[NVIC] Shingles Vaccine Targets Baby Boomers

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BL Fisher Note:

In a vaccine approval frenzy putting big smiles on the faces of drug

company execs, the FDA approved Zostavax, a shingles vaccine made by Merck.

Coming on the heels of licensing a controversial HPV vaccine for genital

warts and cervical cancer that will target 11 year olds, the FDA approved a

shingles vaccine that works half the time in people over 60. Merck really

wants to market the vaccine to people 50 and older but the FDA temporarily

said " No " to that idea because studies hadn't been done.

Zostavax is actually a booster dose of Merck's varicella zoster (chicken

pox) vaccine. It is the equivalent of 14 doses of Merck's pediatric chicken

pox vaccine. The safety of injecting a " souped up " version of the pediatric

chicken pox vaccine into the often immune compromised elderly is yet another

national experiment on one of the two most vulnerable segments of our

society: the frail elderly. The elderly, along with children, often bear the

brunt of medical science's obsession with eradicating microrganisms and the

exploitation by drug companies in search of profits.

Mass use of chicken pox vaccine in American children since 1995 has

caused a shingles epidemic in older Americans. Before mass chicken pox

vaccine use, Americans who had recovered from chicken pox as children would

have their immunity " boosted " naturally and asymptomatically by coming into

contact with young children infected with chicken pox. Now, with no chicken

pox around to do the boosting for older Americans, they get shingles

instead. Chicken pox rarely causes severe complications or death in healthy

children with 50 chickenpox related deaths in children occurring annually

before mass use of chicken pox vaccine..

Some researchers (Goldman, G., International Journal of Toxicology, 2005)

estimate it will take more than 50 years of mass use of chicken pox vaccine

before the shingles epidemic will begin to subside and will affect 14.6

million Americans at a cost of $4.1 billion or about $80 million in annual

health care costs. Shingles cases result in 3 times as many deaths and 5

times as many hospitalizations in adults as chicken pox cases do in

children.

Bottom line: Drug companies double their profit potential when they

create vaccines and drugs which create diseases and disorders that require

creation and purchase of new vaccines and drugs. It gives special meaning to

the phrase " a vicious circle. "

http://www.webmd.com/content/Article/122/114846.htm

WebMD Medical News

FDA Approves First Shingles Vaccine

But Some Experts Express Concerns Over Cost of Vaccine Called Zostavax

By Todd Zwillich

Reviewed By Ann Edmundson, MD

May 25, 2006 – The FDA has approved the first vaccine for adult

shinglesshingles.

The agency cleared the vaccine -- known as Zostavax -- for use in adults age

60 and older: studies showed it can prevent shingles roughly half the time.

But experts say they're worried that partial insurance coverage of the

vaccine may slow its acceptance by doctors and patients.

Shingles causes a rash with blisters that usually lasts for two to four

weeks. The pain associated with the blisters can be quite intense. Once this

initial phase is over, nerve pain called postherpetic neuralgia can set in.

This pain lasts anywhere from 30 days to months or even years. It can be so

severe in some people that it disrupts their lives.

The illness is caused by varicella, the same virus that causes

chickenpoxchickenpox. Shingles occurs when the chickenpox virus lying

dormant in nerve cells " wakes up " in older people or others with health

problems. The vaccine, Zostavax, is actually a boosted dose of the

chickenpox vaccine currently given to children.

Postherpetic neuralgia is more common in people older than 60. It occurs in

less than 10% of people younger than 60 after a bout of shingles but in more

than 40% of people older than 60.

Large Market for Vaccine

There are approximately 50 million Americans over age 60: more than 95% had

chickenpox as children, making them vulnerable to shingles.

" The market is large, " says Fanelle, a spokeswoman for Merck &

Co., the vaccine's manufacturer.

The company originally sought approval to sell the vaccine to adults 50 and

older. But the FDA declined after expert advisors said in December 2005 that

Zostavax hadn't been studied in patients younger than 60. The agency also

rejected a bid to approve the vaccine for preventing postherpetic neuralgia.

Up to one in ten older patients won't be candidates for the vaccine because

of weakened immune systems due to cancercancer therapy, organ transplants,

HIV/AIDSHIV/AIDS, or other causes. The vaccine contains live but weakened

varicella virus that could overwhelm the immune systems of those patients.

Markovitz, MD, a professor of internal medicine at the University of

Michigan who reviewed Zostavax for the FDA, calls it a " highly useful "

vaccine. " It's clear the vaccine markedly reduces the incidence " of

shingles, he says.

Markovitz says that doctors may be tempted to offer " off-label " vaccinations

to adults age 50 to 59 in hopes of providing earlier protection against

shingles. " Off-label " refers to drugs that are used in ways that have not

been not approved by the FDA. But he stressed that the vaccine remains

unstudied in such patients and that researchers still don't know how long

immunity lasts after vaccination.

" I don't think I would rush out and get it myself, " Markovitz, who is 52,

tells WebMD.

Insurance Coverage Worries

Other experts worried about the vaccine's cost. Zostavax is slated for

coverage under MedicareMedicare's Part D prescription program. But under the

program, individual private insurance plans set prices, meaning that

coverage for the vaccine could vary substantially among hundreds of plans

nationwide.

Medicare and private insurers often base coverage decisions on counsel from

the Advisory Committee on Immunization Practices (ACIP) at the CDC.

The committee is expected to make recommendations next fall advising the

government, insurers, and doctors, on how many older Americans should

receive the shinglesshingles vaccine.

Insurance coverage inside and outside of Medicare could have a large impact

on how many adults seek the vaccine. " We certainly think that's very

important, " Fanelle says.

