Dr. Yazbak, a pediatrician, now devotes his time to the research of autoimmune regressive autism and vaccine injury.

Nothing New about Lack of Effectiveness of Influenza Vaccination in Babies

By Red Flags Columnist, F. Edward Yazbak, MD, FAAP
(tlautstudy@aol.com)

A friend sent a copy of my recent “Influenza Vaccination of Infants: A Useless Risk” (1) to a pediatrician with whom he had been sparring for a while about the need to administer mercury-containing vaccines to babies. By return email, he received a copy of a study just published in the October issue of PEDIATRICS, which he forwarded to me.

The message from the well-meaning pediatrician, who is convinced of the need for influenza vaccination of infants, with or without mercury on-board, was clear: This important peer-reviewed article in a first-class pediatric journal carries more weight than anything published on www.redflagsdaily.com

That is obviously not true. My articles are always well-researched, fully documented, carefully edited before submission and then “peer-reviewed” by the site’s exceptional editor and Red Flags’ informed readers. Because I am pro-reasonable and careful vaccination, my reviews would never be accepted in “medical journals,” not because of their quality but because of their content.

The title of the recent article in PEDIATRICS (2) — “Effectiveness of the 2003-2004 Influenza Vaccine among Children 6 Months to 8 Years of Age, with 1 vs 2 Doses” — could easily be voted Most Creative Title of the year. With a few words, it turned two negatives into a positive message because, in fact, the 2003-2004 Influenza vaccine was almost totally off the mark, and the CDC and the authors themselves found one dose of influenza vaccine inadequate.

The lead author, Debra P. Ritzwoller, PhD, and three co-authors, Susan Shetterly, MS, Kristi Yamasaki, PharmD,and Eric K. France, MD, MSPH, are employees of Kaiser Permanente Colorado. Two other co-authors Carolyn Buxton Bridges, MD, and Margarette Kolczak, PhD, work for the National Immunization Program (NIP) at the Centers for Disease Control and Prevention (CDC).

Both the Clinical Research Unit and the Department of Preventive Medicine at Kaiser Permanente have had a long and close relationship with the NIP. 

In a footnote, the authors declared that some of the data had been presented at the June 23, 2004 meeting of the Advisory Committee on Immunization Practices (ACIP) of the CDC and that they had no conflict of interest.

Déjà vu

In the most recent study, the authors included 29,726 children of whom 17.3 percent (5,143) were 6 to 23 months old. Figures in the thousands or millions in medical writings always raise a red flag with me: Why the razzle-dazzle? Is it just a smokescreen?

As I read the paper, I realized that all the comments and findings related to the vaccination of infants were identical to those of a study from Colorado reported in the CDC’s “Mortality and Morbidity Weekly Report” of Aug. 13, 2004 [53(31); 707-719] — research I was well aware of. (3) The release of the earlier study results in MMWR was perfectly timed between the recommendation to vaccinate 6- to 23-month-old children and the beginning of the flu season.

The 2004-2005 flu season was the subject of many articles on Red Flags (4, 5, 6, 7) and was, by far, the most publicized and interesting to watch after its opening salvo with the Chiron debacle.

The 2004 MMWR study was also authored by Ritzwoller, Shetterly, Yamasaki, France, Bridges and others.…

It essentially revealed that:

• The predominantly circulating influenza A (H3N2) virus strain was antigenically different from the influenza A (H3N2) strain in the 2003-2004 vaccine
• The study objective was to evaluate how effective the 2003-2004 influenza vaccine was against “medically attended illnesses” — namely influenza-like illness (ILI) and pneumonia and influenza (P&I) — during the peak influenza activity period of 19 days in the Denver metropolitan area (Nov. 19 to Dec. 7, 2003)
• A total of 5,139 children were included in the analysis
• Of those children, seven percent had chronic illnesses
• Seven percent of the children were fully vaccinated (two doses of vaccine) and 20 percent were partially vaccinated (one dose) on Nov. 19. By the end of the study period, 5 and 27 percent respectively, were fully or partially vaccinated
• Fully vaccinated children had a 25 percent reduction in ILI and a 49 percent reduction in P&I
• Partially vaccinated children had no statistically significant reduction in either.

The study was never published in a peer-reviewed journal. 

In her November 2004 article “How effective is the flu vaccine,” (8) Maryann Napoli criticized the Ritzwoller findings: “But the key question is: 49% and 25% of what? Dr. Ritzwoller was not able to provide the answer. Here's why the question is important: If few children in this study got the flu, then these reductions are less than meets the eye. For example, if 10,000 kids belong to a health plan and only four of the unvaccinated kids and three of the vaccinated kids got an influenza-like illness, that's 25% fewer cases.”

Napoli also questioned why the children were not randomly assigned to a vaccine and placebo group and reported that “When asked whether the flu vaccine caused any adverse reactions, Dr. Ritzwoller said there were none, but acknowledged some gaps in her study. ‘Hospital admissions were not tracked, and the parents were not interviewed,’ she explained, attributing this to inadequate CDC funding.”

