Acute gastroenteritis hospitalizations among children aged < 5 years before and after introduction of rotavirus vaccines: a hospital-based surveillance study in Galicia, Spain.

Rotavirus vaccines were licensed in Spain between late 2006 and early 2007. Rotavirus vaccination was recommended but not reimbursed by the Spanish National Health System. Significant coverage rates have been reached in Galicia, with an average of 47% since the period July 2007-June 2008. We aim to explore eventual variations in the incidence of hospitalizations for acute gastroenteritis (AGE) among children < 5 y of age before and after vaccine introduction. The annual and monthly hospitalization rates for rotavirus-related AGE and all cause AGE, before and after rotavirus vaccine introduction, were calculated by using the official surveillance system for hospital data. The annual hospitalization rates for rotavirus-related AGE in children < 5 y of age decreased by 14.8% for the period July 2008 to June 2009 and by 44.5% for the period July 2009 to June 2010 as compared with the median rate of the pre-vaccination period (July 2003 to June 2007). The corresponding decreases for all cause AGE were 29.9% and 49.0%, respectively. In children < 12 mo of age a more marked decrease was observed. Compared with pre-vaccination years, a decrease in rotavirus-related and all cause AGE hospitalization rates was observed, with a greater decline in the July 2009 to June 2010 period.

Prospective evaluation of indirect costs due to acute rotavirus gastroenteritis in Spain: the ROTACOST study.

BACKGROUND: The effect of rotavirus in developed countries is mainly economic. This study aimed to assess the indirect costs induced by rotavirus acute gastroenteritis (RVAGE) in Spain. METHODS: A prospective observational study was conducted from October 2008 to June 2009. It included 682 children up to 5 years of age with acute gastroenteritis (AGE) who attended primary care (n = 18) and emergency room/hospital settings (n = 10), covering the regions of Galicia and Asturias (North-west Spain). All non-medical expenses incurred throughout the episode were recorded in detail using personal interviews and telephone contact. RESULTS: Among the 682 enrolled children, 207 (30.4%) were rotavirus positive and 170 (25%) had received at least one dose of rotavirus vaccine. The mean (standard deviation) indirect cost caused by an episode of AGE was estimated at 135.17 (182.70) Euros. Costs were 1.74-fold higher when AGE was caused by rotavirus compared with other etiologies: 192.7 (219.8) Euros vs. 111.6 (163.5) Euros (p < .001). The costs for absenteeism were the most substantial with a mean of 91.41 (134.76) Euros per family, resulting in a loss of 2.45 (3.17) days of work. In RVAGE patients, the absenteeism cost was 120.4 (154) Euros compared with 75.8 (123) for the other etiologies (p = .002), because of loss of 3.5 (3.6) vs 1.9 (2.9) days of work (p < .001). Meals costs were 2-fold-higher (48.5 (55) vs 24.3 (46) Euros, p < .001) and travel costs were 2.6-fold-higher (32 (92) vs 12.5 (21.1) Euros, p = .005) in RVAGE patients compared with those with other etiologies. There were no differences between RVAGE and other etiologies groups regarding costs of hiring of caregivers or purchase of material. Patients with RVAGE were admitted to hospital more frequently than those with other etiologies (47.8% vs 14%, p < .001). CONCLUSIONS: Rotavirus generates a significant indirect economic burden. Our data should be considered in the decision-making process of the eventual inclusion of rotavirus vaccine in the national immunization schedule of well developed countries.

Circovirus and impact of temporary withdrawal of rotavirus vaccines in Spain.

The Spanish Medicines and Health Products Agency (AEMPS) did not authorize the release of new batches of rotavirus vaccines onto the Spanish market since March 29 (Rotarix®) and June 10 (Rotateq®), 2010, respectively, due to problems of good manufacturing practice (GMP). On November 4, 2010, AEMPS again allowed the release of batches of the RotaTeq® vaccine. Until March 2010, the average vaccination coverage against rotavirus in Spain had reached 40%. We have tried to estimate the impact of the temporary withdrawal of these vaccines from the Spanish market in terms of disease burden and associated costs. During the five months in which neither of the rotavirus vaccines was distributed in Spanish pharmacies, 84,450 children were not vaccinated against rotavirus and remain at risk, leading to a total avoidable cost between 1,901,498 and 2,172,941 euros. The impact of the temporary withdrawal of rotavirus vaccines in Spain may have been outstanding. The influence of this event in rotavirus vaccination trust may have been even more important.

Effectiveness of rotavirus vaccination in Spain.

With the aim of determining rotavirus vaccine effectiveness (RVVE) in Spain, from Oct-2008/Jun-2009, 467 consecutive children below 2 years old with acute gastroenteritis (AGE) were recruited using a pediatric research network (ReGALIP-www.regalip.org) that includes primary, emergency and hospital care settings. Of 467 enrolled children, 32.3% were rotavirus positive and 35.0% had received at least one dose of any rotavirus vaccine. RRVE to prevent any episode of rotavirus AGE was 91.5% (95% CI: 83.7%-95.6%). RVVE to prevent hospitalization by rotavirus AGE was 95.6% (85.6-98.6%). No differences in RVVE were found regarding the vaccine used. Rotavirus vaccines have showed an outstanding effectiveness in Spain.

Anaphylactoid reaction to high-dose methotrexate and successful desensitization.

Anaphylactic/anaphylactoid reaction to methotrexate (MTX) is uncommon. It may occur with the first dose (non-allergic reactions) or after a previous exposure to the drug (allergic or specific reactions). Desensitization has been shown effective in children with allergic-type reactions permitting the continuation of high-dose methotrexate (HDMTX) therapy. We report the case of a child with localized osteosarcoma who developed an anaphylactoid reaction after a first HDMTX course. A desensitization protocol was successfully applied allowing the administration of four additional courses. In our experience, desensitization can be a safe and effective procedure in children with anaphylactoid reactions to HDMTX.