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In all developed countries there is the possibility to protect oneself from vaccine-preventable diseases. However, not all individuals make use of this option. It is precisely in highly developed countries where a trend to vaccination hesitancy is noticeable, i. e. reluctance to get oneself or one's children vaccinated. The reasons why this is so are many, but the most important reason is the fear of postvaccinal complications, especially of those that imply sequelae or those with fatal outcomes.Whereas there are some proven associations between vaccination and adverse drug reaction, for example febrile seizures after the measles-mumps-rubella (MMR) vaccination, other hypotheses can be refuted, for example autism after the MMR vaccination. On one hand, this article gives an overview of known postvaccinal complications with indication of a causal association with vaccination and on the other hand addresses hypotheses of potential adverse drug reactions that have been refuted by pharmacoepidemiological studies.Only the scientific debate of these hypotheses, which are repeatedly discussed, especially on social media, can contribute to corroborating or refuting a potential causal association. If evidence for a causal association grows, e. g. intussusception, the relevant authorities (e.g. Paul Ehrlich Institute, European Medicines Agency) will take risk-minimizing measures. If studies and meta-analyses do not reveal any evidence of a causal association, a targeted information strategy will be required in order to prevent myths from circulating, vaccination coverages from declining, and infectious diseases from spreading.

This post-hoc analysis of data from a matched cohort study investigated the risk of febrile convulsions (FC) 5-12 days post-first dose of measles-mumps-rubella-varicella vaccine (MMRV) in a low-risk population, compared to measles-mumps-rubella (MMR) and varicella (V) vaccines administered separately. The low-risk population excluded children with personal history of FC (Scenario 1) and children with personal or/and family history (≥1 parent/sibling) of FC (Scenario 2). Incidence of FC post-MMRV in Scenario 2 (excluding at risk children) (36.3-49.5/100,000) and post-MMR+V in the whole cohort including children with personal/family history of FC (43.6/100,000) were similar. The risk difference of FC increased by 0.2 case/100,000 in Scenario 1 and decreased by 5.3-8.6 cases/100,000 of vaccinated children in Scenario 2, compared to the whole cohort. The overall risk of FC post-first dose MMRV vaccination could be lowered by administering MMRV only to children with no personal or family history of FC., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Introduction: Measles, mumps, rubella, and varicella combination vaccines (MMRV) facilitate varicella vaccination uptake compared with separate administration of measles, mumps, and rubella vaccine (MMR) with varicella vaccine (V). However, the risk of developing febrile convulsions (FC) is higher in children vaccinated with MMRV., Objectives: The aim was to demonstrate how to put the increased FC risk associated with MMRV into perspective by comparing it with the lower V-coverage risk associated with MMR + V., Methods: FC and varicella burdens were measured by total numbers or duration of hospitalisations. A model, based on several assumptions and integrating parameters from heterogeneous data sources relevant to Germany, was developed to evaluate hospitalisation ratios (HRs; ratios between yearly numbers of varicella-related hospitalisation days prevented by MMRV and yearly numbers of FC-related hospitalisation days attributed to MMRV, both compared with MMR + V). A sensitivity analysis estimated HR under different scenarios beyond the German experience., Results: For parameter values compatible with the German experience, where MMRV (Priorix-Tetra™, GSK, Belgium) was introduced in 2006, the model predicted that transitioning from MMR + V to MMRV would induce 225 vaccine-related FC hospitalisation days whilst preventing 1976 varicella-related hospitalisation days per year. The HR estimated by Monte Carlo simulations was 8.5 (95 % confidence interval: 1.99-25.22). A sensitivity analysis on two key parameters suggested that transitioning from MMR + V to MMRV would be favourable in situations where MMRV use would significantly impact varicella vaccination uptake., Conclusions: MMRV use instead of MMR + V can substantially reduce the number of hospitalisation days, despite increased FC risk when MMRV is used as a first dose of measles-containing vaccine.

