Flu Vaccine Safety: Creating a Myth
Nov 2006
If one believes a study just published in the October 25, 2006 issue of the Journal of the American Medical Association (JAMA), influenza vaccination of young children is safe. Unfortunately independent researchers, regardless of their affiliations, cannot access and review the study data because they are guarded in the Vaccine Safety Datalink and not available to anyone “from the outside”.
The JAMA article entitled “Safety of Trivalent Inactivated Influenza Vaccine in Children 6 to 23 Months Old” was authored by Hambidge, Glanz, France and others. Four of the co-authors are employed by the Centers for Disease Control and Prevention (CDC).
The authors performed a retrospective analysis, with chart review, of “significant medically attended events” in all 6 to 23 months old children who received trivalent inactivated influenza vaccine between January 1, 1991, and May 31, 2003 at 8 U.S. managed care organizations.
Results of a previous study by investigators in the same Health Maintenance Organization (HMO) were the main argument used to recommend the routine yearly influenza vaccination of ALL infants aged six to 23 months. In addition, that HMO has had a close relationship with the CDC for years and its members have been enrolled in multiple pre-licensure vaccine trials including Prevenar.
“Medically attended events” were apparently all encounters in a clinic, emergency department, or hospital within set time periods following the administration of the influenza vaccine.
The study apparently included “45 356 children who had received 69 359 vaccinations” and the authors were confident in concluding:
“In the largest population-based study to date of the safety of trivalent inactivated influenza vaccine in young children, there were very few medically attended events, none of which were serious, significantly associated with the vaccine. This study provides additional evidence supporting the safety of universally immunizing all children 6 to 23 months old with influenza vaccine.”
The timing of the publication was perfect for the CDC and the vaccine lobby. The “pediatric influenza vaccination initiative” was “Top Priority” and U.S. parents had to be convinced that the flu vaccine was safe, so as to provide a market for the extra 50,000 doses of vaccine that had been pre-ordered for the 2006-2007 season,
It is always a “red flag” when investigators who have access to enormous amounts of recent data and information, choose to “cut-off’ their research prematurely and not use all the latest available information.
In November 2002, a Danish researcher published a study that was funded by the CDC and co-authored by a CDC epidemiologist, in which he compared the incidence of autism among MMR-vaccinated and unvaccinated Danish children born between 1991 and 1998.
The findings of that “population-based” study were that “… the relative risk of autistic disorder in the group of vaccinated children, as compared with the unvaccinated group, was 0.92 (95 percent confidence interval, 0.68 to 1.24), and the relative risk of another autistic-spectrum disorder was 0.83 (95 percent confidence interval, 0.65 to 1.07). There was no association between the age at the time of vaccination, the time since vaccination, or the date of vaccination and the development of autistic disorder.”
The vaccine authorities told the world that “The Big Study from Denmark” had proved that there was no relationship between MMR vaccination and autism and to this date, many believe this fallacy and reporters mention it ad nauseam.
When we reviewed the available Danish data we found that:
A. The incidence of regressive autism was limited during the first years of the study because MMR vaccination rates had not yet peaked nationwide and
B. Because autism was usually diagnosed at about the age of five years in Denmark, most children with autism who were born in 1994 or later were effectively excluded by the 1998 cut-off date.
We also discovered that the incidence of autism among 5 to 9 year olds in Denmark strikingly increased in 2000-2001, well before November 2002 when the study was published in the New England Journal of Medicine.
Our critique can be found at http://www.jpands.org/vol9no3/goldman.pdf
As far as the pediatric influenza vaccination study was concerned, it would certainly have been immensely more relevant to review the pediatric experience during the two most recent influenza seasons, after universal vaccination of infants had been mandated, than to dwell on earlier years when the vaccine was only sporadically administered to high-risk infants.
Reviewing distant years like 1991-2001 may have helped “balloon” the number of participants to an “impressive” 45 thousands but it certainly did not provide the most recent and most accurate safety data.
