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Re: rubella vaccination in early pregnancyFrom: ainsron@msn.comMon Oct 16 11:13:41 2000
Agree with Effrain. Here is the information from Briggs: *Risk Factor C according to manufacturer—Merck Sharpe & Dohme, 1993. Fetal Risk Summary Rubella (German measles) vaccine is a live, attenuated virus vaccine (1, 2). Rubella occurring during pregnancy may result in the congenital rubella syndrome (CRS). The greatest risk period for viremia and fetal defects is 1 week before to 4 weeks after conception (3). Moreover, rubella reinfection, most often presenting as a subclinical infection that can be detected by a rise in antibody titers, may occur in previously vaccinated patients and in those who are naturally immune (4, 5). The fetal risk of infection in these cases is low but has not yet been quantified. The U.S. Department of Health and Human Services Centers for Disease Control (CDC) defines CRS as any two complications from list A or one complication from list A plus one from list B (3): LIST A Cataracts or congenital glaucoma Congenital heart disease Loss of hearing Pigmentary retinopathy LIST B Purpura Splenomegaly Jaundice (onset within 24 hours of birth) Microcephaly Mental retardation Meningoencephalitis Radiolucent bone disease Before April 1979, the CDC collected data on 538 women vaccinated within 3 months before or after conception with either the Cendehill or HPV-77 vaccines (3). A total of 149 of these women were known to be susceptible at the time of vaccination and the outcome of pregnancy was known for 143 (96%). No evidence of CRS or other maternal or fetal complication was found in any of these cases or in an additional 196 infants exposed during pregnancy (3). Eight infants had serologic evidence of intrauterine infection after maternal vaccination, but follow-up for 2–7 years revealed no problems attributable to CRS. Since January 1979, only RA 27/3 rubella vaccine has been available in the United States. In the United States between January 1979 and December 1988, a total of 683 women vaccinated with RA 27/3 have been reported to the CDC (6). The outcomes of these pregnancies were as follows: Total vaccinated (1/79–12/88) 683 Susceptible at vaccination 272 Live births 212 (2 sets of twins) Spontaneous abortions or stillbirths 13 Induced abortions 31 Outcome unknown 18 Immune or unknown at vaccination 411 Live births 350 (1 set of twins) Spontaneous abortions or stillbirths 9 Induced abortions 24 Outcome unknown 29 Evidence of subclinical infection was found in 3 (2%) of the 154 liveborn infants from susceptible mothers who were serologically evaluated (6). However, no evidence of defects compatible with CRS was found in the total sample of 212 liveborn infants. Two infants did have asymptomatic glandular hypospadias, but both mothers had negative rubella-specific IgM titers in the cord blood at birth (6). In a 1985 evaluation of earlier CDC data, no defects compatible with CRS were found in any of the fetuses or infants in whom the outcome was known (7). Examinations up to 29 months after birth have revealed normal growth and development (6, 7). Although no defects attributable to rubella vaccine have been reported, the CDC calculates the theoretical risk of CRS following vaccination to be as high as 4.9% (for those vaccinated within 1 week before to 4 weeks after conception), still considerably lower than the 20% or greater risk associated with wild rubella virus infection during the 1st trimester (6). Because a risk does exist, the use of the vaccine in pregnancy is contraindicated (1-3, 6, 7). However, if vaccination does occur within 3 months of conception or during pregnancy, the actual risk is considered to be negligible and, in itself, should not be an indication to terminate the pregnancy (3, 6-9). Breast Feeding Summary Vaccination of susceptible women with rubella vaccine in the immediate postpartum period is recommended by the American College of Obstetricians and Gynecologists Technical Bulletin No. 160 and the U.S. Centers for Disease Control (1, 10). A large number of these women will breast-feed their newborns. Although two studies failed to find evidence of the attenuated virus in milk, subsequent reports have demonstrated transfer (11-15). In one case, the mother noted rash and adenopathy 12 days after vaccination with the HPV-77 vaccine on the 1st postpartum day (12). Rubella virus was isolated from her breast milk and from the infant's throat (13). A significant level of rubella-specific cell-mediated immunity was found in the infant, but there was no detectable serologic response as measured by rubella hemagglutination inhibition antibody titers (13). No adverse effects were noted in the infant. In a second case report, a 13-day-old breast-fed infant developed rubella about 11 days after maternal vaccination with HPV-77 (16). It could not be determined whether the infant was infected by virus transmission via the milk (17, 18). Nine (69%) of 13 lactating women given either HPV-77 or RA 27/3 vaccine in the immediate postpartum period shed virus in their milk (14). In another report by these same researchers, 11 (68%) of 16 vaccinated women shed rubella virus or virus antigen in their milk (15). No adverse effects or symptoms of clinical disease were observed in the infants. References (1). American College of Obstetricians and Gynecologists. Immunization during pregnancy. Technical Bulletin. No. 160, October 1991. (2). Amstey MS. Vaccination in pregnancy. Clin Obstet Gynaecol 1983;10:13–22. (3). Centers For Disease Control, U.S. Department of Health and Human Services. Rubella vaccination during pregnancy—United States, 1971–1982. MMWR 1983;32:429–32. (4). Burgess MA. Rubella reinfection—what risk to the fetus? Med J Aust 1992;156:824–5. (5). Condon R, Bower, C. Congenital rubella after previous maternal vaccination. Med J Aust 1992;156:882. (6). Centers For Disease Control, U.S. Department of Health and Human Services. Rubella vaccination during pregnancy—United States, 1971–1988. MMWR 1989;38:289–93. (7). Preblud SR, Williams NM. Fetal risk associated with rubella vaccine: implications for vaccination of susceptible women. Obstet Gynecol 1985;66:121–3. (8). Burgess MA. Rubella vaccination just before or during pregnancy. Med J Aust 1990;152:507–8. (9). Linder N, Ohel G. in utero vaccination. Clin Perinatol 1994;21:663–74. (10). American Hospital Formulary Service. Drug Information 1997. Bethesda, MD: American Society of Health-System Pharmacists, 1997:2642–6. (11). Isacson P, Kehrer AF, Wilson H, Williams S. Comparative study of live, attenuated rubella virus vaccines during the immediate puerperium. Obstet Gynecol 1971;37:332–7. (12). Grillner L, Hedstrom CE, Bergstrom H, Forssman L, Rigner A, Lycke E. Vaccination against rubella of newly delivered women. Scand J Infect Dis 1973;5:237–41. (13). Buimovici-Klein E, Hite RL, Byrne T, Cooper LZ. Isolation of rubella virus in milk after postpartum immunization. J Pediatr 1977;91:939–41. (14). Losonsky GA, Fishaut JM, Strussenberg J, Ogra PL. Effect of immunization against rubella on lactation products. I. Development and characterization of specific immunologic reactivity in breast milk. J Infect Dis 1982;145:654–60. (15). Losonsky GA, Fishaut JM, Strussenberg J, Ogra PL. Effect of immunization against rubella on lactation products. II. Maternal–neonatal interactions. J Infect Dis 1982;145:661–6. (16). Landes RD, Bass JW, Millunchick EW, Oetgen WJ. Neonatal rubella following postpartum maternal immunization. J Pediatr 1980;97:465–7. (17). Lerman SJ. Neonatal rubella following maternal immunization. J Pediatr 1981;98:668. (18). Bass JW, Landes RD. Neonatal rubella following maternal immunization (reply). J Pediatr 1981;98: 668–9.
>I have a patient with inadvertent rubella vaccination one week after
-- Ronald E. Ainsworth, MD
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