Background: In July 2006, Priorix-Tetra™, a combined measles-mumps-rubella-varicella (MMRV) vaccine, was licensed in Germany. Since a postlicensure study had shown a more than twofold elevated risk of febrile convulsions (FC) after first dose vaccination with the combined MMRV vaccine ProQuad(®) compared to separately administered MMR and V vaccines (MMR+V), the Paul-Ehrlich-Institute, the German regulatory agency for vaccine licensing and safety, requested a study investigating the risk of FC for Priorix-Tetra™., Methods: We performed a matched cohort study based on claims data of more than 17 million insurees in the German Pharmacoepidemiological Research Database. All children born between 01.01.2004 and 31.12.2008 who received a 1st dose of MMRV vaccine were matched to children vaccinated with MMR, MMR+V and MMR or MMR+V (combined group), respectively, by sex, age, month of vaccination and statutory health insurance. The primary outcome was defined as hospitalization with a diagnosis of FC without any alternative plausible cause of FC, e.g. an infection or neurological condition, coded as main discharge diagnosis. The secondary outcome excluded only neurological conditions to provide a more comparable outcome definition to the one used in the ProQuad(®) study. Numbers needed to harm (NNH), risk ratios and confounder adjusted odds ratios (ORs) with 95% CIs were estimated to compare the exposure groups., Results: In the main risk period 5-12 days after immunization, the adjusted ORs of the primary endpoint for immunization with MMRV vaccine relative to the comparator vaccine indicated in brackets were 4.1 [95% CI 1.3-12.7; MMR], 3.5 [0.7-19.0; MMR+V], and 4.1 [1.5-11.1; MMR and MMR+V]. The corresponding ORs for the secondary outcome were 2.3 [1.4-3.9; MMR], 1.5 [0.8-2.9; MMR+V] and 2.4 [1.5-3.9; MMR and MMR+V]., Conclusions: This study in children younger than 5 years, 90% of them between 11 and 23 months, shows a risk of FC similar in magnitude for Priorix-Tetra™ as has previously been reported for ProQuad(®) suggesting a class effect for these quadrivalent vaccines., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

Preterm infants are at increased risk of suffering from vaccine preventable diseases. Therefore it is recommended to vaccinate them in time at the same chronological age as full term infants. Several reports have shown that vaccinations of very and extreme low birth weight infants are often delayed but till now there are no data for Germany. Our study analysed the vaccination rates and suffered complications of 318 preterm infants with birth weights under 1 500 g at the age of 2 years from all over the country copying their vaccination-record and asking the parents to answer a questionnaire. The preterm infants received the first 3 doses of the pentavalent or hexavalent vaccines consequently (1st dose: 100%, 2nd dose: 100%, 3rd dose: 97.5%), whereas the booster dose was accomplished to a lesser extent (89.0%) during their second year of life. The majority of the vaccinations were administered delayed. Moreover, the preterm infants received the first doses of the pneumococcal conjugate vaccine and the measles-mumps-rubella vaccine quite consequently, but the booster dose was again injected less frequent. According to their parents 17.8% of these preterm infants suffered from non-severe adverse reactions and none of them had an episode of apnoea following the immunisation. In conclusion preterm infants in Germany receive their basic immunisations consequently, but often too late. There is still the need to improve the frequency of the booster dose application especially in the second year of life and to prevent delays of vaccinations., ((c) Georg Thieme Verlag KG Stuttgart-New York.)

