http://www.sfgate.com/cgi-bin/article.cgi?file=/c/a/2004/10/24/FLU.TMP
San Francisco Chronicle

Scarce flu vaccine not designed for new strain
New Zealand variety worries officials

Sabin Russell, Chronicle Medical Writer
Sunday, October 24, 2004

As Americans scramble for scarce doses of flu vaccine in hopes of warding off the respiratory bug this winter, the wily influenza virus may have other plans. Through a natural process known as antigenic drift, a new strain of influenza that can diminish the effectiveness of today's vaccine is already emerging on the far side of the world. A shortage of vaccine occurred when British regulators found contamination problems at a Chiron Corp. factory in Liverpool, effectively wiping out
about half the U.S. supply. The shortage has triggered a run on the remaining doses and a struggle by health authorities to keep the panic in check.

Officials said last week they are optimistic that those who do manage to get a flu shot will be protected. But predictions are impossible, given the way the virus manages to dodge its attackers.
The emergent strain raising questions now is known as A/Wellington, named after the New Zealand city where it was first detected. "The flu season has been late this year, and it seems some people who have been vaccinated have been hit by this changing strain,'' said New Zealand Health Ministry flu chief Dr. Lance Jennings. 

Like weather forecasters watching tropical storms, epidemiologists for the World Health Organization track the ever-evolving strains of influenza. The predominant flu virus around the globe right now is one called A/Fujian, and the vaccine Americans are seeking today is a perfect match for it. But A/Wellington is gaining ground. Tests suggest that 43 percent of recent New Zealand flu cases spring from the new strain, or variants of it. A/Wellington has even turned up about as far from the South Pacific as is geographically possible: in Norway.

So convincing was the late season surge of A/Wellington that the WHO on Oct. 8 recommended that next year's flu vaccine for the Southern Hemisphere, which is shipped in March, be reformulated to protect against it. Dr. Nancy Cox, director of the Influenza Branch at the Centers for Disease Control and Prevention, said there is no way of knowing whether the A/Wellington strain will establish a beachhead in the United States this winter. "Influenza viruses are inherently unpredictable,'' she said in a telephone interview. One reason for concern is that laboratory animal tests suggest that the current vaccine -- which targets A/Fujian -- is about two-thirds less effective in stirring antibodies against A/Wellington than it is against the targeted strain.

That does not mean, Cox emphasized, that the current flu shot would be two-thirds less effective in actual use, should the A/Wellington strain turn up in the United States. People who regularly receive flu shots, she said, may have higher levels of antibody protection against influenza than the laboratory animals. "We would not anticipate that the Wellington strain will cause an enormous problem,'' she said. Doris Bucher, a flu vaccine expert at New York Medical College in Valhalla, N.Y., said the animal tests on A/Wellington are actually encouraging because they show that antibodies stirred up by today's vaccine will inhibit the new strain. "If Wellington rushed in and took over, people would have good protection with the current vaccine,'' she said.

Bucher's lab specializes in d eveloping strains of influenza that grow well in eggs and hence serve as the basis for each year's flu vaccine made from eggs. The current flu vaccine is made from a strain developed by her laboratory, and she is working right now on an A/Wellington-like strain for manufacturers who will make next year's vaccines. When flu vaccines are well-matched to the prevailing flu strains, the shots can prevent flu in 70 percent to 90 percent of vaccinated adults, according to the CDC. Well-matched shots may prevent flu in only 30 percent to 40 percent of nursing home residents, but they can reduce the death rate from influenza and pneumonia in that population by 80 percent.  Last year, the vaccine was a less than perfect match. American manufacturers need a nine-month lead to produce flu vaccine. That requires flu forecasters to predict in February what the prevailing flu strain will be November.

In February 2003, the Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee selected a strain called A/Panama as the target. Another strain, known as A/Fujian, was starting to emerge on the World Health Organization's flu radar, but planners feared there was not enough time to develop a vaccine for it. Influenza struck the United States early and hard last year. The first cases turned up in early October in Texas, and soon anxious Americans were clamoring for vaccine -- a prelude to this year's flu shot frenzy. A near-record 83 million eventually had a flu shot last fall. But the predominant flu strain was not A/Panama -- it was A/Fujian. And the vaccine was only partially effective.

