Availability of Hepatitis B Vaccine That Does Not Contain

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cies and practices have been discontin- CDC Editorial Note: On July 8, 1999, Availability of ued. All hospitals should ensure that the American Academy of Pediatrics newborn infants of hepatitis B surface (AAP) and the Public Health Service Hepatitis B Vaccine antigen (HBsAg)-positive mothers and (PHS) released a joint statement about That Does Not of mothers whose HBsAg status is thimerosal in vaccines, and the Ameri- unknown receive their first dose of can Academy of Family Physicians Contain Thimerosal hepatitis B vaccine within 12 hours of (AAFP) released a comparable state- as a Preservative birth. If hepatitis B vaccine that does not ment.1-3 Thimerosal is a mercury- contain thimerosal as a preservative is containing preservative that has been MMWR. 1999;48:780-782 not available, then thimerosal preser- used as an additive to biologics and vac- vative-containing vaccine should be cines since the 1930s because it is effec- ON AUGUST 27, 1999, MERCK VAC- used for these infants. tive in preventing bacterial and fungal cine Division* (Merck & Co., Inc., West (2) Infants aged Ͻ6 months. contamination, particularly in open Point, Pennsylvania) received ap- When available, hepatitis B vaccines multidose containers. Vaccine manu- proval from the Food and Drug Ad- that do not contain thimerosal as a pre- facturers, FDA, and other PHS agen- ministration (FDA) of a supplement to servative should be used to vaccinate cies are working together to replace Merck’s license application to include infants aged Ͻ6 months (single- expeditiously thimerosal preservative- the manufacture of single-antigen pre- antigen hepatitis B vaccine for infants containing vaccines whenever possible servative-free hepatitis B vaccine (Re- aged Ͻ6 weeks and either single- with vaccines that do not contain thi- combivax HB௡, Pediatric); distribu- antigen or combination products for in- merosal as a preservative while ensur- tion is expected to begin September 13, fants aged greater than or equal to 6 ing maintenance of high vaccination cov- 1999. In addition, SmithKline Beecham weeks). Infants in groups at high risk erage levels and prevention of disease. Biologicals (SmithKline Beecham, Phila- for perinatal and early childhood HBV Previous recommendations for us- delphia, Pennsylvania), expects to make infections should complete the three- ing thimerosal-containing vaccines in- single-antigen preservative-free hepa- dose hepatitis B vaccine series by age dicated that clinicians and parents could titis B vaccine (Engerix-B௡, Pediatric) 6 months. When vaccines that do not take advantage of the flexibility in the available in the near future. Further contain thimerosal as a preservative are immunization schedule to delay hepa- product information will be provided not available, these groups should be titis B vaccination from birth until age when it becomes available. Product vaccinated with thimerosal preserva- 2-6 months for infants born to moth- packaging and labels will indicate tive-containing vaccine. For infants ers who are HBsAg negative.1-4 No that these vaccines do not contain born to HBsAg-negative mothers and changes were made in recommenda- preservative. who are not in high-risk groups, exist- tions for immunization at birth of in- To prevent shortages because of lim- ing recommendations should be used fants of HBsAg-positive mothers or in- ited supplies of single-antigen hepati- for administering thimerosal preserva- fants of mothers with an unknown tis B vaccines that do not contain thi- tive-containing hepatitis B vaccines if HBsAg status. merosal as a preservative and to assure vaccine that does not contain thimero- After the joint AAP/PHS statement on prevention of perinatal and early child- sal as a preservative is not available.1-4 thimerosal, the AAP and CDC pro- hood hepatitis B virus (HBV) infec- These groups should complete the vided additional implementation guid- tion during the transition when both three-dose hepatitis B vaccine series by ance.3,4 CDC guidance included hepa- vaccines that contain and do not con- age 18 months. titis B vaccination should be continued tain thimerosal as a preservative are (3) Children aged Ն6 months, at birth for infants born to HBsAg- available, the following three steps adolescents, and adults. Thimerosal negative mothers belonging to popula- should be taken: preservative-containing hepatitis B tions or groups that have a high risk for (1) Newborn infants. The