US FDA approves Merck vaccine to prevent shingles

[Guest guest]

Well I guess it will be interesting to see whom still trusts

Merck; especially when it comes to being honest & forthcoming about side-effects

like those that effect the heart. However, I believe it does barely meantion

a 'small study', near the end, which showed a slightly higher risk of heart

problems. Doesn't sound like anything to be concerned about though - or is that

what we are supposed to think? Maybe we are supposed to think that it would

never happen to us?

And anyways; aren't vaccines soo very safe & effective

historically?

blessings

Shan

US FDA approves Merck vaccine to prevent shingles

http://today.reuters.com/business/newsArticle.aspx?type=ousiv &

storyID=2006-05-26T180820Z_01_WEN8445_RTRIDST_0_BUSINESSPRO-MERCK-DC.XML

Fri May 26, 2006 2:08 PM

By Toni e and Heavey

BOSTON/WASHINGTON (Reuters) - U.S. health officials on Friday approved the fir

st 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. (MRK.N: Quote, Profile,

Research) 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. 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trying to recover from the fallout of its withdrawn arthritis drug Vioxx.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 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 , 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.

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