Vaccine, Poliovirus Live in Pregnancy and Breastfeeding
Fetal Risk Summary
Poliovirus vaccine live (Sabin vaccine; OPV; TOPV) is a live, trivalent (types 1, 2, and 3) attenuated virus strain vaccine administered orally (1).
Although fetal damage may occur when the mother contracts the disease during pregnancy, the risk to the fetus from the vaccine is unknown (1). A brief 1990 report found no increase in spontaneous abortions or adverse effect on the placenta or embryo following 1st-trimester use of oral poliovirus vaccine (2).
Both the American College of Obstetricians and Gynecologists and the Immunization Practices Advisory Committee (ACIP) recommend use of the vaccine during pregnancy only if an increased risk of exposure exists (1,3). If immediate protection against poliomyelitis is needed, the ACIP states that either the inactivated or oral vaccine may be used in accordance with the recommended schedules for adults (see Reference for specific details) (3). The inactivated vaccine, however, was preferred over the oral form because of a lower risk of vaccine-associated paralysis.
The Collaborative Perinatal Project monitored 50,282 mother-child pairs, 1,628 of whom had 1st-trimester exposure to oral live poliovirus vaccine (4, p. 315). Congenital malformations were observed in 114 (standardized relative risk [SRR] 1.11) of the newborns. Malformations identified with SRR >1.5 were gastrointestinal (GI) defects (SRR 1.67) and Downs' syndrome (SRR 1.60) (4, p. 319). Specific malformations with SRR >1.5 were omphalocele, 3 (SRR 5.4); malrotation of the GI tract, 5 (SRR 7.9); and any benign tumors, 7 (SRR 1.8) (4, p. 474). For use anytime in pregnancy, 3,059 mother-child pairs were exposed (4, p. 436). In this group, there were 44 malformed children (SRR 0.81) with the following specific malformations having SRR >1.5: Hirschsprung's disease, 4 (SRR 8.8); any benign tumors, 12 (SRR 1.7); and pectus excavatum, 8 (SRR 2.0) (4, p. 487). The authors of this study cautioned that these data are uninterpretable without independent confirmation from other studies and that any positive or negative association may have occurred by chance (4).
The death of a 3-month old male infant because of complications arising from bilateral renal dysplasia affecting predominantly the glomeruli was thought to be possibly caused by maternal vaccination with oral poliovirus vaccine during the 1st or 2nd month of pregnancy (5). A causal relationship, however, could not be established based on the pathologic findings.
A 19-year-old previously immune woman inadvertently received oral poliovirus vaccine at 18 weeks' gestation (6). For other reasons, she requested termination of the pregnancy at 21 weeks' gestation. Polio-like changes were noted in the small-for-dates female fetus (crown-rump and foot length compatible with 17.519 weeks' gestation) consisting of damage to the anterior horn cells of the cervical and thoracic spinal cord with more limited secondary skeletal muscle degenerative changes in the arm (6). Poliovirus could not be isolated from the placenta or fetal brain, lung, or liver. Specific fluorescent antibody tests for poliovirus types 2 and 3 were positive in the dorsal spinal cord but not at other sites.
In response to an outbreak of wild type 3 poliovirus in Finland, a mass vaccination program of adults was initiated with trivalent oral poliovirus vaccine in 1985, with 94% receiving the vaccine during about a 1-month period (7). Because Finland has compulsory notification of all congenital malformations detected during the first year of life, a study was conducted to determine the effect, if any, on the incidence of birth defects from the vaccine. In addition to all defects, two indicator groups were chosen because of their high detection and reporting rates: central nervous system defects and orofacial clefts. No significant changes from the baseline prevalence were noted in the three groups, but the data could not exclude an increase in less common types of congenital defects (7).