priority vaccines can continue to be used for early childhood HBV infection, includ- for use of single-antigen hepatitis B vac- vaccinating children aged Ն6 months, ing Asian/Pacific Islanders, immigrant cines that do not contain thimerosal as adolescents, and adults as is recom- populations from countries in which a preservative should be to vaccinate mended.1-6 HBV infection is of high or intermedi- newborn infants. Routine hepatitis B ate endemicity,7 and households with vaccination policies for all newborn Reported by: National Center for Infectious Dis- persons with chronic HBV infection. To eases; National Immunization Program; Agency for infants should be reintroduced imme- Toxic Substances and Disease Registry; National Cen- ensure the prevention of perinatal HBV diately in hospitals in which these poli- ter for Environmental Health, CDC. transmission, hospitals should con-

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tinue policies to vaccinate all infants at a preservative should alert medical 1982-1996, the MMR remained at ap- birth until procedures are in place to facilities to review their policies to en- proximately 7.5.2 In addition, the risk guarantee that (1) the HBsAg status of sure the vaccination of newborns as rec- for maternal mortality consistently has every pregnant woman is reviewed at de- ommended by the Advisory Commit- been higher among black women than livery, (2) appropriate passive-active im- tee on Immunization Practices, AAFP, white women. This report presents munoprophylaxis (hepatitis B immune and AAP. state-specific MMRs for 1987-1996, fo- globulin and hepatitis B vaccine) is pro- cusing on persistent disparities in ma- vided for infants of HBsAg-positive REFERENCES ternal mortality between black and women within 12 hours of birth, and (3) 1. CDC. Thimerosal in vaccines: a joint statement of white women. The findings indicate appropriate active immunoprophy- the American Academy of Pediatrics and the Public that in every state where MMRs could Health Service. MMWR 1999;48:563-5. laxis (hepatitis B vaccine) is provided for 2. American Academy of Pediatrics. Thimerosal in vac- be reliably calculated, black women infants of women with an unknown cines: an interim report to clinicians. AAP News 1999; were more likely than white women to 15:10-2. HBsAg status. 3. American Academy of Family Physicians. Policy die from complications of pregnancy After the statements on thimerosal in statement of the American Academy of Family Phy- and that the 2000 objective will not be sicians on thimerosal in vaccines, July 8, 1999. Avail- vaccines were published, changes oc- able at http://www.aafp.org/policy/camp/20.html. met; however, for white women, it has curred in newborn hepatitis B vaccina- Accessed September 3, 1999. been met in three states. tion policies and practices in some hos- 4. CDC. Implementation guidance for immunization MMRs were calculated using infor- grantees during the transition period to vaccines with- pitals, including unintended changes out thimerosal, July 14, 1999. Available at http:// mation from birth and death certifi- affecting immunization of infants at risk www.cdc.gov/nip/news/thimerosal-guidance.html. cates filed in state vital statistics of- Accessed September 3, 1999. for perinatal HBV transmission. In Au- 5. Advisory Committee on Immunization Practices. fices and compiled by CDC’s National gust 1999, state and territorial health Hepatitis B virus: a comprehensive strategy for elimi- Center for Health Statistics.3,4 Mater- nating transmission in the United States through uni- department hepatitis coordinators con- versal childhood vaccination. MMWR 1991;40(no. RR- nal deaths were defined as deaths that ducted surveys of selected birthing hos- 13). occurred during pregnancy or within 6. CDC. Update: recommendations to prevent hepa- pitals in their project areas. Of 977 hos- titis B virus transmission—United States. MMWR 1999; 42 days after pregnancy termination, re- pitals surveyed in 48 project areas, 773 48:33-4. gardless of pregnancy duration and site, (79%) were aware of the joint AAP/ 7. CDC. Health information for international travel from any cause related to or aggra- 1999-2000. Atlanta, Georgia: US Department of Health PHS statement on thimerosal. Of 574 and Human Services, 1999:98-102. vated by the pregnancy, but not from hospitals that were aware of the state- 8. Margolis HS, Coleman PJ, Brown RE, Mast EE, She- accidental† or incidental causes.