vaccine presentations and programmatic implications who / ivb / epi

Vaccine Presentations and Programmatic Implications

WHO / IVB / EPI

TITLE from VIEW and SLIDE MASTER | April 19, 20232 |

New Vaccine supplyNew Vaccine supply

Supply situation for new vaccines (PCV, RV, Penta) is challenging

Imbalance of preferred vs. alternative products

Delays of introduction foreseen through 2015

Hib– Improved since mid-2011, but two products temporarily suspended and one product with

delayed shipments– Supply tight and needs to be closely managed– Countries requesting switches to 10-dose vial presentation need planning to ensure

wastage is reduced

Pneumococcal– Supply and demand situation is dynamic– PCV supply tight for countries planning to introduce from 2013 onwards (mainly PCV13)– New AMC tender closed– New manufacturers not expected on market before 2015/16


New Vaccine supplyNew Vaccine supply

Rotavirus– Supply is limited with delays expected until 2015– Product preference for RV1 (2-dose) – manufacturer increasing production capacity

Yellow Fever– Fragile market (manufacturer suspended, continuous production challenges)– Supply meets requirements for emergencies and routine immunizations– Limited number of campaigns conducted due to insufficient supply

MenA– Monopoly supply market with increasing, high demand levels


GAVI supply allocation criteriaGAVI supply allocation criteria

ObjectiveMetricSource

Allocation criteria used in situations where total demand exceeds total supply available for new introductions (equal weighting)

Maximize health impactBurden of disease as mortality per 100,000 vaccinated

WHO

Minimize delay of introductionDate of Board/EC approval (Month/Year)GAVI

Provide safe deliveryExistence of functioning country AEFI reporting system (Y/N)

WHO

Provide successful delivery% DTP3 CoverageWHO/UNICEF

Introduction preparedness% of the total required cold chain capacity for new vaccine at central and sub national levels

WHO


PNEUMOCOCCAL VACCINESPNEUMOCOCCAL VACCINES


PCV10 and PCV13 Summary of product characteristics

PCV10 and PCV13 Summary of product characteristics

VaccinePCV10 Synflorix - Two dosePCV13 Prevenar - Single dose

Serotypes1, 4, 5, 6B, 7F, 9V, 14, 18CV, 19F, 23F1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F

Number of doses3 doses

Target Age GroupInfants (under 12 months of age)

EPI Schedule3 doses, with DTP

Min interval between doses

4 weeks

Shelf Life36 months at 2 - 8 degrees celcius24 months at 2 - 8 degrees celcius

InterchangeabilityNo data - WHO recommends completing a course with the product started. If product unavailable, alternative product

may be used to conclude the course.

Method administration

Intramuscular

PresentationLiquid - Two dose vial - preservative freeLiquid - Single dose vial

Per dose cold chain requirement

4.8 cm312 cm3

Price (through AMC)$3.50 per dose

VVM typeVVM7VVM30

Wastage rate10%5%

Special PrecautionsTwo dose preservative free presentation: All opened vials must be discarded 6 hours from first opening or at the end of each session, whichever comes first.

N/A


Two-dose presentation of preservative-free 10-valent pneumococcal conjugate vaccine (Synflorix™)

Two-dose presentation of preservative-free 10-valent pneumococcal conjugate vaccine (Synflorix™)

Two dose preservative free presentation: All opened vials must be discarded 6 hours from first opening or at the end of each session, whichever comes first.

Vaccine WHO prequalified with following considerations:

Pre-introduction– Enhanced HCW training on proper use of two-dose presentation

– Ensure training materials in place in immunization centers

– Place stickers on refrigerators at all levels indicating that opened vials must be discarded six hours after opening

Vaccine will only be shipped once training has taken place – countries need to state readiness, endorsed by WHO, for shipment to take place

Post-introduction evaluations based on random sampling procedures specifically looking at HCW behavior and knowledge to be undertaken six months after introduction.

If PIE shows need for re-training, additional intensified training to be undertaken to assure appropriate continued use of this presentation.


Synflorix™ fridge stickerSynflorix™ fridge sticker

To be placed on all refrigerators prior to vaccine arrival in country

Manufacturer to make it available before vaccine introduction

Countries to distribute to all health facilities and certify that stickers are in place


ROTAVIRUS VACCINESROTAVIRUS VACCINES


Rotavirus vaccinesRotavirus vaccines

SAGE review of evidence on rotavirus disease burden, timeliness of vaccination and safety and effectiveness of different immunization schedules.

