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Is the Flu Vaccine Safe for Toddlers?

Abstract |
Intro |
Bias 1 |
Bias 2 |
Bias 3 |
Bias 4 |
Conclusions |
Financial |
Notes |
Graph_1 |
Table_A |
Graph_2 |
Graph_3 |
Matrix_1 |
Matrix_2 |
References

A critical analysis of a study allegedly proving the safety of influenza vaccines for children
6 months to 23 months of age.

Citation - 10/25/06 JAMA. 2006;296:1990-1997.

Source URLs: PDF | Abstract | Full Text

Despite the conclusion of the authors of the above study and subsequent JAMA article, the influenza vaccine was

The methodology of the study was to compare the number of Medically Attended Events in a group of children in a period after vaccination versus two equal length of time "control" periods for the same group.

- The first reference control period suffered from inflated figures due to population selection.
- The second reference control period was clearly a risk period which included many side effects due to the flu vaccine.
- The adverse medical events on the day of vaccination were rejected from the risk analysis data.
- The risk period chosen for study was the risk period with the fewest medical events in the month after vaccination.
- All risk periods were shortly after the date of vaccination and therefore could not detect delayed reactions to
mercury and other serious adverse effects caused by the vaccine.

Introduction:

Beginning in 2004 flu vaccine began to be recommended for all children between 6 and 23 months. There was very little
information available about the safety of flu vaccine in this age group. Even worse, the
Cochrane Collaboration,
an international organization for medical evaluation revealed that -
Vaccine promoters have had to face the charges leveled against the flu vaccine's safety and efficacy.
- The medically attended events befoe and after the 69,391 vaccinations in 45,356 children were measured.
- Thirteen medically attended events were less likely to occur after flu vaccination in this study group.
- No diagnosis was significantly associated with flu vaccination.
*"This study provides additional evidence supporting the safety of universally immunizing all children 6 to 23 months old with influenza vaccine."*[1]

The JAMA article released in late October claims to address the lack of safety data for the flu vaccine.

Scientific Principles Involved

First one has to define the quantity or quanitities desired to be measured. In this study, the desired quantity was the number of acute (transient) medical events that closely follow vaccination AND which are causally related to the vaccination. Because this figure can not be measured directly, two other quantities will have to be measured first. The desired quantity will be the difference between the two measurements. That is, the vaccine adverse effects will constitute an

A

. A

The

Medical

Diagnosis with an

I.E. An

Medical literature reflects that it is common for some symptoms like fever, cough, redness at vaccine injection site, headaches and sore throat to be more likely to occur after vaccination, that is these incidents have Odds Ratios greater than 1. It is also generally agreed upon, even in the pro-vaccine community, that there is ] NO protective value of flu vaccination for the flu in the two weeks following vaccination. Thus it is unscientific to suggest that the vaccine had a protective effect which lasted only two weeks against 13 diagnosis.

Generally speaking, the number of medically attended events (MAE) in two periods, the control period and the risk period, determine the conclusions for a study. Thus, it is very important to carefully chose the periods and also to do accurate counts of the medically attended events in these two periods. We will see for the JAMA study there there were several risk periods, a common practice, and two control periods, an uncommon practice and clearly incorrect in this case because the second control period was admittedly a risk period.

Problems/Irregularities

An old saying holds that, How well did our JAMA study apply the principles we have outlined above?

Let's have you answer that above question by answering a couple more questions

(1) Question: Given the data of the following risk periods, which do you call the Primary Risk Period and the focus of your study.

1. Vaccination Day zero (0) with its high number of medical events, a fact which is admitted but for which the number is unpublished.

2. Days 1-15 after vaccination with approximately 5095 medical events.

3. Days 15-28 after vaccination with approximately 6449 medical events.

(1) Answer: Hold out your hands. If the first thing that comes into your hands is a child, then use the data from all three periods or pick period 3 above for your Primary Risk Period. If the first thing that comes into your hands is a check from Big Pharma, then pick number 2, the study authors chose number 2 and neglected 1 and 3.

(2) Question: Given the data of the two following periods, which do you pick for your Control Period(s).