§ Cause ingold SH, Arevalo JA. Prevention of hepatitis B virus ment and had existing policies or stand- transmission by immunization: an economic analysis of death is recorded on the death cer- ing orders to vaccinate all newborns, of current recommendations. JAMA 1995;274: tificate by the attending physician, 262 (46%) reported a policy change to 1201-8. medical examiner, or coroner. For the no longer routinely vaccinate new- *Use of trade names and commercial sources is for denominator (live-born infants), ma- borns of HBsAg-negative mothers. In identification only and does not imply endorsement ternal race as indicated on the birth cer- by CDC or the U.S. Department of Health and Hu- addition, 52 (9%) reported they no man Services. tificate was used; for the numerator longer routinely vaccinate any new- (maternal deaths), maternal race as in- born (CDC, unpublished data, 1999). dicated on the death certificate was Such a policy usually requires a phy- State-Specific used. Data for racial groups other than sician’s order to vaccinate infants of black and white are not presented sepa- HBsAg-positive mothers and infants of Maternal Mortality rately because numbers were too small mothers whose HBsAg status is un- Among Black and to provide reliable estimates; how- known. CDC also has received anec- ever, data for other races were in- dotal reports of hospitals in which poli- White Women— cluded in the totals for each state. Data cies were changed, and infants born to for Hispanic women were not avail- HBsAg-positive mothers and infants United States, able from all states and were not ana- born to mothers with unknown HBsAg 1987-1996 lyzed. status were not vaccinated within 12 Data from states with fewer than hours of birth (CDC, unpublished data, MMWR. 1999;48:492-496 seven maternal deaths for black and 1999). Chronic HBV infection devel- 1 table omitted white women were considered unreli- ops in approximately 90% of infants in- able and were not reported (relative fected perinatally; among chronically ONE OF THE NATIONAL HEALTH OBJEC- standard error [RSE]: Ͼ38%). Data for infected infants, the risk for prema- tives for 2000 is to reduce the overall states with seven-19 maternal deaths ture death from HBV-related liver can- maternal mortality ratio* ([MMR] i.e., for black and white women were re- cer or cirrhosis is approximately 25%.8 number of maternal deaths per 100,000 ported. RSE for these maternal deaths The availability of hepatitis B vaccine live-born infants) to no more than 3.3 was 23%-38%; however, data were not that does not contain thimerosal as (objective 14.3)1; however, during considered as reliable as those for states

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with at least 20 maternal deaths. Total fants. A focus for the 2010 objectives the cause of death on the death certifi- MMRs were presented for all states, re- is to eliminate racial disparities in cate does not reflect the relation be- gardless of the total number of deaths. maternal mortality. The fourfold in- tween a woman’s pregnancy and her During 1987-1996, for black women, crease nationally in risk for maternal death. The estimated number of ma- MMRs in 26 states ranged from 8.7 death among black women compared ternal deaths is 1.3-3.0 times higher (Massachusetts) to 28.7 (New York); for with white women is one of the larg- than that reported in vital statistics re- white women, MMRs in 41 states est racial disparities among major pub- cords.6 If a maternal mortality review ranged from 2.7 (Massachusetts) to 9.2 lic health indicators; no improvement discovers that the cause of death on the (Vermont). The MMR for black women has occurred during 1987-1996.2,5 Race death certificate is reported incor- was higher than for white women in ev- and ethnicity are not risk factors for ma- rectly, the certifying physician should ery state where ratios could be calcu- ternal mortality but instead may be be contacted to file an amended related. The black:white ratio of MMRs markers of social, economic, cultural, cord. Second, misclassification of race ranged from 2.6 (Iowa, Maryland, and health-care access and quality, and on death certificates may vary among South Carolina) to 6.3 (Michigan). other interrelated factors that may in- the states and are not known. Total MMRs ranged from 1.9 (New crease the risk for death among preg- To identify interventions that may re- Hampshire) to 22.8 (District of Colum- nant women. duce maternal mortality, 25 states have bia). Eight states and the District of Co- Black women have a higher risk than reestablished maternal mortality re- lumbia had significantly