The Irish government plans to contact
all 30,000 children who have been given a sub-standard vaccine over the
past two and a half years but the UK health department said yesterday it
saw no need to follow suit.
Dublin's move follows the recall in Britain and Ireland of tens of
thousands of unadministered doses of the vaccine from PowderJect
Pharmaceuticals, the controversial drugs company.
The Irish government this week signed a contract with Denmark's
Statens Serum Institut to supply a year's worth of replacement vaccines,
ditching PowderJect as a supplier.
But the UK health department said: "The data from our tests so far
give no proof that there is an issue of efficacy with the batches [of
the vaccine] provided to the UK. We don't believe any children need to
be tested or revaccinated." But the government is also understood to be
considering turning to SSI for future BCG vaccine.
Sample tests of vaccines produced at PowderJect's Liverpool factory
revealed the potency of some batches was lower than required under
licensing rules - raising concerns about doses already administered.
PowderJect has supplied BCG to UK schools and health authorities
under a two-year contract since March last year.
Shortly after Paul Drayson, PowderJect's chief executive and
chairman, donated a second £50,000 cheque to the Labour party, the
company was awarded the government contract to manufacture millions of
doses of smallpox vaccines. The vaccines will also be produced in
Liverpool.
Company insiders have alleged the BCG crisis was caused by shoddy
management. They have alleged that an unreasonably high number of
temporary staff were used at the company's Evans Vaccines plant at Speke.
That is consistent with an investigation by the Irish Medicines
Board, the industry regulator, which concluded it was "dissatisfied with
the procedures adopted by the company in producing this vaccine",
blaming "people and processes".
The company said last night it was "comfortable" the BCG vaccines
given to children in Britain and Ireland would still provide
sufficiently effective inoculation.
But Liam Fox, shadow health secretary, said the discrepancy between
the governments' stances was "astonishing".
"It seems inconceivable that Alan Milburn should continue to stand
back and wash his hands of what is happening."
Ireland's health department said identifying children vaccinated
since April 2000, purchasing replacement vaccines and administering them
would entail a "very significant cost".
Officials said in private that if PowderJect failed to cover those
costs voluntarily, a claim could be made through the courts.
PowderJect said the £10m provision made to cover the vaccine recall
included an assessment of that eventuality. It also insisted that no
temporary staff were used on the BCG production line.
PowderJect said it was convinced it acted entirely properly in not
disclosing details of the affair to the stock market when the first
batch of the vaccine fell short on July 2. The Financial Services
Authority has concluded in an informal check that PowderJect has no case
to answer. Additional reporting by Krishna Guha and Jonathan Guthrie
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