1. The period of 14 days before vaccination in which children were rejected due to medical events creating a

2. The period of 14 days in the 15-28 day period before vaccination which, due to population selection, MAE is

3. The period of 15-28 days after vaccination which has many more medical events than the 1-14 period after vaccination.

(2) Answer: If you are scientifically minded, then you recognize than none of these periods are suitable as a Control Period and you will do the work necessary to generate accurate numbers for a genuine Control Period. On the other hand, in the reference study, the period just before vaccination was rejected for use, and both periods 2 and 3 were used to "predict" the baseline number of medical events in the Primary Risk Period.

It is proper to reject the period just before vaccination due to its artificially low number of MAE, a condition which is created by rejecting for vaccination any child who was sick in this period.

The period 15-28 days after vaccination is not a proper control period but instead is a risk period. We will refer to this as the Secondary Risk Period hereafter for clarity.

The period 15-28 days before vaccination does not contain an accurate count for MAE as shown below in bias sections 2 and 3.

If you have not already done so, it may be best to read the reference JAMA article before trying to digest my comments. Some quotes from the JAMA article follow which sum the JAMA authors' conclusions with some added emphasis:

** Design, Setting, and Participants**

Retrospective cohort using self-control analysis, with chart
review of significant **medically attended events at 8 managed care organizations in the
United States that comprise the Vaccine Safety Datalink. Participants were all children in the
Vaccine Safety Datalink cohort 6 to 23 months old who received trivalent
inactivated influenza vaccine** between January 1, 1991, and May 31, 2003 (45,356 children with 69,359 vaccinations)."

**Results:** "... only 1 diagnosis,
gastritis/duodenitis, was more likely to occur in the 14 days after trivalent inactivated influenza vaccine."

**"Thirteen medically attended events were less likely to occur after trivalent inactivated influenza vaccine,
including acute upper respiratory tract infection, asthma, bronchiolitis, and otitis media."**

Answer: Two control periods each had a higher number of medically attended events (MAE) than did the 14 day period which started 24 hours after vaccination.

It should be obvious that the above conclusion is suspicious, to say the least, and calls for a careful examination of the validity of both control periods as well as the correctness of the number of events in the Primary Risk Period.

Answer: That is a really good question. In the Jama article, in Table 2, eleven diagnosis are listed as follows:

Column marked R/C1 is the Primary Risk Period to Control Period 1 Ratio.

Column marked [R2/C1] is the secondary Risk Period compared to Control Period 1.

ED = Emergency Department

Secondary Risk Period is labeled in the JAMA study as Control Period 2.

Diagnosis R/C1 [R2/C1] Anemia 10/3 [8/3] Convulsions (ED) 33/15 [27/15] Gastritis/duodenitis 11/2 [3/2] General Symptoms (ED) 6/2 [4/2] Lymphadentis 13/3 [12/3] Noninfectious gastroentertis (ED) 36/18 [54/18] Noninfectious gastroentertis (Inpatient) 19/9 [23/9] Serum reaction 5/2 [2/2] Sickle cell anemia 9/6 [6/1] Urticaria (rash) 9/4 [35/4] Viral enteritis 4/7 [2/7]

Let us look at a two important statements from the JAMA article,

*"Of note, the 3-day risk window in the outpatient setting included days 1 to 3, because inclusion of day 0 (the day
of vaccination) has been shown to result in spurious signals when using self-control methods with outpatient data."*
[This time period was included in analysis of

Time line:
Risk periods:

0 to 2 days post vaccination

1 to 3 days post vaccination

1 to 14 days post vaccination (primary period of interest)

15-42 days post vaccination (secondary period of interest)

1-42 days post vaccination

Control period 1: 15-28 days prior to vaccination.

Control period 2: 15-28 days after vaccination. Remember, we are labeling this as Secondary Risk Period.

Prior Vaccination Control 1 Rejected VAX Risk Control/Risk ???? | 15-28 | 1-14 | 0 | 1-14 | 15-28 |

0 to 2 days post vaccination

1 to 3 days post vaccination

1 to 14 days post vaccination (primary period of interest)

15-42 days post vaccination (secondary period of interest)

1-42 days post vaccination

Control period 1: 15-28 days prior to vaccination.

Control period 2: 15-28 days after vaccination. Remember, we are labeling this as Secondary Risk Period.

