BCG VACCINE
The BCG laboratory of Pasteur Institute in
This laboratory was officially recognized by the World
Health Organization for the first time in 1951 and again in 1955.
In 1986, the BCG laboratory was rebuilt and was equipped by
Governmental Organizations and French Non-Governmental Organization as: the
French-Vietnamese Friendship Association, French Ministry of Health, Pasteur
Institute Paris, European communion. The personnel were also trained by the
Pasteur Institute Paris. Since then, the BCG vaccine has been prepared by the
same standardized modern technique of the Pasteur Institute Paris and other
South East Asian laboratories.
At first, the laboratory produced fresh BCG vaccine (liquid
vaccine form).
Since 1970, the freeze dried BCG vaccine has been prepared.
At present, the BCG vaccine produced by Pasteur Institute in
Under the control of the Pasteur Institute Paris, the BCG
vaccine produced from 1997 to 1999 met the requirements for freeze dried BCG
vaccine.
An evaluation of the Statens Serum Institute in
Annual production:
-
BCG
vaccine for Expanded Program Immunization: 1.6 million to 2 million doses per
year.
-
BCG
vaccine for therapy: dependent on the number of patients and prescriptions
issued.
BCG strain:
The vaccine is prepared from the French strain 1173 P2 lot
C, which is provided by the Pasteur Institute in
BCG strain:
The Calmette and
Guerin bacillus (abbreviated to BCG) was derived from Mycobacterium bovis, a
strain that causes bovine tuberculosis. Its virulence was attenuated and the
strain stabilized in non-virulent form between 1908 and 1921 by 230 successive
passages on media impregnated with beef bile. The resulting strain, the BCG
variant, differed from the parent strain by losing its pathogenic potential.
However, most importantly, the strain retained its immunogenicity since it
could produce a delayed type hypersensitivity (DTH) to tuberculin and could
protect against virulent strains of M. bovis.
Tröïc khuaån Calmette
vaø Gueùrin (ñöôïc vieát taét laø BCG) coù nguoàn goác töø vi
khuaån Mycobacterium bovis, moät chuûng vi khuaån gaây beänh lao ôû boø. Chuûng
vi khuaån naøy ñöôïc giaûm ñoäc löïc qua 230 laàn
nuoâi caáy lieân tieáp treân moâi tröôøng khoai taây maät boø töø 1908 – 1921.
Chuûng BCG khaùc chuûng vi khuaån goác ôû tính chaát khoâng gaây beänh, nhöng
ñaëc tính quan troïng nhaát laø vi khuaån BCG coù theå taïo ñöôïc phaûn öùng
quaù maãn muoän vôùi tuberculin vaø baûo veä cô theå khoûi bò beänh lao.
Licensing and
registration:
-
The
manufacturing of vaccine is licensed by the Ministry of Health of
-
Registration
number: VNDP – 106-0802
1.
BCG vaccine for Expanded Program Immunization:
Form and presentation:
·
1mg
per ampoule (20 doses per ampoule)
Dosage:
-
Infants
under 12 months: 0.05mg/0.1ml vaccine
1 ampoule of freeze dried vaccine
(1mg vaccine) + 2ml solvent
1 injection of 0.1ml by intradermal
route
-
Infants
up 12 months: 0.1mg/0.1ml vaccine
1 ampoule of freeze dried vaccine
(1mg vaccine) + 1ml solvent
1 injection of 0.1ml by intradermal
route
·
0.5mg
per ampoule (10 doses per ampoule)
Dosage:
-
Infants
under 12 months: 0.05mg/0.1ml vaccine
1 ampoule of freeze dried vaccine
(1mg vaccine) + 1ml solvent
1 injection of 0.1ml by intradermal
route
Form and presentation:
·
40mg
per ampoule
Efficacy of the BCG
vaccine:
1.
BCG
vaccine for Expanded Program Immunization (1mg, 0.5mg vaccine per ampoule):
this vaccine aims to prevent tuberculosis in infants.
2.
BCG
vaccine for therapy: this vaccine has a very high colony forming unit count
that has a role in stimulating the immune response. Some authors consider that
BCG vaccine therapy could prevent the recurrence of tumors. The BCG vaccine was
administered to the superficial bladder cancer patients who have had an
operation or treatment with Mytocin C.
The study of Harry W. Herr et al. showed a good result with
BCG vaccine in the treatment of early stage superficial bladder cancer patients
with randomized trial of 86 superficial bladder cancer patients,
grade Ta, T1, Tis, 10 year follow-up.