A Colorado study for the CDC concluded last year's flu shots were 52 percent effective in protecting healthy adults against flu, 38 percent effective in preventing flu among those with health conditions putting them at higher risk. Bucher said it is reassuring that tests are showing there is less of a mismatch between the curr ent flu vaccine and A/Wellington than there was last year between A/Panama and A/Fujian.

"It's nothing like the situation we had last year,'' she said.

The issue, of course, will be academic if the A/Fujian strain predominates again this year -- as it did in the Southern Hemisphere during most of the winter season that has now ended there. Those 61 million Americans who will find a vaccine will be protected. There is also some evidence that the A/Fujian strain -- having swept through the globe last year -- may have lost its punch. Despite the late emergence of the new flu strain, influenza was unusually mild throughout the Southern Hemisphere from May through October.
 
One reason may be that the human population, vaccinated or not, developed its own natural resistance to A/Fujian when it came through last winter.  "There are a number of factors that determine whether you will have a good, medium or bad flu year, and clearly a major factor is whether the predominant strain happens to be the same as the one the previous year,'' said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. So far, there have been only isolated cases of flu detected in the United States at the start of this year's flu season, and all have turned out to be A/Fujian.

"Things are looking pretty good, in that regard,'' Fauci said. "But that doesn't mean we won't get into trouble in November or December. "It's much too early,'' he said. "to predict what kind of year we are going to have.''

Annual Number of flu deaths: it’s a guess

By Sherri Tenpenny, DO
www.nmaseminars.com

I have received many requests for a specific reference to the following statement made in my article “The Flu Season Campaign Begins” :

“Even though less than 175 people actually died from influenza in 2003, anticipate that exponentially more messages regarding the “deadly flu” will be pushed through the news media this year.”

After weeks of intense research to locate the full source for that statement, I have unearthed some interesting and powerfully useful information.

Recapping Last Year’s Flu Season

During the 2003--2004 season, influenza activity in the United States began earlier than usual (October 2003), peaked between late November and early December, and then declined rapidly during January-February, 2004. The CDC scrambled as it was discovered that neither of the trivalent influenza vaccines used (Fluzone® or the new intranasal vaccine, FluMist®) contained the strain A/Fujian strain, the most prevalent virus in circulation. By Jan. 15, the CDC issued a press release admitting that ongoing testing showed that the year's vaccine "was not effective or had very low effectiveness" in the test subjects. [i]

As of the week ending March 27, 2004, laboratories at the World Health Organization (WHO) and National Respiratory and Enteric Virus Surveillance System (NREVSS) had tested 115,222 specimens and only 21.0% of the samples were found to be positive for influenza viruses. [ii] During the four most recent influenza seasons (1999-00, 2000-01, 2001-02, and 2002-03), the number of specimens that tested positive for influenza viruses ranged from 23.9 to 30.9% [iii] In other words, over the last 5 winters, 70-80% of the sniffles, fevers and body aches generally characterized as “the flu” were not caused by influenza viruses, but by organisms not covered by  a vaccine, regardless of the strain that was used. 

Influenza-associated pediatric deaths received considerable attention last year, prompting the CDC to request state and local health departments to report influenza-associated deaths in persons less than 18 years of age. As of May 31, 2004, 152 “influenza-associated deaths” in children had been reported by 40 states. [iv] Most of the children who died in last year's flu season were younger than 5 years of age. Because no similarnational data were collected previously, whether this numberof pediatric deaths represents a change from previous seasons is unknown. [v]  

Beginning in 2002, the Advisory Committeeon Immunization Practices (ACIP) began to recommend that all childrenaged 6-23 months and close contacts of children aged 0-23 monthsreceive annual influenza vaccination. With the increased reports of pediatric deaths in 2003, the Council of State and Territorial Epidemiologists (CSTE) approved an initiative to add “all pediatric influenza-associated deaths” to the list of nationally notifiable conditions on June of 2004. [vi] This will turn out to be a boon for flu vaccine manufacturers as the media doggedly tracts and then morbidly reports this season’s statistics, placing fear in the hearts of parents who will in turn demand the flu shot for their children.

It should be noted that this initiative was undertaken after the influenza vaccine was added to the pediatric vaccination schedule, protecting the manufacturers from liability under the rules of the National Vaccine Injury Act.

