Chiron suspension threatens US flu jab shortage
pharmafile | October 7, 2004 | News story | |
The US is facing a 50% shortfall in the supply of flu vaccines after regulators suspended production and distribution from Chiron UK's manufacturing site.
MHRA inspectors enforced a three month ban on distribution and production at the Liverpool production facility after uncovering doubts about sterility standards in the manufacturing process.
The vaccine manufacturer's licence at its Liverpool site has been suspended by the MHRA, preventing it from distributing 50 million doses of Fluvirin for the 2004/5 flu season, mostly destined for the US.
The suspension has led the company to more than halve its expected share earnings for 2004 – last year sales of the vaccine reached $219 million.
The US Department of Health and Human Services (HHS) said the loss of Chiron's flu vaccine posed a serious challenge to its supply and that it would be concentrating on ensuring the most vulnerable would be treated first.
The HHS is now investigating whether Aventis Pasteur MSD can increase production of its flu vaccine to make up some of the shortfall. Talks with Chiron and the UK Government about the situation are also ongoing as the US government seeks to head off a potential public health crisis.
John Lambert, president of Chiron Vaccines, said: "While the MHRA conclusions are unexpected, we respect the regulatory authority's judgement. We apologise unreservedly to the public and our customers for being unable to meet our commitments this year."
The suspension came just one day after the Department of Health launched its annual drive to promote uptake of free flu immunisation. This year the campaign is focused on encouraging people with chronic conditions, such as asthma and diabetes, as well as all those aged 65 and over, to have the free flu jab.
The Department of Health has admitted the suspension could delay vaccine supplies and it has placed additional orders with other suppliers to make up the shortfall.
But the unavailability of supplies has already forced many GP surgeries in Northern Ireland to cancel planned vaccination clinics, according to the British Medical Association.
Dr Eugene Deeny, Treasurer of the BMA GPs' committee, said doctors in the region were furious at being told to prioritise the need for the immunisation.
"The Department blithely asserts that the vaccination can go ahead despite only a pitiful amount of supplies being available and that doctors will prioritise patients most at risk. This is quite a challenge when the at-risk group itself is so large and the supply so small," he said.
Headquartered in Oxford, Chiron is the world's fifth-largest vaccines business and, as well as Fluvirin, its product range includes vaccines for meningitis C, rabies, encephalitis, yellow fever and mumps, measles and rubella (MMR).
