Patient Info Sheet for the Flu Vaccine for Informed Consent
Cammy Benton, MD
For the Pro side, please visit the https://www.cdc.gov/flu/
It is important to review both sets of data to make an informed decision.
It is important to review both sets of data to make an informed decision.
1. Jefferson T, Di Pietrantonj C, Rivetti A, Bawazeer GA, Al ... (n.d.). Retrieved from https://residenciadeclinica.files.wordpress.com/2010/08/influenza-vaccines-cochrane-review-20101.pdf
· Collaboration report included 40 clinical trial studies of more than 70,000 people a perfectly matched year, it showed up to 80% benefit.
· But since they don’t often match the flu strains perfectly, it listed 50% effectiveness, to as low as 30% effectiveness, with the flu vaccine. So just as many people theoretically benefited as didn’t on an average year.
· It showed modest days lost from work with the vaccine and NO evidence was found to decrease hospitalization or complication rates.
· Another analysis put it this way: When the vaccine matched the flu strain, 4 percent who weren’t vaccinated got the flu. One percent of vaccinated people got it. That’s a difference of 3 percent.
· When the vaccine didn’t match the strain, 2 percent of unvaccinated people got the flu, and 1 percent didn’t, for a difference of 1 percent.
2. Kelley NS, Manske JM, Ballering KS, Leighton TR, Moore KA. The Compelling Need for Game-Changing Influenza Vaccines, An analysis of the influenza vaccine enterprise and recommendations for the future. Center for Infectious Disease Research & Policy, October 2012.
· It removed more of the “flawed” studies and found that in a perfectly matched year, it was 59% effective in having the vaccine in the ages of 18-64.
· It showed no benefit in the elderly (over 65) or under 18 has been seen in other studies.
· Their paper suggests that the flu vaccine is not ideal but due to lack of financial incentive, more beneficial vaccines are not likely to be found.
3. Cowling, Fang, Kwok-Hung. Increased Non-Influenza Respiratory Virus Infections Associated with receipt of the Inactivated Influenza Vaccine. Clinical Infectious Diseases, Vol. 54, Issue 12, June 2012 pages 1778-1783, also in Clin Infect Dis 2012 June 15; 54(12): 1778-83
· TIV (trivalent inactivated influenza vaccine) recipients had higher risk of confirmed non-influenza respiratory virus infection (RR, 3.46;95% Cl, 1.19-10.1)
· The majority of the non-influenzas respiratory virus detection were rhinoviruses and coxsackie/echoviruses, and the increased risk among TIV recipients was also statistically significant for these viruses.
4. Minn, Michael, McCullers, J., Klugman, K. Live Attenuated Influenza Vaccine Enhance Colonization of Steptococcus Pneumonia and Staphylococcus Aureus in Mice, mBio 5(1) doi:10.1128/mBio.01040-13
· The potent and often lethal effects of an antecedent influenza virus infection on secondary bacterial disease have been reported.
· Viral replication induced epithelial and mucosal degradation, and the ensuing innate immune response yield diminished capacity to avert secondary bacterial infections.
· Recent clinical and experimental data suggest that influenza virus infection may exert its influence beginning in the URT by enhancing susceptibility to bacterial colonization.
5. Goldman GS Comparison of VAERS fetal-loss reports during three consecutive influenza seasons: Was there a synergistic fetal toxicity associated with the two- vaccine 2009-2019 season? Hum. Exp Toxicol. 2013 May;32(5): 464-75
· There were 77.8 fetal loss reports per 1 million pregnant women vaccinated during the 2009/2010 2 dose influenza season vs 6.8 fetal loss reports during the previous 1-dose influenza season.
· An 11.4-fold increase.
· The two multidose vials contain 25 mcg of mercury per dose those years.
6. Jefferson T, Rivetti A, et al. Vaccines for preventing influenza in healthy children. Cochrane Database Syst. Rev 2012 Aug 15; Issue 8: CD 004879
· 75 worldwide studies, Inc 17 randomized trials, in children older than 2, the inactivated influenza vaccine is about 36% effective.
· Under 2 it was equal to placebo, no evidence to show reduced mortality, hospital admissions, serious complications or community transmission of influenza.
7. Jefferson T, Smith S, et al. Assessment of the efficacy and effectiveness of influenza vaccines in healthy children: systematic review. Lancet 2005 Feb 26; 365 (9461) : 773-80
· No evidence of reduced mortality, admissions, complications, or decreased community transmission of influenza.
