Vaccinations and the Elderly

Looking for regular updates as to where influenza is circulating? Check www.cdc.gov/flu/weekly

(5/1/08)- The current flu season has already been the most severe one in the last three years. Deaths related to the flu and pneumonia were listed as underlying or contributing causes of death in 9.1 percent of the deaths. Any rate over 6.9 percent is considered unusually high.

The deaths include 65 children under the age of 18. In each of the three previous flu seasons, 46 to 74 children died.

The vaccine for the next flu season has already been formulated, and it will contain three completely different strains from the ones used this year. The virus arises in East and Southeast Asia, and reach Europe and America six to nine months later. It then moves on to South America where it dies out.

The CDC estimates that 5 percent to 20 percent of the U.S. population gets the flu, and that more than 200,000 people are hospitalized each year because of the disease and its complications. It also estimates that about 36,000 people die each year because of the disease.

(4/11/08)- GlaxoSmithKline PLC added psychiatric problems to the label of its flu drug Relenza. For additional details on this matter please see our item dated 12/7/07 below.

The new language lists seizures, hallucinations and delirium as among the problems seen in patients taking the drug. Most problems occurred in Japanese children who were taking it. Japan is the largest market in the world for flu medications.

Roche Holding AG made a similar change to the label for its drug Tamiflu last month. Tamiflu last year had sales of $2.4 billion and Relenza's 2007 sales were $520 million.

Although influenza A (H1) viruses predominated through mid-January, an increasing proportion of subtyped influenza A viruses are influenza A (H3) viruses. Influenza A (H3) viruses have been reported more frequently than influenza A (H1) viruses since week 4 (January 20-26), and during week 6 (February 3-9), influenza A (H3) became the predominant virus for the season overall. This season influenza A (H3) viruses have been reported more frequently than A (H1) viruses nationally, as well as in seven of the nine surveillance regions (East North Central, East South Central, Mid-Atlantic, New England, South Atlantic, West North Central, and West South Central). Influenza A (H1) viruses have predominated circulation this season in the remaining two regions (Mountain and Pacific).

The vaccination is usually 70-90% effective in preventing influenza in healthy adults and children. Individuals who have had an anaphylactic reaction to eggs should not take the vaccine.

There are two types of vaccine: line attenuated influenza vaccine (LAIV) and trivalent inactivated vaccine (TIV). The Immunization Action Coalition (www.immunize.org) recommends that you should "not give live attenuated vaccine (LAIV) to persons who are younger than age 5 years, are age 50 years or older, are pregnant, have a history of Guillian-Barre syndrome, or have a chronic disease that constitutes an increased risk when exposed to influenza. Trivalent inactivated influenza vaccine (TIV) is preferred for persons who have close contact with severely immunosurpressed persons during periods when immunocompressed person requires a protective environment." 

(2/19/08)- Because of the fact that the influenza vaccine has to be prepared far in advance of the flu season, scientists must use their best "guesstimate" as to which strain of the disease will hit in the coming flu season. Unfortunately the flu bacteria strain in this year's vaccine did not hit the "spot". That is why we are having a much more serious spread of the disease than normal.

(2/10/08)- For the week ending January 26^th, which is the 18^th week of the flu season, the figures show it to be the third consecutive week of acceleration, even though it was slightly below last year's level.

The proportion of outpatient visits for influenza-like-symptoms (ILI) was above national baseline levels and the proportion of outpatient visits for acute respiratory illness (ARI) was below national baseline levels.

This is the second consecutive week that both the number of states reporting widespread outbreaks and regional activity exceeded last year.

(2/5/08)- Norwegian epidemiologists have called attention to the fact that a mutant flu virus was present in 12 of the 16 (75%) viruses isolated in that country from patients in the early part of the influenza season. The mutation makes it resistant to the anti-influenza drug Tamiflu according to World Health Organization officials.

The predominant flu virus circulating this winter is A/H1N1, but the Tamiflu-resistant form of the virus, known as influenza A(H1Hi H274Y), has been found with varying frequency in Britain, Denmark, France, Norway, Canada and the U.S.

There are no immediate plans to recommend changes in the use of Tamiflu, which is also known as oseltamivir, because the incidence of the mutant virus is still very small.

For the week ending January 19, 2008, which is the so-called 17^th week of the flu season, flu activity was greater than what it was for the same period last year. This is the second week in a row that this has occurred. The proportion of outpatient visits for influenza-like illness (ILI) visits and acute-respiratory illness (ARI) were both above the national baseline.

(12/7/07)- The advisory panel that we refer to in our item dated 11/26/07 went along with the FDA staff members recommendations to add precautionary language to the labels of the flu drugs Tamiflu form Roche Holdings AG, and Relenza, made by GlaxoSmithKline PLC, to reflect reports of abnormal behavior and hallucinations seen among a small group of patients.

The issue now goes to the FDA for formal action. The panel voted 9-5 in favor of additional language on the Tamiflu label, while voting 11-1 in favor of the addition for Relenza. Tamiflu's label previously had noted the observance of abnormal behavior, while the Relenza label did not have such a notation.

Over 48 million patients have used Tamiflu since it entered the market in 1999. Nearly 600 cases of psychiatric behavior by Tamiflu patients have been reported with 75% of them in Japan. Five children in Japan died after "falling from windows or balconies or running into traffic" according to the FDA

(11/25/07)- Staff members of the FDA have recommended to the advisory panel that will be meeting on Tuesday November 27 that a warning should be added to the label for Tamiflu, made by Roche Holding, and Relenza, made by GlaxoSmithKline that they may cause psychiatric side effects. This recommendation has been posted on the agency's Web site.

Five Japanese children who took Tamiflu and became delirious died, and there were reports of abnormal behavior among some children who had been given Relenza. Regulators are not sure if the drugs, the flu virus or a combination of both caused the deaths and abnormal behavior, the FDA staff members said in a memo written November 9.

Tamiflu's prescribing information was updated last year to tell doctors they should monitor patients for signs of abnormal behavior.

(10/27/07)- A federal advisory panel recommended that MedImmune's FluMist nasal influenza vaccine be approved for usage in healthy children as young as two years of age. FluMist had previously been approved for use in children ages five and older, and in adults up to 49 years of age. It is the only flu vaccine on the market that is not an injected shot.

MedImmune is a recently acquired subsidiary of the English pharmaceutical company AstraZeneca PLC. The panel's approval is given to the Secretary of Health and Human Services for final approval.

The panel voted to add FluMist to a federal program that pays for vaccines for uninsured or low-income children up to age 19. Once approved by the HHS, private insurance companies are more likely to cover the vaccination cost.

FluMist is not recommended for children who have a history of wheezing or asthma.

(9/22/07)- Going into the flu vaccination season, because of the large quantity of the vaccine that is available, the Centers for Disease Control and Prevention (CDC) announced that everyone who wants one, will have the shot available. For the last several years the government was urging high risk individuals and children to get first shot at the vaccine.

The CDC also announced that it was safe for younger children over two years of age to the nasal-spray vaccine FluMist.

(8/18/07)- Novartis AG, the Swiss drug company, announced that it has begun shipments to the U.S. of its Fluvirin influenza vaccine, with the aim of making and shipping 20 million doses of the vaccine by September. The company also announced that it hoped to ship a total of 40 million doses of the vaccine to the U.S. in time for the 2007-2008 flu season.

Novartis acquired Chiron Corp as the stepping stone for its entry into the flu vaccine business. The company said that it had developed new and faster manufacturing techniques that have allowed the company to introduce the vaccine earlier than usual. For last year's flu season the company manufactured 30 million doses of the vaccine to be distributed in this country.

Each year a new strain of the flu virus drug is arrived at by experts in the field who try to anticipate which strain of the disease will strike the world's population.

(6/4/07)- The FDA has issued a warning letter to MedImmune Inc. of Gaithersburg Md concerning safety issues at its British manufacturing plant for the company's FluMist vaccine. The warning letter means that there will be a delay in gaining approval by the company of the vaccine for use in children younger than 5 years of age.

MedImmune is in the process of being acquired by the British drug company AstaZeneca PLC. The company is also hoping to gain approval to use the oral vaccine in children as young as 6 months of age who have no asthma or history or wheezing.

FluMist is a nonshot vaccine that is administered through the nose. The FDA posted the warning letter on its site, on which it asserted that bioburden, or bacteria found in material used to make FluMist exceeded specified limits. MedImmune said that it is working with the FDA to resolve the problem so that its flu production for the 2007-2008 season will not be affected.

AstraZeneca said that the delay will not affect its proposed merger with MedImmune.

(5/24/07)- In a unanimous vote ,an FDA advisory panel agreed that Medimmune's nasal spray vaccine FluMist is effective for children in the one year to five-year-old category without a history of wheezing. Most panelists also said that the vaccine worked for children as young as 6 months old.

The FDA has already approved FluMist for healthy people from 5 to 49 years old. Final FDA approval for FluMist is expected to occur shortly.

(5/3/07)- Roche Holding Inc announced that it would cut production of its flu drug Tamiflu because of decreases demand, and also because sufficient amounts of the vaccine are now available in stockpiles throughout the world. The vaccine has been stockpiled because many health experts feel that it is the first line of defenses against avian flu as well as regular flu.

Roche said that it had orders for 215 million doses of the vaccine while its production facilities can make up to 400 million doses of Tamiflu a year.

A similar type statement was issued by GlazoSmithKline PLC, the manufacturer of Relenza which cut production of the vaccine because an oversupply of the flu fighting drug is now available.

It won't be long before you will be reading of millions of batches of the vaccine having to be destroyed because they are not effective in fighting the new versions of the vaccine that must be produced each year.

For more on Tamiflu and Relenza see our items dated 11/24/06, 6/7/06 and 3/11/06.

(4/26/07)- AstraZeneca, the London based drug company announced that it had agreed to buy MedImmune, the biotechnology company that we have written about in this article in an all cash deal for $58 a share.

MedImmune, based in Gaithersburg, Md is best known for FluMist, its nasal spray flu vaccine that is more expensive than the injectible flu vaccines. FluMist was a total flop when it was first introduced, but came into greater usage after the flu shortage that took place in 2004 when Chiron Corp. was forced to close down its flu vaccine production facility in England for safety reasons. To read more about this please see our items dated 2/24/07, 1/11/07 and 9/7/05.

The FDA recently approved a non-refrigerated version of FluMist. MedImmune hopes to win approval from the FDA for usage among children in the 6 month to 5-year age category.

(3/22/07)- The Japanese Ministry of Health, Labor and Welfare issued a warning that the anti-influenza drug Tamiflu should not be given to teenagers after it received a report that two twelve year old boys had jumped from the second floors of their homes within the past two months after receiving the oral vaccine.

Authorities in both the U.S. and Japan cautioned that it was unclear if the drug caused the behavior, or if the behavior was caused by the flu itself of by another cause. The American label for the drug already contains a precaution referring to reports of "self-injury and delirium" among users of Tamiflu.

Roche, the vaccine's manufacturer continues to defend the safety of the drug.

(3/2/07)- An outside advisory panel of experts recommended approval for Sanofi-Aventi SA's vaccine for use in an avian-flu pandemic, despite limited evidence of its efficacy and safety. The FDA and the panel said that is would only be a stopgap measure till newer, better versions are developed.

Sanofi has said that it does not plan to commercially market the first-generation vaccine that was reviewed by the panel.

Doses of the vaccine are expected to comprise part of a national stockpile and could be provided to health workers and other first responders if they are at risk for infection.