Let's Debunk the validity of Control Period 2 first:

Hmmm, that's clever, using an

It may be clever to use a control period within the longer risk period, but scientifically valid it is

Until you actually measure the number of MAE in these two periods you can not predict if the number of MAE in the period immediately following vaccination either should or will be less or more than the number of MAE in the next risk period two weeks later.

If the MAE incidence in this Secondary Risk Period had been

Actually, many people would probably guess that the number of MAE in the two weeks immediately following vaccination will be higher than in the next following two weeks. However, this was not the case in this study.

What does this tell us?

Was the vaccine protective for the first two weeks following vaccination?Or, did the symptoms of vaccine harm increase 3 and 4 weeks following vaccination versus the first two weeks?

Only a few people will buy that a vaccine is "protective" for the first two weeks following vaccination after which the "protection" immediately falls to near zero. In the first two week period following vaccination children commonly experience more fevers and even Influenza Like Illness (ILI). Chronic illness due to vaccination takes longer to emerge.

Given that the flu vaccine administered in the years covered by this study contained mercury, a substance difficult to excrete for some children, and also contained aluminum a substance bonded to the vaccines' antigens for the purpose of making the antigens difficult to eliminate by all individuals, it perhaps should come as no surprise that the number of MAE should rise in the second two week period after vaccination.

Debunking the published MAE rates for Control Period 1

Graph 1:

- Control period 1 figures are
**inflated**by factors discussed below. - Rejected Control period figures are
**deflated**by rejecting children who were sick in this two week period. The remaining number of children in the trial group who had MAE during this rejected period was not published. - MAE figures for Day 0, the day of vaccination, were not published.
- Control period 2 is not a proper control period for estimating MAE in the Primary risk period, 1-14 days following vaccination. We are referring to this period as the Secondary Risk Period.

Abstract |
Intro |
Bias 1 |
Bias 2 |
Bias 3 |
Bias 4 |
Conclusions |
Financial |
Notes |
Graph_1 |
Table_A |
Graph_2 |
Graph_3 |
Matrix_1 |
Matrix_2 |
References

Table A: Medically Attended Events | ||||||
---|---|---|---|---|---|---|

Published data from Table 1, JAMA [1] | Calculated data derived from published data.& | |||||

Diagnosis | MAE Mean of Control 1 & 2 | Odds Ratio, Risk to Control 1 | Odds Ratio, Risk to Control 2 | MAE Control 1, 15-28 days before vaccination. | MAE Risk Period 1-14 days after vaccination. | MAE Control/Risk 15-28 days after Vaccination |

Acute Upper Res. Track Inf. | 2340 | .74 | .81 | 2446 | 1810 | 2234 |

Otitis Media | 1958 | .77 | .76 | 1945 | 1498 | 1971 |

Asthma | 912 | .69 | .80 | 979 | 676 | 845 |

Dyspnea | 338 | .67 | .87 | 382 | 256 | 294 |

Cough | 202 | .67 | .84 | 225 | 151 | 179 |

Pneumonia | 190 | .82 | .82 | 190 | 156 | 190 |

Acute Bronchiolitis | 179 | .74 | .79 | 184 | 136 | 174 |

Other Atopic Dermatitis | 156 | .76 | .75 | 155 | 118 | 157 |

Dermatitis | 141 | .77 | .70 | 134 | 103 | 148 |

Totals: For above diagnosis only. |
6416 + 95 * = 6511[INFLATED] |
? | ? | 6640 + 83 = 6723[INFLATED] * |
4904 + 50 = 4954 |
6192 + 81 = 6273 * |

*
Note: Five more Diagnosis with their Mean MAE are listed in the original table but the MAE incidence
range is from 8 to 33 and so these MAE for 5 diagnosis are not listed on individual lines.
& Table 1 of reference JAMA study: [1] |
||||||

Calculated data from Table 2, JAMA [1] ^ | ||||||

Totals for Table 2. [1] |
--- |
? | ? | 66 |
141 |
176 |

Totals: Table 1 + Table 2 |
--- |
? | ? | 6723+66---------- 6789 |
4954+141---------- 5095 |
6273+176---------- 6449 |

Note: the totals for Table 2 have a "normal" look to their distribution: 66 for Control Period 1. 141 for the first (Primary) Risk Period. 176 for the second Risk Period. |

A discussion of four theoretical errors affecting the ratio of

Vaccine Adverse Effects versus Background (Baseline) MAE

Vaccine Adverse Effects versus Background (Baseline) MAE

Are the published figures for Control Period 1 grossly inflated?

