SYNFLORIX® [(pneumococcal conjugate vaccine (Non-Typeable Haemophilus influenzae (NTHi) protein D, diphtheria or tetanus toxoid conjugates) adsorbed] is a 10- valent pneumococcal polysaccharide conjugate vaccine using protein D derived from Non-Typeable Haemophilus influenzae as a carrier protein for 8 out of the 10 serotypes (1, 4, 5, 6B, 7F, 9V, 14 and 23F). Serotypes 18C and 19F are conjugated to tetanus toxoid and to diphtheria toxoid, respectively. All conjugates are adsorbed onto aluminum phosphate.
“In primary vaccination studies, three (out of 4,431) SYNFLORIX® vaccinees (receiving 12,137 doses) experienced serious adverse events with a fatal outcome. These serious adverse events included one case of Sudden Infant Death Syndrome (SIDS), one case of brain neoplasm, and one case of choking due to aspiration. One out of 1,072 7-valent PCV vaccinees died due to muscle atrophy. None of the fatal cases were assessed by the investigator as causally related to vaccination. No fatal serious adverse events were reported in the completed booster and catch-up immunization studies.” – GSK Product Monograph
GlaxoSmithKline seeks expanded EU approval of Synflorix for pneumonia (“GlaxoSmithKline noted that it has not filed for FDA clearance of Synflorix and has previously indicated that it may not attempt to sell the vaccine in the US market.”)