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According to its official web site, “The Vaccine Adverse Event Reporting System is a cooperative program for vaccine safety of the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS is a post-marketing safety surveillance program, collecting information about adverse events (possible side effects) that occur after the administration of US licensed vaccines.
This Web site provides a nationwide mechanism by which adverse events following immunization (AEFI) may be reported, analyzed and made available to the public. The VAERS Web site also provides a vehicle for disseminating vaccine safety-related information to parents/guardians, healthcare providers, vaccine manufacturers, state vaccine programs, and other constituencies.”
When reviewing any VAERS data, it should be stressed that
2. When evaluating data from VAERS, it is must be understood that an adverse event report to VAERS is not proof that a certain vaccine caused the event.
For the purpose of this investigation, a review of available VAERS reports following influenza vaccination of children five months to less than 24 months (0.5 to 1.9) of age was undertaken. The search was started at five months of age because vaccines due at age six months are sometimes administered a few days earlier.
Emergency Room visits, hospital admissions and death reports in VAERS were considered “medically attended events”.
VAERS reports are now listed ten per page.
RESULTS
Emergency room visits
There were 446 records listed on 45 pages. http://tinyurl.com/vy7ru
There were approximately 82 reports filed between 1990 and 2003 (the period covered by the Hambidge study) or an average of 6 per year.
There were approximately 275 reports filed after October 2004 (Pages 17 to 45) or about 140 during each of the last two influenza seasons, a 2233% increase per year since the infant recommendation was implemented in the United States.
Hospitalizations
There were 91 hospitalizations. http://tinyurl.com/y7qetj
Thirty three infants were hospitalized before the fall of 2004 (2-3 /year x 13 years) compared to 58 in the last two years, a 1060% increase per year.
Admission to a hospital has become more difficult and restricted lately.
If indeed all hospitalized cases were first seen in the Emergency Room, an admission rate of 21% (58 out of 275 children) is quite high and suggests that the adverse events were significant and long-lasting. In many U.S. Emergency Rooms, patients can be held for up to 23 hours, stabilized and discharged homes, without incurring admission charges.
Deaths
There were 16 deaths. http://tinyurl.com/y64gw5
One death was reported in 1994, one in 1998 and 4 in 2003.
There were four death reports during the 2004-2005 flu season and six more during the 2005-2006 season when pediatricians were pressured into recommending influenza vaccination of infants.
Five of the ten infants who died shortly after influenza vaccination during the last two seasons had received the flu vaccine alone. The interval between vaccination and death in those five children were 1, 1, 2, 6 and 13 days.
The interval between vaccination and death in the remaining five children – who had also received other vaccines - were 1, 2, 1, 7 and 5 days.
Seven of the ten infants were males. Only three had pre-existing conditions that may have been considered a valid indication for influenza vaccination in past years. In other words, the remaining seven would NOT have been vaccinated before 2004.
It should again be stressed that only a small percentage of adverse events are filed. It is therefore very likely that many other infants’ deaths that followed the administration of the influenza vaccine were never reported to VAERS. It is also quite likely that deaths diagnosed as SIDS were never reported even if they occurred shortly after vaccination.
The ten death reports
VAERS ID 228504 Vaccination Date: 2004-10-18
Age 0.5 Date filed: 2004-11-01
Sex F - State NY - Died? Yes (date died: 2004-10-19)
Current Illness: NONE
Diagnostic Lab Data: NONE
Previous Vaccinations:
Other Medications: NONE
Preexisting Conditions: NONE
Vaccinations Manufacturer Lot Dose Route Site
1 DTAP SMITHKLINE BEECH 622A2 2 LL
2 FLU AVENTIS PASTEUR, U1407AA 0 LL
3 IPV AVENTIS PASTEUR, X1038 2 LL
4 PNC LEDERLE LABORATO A74404 2 RL
Onset Date: 2004-10-19 Days since Vaccination: 1
Symptoms: BRAIN SYND ACUTE LIVER DAMAGE LUNG DIS NERVOUSNESS REACT UNEVAL RHINITIS
Pt was found dead in her crib on the morning of 19OCT2004 Follow up: congestion of the lungs, liver and brain. Pending investigation and toxicology examination. Follow up: Coroner states that father of baby mentioned the bay was slightly more fidgety than usual the evening before this death.