Do published figures for the Primary Risk Period suffer serious deflation by ignoring the day of vaccination?

Or both?

If one wanted to do a fair study, some obvious changes in protocol would have to be made:Do published figures for the Primary Risk Period suffer serious deflation by ignoring the day of vaccination?

Or both?

- MAE incidence on Day 0 would have to be accounted for.
- All the MAE incidence of the risk periods would have to be accounted for,
perhaps by making a 29 day risk period following vaccination which would include Day 0, days 1-14 and days 15-28. To compare
with a shorter control the daily average for the 29 day risk period could be used.
- Additional data and risk periods would have to be added in order to determine the long range
adverse effects of the vaccine.
- A true study must compare the health of unvaccinated versus vaccinated children living in the
same time period, same general area and with the same health expectations other than the vaccine outcome. Previous studies
of this type show that unvaccinated children have a strong health advantage.

Keep in mind this study deals with a population of children in the 6-23 month age bracket with its intense vaccination schedule.

The risk of side effects from vaccination do not fall immediately to zero following the first two week risk period after previous vaccinations.

Some of the children for the control group for receiving the flu vaccination had another vaccination in the 60 days prior to the flu vaccination. This fact

And if the risk period of previous vaccines is extended in time, which in truth it must be, then virtually all children would have some degree of increased MAE incidence in both the Control Period 1 as well as the Primary Risk Period following the flu vaccination. Because this Primary Risk Period is one month later in time than Control Period 1, it can be assumed that previous vaccination(s) will contribute more MAE incidence to Control Period 1 than will be contributed to the Primary Risk Period for the flu vaccination.

For examples of this decline in MAE see Graph 2 below which plots two different rates of decline with two different starting points..

It is the difference in magnitude of this bias between the control period prior to vaccination and the risk periods following vaccination that we are concerned with here. Even if this factor is one percent or less, it should be taken into account.

Graph 2.

Graph above shows two Hypothetical declines in the contribution to the total of Medically Attended Events made
by a previous vaccine.

The red bars show the decline in the contribution to the total MAE made by vaccines where the beginning example starts at 30 percent of the total MAE and declines weekly at the rate of 10% of its own contribution. (I.E. 10 % of 30 % = 3 % of overall total per week.) [This type of decline is similar to compounding interest calculations, only in reverse, whereby the risk caused by previous vaccinations never fully declines to zero.]

Between 3 weeks prior to vaccination which is the center of the 15-28 days Control Period 1 - and - 1 week after vaccination which is the center of the Primary Risk Period there would be a 7.5 percent reduction in total MAE.

This may be on the high end of probabilities.

The purple bars illustrate an contribution of vaccine side effects which begins at 10 % of the total MAE at 6 weeks prior to vaccination and declines at a rate of 5 % per week of its own contribution. (I.E. 5 % of 10 % = .5 % of overall total/week.)

Between 3 weeks prior to vaccination which is the center of Control Period 1 and 1 week after vaccination which is the center of the Primary Risk Period there would be a 1.6 percent reduction in total MAE.

This second example of hypothetical decline may be closer than our first example to a typical change in MAE in the 28 days between the center of Control Period 1 and the center of the Primary Risk Period.

The red bars show the decline in the contribution to the total MAE made by vaccines where the beginning example starts at 30 percent of the total MAE and declines weekly at the rate of 10% of its own contribution. (I.E. 10 % of 30 % = 3 % of overall total per week.) [This type of decline is similar to compounding interest calculations, only in reverse, whereby the risk caused by previous vaccinations never fully declines to zero.]

Between 3 weeks prior to vaccination which is the center of the 15-28 days Control Period 1 - and - 1 week after vaccination which is the center of the Primary Risk Period there would be a 7.5 percent reduction in total MAE.

This may be on the high end of probabilities.

