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Shingles and the Development of the Zostavax Vaccine

(4/2413)- I don't know what the odds are of getting shingles, but in addition to what I wrote on 9/4/12 below, now 2 other people I know personally have been diagnosed with shingles. Yes, all the shingles sufferers had the chicken pox when they were young, and eventually that dormant bacteria led to their coming down with the disease.

The illness is both very serious and painful. Even though the vaccine works only about 50% of the time, in my opinion it is worth taking in spite of the cost.

(9/4/12)- A little over two months ago, a good friend of mine who is 61 years of age was stricken with a very bad case of the shingles. Last month two other people who I am friendly with also became ill with the disease. Shingles is a very serious, painful condition that negatively impacts the quality of life as well as the physical well being of those who become ill with the disease.

It takes many months to get over the disease, and you can get the ailment again and again.

Before I was allowed to become a subject in the trial of the Zostavax vaccine I was shown videos and photos of people who had become afflicted by the illness. I could clearly see how ugly the rash was from the disease and now painful it was for those who came down with the illness.

My brother Harold got the shot recently and neither he, nor I had any adverse reactions when the vaccine was administered to either one of us.

There is no guarantee that the vaccine will be effective to those who are administered the shot, since it is estimated that it is good in only about 50% to 60% of the time.

I am not a medical professional and I have no financial interest in Merck, the manufacturer of the vaccine, but I do highly recommend that anyone who has had chickenpox, get the shot, even if you have to pay for it yourself.

(8/22/12)- Shingles is caused when the virus that led to the chickenpox becomes active again, usually in the later years of the individual who suffered the disease as a child.

A recent Centers for Disease Control and Prevention survey reported that the incidence of chickenpox in the United States fell 80% from 2000 to 2010. The report attributed the sharp decline to the widespread use of the chickenpox vaccine.

From 2000 to 2006, a period when a single dose of the vaccine was recommended for children 12 to18 months old and for older unvaccinated children, cases fell by 43%.

From 2006 on, a second dose was recommended, and that resulted in a drop of 72% in the second half of the decade.

Hopefully, this decrease in the incidence of chickenpox will mean a similar decrease in cases of shingles down the road.

(4/19/12)- As a follow-up to our item dated 7/18/11, Merck & Co., announced that it has filled all back orders for its shingles vaccine Zostavax, and it will begin running commercials aimed at raising shingles awareness, without mentioning its vaccine in particular. The ads will encourage individuals, particularly older ones, to ask their doctor about shingles.

Merck started selling Zostavax in 2006, but it ran into manufacturing problems because a key ingredient was less potent than required. The company than prioritized production of its chickenpox vaccine Varivax over Zostavax.

The company finally overcame its production problems in connection with the vaccine and is confident that it will have a sufficient supply to meet the demand for Zostavax.

Please keep in mind that there is no guarantee that the vaccine will work, but it does reduce the risk of incurring the disease.

This writer had no adverse side affects from having the vaccine administered to him.

A vaccine advisory committee to the U.S. Centers for Disease Control and Prevention declined, last year, to recommend routine vaccination with Zostavax for people 50 to 59, citing the production shortfall that the company was having in producing the vaccine. The CDC vaccine panel now recommends people 60 and over be administered the vaccine.

(7/18/11)- An article by Paula Span in the July 12th edition of the NY Times entitled "Drive to Stem Shingles Meets Few Expectations" explains why the usage of the shingles vaccine Zostavax is falling far short of expectations. The author of this article was a participant in the study that confirmed the effectiveness of the vaccine, as described below, and the article quotes Dr. Michael Oxman who was the leader of the study that confirmed the worthiness of the vaccine.

Merck & Co. the manufacturer of the vaccine has encountered production problems ever since it introduced the product to the market. Even though the company produced and shipped two million doses of the vaccine in the first 6 months of this year it still remains in short supply.

The company will spend over $1 billion to increase production and has built a new manufacturing plant in Durham, N.C, but that plant won't be fully licensed and functional until 2013.