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VAERS ID 228987 Vaccination Date: 2004-10-18
Age 0.8 Date filed: 2004-11-09
Sex M - State OH - Died? Yes (date died: 2004-10-23)
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Otitis Media
Other Medications: Zithromax suspension
Preexisting Conditions: Micro-cephalic osteodyplastic primoidal dwarfism Type I (lethal genetic disease).
Vaccinations Manufacturer Lot Dose Route Site
1 FLU AVENTIS PASTEUR, U1489AA 0 IM RL
Onset Date: 2004-10-19 Days since Vaccination: 1
Symptoms: APNEA CONVULS DIARRHEA DWARFISM DYSPNEA FEVER GASTROENTERITIS RASH VOMIT
Patient had micro-cephalic osteodysplastic primoidal dwarfism type I, a lethal genetic disorder with DNR/DNI status. Per parent request, vaccine given 10/18. Fever developed 10/19 PM. Other symptoms began 10/22, including vomiting, diarrhea, rash and continued fever. Seizure one time in afternoon. Dyspnea developed about 12 AM. 10/23 Patient transported to hospital; patient died about 0830 on 10/23.
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VAERS ID 232179 Vaccination Date: 2005-01-08
Age 1.7 Date filed: 2005-01-12
Sex M - State NY - Died? Yes (date died: 2005-01-09)
ER or Doctor Visit? No
Hospitalized? No
Current Illness: NONE
Diagnostic Lab Data: Autopsy by coroner.
Previous Vaccinations:
Other Medications: NONE
Preexisting Conditions: Bronchitis treated with Zithromax on 12/28/04.
Vaccinations Manufacturer Lot Dose Route Site
1 FLU AVENTIS PASTEUR, U1411AA IM LL
Onset Date: 2005-01-09 Days since Vaccination: 1
Symptoms: SIDS
Child was found dead early AM about 16-20 hours after the flu vaccine second dose 0.25ml. Child was fine when went to bed. Happy playful and no respiratory difficulty.
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VAERS ID 233373 Vaccination Date: 2005-02-01
Age 1.0 Date filed: 2005-02-03
Sex M - State GA - Died? Yes (date died: 2005-02-03)
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Upper respiratory infection
Diagnostic Lab Data: Autopsy is pending
Other Medications: none
Preexisting Conditions: None
Vaccinations Manufacturer Lot Dose Route Site
1 FLU AVENTIS PASTEUR, 41580AA 1 IM RL
2 MMR MERCK & CO. INC. 0608P 0 SC RA
3 VARCEL MERCK & CO. INC. 0765P 0 SC LA
Onset Date: 2005-02-03 Days since Vaccination: 2
Symptoms: APNEA HYPOTHERMIA
Patient was found this afternoon cold and not breathing. His resuscitation was not successful.
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VAERS ID 246080 Vaccination Date: 2005-10-17
Age 1.2 Date filed: 2005-10-26
Sex F - State TN - Died? Yes (date died: 2005-10-19)
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Upper respiratory infection
Preexisting Conditions: NONE
Vaccinations Manufacturer Lot Dose Route Site
1 FLU AVENTIS PASTEUR, U1765EA
Onset Date: 2005-10-19 Days since Vaccination: 2
Symptoms: FEVER
Unknown Pt died in her sleep morning of 10/19, she did have low grade, subjective fever 10/17 and 10/18.
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VAERS ID 248538 Vaccination Date: 2005-11-22
Age 1.1 Date filed: 2005-12-02
Sex M - State PA - Died? Yes (date died: 2005-11-24)
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Other Medications: NONE
Vaccinations Manufacturer Lot Dose Route Site
1 FLU AVENTIS PASTEUR, U1787DA 0
2 MMR MERCK & CO. INC. 1072P 0
3 VARCEL MERCK & CO. INC. 0418R 0
Onset Date: 2005-11-23 Days since Vaccination: 1
Symptoms: APNEA MALAISE PHARYNGITIS
Patient became ill within 24 hours of vaccine administration with URI symptoms, He was then discovered by parents to have stopped breathing.
