Vaccine
PREGNANCY RECOMMENDATION: Compatible
BREASTFEEDING RECOMMENDATION: No Human Data—Probably Compatible
PREGNANCY SUMMARY
The risk to the fetus from vaccination during pregnancy is unknown. The CDC recommends that if it is given during pregnancy, the woman should consult her health care provider or the vaccine manufacturer, because there are no data available on the safety of the vaccine during pregnancy (1). In one study, vaccination resulted in transfer of maternal antibodies to the fetus, but the transfer was irregular and was not dependent on maternal titer or the period in pregnancy when vaccination occurred (2). If meningococcal vaccine is given in pregnancy, health care professionals are encouraged to call the toll-free number 877-311-8972 for information about patient enrollment in the Organization of Teratology Information Specialists (OTIS) study.
FETAL RISK SUMMARY
Meningococcal vaccine is available in two formulations: meningococcal polysaccharide vaccine, groups A, C, Y, and W-135 combined (Menomune—A/C/Y/W-135), a freeze-dried product requiring reconstitution; and meningococcal (groups A, C, Y, and W-135) polysaccharide diphtheria toxoid conjugate vaccine (Menactra), a fluid product ready for administration. Either formulation is a killed bacteria (cell wall) vaccine (3,4).
Animal reproduction studies have not been conducted with Menomune (3). Reproduction studies have been conducted in mice with Menactra (4). A dose 900 times the human dose (based on body weight) had no effect on fertility, maternal health, embryo–fetal survival, or postnatal development (4). One of the 234 fetal skeletons examined had a cleft palate compared with none in the control group. This was the only skeletal and organ anomaly observed and was not thought to be related to the vaccine.
A 1998 study evaluated the pregnancy outcomes of 34 women who received meningococcal vaccine during pregnancy (5). The trimesters of exposures were 4 (11.8%) in the 1st, 17 (50.0%) in the 2nd, and 13 (38.2%) in the 3rd. There were 34 singleton deliveries with a mean follow-up of the offspring of 13.2 months (range 1–24 months). Excluding one congenital malformation, there was no increase in the observed unusual birth events compared with the expected rates. In fact, there were significantly fewer cases of newborn cardiac murmurs and physiologic jaundice in offspring of vaccinated mothers. One birth defect observed in an infant of a mother vaccinated at 33 weeks’ gestation was consistent with the oromandibular limb hypogenesis spectrum (Charlie M syndrome) (expected frequency <0.00002%). This pattern of defects would probably have occurred very early in gestation. The cause of Charlie M syndrome is unknown; it has not yet been identified as a genetic defect and it has not been associated with teratogens. All of the infants had normal growth and development in the follow-up period (5).
A 1994 review stated that the use of the vaccine during pregnancy is controversial (6). However, in a 1996 study, 75 mothers received meningococcal vaccine in the last trimester of pregnancy (7). No adverse effects in the newborns attributable to the vaccine were observed.
BREASTFEEDING SUMMARY
No reports describing the administration of meningococcal vaccine during human lactation have been located.
References
1.CDC. Guidelines for Vaccinating Pregnant Women. Available at http://www.cdc.gov/vaccines/pubs/preg-guide.htm. Accessed May 16, 2010.
2.Carvalho ADA, Giampaglia CMS, Kimura H, Pereira OADC, Farhat CK, Neves JC, Prandini R, Carvalho EDS, Zarvos AM. Maternal and infant antibody response to meningococcal vaccination in pregnancy. Lancet 1977;2:809–11.
3.Product information. Menomune—A/C/Y/W-135. Sanofi Pasteur, 2005.
4.Product information. Menactra. Sanofi Pasteur, 2007.
5.Letson GW, Little JR, Ottman J, Miller GL. Meningococcal vaccine in pregnancy: an assessment of infant risk. Pediatr Infect Dis 1998;17:261–3.
6.Linder N, Ohel G. In utero vaccination. Clin Perinatol 1994;21:663–74.
7.O’Dempsey TJD, McArdle T, Ceesay SJ, Banya WAS, Demba E, Secka O, Leinonen M, Kayhty H, Francis N, Greenwood BM. Immunization with a pneumococcal capsular polysaccharide vaccine during pregnancy. Vaccine 1996;14:963–70.