The H5N1 bird flu has infected at least 273 people worldwide, killing 166 since the virus re-emerged in late 2003. The Sanofi vaccine was tested in a limited trial by the NIH, with only 91 people being involved in the test. Only 45 % of the people tested responded to large dose of the vaccine.

(2/24/07)- The results of a study that was conducted on 7,852 children from the ages of 6 months to 5 years old found that there were 55% fewer cases of flu when they were protected by Medimmune's FluMist, the nasal spray, compared to those who received the inoculation vaccine.

The FDA has not licensed FluMist for children under five. Researchers from medical schools in St. Louis, Tennessee, California and Finland conducted the study, the results of which were published in The New England Journal of Medicine. Dr. Robert B. Belshe, a vaccine researcher at St. Louis University's Medical School was the lead author for the report about the study.

The study and an editorial contained an important caution: Among children younger than 1 year, there were slightly more hospitalizations and episodes of wheezing in the FluMist group. As a result Medimmune said that is would seek FDA approval to use the product only among children older than one year of age.

The risk of an asthma attack must also be considered before administering FluMist.

(1/11/07)- Medimune Inc. announced that the FDA had approved an updated version of its nasal spray flu vaccine FluMist. The new version of FluMist does not need to be kept frozen, as did the older version of the spray. FluMist is more expensive than inoculation flu vaccines.

The approval pertains only to healthy children and adults between the ages of 5 and 49 years of age. The company said that it expects to begin shipping of the first doses of the new version of the spray for 2007 in time for physicians to start vaccinating patients as early as August.

We at therubins hate to throw cold water on the company, but it is difficult enough to get people to come in for the vaccination in October, let alone expect them to come in as early as August.

(12/18/06)- There are not too many viewers of this site who are surprised by the headline story that ran in Saturday's NY Times article "After Shortage, Flu Vaccine Goes Unused." Just read some of the prior items in this article and you can see that this development comes as no shock at all.

Did you know that the Centers for Disease Control and Prevention had proclaimed November 27^th through December 3 the first ever National Influenza Vaccination Week? "Catch the holiday spirit, not the flu," declared Dr. Julie L.Geberding, the director of the agency were the she declared in the commercial.

It is simple math that government officials and the vaccine manufacturers can't seem to acknowledge. If you produce between 110million to 115 million doses of the vaccine, and the greatest number of doses that have been used in any one year is 83 million, you are going to have an oversupply of the vaccine.

The problem is seems to us at therubins is the fact that you must prove to the public that it really is worthwhile to take the shots. All of us know a lot of people who took the shot and yet they developed the flu. On the other hand we also know of many people who did not take the shot, who did not develop the illness.

Is it really worth the inconvenience and cost of getting the shot? Then again how many times have we heard that the vaccine, which must be produced before the flu season begins, did not have the right ingredients against this year's particular strain.

Authorities estimate that there were 36,000 deaths and 200,000 hospitalizations each year as a result of the flu.

This year there are three manufacturers of the flu shots. Sanofi-Aventis, the French drug company, has shipped 50 million doses so far this year; Novartis, which acquired Chiron has shipped 30 million doses this year; and GlaxoSmithKline has shipped 24 million doses this year. MedImmune, which makes the nasal spray Tamiflu, has sold 2.5 million doses so far this year.

This flu season has not been a serious one at all. Therefore it is unlikely that even 70 million doses will be used. Since the vaccine can't be stored year-to-year we estimate that over 40 million doses will have to be thrown away.

We invite anyone involved in the flu vaccine program, be it a drug company or a governmental agency to dispute these numbers.

(11/24/06)- An FDA staff opinion recommended that the label for Roche Holding Inc.'s flu drug Tamiflu be updated to include a precaution related to possible psychiatric problems in patients who take it.

The recommendation was based on a 10-month review that found 103 cases of "neuro-psychiatric adverse events," including the death of a boy who fell after climbing on a balcony railing.

Of the cases, 67% were in children and 95% occurred outside the U.S., mostly in Japan, where Tamiflu's biggest volume of sales takes place. Tamiflu's label in Japan already contains such a warning.

(10/12/06)- As we pointed out in our item dated 9/12/06, the greatest amount of flu vaccine ever produced was 95 million doses in 1995. Unfortunately history has shown that we have had to throw out millions of doses of the vaccine every year. Two years ago, there was a large outcry about a flu vaccine shortage because 50 million doses of the vaccine that was produced by Chiron Corp., at a plant in Liverpool, England that was found to be unsafe, had to be discarded.

It turned out that no shortage occurred, even then, since it did not become a serious flu season. As a result of the outcry about shortages, and because of fear of the avian flu, the manufacturers will produce the largest amount of doses of the vaccine in history. It is now expected that 115 million doses of the vaccine will be produced this year. Two years ago the total supply came to 61 million doses, and it was sufficient to meet all needs that year.

As we have pointed out in this article the doses cannot be stored from one year to the next, because of the fact that there is a different expected strain of the disease each year. The plan to have the government guarantee the price of the vaccine fell through because of the excessive cost of the program

Manufacturers have delivered 26 million doses of the vaccine to doctor's offices and clinics, according to Curtis Allen, a spokesman for the Centers for Disease Control and Prevention. Seventy-five million doses are expected to be delivered by the end of October.

(9/12/06)- The Centers for Disease Control and Prevention (CDC) expects that over 100 million doses of the flu vaccine will be available this year. That amount is greater than the greatest amount of the vaccine that was ever produced, which was 95 million in 1995.

In previous years, unfortunately a lot of the doses had to be destroyed because they were never used, and the formula for the vaccine must be reset every year.

About 75 million doses of the vaccine will be distributed by the end of October, which is when the vaccination season begins in full.

(8/6/06)- The FDA announced that it had approved influenza vaccines made by GlaxoSmithKline, Chiron, Medimune and Sanofi Pasteur for the 2006-2007 season. Medimune's flu vaccine FluMist is given through a nasal spray, while the other vaccines are administered by injection.

Flu vaccines are reformulated for each season to provide protection against the strain that experts adjudge to be the most likely cause of the illness for each flu season. Thus last year's batch of the vaccine can not be given for this year's flu season.

Manufacturers expect to produce about 100 million doses for the coming season. Vaccinations usually begin in October.

The FDA recently warned Sanofi about contamination at their flu shot manufacturing plant in Pennsylvania, which is the same plant that had contamination problems last year. Sanofi expects to produce about 50 million doses of the vaccine this coming season.

6/7/06)- The World Health Organization formally endorsed amantadine and rimantadine, two generic drugs in the battle against the avian flu. Please see our item dated 5/19/06 on this subject. The endorsement of the two older drugs is contained in a 138-page report released by the organization that contains suggestions on fighting the disease.

Tamiflu, made by Roche Holding AG of Switzerland, remains the WHO's drug of choice for treating bird-flu victims. The report recommended that doctors might consider giving patients either of these generic drugs to their patients with the disease in addition to administering Tamiflu, in places where generic analyses of circulating strains of the virus show that the older class of drugs could work.

(5/19/06)- Two of the older generic drugs that are plentiful and cheaper than Roche's Tamiflu are effective in the battle against the avian flu. The results of the study showing this to be so appeared in the Journal of Infectious Diseases. The two generic drugs are amantadine and rimantadine.

"Amantadine appears to retain the potential to be useful in an H5N1 pandemic in the absence of a vaccine, as a prophylactic agent and as a componennt of combination antiviral therapy," according to the study.

(4/25/06)- According to Kevin Teale, a spokesman for the Iowa Department of Public Health, two airline passengers may have helped spread Iowa's mumps epidemic. This is the first year that the United States has experienced a mumps epidemic in the last twenty years. There have been 815 suspected mumps cases reported in Iowa, 43 in Nebraska; 33 in Kansas; 4 in Illinois, Missouri and Wisconsin, and one in Minnesota.

So far no one has died of the disease, which broke out in either Iowa City or Dubuque in December. About one half of the cases in Iowa involved college students. The vaccine has about an 80% efficacy rate for people who have been inoculated with one dose, and a rate of about 90% for those who have received the recommended two doses.

The CDC has taken steps to provide an additional 50,000 doses of the mumps vaccine, about half of which has been donated by Merck.

Roche Holding AG said that a stockpile of 3 million of its treatment courses of its antiviral drug Tamiflu is ready and at the disposal of the World Health Organization.

Under a separate agreement, the company has donated an additional two million courses of Tamiflu to WHO for use in developing countries most likely affected by bird flu in humans, and cannot afford the drug.

(4/13/06)- The FDA has approved GlaxoSmithKline PLC's antiviral drug Relenza for flu prevention in adults and children ages five and older. The drug had previously been approved for the treatment of flu. It now joins Roche Holdings AG's Tamiflu as a drug that is helpful in preventing the flu, as well as helping to alleviate its symptoms once the disease has set in.

Dr. Debra B. Birnkrant, director of the FDA's division of antiviral products, said that Relenza studies suggest it is effective at preventing the spread of the virus, if treatment is begun within a day and half after a family member comes down with the disease. She also indicated that the agency had no proof that the drug was effective in the treatment of the H5N1 flu strain, which is responsible for the avian flu.

Dr. Birnkrant said that the drug had been studied in a total of 3,800 patients, wherein it showed its effectiveness in preventing the spread of the disease.

(3/11/06)- Government officials announced that they had ordered 12.4 million treatment courses of Tamiflu, made by Roche, and 1.75 million treatment courses of Relenza, made by GlaxoSmithKline to be stockpiled in the event of a pandemic flu outbreak. A Roche spokesman said that he expected that the company would have the ordered filled by this fall.

The government already has 5.5 million drug treatment courses in its pandemic flu stockpile. The U.S. hopes to eventually acquire 80 million treatment courses, which would be enough to treat slightly more than 25% of the population. The states pay three-quarters of the cost of most of those courses.

The Bush budget calls for the government to spend $2.65 billion in 2007 on pandemic flu preparation, on top of this year's expenditure of $3.3 billion. The president said that he would eventually ask Congress to spend a total of 47.1 billion on pandemic flu preparations.

Tamiflu and Relenza reduce the severity and duration of flu infections, but there is no scientific proof that they can stop avian flu from spreading.

(3/4/06)- The Advisory Committee on Immunization Practices has recommended that all children between the ages of 2 years to 5 years old should get flu shots. The recommendations of this panel are usually followed by the Centers for Disease Control and Prevention (CDC). Flu shots are presently recommended for children ages 6 months to 23 months, pregnant women, people 65 and over, and people with chronic health conditions.

(2/15/06)- CSL Ltd., an Australian company that makes flu vaccines in about 40 countries announced that it would apply for approval to market its flu vaccine in this country in time to supply some shots for the 2007-2008 flu season. If the FDA grants the approval that will mean that there will be about 120 million doses of the vaccine available for the 2008- 2009 flu season when the production from its expanded Australian plant will become fully available.

As we have from time to time pointed out, most of the flu seasons in this country has resulted in many millions of the flu doses being thrown out, since they can not be used for the following year's flu season. Most years we do not use even 80 million doses of the vaccine. More companies have entered this field, and those already in the vaccine area have expanded their plant capacities once the government started to guarantee them payments for the vaccines they were producing.

With the avian flu fear running rampant, the governments of the world have been trying to stockpile the flu drugs Tamiflu and Relenza, even though there is no positive proof that they work in stopping the disease. CSL Ltd., said that if granted the approval it would produce about 20 million doses a year in the U.S. The company sells flu vaccine under its name in 16 countries, and supplies bulk vaccine to Berna Biotech, a Swiss company which sells the vaccine in 2r countries.

