Vaccine Health Impact & Safety

Routine pneumococcal immunization programs in North America and pneumococcal conjugate vaccine (PCV) efficacy studies in Africa demonstrate that multi-valent PCVs have the potential to save millions of children worldwide.

Routine pneumococcal immunization programs with the 7-valent PCV in North America have demonstrated a phenomenal health impact. Pneumococcal disease incidence was reduced both in the vaccinated children due to the direct effects of the vaccine and in unvaccinated children and adults due to herd immunity. Routine immunization was also shown to reduce health disparities by substantially improving child survival in certain vulnerable sub populations.

Two studies testing the efficacy of the 9-valent PCV in The Gambia and South Africa demonstrate that multi-valent PCVs are safe and effective even for HIV-positive children. Multi-valent pneumococcal vaccines have the potential to make a major health impact especially in rural settings where access to treatment is limited.

One vaccine efficacy study in The Philippines with the 11-valent PCV is complete and the results are expected soon. This is the only large-scale population-based study in Asia.

In order to assess and demonstrate the effectiveness of PCVs in Asia, PneumoADIP, WHO and other partners have identified seven countries as sites for potential large-scale vaccine evaluations.

Because vaccines are given to healthy children to keep them healthy, vaccine safety is critical.  Pneumococcal conjugate vaccines have a very good safety profile.  The World Health Organization recently reviewed all the available data on the safety of pneumococcal conjugate vaccines and the following statement from their website summarizes their findings:

Pneumococcal conjugate vaccines are primarily intended for use in infants and toddlers. The currently licensed 7-valent vaccine provides immunity against some of the most common serotypes of Streptococcus pneumoniae that cause invasive pneumococcal disease manifested as pneumonia, meningitis or sepsis and non-bacteraemic pneumonia. Trials with vaccines designed to protect against additional serotypes important in developing countries have recently been completed or are underway.

A comprehensive review of all available evidence of the safety of multivalent pneumococcal conjugate vaccines was conducted and presented to the GACVS. The review focused on safety according to: age at vaccination; use in special populations and medically high-risk groups for pneumococcal disease; and safety according to different immunization schedules.

The current evidence on the safety of multivalent pneumococcal conjugate vaccines is reassuring. Clinical trials and post marketing surveillance in countries that introduced the vaccines have not identified major safety concerns. While there has been a weak and inconsistent signal of increases in reactive airway conditions in some studies, these effects have not been consistently observed.