Merck makes progress on vaccines supply issues
pharmafile | July 24, 2009 | News story | Manufacturing and Production |Â Â MerckÂ
Merck & Co's new manufacturing facility in Durham, North Carolina, is on schedule to start production of vaccines in the first half of 2010, according to chief executive Dick Clark, who said the company is making "great progress" with its vaccine supply issues.
Merck has invested $750 million in the production facility, with another block of money – around $250 million – going to update other vaccine plants in West Point, Pennsylvania, and Carlow in Ireland.
The new facility will manufacture Merck's measles, mumps and rubella (MMR) and chickenpox vaccines, as well as its Zostavax shingles vaccine, which was approved by the US Food and Drug Administration (FDA) in 2007 but has recently suffered from a downturn in sales.
In recent months the company has been struggling with some regulatory compliance problems at its West Point facility, which were behind a recall of two childhood vaccines (PedvaxHIB and Comvax) at the end of 2007.
Production of the vaccines were still suspended at the end of June, according to a notice on the Centers for Disease Control (CDC) website. The agency recently recommended restarting a booster shot programme for 12- to 15-month-olds using alternative vaccines supplied by Sanofi Pasteur.
The FDA's current biologics shortage list suggests that Merck is still finding it hard to meet demand for its hepatitis B vaccine Recombivax HB, hepatitis A vaccine Vaqta, Zostavax for shingles and the measles, mumps, rubella and varicella vaccine ProQuad.
"We've invested over $1 billion … to increase capacity and [reduce] redundancy in [our] West Point, Pennsylvania, as well as in our Elton, Virginia, and in our French facility," said Clark during Merck's recent second-quarter results call.
A new plant is also being built in Carlow, he added, and will complement the investment in the Durham facility.
"A lot of positive things are going on from an investment standpoint," said Clark, adding that the efforts to restore full supply of Vaqta and Recombivax HB are "on target".
According to the American Society of Health-System Pharmacists, Merck has said that while paediatric Recombivax HB single-dose vials are available, adult formulations are unlikely to be shipped until 2010.
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