(1/30/06)- The results of a study that was published in the English medical journal Lancelot, concluded that Roche's Tamiflu and GlaxoSmithKline PLC's Relenza were not helpful to patients with flu-like symptoms, and that there was no "credible" evidence that Tamiflu works against the avian flu.

The English Health Department and the Pienmonte region of Italy funded the study, under the leadership of Tom Jefferson, a physician and epidemiologist based in Rome. The study reviewed the data from 50 clinical trials of Tamiflu and other flu drugs. While Tamiflu and Relenza are effective at reducing symptoms of classic seasonal influenza, defined as influenza virus type A or B, they aren't effective against a range of other viruses that cause "flu-like" symptoms.

Roche said it strongly disagreed with the study's "inappropriate" conclusions, and defended Tamiflu's efficacy against seasonal flu. The World Health Organization (WHO)said it continued to recommend that countries continue to stockpile Tamiflu in case of the avian flu pandemic. Both Roche and the WHO agreed however that there are no large human studies that show that Tamiflu is effective against the bird flu.

The strain that will be manufactured to fight the flu bug must be determined many months before the flu season starts because of the large lead-time needed to manufacture it. Therefore health experts must take educated guesses as to which strain of the flu virus they must deal with in the coming months. Past history has shown that the guess is not always the correct one. As a result of this many batches of the vaccine are thrown out at the end of the flu season year, since they can not be used for the following flu season.

In spite of this fact, flu manufacturers announced at a recent conference held in Atlanta for the American Medical Association and the Centers for Disease Control and Prevention that they would produce as many as 120 million doses of the flu vaccine for this coming flu season. The most flu vaccine produced prior hereto took place in the 2002-2003 flu season year when 95 million doses were produced.

Many millions of doses had to be thrown out that year since they were never used. This flu-season year about 86 million doses were produced, and it looks like there will be an oversupply of the vaccine, so many of the doses will have to be disposed of.

Vaccine manufacturers are increasing the supply because they are getting better reimbursements from the federal government, and they hope that federal health officials recommend the flu shot for everyone in the coming flu seasons. This of course assumes that everyone will go by that recommendation, which is of course farfetched.

The higher reimbursement rate by the federal government is causing the manufacturers of the vaccine to throw caution to the wind, since they will have little to lose.

The stockpiling of Tamiflu by different countries throughout the world, at the cost of billions of dollars without proof of its effectiveness in fighting the avian flu is a huge gamble. Is that expensive risk worth taking? Until more scientific evidence proves that it is effective in fighting the disease, we at therubins feel the gamble is not worth taking at this time. That same money could be spent more wisely by health officials of the world for more proven methods of fighting world threatening diseases, such as malaria and AIDS.

(12/30/05)- According to figures from the World Health Organization, three of the 138 people known to have been infected with the A (H5N1) avian influenza virus developed resistance to the antiviral drug Tamiflu. Scientists, led by Menno D. de Jong, a doctor at Oxford University in Ho Chi Minh City looked at 8 Vietnamese patients who were infected by the disease.

One of the patients, a 13-year old girl, died despite receiving Tamiflu within 48 hours after the onset of flu symptoms. One other patient developed resistance to Tamiflu, but that patient was not treated with the drug within the 48-hour period after first onslaught of the disease. Six of the eight patients did not develop resistance to the drug.

Of the 8 patients studied by the scientists, four lived and four died. Tamiflu is designed to keep flu viruses from replicating in a person's body. David Reddy, Roche's influenza pandemic task-force leader said that the company is conducting animal studies to see if higher doses of Tamiflu would be needed to successfully treat avian flu and overcome any resistance that the virus may develop to the drug..

It might be that Tamiflu would have to be used in combination with other drugs in some cases. Roche officials also announced that the FDA had approved expanded marketing of Tamiflu to include preventing the usual seasonal flu among children ages 1 through 12. Thus the drug has been approved for usage by all ages of patients in trying to prevent the disease from occurring.

(12/22/05)-Roche, the Swiss pharmaceutical company announced that it had reached an agreement with China's state-owned Shanghai Pharmaceutical Group to make the drug Tamiflu. This is the first of what are expected to be several more announcements from Roche in which the company is expected to award licensing agreements with about 12 other pharmaceutical companies.

Shanghai Pharmaceutical would have full control over production and pricing of Tamiflu. Roche already owns a venture in China with Shanghai and is expected to provide technical experts to help get the process started. Shanghai will be able to produce the drug for stockpiling purposes only, not for sale during the regular flu season.

It is not clear yet as to when Shanghai Pharmaceutical will be able to start producing the drug..

(12/12/05)- Roche, the Swiss pharmaceutical company said that it is close to announcing agreements to allow 15 pharmaceutical companies or governments to help produce Tamiflu, the flu drug that is being stockpiled in the event of an avian flu pandemic. Mylan Laboratories and Teva Pharmaceuticals are two of the generic-drug companies involved in the discussions.

Roche has not finalized the agreements since the company does not know how many firm orders it has for the drug. The Bush administration plans to order 81 million treatments of either Tamiflu or Relenza from GlaxoSmithKline, but has not made firm commitments yet. Roche recently increased its supply to Taiwan to try and prevent that government from producing the drug for itself in violation of its patent.

Indonesia, Thailand and the Philippines can produce Tamiflu themselves since the drug does not have patents in those countries.

(12/04/05)- The Déjà Vu column of the Wall Street Journal recently had an interesting contribution from Cyntha Crossen entitled: "Political Action, Folly Greeted the Outbreak of Swine Flu in 1976." As the title states, the article dealt with the facts that surrounded the potential outbreak of swine flu in this country in 1976.

An outbreak of swine flu had taken place in this county in February 1976 at an army base in New Jersey. Prior thereto, the virus had been seen only in animals and had never made the leap from one human to another human. In her article she wrote that it was thought at the time by some that, "The swine-flu virus was incurable, potentially lethal, and very few people had natural immunity to it."

A national vaccination program was begun that was funded mainly from an appropriation of $113 million from Congress. Insurers for the companies that had prepared the swine-flu vaccine announced that they would not cover any lawsuits that arose as a result of the inoculation process. Congress passed legislation that required the Justice Department to defend the drug companies from any lawsuits that might arise as a result of the inoculation. The legislation that Congress passed also denied the awarding of punitive damages in this type of lawsuit.

The immunization program began after the legislation was passed, and almost 40 million people, which was about one third of our population at that time received the vaccination. The swine flu however remained dormant and did not pass from the animals to humans. On December 16, 1976 the swine-flu inoculation program was suspended, and 90 million doses of the vaccine went unused.

Before rushing to judgment in connection with the recent outbreak of avian flu let us remember what happened in 1976 and not act in haste.

(11/26/05)-Roche, the Swiss pharmaceutical company that has the patent for Tamiflu, announced that since the drug does not have patent protection in Indonesia, that country could produce the drug for local consumption, without having to pay any royalties to Roche. India recently announced that it would permit Ranbaxy Laboratories and Cipla, the country's two largest generic drug manufacturing companies, to produce generic versions of Tamiflu.

An FDA advisory panel said: "The committee does not think, based on the data presented, that there's any evidence Tamiflu played a role in the deaths" of 12 children in Japan. The agency plans to continue to monitor possible complications from the drug for up to two years. The safety review for the drug was required, since it has been one year since the drug received a 6-month patent extension. This patent extension is offered to all companies that test the safety and effectiveness of their medications in children younger than 14 years of age. Please see our article on Prescription Drugs and the Patent Law in connection with this loophole in the patent law.

Tamiflu was approved in 1999 in the U.S. and late in 2000 in Japan. Of the 13 million prescriptions written for children worldwide, 11.6 million have been in Japan according to figures from Roche. There have been adverse reactions reported in connection with the drug including severe skin reactions in both children and adults. The FDA said that between April 2004 and March 2005, 1.8 million Tamiflu prescriptions were dispensed in the U.S., of which 456,000 were for children 16 years of age or younger

Roche and Gilead Sciences, the company that developed Tamiflu, announced that they had settled the pending litigation between the two of them. Under the terms of the settlement agreement Gilead said that it expected its royalty rate on the drug to increase to between 18%-19% from its present rate of 10%. Roche will make a payment to Gilead of $62.5 million to make that change retroactive to the beginning of 2004.

Under the terms of the settlement Roche will continue to produce and market the drug but committees with representatives from each company will oversee sales, manufacturing and overall strategy. Gilead will have a say as to which companies, if any, will be allowed to produce the drug.

(11/13/05)- Roche, the Swiss pharmaceutical company that makes Tamiflu said that it hoped to be able to sharply increase its production capacity for the drug over the coming years. The company expects to produce 300 million courses of the drug next year, up from the 55 million courses that it will produce this year.

The company also announced that it would charge 12 euros (about $14.10) for a five-day treatment to less-developed countries, as defined by the World Bank, and 15 euros in the developed countries. For seasonal flu, the company charges 20 to 50 euros a course to the public. The company has received over 150 requests for licenses to produce Tamiflu, but is only seriously considering 8 of those requests as of now.

According to the latest figures 64 humans have died of the avian flu.

Roche also announced that it has been in serious discussions to settle the arbitration matter it is presently involved with Gilead Sciences, the American company that invented Tamiflu 11 years ago.

A basic material that is involved in the production of Tamiflu is shikimic acid. Star anise, a rare spice that is found in the mountains of southern China is involved in the production of about two thirds of Roche's shikimic acid supply. The Chines company that is the broker for the spice, Beijing Ginko has declined to supply the item to any other company besides Roche. Beijing Ginko may sell some to the Chinese government, which in turn may allow the country to produce a generic version of Tamiflu.

Fermenting E. coli bacteria makes the other one third of Roche's supply of shikimic acid. Roche said that it is hoping to be able to produce much more of the acid by this latter method in the coming years.

At last count, according to CDC officials, at least 71.5 million doses of flu vaccine have been distributed, including 55 million from Sanofi Pasteur, a unit of Aventis Pasteur; 8 million from Chiron; 7.5 million from GlaxoSmithKline; and 1 million from Medimmune.

About 81 million doses will be distributed by the end of the month. 83 million doses is the most flu vaccine doses that were ever distributed in this country.

(11/9/05)- The Thai government announced that it would begin to manufacture a generic version of oseltamivir (Tamiflu) which is considered to be one of the most effective antiviral drugs for the bird flu. Roche confirmed that Tamiflu was not patented in Thailand, so the country could make it without compensating the company. Thailand expects to have the drug available by February at the earliest.

The journal Nature reported that in a study published in 2002 Roche scientists showed that Tamiflu concentrations in patient's blood were far higher when combined with probenecid, a common generic pill used in the treatment of gout. Probenecid blocks the body from excreting Taniflu's active ingredient in urine, leading to higher concentrations Health officials said that further studies would be required before the procedure could be used with Tamiflu.

Novartis, the Swiss pharmaceutical company that was formed through the merger of Ciba-Geigy and Sandoz said that it would buy the rest already did not of Chiron at $45 per share or a total of $5.1 billion, for the 113 million shares that it does not already own. Ciba acquired the shares in Chiron about 10 years ago. The acquisition is subject to approval of the Chiron shareholders as well as governmental agencies. Chirons independent directors have approved the price.

Recently GlaxoSmithKline offered to buy ID Biomedicals, a Canadian manufacturer of flu shots. The sole American flu vaccine plant factory is in Swiftwater, Pa. It is owned by the French company Sanofi-Aventis. Novartis officials said they would consider building a vaccine factory in this country if the government provided them with sufficient incentives to build it.

