UPDATED: GSK warns of a possible global shortage of chickenpox vaccines

The U.S. is unaffected because the vaccines are not licensed there

January 28, 2014 | By Eric Palmer

It turns out that Germany will not be the only country facing a shortage of GlaxoSmithKline's ($GSK) chickenpox vaccines. While healthcare providers there have already been given a heads up to prepare for rationing, the company says deliveries worldwide will be affected, although the U.S. is unaffected because the company does not sell the vaccines there.

A GSK spokesman told Reuters today that the company will need to reallocate its 2014 supply of its Varilrix chickenpox vaccine, as well as Priorix-Tetra, a MMRV combo vaccine for measles, mumps, rubella and varicella (chickenpox). Robert Perry, director of external communications for GSK in the U.S. told FiercePharma today that the two vaccines are not licensed in the U.S. Varilix is available in more than 90 countries and Priorix Tetra is available in more than 50 countries.

Both vaccines are licensed in Canada, Perry said.

The interruption was attributed to problems at a plant in Belgium. Perry said late last year, GSK uncovered a manufacturing issue that involved some varicella-containing vaccine batches that were not meeting GSK release criteria and standards. "As a pre-cautionary measure, 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," he said.

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Perry said all of the batches of Varilrix and Priorix-Tetra currently on the market meet all release specifications and safe and effective to use. He said the company expects to be able to provide an update in February, "based on the lead time required to conduct the different analyses currently taking place."

The company told Reuters it expects to be shipping again by the end of next quarter. That means first-quarter revenues could be affected, although it might make up lost ground once product returns to the market, the news service notes.

Manufacturing problems have created shortages of a variety of vaccines around the world, and that can wreak havoc on revenues.

French drugmaker Sanofi ($SNY) had its third-quarter earnings dampened last year when plant problems delayed it getting its pertussis-containing vaccines Pentacel, Adacel and Daptacel to market. The company reported that its vaccine sales dropped 7.2% to €1.3 billion ($1.8 billion) because of the production interruption.

It also caused a shortage of the vaccines. GSK had tried to take up some of the slack with its own pertussis-containing vaccines but also warned that the situation could result in some spot outages of its own Boostrix (Tdap) vaccine, according to a November update by the the Centers for Disease Control and Prevention (CDC).

Read more: UPDATED: GSK warns of a possible global shortage of chickenpox vaccines - FiercePharma http://www.fiercepharma.com/story/gs...#ixzz2rj6xRTRf
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