New Vaccines Cold Chain Equipmentextranet.who.int/ivb_policies/reports/new_vaccines.pdf · Cold Chain Equipment Vaccine introduction guidelines. Adding a vaccine to a national immunization

Cold Chain EquipmentVaccine introduction guidelines. Adding a vaccine to a national immunization programme: decision and implementationThe updated MYP should include calculations of the impact of the new vaccine on cold chain requirements at national and subnational levels. This assessment provides an ideal opportunity to establish a national cold-chain inventory, which describes the type of equipment and its status in every part of the country. Included in that inventory should be the expected life of the item so that a planned replacement programme can be instituted. This inventory should be updated every two to three years.

WHO/IVB/05.18page 34

GeneralIntroducing hepatitis B vaccine into national immunization servicesWHO recommends that HepB vaccine be included in routine immunization services in all countries. HepB immunization of all infants as an integral part of the national immunization schedule should be the highest priority in all countries.

WHO/V&B/01.28page 1

Introducing hepatitis B vaccine into national immunization servicesImportant elements of integrating HepB vaccine into national immunization programmes are: _ Revising training and informational materials, immunization cards and forms used to monitor and evaluate immunization services. _Training for health care staff is essential because these staff are responsible for handling and administering HepB vaccine and they are a major source of information for parents and others in the general public. _Advocacy and communication efforts are important in order to generate support and commitment for the new vaccine. The primary target audiences are decision-makers/opinion leaders, health care staff, and the general public including parents.

WHO/V&B/01.28page 3

Introducing hepatitis B vaccine into national immunization servicesAdequate seroprevalence data needed to assess HepB disease burden are generally available in all countries, or from adjacent countries with similar HBV endemicity. Thus, additional seroprevalence studies are usually not needed.

WHO/V&B/01.28page 4

Introducing hepatitis B vaccine into national immunization servicesIn phasing HepB vaccine into the existing infant immunization services, a strategy in which HepB vaccine is given to infants who have not yet completed the DTP vaccine series at the time HepB vaccine is introduced is generally the most feasible to implement.

WHO/V&B/01.28page 4

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http://whqlibdoc.who.int/hq/2005/WHO_IVB_05.18.pdf

http://whqlibdoc.who.int/hq/2001/WHO_V&B_01.28.pdf




Introducing Haemophilus influenzae type b (Hib) conjugate vaccine into national immunization services(Regarding Hib vaccine,) immunization of all infants through routine services is the highest priority for all countries.

WHO/V&B/01.29page 2

Introducing Haemophilus influenzae type b (Hib) conjugate vaccine into national immunization servicesCatch-up vaccination of older children. (Note: The Vaccine Fund does not provide funding to purchase vaccine for catch-up vaccination): Children aged greater than 12 months can be protected with just a single dose of Hib conjugate vaccine. At the time of introduction, some countries have chosen to conduct one-time national campaigns to vaccinate all children 1 to 5 years of age with a single dose of Hib conjugate vaccine. This approach may provide some protection to older children but should be undertaken only if it does not draw resources away from infant immunization. Because the risk of Hib disease falls sharply after age 5 years, vaccination of persons older than age 5 years should not be undertaken.

WHO/V&B/01.29page 2

Introducing Haemophilus influenzae type b (Hib) conjugate vaccine into national immunization servicesAdding Hib conjugate vaccine to the national immunization programme will require: an assessment of cold chain storage capacity and cold chain procedures at all administrative levels; and, development and implementation of plans to modify cold chain storage capacity and cold chain procedures, if needed.

WHO/V&B/01.29page 3

Introducing Haemophilus influenzae type b (Hib) conjugate vaccine into national immunization servicesImportant elements of integrating Hib vaccination into national immunization services include: _ revising training and informational materials, forms used to monitor and evaluate the programme, and vaccination cards. _ information, education and communication (IEC) efforts are important from the beginning in order to generate support and commitment for the new vaccine and to assure that the vaccine is appropriately handled and administered. The primary target audiences for IEC efforts are decisionmakers/ opinion leaders, health care staff, and the general public (including parents).

WHO/V&B/01.29page 3

Introducing Haemophilus influenzae type b (Hib) conjugate vaccine into national immunization servicesVarious tools are available from the WHO regional office which use existing local and regional data to estimate the burden of Hib disease. As a result, disease burden studies will not be needed in most countries (before introducing Hib vaccine.)

WHO/V&B/01.29page 3

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Introducing Haemophilus influenzae type b (Hib) conjugate vaccine into national immunization servicesThe easiest way to introduce Hib conjugate vaccine is to simply begin vaccinating each infant that comes for routine DTP vaccination. Some countries may wish to consider one-time catch-up vaccination of older children (<2 years or <5 years of age). This will lead to a more immediate reduction in Hib cases but will be more expensive and somewhat more complicated to achieve.

WHO/V&B/01.29page 3

Introducing Haemophilus influenzae type b (Hib) conjugate vaccine into national immunization servicesThe introduction of Hib conjugate vaccine into the routine services should be used as an opportunity to strengthen the existing services. Programme elements that need particular attention for the introduction of Hib conjugate include stock management, reducing vaccine wastage, and injection safety. Also, the introduction of this new vaccine against serious childhood illness represents an opportunity to renew community interest in all routine vaccinations.

WHO/V&B/01.29page 4

Introducing Haemophilus influenzae type b (Hib) conjugate vaccine into national immunization servicesCapital and recurrent costs related to the introduction of Hib conjugate vaccine should be estimated and included in the annual EPI budget. Additional capital costs might include: investment in means of transport, cold chain equipment and sterilization equipment. Investment in an information campaign targeted at the general public should also be included. Additional recurrent costs include: vaccines, auto-disable injection devices, salaries, transportation (petrol and maintenance), training, cold chain maintenance, safe disposal of waste, disease surveillance and other supplies, such as laboratory media and stationery.

WHO/V&B/01.29page 4

Introduction of Haemophilus influenzae type b vaccine into immunization programmesWHO recommends that Hib vaccine now be included in routine infant immunization programmes for all children, as appropriate to national capacities and priorities.

WHO/V&B/00.05page 1

Measles vaccines (WHO position paper)Mumps-containing measles vaccine (MMR) is generally not recommended for large-scale measles SIAs in countries with limited resources.