The president George Bush announced his plan for spending $7.1 billion on the vaccine situation, at a speech he gave in Baltimore at the National Institutes of Health. Under his plan spending of $2.8 billion would go towards accelerating a newer "cell based" technique that could produce vaccines for 300 million people on a six-month timetable by 2010.

The plan also calls for spending $1.2 billion to acquire enough egg-based vaccine by 2009 to protect 20 million people against the deadly H5N1 strain of avian flu. About $1 billion would be used to buy the antiviral medications Tamiflu and Relenza.

In a meeting planned for November 16, the FDA plans to examine safety concerns raised by a version of the cell-based method which is used to make other U.S. vaccines but not the flu vaccine.

(11/2/05)- The Senate by a vote of 97-3 approved spending about $7.8 billion as part of the budget for health, labor and education programs that totaled about $145 billion. Under the proposal, $3 billion would be used to stockpile antiviral drugs to treat the avian flu, and $3 billion would go to acquire up to 120 million doses of an avian flu vaccine over the next two years. Other money would go toward increased worldwide monitoring of the flu, public education programs and surveillance of migratory birds.

The government has awarded Chiron Corporation a $62.5 million contract to manufacture millions of doses of a vaccine against the strain of avian flu that is presently threatening many countries in the world. Sanofi-Aventis received a $100 million contract in September, and is expected to deliver its vaccine by the end of this year. Chiron is expected to deliver its batch of the vaccine early next year.

All this has been done in spite of the fact that it has not been proven that there is a vaccine effective against the avian flu, and even if the vaccine is effective no one is sure as to what the dosage should be for the vaccine. If you proceed from this date for these articles dated a few years ago, you will notice that there has been an excess of the flu vaccine, rather than a shortage. More times than not this excess had to be thrown out. In the rush to judgment, Congress and the President think that they can throw money around and thereby solve the vaccine problem. "It ain't going to work." Modern technology is needed to develop modern methods to produce vaccines.

Defense Secretary Donald H. Rumsfeld has recused himself from government decisions concerning medications to prevent or treat avian flu, rather than sell his stock holdings in Gilead Sciences Inc. Gilead is the company that holds the patent for Tamiflu. Mr. Rumsfeld was chairman of Gilead before becoming defense secretary. For further details on the legal battle now going on between Gilead and Roche-Holdings concerning Tamiflu please see our item dated 10/28/05.

So far 8 states have reported flu outbreaks this flu season. The CDC has determined that there is sufficient supply of the vaccine so that it can now be administered to all that ask for it, not to only high-risk candidates.

(10/28/05)- Roche Holdings AG announced that it had temporarily halted shipments of Tamiflu in the U.S., because it said it was trying to prevent hoarding and ensure that adequate supplies remain available in case of emergencies. Roche said that it found that many companies and individuals were hoarding the drug thus creating a shortage of the drug. Roche has also suspended shipment of the drug to Canada, where it found that hoarding was also occurring.

According to Verispan, a drug research sales firm located in Yardley, Pa., the number of prescription for Tamiflu has increased by at least ten-fold in the last few weeks. Last week there were 67,443 prescriptions for the drug compared to the 17,172 prescriptions for the drug for the same week a year ago. Tamiflu is also known as oseltaminvir.

The clamor about Tamiflu is growing daily in connection with the battle against the avian flu. Cases of avian flu have been confirmed most recently in Britain and Croatia. With this growing crescendo of noise about the vaccine let us take a look at some of the facts about the vaccine.

Tamiflu has been used up to now to help reduce the symptoms of the flu. For the vaccine to work most effectively it must be administered within two days of the onslaught of the disease. At that point most patients do not know if they have the flu or a common cold. The FDA has not licensed Tamiflu for usage by children.

Up to now Tamiflu has not been shown to be a prophylaxis to the avian flu. If proven to be effective as a preventative to the avian flu it must be administered at least 6 months before the onslaught of the disease. Roche Holdings AG is fighting with its partner Gillead Sciences Inc. of Foster City, CA for the right to keep selling the Tamiflu. Gilead developed the vaccine in 1996 and licensed Roche to sell it that same year. The drug has failed to be a top seller until recently in the battle against the flu.

In June of 2006 Gilead threatened to revoke the license of Roche to sell Tamiflu and said it planned to take back the rights for the medication. The companies took the matter to binding arbitration in September, and that process can take as long as 18 months before it is resolved.

India, Thailand and Taiwan have all claimed that they can produce a generic version of Tamiflu in a matter of a few weeks. Roche has begun negotiations with 4 generic drug manufacturers to produce Tamiflu. They are Teva Pharmaceutical Industries, Barr Pharmaceuticals, Mylan Laboratories and Ranbxy Laboratories.

The 3 main manufacturers of asian flu vaccine are Sanofi-Aventis, GlaxoSmithKline and MedImmune expect to produce and distribute about 71 million doses of the vaccine. Chiron, the other major manufacturer of the vaccine once again has lowered its estimate of how much of it will be available for usage in this country this flu season. In June Chiron lowered its expectations for production of the vaccine to between 26 million doses and 18 million doses. It did not give an exact number for how many doses it now expects to produce, other than to say it will be less than 18 million doses.

Based on past experience, if there is such an animal in connection with trying to predict the severity of the flu season, about 80 million doses of the vaccine will be needed for the "average" flu season. Therefore even without the Chiron dosages, there should be just about enough of the vaccine available to meet the needs of this coming flu season.

(10/16/05)- The U.S. government is considering spending billions of dollars in order to stockpile the influenza drug Tamiflu, which is manufactured by Roche, the Swiss drug company. Tamiflu is a pill that reduces the duration and severity of human flu symptoms if taken within 48 hours of the infection. At this point it is the only known drug that is approved and available in the fight against avian flu. Avian flu has now been confirmed as having spread to Turkey and Rumania. It has been confirmed that thousands of birds that have died in both those countries succumbed to the same deadly influenza virus that has ravaged Southeast Asia.

Up to now the avian flu has not been shown to be able to pass directly from birds to humans, but the fear is that the virus will mutate and become able to do so. The H5N1 virus is the one that is responsible for the avian flu. It has infected about 120 people so far, but they were people who were in close contact with birds. About half of the infected people have died.

Conventional flu shots, which protect against the seasonal influenza that are taken yearly do not protect against a mutated human bird flu virus, said Dr. David Nabarro, the United Nation's official in charge of flu preparedness.

The Indian drug company Cipla of Bombay has announced that it can make a generic version of Tamiflu. The question of patent protection for this drug now becomes an issue, just as it was when the U.S. government threatened to break the patent for Cipro when the drug was needed because of the anthrax situation in this country several years ago. To see more on this issue please see our articles on Patents and Prescription Drugs.

This rush to find sources for the flu vaccine has been exacerbated by the recent finding by the fact that the 1918 flu epidemic that killed over 50 million people worldwide was also a form of avian flu. There has been no proof so far that the avian flu passes easily from human to human.

Preparing the vaccines takes about 9 months and involves the eggs of chickens. The fear is that the avian flu could wipe out a vast amount of chickens, doses as originally hoped for by Roche. Terrence Hurley, a spokesman for Roche, said that 40 countries had ordered Tamiflu to fill medical stockpiles in case of a pandemic. The U.S. is expected to order about 81 million doses of the pill, but Roche will be unable to supply that amount to this country for several years.

The flu inoculation season has begun in this country and unfortunately the FDA has still not approved Chiron Corporation's doses for the vaccine. A spokeswoman for CDC, Lola Russel, said that even without Chiron's supply of 18 million to 26 million doses, there are 68 million does being provided by the two other manufacturers, Sanofi-Pasteur and GlaxoSmithKline.

GlaxoSmithKline, Europe's largest drug company announced that it planned to triple its North American flu vaccine manufacturing capacity in the next three years. Glaxo has only one plant producing the flu vaccine presently, and it is located in Dresden Germany. If Glaxo's merger with ID Biomedical is approved by the shareholders of both companies it will acquire ID's flu making plant in Vancouver, Canada.

We would like our viewers to keep in mind that the flu vaccine changes from year to year, depending on which strain the experts feel will be the most likely strain to hit in the coming season. Since the vaccine takes 9 months to produce, the experts have very little margin for error in making their advance call. The vaccine can not sit "on the shelf" for any length of time. The government has had to order the disposal of much of the supply of the vaccine in prior years when there was not enough demand for it. Are we rushing to judgment once again, as the fear factor overwhelms our knowledge, and with that rush incurring a large unnecessary expenditure?

(9/29/05)- The results of two studies that were conducted on the effectiveness of the flu vaccine concluded that the vaccine is far less effective than previously thought. One of the studies analyzed the data form patient studies on the flu vaccine performed worldwide in the last 37 years. It determined that vaccines showed at best a "modest" ability to prevent influenza or it complications in elderly people. The results of the studies were published in the London based medical publication, The Lancet.

"There is a wild overestimation of the impact of these vaccines in the community", said Tom Jefferson, a researcher in Rome with the Cochrane Vaccine Fields project. Because of overuseage viruses are becoming resistant to the vaccines.

In people over 65, the vaccines "are apparently ineffective" in the prevention of influenza, pneumonia and hospital admissions, although they did reduce deaths from pneumonia a bit was the conclusion of one of the studies.

In the second paper researchers from the Centers for Disease Control and Prevention in Atlanta found that influenza viruses, especially those from the bird flu strain had developed high rates of resistance to the only class of cheap antiviral drugs available.

The best preventative for the spreading of the flu virus is to wash your hands.

(9/23/05)- Medimmune Inc. has filed an application with the FDA for approval to market a new version of its FluMist vaccine. Unlike the present version of the vaccine that must be frozen, the new version needs only to be refrigerated until just before it is used. Both versions are intended only for people in the 5 to 49 year age categories.

The company also hopes to receive approval to use the new version in children as young as six months. If approved the vaccine could be available for usage in the 2007 flu season. The company also announced that it had priced its FluMist vaccine inhalant at $19.95 per dose. It also announced that it had expanded its manufacturing capacity at both its British and Pennsylvania plants so that it could produce as many as 35 million doses of the vaccine shortly.

(9/7/05)- Chiron Corp. announced that the FDA had completed a nine-day inspection of its flu vaccine plant in Liverpool, England. This was the plant that had been shut down by English authorities, the Medicines and Healthcare Products Regulatory Agency (MHRA) last year, that helped to precipitate the flu vaccine shortage.

The MHRA had conditionally lifted its manufacturing license suspension for the plant in March. The FDA onsite inspection of the plant began July 11^th and took nine days to complete. The company stated that the FDA found the responses and proposed actions taken by Chiron "generally acceptable," but that it would continue to monitor the situation. The MHRA will continue to monitor the plant on a weekly basis.

The company expects to begin shipping between 18 to 26 million doses of the vaccine to the U.S. by October to meet demands for the 2005/2006-flu season. This means there should be a total of over 100 million doses of the vaccine plus FluMist available for the coming season. Thus unlike last year's flu season where there were shortages of the vaccine, there should be more than enough of the vaccine available to meet all demands.

(9/04/05)- Novartis, the Swiss pharmaceutical company, which already owns 41% of Chiron (Emeryville California), announced that it had offered to pay $4.5 billion for the portion of the company that it does not already own. Chiron is the second largest flu vaccine manufacturing company that had its Liverpool manufacturing facility shut down last year by British health officials because of unsafe production conditions at the plant. Sanofi Pasteur, a joint venture of Sanofi Aventis of France and Merck is the largest flu vaccine supplier to the U.S.