higher MMRs white women for dying from every view committees. These committees re- than the national MMR. Because the pregnancy-related cause of death review factors that may have contrib- MMR for black women was 3-6 times ported, including the three leading uted to maternal deaths, including the higher than for white women, states causes (i.e., hemorrhage, pregnancy- quality of medical care and problems with higher percentages of births to induced hypertension, and embo- in the health-care delivery system. All black women tended to have higher to- lism).6 Although prenatal care re- states should implement such review tal MMRs. duces the risk for maternal mortality, mechanisms to help identify and in- To discern possible trends in mater- health-care access and use do not ex- vestigate maternal deaths, discuss each nal mortality, data were divided into plain fully the disproportionate risk for case in a multidisciplinary process, dis- two 5-year periods (1987-1991 and maternal death for black women.7 Other seminate findings, and provide recom- 1992-1996). The national MMR was 7.7 factors, such as quality of prenatal, de- mendations for preventing future for each time period. The MMR did not livery, and postpartum care, and inter- deaths. Both public health surveil- differ significantly between these peri- action between health-seeking behav- lance and prevention research are ods for black women (18.8 and 20.3, iors and satisfaction with care, may needed to understand the underlying respectively) or for white women (5.5 explain part of this difference. Epide- causes of maternal mortality and the and 5.0, respectively). The difference miologic, sociologic, health-care deliv- disparity between black and white in MMRs for the two time periods was ery, and program research are needed women and to guide appropriate inter- not significant in 48 states and the Dis- to identify key factors that may con- ventions and improvements in mater- trict of Columbia. tribute to the disparity between black nal health care. and white women in maternal health Reported by: Div of Reproductive Health, National whether at the individual, clinic, com- REFERENCES Center for Chronic Disease Prevention and Health Pro- munity, or health systems level. 1. Public Health Service. Healthy people 2000: na- motion; Div of Vital Statistics, National Center for The wide disparity that exists among tional health promotion and disease prevention ob- Health Statistics, CDC. jectives—full report, with commentary. Washington, states for both black and white MMRs DC: US Department of Health and Human Services, CDC Editorial Note: Although no is not attributable solely to small num- Public Health Service, 1991; DHHS publication no. (PHS)91-50212. progress has been made in achieving the bers. However, vital statistics data do 2. CDC. Maternal mortality—United States, 1982- 2000 objective to reduce maternal mor- not include information necessary to as- 1996. MMWR 1998;47:705-7. 3. Peters KD, Kochanek KD, Murphy SL. Deaths: fi- tality, the findings in this report indi- sess risk factors and case-fatality rates nal data for 1996. Hyattsville, Maryland: US Depart- cate that for white women, the goal has that may have contributed to these ment of Health and Human Services, CDC, National Center for Health Statistics, 1998. (National vital sta- been achieved in three states (Massa- state-to-state disparities. tistics reports; vol 47, no. 9). chusetts, Nebraska, and Washington) The findings in this report are sub- 4. Ventura SJ, Martin JA, Curtin SC, et al. Report of and has almost been met in eight other ject to at least two limitations. First, al- final natality statistics, 1996. Hyattsville, Maryland: US Department of Health and Human Services, CDC, Na- states (MMRs of Ͻ4). Therefore, in the though U.S. vital statistics data during tional Center for Health Statistics, 1998. (Monthly vi- United States, lower levels of maternal 1987-1996 indicated that 3086 women tal statistics report; vol 46, no. 11). 5. CDC. Differences in maternal mortality among black mortality can be achieved. died because of pregnancy complica- and white women—United States, 1990. MMWR The proposed 2010 objective for ma- tions, these data are underestimates be- 1995;44:6-14. 6. Berg C, Atrash H, Koonin L, et al. Pregnancy- ternal mortality using vital statistics data cause of misclassification on death cer- related mortality in the United States, 1987-1990. Ob- remains at 3.3 per 100,000 live-born in- tificates. Misclassification occurs when stet Gynecol 1996;88:161-7.

