First swine flu vaccine given UK go-ahead

Health Editor,Jeremy Laurance
Friday 25 September 2009 16:36
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The first swine flu vaccine was approved for use in the UK today - but it would not pass muster in America.

European regulators gave the go ahead for Pandemrix, made by GlaxoSmithKline, to be used in adults and children over six months old and pregnant women. A second vaccine, made by Baxter, is still being considered.

Both vaccines contain adjuvants - chemicals that enhance the immune response so that less viral material can be used in each vaccine dose. The European Medicines Evaluation Agency (EMEA) said adjuvants were widely used in vaccine manufacture and have a good safety record. The benefit of adjuvants is that they make the available vaccine go further - which means more of the world’s population can be protected.

However, US regulators have rejected the use of adjuvants for swine flu vaccine. Jesse Goodman, chief scientist at the US Food and Drug Administration, told the New York Times: “These are products that potentially can be given to millions of healthy people. There is not a known, specific safety danger or issue. There's just more uncertainty.”

American public health specialists are worried that using adjuvants could raise fears about vaccine safety among the public just at the time when they are trying to roll out a vaccination programme as widely as possible. As swine flu is mild in most people, but causes serious illness in a few, it may prove difficult to persuade people to accept it - without the added disincentive of the adjuvants.

Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases said: “If you add what the public would perceive as another unknown, there's a concern that people would be reluctant to get vaccinated.”

The European Medicines Agency said the adjuvant used in Pandemrix had been tested in clinical trials in “several thousand subjects.” A second vaccine approved today, Focetria made by Novartis, but which will not be used in the UK, contained an adjuvant used in another flu vaccine since 1997 in 45 million doses

However, Dr Fauci said Novartis's adjuvant had been used mainly among the elderly, who tended to have weaker immune systems, and there was less data on its use among children, younger adults and pregnant women.

Having won approval from the European Medicines Agency, the Pandemrix vaccine now awaits licensing by the European Commission, removing the last regulatory barrier allowing the vaccination programme to get underway.

Time is short because latest figures showing a doubling in the number of swine flu cases last week indicate the second wave of the pandemic is already underway.

A spokesman for the Department of Health said the granting of approval for Pandemrix was “a step forward” but they were still dependent on manufacturer’s delivering sufficient vaccine to allow the programme to be begin.

“We plan to start vaccination in October, subject to vaccine being licensed and manufacturers' delivery schedules.This is not the Department of Health's schedule - it is led by the manufacturers.”

The UK has bought 60 million doses of Pandemrix.

The EMEA said: “As with all medicines, rare adverse reactions may only be detected once the vaccines are used in large numbers of people. The Agency has requested that vaccine manufacturers implement plans to actively investigate and monitor the safety of vaccines as soon as they are used across the EU, so that action can be taken as early as possible if a safety issue emerges. As part of this, the manufacturers have committed to carry out post-authorisation safety studies in about 9,000 subjects for each vaccine.”

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