FDA licenses Merck's shingles vaccine in US

The US Food and Drug Administration (FDA) has licensed Zostavax, Merck's new vaccine to reduce the risk of shingles (herpes zoster) for use in people 60 years of age and older.

Shingles is caused by the varicella-zoster virus, the same virus that causes chickenpox and is estimated to affect two in every 10 people in their lifetime. It can cause severe pain that may last for weeks, months or years after the virus reappears.

Zostavax, a live virus vaccine, has been shown to boost immunity against varicella-zoster virus. The vaccine is given as a single injection under the skin, preferably in the upper arm.

In a study involving approximately 38,000 individuals throughout the US, who were 60 years of age and older, Zostavax was shown to reduced the occurrence of shingles by about 50%, in those aged 60 and above. For individuals aged 60-69, it reduced occurrence by 64%. In addition, the duration of pain following the onset of shingles was slightly reduced.

"Zostavax is the first and only medical option approved for the prevention of shingles," said William Schaffner, professor of preventive medicine, Vanderbilt University School of Medicine, Nashville.

Mark Feinberg, vice-president of policy, public health and medical affairs, Merck Vaccines, said the company would make Zostavax and all its other adult vaccines available free of charge through a new patient assistance programme for low-income individuals. They will become available through this programme in the third quarter of 2006.

Zostavax was approved in the European Union and in Australia earlier this month, and Merck has filed regulatory applications in other world markets. It will begin to commercialise Zostavax outside the US in 2007.

The FDA and other regulatory agencies around the world are now reviewing applications for GARDASIL (quadrivalent human papillomavirus types 6, 11, 16, 18, recombinant vaccine), Merck's investigational HPV and cervical cancer vaccine.