WER 2004, vol. 79, 14, pp 130-142page 138

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http://www.who.int/immunization/wer7914measles_April2004_position_paper.pdf


Mumps virus vaccines (WHO position paper)Large-scale mumps vaccination is recommended in countries with an efficient childhood vaccination programme and sufficient resources to maintain high-level vaccination coverage, and where reduction of mumps is a public health priority. Because WHO considers measles elimination and control of congenital rubella syndrome to be higher priorities than mumps control, it recommends that the introduction of mumps immunization should be considered only in countries that have or are establishing adequate vaccination programmes for measles elimination and control of the congenital rubella syndrome. In countries which decide to use mumps vaccine, the combination of mumps vaccine with measles and rubella vaccines is thus recommended. National decisions to implement large-scale mumps vaccination should be based on careful cost-benefit analyses, including comparative analyses of mumps control versus control of other vaccine-preventable diseases in the country.

WER 2001, vol. 76, 45, pp 346-356page 346

Introduction of Haemophilus influenzae type b vaccine into immunization programmesIn introducing Hib using a catch-up strategy, there will be multiple schedules in the first year for health workers and parents. For example, a schedule for catch-up dosing is outlined in Appendix 15_10. For older children who have already received DTP immunizations, monovalent Hib vaccine will have to be used, not a combination vaccine such as Hib-DTP, thus resulting in two Hib vaccine formations at the health centre level.

WHO/V&B/00.05page 9

Hepatitis B vaccines (WHO position paper)Routine vaccination of all infants against HBV infection should become an integral part of national immunization schedules worldwide. High coverage with the primary vaccine series among infants has the greatest overall impact on the prevalence of chronic HBV infection in children and should be the highest HBV-related priority.

WER 2004, vol. 79, 28, pp 255-263page 255

Measles vaccines (WHO position paper)Where measles vaccine has been combined with rubella vaccine (MR) or mumps and rubella vaccine (MMR), the protective immune response to the individual components remains unchanged. The use of such combined vaccines is logistically and programmatically sound and is recommended in areas where the disease burden of mumps and rubella disease burden is high, when the vaccine is affordable and, in the case of rubella, where vaccine coverage rates can be sustained at >80%.

WER 2004, vol. 79, 14, pp 130-142page 131

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http://www.who.int/immunization/wer7645mumps_Nov01_position_paper.pdf



http://www.who.int/immunization/wer7928HepB_July04_position_paper.pdf




Rubella vaccines (WHO position paper)Rubella vaccination of adults will not alter the transmission dynamics of the virus, whereas inadequately implemented childhood vaccination may result in an increased number of susceptibles among women of childbearing age, and thereby increased risk of CRS. Consequently, it is essential that childhood vaccination programmes achieve and maintain high levels of coverage. Unless high coverage (>80%) can be achieved, large-scale childhood vaccination programmes against rubella are not recommended.

WER 2000, vol. 75, 20, pp 161-169page 162

Rubella vaccines (WHO position paper)WHO recommends the use of rubella vaccine in all countries with well-functioning childhood immunization programmes where reduction or elimination of CRS is considered a public health priority, and where resources may be mobilized to assure implementation of an appropriate strategy.

WER 2000, vol. 75, 20, pp 161-169page 168

Rubella vaccines (WHO position paper)Some countries with limited resources and documented very low susceptibility rates amongst their young females, as also reflected in low incidence of CRS, may be well advised not to start on any large-scale vaccination against rubella.

WER 2000, vol. 75, 20, pp 161-169page 168

Yellow fever vaccine (WHO position paper)In 1988, the joint United Nations Children's Fund/WHO Technical Group on Immunization in Africa recommended that countries at risk for YF (yellow fever) incorporate the 17D vaccine into their national immunization programme.

WER 2003, vol. 78, 40, pp 349-359page 357

Typhoid vaccines (WHO position paper)Decisions on whether or not to incorporate typhoid vaccination into large-scale immunization programmes should be based on detailed knowledge of the local epidemiological situation including data on age-specific incidence and possible subpopulations at particular risk, as well as on information concerning the sensitivity to relevant antimicrobial drugs of the prevailing S. typhi strains. Ideally, cost-benefit analyses should be part of the planning process.

WER 2000, vol. 75, 32, pp 257-264page 258

Typhoid vaccines (WHO position paper)The old, heat inactivated whole-cell (typhoid) vaccine may not always be manufactured according to international standards, whereas both the parenteral Vi-based polysaccharide vaccine and the live attenuated oral Ty21a vaccine are of assured quality and safety. The respective duration of protection is not fully established for any of these vaccines. Because of its considerable reactogenicity, the inactivated whole-cell vaccine should now be replaced by the less reactogenic and equally efficacious modern vaccines. However, for mainly economic reasons the old vaccine is still used in some parts of the world.

WER 2000, vol. 75, 32, pp 257-264page 263

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http://www.who.int/immunization/wer7520rubella%20_May00_position_paper.pdf






http://www.who.int/immunization/wer7840yellow_fever_Oct03_position_paper.pdf


http://www.who.int/immunization/wer7532typhoid_Aug00_position_paper.pdf




Typhoid vaccines (WHO position paper)Neither the Vi-based polysaccharide (typhoid) vaccine nor the Ty21a (typhoid) vaccine is licensed for children aged < 2 years, and with their current formulations they are not considered candidates for inclusion into large-scale vaccination programmes in this age group.

WER 2000, vol. 75, 32, pp 257-264page 263

Conclusions and recommendations from the Strategic Advisory Group of Experts (SAGE) - 9-11 November 2005SAGE recognized that studies on surveillance and disease burden were needed to support evidence-based decision-making in countries that have not introduced routine Hib vaccination, bearing in mind issues such as vaccine supply and cost, and carefully exploring financing options. Cost-benefit studies would also be needed. Whether all countries need to undertake all of these activities has not been resolved. Limitations in laboratory capacity were identified as major impediments that needed to be properly addressed. New financing opportunities for the poorest countries, particularly through the Global Alliance for Vaccines and Immunization and the IFFIm, will need to be encouraged. SAGE strongly recommended that this new framework (GAVI Hib initiative) for Hib introduction should be expanded to the fullest extent possible to increase demand for the vaccine and accelerate the lowering of its price. SAGE also recommended global implementation of Hib vaccination unless robust epidemiological evidence exists of low disease burden, lack of benefit or overwhelming impediments to implementation.

