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Pfizer and Modern COVID-19 vaccines appear to be safe in pregnant patients, according to preliminary results published in the New England Journal of Medicine.
The Centers for Disease Control and Prevention has said that pregnant women are at increased risk for serious COVID-19 diseases; however, this group was excluded from major clinical trials that led to current vaccine approvals.
But based on the new findings, Rochelle Walensky, MD, director of the CDC, announced during a White House COVID-19 briefing that the CDC recommends that pregnant women receive the COVID-19 vaccine.
The new study, which analyzed data between December 14, 2020 and February 28, 2021, from three federal databases, adds to a limited set of vaccine safety and efficacy data. in pregnant women. The researchers did not include people who received the Johnson & Johnson vaccine because it received an emergency use permit on Feb. 27, just a day before the cut study.
“Our hope is that these initial data will be reassuring for pregnant women and their health care providers, as well as for the public, and will help increase vaccination rates,” said the author of a research, Christine Olson, MD, in an interview. “While the data are preliminary and will continue to be analyzed as more reports become available, our findings are reassuring.”
For the study, Olson and colleagues analyzed data from the v-safe survey, data from v-safe pregnancy registrants, and adverse event reporting system reports. vaccines (VAERS).
The researchers found that 86% of pregnancies resulted in a live birth, 12.6% resulted in miscarriages, and 0.1% resulted in a stillbirth. They also found that among live births, 9.4% were premature, 3.2% of babies were small gestational age, and 2.2% had congenital anomalies.
The researchers also found that pain at the injection site, fatigue, and headaches were reported more frequently in pregnant patients than in those who were not pregnant. Among VAERS reports, they found that 70% of adverse events were not specific to pregnancy. Nearly 30% involved pregnancy-specific or neonatal adverse events. The most frequently reported pregnancy-related events were miscarriages, followed by stillbirths, premature rupture of membranes and vaginal bleeding.
“I think the results are really reassuring, as the proportion of pregnancy outcomes, such as pregnancy loss and the health effects of newborns are really quite consistent with what we would expect in the population’s background rate, “Walensky said in a podcast that accompanied the study.” Therefore, this study adds to the growing evidence confirming that pregnant women develop an immune response to COVID-19 vaccination without any adverse events for the mother or fetus so far. “
The researchers said the limitations of the study include the accuracy of self-reported data and that there is limited information on other possible risk factors for adverse pregnancies and neonatal outcomes. They recognized that continued follow-up is needed to examine maternal safety and pregnancy outcomes in the early stages of pregnancy and during the preconception period.
David Jaspan, DO, president of the obstetrics and gynecology department at Einstein Medical Center in Philadelphia, who did not participate in the study, said in an interview that despite the limitations, the study provides much-needed information about safety and security of the vaccine. efficacy in pregnant patients.
“In December we had no data on any pregnant patients,” Jaspan said. “And now just four months later, this document [has data from] it had at least 35,000 people. We can’t answer all the questions, but today we have more answers than we had just 4 months ago. “
Olson hopes the current data will be enough to help make decisions about pregnant patients and their health care providers when deciding on COVID-19 vaccination.
The study author and the interviewed experts did not reveal any relevant financial relationship.
This article originally appeared on MDedge.com, which is part of the Medscape professional network.