Professional Documents
Culture Documents
Tentang PCV
Tentang PCV
• There are > 90 known serotypes of S. pneumoniae. The distribution of serotypes that cause disease
varies over time and by age, disease syndrome, disease severity, geographical region and the presence
of antimicrobial-resistant genes.
• Of the estimated 5.83 million deaths among children < 5 years of age globally in 2015, 294 000
(uncertainty range [UR], 192 000–366 000) were estimated to be caused by pneumococcal infections.
• Before the introduction of pneumococcal conjugate vaccines (PCVs) in the different WHO regions, 6–11
serotypes accounted for ≥ 70% of all invasive pneumococcal disease (IPD). The reported mean annual
incidence of IPD in children aged < 2 years was 44.4/100 000 per year in Europe and 167/100 000 per
year in the United States of America., In comparison, the annual incidence of IPD in children < 2 years in
Africa ranged from 60/100 000 in South Africa to 797/100 000 in Mozambique.
• On average, about 75% of cases of IPD and 83% of cases of pneumococcal meningitis occur in children
aged < 2 years, but the incidence and age distribution of cases may vary by country, study method and
socio-economic status within countries.
• Case fatality rates from IPD in children can be high, ranging up to 20% for septicaemia and 50% for
meningitis in low and middle income countries (LMICs).
Summary of Key Points WHO Position Paper on Pneumococcal conjugate vaccines in infants and children under 5 years of age– February 2019
Disease, diagnosis and treatment
• Pneumococcal infection and disease can affect various organ systems. Bloodstream invasion results in
bacteraemia that occasionally causes infection at secondary sites, such as the meninges, joints and peritoneum.
Contiguous spread from the nasopharynx can cause diseases such as otitis media or sinusitis.
• Pneumonia is often caused by aspiration of pneumococci from the nasopharynx and may also be caused by
blood-borne spread.
• Long-term neurological sequelae such as hearing loss, mental retardation, motor abnormalities and seizures
have been observed in 24.7% (interquartile range, 16.2–35.3%) of survivors of childhood pneumococcal
meningitis; the risk of sequelae was 3 times higher among survivors in Africa and Asia than among those in
Europe.
• Lack of exclusive breastfeeding, nutritional deficiency and indoor air pollution are risk factors for pneumonia,
including pneumococcal pneumonia, in infants and young children.
• While clinical diagnosis of pneumonia or meningitis is based on symptoms, signs and radiological tests,
diagnosis of pneumococcal disease requires laboratory confirmation. A definitive diagnosis of pneumococcal
infection is made by isolating the bacterium from blood or other normally sterile body sites, such as
cerebrospinal fluid.
• Pneumococcal disease can be treated with antimicrobials. The choice of antimicrobial and the duration of
treatment depend on the site of infection and the pattern of susceptibility to antimicrobials; the outcome depends
on age, disease syndrome, severity, duration of illness before initiation of treatment and susceptibility to the
antimicrobials used.
Summary of Key Points WHO Position Paper on Pneumococcal conjugate vaccines in infants and children under 5 years of age– February 2019
Pneumococcal conjugate vaccines
• Two polysaccharide-protein conjugate vaccines have been on the market since 2009: the 10-valent (PCV10)
and the 13-valent (PCV13) vaccines. Previously, a 7-valent pneumococcal conjugate vaccine (PCV7) was
available.
• This position paper pertains to the currently licensed PCV10 and PCV13 used in children < 5 years of age.
• Both PCV10 and PCV13 have been shown to be safe and effective and to have both direct (in vaccinated
individuals) and indirect (in unvaccinated individuals living in communities with vaccinated children) effects
against pneumococcal disease caused by vaccine serotypes when used in a 3-dose schedule (either 2p+1 or
3p+0) or in a 4-dose schedule (3p+1).
• After the third dose of each schedule (post-booster for 2p+1 and post-primary for 3p+0), the 2p+1 schedule
resulted in higher GMCs but a similar percentage of responders as compared with a 3p+0 schedule for most
serotypes, except for serotype 6B, for which the percentage of responders was higher with the 2p+1 schedule.
• Both PCV10 and PCV13 induce antibodies against the serotypes common to both vaccines (1, 4, 5, 6B, 7F, 9V,
14, 18C, 19F and 23F). Although the mean antibody response to the common serotypes differed with the 2
products, in general, they induced comparable immunogenicity.
