[Aseptic meningitis after mumps vaccination]. / Méningites aseptiques après vaccination anti-ourlienne.

The aim of this retrospective study was to evaluate the incidence and the characteristics of spontaneously reported aseptic meningitis (AM) in France following mumps vaccination with monovalent or multivalent vaccines containing the Urabe strain. Fifty-four cases of AM were reported to the regional drug surveillance centres or to the manufacturer from the time each vaccine was launched up until June 1992. Twenty cases were associated with the time off administration of a monovalent mumps vaccine and 34 with a trivalent measles, mumps and rubella vaccine (MMR). A mumps virus was isolated in four cases in the cerebrospinal fluid and an Urabe-like strain was characterised twice by polymerase chain reaction (PCR). A probable mumps origin was assumed in 17 other cases where the patients presented with other clinical or biological signs of mumps infection. The clinical outcome of AM was always favourable. The global incidence of mumps vaccine-associated AM was 0.82/100,000 doses, which is significantly lower than the incidence in the unvaccinated population. Even considering that the actual incidence of AM is much higher when assessed by active surveillance studies, the risk/benefit ratio of mumps vaccine remains in favour of vaccination. The incidence of mumps vaccines containing Jeryl Lynn (ROR Vax et Imu ORR) associated with AM needs to be evaluated.

[Thrombocytopenic purpura after isolated or combined vaccination against measles, mumps and rubella]. / Purpura thrombopénique après vaccination isolée ou associée contre la rougeole, la rubéole et les oreillons.

A retrospective epidemiological survey was conducted to evaluate the incidence and characteristics of thrombocytopenic purpura (TP) reported in France following measles, mumps or rubella vaccination with monovalent or multivalent vaccines. Sixty cases of TP were reported i.e an incidence/100,000 doses of 0.23 and 0.17 for measles or rubella vaccines respectively given alone, to 0.87 for combined measles-rubella vaccine and 0.95 for MMR vaccine. The mean age was 21 +/- 12 months and the delay of diagnosis was 16 +/- 6 days after vaccination. Thrombopenia was severe (mean platelet count: 8000 +/- 6000/mm3) and always associated with purpura. The immediate outcome was favourable in 89.5 per cent of cases. Vaccine-associated TP appears to be similar to acute childhood idiopathic thrombocytopenic purpura but the clear temporal relationship between MMR vaccination and the occurrence of TP make a causal relationship highly plausible. Acute TP seems a rare complication of measles-rubella and MMR vaccination but clinicians had to be informed of the possibility of their occurrence. Acute TP following vaccination should be reported by physicians to their Regional Drug Surveillance Centre.

Aseptic meningitis following mumps vaccine. A retrospective survey by the French Regional Pharmacovigilance centres and by Pasteur-Mérieux Sérums & Vaccins.

Since 1989 many case series and observational studies of aseptic meningitis (AM) associated with the use of live attenuated mumps vaccines containing the Urabe AM9 strain have been reported worldwide. The aim of this retrospective reported AM in France following mumps vaccination with monovalent or multivalent vaccines containing the Urabe strain. Fifty-four cases of AM were reported to the Regional Pharmacovigilance centres or to the manufacturer from the time each vaccine was launched up until June 1992. Twenty cases were temporally associated with the administration of a monovalent mumps vaccine and 34 with a trivalent measles, mumps and rubella vaccine (MMR). A mumps virus was isolated in four cases in the cerebrospinal fluid and an Urabe-like strain was characterized twice by polymerase chain reaction (PCR). A probable mumps origin was assumed in 17 other cases where the patients presented with other clinical or biological signs of mumps infection. The clinical outcome of AM, known in 87% of the population, was always favourable. The global incidence of mumps vaccine-associated AM was 0.82/100,000 doses, which is significantly lower than the incidence in the unvaccinated population. Even considering that the actual incidence of AM is much higher when assessed by active surveillance studies, the risk/benefit ratio of mumps vaccine remains in favour of vaccination.

Thrombocytopenic purpura after measles, mumps and rubella vaccination: a retrospective survey by the French regional pharmacovigilance centres and pasteur-mérieux sérums et vaccins.

BACKGROUND: Thrombocytopenic purpura (TP) after vaccination with measles, mumps and rubella has occasionally been reported. OBJECTIVES: To evaluate the incidence and characteristics of thrombocytopenic purpura reported in France after measles, mumps or rubella vaccination with monovalent or multivalent vaccines. METHODS: A retrospective epidemiologic survey was conducted. All confirmed cases of TP reported spontaneously either to the French Regional Pharmacovigilance Centres or to the manufacturer (Pasteur-Mérieux Sérums et Vaccins) between 1984 and June 30, 1992, were reviewed. RESULTS: Sixty cases of TP in children between 1 and 11 years of age occurred 2 to 45 days after administration of 1 of 7 vaccines. The reported incidence of TP varied from 0.17 and 0.23/100,000 doses of measles or rubella vaccines, respectively, given alone to 0.87/100,000 doses of combined measles-rubella vaccines and 0.95/100,000 doses of the measles-mumps-rubella vaccine. The mean platelet count was 8000 +/- 6000/mm3 and was lower than 10,000/mm3 in 58% of cases. The immediate outcome was favorable in 89.5% of cases. CONCLUSIONS: According to the clinical course and biologic findings, vaccine-associated TP appears to be similar to that occurring after natural measles or rubella infections and is not distinguishable from acute childhood idiopathic thrombocytopenic purpura not associated with vaccination. Such observations, combined with a clear temporal relationship between measles-mumps-rubella vaccination and the occurrence of TP, make a causal relationship highly plausible. Nevertheless the incidence of these events remains relatively low with a favorable immediate outcome.

Estimation of the risk of aseptic meningitis associated with mumps vaccination, France, 1991-1993.

BACKGROUND: Several published studies have recently shown a higher incidence of aseptic meningitis associated with Urabe AM-9 vaccine strain than that estimated previously. In France, where all mumps vaccines produced and marketed contain the Urabe AM-9 vaccine strain, little was known about the incidence of these side effects although several surveillance systems exist. METHODS: The capture-recapture method can be used to estimate the total number of cases of a disease when at least two independent data sources are available. Applying the capture-recapture method, data provided by the national network of hospital virology laboratories (EPIVIR) and by the Pharmacovigilance Department of the vaccine manufacturer (P.M.sv.) during a 3-year period between 1 January 1991 and 31 December 1993 have been used to obtain an estimate of the total number of aseptic meningitis cases associated with Urabe AM-9 vaccine. RESULTS: The number of such aseptic meningitis cases was estimated at 116 (95% confidence interval [CI]: 49-183). The risk of aseptic meningitis can thus be assessed as 1 case per 28,400 doses of Urabe AM-9 sold (95% confidence interval [CI]: 1 case per 18,000-1 case per 67,200). The sensitivity of the systems was 21% for EPIVIR and 23% for P.M.sv. The low number of cases recorded by either system makes it difficult to test the statistical independence of the two systems by the calculation of the correlation coefficient of the sensitivity of the systems after stratification. However, the stratified data by age, by sex, by geographical zone and by type of vaccine show that the totals after stratification are not very different from the crude total. CONCLUSIONS: The French Vaccination Committee has recommended promoting the practice of measles-mumps-rubella vaccination in order to limit the circulation of the wild virus and to prevent an epidemic in insufficiently protected groups of the population, whilst awaiting vaccine containing the Jeryl-Lynn strain.