WER 2006, vol. 81, 1, pp 2-11page 7

Conclusions and recommendations from the Strategic Advisory Group of Experts (SAGE) - 9-11 November 2005SAGE noted that in Phase III trials to date, including those undertaken in south and central America, rotavirus vaccines had been shown to reduce the severity of rotavirus diarrhoea, rather than prevention of infection. SAGE recommended that in countries where rotavirus vaccines are introduced, clear communication strategies be implemented to prevent misconceptions regarding the efficacy of rotavirus vaccines to prevent all childhood diarrhoea. SAGE noted that promotion of the use of oral rehydration therapy should be maintained. SAGE is not yet in a position to make global recommendations about the use of rotavirus vaccines. Additional efficacy studies do not need to be very extensive but should be representative of the respective regions. SAGE supports previous WHO recommendations for obtaining information on co-administration of rotavirus vaccines with routine EPI vaccines, and especially with OPV. The emergence of new serotypes should continue to be monitored after vaccine introduction. SAGE considered that a regional and phased approach could be appropriate in those regions where successful Phase III trials have been undertaken, and provided that other elements such as the appropriate infrastructure and financing mechanisms were available. The lessons of vaccine introduction and post-marketing surveillance from one region could then be useful to others. At the same time, much needed efficacy data should be collected in Africa and Asia.

WER 2006, vol. 81, 1, pp 2-11page 8

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http://www.who.int/vaccines-documents/DocsPDF06/reh_01.pdf




Conclusions and recommendations from the Strategic Advisory Group of Experts (SAGE) - 9-11 November 2005SAGE noted that while (HPV) vaccines might be promoted as cancer-preventing products, additional promotion as vaccines against a sexually transmitted infection may foster negative connotations as some groups may perceive their use as encouraging promiscuity. Although HPV vaccines may have the potential to prevent 70% of cases of cervical cancer, the positive impact of the intervention will only be observed after a considerable number of years, and public expectations of an immediate impact will need to be assuaged. The impact of the availability of vaccination on screening programmes for cervical cancer will require careful evaluation.

WER 2006, vol. 81, 1, pp 2-11page 9

Conclusions and recommendations from the Strategic Advisory Group of Experts (SAGE) - 9-11 November 2005SAGE recommended that WHO gives a clear signal on the priority for wider use of pneumococcal vaccine in children. Lack of clarity of demand is a critical factor inhibiting industrial scaling up of manufacturing capacity. This uncertainty needs to be overcome since validated demand forecasts are essential for the commitments required from industry that will make this vaccine available at affordable prices. In particular, evidence was required through studies on disease burden of the cost benefit of using pneumococcal conjugate vaccines and the feasibility of vaccine delivery to all vulnerable groups. Pneumococcal serotype prevalence studies, undertaken in different settings, are required to judge the appropriateness of the conjugate vaccine to be used. A firm position from SAGE will be required once serotype prevalence studies are completed to judge the appropriateness of the conjugate vaccine available. (SAGE) recognized that a global recommendation, made before resolution of funding and supply issues, could leave vulnerabilities that have been experienced with the implementation of Hib vaccine.

WER 2006, vol. 81, 1, pp 2-11page 10

Introducing hepatitis B vaccine into national immunization servicesAdding HepB vaccine to the national immunization schedule will require cold chain assessments at all administrative levels: _ to assure adequate storage capacity is available, and _ to assure policies and procedures are in place to prevent freezing of HepB vaccine.

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Vaccine introduction guidelines. Adding a vaccine to a national immunization programme: decision and implementation2


Vaccine introduction guidelines. Adding a vaccine to a national immunization programme: decision and implementationOnce a decision has been taken, the rationale, strategies and activities needed for the vaccine introduction have to be identified and integrated into the national comprehensive immunization multi-year plan (MYP). This can either be done by updating an existing MYP, or developing a new one if the time span of the existing MYP is close to the end.


Vaccine introduction guidelines. Adding a vaccine to a national immunization programme: decision and implementationIn general, it is recommended that infants coming after the new vaccine introduction date should have priority in receiving the new vaccine but, if it is feasible, older children can be included to complete their vaccine series.


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Vaccine introduction guidelines. Adding a vaccine to a national immunization programme: decision and implementationThe updated MYP should include calculations of the impact of the new vaccine on cold chain requirements at national and subnational levels. This assessment provides an ideal opportunity to establish a national cold-chain inventory, which describes the type of equipment and its status in every part of the country. Included in that inventory should be the expected life of the item so that a planned replacement programme can be instituted. This inventory should be updated every two to three years.


Vaccine introduction guidelines. Adding a vaccine to a national immunization programme: decision and implementationTraining for vaccine introduction will include aspects related to: details regarding the disease and the new vaccine (schedule, safety, efficacy, AEFI); storage, preparation and administration of the vaccine, including avoidance of freezing; record keeping and reporting of doses administered; and monitoring and reporting the vaccine wastage, and using approaches like the multi-dose vial policy (MDVP) to reduce it.


Vaccine introduction guidelines. Adding a vaccine to a national immunization programme: decision and implementationAdding a vaccine will generally require updating the forms and vaccination cards used for recording and reporting vaccine administration, forms for ordering vaccines and vaccine stock ledgers, and any other forms that list the NIP vaccines. When the change involves substituting one vaccine for another, it is possible to use the same forms, knowing that any record written after the start date relates to the new vaccine. Although it is preferable to adapt the forms to reflect the vaccine that is actually used, this can also be accomplished when they need reprinting.


Vaccine introduction guidelines. Adding a vaccine to a national immunization programme: decision and implementationThe primary method for countries to evaluate the new vaccine introduction is through monitoring immunization coverage at district level, which should cause a reduction in disease over time. If the new vaccine is administered separately, comparison of its coverage and drop-out rate with that of other vaccines provides valuable insight in programme performance. Each level of the NIP should regularly analyse the data from the sub-levels and provide feedback.


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Vaccine introduction guidelines. Adding a vaccine to a national immunization programme: decision and implementationWhile many countries have readily replaced single-antigen measles vaccine with measlesmumpsrubella (MMR) or measlesrubella (MR) vaccines, to prevent a potential gradual increase in rubella susceptibility among women of childbearing age and a paradoxical increase in congenital rubella syndrome (CRS) incidence, efforts are needed to assure that women of childbearing age are also protected against rubella. A strong laboratory-based surveillance mechanism is a must for identification of rubella outbreaks following the introduction of MMR or MR into the NIP. A screening programme should be available for females entering childbearing age because, once the vaccine is introduced into the NIP, the susceptibility of adults getting rubella will be increased.


