Panel Endorses Merck's Zostavax

A federal advisory committee said it supports an experimental Merck (MRK) vaccine to prevent shingles, but the panel restricted its recommendation to people age 60 and older.

Merck had been seeking an endorsement of its Zostavax vaccine for people 50 and above. However, the panel of outside experts, which advises the Food and Drug Administration, said Thursday that Merck didn't provide the necessary clinical data for the younger group.

The FDA usually follows the recommendations of its advisory panels, though it isn't required to do so.

Zostavax would be the first vaccine against shingles, also known as herpes zoster. The condition is a viral infection of nerve roots that can lead to burning and tingling sensations, as well as a rash or skin blisters. Shingles is most common in people over 50, and anyone who has had chicken pox is vulnerable. Shingles is caused by the reactivation of a latent virus that also causes chicken pox.

Zostavax is one of three Merck vaccines under FDA review. Merck recently submitted an application for Gardasil to prevent the human papillomavirus, or HPV, which can cause cervical cancer and genital warts. If approved, Gardasil would be the first HPV vaccine.

On Wednesday, the FDA advisory panel backed Merck's experimental, oral vaccine for preventing a virus-caused intestinal disease in infants and young children. The vaccine, Rotateq, guards against rotavirus, which causes gastroenteritis. Rotateq would be the first rotavirus vaccine in the U.S. if it's ultimately cleared.

Although the disease is more common in developing nations, it still can be fatal in the U.S. Merck has estimated that rotavirus can kill 20 to 40 people a year and lead to 50,000 hospitalizations. Worldwide, the company says, rotavirus annually kills 500,000 children under the age of 5.

In a related matter, GlaxoSmithKline (GSK) said Thursday that its rotavirus vaccine received a positive opinion from a scientific panel that evaluates drugs for the European Union. That means the EU's counterpart to the FDA could approve the vaccine, Rotarix, by as early as February.

GlaxoSmithKline, which has licensed the drug in 24 other countries, sought EU approval 12 months ago. The company has filed applications in 75 countries. Rotarix isn't available in the U.S., although the company says "discussions are ongoing with the FDA."

GlaxoSmithKline licensed Rotarix from Avant Immunotherapeutics (AVAN) of Needham, Mass. Avant's stock gained 38 cents, or 21.7%, to $2.13 on trading that was more than 14 times the average daily volume for the last three months. GlaxoSmithKline's stock dropped 84 cents, or 1.6%, to $50.65.

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