A follow-up to the above report was published in 1993 and included all structural malformations that occurred during the 1st trimester (8). The outcomes of approximately 9,000 pregnancies were studied, divided nearly equally between those occurring before, during, or after (i.e., one study and two Reference cohorts) the vaccination program. Women in the study group had been vaccinated during the 1st trimester (defined as from conception through 15 weeks). A total of 209 cases (2.3%) were identified from liveborns, stillborns, and known abortions. There was no difference in outcomes between the cohorts (the study had a statistical power estimate to detect an increase greater than 0.5%) (8).
The analysis of Finish women receiving the oral poliovirus vaccine during gestation was expanded to anytime during pregnancy in a 1994 report (9). The outcomes of three study groups (about 3,000 pregnant women vaccinated in each of the three trimesters of pregnancy) were compared with two Reference cohorts (about 6,000 pregnant women who delivered before the vaccination program and about 6,000 who conceived and delivered afterward). No differences were found between the study and Reference groups in terms of intrauterine growth or in the prevalences of stillbirth, neonatal death, congenital anomalies, premature birth, perinatal infection, and neurologic abnormalities (9). The authors concluded that the vaccination of pregnant women with the oral poliovirus vaccine, as conducted in Finland, appeared to be safe.
A 1993 report described the use of oral poliovirus vaccine in a nationwide (Israel) vaccination campaign, including pregnant women, after the occurrence of 15 cases of polio in the summer of 1988 (10). The investigators compared the frequency of anomalies and premature births in their area in 1988 (controls) with those in 1989 (exposed). In 1988, 15,021 live births occurred, with 204 malformed newborns (1.36%) and 999 (6.65%) premature infants. These numbers did not differ statistically from those in 1989; 15,696, 243 (1.55%), and 1,083 (6.87%), respectively. The authors concluded that oral poliovirus vaccine was preferred to the inactivated vaccine if vaccination was required during pregnancy (10).
In a follow-up of the Israel vaccination campaign, investigators measured the presence of neutralizing antibodies to the three poliovirus types in the sera of infants whose mothers had been vaccinated 27 weeks before delivery (11). In newborns, higher levels of protecting antibodies were found for poliovirus types 1 and 2 than for type 3, indicating less placental transfer and a greater risk of infection with poliovirus type 3.
Breast Feeding Summary
Human milk contains poliovirus antibodies in direct relation to titers found in the mother's serum. When oral poliovirus vaccine (Sabin vaccine, OPV) is administered to the breast-fed infant in the immediate neonatal period, these antibodies, which are highest in colostrum, may prevent infection and development of subsequent immunity to wild poliovirus (12,13,14,15,16,17,18,19,20,21,22 and 23). To prevent inhibition of the vaccine, breast feeding should be withheld 6 hours before and after administration of the vaccine, although some authors recommend shorter times (18,19,20,21 and 22).
In the United States, the ACIP and the Committee on Infectious Diseases of the American Academy of Pediatrics do not recommend vaccination before 6 weeks of age (4,24). At this age or older, the effect of the oral vaccine is not inhibited by breast feeding and no special instructions or planned feeding schedules are required (4,24,25,26,27 and 28).
- American College of Obstetricians and Gynecologists. Immunization during pregnancy. Technical Bulletin. No. 160, October 1991.
- Ornoy A, Arnon J, Feingold M, Ben Ishai P. Spontaneous abortions following oral poliovirus vaccination in first trimester. Lancet 1990;335:800.
- CDC. Poliomyelitis prevention in the United States: introduction of a sequential vaccination schedule of inactivated poliovirus vaccine followed by oral poliovirus vaccine. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1997;46(No. RR-3):125.
- Heinonen OP, Slone D, Shapiro S. Birth Defects and Drugs in Pregnancy. Littleton, MA: Publishing Sciences Group, 1977.
- Castleman B, McNeely BU. Case records of the Massachusetts General Hospital. Case 471964. Presentation of Case. N Engl J Med 1964;271:67682.
- Burton AE, Robinson ET, Harper WF, Bell EJ, Boyd JF. Fetal damage after accidental polio vaccination of an immune mother. J R Coll Gen Pract 1984;34:3904.