Vaccine introduction guidelines. Adding a vaccine to a national immunization programme: decision and implementationWHO recommends (hepatitis B vaccine) introduction in all countries.


Vaccine introduction guidelines. Adding a vaccine to a national immunization programme: decision and implementationMeningococcus A conjugate vaccine: A well planned and coordinated strategy for introduction will guarantee widespread use of this needed vaccine. This requires not only a sound plan, but the buying in of the user countries. Estimating local disease burden and vaccine costeffectiveness should be integral components.


Measles vaccines (WHO position paper)(W)hen affordable, the MR combination should be considered in countries with a persistently high (>80%) routine measles vaccination coverage, where prevention of congenital rubella syndrome is a public health priority and where an immunization programme has been established for women of childbearing age.

WER 2004, vol. 79, 14, pp 130-142page 138

Hepatitis A vaccines (WHO position paper)The results of appropriate epidemiological and cost-benefit studies should be carefully considered before deciding on national policies concerning immunization against hepatitis A. As part of this decision process, the public health impact of hepatitis A should be weighed against the impact of other vaccine-preventable infections, including diseases caused by hepatitis B, Haemophilus influenzae type b, rubella and yellow fever.

WER 2000, vol. 75, 5, pp 38-44page 39

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http://www.who.int/immunization/wer7505Hepatitis%20A_Feb00_position_paper.pdf


Hepatitis A vaccines (WHO position paper)In countries highly endemic for hepatitis A, almost all persons are infected in childhood with the virus without showing symptoms, effectively preventing clinical hepatitis A in adolescents and adults. In these countries, large-scale vaccination programmes are not recommended. In countries of intermediate disease endemicity, where a relatively large proportion of the adult population is susceptible to HAV, and where hepatitis A represents a significant public health burden, large-scale childhood vaccination may be considered as a supplement to health education and improved sanitation. In regions of low disease endemicity, vaccination against hepatitis A is indicated for individuals with increased risk of contracting the infection, such as travellers to areas of intermediate or high endemicity.

WER 2000, vol. 75, 5, pp 38-44page 39

Hepatitis A vaccines (WHO position paper)(T)he decision to include hepatitis A vaccine in routine childhood immunization services should be made in the context of the full range of immunization interventions available. This includes hepatitis B, Hib, rubella and yellow fever, and, in the near future, pneumococcal vaccines, all of which are likely to have a more profound public health impact.

WER 2000, vol. 75, 5, pp 38-44page 44

Mumps virus vaccines (WHO position paper)The decision to introduce mumps immunization should be based on an assessment of the disease burden of mumps, the efficacy and adverse-event characteristics of the vaccine, the cost of the prevention programme and other disease-prevention priorities. In view of the moderate morbidity and low mortality of this disease, information on the burden (including socioeconomic impact) of mumps is essential when deciding on the priority of mumps vaccination in national immunization programmes. With respect to efficacy, public health authorities should guarantee that mumps vaccine preparations recommended for use in the national immunization programme have an established record of effectiveness. Vaccines that are not effective should not be used.

WER 2001, vol. 76, 45, pp 346-356page 354

Mumps virus vaccines (WHO position paper)Introduction of routine mumps immunization should be prioritized along with other potential prevention options. Introduction of mumps vaccine into national childhood immunization programmes should be considered only in countries that have or are establishing adequate vaccination programmes for measles elimination and control of the congenital rubella syndrome.

WER 2001, vol. 76, 45, pp 346-356page 354

Mumps virus vaccines (WHO position paper)The addition of mumps vaccine to the measles and rubella vaccination programmes using the MMR combined vaccine is logistically sound, and the MMR combination is strongly encouraged where affordable and where vaccine supply is sufficient.

WER 2001, vol. 76, 45, pp 346-356page 355

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Conclusions and recommendations from the Strategic Advisory Group of Experts (SAGE) - 10-11 April 2006SAGE commended the efforts of countries (regarding Japanese encephalitis control) and acknowledged that immunization is the most appropriate means of controlling the disease. It also acknowledged the cost-effectiveness of the measure. (page 216) SAGE recommended that (Japanese encephalitis) immunization strategies be guided by evidence of the burden of disease, the impact and safety of immunization and the ability to integrate JE vaccination into the EPI programme. Interference with the immune response to other vaccinations, the number of doses required and the duration of protection need to be assessed. Efforts to continue measuring incidence of acute encephalitis syndrome and to confirm diagnoses need to be sustained.

WER 2006, vol. 81, 21, pp 210-220page 215

Conclusions and recommendations from the meeting of the immunization Strategic Advisory Group of Experts (SAGE) - November 2006SAGE considers that including pneumococcal conjugate vaccine in national immunization programmes should be a priority and supports the introduction of the currently licensed PCV-7 vaccine. This recommendation is based on epidemiological data and vaccine-impact data from a number of different settings. Countries with mortality among children under the age of 5 years of >50 deaths/1000 births, or with >50 000 annual deaths among children, should make the introduction of PCV-7 a high priority for their immunization programmes.

WER 2006, vol. 82, 1, pp 1-16page 8

Conclusions and recommendations from the meeting of the immunization Strategic Advisory Group of Experts (SAGE) - November 2006The incidence of preventable disease (that is, the product of the proportion of severe disease caused by vaccine serotypes and the rate of pneumococcal disease) should be used to anticipate the likely impact of pneumococcal conjugate vaccine. Where country-specific estimates of the incidence of preventable pneumococcal disease are not available, they may be approximated using data from epidemiologically similar populations.

WER 2006, vol. 82, 1, pp 1-16page 9

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http://www.who.int/wer/2006/wer8121.pdf


http://www.who.int/immunization/sage/SAGE_report_nov_2006.pdf




Conclusions and recommendations from the meeting of the immunization Strategic Advisory Group of Experts (SAGE) - November 2006The burden of pneumococcal disease is substantially higher among individuals infected with HIV. Since pneumococcal conjugate vaccines have been shown to be safe and efficacious in HIV-infected children, SAGE recommends introducing PCV-7 in countries where HIV is a significant cause of mortality and it encourages evaluation of the impact of vaccination among the HIV-infected population. Populations with a high prevalence of other underlying conditions that increase the risk of pneumococcal disease, such as sickle-cell disease, should also be targeted for vaccination.

