi Rao, an assistant clinical professor of obstetrics and gynecology at UCLA Medical Center, and an expert in maternal-fetal medicine, said, ”We just don’t have any data to say that’s OK yet, because pregnant women weren’t included in the trials.”
Dr. Ruth Faden, the founder of the Johns Hopkins Berman Institute of Bioethics, told ABC News that mothers-to-be are seldom included in clinical trials to ensure the safety of the fetus and to avoid legal liabilities around giving pregnant women an experimental drug or vaccine.
”There’s a huge gap between what we know about the safety and effectiveness of a new drug or a new vaccine for the rest of the population and what we know about it specific to pregnancy,” she said.
However, even though the COVID-19 vaccines did not include pregnant women in clinical trials, some volunteers may have become pregnant during the trials which would give researchers a glimpse into the efficacy and safety of the vaccines in this population subset, experts told ABC News.
COVID-19 researchers have been outspoken about the need to have drug trials that include pregnant and lactating women. Even though these women were not included in early trials on the drug remdesivir, many doctors prescribed the drug for their pregnant COVID-19 patients anyway, under compassionate-use guidelines, to save their lives.
The obvious reason researchers shy away from using pregnant women in clinical trials for any sort of drug is that they don’t know what effect it can have on the developing fetus. According to The Wall Street Journal, thalidomide and diethylstilbestrol, known as DES, were once prescribed to pregnant women until it was found they caused serious health problems for fetuses.
The Coalition to Advance Maternal Therapeutics wrote to the heads of the National Institutes of Health and the Food and Drug Administration last spring urging them to find ways to include pregnant women and lactating women in their COVID-19 vaccine and therapeutics development, said the Journal.
Fortunately, the University of Pennsylvania said it is allowing both pregnant and lactating women to enroll in its two convalescent plasma trials for COVID-19 patients. This will give physicians more information on how to safely treat this group of patients.
Neither Pfizer nor Moderna have announced when they will include pregnant women in their vaccine clinical trials.
Dr. Rao suggested that pregnant women wait until they are eligible to get vaccinated if the FDA clears the current vaccine candidates for the general public.
”If you are pregnant you will likely have to wait until you are no longer pregnant or until we gather more data regarding safety and pregnancy,” she told ABC News.
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