Covid vaccines from Pfizer and Moderna not linked to malformations in babies after first trimester injection, study finds
Top line
There is no evidence of major birth defects in babies born to mothers vaccinated against COVID-19 during the first trimester of pregnancy, according to new research published Monday in JAMA Pediatrics, highlighting the safety of vaccination during pregnancy amid growing evidence of the serious health risks infections can pose to mothers and babies.
The study provides additional data supporting the safety and effectiveness of Covid vaccines during pregnancy.
Highlights
Exposure to the Pfizer and Moderna mRNA Covid vaccines during the first trimester of pregnancy was “not associated with an increased risk” of major birth defects, including problems with the eyes, ears, neural tube, kidneys, respiratory system and musculoskeletal system, according to a team of researchers from across the United States.
The findings come from an analysis of health data covering more than 42,000 live birth pregnancies between early March 2021 and late January 2022 that were recorded in the Vaccine Safety Datalink database from eight health systems in California, in Oregon, Washington, Colorado, Minnesota and Wisconsin.
Nearly a fifth of pregnant women, or about 7,600, received a dose of an mRNA Covid vaccine in the first trimester – one of the most vulnerable periods of pregnancy for harmful exposures and birth defects – the researchers said, with 19,000 not having received a vaccine before or during pregnancy and 13,500 receiving a dose in their second or third trimester but not in the first.
This dose was the second dose given to about 1,350 vaccinated pregnant women during their first trimester, the researchers said, with about 46% of the group receiving their second dose during the second or third trimester and 20% receiving a third dose. reminder.
The researchers said their findings indicated no increased risk of major structural birth defects after first-trimester vaccination, adding that this was consistent with the handful of other studies conducted in Scotland and Israel that aimed to comprehensively assess the association between maternal vaccination and birth defects in infants.
The findings, which only apply to the Pfizer and Moderna COVID-19 vaccines, “should provide reassurance to pregnant women and their obstetric care providers,” the researchers said.
Key context
Researchers and officials are understandably very cautious about giving newly approved health products to pregnant women because of the risks to the parents and child. This is especially true during early pregnancy, when the risks of exposure to potential dangers are higher and for newer technologies, such as mRNA vaccines, which have been less widely studied in the population than more established products. , and where drug manufacturers systematically exclude pregnant women. testing for safety reasons. This caution was on full display during the early stages of the vaccine rollout during the COVID-19 pandemic, when vaccines were new and less was known about the virus and the risks it posed to pregnant women. and infants. There was little or no data then on vaccinating pregnant women, and experts and major health agencies around the world, including the World Health Organization, were divided on how to proceed, sometimes discouraging and encouraging sometimes pregnant women get vaccinated. Experts and top health authorities are now widely encouraging pregnant people to get vaccinated without delay and there is a growing body of evidence highlighting the serious health risks to mother and baby from Covid infections, including problems respiratory, premature births, stillbirths and neurological and developmental problems. Research also suggests that maternal vaccination can protect the baby during the first six months of life.
Tangent
The Centers for Disease Control and Prevention (CDC) recommends vaccination at any time during pregnancy and says studies worldwide of hundreds of thousands of people show that vaccination before and during pregnancy is safe , effective and beneficial “for both the pregnant woman and the baby”. mRNA vaccines reduce the risk of severe illness and other health effects from COVID-19 during pregnancy, the CDC said, while helping to form protective antibodies that can protect the baby. The agency emphasizes that “the benefits of receiving a COVID-19 vaccine outweigh the potential risks of vaccination during pregnancy.”
What we don’t know
Data on side effects, particularly rare ones, can take time to emerge and are difficult to collect on relatively small samples, such as those of pregnant people. The researchers said their results only considered singleton births, as well as pregnancies ending in live birth, which would naturally exclude any abnormalities leading to stillbirth or similar outcomes, because those data were not captured in the available database. Some other problems can take time to emerge, the researchers acknowledged, and although they were only able to assess abnormalities up to four months after birth, they said that this time frame had been shown to have strong predictive value in the past.
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