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US FDA approves Merck vaccine to prevent shingles

May 26, 2006

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withdrawn arthritis drug Vioxx.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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