The FDA approved GlaxoSmithKline's flu vaccine, Fluarix, for sale in the U.S. last week. At the same time the company announced it would buy a Marieta, Pa., vaccine production and research operation for an undisclosed sum from Wyeth as it seeks to expand its capabilities to produce the flu vaccine.

Novartis recently announced a deal which will make it the largest generic company in the world.

(8/25/05)- The FDA has sent MedImmune a warning letter concerning promotional fliers put out by the company about its FluMist vaccine. The letter, dated June 21, 2005 said the consumer-directed flier was "misleading because it fails to reveal material facts regarding the risks associated with the use of FluMist."

The letter went on to state that "By failing to include sufficient information on risks and adequate directions for use, you have encouraged the potentially unsafe use of FluMist". Missing from the promotional material were the "fact that it shouldn't be used by pregnant women, patients with chronic underlying medical conditions like asthma, people with egg allergies and people who are on aspirin therapy." Although the flier said that healthy adults between the ages of 19-49 could use it when in fact the correct statement should have been it is approved for healthy adults between the ages of 18-49.

ID Biomedical Corp. said its flu vaccine has been granted "fast track" status by the FDA as part of the effort to avoid a flu-shortage this coming season. Michele Roy, a company spokeswoman, said the company is expecting approval from the FDA in the first half of next year, and could then supply 20 million to 25 million doses for the 2006-2007 season. The company is also working on an inhaled version of its flu vaccine which could reach the market as early as 2009.

(6/18/05)- Chiron Corporation said that it would be able to provide only between 18 million to 26 million doses of the flu vaccine for the coming flu season instead of the 25 million to 30 million doses that it predicted it would have available earlier this year. It was the shutdown of the Chiron plant in Liverpool, England that led to the shortages of the vaccine last flu season.

Chiron executives said that the problem was caused by the fact that it is taking longer to train more than 100 new workers and to put into effect dozens of new operating procedures at the Liverpool plant. Federal officials and vaccine industry executives said that there would be enough of the vaccine available this coming flu season to avert another severe vaccine shortage this coming season.

(5/19/05)- Sanofi-Pasteur, the flu vaccine-making unit of Paris based Sanofi-Aventis SA will charge $9.95 a dose up 17% from last year's price of $8.50 a dose. The company plans to produce 50 million shots and can make an additional 10 million doses later in the flu season if needed. Buyers have already snapped up the full amount of the expected production.

Chiron Corp. said it plans to deliver 25 million to 30 million doses of its flu vaccine in this country if all goes well with its resumption of production from its plant in Liverpool. The closure of that plant last year was the direct cause of the flu shortage that we experienced here in the U.S. last flu season. All of its expected flu vaccine production is already been spoken for by the flu-vaccine distributors.

Medimune Inc. plans to increase its nasal spray FluMist by a modest amount over last year's production of 3 million doses. Britain's GlaxoSmithKline PLC will be a new entrant to the flu vaccine supply production in this country this coming flu season when it plans to have about 8 million to 10 million doses available in the U.S.

Without Chiron, the U.S. flu-supply is expected to be no more than 73 million doses. Last year 3.9 million flu shot doses were thrown out, while 12million doses went unused in the 2002-2003 flu season. It is estimated that there are about 185 million Americans in the "high risk" group for which the shot is hghly recommended.

The federal government has doubled it annual budget for modernizing flu-shot production to nearly $100 million, and another $120 million is proposed in the budget for 2006. The CDC is spending $30 million for an emergency stockpile of investigational vaccine should regular supplies run short.

FDA inspectors are not expected to visit Chiron's Liverpool facility until sometime in June, which is normally the height of the flu-vaccine production season. A "normal" flu season sees about 80 million doses of the vaccine being administered.

(5/7/05)- Chiron Corp. announced that it expected to produce about 25 million to 30 million doses of its flu vaccine for the coming season if the FDA gives it approval to make the vaccine after inspecting its plant in Liverpool, England. That was the plant that was shut down by British health authorities last October, that resulted in the flu shortage that ensued in this country.

Regulators in England gave approval to resume operations at the plant in March, but the approval is subject to the results of further inspections by the British authorities in the coming weeks. Last year there were about 61 million doses of the vaccine that were produced as opposed to the normal amount that is about 80 million doses.

GlaxoSmithKline, the British company, is applying to enter the American market this year with about 7 million to 10 million doses for this coming flu season..

(4/1/05)- Jeanne Santoli, an immunization expert at the CDC, said flu shots for the groups most at risk from influenza nearly matched the level of the previous flu season, despite the early shortage of the vaccine. Some 16 to 17 million Americans voluntarily gave up their flu shot this past winter to help alleviate the shortage.

The vaccination rate for "priority adults"-those over 65, the sick and health-care workers with direct patient contact-was over 43% for the 2004-05 flu season compared with the 48% rate for the prior flu season.

(3/7/05)- According to the Centers for Disease Control and Prevention the incidence of influenza steadily increased in January and February, and has not clearly peaked yet. New York City, Washington and 33 states have reported widespread outbreaks of the disease. About one half of the flu strains that have been isolated so far are of the California strain, which has emerged since the beginning of the season. The California strain of the flu is a variant of the strain that was expected, so that this season's flu shot may not fully protect against it.

The British Medicines and Healthcare Products Regulatory Agency granted Chiron Corp. permission to resume the production of its flu vaccine from its plant in Liverpool. This is the plant that had been shut down in 2004 because of safety issues in connection with the production of its flu vaccine that resulted in shortages of the vaccine in this country.

Even though the company can begin production of the vaccine again, it still needs approval from the FDA in this country before it can begin to sell it here. Dr. Jesse L. Goodman, the director of the FDA's branch in charge of vaccines stated, " They do still have a number of things to do to convince the FDA, and make us comfortable that the vaccine they produce will be as safe and effective as we expect."

GlaxoSmithKline, which sells a flu vaccine overseas that was used by us to help alleviate our shortage this past winter, has said it hopes to enter the American market this year, and could supply between 10 to 15 million doses of the vaccine. The company is presently running into a safety issue in connection with its production of its drug PaxilCR, the controlled release of its Paxil drug which came off patent recently.

(2/23/05)-Have health officials erred in emphasizing the flu vaccination of the elderly, when in fact the emphasis should be on the young, since they are the greatest spreaders of the disease? The results of a study that was led by researchers from the National Institute of Health suggests that giving the flu shots to the elderly has not saved lives. Lone Simonsen, a senior epidemiologist at the National Institute of Allergy and Infectious Diseases in Bethesda, MD led the study group that examined the data over the last 3 decades.

Most medical experts agree that schoolchildren are the biggest spreaders of the disease. According to the Centers for Disease Control and Prevention (CDC) about 59% of older Americans got flu shots in 2004, down from 65% in 2003. In examining the data, the team of researchers could not find any appreciable decrease in the death rate for the elderly as a result of taking the flu vaccination.

The CDC announced that, in spite of this study, it has no plans to change its advice on who should get the flu shots in the future. A single study should not cause a change in policy, said CDC spokesman Glen Nowak.

(1/25/05)-The New York State Department of Health announced that it was lifting all restrictions in regards to making the flu shot available to any resident of the state who wants to get the shot. The department is presently distributing an extra 70,000 doses that it recently received. There are at least seventeen other states that have eliminated all restrictions in regard to administering the flu shots. The states that have lifted all restrictions are, Alaska, Cal., Col., Kan., Mass., Mich., Minn., Neb., New Mexico, N.Y., NC, Okla., Ore., SD, Utah, Wis., and Wyo.

In all probability most of the other states that have not lifted the restrictions on the flu vaccine will do so shortly. It is even beginning to look like there will be many extra doses of the vaccine available, so that the extra supply will have to be thrown away. The flu season lasts through at least March, but many individuals who have not gotten the shot, will not want to have one by the end of the flu season.

(12/21/04)- An advisory panel to the CDC has recommended that there is now sufficient flu shots available so that all people 50 years and older, and also people who come in close contact with those at high risk for the flu receive the shot. The panel, the Advisory Committee on Immunization Practices made its recommendation to the CDC, and the recommendation is usually followed by the agency.

The expanded recommendation will apply only to areas where there is an excess supply of the vaccine. Only about half of the group that is at high risk has gone to get the flu so far this year. An estimated 50 million people are aged 50 to 64, according to the centers, with about 13.5 million of this group estimated to have chronic illnesses.

The flu vaccine is good for one flu season only, since the strain changes from year to year. Any excess must be disposed of at the end of the season, so it is next to impossible to figure how many doses will be needed year to year. That is one of the reasons that there are so few companies that make vaccines in this country. The other reason for the hesitancy for companies to go into the vaccination business is because of the large risk of being sued for any problems that may arise as a result of having gotten the shot. Insurance companies charge the vaccine manufacturers substantial premiums for risk coverage so it is not financially worth the risk.

For those who recommend that the federal government go into the business of buying a set amount of the vaccine, they must look at the fact that the manufacturers have had to throw out the excess batches for the last several years. Last year for example was one in which the flu season started very early and hit a lot of people. By the end of the year, however, it turned into a normal "flu season" year.

(12/5/04)-Outgoing Secretary of Health and Human Services Tommy Thompson is expected to announce tomorrow that his agency will allow some 5 million doses of foreign flu vaccinations into the U.S. from GlaxoSmithKline and ID Biomedical. This additional amount of vaccination should be available to be used by high-risk individuals in various states shortly thereafter. The FDA has inspected the plants that produced the vaccine and is attesting to the safety of the product.

(11/13/04)-In an odd twist of fate Illinois Governor Rod R. Blagojevich, who has been a prime proponent in favor of the importation of prescription drugs from overseas, is being instrumental in helping alleviate the flu vaccine shortage. To see more about Governor Blagojevich on the issue of importation of drugs from overseas please see our article on this topic at "Crossing the Border to Obtain Cheaper Prescription Drugs-Part IV"

New York City obtained 200,000 doses of the flu vaccine with the help of connections that the state of Illinois had made with overseas suppliers through the discount network site that the state operates using overseas distributors. Illinois also has helped the state of New Mexico obtain 150,000 doses of the flu vaccine through these same sources.

The vaccine that New York City is buying from Aventis Pasteur in France and GlaxoSmithKline in Germany costs about $10 a dose. The FDA must first inspect the vaccine for safety, as well as the plants that are producing it before it can be sold in this country. The city will also be obtaining 375,000 doses of the flu vaccine from the CDC.

The vaccine will be made available only to high-risk individuals, which means adults 65 and over, children ages 6 months to 23 months and the chronically ill. The city estimates that there are 1.1 million adult New Yorkers who are at high risk of getting the flu. It is unknown at this time how many of the high risks adults have already received their flu shots. There have been 4 deaths reported so far in the city at a nursing home in Queens as a result of the flu.

(11/9/04)-As of November 1, 28 states have reported flu outbreaks. At this time last year the outbreak had been reported in many more states, but exact comparisons are meaningless from year to year. The U.S. supply of flu vaccine is estimated to be at about the 60 million-dose mark. Aventis will make available an additional 2.6 million doses in January and Medimmune said that it would have an additional 1 million of its nasal spray also available shortly. Five million more doses will also be available shortly from plants in Germany and Canada.

Last year about 83 million doses of the vaccine were used in the U.S. With at least 68.6 million doses available by January we should be able to get bye if there is not a serious flu epidemic outbreak. It has been estimated that over 1 million doses were used by Americans either overseas, or by obtaining the shot by "other means".