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VAERS ID 249021 Vaccination Date: 2005-11-03
Age 1.1 Date filed: 2005-12-09
Sex M - State NJ - Died? Yes (date died: 2005-11-10)
ER or Doctor Visit? No
Hospitalized? No
Current Illness: History of RAD
Other Medications: Pulmicort, Zantac, Singulair, Albuterol, AccuNeb
Preexisting Conditions: Premie
Vaccinations Manufacturer Lot Dose Route Site
1 FLU AVENTIS PASTEUR, U1904AA IM RL
2 HIBV MERCK & CO. INC. 0347R IM LA
3 PNC LEDERLE LABORATO A25962H IM RA
Onset Date: 2005-11-10 Days since Vaccination: 7
Symptoms: AGITATION HEART FAIL MYOCARDITIS
Received vaccine 11/03/2005, admitted in heart failure, myocarditis 11/10/2005, Died 11/10/2005.
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VAERS ID 249821 Vaccination Date: 2005-12-06
Age 1.6 Date filed: 2005-12-28
Sex F - State IL - Died? Yes (date died: 2005-12-12)
ER or Doctor Visit? No
Hospitalized? No
Other Medications: NONE
Preexisting Conditions:
Vaccinations Manufacturer Lot Dose Route Site
1 FLU AVENTIS PASTEUR, U1788FA 1 IM LL
Onset Date: 2005-12-12 Days since Vaccination: 6
Symptoms: REACT UNEVAL
None Stated
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VAERS ID 250504 Vaccination Date: 2005-10-25
Age 1.0 Date filed: 2006-01-18
Sex M - State VA - Died? Yes (date died: 2005-10-30)
ER or Doctor Visit? No
Hospitalized? No
Preexisting Conditions:
Vaccinations Manufacturer Lot Dose Route Site
1 FLU AVENTIS PASTEUR, U1762AA
2 MMR MERCK & CO. INC. 0935P LL
3 VARCEL MERCK & CO. INC. 0195P RL
Onset Date: 2005-10-30 Days since Vaccination: 5
Symptoms: AGITATION FEVER SIDS
Child reportedly fussy, irritable and with mild fever during interval between vaccines and death.
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VAERS ID 258294 Vaccination Date: 2005-10-13
Age 1.9 Date filed: 2006-06-12
Sex M - State CA - Died? Yes (date died: 2005-10-26)
ER or Doctor Visit? No
Hospitalized? No
Current Illness: viral stomatitis
Diagnostic Lab Data: Final autopsy report just received. Cause of death "complications of viral infection." All cultures negative. Pathology of brain showed "focal perivascular chronic inflammation consistent with viral encephalopathy, slight brain swelling.
Previous Vaccinations:
Other Medications: none
Preexisting Conditions: none
Vaccinations Manufacturer Lot Dose Route Site
1 FLU AVENTIS PASTEUR, U1765CA 0 IM RL
Onset Date: 2005-10-26 Days since Vaccination: 13
Symptoms: AGITATION DIARRHEA EDEMA BRAIN ENCEPHALOPATHY FEVER INFECT VIRAL STOMATITIS ULCER MOUTH
Death on 10/26/2005 (found deceased in bedroom), flu vaccination given 10/13/05. Patient also seen at that time for low-grade fever, crankiness, diarrhea, diagnosed with viral stomatitis given finding of ulcers inside lower lip.
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Relative to Report 228987: This 8-month old baby from Ohio died 5 days after receiving a dose of influenza vaccine lot U1489AA. The health care provider made sure to report that the baby was “Micro-cephalic osteodyplastic primoidal dwarfism Type I (lethal genetic disease).”
A VAERS review revealed that a 50 year old woman from Maryland [Report 228231] who received a dose from the same lot (U1489AA) of flu vaccine developed a myriad of symptoms and problems and died 12 days after vaccination. Her only pre-existing conditions were sciatica and hypertension.
