smallpox vaccine and vaccination in the intensified ... - libdoc.who.int

11. VACCINATION IN THE INTENSIFIED PROGRAMME
Table 1 1.7. WHO survey, 1967: bacterial contenta of vaccines
Continent
Africa 8
Americas 12
Asla and Oceania 13
Europe 20
Number of producers Number of
reporting batches
Bacterial count per ml
0 1-9 10-99 100-499 2500~
Total 53 138 50 10 28 38 12
a Viable non-pathogenic bacterla.
bunacceptable by WHO standards.
titre of about half was reduced to less than
107.5 pock-forming units per m1 after heating.
Bacterial Count
Since most smallpox vaccine was produced
in animal skin, bacteriological sterility was
not attainable. WHO standards required that
the bacterial count should be less than 500
microorganisms per m1 and that no patho-
genic bacteria should be present. Satis-
factory results were obtained in most labora-
tories (Table 11.7) ; of 138 batches on which
reports were supplied, in only 12 was the
maximum acceptable count exceeded. These
came from 8 different laboratories, distribut-
ed over 4 continents. Of the 50 lots for which
a bacterial plate count of zero (per ml) was
recorded, 10 were produced in chick embryos
or tissue culture, in 3 countries.
ESTABLISHMENT OF THE WHO
REFERENCE CENTRES FOR
SMALLPOX VACCINE
The results of the survev confirmed earlv
misgivings about the quality of the vaccine
being supplied for use in endemic countries. It
was clear that WHO needed a mechanism for
the periodic testing of vaccine supplied to the
eradication programme, whether by donation
to the Organization, through bilateral assist-
ance agreements or by local production in
the endemic countries.
WHO does not have laboratories attached
directly to it, either at Headquarters or in the
regional offices. For purposes of quality
control of the vaccine, therefore, the Organi-
zation had to make contractual service agree-
ments with appropriate laboratories whereby
they would undertake to conduct specified
tests.
In December 1966 the Connaught Medical
Research Laboratories, University of Toron-
to, Canada, had accepted a contract from
the WHO Regional Office for the Americas
for the provision of technical services to
improve the quality of smallpox vaccine being
produced by laboratories in that region (see
Chapter 12). The services involved included
an evaluation of existing smallpox vaccine
production facilities and their personnel in
the region, the provision of training for
production personnel, and advice on the
selection of equipment necessary for the
production and testing of smallpox vaccines
being produced in the region. Dr Robert
Wilson and Dr Paul Fenje, experts from the
Connaught Laboratories, visited production
laboratories in the region, especially in South
America, where 11 laboratories were produc-
ing smallpox vaccine, many of them provid-
ing: material that did not meet WHO stan-
dards, as judged by the survey conducted in
1967.
In 1967, similar arrangements were made
by WHO with the National Institute of
Public Health, Bilthoven, Netherlands, of
which the Director-General was Dr Jan
Spaander. The head of the vaccine laboratory
was Dr Anton Hekker.
In 1969 the Connaught Laboratories were
formally designated as the WHO Regional
Reference Centre for Smallpox Vaccine in the
Region of the Americas, and the National
Institute of Public Health in Bilthoven as the
WHO International Reference Centre for
Smallpox Vaccine. The services provided by
the International Reference Centre were as
follows :