Bexsero


Generic Name: Meningococcal group B Vaccine (rDNA, component, adsorbed) Manufacturer: Novartis Bexsero Vaccine Safety The product information published on the website of the European Medicines Agency says 14 safety studies exist, involving 8776 individuals including 5849 under the age of 2. [3] The document is short on detail but the US version of the Bexsero product information says Novartis conducted four safety trials involving a total of 3058 individuals. In only one of these a saline placebo was used as control for the first dose of Bexsero. For the second dose the control was another vaccine. In the other trials the “placebo” groups received aluminium hydroxide (the vaccine’s adjuvant) and other vaccines instead of a true placebo. The published prescribing information lists “solicited” (pre-determined) adverse reactions for the one trial where a saline placebo was used. In almost all cases Bexsero recipients suffered a much higher rate of side-effects, especially for sever reactions, compared to placebo. Severe Pain: Bexsero 20 – Placebo 2 Severe Fatigue: Bexsero 4 – Placebo 0 Severe Nausea: Bexsero 4 – Placebo 0 Severe Myalgia: Bexsero 12 – Placebo 1 Severe Athralgia: Bexsero 2 – Placebo 0 Severe Headache Bexsero 4 – Placebo 1 Unsolicited Serious Adverse Events were apparently reported by 0.8% of vaccine recipients but no further details was given. [2] None of these four trials involved infants. However, an infants trial was conducted later on by the European MenB Vaccine Study Group on behalf of and with funding from Novartis. Groups of infants were either given MenB vaccine plus a range of routine childhood vaccinations, or only routine vaccinations. Out of 1885 infants, serious adverse events were reported in 158 but only 20 were thought to be possibly vaccine related by the study investigators. There were two cases of Kawasaki disease. [5] The…

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