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Discussion
Obviously even if Hambidge, Glanz, France and friends had proved conclusively that the influenza vaccine was safe for infants six to 23 months of age, which they did not, the CDC would have still had to show that the influenza vaccine was also effective.
In a document aimed at health professionals entitled “Efficacy and Effectiveness of Inactivated Influenza Vaccine” and available at http://www.cdc.gov/flu/professionals/vaccination/efficacy.htm, the CDC tried to do that by quoting two studies:
I: “A 2-year randomized study of children aged 6--24 months determined that 89% of children seroconverted to all three vaccine strains during both years. During year 1, among 411 children, vaccine efficacy was 66% (95% confidence interval [CI] = 34%--82%) against culture-confirmed influenza (attack rates: 5.5% and 15.9% among vaccine and placebo groups, respectively). During year 2, among 375 children, vaccine efficacy was -7% (CI = -247%--67%; attack rates: 3.6% and 3.3% among vaccine and placebo groups, respectively); the second year exhibited lower attack rates overall and was considered a mild season. In both years of this study, the vaccine strains were well- matched to the circulating influenza virus strains.”
II: “ A retrospective study among approximately 5,000 children aged 6--23 months conducted during a year with a suboptimal vaccine match indicated vaccine effectiveness of 49% against medically attended, clinically diagnosed pneumonia or influenza among children who had received 2 doses of influenza vaccine. No effectiveness was demonstrated among children who had received only 1 dose of influenza vaccine..”
That was it as far as convincing evidence by our best and brightest: Based on that research, influenza vaccination of children six to 24 months of age was effective.
To this day, the CDC still chooses to ignore a comprehensive review of the subject by the Cochrane Collaboration that was published in The Lancet in 2005, where Jefferson et al concluded, after literally analyzing every available reference, that:
1. There is no evidence of the effectiveness of the vaccine or reduction in symptomatic cases
2. The efficacy of the vaccine, reduction in laboratory-confirmed cases, is similar to that of placebo.
On October 28, 2006, Editor of the British Medical Journal (BMJ) Fiona Godlee wrote: “As if to prove the point, we publish this week a broadside (based on a systematic review of the literature) about the lack of evidence for influenza vaccine. Why, asks Tom Jefferson (p 912), is there such a gap between evidence and policy? Governments go to great lengths to promote and provide the vaccine. But there is almost no valid evidence that it does any good. Jefferson puts the gap down to our desire to do something, combined with "optimism bias"—an unwarranted belief in the value of interventions. Would randomised trials be unethical? No, says Jefferson, they are the only ethical response to the possible waste of resources on ineffective or only partially effective care. The problem is that the UK has no transparent process for evaluating the effectiveness or cost effectiveness of vaccines. NICE would like to take this on. The government should let it.”
On October 27, 2006, Michael Blackley commenting in the Scotsman on Jefferson’s most recent publication wrote: “Leading health researchers claimed today that giving them to children under the age of two has the same effect as giving them a dummy drug……There is little clinical evidence that the vaccines have an impact on hospital stay, time off work, death …” Quoting Jefferson, he added that there was little comparative evidence on the safety of the vaccines and that an "urgent" review of the vaccination campaign was needed.
Conclusions
Influenza vaccination seems to be ineffective at any age.
It is therefore strange that people still attempt to prove that the useless vaccine is safe.
A recent study on the safety of influenza vaccination of children 6 to 23 months of age examined irrelevant data and failed to investigate the very important two most recent flu seasons.
A limited review of VAERS reports filed following influenza vaccination of children under the age of two years provides ample reasons for alarm.
The CDC’s recent decisions to recommend and promote influenza vaccination programs for healthy infants, young children and pregnant women were ill-advised and should be retracted.
The Medical Authorities of the United Kingdom should carefully and promptly review the available scientific evidence related to influenza vaccination and proceed with extreme care. Contemplating influenza vaccination programs for infants and pregnant women at this time is reckless specially when no serious adverse events reporting system is in place.
References
F. Edward Yazbak, MD, FAAP
Falmouth, Massachusetts.