BCG vaccination of neonates, infants, schoolchildren and adolescents. Part II: Safety of a vaccine with strain 1331 Copenhagen.

The safety of the vaccine could be assessed by three different investigations: a) During the dose finding study (part I) the vaccine showed good safety in all concentrations employed concerning reactions at the site of injection; palpable lymph node enlargement was common. There was one case of suppurative lymphadenitis amond the 262 children who were given the vaccine in the highest concentration (25 X 10(4) VU). b) Subsequent trials in the course of 21 months, when high risk persons could be vaccinated, revealed a rate of this complication in the 1:1,000 range, no case was reported among older persons. c) After the official approval of the vaccine (10 - 30 X 10(4) VU/ml) in the FRG 1 supp. lymphadenitis among 5,000 vaccinated newborns can be calculated.

Mono- and polyneuritis after tetanus vaccination (1970--1977).

Due to the similarity of symptoms, 22 cases of mono- and polyneuritis after tetanus vaccination from our own records covering the years 1970--1977, as well as 6 additional cases taken from existing literature, are being analyzed. As expected, the number of male vaccinees exceede that of female vaccinees, the former being younger than the latter and women generally received less previous tetanus vaccination than men. Three out of four cases occurred during the summer season. The interval between vaccination and the first symptoms was shorter in mononeuritis than in polyneuritis. The prognosis of most cases was benign, irrespective of age, sex and tetanus vaccination history. Cases with delayed recovery only occurred during the summer months. In cases of polyneuritis it seems that the longer the interval between vaccination and the first symptoms, the slower the recovery. It has to be emphasized that the discussed cases of neuritis have to be viewed as extremely rare complications due to tetanus vaccine.

Vaccine induced mumps-like diseases.

Sixteen cases of parotitis and 2 cases of diabetes mellitus after mumps vaccination have been reported since the introduction of the live attenuated mumps vaccine in the F. R. Germany in the fall of 1976. Due to the post-vaccination incubation of 7 to 10 days, support is given to the assumption that these cases are vaccine induced and not coincidental wild virus infections. The diabetes mellitus cases, however, are too few to be included in this rational.