Therefore, my statement that “less than 175 people who died” was technically incorrect and should have read, “less than 175 children died” in last year’s flu season. However, as few as 175 adult deaths could have occurred too. Here’s why…

Predicting 36,000 deaths

The CDC claims that influenza is “a highly contagious virus that causes an average of 36,000 deaths and 200,000 hospitalizations in the U.S. every year.” But how does the CDC determine the number of deaths related to influenza? Where is the tangible, annual report somewhere in the CDC’s database with an actual number of reported deaths among adults, such as the 152 reported deaths among children? These questions deserve answers. Upon intense investigation, I uncovered a startling truth.

The CDC receives information on influenza cases from a several different sources. During each October to May period, the CDC receives weekly reports from approximately 120 World Health Organization (WHO) and National Respiratory and Enteric Virus Surveillance System (NREVSS) collaborating laboratories in the United States regarding influenza virus isolations. In addition, reports from several hundred “sentinel physicians” are received regarding the total number of patient visits and the number of visits for influenza-like illness (ILI). Sentinel physicians are randomly selected physicians who work in the community or for local health departments who collect nasal swabs on patients reporting flu-like symptoms. These swabs are sent to laboratories for organism identification and quantification.

A third source is the state and territorial epidemiologists who estimate the level of local influenza activity. The final source, the vital statistics offices for 122 cities across the country, report the total number of death certificates filed and the number of those in which 1) pneumonia was identified as the underlying cause of death or 2) influenza was listed anywhere on the death certificate. These reports from death certificates are filed throughout the year. From the number of positive nasal swabs and the complied data from epidemiological  death certificates, the CDC “determines” the number of deaths per year from influenza. [vii]

A CDC spokesman, Mr. Curtis Allen told Insight Magazine last year,

“There are a couple problems with determining the number of deaths related to the flu because most people don't die from influenza - they die from complications of influenza - so the numbers [of deaths] are based on mathematical formulas. We don't know exactly how many people get the flu each year because it's not a reportable disease and most physicians don't do the test [nasal swab] to indicate whether [the symptoms are caused by] influenza.” [viii]

Hence, the oft-repeated “36,000 deaths nationwide” is nothing more than a computer-generated, ominous-sounding guesstimate, rather than an actual number.

NOTE: Between Oct 1, 2003 and Apr 9, 2004, the CDC identified 863 antigenically DIFFERENT influenza viruses. [ix] Therefore, even if one assumes that the flu vaccines work for the three chosen strains, it is important to understand that the vaccineswill not provide protection against the other 860 influenza viruses known to be in circulation. 

Hence the CDC’s statement about the flu is correct:

Yearly, adults can average one to three and children three to six influenza-like illnesses (ILIs). The vaccine does not prevent influenza-like illnesses caused by infectious agents other than influenza [strains found in the shot], and many persons vaccinated against influenza will still get the flu. [x]

Special thanks to Mrs. Lujene Clark and Mrs. Dawn Richardson for help with this research.

1. CDC fact sheet. Influenza Vaccine Effectiveness Studies. Jan. 15, 2004.
2. MMWR. Update: Influenza Activity --- United States, 2003--04 Season. April 9, 2004 / 53(13);284-287
3. MMWR. Surveillance for Influenza --- United States, 1997--98, 1998--99, and 1999--00 Seasons. October 25, 2002 / 51(SS07);1-10.
4. 2003 - 04 U.S. INFLUENZA SEASON SUMMARY.
5. JAMA. Vol. 292, No. 12. Sept 22-29, 2004. Also MMWR. 2004;53:547-552.
6. JAMA. Ibid.
7. MMWR. Surveillance for Influenza --- United States, 1997--98, 1998--99, and 1999--00 Seasons. October 25, 2002 / 51(SS07);1-10.
8. Insight Magazine. Jan. 19, 2004. “Flu Secrets You Should Know”, by Kelly Patricia O’Meara
9. Insight Magazine. Ibid.
10. MMWR. November 9, 2001 / 50(44);984-6

BL Fisher Note:

When I wrote a special report for THE VACCINE REACTION newsletter published by NVIC in 2004 entitled "Flu Vaccine: Missing the Mark," I kept running into the figure of 36,000 influenza deaths annually in the U.S. being repeated by public health officials like a mantra. But when I searched back
for the origins of the 36,000 annual flu death statistic, I kept running into a dead end. Nowhere was there a published study explaining or confirming the 36,000 figure.

Then in 2003, I learned at an FDA meeting that only about 20 percent of all flu-like illnesses are actually caused by influenza virus. That means that, unless doctors and coroners all over America are culturing for influenza every time somebody dies from a respiratory illness that looks like the flu, they are just guessing it is the flu. And they will be right only 20 percent of the time.