Background: When this trial was initiated, the combined measles, mumps and rubella (MMR) vaccine was licensed for subcutaneous administration in all European countries and for intramuscular administration in some countries, whereas varicella vaccine was licensed only for subcutaneous administration. This study evaluated the intramuscular administration of an MMR vaccine (M-M-RvaxPro) and a varicella vaccine (VARIVAX) compared with the subcutaneous route., Methods: An open-label randomised trial was performed in France and Germany. Healthy children, aged 12 to 18 months, received single injections of M-M-RvaxPro and VARIVAX concomitantly at separate injection sites. Both vaccines were administered either intramuscularly (IM group, n = 374) or subcutaneously (SC group, n = 378). Immunogenicity was assessed before vaccination and 42 days after vaccination. Injection-site erythema, swelling and pain were recorded from days 0 to 4 after vaccination. Body temperature was monitored daily between 0 and 42 days after vaccination. Other adverse events were recorded up to 42 days after vaccination and serious adverse events until the second study visit., Results: Antibody response rates at day 42 in the per-protocol set of children initially seronegative to measles, mumps, rubella or varicella were similar between the IM and SC groups for all four antigens. Response rates were 94 to 96% for measles, 98% for both mumps and rubella and 86 to 88% for varicella. For children initially seronegative to varicella, 99% achieved the seroconversion threshold (antibody concentrations of >or= 1.25 gpELISA units/ml). Erythema and swelling were the most frequently reported injection-site reactions for both vaccines. Most injection-site reactions were of mild intensity or small size (

Background: Measles, mumps, and rubella (MMR) and varicella (V) vaccines are often coadministered at 1 clinic visit. This study (104389/NCT00127023) was undertaken to assess the immunogenicity and safety of a new refrigerator-stable tetravalent MMRV vaccine after 1 dose and after 2 doses administered during the second year of life., Methods: Nine hundred seventy healthy children aged 10-21 months received 2 doses of MMRV vaccine (Priorix-Tetra; GlaxoSmithKline Biologicals, Rixensart, Belgium) 42 days apart (MMRV group; N = 732) or 1 dose of MMR vaccine (Priorix) coadministered with varicella vaccine (Varilrix) followed by a second dose of only MMR vaccine 42 days later (MMR + V group; N = 238)., Results: Observed seroconversion rates for measles, mumps, rubella, and varicella antibodies 42 days postdose 1 were 94.5%, 96.1%, 99.7%, 95.5% in the MMRV group and 93.4%, 93.6%, 98.1%, 95.6% in the MMR + V group. Respective seroconversion rates postdose 2 were 98.3%, 99.4%, 99.7%, 99.7% in the MMRV group and 97.6%, 99.5%, 100%, 97.5% in the MMR + V group. Observed antimeasles and antimumps geometric mean titers (GMTs) were higher after each dose in the MMRV group than in the MMR + V group. Antivaricella GMT increased 21-fold in the MMRV group postdose 2, and was markedly higher than in the MMR + V group who did not receive a second dose of varicella (1903.3 and 80.3 dilution, respectively). Both vaccine regimens were generally well-tolerated in terms of local reactions, fever >39.5 degrees C, and vaccine-related rashes., Conclusions: Both after 1 dose and after 2 doses, the MMRV vaccine was at least as immunogenic as concomitant MMR and varicella vaccination suggesting that it could be suitable for use according to current vaccination schedules.

The reactogenicity and immunogenicity of three combined measles, mumps and rubella (MMR) vaccines and one administered with a varicella vaccine was studied in infants. The vaccines were Priorix (designated MeMuRu, Group 1), M-M-R II (Group 2), Triviraten (Group 3) and Priorix + a varicella vaccine, Varilrix (Group 4). Fever was greater in Group 2 (61.3%) compared to Group 1 (48.5%; p = 0.033) or Group 3 (37.1%; p = 0.009). Rash with fever was reported in Group 2 (4.8%) and Group 4 (3.3%), but not for Group 1. Anti-measles, -mumps and -rubella seroconversion was similar for Group 1 (96.1%, 96.1% and 100%, respectively), Group 4 (98% for all three), and Group 2 (91.5%, 93.6% and 97.9%) 60 days post-vaccination. GMTs for measles (3,053.7-3,412.2 mIU/ml), mumps (1,001.5-1,158.8 U/ml) and rubella (68.7-89.1 IU/ml) were similar for Groups 1, 2 and 4 at Day 60. Antibody persistence was noted 2 years post-vaccination. The MeMuRu + varicella combination showed no clinically relevant increase in reactogenicity and should facilitate introduction of a varicella vaccine into national immunization schedules.