8. Joshi, AY, Iyer VN, et al. Effectiveness of trivalent inactivated influenza vaccine in influenza-related hospitalization in children: a case-control study. Allergy Ashthma Proc 2012 Mar-Apr;33(2): e23-7
· Study of kids 6 months to 18 years from 1999-2007.
· Children who were vaccinated against influenza were 3 times more likely to be hospitalized for influenza related complications than children who did not receive an influenza vaccine (OR=3.67).
· Asthmatic children who received the influenza vaccine were also more likely to be hospitalized than those who did not receive it. The severity of asthma did not affect the outcome.
9. Seasonal Influenza and Vaccine Herd Effect
· Study 1968-2001-Observational study showed no decreased mortality rate with increasing vaccination from 15% to 65%
10.Thomas RE, Jefferson T, Lasserson TJ Influenza vaccination for health care workers who care for people aged 60 or older living in long-term care institutions. Cochrane Database Syst Rev 2013 ; Issue 7: CD 005187
· No evidence to support that vaccinating healthcare workers in long-term care facilities showed effect on laboratory proven influenza or complications (pneumonia, hospitalization, or death due to pneumonia) in those residence over age 60.
11. Doshi, P. (2013). Influenza: Marketing vaccine by marketing disease. Bmj, 346(May16 1). doi:10.1136/bmj.f3037
· Too much to list or explain, but worth the read.
12. Doshi, P. (2005). Are US flu death figures more PR than science? Bmj, 331(7529), 1412. doi:10.1136/bmj.331.7529.1412
· A 2013 BMJ article documented that public health authorities’ aggressive promotion of the influenza vaccine is not supported by the medical literature and fails to acknowledge serious vaccine risks.
· eg, contrary to wildly mistaken claims, only 16% of tested respiratory specimens are positive for influenza, and serious vaccine adverse events are well documented internationally.
13. Carrat, F., Lavenu, A. et al, Repeated influenza vaccination of healthy children and adults borrow now, pay later? Epidemiol. Infect. (2006) 134, 63-70
· Shows that repeated influenza vaccination at a younger age substantially increases the risk of influenza in older age
14.Phone conversation with (protected name now), MD, MPH, CAPT, USPHS Medical Officer Epidemiology and Prevention Branch Influenza Division, NCIRD Centers for Disease Control and Prevention
· Agreed with all information here and says this is the best we can do. Due to lack of evidence, they do not officially endorse flu vaccine mandates.
· Also, she admits that we will never have good studies due to changing viral strains and vaccines that may not match.
15. Skowronski DM, De Serres G, et al. Association between 2008-2009 seasonal influenza vaccine and pandemic H1N1 illness during Spring-Summer 2009:four observational studies from Canada PLoS Med 2010 April 6; 7(4) e1000258
· Recipients of the influenza vaccine had significantly increase influenza compared to those who didn’t.
· Recipients had increased need for requiring medical attention due to the H1N1 virus.
16. Link: http://www.bmj.com/cgi/content/full/316/7137/S2-7137 seemed to go ... (1998). Bmj, 316(7149). doi:10.1136/bmj.316.7149.3a
18. Link: http://www.cidrap.umn.edu/news-perspective/2016/04/study-prior-year-vaccination-cut-flu-vaccine-effects-2014-15
· Prior year vaccination cut the current year efficacy of the flu vaccine.
· Children who get the flu vaccine have three times the rate of hospitalization for flu.
20.Vaccine-Induced Anti-HA2 Antibodies Promote Virus Fusion and Enhance Influenza Virus Respiratory Disease, Sci Transl Med 28 August 2013: Vol. 5, Issue 200, p. 200ra114 Sci. Transl. Med.
21.Effectiveness of trivalent inactivated influenza vaccine in influenza-related hospitalization in children: a case-control study. Joshi AY1, Iyer VN, Hartz MF, Patel AM, Li JT
· TIV (The inactivated flu vaccine) did not provide any protection against hospitalization in pediatric subjects, especially children with asthma.
· On the contrary, we found a threefold increased risk of hospitalization in subjects who did get the TIV vaccine.
22.Influenza vaccines seem to be modifying influenza into a dangerous dengue like disease.
23.Death rates due to actual positive flu tests average under 1000 per year in over 300,000,000 patients according to the CDC National Vital Statistics Report.
· The number that you hear in the media of 30K to 50K deaths are due to flu AND pneumonia (all cause pneumonia including from HIV, COPD, elderly, cancer etc).
· The number is inflated to increase flu vaccination.
· Pediatric flu deaths are reportable and range from 60-120 annually.
