The place of SYNFLORIX™ in the pneumococcal vaccination strategy in children under 5 years of age

At the request of the Ministry of Solidarity and Health and as part of the market access procedure submitted by GlaxoSmithKline (GSK) for SYNFLORIX™ pneumococcal vaccine, the Haute Autorité de Santé (HAS) provides recommendations on the place of this vaccine in the current pneumococcal infection prevention strategy in children under 5 years of age in France.

SYNFLORIX™ is a 10-valent pneumococcal conjugate vaccine (PCV-10) (containing serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F) which is currently indicated for “active immunisation against invasive disease, pneumonia, and acute otitis media caused by Streptococcus pneumoniae (Sp) in infants and children aged 6 weeks to 5 years”.

The HAS has taken into consideration the key available data for this vaccine, detailed in the full report, that are:

• The evolution of epidemiological French data regarding pneumococcal invasive disease since the introduction of the vaccination in France ;
• WHO Recommendations on conjugate pneumococcal vaccines ;
• The immunogenicity of PCV-10 ;
• The clinical efficacy of PCV-10 against pneumococcal invasive disease and pneumonia caused by vaccine serotypes;
• The degree of cross-protection against non-vaccine serotypes pneumococcal invasive disease, especially for serotype 19A ;
• Epidemiological surveillance data in the countries that introduced PCV-10 ;
• The security profile of PCV-10 which is comparable to other conjugate pneumococcal vaccines;
• The risk of the possible re-emergence of serotype 19A  in France (which demonstrates its antibiotic resistance), and of serotype 6A, in case of change from PCV-13 to PCV-10 strategy in France.

At the end of its assessment, the HAS believes that the French and international epidemiological data do not currently support the use of SYNFLORIX™ in the pneumococcal infection prevention strategy in the specific French context.

The HAS is not in favour ofadding vaccination with SYNFLORIX™ to the paediatric strategy for prevention of invasive pneumococcal diseases in the specific French context.

To date, in France, the pneumococcal infection prevention strategy in children is based on vaccination by the 13-valent conjugate vaccine (PREVENAR 13®) in:

• all children under 2 years of age, including premature babies and infants at increased risk[1] of pneumococcal infections ;

• children aged 2 years to under 5 years who are immunosuppressed or at increased risk1 of pneumococcal infections.