tetano
Editor, Senior Moderator
N Engl J Med
. 2021 Apr 21.
doi: 10.1056/NEJMoa2104983. Online ahead of print.
Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons
Tom T Shimabukuro[SUP] 1 [/SUP], Shin Y Kim[SUP] 1 [/SUP], Tanya R Myers[SUP] 1 [/SUP], Pedro L Moro[SUP] 1 [/SUP], Titilope Oduyebo[SUP] 1 [/SUP], Lakshmi Panagiotakopoulos[SUP] 1 [/SUP], Paige L Marquez[SUP] 1 [/SUP], Christine K Olson[SUP] 1 [/SUP], Ruiling Liu[SUP] 1 [/SUP], Karen T Chang[SUP] 1 [/SUP], Sascha R Ellington[SUP] 1 [/SUP], Veronica K Burkel[SUP] 1 [/SUP], Ashley N Smoots[SUP] 1 [/SUP], Caitlin J Green[SUP] 1 [/SUP], Charles Licata[SUP] 1 [/SUP], Bicheng C Zhang[SUP] 1 [/SUP], Meghna Alimchandani[SUP] 1 [/SUP], Adamma Mba-Jonas[SUP] 1 [/SUP], Stacey W Martin[SUP] 1 [/SUP], Julianne M Gee[SUP] 1 [/SUP], Dana M Meaney-Delman[SUP] 1 [/SUP], CDC v-safe COVID-19 Pregnancy Registry Team
Affiliations
Abstract
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.
. 2021 Apr 21.
doi: 10.1056/NEJMoa2104983. Online ahead of print.
Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons
Tom T Shimabukuro[SUP] 1 [/SUP], Shin Y Kim[SUP] 1 [/SUP], Tanya R Myers[SUP] 1 [/SUP], Pedro L Moro[SUP] 1 [/SUP], Titilope Oduyebo[SUP] 1 [/SUP], Lakshmi Panagiotakopoulos[SUP] 1 [/SUP], Paige L Marquez[SUP] 1 [/SUP], Christine K Olson[SUP] 1 [/SUP], Ruiling Liu[SUP] 1 [/SUP], Karen T Chang[SUP] 1 [/SUP], Sascha R Ellington[SUP] 1 [/SUP], Veronica K Burkel[SUP] 1 [/SUP], Ashley N Smoots[SUP] 1 [/SUP], Caitlin J Green[SUP] 1 [/SUP], Charles Licata[SUP] 1 [/SUP], Bicheng C Zhang[SUP] 1 [/SUP], Meghna Alimchandani[SUP] 1 [/SUP], Adamma Mba-Jonas[SUP] 1 [/SUP], Stacey W Martin[SUP] 1 [/SUP], Julianne M Gee[SUP] 1 [/SUP], Dana M Meaney-Delman[SUP] 1 [/SUP], CDC v-safe COVID-19 Pregnancy Registry Team
Affiliations
- PMID: 33882218
- DOI: 10.1056/NEJMoa2104983
Abstract
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.