• PCV13 has 3 additional serotypes, 3, 6A and 19A. PCV13 induces an immune response to serotype 3; PCV10
contains neither serotype 3 nor any cross-reactive serotype, and immunogenicity against serotype 3 is not
measured in studies of this vaccine. Both PCV10 and PCV13 induce an antibody response to serotype 6A,
which is included in PCV13 but not in PCV10. Both PCV10 and PCV13 induce an antibody response against
serotype 19A.
Summary of Key Points WHO Position Paper on Pneumococcal conjugate vaccines in infants and children under 5 years of age– February 2019
WHO Position
• WHO recommends the inclusion of PCVs in childhood immunization
programmes worldwide.
• Currently available PCVs are safe and effective, and the increase in the number
of serotypes in these vaccines as compared with the first licensed PCV7
represents significant progress in the fight against pneumococcal disease-related
morbidity and mortality, particularly for developing countries.
Summary of Key Points WHO Position Paper on Pneumococcal conjugate vaccines in infants and children under 5 years of age– February 2019
WHO Position- Schedule
• For administration of PCV to infants, WHO recommends a 3-dose schedule administered either
as 2p+1 or as 3p+0, starting as early as 6 weeks of age.
• In choosing between the 2p+1 and 3p+0 schedules, countries should consider programmatic
factors, including timeliness of vaccination and expected coverage. The 2p+1 schedule has
potential benefits over the 3p+0 schedule, when programmatically feasible, as higher antibody
levels are induced in the second year of life, which may be important in maintaining herd
immunity, although no high-quality evidence is available.
• If the 3p+0 schedule is used, a minimum interval of 4 weeks should be maintained between
doses.
• If the 2p+1 schedule is selected, an interval of ≥ 8 weeks is recommended between the 2 primary
doses, but the interval may be shortened if there is a compelling reason to do so, such as
timeliness of receipt of the second dose and/or achieving higher coverage when a 4-week
interval is used. The booster dose should be given at 9–18 months of age, according to
programmatic considerations; there is no defined minimum or maximum interval between the
primary series and the booster dose.
• Previously unvaccinated or incompletely vaccinated children who recover from IPD should be
vaccinated according to the recommended age-appropriate regimens. Interrupted schedules
should be resumed without repeating the previous dose.
Summary of Key Points WHO Position Paper on Pneumococcal conjugate vaccines in infants and children under 5 years of age– February 2019
WHO Position- Product Choice
Summary of Key Points WHO Position Paper on Pneumococcal conjugate vaccines in infants and children under 5 years of age– February 2019
WHO Position- Interchangeability of Vaccines
Summary of Key Points WHO Position Paper on Pneumococcal conjugate vaccines in infants and children under 5 years of age– February 2019
WHO Position- Catch-up Vaccination
• Wherever possible, catch-up vaccination at the time of introduction of PCV should be used to accelerate its
impact on disease in children aged 1–5 years, particularly in settings with a high disease burden and mortality.
• If there is limited availability of vaccine or of financial resources for catch-up vaccination, the youngest children
(e.g. < 2 years of age) should be prioritized to receive catch-up doses of PCV because of their higher risk for
pneumococcal disease.
• Catch-up vaccination can be done with a single dose of vaccine for children ≥ 24 months.
• Current data are insufficient for a firm recommendation on the optimal number of doses (1 or 2) required in 12–
23-month-olds as part of catch-up vaccination, so countries choosing to use 1 dose might wish to monitor for
impact and vaccine failures.
• Unvaccinated children aged 1–5 years who are at high risk for pneumococcal infection because of underlying
medical conditions, such as HIV infection or sickle-cell disease, should receive at least 2 doses separated by at
least 8 weeks.
• In humanitarian or other emergency situations, age-appropriate schedules of PCV vaccination should be used
for children < 1 year of age and considered for children ≤ 5 years of age, as indicated by the situation.
• Catch-up vaccination may also be an important means to prevent outbreaks. Vaccine campaigns in response to
outbreaks of confirmed vaccine-type pneumococcal disease are under consideration, but experience is currently
lacking.
Summary of Key Points WHO Position Paper on Pneumococcal conjugate vaccines in infants and children under 5 years of age– February 2019
WHO Position- Vaccination of Special Populations
Summary of Key Points WHO Position Paper on Pneumococcal conjugate vaccines in infants and children under 5 years of age– February 2019
WHO Position- Surveillance
• While a comprehensive surveillance system for pneumococcal disease is
recommended, countries without such a system in place should not wait to
introduce PCV vaccines.
Summary of Key Points WHO Position Paper on Pneumococcal conjugate vaccines in infants and children under 5 years of age– February 2019
WHO Position- Research Priorities
Summary of Key Points WHO Position Paper on Pneumococcal conjugate vaccines in infants and children under 5 years of age– February 2019