Jorgensen said the study “does provide more reassuring data on the safety of these vaccines for the newborns and infants.” The researchers aimed to measure whether the babies of mothers vaccinated during pregnancy had any elevated risks of health problems. Jorgensen, a pharmacist and postdoctoral fellow at the University of Toronto, told us. The study was a safety study and was not meant to assess vaccine effectiveness in pregnant women, co-author Sarah C. This contradicts the conclusions of the authors of the paper, who wrote, “Maternal mRNA COVID-19 vaccination during pregnancy was not associated with increased adverse newborn and early infant outcomes and may be protective against adverse newborn outcomes.” We reached out to McCullough with questions but did not receive a response. “Surely there was no benefit of COVID-19 vaccination, so why expose mothers and infants to any risk at all?” the newsletter misleadingly concluded. The newsletter focused on the new JAMA Pediatrics study on vaccine safety, also claiming that it found “No Assurances on Safety.” Peter McCullough, a prolific spreader of vaccine misinformation. Going against the now-extensive record on COVID-19 vaccines and pregnancy, a recent Instagram post claimed that there is “No Discernable Benefit of COVID-19 Vaccination in Pregnancy.” The post was quoting a Substack newsletter from Dr. 23 in JAMA Pediatrics adds to the evidence that the mRNA COVID-19 vaccines are safe and do not lead to problems for newborn babies and infants when given to their mothers during pregnancy. Research does not show increased risk of miscarriage, birth defects or other pregnancy complications after vaccination, and it indicates vaccination may reduce the risk of preterm birth and stillbirth. The mRNA COVID-19 vaccines come with similar side effects regardless of whether a person is pregnant. Maternal vaccination reduces these risks. Young babies also are particularly vulnerable to hospitalization from COVID-19. Pregnancy puts people at elevated risk of severe COVID-19. The CDC and FDA vaccine safety monitoring systems, which were expanded for the COVID-19 vaccines and also include a new smartphone-based reporting tool called v-safe, have subsequently identified only a few, very rare adverse events.įor more, see “ How safe are the vaccines? ” In the case of the COVID-19 vaccines, randomized controlled trials involving tens of thousands of people, which were reviewed by multiple groups of experts, revealed no serious safety issues and showed that the benefits outweigh the risks. to identify adverse events related to vaccination in near real time. The information is still valuable because it’s a way of being quickly alerted to a potential safety issue with a vaccine, which can then be followed-up by government scientists.Īnother monitoring system is the CDC’s Vaccine Safety Datalink, which uses electronic health data from nine health care organizations in the U.S. There is no screening or vetting of the report and no attempt to determine if the vaccine was responsible for the problem. As its website explains, VAERS “is not designed to detect if a vaccine caused an adverse event, but it can identify unusual or unexpected patterns of reporting that might indicate possible safety problems requiring a closer look.”Īnyone can submit a report to VAERS for any health problem that occurs after an immunization. One key vaccine safety surveillance program is the Vaccine Adverse Event Reporting System, or VAERS, which is an early warning system run by the Centers for Disease Control and Prevention and FDA. In addition, the Food and Drug Administration inspects vaccine production facilities and reviews manufacturing protocols to make sure vaccine doses are of high-quality and free of contaminants. No vaccine or medical product is 100% safe, but the safety of vaccines is ensured via rigorous testing in clinical trials prior to authorization or approval, followed by continued safety monitoring once the vaccine is rolled out to the public to detect potential rare side effects.
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