Schaffner, MD, chair of the department of preventative medicine at

Vanderbilt University and an ACIP member, says that partial insurance

coverage could impede lower-income people from purchasing the vaccine and

limit its spread among patients who could benefit.

" Many of us are distressed about that possibility, " notes Schaffner, who

says he received financial payment from Merck to discuss Zostavax with

reporters.

Follow-Up Study

The company followed patients in its study for four years. Officials told

the FDA that they plan to follow patients for 10 years to determine how long

patients retain immunity before requiring boosters. The company is also

planning to study the vaccine in immunocompromised patients, officials said

in December.

Markovitz says the company's original study focused on whites and that the

company should also expand testing in minorities, who can have varying

immune responses.

" Realistically, we can say this works in white people, and it's just too bad

this continues to happen in every darn study, " he said.

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SOURCES: Markovitz, MD, professor of medicine, University of Michigan.

Fanelle, spokeswoman, Merck & Co. Schaffner, MD, chair,

department of preventative medicine, Vanderbilt University.

" The science behind the vaccine is relatively simple. Zostavax is roughly

equivalent to 14 doses of the pediatric chickenpox vaccine. "

http://www.nytimes.com/2006/05/27/health/27shingles.html?ex=1306382400 & en=8f

544eb6be547329 & ei=5088 & partner=rssnyt & emc=rss

The New York Times

Printer Friendly Format Sponsored By

May 27, 2006

Vaccine to Cut Risk of Shingles in Older People Is Approved

By GARDINER HARRIS

WASHINGTON, May 26 — Federal drug regulators have approved the first vaccine

intended to reduce the risk of shingles in people 60 and older.

The vaccine, called Zostavax, is a souped-up version of the chickenpox

vaccine. Both chickenpox and shingles are caused by the herpes zoster virus,

which is present in almost everyone. The approval was announced on Friday.

Zostavax, made by Merck, works by mimicking a shingles attack, but without

the pain or blisters that shingles causes. The vaccine strengthens the

body's immune response against the virus, reducing the chances of an

outbreak, as well as the severity of the disease if it does occur.

The science behind the vaccine is relatively simple. Zostavax is roughly

equivalent to 14 doses of the pediatric chickenpox vaccine.

Nonetheless, Zostavax represents a significant breakthrough, several

scientists said. It is the first therapeutic vaccine, meaning it prevents or

eases the severity of the problems from an infection that has already

occurred.

Scientists have been hoping to create such vaccines against cancer and AIDS,

but without much success.

" It's a breakthrough in that it's the first vaccine that is actually

designed to keep an infection in check, " said Dr. Walter Orenstein,

associate director of the Emory Vaccine Center at Emory University, who has

consulted for Merck.

Zostavax is also the first vaccine in 30 years that is intended exclusively

for older people, and it comes in the midst of a minor surge in nonpediatric

vaccines.

Last year, the Food and Drug Administration approved Menactra, a vaccine to

prevent meningococcal meningitis. Menactra is generally given to teenagers.

And Merck is expected to gain approval next month for a cervical cancer

vaccine that is likely to become popular among teenagers and young adults.

The herpes zoster virus normally lives neutered and imprisoned in nerve

cells buried near the spine. During a shingles outbreak, the body's prison

guards — crucial parts of the immune system called lymphocytes — become

weakened and allow the virus to escape. The result is a painful itch that

usually starts at the spine and travels across the midsection on one side of

the body. This pain is often followed by a belt of blisters.

Outbreaks can recur, and the virus can significantly damage nerve cells and

lead to pain that can endure for months or years. Zostavax primes again the

body's defenses against the virus.

There are an estimated one million new cases of shingles in the United

States each year, and the risk of contracting the disease ranges from 10

percent to 30 percent over a lifetime. For those over 85, the risk hovers

around 50 percent. The incidence of the disease has gradually increased for

decades, perhaps because of longer lives.

About half of all cases occur in those over 60, but younger people with

immune problems, AIDS or cancer also have a higher risk.

To prove Zostavax effective, Merck sponsored a trial in 38,546 people over

60 who had never had shingles. Half got the vaccine, and half received a

placebo. After three years, those who did not receive Zostavax suffered

twice as many shingles cases as those who did.

Perhaps just as important, those who received the vaccine and then developed

shingles generally experienced less pain than those who received placebos.

" The best way to treat chronic pain is to prevent it, " said Dr. Anne Louise

Oaklander, an associate professor of neurology at Harvard Medical School,

who described the vaccine as a landmark. " Shingles is the most common

neurological disease in the country. "

Merck will charge $152.50 for the vaccine, which is administered with a

single injection. Doctors will probably charge more.

Merck expects to begin shipping the vaccine " soon, " the company said in a

news release. But its adoption may be slow, because doctors must store the

vaccine in freezers, and many geriatricians do not have freezers in their

offices.

Arnold, a senior research analyst at Credit Suisse, an investment

bank, estimated that Zostavax would generate $1 billion in sales for Merck

by 2010.

" But I could be biased, " said Ms. Arnold, who suffered a painful case of

shingles that began in September 2004 and has only recently subsided. The

pain was so intense that she underwent a spinal injection of steroids and

ended up taking a collection of other drugs orally.

" It was my constant foe for almost two years, " she said. " I can imagine

being over 60, and being in less-good health, and being really miserable. "

Since Zostavax uses the same medicine as the pediatric chickenpox vaccine,

it is expected to be extremely safe, Dr. Oaklander said. In tests, the

vaccine caused some tenderness at the injection site and a slight increase

in headaches. It is not expected to be of use in treating a shingles attack.

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