Hexavalent vaccines | NITAG RESOURCE CENTER

Overview

Hexavalent vaccines containing diphtheria, tetanus, acellular pertussis (DTaP), hepatitis B (hep B), Haemophilus influenzae type b (Hib), and inactivated poliovirus vaccines (IPV) (hexa-aP) were licensed for use in 2000 and were introduced into routine infant vaccination schedules in many countries (mostly high-income countries using the acellular pertussis vaccine in their infant immunization schedules) shortly thereafter.

In March 2024, WHO prequalified a new hexavalent combination vaccine in which the acellular pertussis vaccine was replaced by the whole-cell pertussis (wP) vaccine (hexa-wP). The evidence summarised here is targeted primarily to countries currently using pentavalent (DTwP-HepB-Hib) vaccines in their infant vaccination schedules that are considering switching to one of the two hexavalent vaccine formulations (hexa-aP or hexa-wP). This information is also applicable to countries considering switching from acellular pertussis combination vaccines to the newly prequalified hexa-wP vaccine. The focus is primarily on the use of this vaccine for prevention of poliomyelitis and poliovirus transmission. This guidance sheet should be read within the context of the recommendations on the use of each component in the combination vaccine.

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General indicators for Hexavalent vaccines

Number of new cases per year (last 3-5 years)

Proportion of the population affected by the disease or infected with the antigen

Serogroup or serotype distribution (for serogroup- or serotype-specific vaccines)

Number of deaths from the disease per year

Case Fatality ratio (number of deaths / number of new cases, in %)

Outbreak, epidemic or pandemic risk

Contribution of the vaccine to achievement of the national, regional or global disease goals

Serogroup or serotype coverage by vaccines considered (for serogroup- or serotype-specific vaccines)

Efficacy and effectiveness estimates (e.g. against infection, disease, hospitalization, death), including in different populations

Duration of protection and waning of immunity in general and risk groups

Type, including severity, consequences and frequency of short- and long-term adverse events following vaccination

Perception of the target population on the risk of disease

Acceptability of the vaccine and of vaccination against the disease

Estimated financial cost of materials per vaccine dose (syringes, needles, safety box) (in USD)

Estimated vaccine financial cost per dose (in USD)

Estimated financial cost per person vaccinated (in USD)

Cost-effectiveness ratio

Is there a Gavi programme to support the introduction of this vaccine? If a Gavi programme is available, what support is available to countries?

Available vaccines, licensing status, prequalification status, presentation, formulation, dosage and route of administration

Number of doses and timing of administrations

Cold chain volume required per vaccine dose (in cm3)

Disclaimer

Data are mostly derived from recent WHO and NITAGs official publications, peer reviewed papers and other publicly available sources or other institutional publications. Not all data are the result of systematic reviews with an assessment of the certainty of evidence. In addition, the evidence presented here does not cover every aspect of the respective indicators. Users are encouraged to review the data sources in detail and consider any additional data that may be available (e.g. regional and local).