Implementation of Newborn Hepatitis B Vaccination --- Worldwide, 2006

November 21, 2008

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5746a1.htm?s_cid=mm5746a1_e

MMWR Weekly

57(46);1249-1252

November 21, 2008

Implementation of Newborn Hepatitis B Vaccination --- Worldwide, 2006

Globally, hepatitis B virus (HBV) infections are a major cause of cirrhosis and

liver cancer and result in an estimated 620,000 deaths annually (1). In 1992,

the World Health Organization (WHO) set a goal for all countries to introduce

hepatitis B (HepB) vaccine into national routine infant immunization programs by

1997 (2). In countries where a high percentage of HBV infections are acquired

perinatally (where general population prevalence of chronic HBV infection

is>8%), WHO recommends administering the first HepB vaccine dose 8% chronic HBV

infection prevalence (5), HepB vaccine birth dose coverage was 36%. These

findings highlight the global need to implement this key hepatitis B prevention

strategy more widely.

Since 1998, WHO and UNICEF have used the Joint Reporting Form to collect

information annually from WHO member states on coverage and indicators of

immunization system performance for all WHO-recommended infant vaccines (4). For

HepB vaccine, information is collected about the schedule used, the number of

infants receiving the recommended 3 doses of vaccine, and (for those countries

where the national immunization schedule includes a HepB vaccine birth dose) the

administrative coverage of HepB vaccine birth dose.

As of 2006, 81 (42%) of 193 WHO member states indicated that a HepB vaccine

birth dose was included in the national infant immunization schedule. Of the 87

countries where chronic HBV infection prevalence has been high historically

(>8%), 38 (44%) reported including a HepB vaccine birth dose in their

immunization schedules (Table 1). Of the 135.0 million infants born worldwide in

2006, 62.7 million infants were born in countries where chronic HBV infection

prevalence has been high historically.

Global and regional HepB vaccine birth dose coverage were calculated using

reported coverage figures from the Joint Reporting Form and estimates of the

number of live births (6). In this analysis, countries that did not report birth

dose coverage on the Joint Reporting Form were assumed to have 0% birth dose

coverage. Among the 81 countries reporting a HepB vaccine birth dose in their

immunization schedules, 22 (27%) did not report birth dose coverage data. As a

result, 11%--20% of the birth cohort might have received a HepB vaccine birth

dose but was assumed to have 0% coverage because of lack of reporting. Birth

dose coverage worldwide was 27% and varied widely by region, from 3% to 71%

(Table 2). Birth dose coverage for countries with>8% chronic HBV infection

prevalence was 36% (range by region: 1%--92%), and for countries with 8%). The

relatively low coverage is consistent with survey data from several countries

(7) and suggests that program performance for newborn HepB vaccination needs

improvement.

Two major modes of HBV transmission occur during infancy: 1) from an infected

mother to her newborn during delivery, and 2) from an infected household contact

to the infant. Perinatal HBV transmission accounts for an estimated 21% of

HBV-related deaths globally and 13%--26% regionally (1). HepB vaccine is

70%--95% effective as postexposure prophylaxis in preventing mother-to-infant

HBV transmission when the first dose is administered within 24 hours after birth

(8). HepB vaccination of newborns also provides early preexposure protection to

infants born to uninfected women during a period when, if HBV exposure were to

occur, the risk for developing chronic HBV infection is greatest (i.e., during

the first year of life). Infants who become HBV infected have an approximately

90% risk for developing chronic HBV infection, and when chronically infected,

have a 25% risk for dying prematurely from cirrhosis or liver cancer. Thus,

newborn HepB immunization is a key intervention to prevent perinatal HBV

transmission and a critical strategy to reduce the global morbidity and

mortality associated with hepatitis B.

When introducing HepB vaccine into infant immunization programs, national policy

makers must decide when to begin the HepB vaccine series: 1) at birth for all

infants, 2) at birth, but targeted only to newborns of HBV-infected women, or 3)

at the same time in the immunization schedule as other vaccines are administered

to all infants (e.g., at 6 weeks, when national immunization programs in most

developing countries initiate administration of other vaccines to infants) but

at a time that is too late to prevent perinatal HBV infection. Administering a

HepB vaccine birth dose only to newborns of HBV-infected women usually is not

feasible in developing countries where hepatitis B is highly endemic (3), is a

practice that is prone to error and results in missed postexposure prophylaxis

of infants (even in countries where testing and identifying infected women

during pregnancy is well established) (8), and fails to provide early

preexposure protection to newborns of uninfected women who might have household

contacts who are infected.

In the WHO Western Pacific region (where hepatitis B is highly endemic in many

countries), 23 of 26 countries have introduced HepB vaccine starting at birth.

However, countries with>8% endemic chronic HBV infection in other regions might

not have introduced a HepB vaccine birth dose because disease burden from

perinatal HBV transmission was not believed to be significant or because of

challenges in implementing the birth dose (1,9).

Challenges to administering HepB vaccine to newborns within 24 hours after birth

can be logistical and financial. First, many infants, especially in remote or

poor areas, are born at home and do not have access at birth to skilled

attendants who can administer vaccinations. Increasing the number of infants

born in facilities or attended by trained health staff would improve birth dose

coverage. Second, infant vaccinations usually are administered by vaccination

providers in well-baby clinics or other outpatient health settings or during

outreach immunization sessions in the community, whereas care of the mothers

during delivery and of infants immediately after birth often is provided by

maternal health workers, so coordination of these two types of workers is

needed. Third, in many parts of the world, vaccines are transported and

delivered in cold storage boxes at monthly or even longer intervals from a

central source to locations where they will be administered and can only be

stored for several days. As a result, HepB vaccine might not be available when

infants are born at more remote facilities. Improving the range of the cold

storage delivery chain and exploring options for making vaccine available

outside that range are needed. Fourth, many developing countries have modified

their immunization schedules to include new multivalent vaccines (e.g., combined

Haemophilus influenzae type b and HepB vaccine) that cannot be administered to

newborns. These vaccines provide antigens against two or more diseases and are

supported by international donors, but the countries must rely on their own

limited resources to purchase separately the monovalent HepB vaccine necessary

for the HepB vaccine birth dose. Finally, awareness among providers and parents

about the importance of administering HepB vaccine within 24 hours of birth

often is lacking, so health promotion and training are needed (9,10).

The findings in this report are subject to at least two limitations. First,

coverage data were missing from 27% of countries that reported having HepB

vaccine birth dose in their immunization schedules, and for which an assumption

was made of 0% birth dose coverage. Second, HepB vaccine birth dose coverage

reported by countries sometimes might have included doses administered after 24

hours of birth, as indicated by the response on the Joint Reporting Form from

several countries that a first dose administered beyond 24 hours of birth would

be considered a birth dose. This lack of understanding as to what constitutes an

appropriate birth dose of HepB vaccine might reflect the fact that the term

" birth dose " also is used widely for bacille Calmette-Guérin vaccine

administration a few weeks after birth, and for oral poliovirus vaccine

administration several days after birth. Data on HepB vaccine birth dose

coverage from the Joint Reporting Form could be validated by using national

coverage surveys that compare date of birth with date of administration of the

first HepB vaccine dose for infants.

More complete implementation of routine newborn HepB vaccination globally would

reduce the substantial morbidity and mortality caused by perinatally acquired

HBV infection. Newborn HepB vaccination is of highest priority in highly endemic

areas where the contribution of perinatal transmission to the overall disease

burden is greatest. However, even in countries with

Tables

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Date last reviewed: 11/20/2008

November 21, 2008