Manufacturer: GlaxoSmithKline Generic name: Rotavirus Vaccine, Live, Oral Rotarix Safety Side-effects were investigated in several clinical trials where Rotarix was compared to a placebo group. In some trials, both groups also received other vaccines at the same time. Neither GSK nor the regulator say whether the placebo was a true placebo or another vaccine. A real placebo is sometimes called a saline placebo, but here only a “placebo” is mentioned. As this term has often been used to mean another vaccine or a substance containing the non-active ingredients of the trial vaccine, we cannot be sure which is the case. The clinical trials found no increased risk for adverse reactions from Rotarix. Serious adverse reactions were all judged to be not vaccine related by GSK’s study investigators.[1] The US VAERS database has recorded up to 20 deaths, 41 life-threatening events and 291 hospitalisations per year possibly due to live rotavirus oral vaccines. Although VAERS staff follow up all serious reports, the data does not mean that the vaccine was to blame for all or even any of the cases. At the same time, vaccine adverse reactions are thought to be widely under-reported and the reported numbers could reflect as little as 1% of cases. Parents should be aware that the virus contained in the vaccine can be shed in infants’ stool and infect other household members. Rotarix Efficacy Unlike some other vaccines, Rotarix underwent proper efficacy trials. Rather then looking at immunogenicity only, these trials examined how many children got ill from severe rotavirus gastroenteritis during a certain time period following vaccination. In the main study conducted in Latin America, several thousand children received the vaccine or a placebo and during an average follow-up time of 8 months, subjects in the vaccine group were much less likely to get ill…

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