The constant fear-mongering by CDC officials and drug companies using phony flu incidence and death statistics is nothing more than a way to soften up tax paying citizens to allow their taxes to be used to create flu vaccines they will be forced to buy and use every year. The people are getting fleeced twice while the CDC is getting fat and the drug companies are getting rich.

What a racket.

  Pediatrician Ed Yazbak, M.D. has written an excellent critique of the 36,000 annual flu death myth for Red Flags. Recommended reading for all those afraid of the flu and those who are not.

FIRST PUBLISHED ON REDFLAGS ON  JUNE 16, 2006
http://www.redflagsdaily.com/yazbak/2006_jun16


Calculating U.S. Influenza Deaths

By F. Edward Yazbak, MD, FAAP

For years, the Centers for Disease Control and Prevention (CDC) has been telling anyone who would listen: “Every year in the United States, on average: 5 percent to 20 percent of the population gets the flu, more than 200,000 people are hospitalized from flu complications, and about 36,000 people die from flu.” (1) It is not clear how the specific statistic — 36,000 American deaths a year “on average” — was formulated or from what sources it was derived. It seems to have just suddenly appeared, like a rabbit from a top hat. It certainly could have been any other number of thousands of cases. After all, what are a few thousand deaths up or down?

No one knows when the next number change will come but, when it does, it is guaranteed to be an increase. Scaring people, especially old people, out of their wits always sells vaccine and that seems to have become the CDC’s main purpose.

Another well-kept secret is over how many years the influenza deaths were “averaged.” Did the CDC calculate “average deaths” from 2000 to 2004 or from 1980 to 2004?

To have 36,000 deaths “on average,” there must be years with 26,000 deaths and about the same number of years with 46,000 deaths and, not to belabor the point, as many years with 16,000 deaths as with 56,000. At least, this is what most people would think averaging and “on average” mean.

The past influenza season came and went very quietly because the CDC was busy with dying birds in the Far East and Turkey. We will never find out where exactly the most recent “deaths from flu” will fit on the curve, but it is a good bet that 2005-2006 will not be, propaganda-wise, a “real good year.”

Testifying before the committee on government reform of the U.S. House of Representatives on Feb. 12, 2004, CDC Director Julie L. Gerberding, MD, carefully stated that “CDC scientists estimate that an average of 36,000 people die from influenza-related complications each year in the United States.” (2)

It is not clear why the director made the distinction, while under oath, between deaths from the flu and deaths from complications of the flu. A few people, including this writer, think there is a distinct difference between the two; many others do not think so.

To place the CDC influenza deaths in perspective, the U.S. lost 33,741officers and enlisted men and women in Korean War battles from 1950 to 1953. (3) And a special communication published by the Journal of the American Medical Association listed 43,000 deaths due to motor vehicle crashes and
29,000 involving firearms in the U.S. in 2000. (4)

The National Vital Statistics Report for 2001, published on Sept. 18, 2003 [Vol. 52, No. 3], was the last official U.S. government report on influenza mortality before the CDC director’s appearance at the February 2004 Congressional hearing. Certified figures about Influenza mortality [J10-J11] were listed on page 31 of the report. (5)

There were, in all, 257 influenza deaths recorded in 2001.

Of those, 13 deaths were under the age of 5; 50 were between 5 and 54; 21from 55 to 64; 21 between 65 and 74; 56 from 75 to 84; and 96 were 85 years old or older.

Also in 2001, there were 61,777 official deaths due to pneumonia (J12-J18) of which 48,686 (79 percent) were 75 years old or older.

The same document (table 11, page 35) lists the reciprocal number of deaths per 100.000 population. In 2001, influenza-pneumonia deaths (J10-J18) amounted to 21.8 per 100.000 with influenza at 0.1 and pneumonia at 21.7.

With the U.S. population being around 284 million in 2001, it would seem that the calculated number of 284 (0.1/100.000) deaths from influenza would be close enough to the actual listed number of 257.

The following should be kept in mind:

“Pneumonia” is caused by bacteria, viruses and fungi. Elderly patients (75 years and over) who have laboratory confirmed influenza disease may develop pneumonia but die from other underlying serious conditions, such as heart or kidney failure to name just two. It is not known how many of the 48,686 elderly individuals who died in 2001 had received the influenza vaccine that year. People of that age are usually vaccinated early in the season and certainly more frequently than others. In the U.S., influenza/influenza-like illnesses only occur during the flu season, a period of three months on average and rarely four months. Pulmonary complications and specifically deaths due to influenza will only occur during that short period, while other causes of pneumonia deaths exist year-round.