(10/31/04)-The CDC is close to coming to an agreement with some European countries for the purchase of several million doses of flu vaccine that will be used for flu shots to be given to high-risk individuals, nursing home residents and children under 2. The Governor of Illinois, Rod Blagojevich has written a letter to the FDA asking for permission to allow the state to import 30,000 doses of the vaccine from Europe to be administered to high-risk individuals in the state.

The CDC also announced that for the first time in its history it has created a permanent panel of ethicists on the question of vaccine distribution. The purpose of the panel is not only to deal with the present question in regards to the distribution of the flu vaccine, but also to deal with how the agency should deal with any future epidemics.

(10/28/04)-Federal health officials are warning the nation's elderly to get their pneumococcal vaccinations, but at the same time advising us that the pneumonia vaccine is in short supply. Merck & Co. the nation's only manufacturer of the vaccine, called Pneumovax 23 said that they intended to triple production immediately to fill an expected surge in orders.

Merck is the sole provider of vaccines against measles, mumps and rubella, chicken pox and pneumococcal pneumonia in this country. The most common complication from the flu is pneumococcal infections getting into the lungs after the flu weakens immune defense. Most deaths from the flu are caused by pneumonia, which is the 7^th leading cause of death in this country.

Pneumovax 23 is only partly protective since it reduces the risk of contracting the disease by 60% to 70%. The vaccine's effectiveness fades with time, so that health officials recommend that it be retaken every 5 years. The vaccine sells for about $20 a dose.

According to the Wall Street Journal, which had obtained a draft of a news release from Chiron Corp. dated September 27, 2004, the company was preparing to tell investors and health officials that its "internal quality assurance confirmatory testing" of its Fluvirin vaccine "failed" to provide results necessary to permit release of the vaccine to the market. Again according to the draft, Chiron could not pinpoint the source of the contamination, "prompting the company to withhold its release of Fluvirin." On September 28^th the company issued a news release declaring its intention to ship the vaccine on time. On October 5^th U.K. health officials suspended the manufacturing license of their plant in Liverpool.

(10/23/04)-The New York City Health Department is administering flu shots throughout the city during the work week. A limited amount of shots are being administered daily to high risk individuals, so check for the locale nearest you where shots are being given. The Web address to see is: https://a816-health12ssl.nyc.gov/dohroot/prjflp/

(10/20/04)-Please keep in mind that even though you have gotten a flu shot, it does not guarantee you of the fact that you can't catch the flu. Remember that health officials and vaccine manufacturers have to prepare the vaccine many months before the flu season begins in October so they have to make educated guesses as to which strain of the virus is the one that most likely will spread its ugly face throughout the world. Sometimes the guess can be wrong, or even if it is the right strain vaccine that you received, it doesn't mean that you can't still get the virus.

If you do get sick with the flu there are several antiviral drugs that are available with a doctor's prescription that can be used to cut the duration and extent of the disease by a day or two. The Centers for Disease Control and Prevention (CDC) is building a stockpile of antiviral drugs in case a shortage develops because of the high number of flu cases for the rest of the 2004-05 flu season. The CDC is also drawing up a plan to prioritize the antiviral drugs to high-risk individuals in case supplies run low. The CDC is also working with the manufacturers of the antiviral drugs to increase production this year, just in case a problem should develop.

Antiviral drugs are easier to manufacture than are the flu vaccines as long as the raw materials to make the drugs are available. The most popular antiviral drugs that are on the market, but can be bought only by prescription are:

• Amantadine (generic) from Novartis;
• Flumadine from Forest Labs;
• Relenza from GlaxoSmithKline and
• Tamiflu from Roche.

(10/18/04)- With the federal government desperately seeking extra dosages of the flu vaccine from overseas sources, and long lines forming at sites that are administering the flu shots, it is time for us to stand back, and look at some of the basics in connection with the disease. For more detailed facts in connection with the disease you may want to look at the site for the disease from the Centers for Disease Control (CDC) at www.cdc.gov/flu .

One of the most important facts to know about the disease is that it is contagious. As its name implies it is a respiratory illness caused by the influenza virus. The degree of occurrence varies greatly in regards to the percentage of the population that it affects. Please keep in mind, that in spite of all the publicity early last year that a flu epidemic was about to occur, it never did materialize in most states.

The symptoms of the flu include:

• fever (usually very high),
• headache,
• extreme tiredness,
• dry cough,
• sore throat,
• runny or stuffy nose, and
• muscle aches.
• Gastro-intestinal symptoms, such as nausea, vomiting and diarrhea, are much more common among children than adults

All of us can practice good health habits to prevent the onslaught of the disease. Most of the time the germ is picked up in your hands. Therefore it is important to wash your hands frequently throughout the day. Avoid touching your eyes, nose or mouth since the germs will spread from your hands to your respiratory system by entering your body through one or several of these orifices. Cover your mouth and nose whenever you sneeze or cough. Try avoiding as much as possible close contact with a person who has the disease.

Chiron Corp. announced that it had received a subpoena from the U.S. attorney's office for the Southern District of New York, in connection with its flu vaccine, Fluvirin. A grand-jury subpoena from the U.S. attorney's office typically implies a criminal investigation. In June 2003 FDA officials documented what they called "deviations" from good manufacturing standards at the Chiron plant in Liverpool. John Taylor, the FDA's associate commissioner for regulatory affairs, said "systemic quality-control issues" led inspectors to conclude that Chiron wouldn't necessarily be able to discover problems, identify the root cause and take steps to prevent similar issues from arising again.

In speeches to investors and in testimony to a Senate committee on September 28, 2004, Howard H.Plen, Chiron's chief executive said that the company had detected bacterial contamination in a small number of lots in its flu vaccine in August, but that it was not a major problem. He further stated that the company was on track to begin shipping 46 million to 48 million doses of the vaccine in October. On October 5^th, the company said that it was completely surprised when the British health authorities suspended its manufacturing license for 3 months because of quality control problems at its Liverpool plant.

(10/6/04) Health and Human Services Secretary Tommy Thompson said that he is dispatching a team of FDA scientists to Chiron Corp.'s plant in Liverpool England to check into why the British regulatory authorities had suspended the license of the company for three months. Chiron is one of the two largest suppliers of the flu vaccine to the U.S. Chiron was expected to supply this country with about half our flu vaccine supply for this fall and winter flu season. None of the flu vaccine supply produced by Chiron at this plant will be available to be used in this country.

Secretary Thompson said that U.S. authorities were completely surprised by this development. The Chiron plant in Liverpool had produced about 6 to 8 million vaccine doses at this plant. Chiron had planned to ship between 46 to 48 million doses of the vaccine out of the total of 100 doses that was expected to be used this coming flu season in the U.S.

The other major supplier to the U.S. is Aventis, a unit of Sanofi-Aventis of France, which is expected to supply between 54 to 56 million doses of the vaccine. Medimmune Inc. is expected to supply between 1 to 2 million doses of its FluMist nasal spray, but keep in mind that this spray is more expensive than is the flu inoculation shot.

Healthy adults have been requested to delay getting their shots until the higher risk individuals have received their shots. The health authorities have also requested that corporations that normally get a shipment of the vaccine for their employees defer receiving their shipments until later in the year. We at therubins would like to remind our viewers that one of the best precautions that you can take to avoid getting any disease is to wash your hands a little more frequently than you would do normally.

For the first time federal officials are officially recommending a flu shot for children from 6 months to 23 months old, after merely encouraging them in previous years. Experts expect that this will mean about 13 million infants and toddlers will be added to the list of those most exposed to the disease.

About 100 million doses of the shot were originally expected to be available this year as opposed to the 83 million that were available last year. Many of you still remember the early shortages of the shot because of the early outbreak of the flu in many communities. The federal government estimates that there are about 185 million Americans who are considered at high risk at coming down with the flu.

By the end of the flu season in 2003 at least 152 children under the age of 18 had died of influenza related causes. There will be about 19,000 locations set up throughout the U.S. where you can get the shot at a site other than your own physicians' office. To find a site near you where you can get the shot go to www.findaflushot.com. Users can type in their ZIP code to find the place closest to them to get the shot.

The Centers for Disease Control and Prevention announced that a study of more than 1,300 people in Colorado found that the flu vaccine used last year was effective more than half of the time. This was true even though the shot wasn't an exact match for that particular strain of the disease. The shot is normally effective 90% of the time.

The vaccine worked about 52% of the time for healthy adults, and 38% of the time for those with previous medical conditions. The CDC reported that the flu shot "still provided substantial health benefit."

The CDC announced that the government would stockpile about 4 million doses of flu shots this year that will be set aside for children under 18 years of age. Dr. Stephen Cochi, acting director of the national immunization program said that the government expects to spend about $80 million over the next two years to pay for the stockpile.

The stockpile will be set aside for children under 18, but some adults may be allowed to use that supply in a crisis, if approved by Congress, according to Lance Rodewald, director of the immunization services for the CDC. This past flu season turned out to be a typical one even though it got off to a fast start. In this past flu season 143 children died of the flu. In an average flu year about 20% of the population will be affected by the flu and about 114,000 will be hospitalized by the disease.

Only 36% of health workers receive influenza vaccinations each year according to the National Foundation for Infectious Diseases. The foundation urged an advisory panel for the Centers for Disease Control and Prevention to take stronger action to increase compliance with the long standing federal recommendation that such workers be immunized both for their own and their patients protection.

The panel, the Advisory Committee on Immunization Practices, has recommended flu vaccinations for health care workers since 1986. The Department of Health and Human Services appoints the 15-member panel to advise the CDC on immunization matters. How can the CDC be urging people to get the flu shots when members of the health community are not getting such shots themselves?

Well the results for Medimmune's FluMist vaccine continue to show that it is not being used by the public to any great extent. According to the latest figures about 80% of the vaccine went unused, even when there was the great hullabaloo about the flu vaccine shortage in the winter of 2003. According to an official of Medimmune the remaining supply of the vaccine will have to be destroyed.

Pharmaceutical companies made about 87 million doses of the vaccine for use in the U.S. during the 2003-2004 flu season, which was about 8 million fewer than were made for the 2002-2003 flu season. In the 2002-2003 season about 12 million dosages of the supply of the vaccine had to be destroyed because of nonuse, while the basically the entire supply was used in the 2003-2004 season.

Medimmune said that intends to ask the FDA to expand approval for FluMist to include children younger that 5years of age, and adults ages 50 to 64 for the next flu season. At least 135 children in 39 states have died from influenza so far during this flu season, though the deaths could not be solely attributable to the flu alone.

Both the World Health Organization and the FDA have recommended changes to two of the three stains of virus to be used in next season's influenza vaccine in the Northern Hemisphere. The choice has to be made at this time of the year, because it takes several months to adapt the virus growth in the eggs and to buy the tens of millions of eggs needed to produce a supply for the consumers of the vaccine.

For next season the Fujian strain will replace the strain known as A/Moscow. The B/Shanghai strain will replace the B/Hong Kong strain, while the A/New Caledonia strain will stay the same. Although February can still be a very risky month for those who will suffer from the flu, the worst seems to be behind us now. As of the last report there are no states that are experiencing widespread outbreaks of the flu.

A small study conducted by the Centers for Disease Control and Prevention has found that this season's influenza vaccine failed to protect against the Fujian strain that has caused most cases. The study involved a questionnaire sent to 3,100 health workers at Children's Hospital in Denver asking whether they had been vaccinated, when and whether they developed an illness compatible with influenza. The study involved the period of time from October through late November when Colorado experienced the height of its outbreak of the disease.

