Article

[Suspected adverse events to measles, mumps and rubella vaccine reported to the Community of Valencia Pharmacovigilance Centre.]

Área de Investigación en Vacunas, Centro Superior de Investigación en Salud Pública (CSISP), Valencia, España. Electronic address: .
Anales de Pediatría (Impact Factor: 0.83). 09/2012; 78(5). DOI: 10.1016/j.anpedi.2012.07.013
Source: PubMed

ABSTRACT

Introduction:
A Pharmacovigilance system is an important tool for post-marketing monitoring on vaccine safety. Measles, mumps, rubella (MMR) vaccine is a combined vaccine of live attenuated virus. Since its approval, and although the adverse events are considered generally mild, the vaccine has been widely questioned for the controversies arising around its safety. Our objective was to describe suspected adverse events related to MMR vaccine reported to the Valencian Pharmacovigilance Centre.

Material and methods:
Descriptive study from cases reported between May 15th, 2005 and May 15th, 2010. After grouping the suspected adverse events by diagnostic criteria, a descriptive analysis of variables was performed.

Results:
After 545,830 doses administered, 96 notifications were reported (1.76 notifications/100,000 doses) including 181 adverse events. Fever (42.7%) and local inflammation (36.5%) were the most reported events. There were 8.3% notifications classified as severe. Recovery was complete in all cases.

Conclusions:
The suspected adverse events reported coincided with those described in the Summary of Product Characteristics of the vaccine. The frequency of reports was lower than previously published estimates. Despite the limitations, the data obtained allowed us to conclude that MMR vaccine has a good safety profile, according to previously published studies.

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Available from: Javier Díez-Domingo, Mar 04, 2014
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    ABSTRACT: Introduction: Mumps vaccine was introduced in the National Immunization Program in Portugal in 1987, rapidly reaching a national coverage > 92%, with important reduction in the annual incidence of the disease. We report a mumps outbreak in the Central Region of Portugal, occurred in the winter 2012-13. Material and Methods: Cases of salivary-gland swelling and other symptoms compatible with mumps were investigated. Geodemographics, clinical, laboratory and vaccination data were analyzed. Results: Over six months, 148 outbreak-related cases were reported: 87.8% occurred in three of the 16 affected counties and 78.4% had a known epidemiological link. Median age was 14.5 years (2-62) and 70.3% were 11-20 years old; 61.5% were male. The mean duration of disease was seven days (2-20). The disease was generally mild; 80.4% had fever and in 55.4% there was unilateral involvement of the parotid gland. Seven cases had orchitis, one oophoritis and one had nephritis. Two cases were hospitalized. School transmission predominated and class attack rates were < 30%. Most of the cases occurred in vaccinated individuals (92%) of whom 86.8% had received 2 doses; 17.7% had received one dose of the vaccine containing the Rubini strain. Mumps virus genotype G was identified in 4 cases. Discussion: This mumps outbreak among a highly vaccinated population, occurring mostly in teenagers at school, could be due to the partial effectiveness of the vaccine against the disease (particularly in the group vaccinated with Rubini strain), waning immunity overtime and genotype mismatch. Conclusions: This outbreak report shows the importance of discussion about the need of more booster dose of the actual vaccine or new vaccine including more genotypes to improve immunogenicity.
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