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US FDA approves Merck vaccine to prevent shingles

Posted on: Friday, 26 May 2006, 13:08 CDT

By Toni Clarke and Susan Heavey

BOSTON/WASHINGTON (Reuters) - U.S. health officials on Friday approved the first vaccine to prevent shingles, a painful disease characterized by a blistering rash that affects nearly 1 million, mostly older adults every year.

The vaccine, Zostavax, which is made by Merck & Co. and aims to boost the immune system, was approved for adults age 60 and older.

Shingles is caused by a reactivation of the virus that causes chickenpox. Treatments generally only relieve pain and shorten the duration of the disease, which can cause nerve pain that can last for weeks or even months and years.

The varicella-zoster virus can lie dormant after childhood and strike again when the immune system weakens with age or illness.

"Essentially this is a booster vaccine," said Dr. Jesse Goodman, head of the Food and Drug Administration's Center for Biologics Evaluation and Research. "It boosts an older person's immunity against the virus in order to prevent the virus from reemerging and causing shingles."

The vaccine is injected in a single dose. Merck said it will be available within weeks and priced at $145.35.

Everyone who has been infected with chickenpox -- about 90 percent of U.S. adults -- can develop shingles but not all do.

Of the roughly 1 million U.S. shingles cases each year, 40 percent to 50 percent affect those 60 and older.

Approval of the vaccine is the latest positive news for Merck, which is trying to recover from the fallout of its withdrawn arthritis drug Vioxx.

It follows a recommendation last week by an FDA advisory for approval of a Merck vaccine to prevent the human papilloma virus that can cause cervical cancer.

"This is going to be one of our important products," said Christine Fanelle, a Merck spokeswoman, of Zostavax. "We have a lot of plans to make it a big success."

Most of the roughly 50 million Americans over the age of 60 would be eligible for the shingles vaccine, the company said.

Industry analysts said the approval was a solid addition to Merck's vaccine line. Deutsche Bank analyst Barbara Ryan, in a research note on Friday, estimated worldwide revenue of $650 million in 2009. Cowen and Co. analysts earlier estimated $900 million in global sales by 2010.

It is still unclear whether the U.S. Medicare insurance program for the elderly and other insurers will cover the vaccine.

The U.S. Advisory Committee on Immunization Practices may make a federal recommendation later this year on who should receive the vaccine, Merck and the FDA said.

The drugmaker sought approval for adults as young as 50 but had no data for those under 60. The FDA said it could not approve such use without more information.

"We'll be working with the FDA to talk about an indication beginning at age 50 and what it is specifically the FDA would like to see," said Dr. Jeffrey Silber, Merck's senior director of clinical research.

Symptoms of shingles begin with pain or tingling, followed by a blistering rash.

FDA's Goodman said the future need for Zostavax was unclear as more children get vaccinated for chickenpox. "I think time will tell what the long term goal of this vaccine is," he said.

People who have shingles or who had it in the past should not be vaccinated, as well as HIV patients and others with poor immune systems, he added.

Some experts are also concerned the vaccine will delay shingles rather than prevent it. So far, it has been shown to last for four years.

Merck studied the vaccine in nearly 40,000 people. About half received the vaccine with 315 developing the painful rash, compared to 642 cases in the placebo group.

A smaller study showed a slightly higher risk of heart-related problems following treatment, the FDA said. Other side effects included itching, headache and injection pain. The company will also have to conduct a long-term follow-up study.

Merck's shares were up 40 cents, or 1.2 percent, at $34.79 in afternoon trade on the New York Stock Exchange.

Source: REUTERS

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