Zostavax is the most expensive adult vaccine, sells for about $160 a dose, plus the cost for the office visit. Most insurers will not cover the cost for people under 60 who take the shot. The vaccine must be stored in a freezer, so many physicians are not willing to stock the vaccine.

Pharmacies can bill Medicare directly under Part D, whereas physicians are reimbursed under Part B, and therefore may require patients to pay for the vaccine themselves, and then file for reimbursement.

Although the vaccine is not 100% effective in preventing the disease, this writer based on my experience as a member of the trial group, highly recommends that you get the vaccine even if it does cost $160. It is effective in about 55% of all age groups in reducing shingles according to a study of 300,000 adults age 60 and older at Kaiser Permanente health centers in California.

(3/28/11)- The Food and Drug Administration approved the use of Zostavax for the prevention of shingles in individuals 50 to 59 years of age. The vaccine had previously been approved for individuals over 60 years of age.

It is estimated that about 200,000 healthy people between the ages of 50 to 59 years old are affected by the disease every year.

Approval was based on a multi-center study conducted in the United States and four other countries, using about 22,000 subjects who were in the 50-59-age category. Half received a placebo, and half received the Zostavax vaccine. Study participants were then monitored for at least one year to see if they developed shingles.

Compared with the placebo group, Zostavax reduced the risk of developing shingles by approximately 70%.

The most common side effects observed in the Zostavax group was redness, pain and swelling at the site of the injection and headaches. Since I was a subject in the original testing group for the vaccine, as I describe in this article below, I did not suffer any side-effects at all when I eventually got the vaccination.

The vaccine was originally approved for usage in individuals 60 years and older on May 26, 2006.

(3/5/11)- Researchers at the Olmsted Medical Center in Rochester, Minn., examined the medical records of almost 1,700 patients who had a documented case of shingles between 1996 and 2001, and the results of their study were published in a recent edition of the journal Mayo Clinic Procedure.

The study concluded that people could get shingles more than once in their lifetime. It is estimated that about one million American suffer from the disease on a yearly basis, and that one in three will get the disease at some point in their life.

More than half the cases arise in people over the age of 60, and that women are more likely to get the disease than men. The Varicella zoster virus, or VSZ, the same virus that causes chicken pox, causes it. Like other herpes viruses in never leaves the body of an infected individual.

The researchers found that more than 5% of the infected individuals were treated for a second bout with the disease, with the second episode occurring within 8 years of the first time the affliction appeared.

Nerve pain that lingers for more than a month is called postherpetic neuralgia, or PHN. It is treated with antiviral medications. Patients who had the disease last for more than 30 days were more likely to get a repeat case of it than those who suffered from it for shorter periods of time.

The fact is only about 10% of the 50 million people who should get the vaccine actually have. ... The vaccine is expensive -- $160 a shot, plus an administration fee. For those over 65, Medicare covers it under its new Plan D, but reimbursement can be complicated. Most private health insurers cover it for patients between 60 and 65, but not all of them do.

It is estimated that the vaccine is effective in only about 50% of the individuals who receive it.

(11/30/08)- Merck & Co. said that the supply problems for its shingles vaccine Zostavax are beginning to abate. Until recently there was a 10-week delay in shipping the vaccine to medical professionals.

The vaccine does not eliminate altogether your chances of getting the disease but it does reduce your risk of getting it by about 51% compared to those in the placebo group in the original study. Since the vaccine is relatively new, there is no proof as to how long it is effective It did reduce the incidence of post-herpetic neuralgia by 67%.

Among those who got the vaccine in the original trial group, the vaccine appeared to reduce the severity the disease according to results published in the New England Journal of Medicine.

The vaccine appeared to be more effective in the 60-69 age group than in the over 70 age group.

Since this writer was a member of that original trial group for the vaccine, I have not received any communication whatsoever from the medical professionals who injected me with the vaccine. I did not receive the vaccine in the trial, but did receive a free inoculation afterwards from the people who conducted the trial.

