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Glaxo has bird flu ‘breakthrough’
UK
drugs firm GlaxoSmithKline believes it has developed a vaccine for the
H5N1 deadly strain of bird flu that may be capable of being mass
produced by 2007.
The
vaccine has proved effective at two doses of 3.8 micrograms during
clinical trials in Belgium, BBC business editor Robert Peston has
learned.
It is the size of the dose that is highly significant,
Glaxo explained.Firms want the smallest effective dose so that they can
get the maximum number of shots out of a quantity of vaccine.Glaxo has
yet to publish the results of its tests.The news of the work on a
potential vaccine came as Glaxo reported its profits had risen 14% in
the three months to June to £1.32bn (US$2.4bn).Delivery
Glaxo
said that governments could order the vaccine for delivery and
stockpiling in early 2007.One of Glaxo’s main rivals, the French drug
company Sanofi Aventis, has also been working on a vaccine.A study
published in the Lancet in May showed that Sanofi’s vaccine had some
effectiveness in some patients who were treated with two 7.5 microgram
doses.In February, the NHS awarded a contract to another firm – Baxter
International – for two million doses of its H5N1 vaccine to inoculate
“key” public service workers.Government talks
Drug
companies are looking to develop treatmentsbecause of concerns that the
H5N1 virus will combine with a human flu virus and mutate into a form
which can spread between humans.Since 2003 there have been 231 cases of
bird flu in humans, resulting in 133 deaths.A pandemic flu strain
spreading between humans has yet to emerge. Since no one knows what
such a strain would look like, companies cannot yet develop a targeted
vaccine.But a number of firms, including Glaxo, are seeking to develop
vaccines based on the existing H5N1 strains in order to give humans
some form of protection.Glaxo says it will now start discussing with
governments about whether they want the vaccine and how much they may
want to order.Its vaccine, like others in development, is on a fast
track for approval with the relevant licensing authorities in the US
and Europe – the US Food and Drug Administration (FDA) and the European
Medicines Evaluation Agency (EMEA).”All being well, we expect to make
regulatory filings for the vaccine in the coming months,” said Glaxo
chief executive Jean-Pierre Garnier.Prime desire
Glaxo
seems highly confident that demand for itsvaccine will be huge, the
BBC’s business editor said.The UK and US have both indicated a desire
to “prime” their respective populations with an initial inoculation.Mr
Garnier said he recently met US President George W Bush to discuss the
vaccination programme.Following that meeting, Glaxo received $272m
(£148m) of funding, earmarked in part for the development of new
technologies to produce vaccines.Glaxo said its new vaccine would give
limited immunity to bird flu in the event of a pandemic. A second shot
would be necessary for complete immunisation, the company said.If there
were a pandemic outbreak in the early autumn, mass manufacture of
Glaxo’s vaccine could probably be started quickly through collaboration
with rival pharmaceutical companies.Glaxo said it was also talking to
the Gates Foundation about how to provide the vaccine to poorer,
developing countries.Shotgun effect
Despite
the company’s optimism, there were a number of unanswered questions,
the BBC’s business editor said.Firstly, there is uncertainty over how
many doses can be manufactured quickly, and how easy it would be to
make the transition from laboratory testing to mass production.And
secondly, it is not clear how effective the vaccination would be if
H5N1 were to mutate significantly.Glaxo says its vaccine is more akin
to shotgun treatment than a “precision-rifle cure”, which means that it
appears to be effective against small mutations in the virus
strain.However, it has yet to determine the effectiveness of the
vaccine against big changes in the H5N1 strain.Glaxo said the cost of
the vaccine is likely to be a little more than for conventional flu
vaccines, which retail for about £4 per shot.According to Glaxo, the
side effects or reactions to its bird flu vaccine have been very
similar to those generated by a conventional influenza treatment, and
have been limited to a fever in a number of patients.Drug companies
including Glaxo have been looking to expand their vaccination
programmes as fears rise about an outbreak of a viral pandemic and
governments come under increased pressure to protect their
populations.Glaxo bought Canadian vaccine company, ID Biomed, for $2bn
last autumn and is now probably the second-largest manufacturer of flu
vaccines after Sanofi.
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