The Food and Drug Administration will likely recommend against giving the Pfizer vaccine to pregnant women, according to a report.
Women who are pregnant, breastfeeding or planning a pregnancy are excluded from vaccination programs because inoculation candidates were not tested on such demographic during trials, The Washington Post reported.
“I think the recommendation will be that pregnant women not receive this vaccine until we know more,” Dr. Paul Offit, a member of the agency’s Vaccines and Related Biological Products Advisory Committee, told CNN.
“However, as shown in this trial, whenever you do any sort of large clinical trial, invariably you do get pregnant women because women don’t find out they’re pregnant until after they’ve gotten one or two doses,” he said.
“So there were about two dozen women in this trial that were pregnant and there doesn’t appear to be any harmful effects on them, but their babies haven’t been born yet to find out,” Offit added.
He said this also will happen when the vax rolls out to health care workers and people in long-term care facilities. Some of those inoculated will invariably include pregnant women.
On Friday, Health and Human Services Secretary Alex Azar said Pfizer’s vaccine will get the green light for use in the US by the FDA — and that vaccinations could begin as early as Monday.
Medical experts acknowledge that — given a lack of scientific data on how vaccines interact with pregnancies — there is insufficient evidence to safely recommend their use, according to The Washington Post.
But some also describe that as a manifestation of a more widespread problem — and urge for trials to begin including pregnant and breastfeeding women.
“The lack of vaccination data on pregnant and breastfeeding people is definitely important as it means it’s not truly inclusive data, but also — women make up a significant portion of the healthcare workforce,” Saskia Popescu, an infectious-disease epidemiologist at the University of Arizona, told the paper in an email.
“Moreover, we have seen that pregnant women are at risk for severe disease and preterm birth as a result of SARS-CoV-2 infection. The vaccines are still very new but we really need to be mindful of these knowledge gaps and that moving forward, we will need to address them both from a safety standpoint, but also an ethical one,” added Popescu, who also advises the European Center for Disease Prevention and Control.
Pregnant women and kids have historically been excluded from early vaccine trials because they are classified as more vulnerable populations, said Alyson Kelvin, an infectious-disease researcher at the Canadian Center for Vaccinology and Dalhousie University, told The Washington Post.
Pregnant women are “immunologically different” to protect the developing fetus, added Kelvin, so “pregnant women might have a different response” to a vaccine “when she’s pregnant versus when she’s not pregnant.”
Ruth Faden, founder of Johns Hopkins University’s bioethics institute, recently urged the FDA to permit pregnant and lactating women to receive the Pfizer vaccine while acknowledging the unknown safety implications.
On Thursday, Dr. Anthony Fauci said drugmakers and US regulators plan to launch clinical trials in January testing the safety of vaccines on pregnant women and young children, CNBC reported.
Fauci, the director of the National Institute of Allergy and Infectious Diseases, said in a discussion sponsored by Columbia University that pregnant women have so far not been included in any vaccine clinical trials.
He said studies on pregnant women will come in later trials.
“That will not necessarily be looking at efficacy, but we’ll be looking at safety and immunogenicity to bridge to the efficacy in the adult non-pregnant population,” he said at Columbia University’s Grand Rounds 2020 event. “The same holds true for the pediatric population. Those studies will probably start in mid- to late-January.”