Skip to main content

Merck

(MRK) - Get Merck & Co., Inc. (MRK) Report

has picked up a valuable endorsement for its Zostavax shingles vaccine from a federal medical advisory group.

Although the vaccine was approved by the Food and Drug Administration in May, Zostavax will gain more clout among doctors and insurers thanks to Wednesday's endorsement by the Advisory Committee on Immunization Practices. The committee, which consists of experts in immunization and other fields, advises the federal Centers for Disease Control and Prevention.

The committee's vote was unanimous for the vaccine aimed at adults age 60 and older. Shingles is a condition characterized by painful itching, burning and tingling and a blistering rash. Zostavax is the only shingles vaccine.

"While a number of health plans are already offering insurance coverage of Zostavax, the panel's recommendation is likely to further increase coverage of the vaccine," said Dr. Mark Feinberg, a vice president for Merck's vaccine division.

TheStreet Recommends

Merck said the committee's recommendations "do not result in requirements for vaccine coverage by insurers; however, private insurers typically follow the committee's guidance."

The committee meets periodically to discuss vaccines and public health issues. Its recent

support of Merck's Gardasil, a vaccine against the virus that can cause cervical cancer, was seen by analysts and the company as an important development for sales.

As with all committee recommendations, the Zostavax comments will be reviewed by the CDC and the Department of Health and Human Services, which has the final say. The guidelines become official when they are published in a weekly CDC publication.

Merck said a major clinical trial, involving more than 38,000 people, showed that that patients receiving the vaccine had a 51%-reduced risk of shingles vs. people who received a placebo. However, Merck said it doesn't know how long protection against shingles will last from a single shot of Zostavax. In a major clinical trial, "protection ... was demonstrated through four years of follow-up," the company said. "The need for revaccination has not been defined."

Merck said that 40% to 50% of the 1 million annual U.S. shingles cases occur in people who are at least 60. The company had asked the FDA to approve Zostavax for people 50 and older, but the agency said Merck didn't provide enough data. People who have had chicken pox are at risk for shingles, which can strike at any time.

Zostavax also has been approved by regulators in the European Union and in Australia, and Merck is seeking approval in other countries. The company plans to start selling the vaccine in foreign markets next year.