Safety of Vaccines

Jozef Nauta ()
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Jozef Nauta: Global Statistics, Solvay Pharmaceuticals

Chapter Chapter 9 in Statistics in Clinical Vaccine Trials, 2011, pp 117-129 from Springer

Abstract: Abstract To proof the safety of a vaccine is much more challenging than proving its efficacy. Many vaccines are administered to several hundred million, often healthy people (e.g., childhood vaccines), in which case even extremely rare but serious adverse vaccine events can come to light, which may change the opinion of the medical community on the benefit/risk ratio. If a rare but serious condition occurs in, say, 0.1% of the target population and a vaccine doubles the risk to 0.2%, then there will be an additional 1,000 cases for every million persons vaccinated. A recent example of such an increased risk was a combination MMRV(measles, mumps, rubella, varicella) vaccine for children aged twelve months through twelve years, as alternative for two separate MMR and V vaccines.

Keywords: False Discovery Rate; Chronic Fatigue Syndrome; Sudden Infant Death Syndrome; Local Reaction; Febrile Seizure (search for similar items in EconPapers)
Date: 2011
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Persistent link: https://EconPapers.repec.org/RePEc:spr:sprchp:978-3-642-14691-6_9

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DOI: 10.1007/978-3-642-14691-6_9

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