Drugs firm stayed silent over its faulty vaccines
Note: This firm is making vaccines for the US to Stockpile.
Liverpool, UK
By Alan Weston Daily Post Staff
A DRUGS firm which employs around 600 people on Merseyside is embroiled in
fresh controversy after revelations that it stayed silent over thousands of
faulty vaccines.
PowderJect, run by multi-millionaire Labour donor and Government defence
minister Lord Drayson, knew for nearly two years that nine batches of
anti-TB jabs produced at its Liverpool factory had failed quality control
checks.
But the Speke-based company - now known by the name of new owners Chiron -
did not inform health regulators or the National Health Service, its main
customer.
Senior Labour backbencher Ian Gibson said: "We need a public inquiry into
this business. It doesn't smell as sweetly as it might."
But the Department of Health said a National Audit Office investigation had
already concluded the Government had acted correctly.
An investigation for the BBC's Money Programme found that internal tests at
the Liverpool vaccines plant revealed a problem with the vaccine's shelf
life from 1989 onwards, 11 years before Lord Drayson bought the factory.
But when PowderJect took over in October 2000, the company remained silent
about the failures and continued producing the BCG jab - at least one batch
of which also failed internal tests.
The firm finally had its licence to produce the vaccine suspended after an
inspection in July 2002 by the Medicines Control Agency, the Department of
Health body that monitors the effectiveness of medicines.
The problems are detailed in a report from the Medicines Control Agency (now
the Medicines and Healthcare Products Regulatory Authority) obtained under
the Freedom of Information Act.
"Since 1989, batches of BCG vaccine have been on a stability monitoring
programme of which nine have had sub-potent results at one or more time
points and had therefore failed to meet their end of shelf-life potency
criteria," it said.
"There is no evidence that failing stability (potency) reports have been
reported to the MCA."
The Department of Health has refused to say how many doses of the vaccine
might have been affected. The MHPRA said that the average batch size was
100,000, meaning 900,000 individual doses may have been involved.
In Ireland 15,000 children inoculated with the under-strength PowderJect
jabs were retested and 287, or 2%, revaccinated.
The Department of Health said that was not deemed necessary here.
"Revaccinating those who had already received the BCG vaccine could have
increased the likelihood of adverse reactions in some patients."
The Speke plant has only recently returned to flu jab production after a
contamination scare last year. It had its licence to manufacture the
Fluvirin vaccine suspended by the MHRA for three months, after it was
discovered 4m doses were contaminated with bacteria.
It is also ramping up the manufacture of treatment for a strain of bird flu
for America to stockpile.
The Department of Health has refused to say how many doses of the vaccine
might have been affected. The MHPRA said that the average batch size was
100,000, meaning 900,000 individual doses may have been involved.
In Ireland 15,000 children inoculated with the under-strength PowderJect
jabs were retested and 287, or 2%, revaccinated.
The Department of Health said that was not deemed necessary here.
"Revaccinating those who had already received the BCG vaccine could have
increased the likelihood of adverse reactions in some patients."
The Speke plant has only recently returned to flu jab production after a
contamination scare last year. It had its licence to manufacture the
Fluvirin vaccine suspended by the MHRA for three months, after it was
discovered 4m doses were contaminated with bacteria.
It is also ramping up the manufacture of treatment for a strain of bird flu
for America to stockpile.
It was announced earlier this month that the plant is set to change hands
again in a £3bn merger with Swiss drugs giant Novartis.
Novartis already owns 42% of California-based Chiron. A deal for the
outstanding 58% should be rubberstamped next year.