Yes as strictly a layman who received the vaccine, I would recommend that you take it also.

Some doctors do not keep the vaccine on hand because it is more complicated to store and administer than other vaccines. It has to be stored in a freezer, and must be injected within 30 minutes after it thaws.

(6/27/08)- When it was in plentiful supply there was no urgent demand for Merck & Co.'s shingles vaccine Zostavax. Now that the supply has been constricted by production problems at the company's plant that made so-called bulk varicella, a key ingredient of the vaccine, the demand for the vaccine has begun to increase by a substantial amount.

Merck began marketing the vaccine in 2006, and last year it had sales of $236 million. The problem arose last year when the company disclosed that it had made a batch of bulk varicella that was less potent than required. The company also uses bulk varicella for its Varivax chickenpox vaccine for children.

Demand for Varivax increased after a national vaccine program recommended children get a second dose of the chickenpox vaccine. Varivax had sales of $854.9 million in 2007. The problem led the company to stop filling orders for a combination vaccine called ProQuad.

Merck has resumed manufacturing bulk varicella, but the FDA has to give clearance before the ingredient can be used in the vaccine. Merck has given precedent to the chicken pox vaccine Varivax, which has much better sales numbers than does Zotavax.

Customers could face as much as six weeks delay in shipments of the shingles vaccine according to Amy Rose, a Merck spokeswoman.

(5/21/08)- Nearly 1 million Americans receive medical care for shingles or its complications each year, according to the latest News and Numbers from the Agency for Healthcare Research and Quality

U.S. health officials strongly recommend that people 60 and older should get a one-time shingles Zostavax shot for the prevention of the disease. Although there is only a 50-50 chance that it will prevent the disease, the odds against it working increase as you get older. The shot costs on average about $160, and the vaccine is made by Merck & Co.

This author of this article was a participant in the clinical trial of the vaccine, and although I only got a placebo in the double-blind trial, I did receive the vaccination after the end of the trial. I did not suffer any negative effects from the vaccination and I have been shingles free so far all my life.

Only 2% of the 43 million people at risk for shingles have been immunized since its approval in May 2006, according to data from the Centers for Disease Control and Prevention.

More than one million people develop the disease each year, and anyone who had chickenpox is susceptible to it, since the virus lays dormant in your system for the rest of your life.

Before I signed up to be a part of the trial I was shown vivid examples of what an "ugly" and painful disease shingles is, and how difficult it can be to treat once it develops.

(4/6/07)- The following is an email that we at therubins received from one of our viewers and the response from Harold Rubin to that email:

----- Original Message ----- From: stouf@usfamily.net To: hrubin12@nyc.rr.com Sent: Tuesday, April 03, 2007 11:38 PM
Subject: shingles vac(c)ine

"Nowhere in the article did you mention any side effects from having the vac(c)ination. This is important to the study and should be in the report."

We agree with you that it is important to provide information on adverse effects of any treatment received by individuals. This is especially important in the postapproval of a treatment regimen. We intend to put most of the information below into our article. Thank you for pointing out our omission.

The FDA in its news release of May 26, 2006 stated: "The most common side effects in people who received Zostavax were redness, pain and tenderness, swelling at the site of injection, itching and headache. The percent of significant adverse events observed in the study were not different between persons who received the vaccine versus placebo.

As part of the development program, a smaller study was conducted to look more closely at safety. In this smaller study, serious adverse events for all age groups were noted more frequently in those who received Zostavax (1.9%) than those who received placebo (1.3%). Although FDA has concluded that the available data do not establish that these events are related to the vaccine, the manufacturer will perform a Phase 4 (postmarket) study to provide additional safety information." For further information you can call 1-888-INFO-FDA

Zostavax is manufactured by Merck & Co., Inc., of Whitehouse Station, New Jersey. We would suggest that you also contact them for the kind of information you want about the vaccine.