The purple bars illustrate an contribution of vaccine side effects which begins at 10 % of the total MAE at 6 weeks prior to vaccination and declines at a rate of 5 % per week of its own contribution. (I.E. 5 % of 10 % = .5 % of overall total/week.)

Between 3 weeks prior to vaccination which is the center of Control Period 1 and 1 week after vaccination which is the center of the Primary Risk Period there would be a 1.6 percent reduction in total MAE.

This second example of hypothetical decline may be closer than our first example to a typical change in MAE in the 28 days between the center of Control Period 1 and the center of the Primary Risk Period.

The true difference in rate of contribution of the side effects from a previous vaccination between the Control Period and the Primary Risk Period must be taken into effect when calculating expected MAE in the Primary Risk Period.

Upper and lower limits of 1.6 and 7.5 percent is only a suggested range of needed correction to baseline MAE. In the JAMA study this correction is between a minimum of 1.6 % of 6789 = 109 and 7.5 % of 6789 = 509.

Min. Max. correction Starting MAE 6789 6789 Correction one -109 -509 --------------------------- Result 6680 to 6280

Imagine a hypothetical population of children:

1 % are totally unvaccinated and have perhaps 1 MAE per year.

12 % have frequent acute illness or chronic illness and have perhaps 12 MAE per year.

20 % have single parents working two jobs and the children's average health is such they have 4 MAE per year.

67 % have "average health" and this group has about 3 MAE, on average, per year.

The children whose parents have the time and interest to have their child vaccinated with a vaccine which is not yet recommended will mostly come from our last population. [the 67 %]

The 3 MAE per year for this population is for purposes of illustration such that, on average, 1 child in 8 will have a MAE every 2 weeks.

A1 B1 C1 D1 E1 F1 G1 H1

A2 B2 C2 D2 E2 F2 G2 H2

A3 B3 C3 D3 E3 F3 G3 H3

A4 B4 C4 D4 E4 F4 G4 H4

A5 B5 C5 D5 E5 F5 G5 H5

A6 B6 C6 D6 E6 F6 G6 H6

A7 B7 C7 D7 E7 F7 G7 H7

A8 B8 C8 D8 E8 F8 G8 H8

When we select a portion of this population for our vaccine trial, we reject all (or nearly all) the children who were sick in the 2 weeks prior to the vaccination date. Mentally remove all the children from Column H in the matrix above. The remaining population in our selection is now 7/8 of its size two weeks earlier but still retains all of the children who were sick in the 15-28 day Control Period 1 and these children now constitute 1 child in 7 instead of the previous 1 in 8 ratio which was our starting or true MAE/Period ratio. Is this significant? Yes, this action

To better visualize this, refer to graph 3 above. Note that the right hand section of the graph, under period "H" has a large "X" at the bottom indicating that most of the 6800 children, possibly all, are removed from the vaccine trial. This is one-eighth of our starting example population. Of importance is the fact that nearly all the children who had an MAE in period

Let us say for sake of illustration, one that closely parallels our JAMA study, that the number of children who have an MAE every 2 weeks is 6789, approximately what was published for Table 1 plus Table 2 of the JAMA study.[1] However, this 6789 is for a larger population (8/8) and reducing the population by 1 in 8 children requires an equal percentage reduction of 12.5%, for this control group which has become 7/8 of the original population.

These figures are for illustration only. Some population, say 52,000 was reduced to 45,356 for the first flu vaccination. This population of 45,356 was further reduced to 24,003 for the second round of flu vaccinations. Some portion of the second reduction in population was due to children aging above 23 months and another part was due to MAE in the two weeks prior to the second vaccination. Because the relative contributions of age and MAE in the two weeks prior to the second vaccination are not published, no attempt will be made to refine this calculation. There is a wide margin for error. The true figure for the combined vaccination schedule could be less than 10 to over 25 percent.

Min. Max. correction Starting MAE 6789 6789 Correction one -109 -509 Correction two -840 -840 -------------------------- Result 5840 to 5440

The bias of removing the children who had an MAE in the two weeks prior to vaccination does not end with simply inflating the relative number of MAE compared to the population size. The 1 in 8 children with an MAE each two week period is simply an average. Even in this relatively healthy population, some children will seldom have an MAE and others will have relatively frequent MAE. For sake of illustration, let us say that 10 percent of the children will contribute 33.3 percent of the total MAE.

