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The Lancet urges vaccine caution
listen Friday, 31 July 2009 10:39

Countries need to assess carefully the risks and benefits of rapid approval of a human swine flu vaccine, especially since the disease has so far been mild, with most patients making a full recovery, according to an editorial in the latest edition of medical journal The Lancet.

It says many national regulatory agencies have set up fast-track approval processes for the H1N1 vaccine, expected around September, which means that 'a vaccine might be licensed without the usual safety and efficacy data requirements'.

In Ireland, the Department of Health's Chief Medical officer, Dr Tony Holohan, said Ireland will not be recommending people have the vaccine unless the balance of risk and benefit is in favour of someone getting it.

Dr Holohan the vaccine may be licensed first for some sections of the population before it is permitted to be given to the wider population.

'We will not be recommending the use of an unsafe vaccine', Dr Holohan said.

The exact licensing arrangements are expected to become clearer in the autumn and closer monitoring of the vaccine is also likely after it has first been given to certain groups.

The Lancet says some fear a repeat of the 1976 H1N1 outbreak in the US where mass vaccination was associated with complications, which stopped the campaign and led to the withdrawal of the vaccine.

As a result it says vaccine safety will have to be monitored through post-marketing surveillance.

Last week, Australia and the US said they would begin trials of an H1N1 vaccine.

The Lancet says that while all countries will require the vaccine, current global manufacturing capacity will not be able to meet this demand and the requirement for people to get two doses is likely to reduce capacity further.