You are on page 1of 4

WHO/V&B/01.

29
ORIGINAL: ENGLISH
DISTR.: GENERAL

Haemophilus influenzae type b


immunization

Introducing Haemophilus influenzae type B (Hib)


conjugate vaccine into national immunization services

learning disabilities, and difficulties in Studies have shown that vaccination



Background


movement is not uncommon among reduces the risk of invasive Hib disease


The bacterium, Haemophilus


those who survive infection. Studies have in young children by >90%, and in


influenzae type B (Hib), is an


important cause of infections in also shown that Hib accounts for up to some cases, has even led to protection

one-quarter of the severe pneumonia of unimmunized populations by


infants and young children; severe


cases in young children in developing “herd immunity”.


disease in adults due to Hib is


countries. WHO estimates that without


uncommon. Where it has been studied Since 1998,, WHO has recommended that

carefully, Hib is typically the leading vaccination 400 000 children die each

year of Hib disease. Hib conjugate vaccine be included in


cause of acute bacterial meningitis in routine infant immunization services in



infants and children less than five years Safe and effective vaccines against Hib all countries where the resources permit


old, accounting for one-third to one- infections exist. These vaccines have been its use and the burden of disease is

half of all cases of bacterial meningitis


routinely used to vaccinate infants in established. This document provides an


in this age group. Bacterial meningitis many countries for over 10 years. The outline of information needed to


is fatal unless treated immediately experience with these vaccines has shown implement a national decision to


with antibiotics. Even with proper that they are very safe and highly introduce Hib vaccine, with a particular

treatment 3-25% of affected children


effective for preventing severe Hib disease, focus on issues relevant to countries

may die. Permanent disability with including meningitis and pneumonia. applying for support for the introduction


sequelae that include deafness, of Hib vaccine from The Vaccine Fund.







DEPARTMENT OF VACCINES
AND BIOLOGICALS
World Health Organization
1211 Geneva 27
2001
Objectives The currently available pentavalent Administration



vaccine requires the reconstitution of


The primary objective of Hib Hib conjugate vaccine is administered


lyophilized Hib conjugate vaccine with


immunization strategies should be to by intramuscular or subcutaneous


prevent severe Hib disease in infants and liquid DTP-hepatitis B vaccine. In this injection in the anterolateral aspect of


instance, the Hib vaccine should be


young children because nearly all severe the thigh (infants) or the deltoid muscle


reconstituted only with the


Hib disease occurs in children less than (older children). It can be given safely at


DTP-hepatitis B vaccine produced


five years of age, and the majority of the the same time as other vaccines such as


deaths occur among infants. by the same manufacturer. Similarly, DTP, polio, hepatitis B, measles, BCG,


there is at least one DTP-Hib


and yellow fever vaccines. If given as a



combination that requires the


Immunization strategies combination with DTP in the same


reconstitution of the lyophilized Hib


Universal infant immunization
immunization. syringe, it should be given


conjugate vaccine with liquid DTP intramuscularly.


Immunization of all infants through vaccine, and the Hib vaccine should be



routine services is the highest priority for reconstituted only with the DTP


Injection equipment


all countries. This strategy has been vaccine produced by the same


proven effective in many areas. The injection equipment for Hib


manufacturer.


conjugate vaccine is the same type as


Catch-up vaccination of older


Combination vaccines that contain Hib that for DTP or hepatitis B:


children
children. (Note: The Vaccine Fund does conjugate vaccine:



not provide funding to purchase vaccine · can be used anytime all of the · 0.5 ml (auto-disable), 1.0ml or



for catch-up vaccination.) antigens in the vaccine are indicated 2.0ml syringe



Children aged greater than 12 months by the schedule; · 25mm, 22 or 23 gauge needle



can be protected with just a single dose of · cannot be used before 6 weeks of age Sterile auto-disable (AD) injection


Hib conjugate vaccine. At the time of (e.g. for the birth dose of hepatitis B devices are recommended.


introduction, some countries have chosen vaccine) because the


to conduct one-time national campaigns Dosage


immunogenicity of the DTP and


to vaccinate all children 1 to 5 years of Hib components will be reduced if


The standard paediatric dose is 0.5 ml.


age with a single dose of Hib conjugate given before this age.


vaccine. This approach may provide some Vaccine procurement


Schedule

protection to older children but should be


undertaken only if it does not draw In most countries, Hib conjugate vaccine

Immunization of infants with Hib


procured through The Vaccine Fund will

resources away from infant conjugate vaccine is usually


be supplied through the UNICEF


immunization. Because the risk of Hib accomplished by giving the vaccine at


procurement mechanism.

disease falls sharply after age 5 years, the same ages as DTP vaccine, either as a

vaccination of persons older than age


separate injection or in combination. The number of Hib conjugate vaccine


5 years should not be undertaken. In general, infants should receive a


doses required is estimated using the size


primary dose schedule of 3 doses of of the birth cohort, the coverage rate for


Vaccine formulations Hib conjugate vaccine in the first year of DTP and the number of doses in the


Hib conjugate vaccines are available life. Doses of Hib conjugate vaccine immunization schedule. These

should be administered at least 4 weeks


in several different formulations. calculations should also include wastage


apart. Children older than one year of and the size of the reserve stock.

They can be obtained as a liquid or


freeze-dried powder (lyophilized), age require only a single dose of Hib



in single or multi-dose vials, and as conjugate vaccine. Booster doses of Hib Presentation


monovalent vaccines (Hib conjugate conjugate vaccine may be given to


Hib conjugate vaccines are generally

children in the second year of life, but


vaccine only) or in combination available in single-dose and multi-dose


successful control of Hib disease does not


with other routine vaccines (e.g. DTP, (2 and 10 dose) vials, and in liquid and

DTP-hepatitis B). require a booster dose.


lyophilized formulations.