WER 2006, vol. 82, 1, pp 1-16page 9

Conclusions and recommendations from the meeting of the immunization Strategic Advisory Group of Experts (SAGE) - November 2006The risk of serious pneumococcal disease remains high throughout childhood. When vaccine is introduced, maximum individual protection and community-level protection can be achieved by also vaccinating children aged 1 year to 5 years with a single dose. Countries should determine the feasibility of reaching such children and, where possible, implement strategies for vaccinating this population within the first year of vaccine introduction.

WER 2006, vol. 82, 1, pp 1-16page 10

Conclusions and recommendations from the meeting of the immunization Strategic Advisory Group of Experts (SAGE) - November 2006When other formulations of pneumococcal vaccine that are appropriate for infant immunization become available, countries using PCV-7 should assess the value of switching to one of these formulations.

WER 2006, vol. 82, 1, pp 1-16page 10

Pneumococcal conjugate vaccine for childhood immunization (WHO position paper)Recognizing the heavy burden of pneumococcal disease occurring in young children and the safety and efficacy of PCV-7 in this age group, WHO considers that it should be a priority to include this vaccine in national immunization programmes, particularly in countries where mortality among children aged <5 years is >50/1000 live births or where >50 000 children die annually. (Page 103) - WHO considers that pneumococcal conjugate vaccine should be a priority for inclusion in national childhood immunization programmes. Countries with mortality among children aged <5 years of >50 deaths/1000 births or with more than 50 000 childrens deaths annually should make the introduction of PCV-7 a high priority for their immunization programmes.

WER 2006, vol. 82, 10, pp 93-104page 95

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http://www.who.int/immunization/wer8212pneumococcus_child_Mar07_position_paper.pdf


Pneumococcal conjugate vaccine for childhood immunization (WHO position paper)The burden of pneumococcal disease is substantially higher among individuals who are infected with HIV. Since pneumococcal conjugate vaccines have been shown to be safe and efficacious when used in children infected with HIV, WHO recommends that countries with a high prevalence of HIV prioritize the introduction of PCV-7. Furthermore, populations with a high prevalence of other underlying conditions that increase the risk of pneumococcal disease, such as sicklecell disease, should also be targeted for vaccination. (Page 103) The burden of pneumococcal disease is substantially higher among individuals who are infected with HIV. Since pneumococcal conjugate vaccines have been shown to be safe and efficacious in HIV-infected children, WHO recommends prioritizing the introduction of PCV-7 in countries where HIV is a significant cause of mortality. Evaluations of the impact of vaccination among the population infected with HIV are encouraged. Populations with high prevalence of other underlying conditions that increase the risk of pneumococcal disease, such as sickle-cell disease, also should be targeted for vaccination.

WER 2006, vol. 82, 10, pp 93-104page 95

Pneumococcal conjugate vaccine for childhood immunization (WHO position paper)Once pneumococcal vaccines offering broader serotype coverage become available, countries using PCV-7 should assess whether it would be helpful to switch to these vaccines. This assessment should be based on the distribution of serotypes causing invasive pneumococcal disease in the affected population and the likely additional benefit to be gained from broadening the spectrum of vaccine serotypes. The introduction of pneumococcal conjugate vaccines with broader coverage will be facilitated if PCV-7 is already in use.

WER 2006, vol. 82, 10, pp 93-104page 96

Measles vaccines (WHO position paper)General WHO position on vaccines Vaccines for large-scale public health interventions should: - meet the quality requirements as defined in the current WHO policy statement on vaccine quality; - be safe and have a significant impact against the actual disease in all target populations; - if intended for infants or young children, be easily adapted to the schedules and timing of national childhood immunization programmes; - not interfere significantly with the immune response to other vaccines given simultaneously; - be formulated to meet common technical limitations, e.g. in terms of refrigeration and storage capacity.

WER 2004, vol. 79, 14, pp 130-142page 140

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HIV/AIDS and immunosuppressionConclusions and recommendations from the meeting of the immunization Strategic Advisory Group of Experts (SAGE) - November 2006The burden of pneumococcal disease is substantially higher among individuals infected with HIV. Since pneumococcal conjugate vaccines have been shown to be safe and efficacious in HIV-infected children, SAGE recommends introducing PCV-7 in countries where HIV is a significant cause of mortality and it encourages evaluation of the impact of vaccination among the HIV-infected population. Populations with a high prevalence of other underlying conditions that increase the risk of pneumococcal disease, such as sickle-cell disease, should also be targeted for vaccination.

WER 2006, vol. 82, 1, pp 1-16page 9


WER 2006, vol. 82, 10, pp 93-104page 95

Hepatitis AHepatitis A vaccines (WHO position paper)The results of appropriate epidemiological and cost-benefit studies should be carefully considered before deciding on national policies concerning immunization against hepatitis A. As part of this decision process, the public health impact of hepatitis A should be weighed against the impact of other vaccine-preventable infections, including diseases caused by hepatitis B, Haemophilus influenzae type b, rubella and yellow fever.

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WER 2000, vol. 75, 5, pp 38-44page 39


WER 2000, vol. 75, 5, pp 38-44page 44

Hepatitis BIntroducing hepatitis B vaccine into national immunization servicesWHO recommends that HepB vaccine be included in routine immunization services in all countries. HepB immunization of all infants as an integral part of the national immunization schedule should be the highest priority in all countries.

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HibIntroducing Haemophilus influenzae type b (Hib) conjugate vaccine into national immunization services(Regarding Hib vaccine,) immunization of all infants through routine services is the highest priority for all countries.

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Conclusions and recommendations from the Strategic Advisory Group of Experts (SAGE) - 9-11 November 2005SAGE recognized that studies on surveillance and disease burden were needed to support evidence-based decision-making in countries that have not introduced routine Hib vaccination, bearing in mind issues such as vaccine supply and cost, and carefully exploring financing options. Cost-benefit studies would also be needed. Whether all countries need to undertake all of these activities has not been resolved. Limitations in laboratory capacity were identified as major impediments that needed to be properly addressed. New financing opportunities for the poorest countries, particularly through the Global Alliance for Vaccines and Immunization and the IFFIm, will need to be encouraged. SAGE strongly recommended that this new framework (GAVI Hib initiative) for Hib introduction should be expanded to the fullest extent possible to increase demand for the vaccine and accelerate the lowering of its price. SAGE also recommended global implementation of Hib vaccination unless robust epidemiological evidence exists of low disease burden, lack of benefit or overwhelming impediments to implementation.