· Adult flu deaths are not reportable but obtained via death certificates so that gives freedom for "estimation" to go from a 1000 to the 10's of thousands with no real proof.
· It is strange that if there are 30-50K deaths from flu and pneumonia, that 80% would be from flu when it only happens a few months out of the year.
24. Adverse reactions- flawed due to reporter bias.
· Our training is to say that any significant flu like illness is likely coincidence or would have been worse without the vaccine.
· We are not trained to recognize serum sickness and we are also too busy to report.
· Miller’s Review of Critical Vaccine Studies used as a resource
25.Nanri, A., Nakamoto, K., Sakamoto, N., Imai, T., Akter, S., Nonaka, D., & Mizoue, T. (2017). Association of serum 25-hydroxyvitamin D with influenza in case-control study nested in a cohort of Japanese employees. Clinical Nutrition, 36(5), 1288-1293. doi:10.1016/j.clnu.2016.08.016
· Lower influenza risk associated with vitamin D sufficiency among unvaccinated participants warrants further investigation.
26. Roos R. Study: Prior-year vaccination cut flu vaccine effects in 2014-15. CIDRP News. In: Center for Infectious Disease Research and Policy website.
· Available at: http://www.cidrap.umn.edu/news-perspective/2016/04/study-prior-year-vaccination-cut-flu-vaccine-effects-2014-15. Accessed 08Nov16
27. Smith DJ, Forrest S, Ackley DH, Perelson AS. Variable efficacy of repeated annual influenza vaccination. Proc Natl Acad Sci U S A 1999; 96:14001–6.
· Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC24180/pdf/pq014001.pdf.
28. Skowronski, D. M., & Serres, G. D. (2018). Role of Egg-adaptation Mutations in Low Influenza A(H3N2) Vaccine Effectiveness During the 2012–2013 Season. Clinical Infectious Diseases. doi:10.1093/cid/ciy350
· Using a case control study design and data from Canada's Sentinel Practitioner Surveillance Network (SPSN) for the 2014-2015 influenza season, Dr. Skowronski’s group reported that study participants who received the 2014–2015 vaccine without vaccination the year before had significant protection against influenza A(H3N2), but those who had received the identical 2013-2014 vaccine the previous year had no increased protection.
· Those who were vaccinated three years in a row actually had an increased risk of contracting influenza compared with unvaccinated participants.
· 29. Systemic autoimmunity appears to be the inevitable consequence of over-stimulating the host’s immune system by repeated immunization.
30. The Autoimmune/Inflammatory Syndrome induced by adjuvants (ASIA)
31.Subgroup analysis demonstrates that immunosuppressive therapies and the nonadjuvanted lead to less immunogenicity in humoral response in flu-vaccinated SLE (Lupus) patients.
33. “...This study shows that children aged 4 years and under who had received TIV from one vaccine manufacturer (CSL Biotherapies) had a 200-fold higher rate of febrile convulsions than that of the only reliable published estimate...”
· Link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3191393/
34. “In order to prevent the spread of influenza (that you do not have!), you will be required to wear a mask while working.”
· “With universal vaccination, 97% of influenza cases will occur in vaccinated workers who will not be masked. Thus, masking unvaccinated workers is most likely punitive and coerciverather than a well-reasoned strategy for reducing transmission in the healthcare setting.” (See reference in first comment.)
35. The four cRCTs underpinning policies of enforced HCW influenza vaccination attribute implausibly large reductions in patient risk to HCW vaccination, casting serious doubts on their validity.
· The impression that unvaccinated HCWs place their patients at great influenza peril is exaggerated.
· Instead, the HCW-attributable risk and vaccine-preventable fraction both remain unknown and the NNV to achieve patient benefit still requires better understanding.
· Although current scientific data are inadequate to support the ethical implementation of enforced HCW influenza vaccination, they do not refute approaches to support voluntary vaccination or other more broadly protective practices, such as staying home or masking when acutely ill.
· If a person’s immune system contains the cells that we have identified as the culprits behind narcolepsy and comes into contact with either H1N1 or the vaccine against H1N1, the immune system’s response can become activated and the narcolepsy disorder can develop.
37. What, in Fact, Is the Evidence That Vaccinating Healthcare Workers against Seasonal Influenza Protects Their Patients? A Critical Review, Int J Family Med. 2012; 2012: 205464, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3502850/.
· In November of 2012, a critical review in The International Journal of Family Medicine concluded: “The arguments for uniform healthcare worker influenza vaccination are not supported by existing literature. The decision whether to get vaccinated should, except possibly in extreme situations, be that of the individual healthcare worker, without legal, institutional, or peer coercion.”