This last statement by the lead author now creates two real problems for the CDC:

1. If “hospital admissions were not tracked,” then how can the ACIP claim that vaccination of children 6 to 23 months will decrease hospitalization rates?
2. If the CDC funded the study reported in MMWR last year, it certainly — at least in part — funded the recent study just published in PEDIATRICS.

This latter was not acknowledged and raises at least one question: How can a study by scientists employed by a vaccine-promoting agency and others who are funded by that same agency be published with a footnote stating “No conflict of interest declared”? 

The October 2005 publication

The article’s conclusion was as creative as the title — “Influenza vaccine was shown to prevent medically attended ILI among children six to 23 months of age, as well as older children, even with a suboptimal match” — and challenged both logic and definition.

From the point of scientific logic: As much as the authors (and the CDC) believe that the mismatched 2003-2004 influenza vaccine should, would or could have affected clinical illness in the community, it is unlikely that intelligent readership would accept that it actually did.

From the point of simple definition:

• Optimal means most favorable or desirable, and most favorable should be in the vicinity of  90 percent
• Suboptimal usually connotes something just slightly less than optimal, perhaps 85 percent and even possibly 75 percent. But it certainly was never ever intended to describe an 11 percent antigenic match between the predominant circulating influenza A virus strain and any strain in the available vaccine. That match can only be described as terrible!

The rest of the article reveals the following:

• Vaccine effectiveness findings were listed under the subtitle “Estimates of VE”
• The authors conceded that “because this was an observational study, vaccination status was not randomized.  Therefore, irrespective of the adjustment variables used, selection bias may exist with respect to which patients obtained vaccination.”
• The respiratory outcomes were not laboratory-confirmed and were based only on available data on the HMO computers. 
• The analyses and conclusions were limited to a very short period of 19 days from Nov. 19 to Dec. 7, 2003.
• Only 17.3 percent (5,143) of the 29,726 children included in the analysis were 6 to 23 months old.
• By the start of the study period on Nov. 19, only 7.5 percent of children 6 months to 8 years old were fully vaccinated and 9.9 percent were partially vaccinated
• By the end of the study period, children 6 to 23 months of age had vaccination rates of 14.6 percent and 27 percent, respectively for full or partial immunization, the highest rate achieved in the Colorado HMO.
• “Vaccine effectiveness” for fully vaccinated 6 to 23 months old children was reported again as it was in 2004 at 25 percent for ILI and 49 percent for P&I.
• One dose of vaccine was useless and did not affect the incidence of both disease categories in any statistically significant fashion.
• Some 46 children in all, aged five to eight years, received the live attenuated influenza vaccine as the vaccine is contraindicated in children under five

Viral Surveillance 2003-04

1. In the fall of 2003, the population of the United States was estimated to be 292 million.
2. During the complete influenza season — Sept. 28, 2003 to May 22, 2004 — there were 130,577 respiratory specimens for influenza viruses tested in the United States by CDC-approved laboratories. (8)
3. Only 18.9 percent or 24,649 specimens were positive. In other words, almost 80 percent of individuals suspected to have influenza in the United States did not have evidence of the virus on culture and could not be presumed to have influenza.
4. Of the positive cultures, 99 percent or 24,393 were influenza A viruses and 249 were influenza B viruses. 
5. Of the influenza A specimens, 7191 or 29.5 percent were sub-typed. Of these, 7,189 (99.9 percent) were influenza A (H3N2) viruses, and two (0.1 percent) were influenza A (H1) viruses.
6. The proportion of specimens testing positive for influenza peaked at 35.2 percent during the week ending Nov. 29. During the previous four seasons, the peak percentage of specimens testing positive for influenza ranged from 23 percent to 31 percent. The peaks were also later in the season.
7. By June 15, 2004, CDC had antigenically characterized 1,024 influenza viruses collected by U.S. laboratories since Oct. 1, 2003.
8. Of the 949 influenza A (H3N2) isolates characterized, only 106 (11.2 percent) were similar antigenically to the vaccine strain A/Panama/2007/99 (H3N2) and 88 percent or 843 were different.

Looking at the pediatric population of the Colorado HMO, of the 5,143 children aged 6 to 21 months, only 750 (14.6 percent) at most received two doses of vaccine. Of those, only 11.2 percent or 84 children could have possibly acquired vaccine-induced immunity — if indeed the vaccine is effective as the CDC claims and many others deny. (1)

A new, simpler and cheaper study should now be done that could help us all.
Ritzwoller should get her favorite computer programmer to identify the 750 records of infants under the age of 23 months enrolled in the HMO who received two doses of flu vaccine. She should then exclude infants with pre-existing or chronic conditions and compare the rest of the group with a matched sample of unvaccinated infants.

Now those results will be worth publishing on www.redflagsdaily.com.

*          *            *

Safety of influenza vaccines in children

In a letter to the editor of The Lancet on Sept. 3, 2005, T. Jefferson, S. Smith, V. Demichelli, A. Hamden and A. Rivetti expressed their concerns and frustration at the fact that, though they tried, they were unable to get reliable information regarding the safety of influenza vaccines on the market.

