Swine flu vaccine: Out-dated methods ‘cause delay’

The world's largest drugs companies may inadvertently be putting thousands of lives at risk by producing swine flu vaccines too slowly, employing out-dated technology, an Australian scientist told The First Post today.

Pharmaceutical giants such as GlaxoSmithKline are using manufacturing techniques that are over half-a-century old, despite a new method being available that is potentially faster, safer and more effective, according to Professor Nikolai Petrovsky.

Petrovsky is chairman of Vaxine, a small Adelaide-based biotechnology company which is pioneering a new technique for making vaccine and is now one of the two companies conducting human trials in Australia, as reported yesterday.

‘We see it as the battle of new versus old technology and only one can win’

Employing just 20 staff, Vaxine took less than three months to develop a vaccine after the H1N1 virus was first identified in April. Petrovsky claims this is a record.

"We see it as the battle of new versus old technology and only one can win," he said. "I believe the old technology is dead in the water and it's just a matter of time - if there's a better technology then eventually it has to take over."

The vaccine's effectiveness will not be known until the conclusion of the clinical trials involving 300 people which began this week in Adelaide. But if these studies are successful then it could signal the end of the traditional egg-based influenza vaccines.

"All the big players are using technology that was developed post-war and it hasn't changed in 50 years," Petrovsky said. "It involves injecting eggs (pictured above) with the live virus, growing up the virus in the eggs, purifying it, inactivating it and that's the vaccine.

"Our vaccine is produced using a recombinant protein, so there is no virus involved. It's the latest in cell culture technology with animal-free products so, essentially, it's all synthetic. There is no risk of contaminants; it is high-yield and very reliable to manufacture so we know for certain what doses we'll get."

Vaxine's synthetic technology is important because, as reported yesterday, scientists using the traditional methods have warned the World Health Organisation that the 'seed strains' grown to produce the vaccine are giving poor yields of antigen. The yield is a quarter to a half of that which vaccine makers typically get for seasonal flu vaccine production.

Pharmaceutical giants like GlaxoSmithKline are not contractually bound by any delivery dates, but have huge orders from governments around the world, once they can get their vaccines tested and manufactured. GSK, for instance, has orders for 195m doses, including 60m for the British government.

But because of the poor antigen yield, Petrovsky believes companies like GSK will fall behind in production. "What the big companies are not saying much about is that they're having major manufacturing problems," Petrovsky told The First Post.

"I know they are all struggling as this virus doesn't grow well. I believe the time-frames for delivery will blow out enormously beyond what they non-contractually promised the government."

Petrovsky believes the capacity to supply the vaccine could be very restricted to "a fifth, or a tenth, or even a hundredth" of what governments are expecting.

A spokesman for GlaxoSmithKline explained that the length of time it takes the company to deliver the full order is dependent on the yield of the antigen, but that they expected to deliver the first batches of vaccine by the end of September.

Defending their production facilities, the spokesman said: "We do use eggs... but whatever method that gets out the vaccine as quickly as possible is fine by us. We are using an adjuvant to increase the efficiency in the vaccine: we've invested a lot of time and money in researching that technology, so we're going to stick with that."