A double blind, randomized, active controlled study to assess the safety, tolerability and immunogenicity of measles, mumps rubella, and varicella vaccine (MMRV) manufactured using an alternative process

Marshall, Gary S.; Senders, Shelly; Shepard, Julie; Twiggs, Jerry; Gardner, Julie L.; Hille, Darcy A.; Hartzel, Jonathan; Valenzuela, Rowan; Stek, Jon E.; Helmond, F.A.

doi:10.1080/21645515.2016.1165374

Cited by 6 publications

(4 citation statements)

References 34 publications

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“…A specific aspect concerns the incidence of febrile seizures after vaccination with MMRV. According to the research in Apulia would be 0.5 cases per 1000 follow-ups, much lower than what was reported so far by randomized studies and meta-analyses [7][8][9][10][11] . However, this calculation was obtained after discarding 3 out of 4 cases of febrile seizures by applying the WHO causality assessment algorithm.…”

Section: Introductionmentioning

confidence: 66%

“…However, this paper concerned an adjuvanted vaccine against H5N1 influenza and adult participants. A previous randomized controlled trial of active surveillance for the MMRV vaccine (ProQuad) 11 reported an AEFI rate of 65.6%, of which 37.7% were judged to be related. However, only 0.7% of the described AEFIs were classified as serious and, among them, 0.3% were judged to be related.…”

Section: Emerging Signalsmentioning

confidence: 99%

“…Applying the Causality Assessment algorithm, the cause/effect relationship between vaccination and adverse events is classifiable as inconsistent: even the biological plausibility of AEFI, the time window between vaccination and adverse reactions (hyperpyrexia and febrile seizure) is not compatible (too short ).” Note: Although hyperpyrexia caused by MMRV vaccine usually peaks after one week from the first dose in about 10% of subjects, in some subjects it occurs between the first and the 5th day after inoculation. In a randomized study with active surveillance 11 it was observed that the rate of fever (temperature > 39.0° C) in the first 5 days after first dose of MMRV was 8 cases every 1000 doses. This data makes it improper to exclude causation in a case of febrile seizures by applying only a weak criterion such as a time window that excludes the first day after the vaccine injection.…”

Section: Incidence Of Clonus/febrile Seizures and Causality Assessmenmentioning

confidence: 99%

“…Note: Although hyperpyrexia caused by MMRV vaccine usually peaks after one week from the first dose in about 10% of subjects, in some subjects it occurs between the first and the 5th day after inoculation. In a randomized study with active surveillance 11 it was observed that the rate of fever (temperature > 39.0° C) in the first 5 days after first dose of MMRV was 8 cases every 1000 doses. This data makes it improper to exclude causation in a case of febrile seizures by applying only a weak criterion such as a time window that excludes the first day after the vaccine injection.…”

Section: Incidence Of Clonus/febrile Seizures and Causality Assessmenmentioning

confidence: 99%

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Adverse events following measles-mumps-rubella-varicella vaccine: an independent perspective on Italian pharmacovigilance data

Bellavite

Donzelli

2020

F1000Res

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Vaccine surveillance programs are crucial for the analysis of the vaccine’s safety profile and the guidance of health policies. The Epidemiological Observatory of the Italian Apulia Region carried out an active surveillance program of adverse effects following immunization (AEFI) after the first dose of the measles-mumps-rubella-varicella (MMRV) vaccine, finding 462 AEFIs per 1000 doses, with 11% rated serious. Applying the World Health Organization (WHO) causality assessment algorithm, 38 serious AEFIs/1000 enrolled were classified as ‘consistent causal associations’ with MMRV immunization. Severe hyperpyrexia, neurological symptoms and gastrointestinal diseases occurred in 38, 20 and 15 cases/1000 enrolled, respectively. A projection of such AEFIs in an Italian birth cohort would give tens of thousands of serious AEFIs. These incidence data are much greater than the incidence of serious AEFIs reported by the Italian Medicines Agency (AIFA) for years 2017 and 2018, mainly based on passive (or mixed) pharmacovigilance. In a previous epidemiological study in the same Italian Region, during an eight year passive surveillance, the reporting rate of serious AEFI was 0.06/1000 doses, and no cases of febrile seizures were detected applying the WHO algorithm. Taken together, the data suggest that passive pharmacovigilance is utterly inadequate to document the real incidence of serious AEFIs and that current methods of assessing causality may be questioned. Active surveillance programs are required in representative population samples, with results presented separately from those of spontaneous reporting, and causality assessment should be performed carefully and using a correct technique for AEFIs presenting as complex and multifactorial diseases, like those with serious neurologic disorders.

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