Harold Rubin

(3/17/07)- We in the United States have been using the chickenpox vaccine Varivax since 1995. According to a recent study it has reduced the number of cases of the disease in children, but its protection does not last that long.

According to the study, unvaccinated children or those who get only one dose of the vaccine get the chickenpox later in life, when the risk of complications are greater.

Preliminary findings have prompted the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices to recommend a booster shot at age 4 to 6, and also for older children, adolescents and adults.

No one knows how long the effects of a second shot would last, said the research team, led by Dr. Sandra Chaves of the CDC. The study team used vaccination and illness data from Antelope Valley, Cal., northeast of Los Angeles, to track the effectiveness of Varivax, which is manufactured by Merck & Co.

The vaccination cut the number of cases by 85% between 1995 and 2004. In 1995, 1% of the 2,794 reported cases of chickenpox were among vaccinated children, In 2004, there were fewer cases-420- but 60% were in the vaccinated children.

Merck's Zostavax was approved for usage in May 2006 against shingles, since the chickenpox virus remains dormant in the nervous system of people who have gotten the disease. It will take many more years of data to determine exactly how effective Zostavax is in preventing shingles.

(10/27/06)- The Advisory Committee on Immunization Practices voted to recommend Merck & Co.'s Zostavax vaccine for shingles in people over the age of 60. This is the first time in almost 30 years that this governmental panel has added a vaccine to the lit of preventive shots recommended for older adults against debilitating or life-threatening illnesses.

The committee is composed of doctors and immunization experts and it convenes three times a year. Its recommendations help determine the medical practice and insurance coverage issues in connection with vaccinations. The panel's recommendations are sent on to the Centers for Disease Control and Prevention. It meets three times a year.

The FDA had approved Zostavax in May 2006 to prevent shingles, or herpes zoster, in patients over 60. There are about 1 million new cases of shingles reported annually in the U.S., of which about 250,000 turn into more severe postherpetic neuralgia, or chronic nerve pain according to a spokesperson for Merck.

Zostavax had about $11 million in sales in the 3rd quarter this year. A few health plans, such as Aetna Inc.does already cover the vaccine's cost for reimbursement to its members, while Cigna Corp. and Wellpoint (the largest health care plan in the U.S.) usually follow the recommendations of the panel.

(6/28/06)- As a follow-up to our item about Zostavax, the shingles vaccine, I will relate to you, our viewers my experience when I went to get my free version of the vaccine. I was one of the 18,000 subjects who received the placebo, and not the vaccine itself in the study. The study promised all of us who did not receive the vaccine, the choice of receiving it, if the study showed it worked.

I was very well treated by the staff who were to administer the vaccine to me. The nurse who administered the .65 mg version of the shot to me was very efficient and pleasant. I was clearly warned about any possible risks associated with what I was doing. I had to sign a consent form, that was very properly explained to me.

The consent form warned of any adverse experience that I might suffer from in the first 28-days after the shot was administered to me. The consent form did contain the following background item:

"The results of the Shingles Prevention Study show that the vaccine reduced the number of new cases of shingles by about half (51%) compared to the placebo. In addition, the vaccine reduced the total burden of illness due to the pain and discomfort caused by shingles by 61 percent and reduced the incidence of long-lasting chronic nerve pain cause by shingles, called postherpetic neuralgia, by about two-thirds (66%) compared to placebo."

(6/19/06)- We at therubins took a little extra pleasure from the announcement the other day that the FDA had approved the first vaccine intended to reduce the risk of shingles in people 60 and older. The vaccine, named Zostavax also reduced the severity of the attack in the patients who had been given the inoculation. The reason for our added pleasure in the development of such a vaccine was because of the fact that one of the co-editors was one of the 38,546 people who took part in the study that led to the approval of the drug.

