L Bensouda-Grimaldi1, A-P Jonville-Béra, E Autret-Leca. 1. Service de pharmacologie, centre régional de pharmacovigilance et d'information sur le médicament, CHRU de Tours, 2, boulevard Tonnellé, 37044 Tours cedex 09, France.
Abstract
OBJECTIVE: The aim was to detect as soon as possible a rare but severe or unexpected adverse effect (AE) of Prevenar vaccine. A pharmacovigilance survey was required by the French drug agency (Afssaps) to the regional pharmacovigilance centre of Tours (France). METHOD: Two approaches were used. One based upon systematic reports and the other upon spontaneous reports. Only severe and /or unexpected AEs were recorded. RESULTS: During the 19 months of intensive follow up, 24 AEs (8.7 [5-12.7]/100000 vaccinations) reported by 349 participating paediatricians have been analyzed. Prevenar was the only drug taken in 67% of children. AEs were severe (19 cases) or non severe but unexpected (5 cases). AEs were fever above 39 degrees C (10 cases), cutaneous manifestations (6 cases), neurologic manifestations (5 cases), diarrhoea-vomiting (2 cases), and purulent otitis media (1 case). During the 3.5 years of spontaneous reporting, 130 AEs (6 [5-7]/100000 vaccinations) have been reported and analyzed. AEs were severe (107 cases) or non severe but unexpected (23 cases). AEs were mainly: fever above 39 degrees C (17 cases), cutaneous (39 cases), neurologic (34 cases) and haematological (3 cases) manifestations and diarrhoea-vomiting (5 cases). In 3 children local AE limited the walk (5 cases). DISCUSSION: Our results are not far from north American data (VAERS) regarding incidence, kind of AEs and severity. Abnormal crying, members hypertonia and vascularitis not yet mentioned in Prevenar SPC need to be added. CONCLUSION: Regarding these new data, benefice-risk balance of Prevenar vaccine remains favourable for active immunisation against invasive infections due to pneumococcus in children.
OBJECTIVE: The aim was to detect as soon as possible a rare but severe or unexpected adverse effect (AE) of Prevenar vaccine. A pharmacovigilance survey was required by the French drug agency (Afssaps) to the regional pharmacovigilance centre of Tours (France). METHOD: Two approaches were used. One based upon systematic reports and the other upon spontaneous reports. Only severe and /or unexpected AEs were recorded. RESULTS: During the 19 months of intensive follow up, 24 AEs (8.7 [5-12.7]/100000 vaccinations) reported by 349 participating paediatricians have been analyzed. Prevenar was the only drug taken in 67% of children. AEs were severe (19 cases) or non severe but unexpected (5 cases). AEs were fever above 39 degrees C (10 cases), cutaneous manifestations (6 cases), neurologic manifestations (5 cases), diarrhoea-vomiting (2 cases), and purulent otitis media (1 case). During the 3.5 years of spontaneous reporting, 130 AEs (6 [5-7]/100000 vaccinations) have been reported and analyzed. AEs were severe (107 cases) or non severe but unexpected (23 cases). AEs were mainly: fever above 39 degrees C (17 cases), cutaneous (39 cases), neurologic (34 cases) and haematological (3 cases) manifestations and diarrhoea-vomiting (5 cases). In 3 children local AE limited the walk (5 cases). DISCUSSION: Our results are not far from north American data (VAERS) regarding incidence, kind of AEs and severity. Abnormal crying, members hypertonia and vascularitis not yet mentioned in Prevenar SPC need to be added. CONCLUSION: Regarding these new data, benefice-risk balance of Prevenar vaccine remains favourable for active immunisation against invasive infections due to pneumococcus in children.