A1 B1 C1 D1 E1 F1 G1 H1

A2 B2 C2 D2 E2 F2 G2 H2

A3 B3 C3 D3 E3 F3 G3 H3

A4 B4 C4 D4 E4 F4 G4 H4

A5 B5 C5 D5 E5 F5 G5 H5

A6 B6 C6 D6 E6 F6 G6 H6

A7 B7 C7 D7 E7 F7 G7 H7

A8 B8 C8 D8 E8 F8 G8 H8

In other words, 10 % of the children will have one MAE per each 3 periods (total of 6 weeks) while the other 90% of the children will thus have less than 1 MAE per 8 periods. Since one-third of these high risk children will have one MAE in in any 2 week period, including the period immediately prior to vaccination, this means that fully one-third of these high risk children are eliminated from our control group. This fact causes a need to reduce by an additional 11.1% (one third of 33.3%) the number of MAE expected to occur in any two week period following this population reduction. Eleven point one percent of our base of 6789 is 754.

Min. Max. correction Starting MAE 6789 6789 Correction one -109 -509 Correction two -840 -840 Correction three -754 -754 ---------------------------- Result 5086 4686

Warning:

It should be noted that bias 2 and 3 likely interact in a way that reduces the amount of total error of bias 2 plus bias 3 to be less than illustrated in the two combined examples. However, corrections for bias 2 and 3 need to be made to achieve an accurate baseline control MAE figure even if a more complex formula must be used and of course using real data. None the less, the above example illustrates the principle.

The day of vaccination is not included in the published study for the obvious reason that there will be a high rate of MAE incidence on this date. This high incidence of MAE on this date due to the stress of vaccination likely lowers the number of MAE for a few following days by triggering events which were already in the making. The Day 0 MAE must be taken into account in order to have an accurate number of MAE for the Primary Risk Period. See Graph 1 and note the large spike of MAE incidence in Day zero (0). This is for illustration only as the actual rate for Day 0 of this trial was not published.

Let us assume for sake of illustration that the incidence rate on this day is only twice as high as for the days 1-14. The 5095 MAE in days 1-14 divided by 14 gives a figure of 364 per day. If we use this estimate for the MAE on day zero by multiplying by two we get 728.

See Graph 1 and imagine we create an

Min. Max. Control Period 1. Primary Risk Period Starting MAE 6789 6789 |Starting MAE 5095 Correction one -109 -509 |Estimated Correction + 364 Correction two -840 -840 | Correction three -754 -754 | ---------------------------- | ---------------------------- Result 5086 4686 |Adjusted Total 5459 Estimated (using the LARGER of our Control Period 1 estimates.) excess MAE in Adjusted Primary Risk Period is 5459-5086 = 373 Estimated (using the SMALLER of our Control Period 1 estimates.) excess MAE in Secondary Risk Period (15-28) is 6449-5086 = 1363

The Odds Ratio for 5459/5086 is 1.07 and the Odds Ratio for 6449/5086 is 1.27.

These Odds Ratios for the risk of flu vaccination shown above are much more likely to be within range of true values than the published Odds Ratios of less than 1 for risk of vaccination.

Risk period 15-28 days after vaccination with 6449 MAE is greater by 1363 than estimated 5086 MAE for estimated background incidence.

- Population selection bias upon the Control Period 1.
- Choosing the risk period with the least number of MAE.
- Using a risk period as a control period.
- Neglect of Day 0 in risk period.

