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Independents' Day

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Experts say the Government needs to learn the lessons of supply chaos over GPs' flu and MMR campaigns by tackling the ailing vaccine industry ­ Emma Wilkinson reports

It has been a torrid six

months for GP immunisation campaigns.

First the flu campaign was left in chaos by the withdrawal of supplies from Chiron; then GPs had to cancel MMR catch-up clinics as vaccine supplies ran dry.

Isolated glitches? Not according to leading immunisation experts, who believe the problems are indicative of a far wider malaise in the world of vaccine supply.

Dr Paul Offit, a leading authority on the vaccine industry and former member of the US Centers for Disease Control and Prevention advisory committee, warns: 'During the past 50 years the number of companies making vaccines has decreased dramatically and those that still make them have reduced resources to make new ones. What we are seeing is the crumbling of the infrastructure.'

There are a number of reasons for the shrinking number of suppliers. Partly it is a symptom of the consolidation of the world's pharmaceutical industry, with mergers creating a smaller number of super sized companies.

There is also little money in vaccine production. An unpredictable market, high production costs and the lack of potential for repeated sales all combine to eat at profit margins.

Professor Robert Read, professor of infectious diseases at the University of Sheffield and member of the British Infection Society, says: 'The problem is companies don't make a lot of money because vaccines are a one-off and the development costs are quite large. Also, governments can decide what the price is going to be'.

Dr Offit, who is chief of the division of infectious diseases at the Children's Hospital of Philadelphia, claims vaccines account for less than 10 per cent of the revenue for the four biggest producers ­ Wyeth, GSK, Sanofi Aventis and Merck.

'All four companies could stop making vaccines tomorrow without much impact on their bottom lines,' he says.

There is some evidence this is happening with Wyeth, for instance, halting production of the DTaP vaccine in 2002.

The House of Commons public accounts committee warned last year that the shrinking numbers of suppliers was putting the UK at growing risk of vaccine shortages.

It urged action from the Department of Health after finding stocks of 11 of 16 essential vaccines in the UK were dependent on just a single supplier.

GPs are becoming increasdingly concerned that the ailing vaccine industry is making it harder for the department to source vaccine supplies, raising the likelihood of future shortages.

Dr Mayur Lakhani, RCGP chair and a GP in Loughborough, Leicestershire, says: 'Most of the time it works fairly well but when there are interruptions in supply it is really unhelpful. We need a vibrant and healthy pharmaceutical industry and I'm concerned conditions are becoming so difficult it will work against innovation and progress.'

Professor John Oxford, professor of virology at Queen Mary, University of London, argues that last winter's chaos over flu vaccination could be a sign of further problems to come.

'We have a nasty practical example of where that has happened with flu,' he says. 'Maybe we should be encouraged that the department had five suppliers whereas in the US they only had two.'

But, he added, 'they need to learn from that experience for other vaccines'.

Professor Oxford argues that small companies need to be provided with financial incentives to take on vaccine production.

'Maybe smaller companies should be encouraged to come back to vaccine manufacture by grants or tax breaks. Vaccine production is more important than it ever was,' he says.

But other experts believe that for unpredictable diseases, such as flu, companies are poorly suited to the job of vaccine supply.

They worry that the UK would be increasingly ill-prepared for a flu pandemic and argue that Government production is the only answer.

Professor Read says: 'If the Government or WHO got

involved in primary manufacture it would take the

risk away from the pharmaceutical industry and we would get a more demand-led system.'

Dr Offit agrees. 'It's governments that are going to have to step forward. It is that simple. There has to be a willingness to take vaccines forward.'

There are signs that there are moves afoot for the Government to take a more active role in vaccine production. Professor Read talks of an

'undercurrent' of Government thinking in this direction.

The Health Protection Agency earlier this year

submitted a report to the

department calling for a

strategic vaccine facility for

the UK.

The proposal would combine an emergency rapid response unit with a development team that would work in partnership with industry.

The facility would 'provide the capability to the UK to deal with new and emerging disease threats,' the HPA said.

The implication is clear. As things stand, that capability may not be there.

Why vaccine industry is in crisis

·One-off nature of vaccination means market for vaccines is small

·Vaccines are expensive to develop and take longer to license than other drugs

·Mergers have eliminated many companies that made vaccines

·Vaccine scares have raised the risk of litigation

·Vaccine use is dependent on Government decisions

What the experts

are suggesting

·Public-private partnerships for research and development of new vaccines

·Government-run production of vaccines for unpredictable diseases

·Closer industry involvement in policy

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