University of Antwerp to start human tests for swine flu vaccine in
August
24 July 2009
The University of Antwerp is organising vaccine studies for different
producers of swine/Mexican flu (H1N1v) test vaccines in August and
September. 300 to 400 volunteers will be recruited for these tests.
“There is a good chance that a Mexican flu vaccine is available early
November”, expects vaccine expert prof. dr. Pierre van Damme, director
of the Centre for the Evaluation of Vaccination (CEV), a department of
the Vaccine & Infectious Disease Institute (VAXINFECTIO) at the
University of Antwerp.
“We were contacted by a number of vaccine producers to test their
vaccines as soon as they had a test version”, explains Van Damme. “The
CEV can look back on more than 20 years of experience in the scientific
evaluation of test vaccines for different producers. We have been
cooperating with some of these vaccine companies for many years.
Obviously, they do not want to lose time now. That is why the number of
test centres has been limited.” Together with the University of Antwerp,
the University of Ghent and some centres in Finland, France and Germany
are involved in the testing.
“Most producers will have their test vaccines ready by the middle or
end of August” says Van Damme. “But a vaccine can only be launched on
the market when is has been tested on healthy volunteers. This procedure
is also followed for other test vaccines. The vaccination of volunteers
will take place in the course of August and September, because all test
vaccines come with a vaccination scheme of 2 doses.”
Van Damme expects the final test results in October. "Then the test
reports will be delivered to the proper authorities (eg EMEA) and it is
up to them to give the go-ahead to the vaccine. Consequently, the mass
production can start and a few weeks later the vaccine can be launched.
This means that a vaccine will probably be available by the beginning of
November.”
Van Damme points out that the production will not immediately be
sufficient to vaccinate everyone. “That’s way most countries are now
identifying target groups to be vaccinated first. It concerns people
with crucial professions during a pandemic (eg health workers), standard
high-risk groups (eg people aged over 65 with underlying disorders or
people who are chronically ill) and potentially also young children
because they can play an important role in the spreading of the flu.”
Time pressure
Van Damme confirms that there is time pressure, but emphasises the
need to follow the standard evaluation procedure. “Luckily, this
procedure is very similar to the one we use with the winter flu, for
which we also use a killed or inactivated vaccine. So we know what side
effects we can expect, and we can be certain that the test vaccine will
not cause flu symptoms.”
Whether the vaccine will be available on time, is an open question.
“On the basis of recent epidemiological data, we estimate the chance
that the Mexican flu will quietly fade away (as SARS did a few years
ago) to be nearly zero. The data from Spain and the United Kingdom
clearly show an increasing spread of the Mexican flu. It is still not
clear what the course of the disease will be, but currently the disease
symptoms and complications seem to be in the order of the annual winter
flu. This situation can continue, but there is also a chance that the
flu becomes more serious, for instance when the virus mutates or
exchanges genetic material with other winter flu viruses that start
circulating. We need to be prepared for these scenarios as well.”
Bookmark this page