WER 2006, vol. 81, 1, pp 2-11page 7

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WHO/V&B/01.29page 4


WHO/V&B/01.29page 4

Immunization CoverageRubella vaccines (WHO position paper)Rubella vaccination of adults will not alter the transmission dynamics of the virus, whereas inadequately implemented childhood vaccination may result in an increased number of susceptibles among women of childbearing age, and thereby increased risk of CRS. Consequently, it is essential that childhood vaccination programmes achieve and maintain high levels of coverage. Unless high coverage (>80%) can be achieved, large-scale childhood vaccination programmes against rubella are not recommended.

WER 2000, vol. 75, 20, pp 161-169page 162



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JEConclusions and recommendations from the Strategic Advisory Group of Experts (SAGE) - 10-11 April 2006SAGE commended the efforts of countries (regarding Japanese encephalitis control) and acknowledged that immunization is the most appropriate means of controlling the disease. It also acknowledged the cost-effectiveness of the measure. (page 216) SAGE recommended that (Japanese encephalitis) immunization strategies be guided by evidence of the burden of disease, the impact and safety of immunization and the ability to integrate JE vaccination into the EPI programme. Interference with the immune response to other vaccinations, the number of doses required and the duration of protection need to be assessed. Efforts to continue measuring incidence of acute encephalitis syndrome and to confirm diagnoses need to be sustained.

WER 2006, vol. 81, 21, pp 210-220page 215

MMRMeasles vaccines (WHO position paper)Mumps-containing measles vaccine (MMR) is generally not recommended for large-scale measles SIAs in countries with limited resources.

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WER 2001, vol. 76, 45, pp 346-356page 346

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WER 2004, vol. 79, 14, pp 130-142page 131




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MeaslesMeasles vaccines (WHO position paper)Where measles vaccine has been combined with rubella vaccine (MR) or mumps and rubella vaccine (MMR), the protective immune response to the individual components remains unchanged. The use of such combined vaccines is logistically and programmatically sound and is recommended in areas where the disease burden of mumps and rubella disease burden is high, when the vaccine is affordable and, in the case of rubella, where vaccine coverage rates can be sustained at >80%.

WER 2004, vol. 79, 14, pp 130-142page 131


WER 2004, vol. 79, 14, pp 130-142page 138

MeningococcalVaccine introduction guidelines. Adding a vaccine to a national immunization programme: decision and implementationMeningococcus A conjugate vaccine: A well planned and coordinated strategy for introduction will guarantee widespread use of this needed vaccine. This requires not only a sound plan, but the buying in of the user countries. Estimating local disease burden and vaccine costeffectiveness should be integral components.


MumpsMeasles vaccines (WHO position paper)Mumps-containing measles vaccine (MMR) is generally not recommended for large-scale measles SIAs in countries with limited resources.

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WER 2004, vol. 79, 14, pp 130-142page 131


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Outbreak ControlVaccine introduction guidelines. Adding a vaccine to a national immunization programme: decision and implementationWhile many countries have readily replaced single-antigen measles vaccine with measlesmumpsrubella (MMR) or measlesrubella (MR) vaccines, to prevent a potential gradual increase in rubella susceptibility among women of childbearing age and a paradoxical increase in congenital rubella syndrome (CRS) incidence, efforts are needed to assure that women of childbearing age are also protected against rubella. A strong laboratory-based surveillance mechanism is a must for identification of rubella outbreaks following the introduction of MMR or MR into the NIP. A screening programme should be available for females entering childbearing age because, once the vaccine is introduced into the NIP, the susceptibility of adults getting rubella will be increased.


PneumococcalConclusions and recommendations from the Strategic Advisory Group of Experts (SAGE) - 9-11 November 2005SAGE recommended that WHO gives a clear signal on the priority for wider use of pneumococcal vaccine in children. Lack of clarity of demand is a critical factor inhibiting industrial scaling up of manufacturing capacity. This uncertainty needs to be overcome since validated demand forecasts are essential for the commitments required from industry that will make this vaccine available at affordable prices. In particular, evidence was required through studies on disease burden of the cost benefit of using pneumococcal conjugate vaccines and the feasibility of vaccine delivery to all vulnerable groups. Pneumococcal serotype prevalence studies, undertaken in different settings, are required to judge the appropriateness of the conjugate vaccine to be used. A firm position from SAGE will be required once serotype prevalence studies are completed to judge the appropriateness of the conjugate vaccine available. (SAGE) recognized that a global recommendation, made before resolution of funding and supply issues, could leave vulnerabilities that have been experienced with the implementation of Hib vaccine.

WER 2006, vol. 81, 1, pp 2-11page 10

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Conclusions and recommendations from the meeting of the immunization Strategic Advisory Group of Experts (SAGE) - November 2006SAGE considers that including pneumococcal conjugate vaccine in national immunization programmes should be a priority and supports the introduction of the currently licensed PCV-7 vaccine. This recommendation is based on epidemiological data and vaccine-impact data from a number of different settings. Countries with mortality among children under the age of 5 years of >50 deaths/1000 births, or with >50 000 annual deaths among children, should make the introduction of PCV-7 a high priority for their immunization programmes.

WER 2006, vol. 82, 1, pp 1-16page 8

Conclusions and recommendations from the meeting of the immunization Strategic Advisory Group of Experts (SAGE) - November 2006The incidence of preventable disease (that is, the product of the proportion of severe disease caused by vaccine serotypes and the rate of pneumococcal disease) should be used to anticipate the likely impact of pneumococcal conjugate vaccine. Where country-specific estimates of the incidence of preventable pneumococcal disease are not available, they may be approximated using data from epidemiologically similar populations.

WER 2006, vol. 82, 1, pp 1-16page 9


WER 2006, vol. 82, 1, pp 1-16page 9

Conclusions and recommendations from the meeting of the immunization Strategic Advisory Group of Experts (SAGE) - November 2006The risk of serious pneumococcal disease remains high throughout childhood. When vaccine is introduced, maximum individual protection and community-level protection can be achieved by also vaccinating children aged 1 year to 5 years with a single dose. Countries should determine the feasibility of reaching such children and, where possible, implement strategies for vaccinating this population within the first year of vaccine introduction.

WER 2006, vol. 82, 1, pp 1-16page 10

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Conclusions and recommendations from the meeting of the immunization Strategic Advisory Group of Experts (SAGE) - November 2006When other formulations of pneumococcal vaccine that are appropriate for infant immunization become available, countries using PCV-7 should assess the value of switching to one of these formulations.

