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Because of the advent of a new influenza A H1N1 strain, many countries have begun mass immunisation programmes. Awareness of the background rates of possible adverse events will be a crucial part of assessment of possible vaccine safety concerns and will help to separate legitimate safety concerns from events that are temporally associated with but not caused by vaccination. We identified background rates of selected medical events for several countries. Rates of disease events varied by age, sex, method of ascertainment, and geography. Highly visible health conditions, such as Guillain-Barré syndrome, spontaneous abortion, or even death, will occur in coincident temporal association with novel influenza vaccination. On the basis of the reviewed data, if a cohort of 10 million individuals was vaccinated in the UK, 21·5 cases of Guillain-Barré syndrome and 5·75 cases of sudden death would be expected to occur within 6 weeks of vaccination as coincident background cases. In female vaccinees in the USA, 86·3 cases of optic neuritis per 10 million population would be expected within 6 weeks of vaccination. 397 per 1 million vaccinated pregnant women would be predicted to have a spontaneous abortion within 1 day of vaccination.

Background. Rubella vaccination is contraindicated during pregnancy. During mass immunization of women of childbearing age against rubella, women unknowingly pregnant may be vaccinated. To evaluate the effects of rubella vaccination during pregnancy, the Brazilian state of Sâo Paulo conducted a follow-up study of pregnant women vaccinated during a rubella campaign in 2001. Methods. Women vaccinated during pregnancy were reported to a national surveillance system. In the state of Sâo Paulo, follow-up of vaccinated women included household interviews. Serum samples from vaccinated women were tested for antirubella antibodies to classify susceptibility to rubella infection. Children born to susceptible mothers were tested for evidence of congenital rubella infection and evaluated for signs of congenital rubella syndrome. Results. The São Paulo State Health Department received 6473 notifications of women vaccinated during pregnancy. Serology performed for 5580 women identified 811 (15%) that were previously susceptible. Incidence of spontaneous abortion or stillbirth among previously susceptible vaccinated women was similar to women with prior immunity. Twenty-seven (4.7%) of 580 newborns tested had evidence of congenital rubella infection; none had congenital rubella syndrome. Conclusions. Mass rubella vaccination of women of childbearing age was not associated with adverse birth outcomes or congenital rubella syndrome among children born to women vaccinated during pregnancy.

The immunogenicity and safety of a new human rabies vaccine, produced in Vero cells by a process that does not require supplementation with human or animal derived components in production, were assessed. Thus, the objective is to produce a safer vaccine at a lower cost. A total of 296 volunteers was divided into two groups: Group 1, which received the study vaccine, and Group 2, which received the Vero cells vaccine produced by Sanofi Pasteur. Five doses were given on days 0, 3, 7, 14 and 28. Blood samples for determination of rabies virus neutralizing antibodies were collected on days 0, 14, 38 and 90. The geometric mean titers (GMT) were much higher than 0.5IU/ml in both groups on days 14, 38 and 90, indicating seroconversion according to the World Health Organization. In Group 1, however, the GMTs were higher than in Group 2, the difference being statistically significant in the two last samples. There was no statistical difference between the groups in the ratio of individuals with titers ≥0.5IU/ml in each sample. Pain at the injection site was the most common adverse reaction and occurred most often in Group 1 (p<0.001). All cases had a favorable evolution. There were no severe adverse reactions. It was concluded that the new vaccine is safe and immunogenic.

This multicentre study was designed to establish the reactogenicity and immunogenicity profiles of primary and booster vaccination with diphtheria, tetanus, and pertussis whole-cell–hepatitis B/ Haemophilus influenzae type-b (DTPw–HB/Hib) administered as either a syringe mix or as separate injections in 400 Latin American children. Both vaccine regimens were equally well tolerated and elicited post-primary excellent seropositivity rates at or close to 100% for all five component antigens. With regard to HB, 100% of subjects in the combined vaccination group, and 98.8% subjects in the separate injection vaccination group reached seroprotective antibody concentrations (≥10 mIU/ml) 1 month after the primary vaccination course. Equally high anti-PRP antibody concentrations were reached 1 month after vaccination, with 100% of seroprotected subjects in the combined vaccination group (antibody concentrations ≥0.15 μg/ml), against 99.4% in the separate injection vaccination group. Seroprotective anti-HBs and anti-PRP antibody concentration levels persisted approximately 1 year after the primary vaccination course, just prior to booster vaccination. Finally, a significant increase of all antibody concentrations could be observed after the booster vaccination, since all but one subject in the separate injection vaccination group had protective levels of anti-HBs and anti-PRP antibodies 1 month after the booster dose. These results suggest that the combination of DTPw–HB and Hib vaccines provides an effective means for increasing vaccine coverage in childhood vaccination programmes.