Most people who have influenza-like illness, as the condition is fondly referred to by the CDC, do not have influenza; only a small percentage of them are ever confirmed by culture or other accurate laboratory means. For the period 2000-2005, influenza virus positive cultures were 11 to 18.9 percent of the obtained cultures with a mean of 12.5 percent. It is well known that the virus strains in the community may be different from those in the available vaccine. Because immunity is strain-specific, vaccination in such cases is essentially ineffective in preventing disease. The percent of antigenic match between 2000 and 2005 varied from 11 to 63.2 percent with a mean of 54.2 percent. The maximum effectiveness of the vaccination effort, therefore, ranged between 2.1 percent in 2003-2004 and 11.5 percent in 2002-2003 with a mean of 7.2 percent. (6)

Taking all these facts into consideration, it is safe to say that only a small percentage of the 61,777 individuals who died of pneumonia in 2001 actually had influenza. Clearly, therefore, a large majority of individuals who died that year of pneumonia did not die of influenza or influenza-related complications.

In addition, the CDC figures clearly show that a large percentage of those who died were elderly and, historically, the elderly, as a group, have always been better vaccinated. As to the 257 individuals who were actually listed as influenza deaths in the 2001 statistical report, the influenza virus was actually identified in only 18 of them, the 18 classified as J10. (6)

Apparently in 2001, not even 257 people died of influenza or influenza-related complications.

The Monthly Vital Statistics Report of Sept. 17, 1981 sheds additional light on the issue. Under pneumonia and influenza, the report states: “An estimated 52,720 deaths in 1980 were attributed to pneumonia and influenza. The age-adjusted death rate for this cause increased about 14 percent from
11.1 per 100,000 population in 1979 to 12.6 in 1980, reflecting the influenza epidemics in 1980 and the absence of one in the previous year. For pneumonia and influenza, death rates increased for the age groups 35 years and over.” (7)

The above statement by none other than the CDC suggests that around 1.5 deaths per 100,000 were or could have been attributed to influenza or influenza complications in 1980, an epidemic year, when one would have expected a very large number of cases and more severe illness and certainly in a period when influenza vaccination was not as popular as it is now.

Considering that the U.S. population was around 226.5 million in 1980, 1.5 deaths per 100.000 would translate to around 4,000 deaths that year. So here we have official CDC statistics listing around 4,000 deaths, unconfirmed by viral cultures, from influenza and influenza-related complications in 1980, a banner year, and maybe 18 or 257 in 2001 and the propaganda machine is still talking about “an average of 36,000 deaths” a year.

How preposterous.

References
1. Key Facts about Influenza and the Influenza Vaccine, CDC.

Available at http://www.cdc.gov/flu/keyfacts.htm

2. J.L. Gerberding. Protecting the Public's Health: CDC Influenza Preparedness Efforts. Testimony before the Committee on Government Reform U.S. House of Representatives, Feb. 12, 2004.

Available at http://www.cdc.gov/washington/testimony/In2122004200.htm

3. America's Wars: U.S. Casualties and Veterans.

Available at http://www.infoplease.com/ipa/A0004615.html

4. A.H. Mokdad et al. Actual Causes of Death in the United States, 2000. JAMA. 2004; 291: 1238-1245. Available at http://jama.ama-assn.org/cgi/content/abstract/291/10/1238

5. E. Arias et al. Deaths: Final Data For 2001. National Vital Statistics Reports. Volume 52, Number 3. Sept. 18, 2003.

Available at  http://www.cdc.gov/nchs/data/nvsr/nvsr52/nvsr52_03.pdf

6. D.M. Ayoub, F.E. Yazbak. Influenza Vaccination During Pregnancy: A Critical Assessment of the recommendations of the Advisory Committee on Immunization Practices. J. Am Phys Surg. 2006; 11(2): 41-47. Available at http://www.jpands.org/vol11no2/ayoub.pdf

7. Annual Report of Births, Deaths, Marriages and Divorces: United States1980. Monthly Vital Statistics Report: Vol. 29, No.13. Sept. 17, 1981.

Available at http://www.cdc.gov/nchs/data/mvsr/supp/mv29_13.pdf
 

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