2
Storage and shipping volume It also serves as a tool for improving the Information, education, and



practices of health centres when wastage communication needs


Storage volumes (vial plus packet


rates are found to be unacceptably high.


containing the vial plus any other When introducing Hib conjugate


packaging) for some available vaccines


Strategies to reduce vaccine wastage vaccine into national immunization


are: include the following: services, information, education and



· careful planning of vaccine ordering communication (IEC) efforts are


· 32.3 cm3 per dose for liquid Hib in


and distribution; important from the beginning in order


single-dose vials,


· use of both single-dose and multi- to generate support and commitment


· 9.7 cm3 per dose for lyophilized Hib for the new vaccine and to assure that



dose vials ;


in single-dose vials, ○

the vaccine is appropriately handled


· careful maintenance of the cold


(Diluent for freeze-dried vaccines doubles and administered. The primary target


the necessary storage space at the health chain;


audiences for IEC efforts are decision-


centre level.) · implementation of WHO’s multi- makers/opinion leaders, health care staff,



· 13.8 cm3 per dose for liquid Hib or dose vial policy, when appropriate. and the general public (including



DTP-Hib vaccine in 10 dose vials, parents).


Injection safety


· 9.7 cm3 per dose for DTP-HepB-Hib


Hib conjugate vaccine procured through


vaccine in 2 dose vials. What information is needed to


The Vaccine Fund will be supplied with


For comparison, the WHO standard assess Hib disease burden?


auto-disable syringes and safety boxes.


storage volumes for DTP vaccine are Various tools are available from the WHO


Additional disposable syringes will be


2.5 cm3 per dose in 20 dose vials and needed for lyophilized vaccines that regional office which use existing local



3.0 cm3 per dose in 10 dose vials. require reconstitution. Managers at each and regional data to estimate the burden


of Hib disease. As a result, disease burden

level are responsible for ensuring that


Cold chain issues studies will not be needed in most


adequate supplies are available at all


times. Attention should also be given to countries.


The storage temperature for Hib


conjugate vaccines is the same as for the proper use and disposal of the safety


DTP and hepatitis B vaccines, from boxes used to collect these materials. How should Hib conjugate


2°C to 8°C. vaccine be phased into the



Revision of reporting forms and existing infant immunization


Adding Hib conjugate vaccine to the


training materials services?


national immunization programme will


require: An important element of integrating Hib The easiest way to introduce Hib


· an assessment of cold chain storage vaccination into national conjugate vaccine is to simply begin


capacity and cold chain procedures immunization services is to revise vaccinating each infant that comes for

training and informational materials,


at all administrative levels; and, routine DTP vaccination. Some


forms used to monitor and evaluate the countries may wish to consider one-time

· development and implementation


programme, and vaccination cards. catch-up vaccination of older children


of plans to modify cold chain


(<2 years or <5 years of age). This will


storage capacity and cold chain


lead to a more immediate reduction in


procedures, if needed.

Hib cases but will be more expensive and


Monitoring and reducing vaccine somewhat more complicated to achieve.




wastage


Monitoring vaccine wastage becomes



increasingly important as the costs of the



vaccine rise. Monitoring increases


ordering accuracy and reduces wastage by



providing reliable data for estimating the



number and size of vials to be ordered.





3
Which type of Hib conjugate Use of combination vaccines may offer safety. Also, the introduction of this new
vaccine is most suitable? certain programmatic advantages. vaccine against serious childhood illness
These include: represents an opportunity to renew
The following issues should be considered community interest in all routine
when planning for the procurement of • a decrease in the number of
injections required per visit vaccinations.
Hib conjugate vaccine:
(and thus decrease the number of
• the existing immunization schedule Budgeting for Hib conjugate
auto-disable needles and syringes
and planned Hib conjugate vaccine required); and
schedule; vaccine introduction
• a decrease in the amount of space Capital and recurrent costs related to the
• the proper mix of monovalent/
required for cold chain storage and introduction of Hib conjugate vaccine
combination vaccines in single/
transport. should be estimated and included in the
multi-dose vials;
annual EPI budget. Additional capital
• formulation (lyophilized vs. liquid); How can the addition of Hib costs might include: investment in
• total number of injections per visit; conjugate vaccine be used to means of transport, cold chain
• impact on local vaccine production; strengthen the national equipment and sterilization equipment.
and immunization services? Investment in an information campaign
• cost. targeted at the general public should
The introduction of Hib conjugate
also be included. Additional recurrent
vaccine into the routine services should
costs include: vaccines, auto-disable
be used as an opportunity to strengthen
injection devices, salaries, transportation
the existing services. Programme
(petrol and maintenance), training,
elements that need particular attention
cold chain maintenance, safe disposal of
for the introduction of Hib conjugate
waste, disease surveillance and other
include stock management,
supplies, such as laboratory media and
reducing vaccine wastage, and injection
stationery.

Ordering code: WHO/V&B/01.29


Printed October 2001

This document is available on the Internet at:


www.who.int/vaccines-documents/

Copies may be requested from:


World Health Organization
Department of Vaccines and Biologicals
CH-1211 Geneva 27, Switzerland
• Fax: + 41 22 791 4227 • Email: vaccines@who.int •

© World Health Organization 2001

This document is not a formal publication of the World Health Organization (WHO), and all rights are reserved by the Organization. The
document may, however be freely reviewed, abstracted, reproduced and translated, in part or in whole, but not for sale nor for use in
conjunction with commercial purposes. The views expressed in documents by named authors are solely the responsibility of those authors.