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Scooped by
Juan Lama
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BACKGROUND Many pregnant persons in the United States are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. METHODS From December 14, 2020, to February 28, 2021, we used data from the “v-safe after vaccination health checker” surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. RESULTS A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). CONCLUSIONS Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes. Published in NEJM (June 17, 2021): https://doi.org/10.1056/NEJMoa2104983 See also NEJM (June 17, 2021): https://doi.org/10.1056/NEJMe2107070
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Scooped by
Juan Lama
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For the vast majority of us, 2021 is poised to be the year we each get the COVID-19 vaccine. But for women who are pregnant or breastfeeding there's a question about whether or not they should take it. They weren't included in the vaccine trials. SAN FRANCISCO (KGO) -- For the vast majority of us, 2021 is poised to be the year we each get the COVID-19 vaccine. But for women who are pregnant or breastfeeding there's a question about whether or not they should take it. They weren't included in the vaccine trials. Serena Meyer is a registered nurse and lactation consultant who runs the popular Facebook group, "Bay Area Breastfeeding Support." She says many of the women in her group have expressed concerns. "The topic of, 'Is this safe? Do I have to ween?' has come up quite a bit," Meyer said. Alison Flower, a frontline health care worker in Oakland and mom to a 10-month-old, is one of those members. "Any mom is going to be scared about protecting their kid. Any mom is going to be scared about protecting their pregnancy," Flower said. "I think all of us just want to do what is best for our children." So, is it safe? According to Dr. Stephanie Gaw, an Assistant Professor of maternal-fetal medicine at UCSF who has been studying the impacts of COVID-19 on pregnant women, the medical consensus is yes. "Scientifically, there's probably very, very low risk of anything bad happening during pregnancy with the vaccine, but we don't have any direct proof yet because it hasn't been studied, unfortunately," Dr. Gaw explained. Although there is no clinical data yet, Dr. Gaw said there were roughly 20 participants in the COVID-19 vaccine trials who ended up getting pregnant or were vaccinated before they knew they were pregnant. "There were no adverse outcomes," she said. "But of course the number is too low to really know how it would impact the broader community." Still, she said there are other reasons to believe the vaccine is safe. For one, Dr. Gaw said, the vaccine does not contain any live virus, which is something pregnant women are often advised to avoid. (For instance, the measles vaccine does contain live virus and is not recommended during pregnancy.) It's also a matter of assessing the risk versus the potential benefits. "The potential benefits of a vaccine working are great...we know COVID-19 is really dangerous in pregnancy," Dr. Gaw said. Both Dr. Gaw and Meyer are advising their patients to take the vaccine, especially if they are not able to fully quarantine and have the potential to be exposed. "Somehow pregnant people become these unicorns that can't have healthcare," Meyer said. "I don't think that's helpful." Dr. Gaw is now beginning a new study that will look at the impacts of the vaccine on pregnant women. She's hoping to have some preliminary data in six months. Until then, there is a little bit of an unknown. She said ultimately it's up to each individual woman, along with her doctor, to make the decision. "Talk to your family, your own risk," she said. "If I were pregnant right now I would get it. Definitely."
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Scooped by
Juan Lama
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In an early analysis of coronavirus vaccine safety data, researchers at the Centers for Disease Control and Prevention have found no evidence that the Pfizer-BioNTech or Moderna vaccines pose serious risks during pregnancy. The findings are preliminary and cover just the first 11 weeks of the U.S. vaccination program. But the study, which included self-reported data on more than 35,000 people who received one of the vaccines during or shortly before pregnancy, is the largest yet on the safety of the coronavirus vaccines in pregnant people. During the clinical trials of the vaccines, pregnant women were excluded. That left patients, doctors and experts unsure whether the shots were safe to administer during pregnancy. “There’s a lot of anxiety about whether it’s safe and whether it would work and what to expect as far as side effects,” said Dr. Stephanie Gaw, a maternal-fetal medicine specialist at the University of California, San Francisco. The new data, Dr. Gaw said, demonstrate that “a lot of pregnant people are getting the vaccine, there isn’t a significant increase in adverse pregnancy effects at this point, and that side effect profiles are very similar to nonpregnant people.” “I think that’s all very reassuring,” she said, “and I think it will really help providers and public health officials more strongly recommend getting the vaccine in pregnancy.” Covid-19 poses serious risks during pregnancy. Pregnant women who develop symptoms of the disease are more likely to become seriously ill, and more likely to die, than nonpregnant women with symptoms.Beca use of those risks, the C.D.C. has recommended that coronavirus vaccines be made available to pregnant women, though it also suggests that they consult with their doctors when making a decision about vaccination. The new study, which was published on Wednesday in The New England Journal of Medicine, is based largely on self-reported data from V-safe, the C.D.C.’s coronavirus vaccine safety monitoring system. Participants in the program use a smartphone app to complete regular surveys about their health, and any side effects they might be experiencing, after receiving a Covid-19 vaccine. The researchers analyzed the side effects reported by V-safe participants who received either the Pfizer or Moderna vaccine between Dec. 14, 2020, and Feb. 28, 2021. They focused on 35,691 participants who said that they had been pregnant when they received the vaccine or became pregnant shortly thereafter. After vaccination, pregnant participants reported the same general pattern of side effects that nonpregnant ones did, the researchers found: pain at the injection site, fatigue, headaches and muscle pain. Women who were pregnant were slightly more likely to report injection site pain than women who were not, but less likely to report the other side effects. They were also slightly more likely to report nausea or vomiting after the second dose. Pregnant V-safe participants were also given an opportunity to enroll in a special registry that tracked pregnancy and infant outcomes. By the end of February, 827 of those enrolled in the pregnancy registry had completed their pregnancies, 86 percent of which resulted in a live birth. Rates of miscarriage, prematurity, low birth weight and birth defects were consistent with those reported in pregnant women before the pandemic, the researchers report. “This study is of critical importance to pregnant individuals,” Dr. Michal Elovitz, a maternal-fetal medicine specialist at the University of Pennsylvania, said in an email. “It is very reassuring that there were no reported acute events in pregnant individuals” over the course of the study, she said. But the report has several limitations and much more research is needed, experts said. Enrollment in the surveillance programs is voluntary and the data are self-reported. In addition, because the study period encompassed just the first few months of the U.S. vaccination campaign, the vast majority of those enrolled in the pregnancy registry were health care workers. And there is not yet any data on pregnancy outcomes from people who were vaccinated during the first trimester of pregnancy. “I think we can feel more confident about recommending the vaccine in pregnancy, and especially with pregnant people that are at risk of Covid,” Dr. Gaw said. “But we do need to wait for more data for complete pregnancy outcomes from vaccines early in pregnancy.” Findings published in NEJM (April 21, 2021): https://doi.org/10.1056/NEJMoa2104983
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