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7. Koonin L, MacKay A, Berg C, et al. Pregnancy- dorsement of these organizations or their programs state and local health departments are related mortality surveillance—United States, 1987- by CDC or the U.S. Department of Health and Hu- 1990. MMWR 1997;46(no. SS-4):17-34. man Services. CDC is not responsible for the content encouraged to ensure local media cov- of pages found at these sites. erage to alert persons who had con- *CDC’s National Center for Health Statistics uses the term “rate” when reporting this indicator of mater- tact with the bear after July 30 to the nal mortality. The term “ratio” is used instead of rate need for exposure assessment. Per- in this report because the numerator includes some maternal deaths that were not related to live-born Multiple Human sons who attended the barnwarming infants and thus were not included in the denomi- also need to be assessed for pro- nator. Exposures to a † When a death occurs under “accidental” circum- phylaxis. stances, the preferred term within the public health Rabid Bear Cub Information is available from the community is “unintentional injury.” emergency telephone number of the §International Classification of Diseases, Ninth Revi- at a Petting Zoo sion, codes 630-676. Iowa Department of Public Health: and Barnwarming— (515) 323-4360. Iowa, August 1999 Reported by: Center for Acute Disease Epidemiol- Satellite Broadcast ogy, Iowa Dept of Public Health. on Diagnostic and MMWR. 1999;48:761 Therapeutic ON AUGUST 27, 1999, A BLACK BEAR CUB, Epidemiology Dilemmas for approximately 5-6 months old, died after several hours of acute central ner- in Action Gonococcal and vous system symptoms; preliminary test results available on August 28 indi- MMWR. 1999;48:638 Chlamydial Infections cated the bear had rabies. The bear was part of the Swenson’s Wild Midwest CDC AND EMORY UNIVERSITY’S ROLLINS MMWR. 1999;48:717-718 Exotic Petting Zoo in Clermont, Iowa School of Public Health will co- THE CDC-SPONSORED NATIONAL NET- (northeastern Iowa). At the petting zoo, sponsor a course, “Epidemiology in Ac- work of STD/HIV Prevention Train- visitors fed, wrestled, and may have been tion,” during November 8-19, 1999, in ing Centers (PTC) will broadcast STD nipped by the bear. The bear also was Atlanta. The course is designed for state Diagnostic and Therapeutic Dilemmas: taken to an August 14 barnwarming at and local public health professionals. Gonococcal and Chlamydial Infections, the Tharp barn in Holy Cross, Iowa The course emphasizes the practical an interactive satellite broadcast, in En- (eastern Iowa), where it reportedly application of epidemiology to public glish and Spanish on October 14, 1999, nipped people. An estimated 400 people health problems and will consist of lec- from 1 PM to 2:30 PM eastern daylight from 10 states (Arizona, California, tures, workshops, classroom exercises time. The broadcast is intended for pri- Florida, Illinois, Iowa, Minnesota, New (including actual epidemiologic prob- mary-care and managed-care provid- Mexico, New York, Ohio, and Wiscon- lems), and roundtable discussions. Top- ers and health-care clinicians caring for sin) and Australia had contact with the ics covered include descriptive epide- patients exposed to or infected with bear cub at either the petting zoo or the miology and biostatistics, analytic gonococcal and chlamydial infec- barnwarming during the 28 days be- epidemiology, epidemic investiga- tions. The broadcast will cover state- fore its death, during which the bear may tions, public health surveillance, sur- of-the-art screening and diagnostic have transmitted rabies virus. veys and sampling, Epi Info software interpretations of chlamydial and gono- On the basis of telephone calls to pet- training, and discussions of selected coccal technologies. Continuing medi- ting zoo visitors who signed the guest prevalent diseases. There is a tuition cal education credit is available. register and provided contact informa- charge. Additional information is available tion, approximately 150 of the 400 per- Deadline for application is October from the STD/HIV PTC, Dallas County sons were exposed to the bear’s saliva 8, 1999. Additional information and ap- Health and Human Services, 2377 N. and need to obtain vaccine and rabies plications are available from Emory Stemmons Fwy., #430, Dallas, TX immune globulin. Public health au- University, International Health, Dept. 75207-2710; telephone (214) 819- thorities are attempting to contact pet- (PIA), 1518 Clifton Rd., N.E., Room 1947; or from the World-Wide Web, ting zoo visitors by telephone and the 742, Atlanta, GA 30322; telephone http://www.stdptc.uc.edu.* Internet. However, because not all pet- (404) 727-3485; fax (404) 727-4590; ting zoo visitors signed the register or or on the World-Wide Web, http:// *References to sites of nonfederal organizations on the World-Wide Web are provided as a service to provided sufficient information to en- www.sph.emory.edu/EPICOURSES/; or MMWR readers and do not constitute or imply en- able health authorities to locate them, e-mail [email protected].

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