GSK halts chickenpox vaccines over quality concerns
pharmafile | January 29, 2014 | News story | Manufacturing and Production, Sales and Marketing | Boostrix-Polio, GSK, Varilrix, chickenpox, vaccines
GlaxoSmithKline has suspended worldwide distribution of two chickenpox vaccines after production standards were not met at one of its facilities in Belgium.
The products in question are single shot Varilrix, and combined measles, mumps, rubella (MMR) and varicella (chickenpox) jab Priorix-Tetra. The precise nature of the manufacturing problem is not yet clear.
GSK had already recommended that doctors in Germany ration supplies of the two vaccines, but it appears that the disruption may now spread further afield.
The company’s US director of external communications, Robert Perry, told FiercePharma that a manufacturing problem was detected at the Belgian plant late last year – and that distribution has been put on hold as a ‘pre-cautionary measure’.
He commented: “The final release of all varicella-containing vaccine has been put on hold until we complete testing and analysis designed to identify the root cause of the issue.”
Perry also clarified that there are no problems with any vaccine batches already on the market and that products currently available are safe to use.
GSK is a major global player in vaccine production, with sales of over £3.3 billion in 2012. It markets over 30 vaccines worldwide and has a sizable pipeline, including experimental shots for malaria and tuberculosis.
The financial impact of this suspension on the firm’s earnings is not clear, but Reuters reports that the British firm expects to recommence distribution at the end of March, with some distribution catch-up expected in the second quarter of the year.
A GSK spokesperson said: “We’re committed to resolve this supply disruption situation as soon as possible and are actively involved in keeping regulatory authorities and customers informed as we look to minimise the impact of this temporary supply disruption.”
Coincidentally, GSK is also experiencing a shortage of Boostrix-Polio, its combination shot against diphtheria, tetanus, whooping cough and polio – although this is due to unprecedented demand, rather than manufacturing problems.
Priorix, a version of Priorix-Tetra without the chickenpox element, is routinely administered to British children on the NHS. However, this product has not been affected by the manufacturing problem and no shortage of MMR vaccinations is expected in the UK.
Hugh McCafferty
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