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Racing to save lives and fighting the PR battle

Published on 06/08/09 at 01:32pm
A vial of GSK's H1N1 vaccine

Vaccine companies are working round the clock to develop and manufacture a vaccine for the H1N1 pandemic flu, and are under pressure to perform on every level.

Governments and vaccine firms were well prepared for a pandemic, but the clinical and manufacturing challenges of producing millions of doses of a safe and effective vaccine are stretching all the companies involved.

But it is not just researchers and manufacturing personnel doing overtime - media departments and senior execs are also on call, rebutting accusations of profiteering and quelling fears about safety.

Novartis is one company in the race to produce a vaccine, and its spokesman Eric Althoff said: "Since the early days, Novartis has been fully engaged to develop and manufacture as quickly as possible as much vaccine as possible. People across our vaccine division are fully committed and we are working 24/7 to achieve our goal."

Governments around the world are currently ordering supplies to counter the virus the World Health Organisation has called 'unstoppable.' The big companies moving closer to finalising the first jabs against it are GSK, Sanofi-Pasteur MSD, Baxter, Novartis and MedImmune.

Other smaller players include the Australian company CSL and two Chinese firms Hualan Biological Engineering and Sinovac Biotechnology.

Profits

GlaxoSmithKline is the most high profile of the companies involved, as it markets an antiviral Relenza, and is also expected to be one of the biggest producers of H1N1 flu vaccines globally.

It has been accused of making disproportionate financial gains from the swine-flu pandemic with worldwide sales of the two drugs expected to reach £3bn by January 2010. Sales of Relenza rose to £60 million in the second quarter this year - 20 times the volume of the period a year earlier.

GSK chief executive has confirmed that each dose will cost the UK around £6 a jab, but denied reports the vaccine cost as little as £1 to manufacture. Developing nations will pay much less for the vaccine, Mr Witty added.

"We are not trying to generate some crazy level of profit," he told analysts at the company second quarter results conference.

"We've been preparing and investing in something like this pandemic situation for a very long time. We've spent £1.2 billion on vaccine technology in the last four years."

He added: "We've deliberately been very responsible about pricing - the vaccine is not being sold at a special premium and we have been very proactive about making sure there is enough capacity to produce the huge number of vaccines required."

The frontrunners

Sanofi Pasteur, GSK and Novartis are set to reap the greatest financial rewards, but have the challenge of producing huge quantities of a safe and effective vaccine in a matter of weeks.

Baxter looks set to be first in producing its jabs, with the first doses expected as early as August. They are being made in plants in Germany, Austria and the Czech Republic.

However, the company recently declared it has reached its full production capacity after accepting orders equivalent to 80 million doses. At GSK, Witty said it had been investing in vaccines for 18 years, far longer than any other company, and has received orders for 195 million doses from 16 countries, including the UK. It claims to be in talks with 50 countries in total, and the first batches of its vaccines will be shipped from its production sites in Germany and Canada in September. Analysts Datamonitor say the deals could earn GSK $2.1bn in 2010.

Meanwhile Novartis started clinical trials in July and began large-scale production at its flu vaccine manufacturing sites in Liverpool, Siena and Marburg.

It has secured several orders amid discussions with over 35 governments, with analysts expecting its sales to be potentially worth between $1bn and $1.5bn if a single dose is sold for $10.

Sanofi Pasteur MSD is making use of its production sites in the US and France. It expects to have its first doses ready in 4-6 months, a little later than the other companies.

Sanofi has signed agreements with the French and US governments, the latter deal worth around $1bn. Globally, Sanofi Pasteur MSD will reserve 10% of its output for the WHO as a donation to developing countries, and has also signed a contract with the Australian government to supply the vaccine.

Production and safety

But all companies are facing major challenges in the production of the vaccines, as it is proving difficult to cultivate the quantities of the H1N1 virus needed.

The strain does not grow well in eggs, the principal medium used by the industry in vaccines, and reportedly yields 50-75% less antigen - the substance that induces immunity - compared with a typical seasonal flu strain.

Novartis has an advantage as it is using both traditional egg-based manufacturing as well as a newer and faster cell-based vaccine production technique to maximise supplies, a technology that Baxter has also adopted.

But Novartis admitted: "At this point in time it is difficult to predict [the doses that could be made by December], as the exact yields remain uncertain as well as what level antigen will be used with our adjuvant in the final vaccine." GSK and Novartis can both call on another technology - adjuvants - to boost the yield from the process.

Adjuvants are a new technology that boosts the potency of antigen, meaning the same volume of vaccine can be split into more doses.

Some groups still doubt the safety profile of adjuvants. The US FDA has not approved their use under normal conditions, and looks unlikely to approve their use for US supplies.

Sanofi Pasteur has neither an approved adjuvant nor new cell technology, but it does in theory have the biggest capacity to produce vaccines. However, this depends largely on how many of its sites it devotes to H1N1 strain.

On top of these complications is the added pressure that manufacturers are also having to produce vaccines for the annual flu season. The northern hemisphere flu vaccine production cycle runs annually from January to September, demonstrating just how long large-scale flu vaccine production usually takes.

Frances Luff, a spokesperson from the UK Vaccine Industry Group, said the situation created a double burden for the companies.

She said of the process: "It's not something you can switch on and switch off. It all takes time, and it's not something you can just do in a couple weeks."

SWINE FLU AND ARGENTINA

Swine flu has killed more people in Argentina than almost any other nation, 165 deaths out of just over 3,000 cases reported - a rate of 5.5%.

Scientists are now trying to determine whether a more dangerous mutant strain has emerged after analyses of specimens taken from two severely ill patients showed subtle genetic differences in the virus.

Scientists now plan to decode the complete genomic sequences of at least 150 virus samples to gauge the frequency of the changes and whether they are linked to more severe illness. Major changes in the pandemic virus could reduce the effectivenes of vaccines being developed and cause resistance in anti-virals.

Swine flu has now infected 169,000 people globally, killing around 1,050. Only the US, with 302 deaths, has recorded more deaths than Argentina.

Doctors in the country have speculated that the virus circulating in Argentina swapped some of its genes with a seasonal strain, spawning a new variant.

Shortcomings in the health system, and the fact that the government delayed taking action until after its mid-term elections, have also been blamed.

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