Because only 61% of the health workers responded experts said the study is of limited use. Many larger studies are now first being evaluated and we will get these results shortly. According to the Colorado study however only between zero to 14% of those who got the shot ended up being protected from getting the disease up to the end of 2003.

According to Dr. Stephen M. Ostroff, an official with the CDC the influenza season appears to have reached its peak in this country. It is however too early to tell whether the number of flu cases will decline sharply or stay at a plateau for another few weeks. Dr. Ostroff also said it was still too early to know whether a second wave would occur later in the winter.

Unfortunately the flu is notoriously unpredictable. In past years the ebb and flow of the effected areas has made predicting the path of the disease impossible. The duration of the peak period could be crucial in determining the severity of the outbreak. Past experience has shown that February is another month of high incidence for the disease.

Aventis, one of the two major manufacturers of the vaccine announced that it would team with Crucell, a Dutch biotechnology company to produce flu vaccine in cultures of human cells, rather than in hen's eggs. This new vaccine will not even begin to be tested in people until 2005 and will not be approved for use for several years thereafter.

As the CDC struggles to find some flu vaccine throughout the world we have to look at how concerned we should be in connection with this outbreak. Since the strain of the flu that is causing this current outbreak is not a new one, you should be vigilant but not overly concerned about it. Since this strain is similar to the one that took place in the 1990s it is not a pandemic flu situation.

Many of us have built up some immunity to the strain since we were around for the prior outbreak. Medical professionals say that for a child under 8 years of age, a booster shot is necessary within 30 days of the first shot for the vaccine to be effective. Incidentally the same is true for children who receive the FluMist protection. There is enough of the vaccine being made available so those children under 8 will receive a priority in getting whatever vaccine is available.

Preventive measures should be taken whether or not you receive the shot. Wash hands often, and avoid touching your eyes, nose or putting your hand in your mouth. These orifices are the gateways for the virus to enter into your body. There are four antiviral medications on the market that can shorten the course of the disease by a few days if you start taking them immediately upon onset of the illness. Their brand names are Tamiflu, Symmetrel, Flumadine and Relenza.

The Department of Health and Human Services said that it has bought an additional 375,000 doses of the flu vaccine from Chiron Corp. This vaccine is in bulk form, and must be separated into individual doses before it can be distributed to state and local health departments. It seems as if the two states that were the first to reach epidemic conditions with the flu, seem to have seen the number of reported cases of the disease fall off in the last few weeks. Those states are Colorado and Texas.

The administration said that it plans to help modernize vaccine manufacturing to avoid future shortages and prepare for a possible pandemic outbreak in the coming years. The administration has asked Congress to approve $50 million in the pending budget that Congress will consider in January to help modernize and improve the facilities that make vaccines in this country. Funds would be spent to encourage the industry to diversify into newer and faster technologies.

Baxter International Inc.of Deerfield Ill., said that it expects to launch a new flu vaccine in Europe in 2005 that is produced using vero-cell technology instead to using egg cells to produce the vaccine as is the present methodology. Crucell NV , a Dutch company, has also developed its own technology for using a cell line to produce the flu vaccine.

The CDC was too premature when it announced that for the second year in a row there would be enough flu vaccination available for everyone who wants it. The two biggest producers of injectible flu vaccine, Aventis SA and Chiron Corp. reported that they no longer have any supply of flu vaccine available in this country. We have to be alert to the fact that when we last had an outbreak of the disease in 2000, some disreputable wholesalers took advantage of the situation by inflating their price for the vaccine.

Vaccine manufacturers have produced over 83 million vaccines this year, but unlike last year when over 10 million of the vaccines went unused, and had to be thrown away, it looks like there will be shortages of the vaccine this year. Because flu strains vary from year to year, a new vaccine must be formulated every year. It takes several months to produce the vaccine for any given year, so that is why it can not be produced on demand.

Influenza cases are surging so that there were only 5 states that were able to say it had not reached epidemic stages in their area. What the officials hope to do is to find out what areas have shortages of the vaccine and which have more than a sufficient supply to meet their pending needs. Dr. Keiji Fukuda, chief of the influenza epidemiology branch of the Centers for Disease Control and Prevention stated: " This is looking like a year when more vaccine is being used by more people in the U.S. than any other year."

The flu season usually peaks in January, but it is off to a much earlier start in both Europe and the U.S. so far this year. Colorado has seen the outbreak of the disease hit over 6,300 individuals so far this year, with at least 6 children having died from the disease. The 6,300 reported cases of the disease already exceed the 6,239 cases that were reported in the state for the two previous years. Of the 6 children who died of the disease, three had pre-existing conditions that complicated the matter.

The CDC analyzed a number of samples from labs across the country and found that 82% were Fujian A strain and 18% were the Panama A strain. The vaccine that was prepared for this year's batch of vaccine was aimed at the Panama A strain, which is related to the Fujian A strain so the vaccine may still be helpful in warding off the disease. The vaccine this year protects against three other strains, two forms of influenza A, and one of influenza B.

So far New York City has been spared from the onslaught of the disease, with reported cases of influenza running only slightly ahead of last year's numbers. According to Health and Mental Hygiene Commissioner Thomas R. Frieden, the city has about 500,000 cases of influenza in a "normal" year. The commissioner stated that only 37% if residents 65 and older received the flu shot.

Information about the flu and the vaccine can be found at the CDC's web site: www.cdc.gov/ncidod/diseases/flu/fluinfo.htm The CDC has not found a shortage of the vaccine in Europe, and has stated that it would redistribute the vaccine as needed.

The vaccine that is now being given was not developed to protect against a strain of the virus that has surfaced in this country this fall, but the CDC is optimistic that this year's vaccine will stave off a serious outbreak of the disease. The flu vaccine includes three strains of influenza virus, but was not designed to protect against a new one that has appeared in a number of countries over the last year. It is known as the Fujian A strain, a variant of the Panama A strain this is included in the current vaccine. Both are categorized as H3N2 strains that have been linked to higher rates of serious illness requiring hospital admissions.

Although the World Health Organization committee that makes the recommendations for the flu vaccine knew about the Fujian strain in February they were aware of the fact that not enough of the vaccine could be prepared in time for the flu season in the Northern Hemisphere. Since the flu season usually takes place in the wintertime, the vaccine being prepared for the Southern Hemisphere will contain the Fujian strain. Texas and Colorado were the first two states to have been hit hard by the disease.

Chiron, which is located in Emeryville, California recently completed its merger with Powderjet, said it prepared about 40 million dosages of the vaccine this year. It expects to supply about half the U.S. market this year. Aventis, which is based in Strasbourg, France also, has experienced a sharp increase in its flu vaccine sales this year.

The flu season typically runs from November through March. On average more than 36,000 Americans die from the flu each year and more than 114,000 are hospitalized as a direct result of it. This will be the first flu season that a nasal vaccine, FluMist, made by Medimune Inc. and marketed jointly with Wyeth will be available. The FDA approved it for sale in June of 2003 to healthy individuals between the ages of 5 through 49.

The companies had planned an initial product run of four to five million doses of FluMist. FluMist dosages are being sold to doctors and pharmacies for $46 each as compared to a cost of between $7.50 to $8.50 for an injection. Even thought the makers has spent $25 million on an advertising campaign that was rolled out this fall, the sales of FluMist have flopped badly. So far about 400,000 doses have been sold, and not many more sales are expected for the nasal spray vaccine.

In addition to the poor sales the manufacturers are faced with the prospect of many of the pharmacies returning the product. Unlike the injectible vaccine, which is non-returnable, the spray mist product can be returned to the manufacturer, and the payments are refunded. FluMist must be kept frozen till used and it contains a live virus that is made from attenuated flu viruses. To try to help sales Wyeth and Medimmune are now offering consumers mail-in rebates of up to $25.

According to a study, which reviewed data from about 286,000 patients over the age of 65, the risk of being hospitalized for cardiac disease fell by 19% and for stroke by as much as 23% for the elderly if they had taken the influenza shot during the flu season. The study was led by researchers at the Veterans Affairs Medical Center in Minneapolis and the University of Minnesota. The study also showed that those over 65 who received the vaccination for flu were as much as 50% less likely to die from any cause during the same period and 32% less likely to be hospitalized for flu or pneumonia.

Lead researcher Kristin Nichol, chief of medicine at the Minneapolis VA center, said the vaccinations' benefits appear to stem from the prevention of flu rather than any direct medical or chemical impact of the vaccine itself upon heart disease or stroke. According to a recent federal report, there are about 36,000 annual deaths now attributed to the flu-related causes.

The Centers for Disease Control and Prevention issued, for the first time, the following recommended schedule of vaccinations for people 50 and older:

• Flu shots-one each year;
• Pneumococcal vaccine-If 65 years of age or older, or if you have a chronic condition such as heart, pulmonary or liver disease, diabetes or HIV, a one-time dose, if last vaccinated more than 5 years ago or never;
• Tetanus/diphtheria-one booster dose every 10 years.

For more information and locations in your area to receive your inoculations, call the National Immunization Hotline at 1-800-232-2522 for English-speakers: 1 800 232 0233 for Spanish-speakers; and 1 800 243 7889 for TTY users

In spite of the availability of the flu vaccine, researchers now estimate that about 36,000 people a year die from the flu. Earlier estimates had put this figure at about 20,000 Americans every year, and most of the deaths are in people who are over 65 years of age. According to the latest figures that are available, which covers the period from 2000 to 2001 about 65% of adults who are on Medicare get annual flu shots and pneumococcal shots. Only 10% of adults under 50 who are at high-risk to get pneumonia get a pneumococcal vaccine shot.

The study, which was conducted by the Centers for Disease Control and Prevention, also estimated that about 11,000 people a year die from the respiratory virus RSV, with most of the deaths also occurring among the elderly. CDC Director Julie Gerberding said, "These data indicate that the magnitude of the problem is larger than we once thought."

The flu season was relatively mild in 2001 and 2002, but cases are likely to be increasing significantly in 2003. It is still not too late for those who are most at risk to get these vaccinations immediately. According to one measure detailed in the study, flu-related deaths in the U.S. nearly quadrupled, from 13,000 in the 1976-1977 season to nearly 46,000 in the 1998-1999 season.

The researchers further concluded that a large part of this increase was due to the fact that there was almost a doubling of those over 85years of age in the latter period from those over 85 years of age in the earlier period. The elderly are more susceptible because their immune system weakens with age.

Another factor was the predominance in the 1990s of an especially virulent strain, influenza A (H3N2), one of the three major strains of the flu virus. Of the total annual deaths over 90% of the victims were 65 years of age or older. In 2003 children under two seem to be suffering a higher than usual death rate from infuenza.

In the fall and winter of 2001 we were faced with a shortage of the flu vaccine. The U.S.Centers for Disease Control and Prevention (CDC) requested that only the most vulnerable individuals receive the flu shot at this time. Drug manufacturers shipped about 50 million doses by the end of October of 2001and another 29.1 million doses during November and December. Ideally, 80 million doses should have been available by late October. Since 2000 the CDC has recommended that those in the age category of over 50 receive the shot, whereas prior to 2000 the recommendation was meant mainly for those 65 or older.

A flu shot is recommended in the following cases:

• If you are 50 years of age or older;
• If you have a chronic heart disease, or problems with your lungs, kidneys or immune system;
• If you live with or care for a person with any of the above conditions;
• If you work in a health care facility.

