Adverse reactions to BCG. 1995

E Vítková, and J Galliová, and K Krepela, and M Kubín
State Institute for Drug Control, Prague, Czech Republic.

In the post-war period the following BCG vaccines were successively in use for preventive vaccination in the Czech territory: (a) Copenhagen BCG, 1947-1950, (b) Prague BCG 725, 1951-1980, (c) Moscow BCG, 1981-1993, and (d) Behring BCG, from 1994 onwards. These BCG substrains can be now identified by modern methods of molecular genetics. Introducing the Moscow BCG brought about an elevated incidence of iatrogenic local and regional lymph node adverse reactions compared with the previous Prague BCG product and, as a new phenomenon, bone and joint involvements in children vaccinated at birth. The aim of this study was to analyze the incidence of postvaccination adverse reactions reported in the period from 1981 to 1993 as related to the Moscow BCG vaccine and, to demonstrate the effect of lower vaccination dosage on their frequency. The concentration of the Moscow BCG varied from 11 to 22.6 x 10(6) (average 16.2) CFU per 1 mg. In the period when full dose of BCG (0.05 mg per 0.1 ml) was applied to newborns 437 local and 195 regional lymph node complications were recorded, i.e. 0.08% of vaccinated were affected, demanding antituberculosis chemotherapy in 6.5% and surgical interventions in 24%. When the lowered vaccination dose (0.025 mg per 0.1 ml) was inoculated to newborns the local adverse reactions rose paradoxically affecting 0.1% of vaccinated but the regional lymph node reactions fell considerably to reach 0.01%; the demand for chemotherapy and surgery also fell down to 3.1 and 4.8% respectively. Bone and joint adverse involvements were recorded in 28 cases, i.e. in 3.7 per 10(5) of those vaccinated with the full dose.(ABSTRACT TRUNCATED AT 250 WORDS)

UI MeSH Term Description Entries
D007231 Infant, Newborn An infant during the first 28 days after birth. Neonate,Newborns,Infants, Newborn,Neonates,Newborn,Newborn Infant,Newborn Infants
D008297 Male Males
D009163 Mycobacterium bovis The bovine variety of the tubercle bacillus. It is called also Mycobacterium tuberculosis var. bovis. BCG,Calmette-Guerin Bacillus
D010000 Osteitis Inflammation of the bone. Bone Inflammation,Inflammation, Bone
D004305 Dose-Response Relationship, Drug The relationship between the dose of an administered drug and the response of the organism to the drug. Dose Response Relationship, Drug,Dose-Response Relationships, Drug,Drug Dose-Response Relationship,Drug Dose-Response Relationships,Relationship, Drug Dose-Response,Relationships, Drug Dose-Response
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D001500 BCG Vaccine An active immunizing agent and a viable avirulent attenuated strain of MYCOBACTERIUM BOVIS, which confers immunity to mycobacterial infections. It is used also in immunotherapy of neoplasms due to its stimulation of antibodies and non-specific immunity. Bacillus Calmette Guerin Vaccine,Calmette Guerin Bacillus Vaccine,Calmette's Vaccine,Calmette Vaccine,Calmettes Vaccine,Vaccine, BCG,Vaccine, Calmette's
D014376 Tuberculosis Any of the infectious diseases of man and other animals caused by species of MYCOBACTERIUM TUBERCULOSIS. Koch's Disease,Kochs Disease,Mycobacterium tuberculosis Infection,Infection, Mycobacterium tuberculosis,Infections, Mycobacterium tuberculosis,Koch Disease,Mycobacterium tuberculosis Infections,Tuberculoses
D014388 Tuberculosis, Lymph Node Infection of the lymph nodes by tuberculosis. Tuberculous infection of the cervical lymph nodes is scrofula. Cervical Tuberculous Lymphadenitis,Lymphadenitis, Tuberculous,Mycobacterial Cervical Lymphadenitis,Scrofula,Cervical Lymphadenitis, Mycobacterial,Lymph Node Tuberculoses,Lymph Node Tuberculosis,Lymphadenitis, Cervical Tuberculous,Lymphadenitis, Mycobacterial Cervical,Scrofulas,Tuberculoses, Lymph Node,Tuberculous Lymphadenitis,Tuberculous Lymphadenitis, Cervical

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