WER 2006, vol. 82, 1, pp 1-16page 10


WER 2006, vol. 82, 10, pp 93-104page 95


WER 2006, vol. 82, 10, pp 93-104page 95

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WER 2006, vol. 82, 10, pp 93-104page 96

PolicyIntroducing hepatitis B vaccine into national immunization servicesWHO recommends that HepB vaccine be included in routine immunization services in all countries. HepB immunization of all infants as an integral part of the national immunization schedule should be the highest priority in all countries.

WHO/V&B/01.28page 1


WHO/V&B/01.28page 3


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WHO/V&B/01.28page 4

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Introducing Haemophilus influenzae type b (Hib) conjugate vaccine into national immunization services(Regarding Hib vaccine,) immunization of all infants through routine services is the highest priority for all countries.

WHO/V&B/01.29page 2


WHO/V&B/01.29page 2


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WHO/V&B/01.29page 3


WHO/V&B/01.29page 3

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WHO/V&B/01.29page 3


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WHO/V&B/00.05page 1

Measles vaccines (WHO position paper)Mumps-containing measles vaccine (MMR) is generally not recommended for large-scale measles SIAs in countries with limited resources.

WER 2004, vol. 79, 14, pp 130-142page 138

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WER 2001, vol. 76, 45, pp 346-356page 346


WHO/V&B/00.05page 9


WER 2004, vol. 79, 28, pp 255-263page 255


WER 2004, vol. 79, 14, pp 130-142page 131

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WER 2000, vol. 75, 20, pp 161-169page 162


WER 2000, vol. 75, 20, pp 161-169page 168


WER 2000, vol. 75, 20, pp 161-169page 168

Yellow fever vaccine (WHO position paper)In 1988, the joint United Nations Children's Fund/WHO Technical Group on Immunization in Africa recommended that countries at risk for YF (yellow fever) incorporate the 17D vaccine into their national immunization programme.

WER 2003, vol. 78, 40, pp 349-359page 357

Typhoid vaccines (WHO position paper)Decisions on whether or not to incorporate typhoid vaccination into large-scale immunization programmes should be based on detailed knowledge of the local epidemiological situation including data on age-specific incidence and possible subpopulations at particular risk, as well as on information concerning the sensitivity to relevant antimicrobial drugs of the prevailing S. typhi strains. Ideally, cost-benefit analyses should be part of the planning process.

WER 2000, vol. 75, 32, pp 257-264page 258


WER 2000, vol. 75, 32, pp 257-264page 263

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WER 2000, vol. 75, 32, pp 257-264page 263


WHO/V&B/01.28page 3


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WHO/V&B/01.29page 4

Vaccine introduction guidelines. Adding a vaccine to a national immunization programme: decision and implementation2


Vaccine introduction guidelines. Adding a vaccine to a national immunization programme: decision and implementationOnce a decision has been taken, the rationale, strategies and activities needed for the vaccine introduction have to be identified and integrated into the national comprehensive immunization multi-year plan (MYP). This can either be done by updating an existing MYP, or developing a new one if the time span of the existing MYP is close to the end.


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Vaccine introduction guidelines. Adding a vaccine to a national immunization programme: decision and implementationIn general, it is recommended that infants coming after the new vaccine introduction date should have priority in receiving the new vaccine but, if it is feasible, older children can be included to complete their vaccine series.


Vaccine introduction guidelines. Adding a vaccine to a national immunization programme: decision and implementationThe updated MYP should include calculations of the impact of the new vaccine on cold chain requirements at national and subnational levels. This assessment provides an ideal opportunity to establish a national cold-chain inventory, which describes the type of equipment and its status in every part of the country. Included in that inventory should be the expected life of the item so that a planned replacement programme can be instituted. This inventory should be updated every two to three years.


Vaccine introduction guidelines. Adding a vaccine to a national immunization programme: decision and implementationTraining for vaccine introduction will include aspects related to: details regarding the disease and the new vaccine (schedule, safety, efficacy, AEFI); storage, preparation and administration of the vaccine, including avoidance of freezing; record keeping and reporting of doses administered; and monitoring and reporting the vaccine wastage, and using approaches like the multi-dose vial policy (MDVP) to reduce it.


Vaccine introduction guidelines. Adding a vaccine to a national immunization programme: decision and implementationAdding a vaccine will generally require updating the forms and vaccination cards used for recording and reporting vaccine administration, forms for ordering vaccines and vaccine stock ledgers, and any other forms that list the NIP vaccines. When the change involves substituting one vaccine for another, it is possible to use the same forms, knowing that any record written after the start date relates to the new vaccine. Although it is preferable to adapt the forms to reflect the vaccine that is actually used, this can also be accomplished when they need reprinting.




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Vaccine introduction guidelines. Adding a vaccine to a national immunization programme: decision and implementationMeningococcus A conjugate vaccine: A well planned and coordinated strategy for introduction will guarantee widespread use of this needed vaccine. This requires not only a sound plan, but the buying in of the user countries. Estimating local disease burden and vaccine costeffectiveness should be integral components.



WER 2004, vol. 79, 14, pp 130-142page 138

Hepatitis A vaccines (WHO position paper)The results of appropriate epidemiological and cost-benefit studies should be carefully considered before deciding on national policies concerning immunization against hepatitis A. As part of this decision process, the public health impact of hepatitis A should be weighed against the impact of other vaccine-preventable infections, including diseases caused by hepatitis B, Haemophilus influenzae type b, rubella and yellow fever.

WER 2000, vol. 75, 5, pp 38-44page 39

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WER 2000, vol. 75, 5, pp 38-44page 39


WER 2000, vol. 75, 5, pp 38-44page 44


WER 2001, vol. 76, 45, pp 346-356page 354


WER 2001, vol. 76, 45, pp 346-356page 354


WER 2001, vol. 76, 45, pp 346-356page 355

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WER 2006, vol. 82, 10, pp 93-104page 95


WER 2006, vol. 82, 10, pp 93-104page 95


WER 2006, vol. 82, 10, pp 93-104page 96

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Measles vaccines (WHO position paper)General WHO position on vaccines Vaccines for large-scale public health interventions should: - meet the quality requirements as defined in the current WHO policy statement on vaccine quality; - be safe and have a significant impact against the actual disease in all target populations; - if intended for infants or young children, be easily adapted to the schedules and timing of national childhood immunization programmes; - not interfere significantly with the immune response to other vaccines given simultaneously; - be formulated to meet common technical limitations, e.g. in terms of refrigeration and storage capacity.

