10-year review reveals no new, unexpected concerns for women vaccinated during pregnancy
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A 10-year review of the Vaccine Adverse Events Reporting System demonstrated no new or unexpected concerns regarding vaccine safety among women who were vaccinated during pregnancy.
The findings were presented during the Virtual Annual Conference on Vaccinology Research sponsored by the National Foundation for Infectious Diseases.
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“My previous research has been in drug safety in relation to women and pregnant women,” Salena Marie Preciado, MS, PhD student at Chapman University School of Pharmacy in Orange, CA, told Healio. “We then decided to look specifically at vaccine safety since we know women have some concerns about getting vaccinated while pregnant due to alleged safety concerns. Therefore, we deemed it necessary to examine this further and determine if there truly are reasons for this apprehension.”
Preciado and colleagues examined the Vaccine Adverse Events Reporting System (VAERS) for reports from Jan. 1, 2010 through Oct. 14, 2019, to identify pregnancy reports for women aged 12 to 44 years. The researchers classified serious adverse events (AEs) as resulting in death, life-threatening, hospitalization, ED visit and disability; they further classified pregnancy-related AEs as serious and nonserious. The researchers also calculated descriptive statistics, including reporting rates, to describe AEs by vaccine type and severity.
According to Preciado, the review found no new or unexpected vaccine safety concerns among pregnant women.
In total, VAERS received 3,846 reports for pregnant women during the time period analyzed. Of those, 1,042 (27%) cited a serious AE and 1,012 (26%) mentioned a pregnancy-related serious AE. The maternal mean age was 26 years.
The researchers found that the most frequent reports of AEs were for HPV-quadrivalent (n = 955), tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (n = 589) and varivax-varicella virus live (n = 467) vaccines. Pregnancy-related serious AEs included 862 spontaneous abortions at less than 20 weeks, 292 miscarriages, 63 stillbirths at more than 20 weeks, 51 preterm deliveries at less than 37 weeks, 11 preterm labors and eight birth defects. Effects of serious AEs included five deaths (0.1%), 36 life-threatening events (0.9%), 892 ED visits (23%), 223 hospitalizations (5.8%) and 42 disabilities (1.1%).
Proportional reporting ratios screening criteria were reached for one of the Tdap vaccines and ectopic pregnancy (proportional reporting ratio, 2; 95% CI, 1.1-4.8). The researchers found no safety signals for all other vaccines.
“The findings of our study confirm and reassure the safety of vaccination during pregnancy following clinical recommendations,” Preciado said. “We expect these results will encourage women to pursue vaccination during pregnancy given the benefit for maternal and infant health.”
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Preciado SM, et al. Surveillance of vaccine adverse events in pregnant women reported to the vaccine adverse events reporting system (2010-2019). Presented at: NFID Annual Conference on Vaccinology Research; June 18-19, 2020 (virtual meeting).
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