I have tried to keep the suggestions in these illustrations above within the bounds of reason.

the published Odds Ratios for this vaccine can not be correct as stated in the JAMA article. [1]

- Control Period 1 suffers from multiple inflating influences.
- The Secondary Risk Period falsely labeled as Control Period 2 is not valid for estimating a baseline MAE incidence to compare to the Primary Risk Period.
- The Control Period 2 in this study is not only a "secondary" risk period, but as the MAE incidence in this period is 27 % higher than in the Primary Risk Period, this study should have used this risk period as the Primary.
- Figures for the Primary Risk Period are significantly deflated by ignoring the Medically Attended Events which occur on the day of vaccination.
- The reference study which claims that the influenza vaccine proved to be safe is not correct and needs to be done again. The methodology of this study is clearly not valid. [1]

Conclusions:

Abstract |
Intro |
Bias 1 |
Bias 2 |
Bias 3 |
Bias 4 |
Conclusions |
Financial |
Notes |
Graph_1 |
Table_A |
Graph_2 |
Graph_3 |
Matrix_1 |
Matrix_2 |
References

Clinical Research Unit, Kaiser Permanente Colorado (Drs Hambidge, Glanz, France, McClure, Xu, and Yamasaki),

Community Health Services, Denver Health,

and Department of Pediatrics, University of Colorado School of Medicine (Dr Hambidge),

and Department of Preventive Medicine and Biostatistics,

University of Colorado School of Medicine (Drs Hambidge, Glanz, and France),

Denver; Center for Health Studies,

Group Health Cooperative, Seattle, Wash (Dr Jackson);

Center for Health Research, Northwest Kaiser Permanente, Portland, Ore (Dr Mullooly);

UCLA Center for Vaccine Research,

Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Calif (Dr Zangwill);

Southern California Kaiser Permanente, Panorama City (Dr Marcy);

Kaiser Permanente Vaccine Study Center, Northern California Kaiser Permanente,

Oakland (Dr Black and Mr Lewis);

University of California, San Francisco (Dr Shinefield);

Marshfield Clinic Research Foundation, Marshfield, Wis (Dr Belongia);

Health Partners Research Foundation, Minneapolis, Minn (Dr Nordin);

Centers for Disease Control and Prevention, Atlanta, Ga (Drs Chen, Shay, Davis, and DeStefano).

Dr France reports having received vaccine study funding from Sanofi Pasteur and MedImmune.

Dr Yamasaki reports being a coinves- tigator in clinical trials for MedImmune (FluMist) and Adventis (Tdap).

Dr Jackson reports having received grant support from GlaxoSmithKline, having received grant support from and working as a consul- tant for Sanofi Pasteur and Chiron (now Novartis), and serving on the speakersâ€™ bureau for Sanofi Pasteur.

Drs Mullooly and Nordin report having received grant support from Sanofi Pasteur.

Dr Marcy reports working as a consultant for Sanofi Pasteur, Merck, GlaxoSmithKline, MedImmune, and Abbott and serving on the speakersâ€™ bureau for Sanofi Pasteur and GlaxoSmithKline.

Dr Black and Mr Lewis report having received grant support from Sanofi Pasteur, Chiron, and MedImmune.

Dr Shinefield reports having received grant support from and serving on the speakersâ€™ bureau for Sanofi Pasteur.

The authors report that there was no industry involvement in any aspect of this study. The other authors report no financial disclosures.

According to http://www.medscape.com/viewarticle/546470

- Affiliations with seven pharmaceutical companies.
- CDC has a $2.1 Billion per year budget for the promotion of Vaccines.
- Insurance companies.

Notes:

Flu Shots for Toddlers Not Backed By Evidence, Major Study Says
http://www.cfah.org/hbns/getDocument.cfm?documentID=1211

Only a few studies of the vaccine have been conducted in children under 2 years old,
and findings suggest that the injection is no better than a placebo at preventing influenza.
Moreover, __only one tiny study has looked specifically at the safety of flu shots in toddlers.__

The Cochrane review [The Cochrane Collaboration, an international organization that evaluates medical research.] comprised 51 studies of influenza vaccines — including 17 papers translated from Russian for the first time — involving more than 250,000 healthy youngsters under age 16.

Yet only a fraction of these studies focused on children younger than 2. Two efficacy studies involving about 1,000 toddlers indicate that flu shots containing inactivated virus — the only vaccine approved for this age group — are no more effective at preventing the flu than placebo.

References:
[1]
"Safety of Trivalent Inactivated Influenza Vaccine in Children 6 to 23 Months Old"Citation_date="10/25/2006" JAMA. 2006;296:1990-1997.Source URLs: PDF | Abstract | Full Text [2] Alternate source for downloading this article: PDF file: http://www.putchildrenfirst.org/media/jama.pdf |