WHO continues to recommend that first dose of rotavirus vaccine be administered as soon as possible after 6 weeks of age, along with DTP doses.

Current age restrictions of rotavirus vaccines may prevent vaccination of many vulnerable children in settings where DTP doses are given late (i.e. after 15 weeks for DTP1 or after 32 weeks for DTP2 or DTP3).

By allowing children to be immunized with RV at any time, able to immunize children who are currently excluded from the benefits of rotavirus vaccines.

Models developed by PAHO to detect AEFI associated with RV to be disseminated to all introducing countries.

Important to establish baseline incidence of intussusception at sentinel sites and to use epidemiological studies to assess safety of RVs.


Rotarix™ and Rotateq™ Summary of product characteristics

Rotarix™ and Rotateq™ Summary of product characteristics

VaccineHuman monovalent (Rotarix)Human-bovine, pentavalent (RotaTeq)

Number of doses in schedule

23

EPI Schedule2 doses - with DTP 3 doses with DTP

Min interval between doses4 weeks

Method administrationOral

PresentationLiquidLiquid

Per dose cold chain requirement

17.1 CM346.3 CM3

Shelf Life36 months at 2 - 8 degrees celcius24 months at 2 - 8 degrees celcius

VVM typeVVM 14No VVM

Wastage rate5%5%

Special Precautions

Additional training need of health care workers to alert them to the Rotarix™ safety attention point (proper opening of twist-cap tube to avoid programmatic errors).

No VVM technology has been validated for use with this vaccine as those currently available do not match the stability profile of vaccine components.

It is very important for potency of this vaccine that the cold chain storage conditions are maintained from delivery to administration.


Rotavirus vaccines: Key program elements for introduction

Rotavirus vaccines: Key program elements for introduction

Key issues related to rotavirus vaccine safety:

1) AEFI monitoring• Should ideally have AEFI surveillance that can detect intussusception cases • Assess the baseline intussusception rate in the country• Have a well-trained AEFI committee capable of monitoring and assessing AEFIs• Report whether country has an Institutional Development plan

2) Training • Ensure that health workers know that on-time vaccination is important

1) Preparation for risk communication• Need to have in-country personnel who are well-informed about all aspects of the

vaccine and are able to discuss the vaccine benefits, risks and how risk is being monitored.


HUMAN PAPILLOMAVIRUS (HPV)

HUMAN PAPILLOMAVIRUS (HPV)


WHO position paper on HPV vaccineWHO position paper on HPV vaccine

WHO recommends that HPV vaccination should be introduced into national immunization programmes where prevention of cervical cancer and other HPV-related diseases is a public health priority and vaccine introduction is programmatically feasible and financially sustainable.

Recommendation is to prioritize high coverage in primary target population of girls 9 through 13 years old.

Other considerations:– Priority should be given to strategies that include populations who are likely to have less

access to cervical cancer screening later in life.

– HPV vaccine introduction should not divert resources from effective cervical cancer screening programmes.

– HPV vaccination should be introduced as part of a coordinated strategy to prevent cervical cancer and other HPV-related disease.

– Opportunities to link vaccine delivery to other health programmes targeting young people should be sought.


HPV vaccinesHPV vaccines

Two vaccines currently available, widely licensed, and WHO prequalified:

– Cervarix® (bivalent): Prevents precancerous lesions from HPV types 16 and 18

– Gardasil®/Silgard® (quadrivalent): Prevents precancerous lesions from HPV types 16 and 18 and anogenital warts from HPV types 6 and 11

Up to 30% of all cervical cancer cases caused by HPV types other than 16 and 18, so these vaccines do not eliminate need for future cervical cancer screening.

Neither vaccine will treat women with current HPV infection; both vaccines demonstrate best efficacy in individuals HPV-naïve to the vaccine types so best to vaccinate girls prior to initiation of sexual activity.