WER 2004, vol. 79, 14, pp 130-142page 140

Program ManagementIntroducing Haemophilus influenzae type b (Hib) conjugate vaccine into national immunization servicesAdding Hib conjugate vaccine to the national immunization programme will require: an assessment of cold chain storage capacity and cold chain procedures at all administrative levels; and, development and implementation of plans to modify cold chain storage capacity and cold chain procedures, if needed.

WHO/V&B/01.29page 3


WHO/V&B/01.28page 3

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RotavirusConclusions and recommendations from the Strategic Advisory Group of Experts (SAGE) - 9-11 November 2005SAGE noted that in Phase III trials to date, including those undertaken in south and central America, rotavirus vaccines had been shown to reduce the severity of rotavirus diarrhoea, rather than prevention of infection. SAGE recommended that in countries where rotavirus vaccines are introduced, clear communication strategies be implemented to prevent misconceptions regarding the efficacy of rotavirus vaccines to prevent all childhood diarrhoea. SAGE noted that promotion of the use of oral rehydration therapy should be maintained. SAGE is not yet in a position to make global recommendations about the use of rotavirus vaccines. Additional efficacy studies do not need to be very extensive but should be representative of the respective regions. SAGE supports previous WHO recommendations for obtaining information on co-administration of rotavirus vaccines with routine EPI vaccines, and especially with OPV. The emergence of new serotypes should continue to be monitored after vaccine introduction. SAGE considered that a regional and phased approach could be appropriate in those regions where successful Phase III trials have been undertaken, and provided that other elements such as the appropriate infrastructure and financing mechanisms were available. The lessons of vaccine introduction and post-marketing surveillance from one region could then be useful to others. At the same time, much needed efficacy data should be collected in Africa and Asia.

WER 2006, vol. 81, 1, pp 2-11page 8

RubellaMeasles vaccines (WHO position paper)Where measles vaccine has been combined with rubella vaccine (MR) or mumps and rubella vaccine (MMR), the protective immune response to the individual components remains unchanged. The use of such combined vaccines is logistically and programmatically sound and is recommended in areas where the disease burden of mumps and rubella disease burden is high, when the vaccine is affordable and, in the case of rubella, where vaccine coverage rates can be sustained at >80%.

WER 2004, vol. 79, 14, pp 130-142page 131


WER 2000, vol. 75, 20, pp 161-169page 162

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WER 2000, vol. 75, 20, pp 161-169page 168


WER 2000, vol. 75, 20, pp 161-169page 168




WER 2004, vol. 79, 14, pp 130-142page 138

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SAGE - recommend to WHOConclusions and recommendations from the Strategic Advisory Group of Experts (SAGE) - 9-11 November 2005SAGE recommended that WHO gives a clear signal on the priority for wider use of pneumococcal vaccine in children. Lack of clarity of demand is a critical factor inhibiting industrial scaling up of manufacturing capacity. This uncertainty needs to be overcome since validated demand forecasts are essential for the commitments required from industry that will make this vaccine available at affordable prices. In particular, evidence was required through studies on disease burden of the cost benefit of using pneumococcal conjugate vaccines and the feasibility of vaccine delivery to all vulnerable groups. Pneumococcal serotype prevalence studies, undertaken in different settings, are required to judge the appropriateness of the conjugate vaccine to be used. A firm position from SAGE will be required once serotype prevalence studies are completed to judge the appropriateness of the conjugate vaccine available. (SAGE) recognized that a global recommendation, made before resolution of funding and supply issues, could leave vulnerabilities that have been experienced with the implementation of Hib vaccine.

WER 2006, vol. 81, 1, pp 2-11page 10

TravellersHepatitis A vaccines (WHO position paper)In countries highly endemic for hepatitis A, almost all persons are infected in childhood with the virus without showing symptoms, effectively preventing clinical hepatitis A in adolescents and adults. In these countries, large-scale vaccination programmes are not recommended. In countries of intermediate disease endemicity, where a relatively large proportion of the adult population is susceptible to HAV, and where hepatitis A represents a significant public health burden, large-scale childhood vaccination may be considered as a supplement to health education and improved sanitation. In regions of low disease endemicity, vaccination against hepatitis A is indicated for individuals with increased risk of contracting the infection, such as travellers to areas of intermediate or high endemicity.

WER 2000, vol. 75, 5, pp 38-44page 39

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TyphoidTyphoid vaccines (WHO position paper)Decisions on whether or not to incorporate typhoid vaccination into large-scale immunization programmes should be based on detailed knowledge of the local epidemiological situation including data on age-specific incidence and possible subpopulations at particular risk, as well as on information concerning the sensitivity to relevant antimicrobial drugs of the prevailing S. typhi strains. Ideally, cost-benefit analyses should be part of the planning process.

WER 2000, vol. 75, 32, pp 257-264page 258


WER 2000, vol. 75, 32, pp 257-264page 263


WER 2000, vol. 75, 32, pp 257-264page 263

VPD SurveillanceVaccine introduction guidelines. Adding a vaccine to a national immunization programme: decision and implementationWhile many countries have readily replaced single-antigen measles vaccine with measlesmumpsrubella (MMR) or measlesrubella (MR) vaccines, to prevent a potential gradual increase in rubella susceptibility among women of childbearing age and a paradoxical increase in congenital rubella syndrome (CRS) incidence, efforts are needed to assure that women of childbearing age are also protected against rubella. A strong laboratory-based surveillance mechanism is a must for identification of rubella outbreaks following the introduction of MMR or MR into the NIP. A screening programme should be available for females entering childbearing age because, once the vaccine is introduced into the NIP, the susceptibility of adults getting rubella will be increased.


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WER 2006, vol. 82, 1, pp 1-16page 9

Yellow FeverYellow fever vaccine (WHO position paper)In 1988, the joint United Nations Children's Fund/WHO Technical Group on Immunization in Africa recommended that countries at risk for YF (yellow fever) incorporate the 17D vaccine into their national immunization programme.

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New Vaccines Cold Chain Equipmentextranet.who.int/ivb_policies/reports/new_vaccines.pdf · Cold Chain Equipment Vaccine introduction guidelines. Adding a vaccine to a national immunization

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