The herpes zoster virus that causes both the chicken pox and shingles, is present in almost all of us. The vaccine arouses the body's immune system so that it is better able to fight the disease. Zostavax is roughly equivalent to 14 doses of the pediatric chickenpox vaccine. It is another example of the renewed effort that the drug companies are now making in the vaccine research area.

Last year the FDA approved Menactra, a vaccine to prevent meningococcal meningitis in teenagers.

The herpes zoster virus usually continues to live in the nerve cells near the spine after an attack of chickenpox. It can lay dormant for many, many years until it strikes again. Outbreaks of shingles can recur, and the length of each attack can vary. Nerve cells are damaged during the attack, and that is one of the reasons for the extreme severity of the pain.

There are an estimated one million new cases of shingles in the United States each year, and the risk of contacting the disease rises with the aging of the individual. It is estimated that one out of every two individuals over 85 is at risk for getting the disease. About half of all cases occur in people over 60, but the risk is also extremely high for younger people with immune problems, AIDS sufferers and people with cancer.

Merck expects to be shipping the vaccine "soon". Doctors must store the vaccine in a freezer, and many geriatricians do not have freezers in their offices. Merck will charge $152.50 for the vaccine, which is administered with a single shot. For those of us who received the placebo instead of the vaccine during the study, we will get the vaccination free of charge at the veterans administration facility where we took part in the study.

The following is an excerpt from the letter I received from the Department of Veterans Affairs, New York Harbor Healthcare System, dated June 14, 2006, signed by Margot Lachner, R.N., M.P.H.:

"As you may have heard, the use of the Varicella-zoster vaccine reduced the burden of illness due to Herpes Zoster (shingles), reduced the incidence of shingles, and reduced the incidence of post-herpetic neuralgia (the pain that lingers after the shingles disappears)…To receive the vaccine, you CANNOT have your flu vaccine less than 7 days before vaccination and for 28 days after receiving the vaccination."

To see more about the shingles please see our article on this subject "Shingles and the Development of the Zostavax Vaccine".

(6/19/06 and 5/29/06)- We at therubins took a little extra pleasure from the announcement the other day that the FDA had approved the first vaccine intended to reduce the risk of shingles in people 60 and older. The vaccine, named Zostavax also reduced the severity of the attack in the patients who had been given the inoculation. The reason for our added pleasure in the development of such a vaccine was because of the fact that one of the co-editors was one of the 38,546 people who took part in the study that led to the approval of the drug.

The herpes zoster virus that causes both the chicken pox and shingles, is present in almost all of us. The vaccine arouses the body's immune system so that it is better able to fight the disease. Zostavax is roughly equivalent to 14 doses of the pediatric chickenpox vaccine. It is another example of the renewed effort that the drug companies are now making in the vaccine research area.

Last year the FDA approved Menactra, a vaccine to prevent meningococcal meningitis in teenagers.

The herpes zoster virus usually continues to live in the nerve cells near the spine after an attack of chickenpox. It can lay dormant for many, many years until it strikes again. Outbreaks of shingles can recur, and the length of each attack can vary. Nerve cells are damaged during the attack, and that is one of the reasons for the extreme severity of the pain.

There are an estimated one million new cases of shingles in the United States each year, and the risk of contacting the disease rises with the aging of the individual. It is estimated that one out of every two individuals over 85 is at risk for getting the disease. About half of all cases occur in people over 60, but the risk is also extremely high for younger people with immune problems, AIDS sufferers and people with cancer.

Merck expects to be shipping the vaccine "soon". Doctors must store the vaccine in a freezer, and many geriatricians do not have freezers in their offices. Merck will charge $152.50 for the vaccine, which is administered with a single shot. For those of us who received the placebo instead of the vaccine during the study, we will get the vaccination free of charge at the veterans administration facility where we took part in the study.

