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Merck Shingles Vaccine Approved

Althea Chang

Merck (MRK Quote) received Food and Drug Administration approval for a vaccine to prevent shingles in people age 60 and older.

The company's application for Zostavax was based on studies of more than 40,000 people, in which more than 21,000 received the vaccine. Those patients receiving the vaccine saw a 51% reduction in the risk of developing the skin infection, also known as herpes zoster, when compared with a placebo.

"Zostavax is the first, and only, medical option approved for the prevention of shingles," said Dr. William Schaffner, professor of preventive medicine at Vanderbilt University School of Medicine in Nashville. "Approval of a vaccine against shingles represents a major public health advance for people 60 and older."

The company was supposed to hear an FDA decision on Zostavax in late February, but the agency said it needed 90 more days to review the drug. In December 2005, an FDA advisory committee had recommended the vaccine for people 60 and above. Merck had been hoping to have the drug approved for people over 50, but the advisory committee said the company didn't provide enough trial data on patients between the ages of 50 and 59.

Anyone who has been infected with chickenpox, which includes more than 90% of adults in the U.S., is at risk for developing shingles, according to Merck. That's because shingles is caused by the reactivation of a latent virus that causes chickenpox. The condition is a viral infection of nerve roots that can cause burning and tingling sensations, a rash or skin blisters.

Shares of Merck were up 22 cents to $34.61 Friday.

Zostavax is one of a series of vaccines Merck is betting on to help it deal with the sales that have been erased since it pulled the painkiller Vioxx off the market in September 2004 and the revenue that it stands to see vanish when the cholesterol fighter Zocor loses U.S. patent protection next month.

Earlier this year, the FDA approved its Rotateq, a vaccine designed to prevent rotavirus gastroenteritis, a leading cause of severe diarrhea in infants and young children that can be fatal.

Last week, FDA advisers unanimously said the agency should clear another Merck vaccine, called Gardasil, that's meant to stop a virus that causes cervical cancer. The FDA isn't required to follow its advisers' recommendations, but it usually does.

The agency is scheduled to act on Merck's application by June 8, and if Gardasil is approved, it would be the first vaccine against human papillomavirus, or HPV.