Even though there was a flu vaccination shortage in 2000, somehow or other there is always a way for some firms to profit from shortages. Some of the smaller drug and vaccine-distributing firms managed to get a supply of the flu vaccine and sold it at up to 5 times its normal price. Some hospitals confirmed that they received offers from some small drug distributing firms which offering to sell the vaccine at up to $150 a vial versus its normal selling price of $20 to $30 per vial. A vial contains 10 doses of the vaccine.

The delay in 2000 was attributed in part to difficulty in growing two new influenza strains in that year's vaccine. The Food and Drug Administration had ordered two of the four manufacturers of the vaccine to correct production problems at their plants. King Pharmaceuticals, Bristol, Tenn. had to stop making flu vaccine because of its manufacturing problems.

The flu vaccine in 2000 protected against three strains of the disease. The two new strains are A/Panama and A/Caledonia. The third strain is B/Yamanashi, which was in 1999's strain. Growth of the two new strains vaccines was much more difficult than originally estimated. The peak of the flu season usually takes place starting late November.

Recipients of the vaccine develop the immunization one or two weeks after receiving the inoculation. Presently there are four manufacturers of the vaccine for usage in the U.S. They are Evans Medical, an affiliate of Medeva Pharmaceuticals; Aventis-Pastur (manufacturer of over half of this country's vaccine supply); Parkdale Pharmaceuticals; and Wyeth-Ayerst Laboratories Inc a subsidiary of Wyeth. Wyeth-Ayerst has also encountered manufacturing problems that forced it to scale back production until the problem was remedied.

In 2000 only 27 million doses of the needed 75 million doses of the flu strain vaccine were available by the end of the month of October. By that time in 1999 nearly all of the needed flu strain vaccine had been released. The shot is most effective if given before the height of the flu season, which normally begins about the end of November. The Center for Disease Control estimates that flu kills 20,000 people (new estimate is it now kills about 35,000 people a year) a year and hospitalize another 110,000.

In 14 of the last 18 flu seasons the highest number of cases did not show up until January. The problem is compounded by the fact that the manufacturers of the vaccine have contractual obligations with many employers who locked in delivery of the vaccine many months ago. In times of vaccine shortages the CDC requests that the manufacturers of the vaccine voluntarily delay receipt of the vaccine until later dates. The manufacturers often request that the employers who have contracted for their shipments of the vaccine, substitute nursing homes, instead of themselves, for the early shipments.

Vaccination may not only help the individual, but also may prove beneficial for our economy. Nichol et al in a study that appeared in the Archives of Internal Medicine (1999; 159:2437-2442) looked at the health and economic benefits associated with pneumococcal vaccinations of the elderly.

He studied 1,898 individuals with chronic lung disease, aged 65 and older -67% of these individuals having received pneumococcal vaccination- over a two year period of time which included two influenza seasons. During that time, 174 individuals were hospitalized for pneumonia and influenza and 1,477 were hospitalized for non-pneumonia illness and 275 patients died.

Nichol and associates state "Pneumococcal vaccination was associated with a 43% reduction in the numbers of pneumonia- and influenza-related hospitalizations, and with a 29% reduction in the risk of all-cause deaths. There was no significant difference between the vaccinated and unvaccinated persons with regard to the risk of non-pneumonia-related hospitalization.

During the two influenza seasons, patients who received both pneumonia and influenza vaccines had a 72% reduction in the number of hospitalizations for pneumococcal pneumonia and influenza and an 82% reduction in the risk of death, compared with persons who did not receive either vaccine".The authors of this study estimate a 2-year cumulative cost savings of $113 to $512 for each person vaccinated.

Pneumococcal vaccination is a way to enhance your chances to weather the ravages of a winter season at the least possible risk. Consult your physician as to whether you are at risk for the diseases of influenza and pneumonia and see if you can benefit from vaccination. The research evidence would support such a step.

Remember that advancing age brings with it an increased vulnerability to infectious agents. Infection is the fifth most common cause of death in the elderly population, with viral and bacterial pneumonia leading the list.

(The reference for the above material is: Nichol KL, Baken L, Wuorenma J, Nelson A. The health and economic benefits associated with pneumococcal vaccination of elderly persons with chronic lung disease. Arch Inter Med 1999; 159:2437-2442.)

In a study led by Dr. Peter T. Ender, of the Wright-Patterson Air Force Base Medical Center near Dayton, Ohio and a team of military doctors, and published in Infectious Diseases in Clinical Practices (2001:10:81-85), it was determined that multivitamins do not enhance the effectiveness of the flu vaccine.

The object of the study was to look at the role of multivitamins in interaction with the flu vaccination. Findings indicate that subjects that took multivitamins for 100 days before getting their flu vaccination had a poorer immune response 1-month after vaccination when compared with those who took placebo.

One possible reason for the poor response in multivitamin users, Dr. Ender said, is that the supplement used in this study included vitamins A, B, C, D, E, as well as thiamine, riboflavin, niacin, folate and pantothenic acid, but no trace elements such as zinc. Other recent studies have suggested that multivitamins containing those trace elements do have beneficial effects on the body's immune response.

Dr. Ender concludes that: "Physicians and patients should be cautious with multivitamin use. Depending on the combination, they may have harmful rather than beneficial effects."

This study should not be viewed as a definitive statement on the role of vitamins in retarding the flu vaccine. It would have to be repeated with greater control of the content of the vitamins taken and a longer period of time after the flu vaccination. There may also be a genetic and/or personality difference in those individual who take vitamins as opposed to those who do not take vitamins that can have potentiating or debilitating effects on the flu vaccination.

The FDA has approved the flu drug Tamiflu, made by Roche Holding Ltd. for prevention of the flu. The recommended dose for prevention is one pill a day for 7 days, if a family member has come down with the flu. For prevention in a nursing-home setting, the drug is taken for up to 42 days.

The drug had been previously approved by the FDA for treating the flu. Both the FDA and Roche have stressed that the drug is not a replacement for the flu vaccine. The average wholesale price for its 10-pack is $49. In clinical trials conducted among nursing-home residents who took the recommended dose, less than one-half of 1% came down with the flu. Among residents who took a placebo, or sugar pill, 4.4% came down with the flu.

We have all heard of the importance of getting a flu shot, but we would like to remind you that getting your pneumococcal polysaccharide vaccine (PPV) shot is just as important to anyone in the over 65 age grouping. Federal officials now recommend that anyone 50 years and above get the pneumonia shot.

The vaccination will protect you against 23 types of pneumococcal bacteria, and it has been available for over 17 years. Bacterial pneumonia caused over 40,000 deaths in 1999, of which about 90 % fell into the over 65 age catagory. One of the deadliest types of pneumonia results from a staph bacterial infection in the lungs that unfortunately infect the blood stream also.

Pneumococcal disease is a leading cause of illness in young children and is one of the leading causes of death amongst the elderly. As a matter of fact pneumococcal disease kills more people in the U.S. each year than all other vaccine-preventable diseases combined. A certain type of bacterium called Streptococcus pneumoniae causes the disease.

When these bacteria invade the lungs, they cause the most common kind of bacterial pneumonia. The bacteria can also invade the bloodstream-to cause bacteremia-or the brain-to cause meningitis. About 1 in 20 who get the disease will die from it. About 2 in 10 who get bacteremia, and 3 people out of 10 who get meningitis, will die from it.

Pneumococcal diseases account for over 40,000 deaths in the United States, and sadly enough, about one half of these deaths might not have occurred if the individual had been vaccinated. This type of disease causes an estimated 500,000 cases of pneumonia, 50,000 cases of bacteremia, and 3,000 cases of meningitis each year. The disease can be treated with several different antibiotics, including penicillin and broad-spectrum cephalosporins.

However, the bacterium S. pneumoniae, which causes pneumococcal disease, is developing resistance to the antibiotics usually used to manage the infection. High levels of penicillin resistance and multi-drug resistance often complicate the management of pneumococcal infections. This just further underscores the importance of getting your pneumococcal vaccination. It has been shown that the vaccine protects against up to 90% of the pneumococcal bacteria types that cause the disease. Furthermore, the vaccine can be administered to appropriate high-risk individuals at any time during the year. Please remember that the following preventive measures are partially or fully paid for by Medicare:

• Flu vaccine.
• Pneumococcal vaccine.
• Mammogram.
• Pap smear and pelvic exam.
• Free PSA exam
• Screening tests for cancer of the colon and rectum.  

An estimated 1 million Americans suffer a painful shingles attack each year. According to the New England Journal of Medicine those in the 60-69-age category have a 3 times higher incidence of shingles than those in the 40-49-age category. One reason that may explain this increase is the progressive weakening of the immune system as we age.

There is some scientific evidence that a vaccine to prevent chicken pox may also prevent the occurrence of shingles later in life. Dr. Abbas Vafai, chief of biologics at the Center for Disease Control and Prevention in Atlanta believes he has developed such a vaccine. The varicella-zoster virus usually lingers behind after the signs of chicken pox disappear. It lies concealed hiding in the sensory nerve cells near the spinal cord. It stays dormant there for many years until rearing its ugly head in the form of shingles to torment the aging sufferer. It painfully affects approximately 1 million people each year since it pinches the nerve cells.

There are no drugs currently available to prevent the disease from occurring or recurring. Dr.Vafai's vacine does not use a live virus. It utilizes a piece of glycoprotein to attach to the surface of the varicella-zoster virus. His patent # 5,824,319 was assigned to Research Corporation Technologies. Experts now suggest taking an antiviral agent such as Famvir or Valtrex within 3 days of the first signs of a rash or unusual skin sensitivity. In addition to nerve injections of anesthetics, pain centers are using radio wave induced heating as well as freezing to kill the nerves causing the pain.

In an article written by Abigail Zuger in the New York Times entitled" Making Inroads in Fight Against Shingles Pain" dated February 15, 2000 the author discusses the possible relationship between shingles prevention and chickenpox vaccination. Researchers have undertaken a study wherein a weakened strain of the chickenpox vaccine is administered to older adults who had been inoculated with the vaccine when they were young children.

Early indications show that in addition to boosting the immunity against chickenpox, the inoculation also has the added benefit of reducing the severity of the shingles attack. The researchers are presently looking for 37,200 volunteers to join in the study. If you are over 60 and want to volunteer for the study being headed by Dr. Michael Simberkoff, chief of staff for the VA medical system in the New York area.

The Shingles Prevention Study is a VA Cooperative Study carried out with the collaboration of the NIH and Merck & Co. It is a double blind, placebo controlled trial that is enrolling 37,200 adults age 60 and over. Participants will be followed by telephone for 4 years and any that develop shingles will be evaluated and offered state of the art treatment without charge. If the vaccine is proven effective, people who received the placebo will be offered the vaccine at the end of the study, before it becomes available to the general public. One of the editors of therubins is presently enrolled in this study group.

Updating this study-the study that we mention above has been completed and the subjects who took part in it are being debriefed at this time. We will keep you apprised of the results as soon as we hear what they are.

For more info please call 1-888-845-4540 in New York. Outside NY the Nationwide Toll-Free Number is 1-877-841-6251.

See our Article on Respiratory Infections

FOR AN INFORMATIVE AND PERSONAL ARTICLE ON PRACTICAL SUGGESTIONS WHEN SELECTING A NURSING HOME SEE OUR ARTICLE "HOW TO SELECT A NURSING HOME"

Allan and Harold Rubin, MS, ABD, CRC, Guest Lecturer
updated May1, 2008

http://www.therubins.com

To e-mail: hrubin12@nyc.rr.com or rubin@brainlink.com

Return to Home