HPV vaccine product characteristicsHPV vaccine product characteristics

CompositionBivalent Human Papilloma Virus (Types 16 & 18)Quadravalent Human Papilloma Virus (Types 6,11,16 & 18)Trade nameCervarix®Gardasil®/Silgard® Pharmaceutical FormLiquidPresentation1 & 2 dose vials1 dose vialVaccine Vial MonitorType 14Type 30

Route of administrationintramuscular

Shelf life36 (2 dose vial) & 48 (1 dose vial) months at 2-8C36 months at 2-8C

Schedule

3-dose schedule: a) baselineb) after 1 monthc) after 6 months

3-dose schedule: a) baselineb) after 2 monthsc) after 6 months

Minimum intervals between doses

If flexibility in the schedule is necessary, the manufacturer recommends that the second dose is administered between 1 and 2.5 months after the first dose.

A minimum interval of 4 weeks between first and second dose; and minimum interval of 12 weeks between second and third dose

Target groups for immunization

Females aged 9 years onwardsFemales aged 9 years onwards

Cold chain volume (per dose)

1 dose vial:57.7 cm3 (carton of 1 vial)11.5 cm3 (carton of 10 vials)9.7 cm3 (carton of 100 vials)2 dose vial:28.8 cm3 (carton of 1 vial)5.7 cm3 (carton of 10 vials)4.8 cm3 (carton of 100 vials)

75cm3 (carton of 1 vial)15 cm3 (carton of 15 vials)

Special considerations

Two dose preservative free presentation: All opened vials must be discarded 6 hours from first opening or at the end of each session, whichever comes first.


National application for HPV vaccine support Special considerations (1)


Countries must :

Identify a single-year target vaccination cohort within the target population of 9-13 year old girls.

Have demonstrated ability to deliver a complete multi-dose series of vaccines to at least 50% of the target vaccination cohort (i.e., 9-13 year old girls) in an average size district (preferably comprising urban and rural areas) using a strategy similar to the one proposed for national HPV vaccine delivery.

Provide a report on the costing analysis of the proposed delivery strategy or strategies and evidence of non-GAVI resources to support delivery costs.




Countries are also requested to:

Clarify how their plans for communication and social mobilization reflect the unique needs of the programme for reaching the priority audiences.

Provide description of health services and/or health education currently provided to 9-13 year old girls.

Provide cervical cancer burden (e.g. from Globocan database)

Share national strategy for cervical cancer prevention and control with status of activities and next steps

Finally, all technical elements common to any vaccine introduction need to be addressed as standard components of a GAVI application.




For all applications proposing to use a school-based strategy for HPV vaccine delivery, the following conditions must be met:

The minimal proportion of girls of the target vaccination cohort or target grade that is enrolled in school must be 75%.

If the strategy targets girls enrolled in a selected grade, the majority of girls must be between the ages of 9-13 years old with no more than 20% of girls aged 14 years old or above.

A strategy or strategies for vaccinating girls not in school must also be planned and described.

Additional information describing the educational system for girls and any existing school-based health programming will need to be described.

Documentation that the Ministry of Education (MoE) is an ICC member and/or the signature of the Minister of Education is also needed with the application.


HPV vaccine delivery costsHPV vaccine delivery costs

Available estimates quantify HPV vaccine operational costs as higher than recurrent delivery costs for other GAVI vaccines.

GAVI provides introduction grant of 2.40 USD per eligible girl.

GAVI will not provide financial support for recurrent operational costs related to vaccine delivery.

Countries are encouraged to seek other national or partner financial resources to cover these costs.

The country report on the costing analysis of the proposed delivery strategy for the national application to GAVI must provide evidence of these non-GAVI resources to support delivery costs.


HPV vaccine demonstration projectsHPV vaccine demonstration projects

Countries unable to demonstrate ability to vaccinate 9-13 year old girls but wishing to introduce HPV vaccines have an opportunity to apply for a HPV Vaccine Demonstration Project.

Learn by doing– Asses potintial HPV vaccine, delivery strategies , adapting necessary tools– Explore feasibility of integrating selected adolescent health interventions– Encouraging HPV vaccination in national cervical cancer control approach

2 year proogramme

Max. 20,000 girls

Vaccination with selected strategy and evaluation of coverage, acceptability, feasibility, costs

Assessment of feasibility of integrating adolexcent health or sexual and reproductive health interventions

Develop or strengthen comprehensive cervical cancer prevention and control strategy

Multi stakeholder TAG required

No co-financing, programmatic grant provided

vaccine presentations and programmatic implications who / ivb / epi

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