This team has written and published several comprehensive publications on vaccination practices.  My most recent article on influenza vaccination of infants 6 to 23 months (1) was mostly based on their impressive review of the efficacy and effectiveness of influenza vaccines in children, a review that included every study they could find in any language.

In the letter to The Lancet, Jefferson and associates expressed deep concern that safety studies were not done, the studies were too old and too small, or the vaccine manufacturer simply refused to allow the team to review the data from the vaccine trials.

The frustrated authors ended their letter stating, “We believe all unpublished trial safety data should be readily accessible to both the regulatory bodies and the scientific community on request. Our evidence gives rise to a concern that lack of access to unreported data prevents published data being put into context and hinders full and independent review. This cannot be good for public confidence in these vaccines.”

* * *

According to both the FDA and the CDC, “The fact that an adverse event occurred following immunization is not conclusive evidence that the event was caused by a vaccine.”

A VAERS (Vaccine Adverse Events Reporting System) search performed on Oct. 10, 2005 yielded three reports in the past two years of children younger than 23 months of age who died shortly after receiving a dose of influenza vaccine. No other vaccines were administered at the same time and all three children had underlying diseases.

Report # 210764: 8-month-old vaccinated 10/7/2003. Died suddenly 10/8/2003.
Report # 214136: 1.7-year-old vaccinated 11/24/2003. Died suddenly 11/29/2003.
Report # 228987: 8-month-old vaccinated 10/18/2004. Developed symptoms within 24 hours and died on 10/23/2004.

* * *

Procter and Gamble and the Simple Solution

On July 16, 2005, Luby, Agboatwalla, Feikin et al published in The Lancet a simple and convincing randomized controlled study, which showed that hand washing with soap can prevent diarrhea and lower respiratory infections, the two clinical syndromes responsible for the largest number of childhood deaths globally. Four of the investigators, including the lead author, are CDC employees. (10)

Neighborhoods in adjoining squatter settlements in Karachi, Pakistan, were randomly assigned. Three hundred households in 25 neighborhoods were assigned to use plain soap and an equal number of households were assigned to use antibacterial soap with triclocarban. Three hundred and six households in 11 different neighborhoods were randomized as controls. Weekly home visits by trained workers were used to encourage hand washing in the “treated” group and to carefully record illnesses in all groups.
There was a 50 percent lower incidence of pneumonia among children younger than five in households that received plain soap and hand-washing promotion than among controls. Pneumonia was defined according to the World Health Organization clinical case definition. Analysis was by intention to treat.
In addition, children under the age of 15 in the plain-soap group had a 53 percent lower incidence of diarrhea and a 34 percent decreased incidence of impetigo than matched controls.
Incidence of disease was about the same between the soap groups.

* * *

Advantages of the plain bar of soap

• It really works
• It is absolutely safe
• It is competitively priced
• It is easily available
• It has never contained thimerosal
• It has a very long shelf life
• It does not require refrigerated transport
• It does not hurt unless you get it in the eye
• It carries a lifetime guarantee not to cause Guillain Barre Syndrome and intussusception
• It makes much more sense

Conclusions:

1. A recent study is not convincing as to the effectiveness of the available pediatric influenza vaccine.
2. Other national and international studies have questioned the vaccine’s efficacy and effectiveness in children less than 23 months of age.
3. A smaller simple study was outlined that can provide more reliable and believable results with little effort and without extra funding by the CDC.
4. It is more than likely that there will be a shortage of preservative-free influenza vaccine this season and that the CDC will still assert that any vaccine containing mercury is better than nothing.
5. The FDA should investigate vaccine manufacturers who refuse to reveal the findings of their vaccine safety studies to reputable and discreet researchers.
6. Unbiased vaccine research, free of any conflict of interest, is much needed.
7. Think soap.

*          *            *

References:

1. http://www.redflagsdaily.com/yazbak/2005_sep30.php
2. Ritzwoller DP, Bridges CB, Shetterly S, Yamasaki K, Kolczak M, France EK; Effectiveness of the 2003-2004 influenza vaccine among children 6 months to 8 years of age, with 1 vs 2 doses. Pediatrics. 2005 Jul;116(1):153-9.
3. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5331a1.htm
4. http://www.redflagsdaily.com/conferences/vaccines/2004_nov17.php
5. http://www.redflagsdaily.com/conferences/vaccines/2004_dec03.php
6. http://www.redflagsdaily.com/yazbak/2005_feb17.php
7. http://www.redflagsdaily.com/yazbak/2005_feb25.php
8. http://www.medicalconsumers.org/pages/FluVaccineisRarelyEffective.html
9. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5325a1.htm
10. Luby SP,  Agboatwalla M,  Feikin DR, Painter J, Billhimer W, Altaf A, Hoekstra RM Effect of handwashing on child health: a randomised controlled trial. The Lancet 2005; 366:225-233

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