The following is an excerpt from the letter I received from the Department of Veterans Affairs, New York Harbor Healthcare System, dated June 14, 2006, signed by Margot Lachner, R.N., M.P.H.:

"As you may have heard, the use of the Varicella-zoster vaccine reduced the burden of illness due to Herpes Zoster (shingles), reduced the incidence of shingles, and reduced the incidence of post-herpetic neuralgia (the pain that lingers after the shingles disappears)…To receive the vaccine, you CANNOT have your flu vaccine less than 7 days before vaccination and for 28 days after receiving the vaccination."

To read more about how the process evolved please see our articles below dated: 6/5/05; 3/14/05 and 6/25/04.

(6/5/05)- The June 2005 edition of the New England Journal of Medicine published the results of the trial of the shingles vaccine from Merck that we discussed in our item on 3/14/05. I was a participant in the trial for a little over 4 years, and after the trial was over I was informed that I had received a placebo, not the vaccine.

The study was done under the leadership of Dr. Michael N. Oxman a staff physician in infectious disease at the VA San Diego Healthcare System. It was determined that the vaccine reduced both the incidence and severity of shingles by more than half. Merck, the developer of the vaccine, has applied to the FDA to receive approval, which it hopes to receive by February 2006.

The same virus that causes chicken pox causes shingles. The virus (herpes varicelis-zoster) remains dormant so that people who have had chicken pox are more susceptible to getting shingles. Shingles affects anywhere from 300,000 to 900,000 people a year in this country, according to the CDC. The condition need not be reported to the CDC so that is why there is not a more exact figure on the number of people who do get the disease.

Of the 19,254 people in the vaccinated group (Zostavax), 315 got shingles and 27 of them continued to suffer from the rash more than 3 months later. Of the 19,247 in the placebo group (my group), 642 got shingles and 80 still had the rash 3 months later. A spokesman for Merck said that the company had not determined the price that it would charge for the vaccine once it had gained approval to sell it from the FDA.

(3/14/05)-One of the co-editors of this site was a voluntary participant in a recently completed 4-year Shingles Prevention Study that investigated the effectiveness of a varicella-zoster vaccine for the illness. According to Dr. Michael N. Oxman, the National Study Chairman, the "vaccine reduced the frequency and severity of shingles and postherpetic neuralgia (long lasting pain after the rash disappears) for many subjects." We discussed this study on 6/25/04.

Dr. Oxman's letter to the participants in the study went on to state that, "Based on these results, we understand that Merck intends to pursue approval of the investigational varicella-zoster vaccine from the Food and Drug Administration (FDA)." The letter goes on to state that the FDA approval process is going to take at least a year or more.

(6/25/04)- One of the co-editors of therubins is involved in a drug trial, which in his case involves a study being conducted at the Veterans Administration in New York in connection with a potential vaccine for shingles. In order to qualify for this study the subjects had to have had chicken pox, be over the age of 50 and never have had shingles. He had read about the search for subjects in an article that he read in the New York Times on shingles. The study has been concluded and the results should be announced shortly.

Before being allowed to enroll in the study he was interviewed and examined by the study team at the VA Hospital in Manhattan. He was shown a movie about shingles and also was given written material to read about the topic. A nurse thoroughly explained the risks associated with being involved as a subject in the test.

He was also told that he would not know whether or not he would be receiving a placebo or the vaccine involved in the study. He was than given some time to think it over before deciding whether or not he would want to be a subject in the test. After deciding that he wanted to be involved in the test he was given an injection with either a placebo or the potential vaccine for shingles.

The study lasted for a four-year period of time. He must call in once a month to answer some questions, which would indicate whether or not he has come down with shingles. The telephone interview lasts for about 30 seconds. 

FOR AN INFORMATIVE AND PERSONAL ARTICLE ON PRACTICAL SUGGESTIONS WHEN SELECTING A NURSING HOME SEE OUR ARTICLE "Selecting a Nursing Home"

by Allan Rubin and Harold Rubin, MS, ABD, CRC, Guest Lecturer
updated April 24, 2013

To e-mail: hrubin12@nyc.rr.com or allanrubin4@gmail.com

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