- Harjulehto T, Aro T, Hovi T, Saxen L. Congenital malformations and oral poliovirus vaccination during pregnancy. Lancet 1989;1:7712.
- Harjulehto-Mervaala T, Aro T, Hiilesmaa VK, Saxen H, Hovi T, Saxen L. Oral polio vaccination during pregnancy: no increase in the occurrence of congenital malformations. Am J Epidemiol 1993;138:40714.
- Harjulehto-Mervaala T, Aro T, Hiilesmaa VK, Hovi T, Saxen H, Saxen L. Oral polio vaccination during pregnancy: lack of impact on fetal development and perinatal outcome. Clin Infect Dis 1994;18:41420.
- Ornoy A, Ben Ishai PB. Congenital anomalies after oral poliovirus vaccination during pregnancy. Lancet 1993;341:1162.
- Linder N, Handsher R, Fruman O, Shiff E, Ohel G, Reichman B, Dagan R. Effect of maternal immunization with oral poliovirus vaccine on neonatal immunity. Pediatr Infect Dis J 1994;13:95962.
- Lepow ML, Warren RJ, Gray N, Ingram VG, Robbins FC. Effect of Sabin type I poliomyelitis vaccine administered by mouth to newborn infants. N Engl J Med 1961;264:10718.
- Holguin AH, Reeves JS, Gelfand HM. Immunization of infants with the Sabin oral poliovirus vaccine. Am J Public Health 1962;52:60010.
- Sabin AB, Fieldsteel AH. Antipoliomyelitic activity of human and bovine colostrum and milk. Pediatrics 1962;29:10515.
- Sabin AB, Michaels RH, Krugman S, Eiger ME, Berman PH, Warren J. Effect of oral poliovirus vaccine in newborn children. I. Excretion of virus after ingestion of large doses of type I or of mixture of all three types, in relation to level of placentally transmitted antibody. Pediatrics 1963;31:62340.
- Warren RJ, Lepow ML, Bartsch GE, Robbins FC. The relationship of maternal antibody, breast feeding, and age to the susceptibility of newborn infants to infection with attenuated polioviruses. Pediatrics 1964;34:413.
- Plotkin SA, Katz M, Brown RE, Pagano JS. Oral poliovirus vaccination in newborn African infants. The inhibitory effect of breast feeding. Am J Dis Child 1966;111:2730.
- Katz M, Plotkin SA. Oral polio immunization of the newborn infant; a possible method for overcoming interference by ingested antibodies. J Pediatr 1968;73:26770.
- Adcock E, Greene H. Poliovirus antibodies in breast-fed infants. Lancet 1971;2:6623.
- Anonymous. Sabin vaccine in breast-fed infants. Med J Aust 1972;2:175.
- John TJ. The effect of breast-feeding on the antibody response of infants to trivalent oral poliovirus vaccine. J Pediatr 1974;84:307.
- Plotkin SA, Katz M. Administration of oral polio vaccine in relation to time of breast feeding. J Pediatr 1974;84:309.
- Deforest A, Smith DS. The effect of breast-feeding on the antibody response of infants to trivalent oral poliovirus vaccine (reply). J Pediatr 1974;84:308.
- Kelein JO, Brunell PA, Cherry JD, Fulginiti VA, eds. Report of the Committee on Infectious Diseases. 19th ed. Evanston, IL: American Academy of Pediatrics, 1982:208.
- Kim-Farley R, Brink E, Orenstein W, Bart K. Vaccination and breast-feeding. JAMA 1982;248:24512.
- Deforest A, Parker PB, DiLiberti JH, Yates HT Jr, Sibinga MS, Smith DS. The effect of breast-feeding on the antibody response of infants to trivalent oral poliovirus vaccine. J Pediatr 1973;83:935.
- John TJ, Devarajan LV, Luther L, Vijayarathnam P. Effect of breast-feeding on seroresponse of infants to oral poliovirus vaccination. Pediatrics 1976;57:4753.
Welsh J, May JT. Breast-feeding and trivalent oral polio vaccine. J Pediatr 1979;95:333.