INFLUENZA (FLU) – VACCINE RISK STATEMENT (VRS)
© 2020 Physicians for Informed Consent, an independent 501(c)(3) nonprofit educational organization.
All rights reserved. For more information, visit physiciansforinformedconsent.org.
1. THE FLU VACCINE INCREASES THE
RISK OF CONTRACTING A NON-FLU
RESPIRATORY ILLNESS BY 65%.
Although some studies suggest positive effects of the flu
vaccine on the incidence of illness caused by flu viruses,
that benefit is potentially outweighed by the negative effects
of the flu vaccine on the incidence of non-flu respiratory
illness.1
To address the concern among patients that the
flu vaccine causes illness (i.e., acute respiratory illness), the
Centers for Disease Control and Prevention (CDC) funded a
three-year study,2
published in Vaccine, to analyze the risk of
illness after flu vaccination compared to the risk of illness in
unvaccinated individuals.
The study found there is a 65% increased risk of suffering from
a non-flu acute respiratory illness within 14 days of receiving
the flu vaccine. The authors state, “Patients’ experiences of
illness after vaccination may be validated by these results.”
This is important because although flu vaccines target three
or four strains of flu virus,3
over 200 different viruses cause
illnesses that produce the same symptoms—fever, headache,
aches, pains, cough, and runny nose—as influenza,4
and more
than 85% of acute respiratory illnesses do not involve the flu.5
2. THE FLU VACCINE DOESN’T REDUCE
DEMAND ON HOSPITALS.
The National Institute of Health (NIH) funded a study6
to
measure the effect of seasonal influenza vaccination on
hospitalization among the elderly. The study analyzed 170
million episodes of medical care and found that “no evidence
indicated that vaccination reduced hospitalizations.”
In addition, a 2018 Cochrane review7
of 52 clinical trials
assessing the effectiveness of influenza vaccines did not
find a significant difference in hospitalizations between
vaccinated and unvaccinated adults. Instead, the reviewers
found “low-certainty evidence that hospitalization rates and
time off work may be comparable between vaccinated and
unvaccinated adults.”
Furthermore, the Mayo Clinic conducted a case-control
study8
to analyze the effectiveness of the trivalent inactivated
influenza vaccine (TIV) in preventing flu hospitalization in
children 6 months to 18 years old. The study evaluated the
risk of hospitalization in both vaccinated and unvaccinated
children over an eight-year period. The authors state: “TIV is
not effective in preventing laboratory-confirmed influenzarelated hospitalization in children.” Instead, “[W]e found a
threefold increased risk of hospitalization in subjects who
did get the TIV vaccine.”
3. THE FLU VACCINE DOESN’T PREVENT
THE SPREAD OF THE FLU.
Households are thought to play a major role in community
spread of influenza, and there has been a long history of
analyzing family households to study the incidence and
transmission of respiratory illnesses of all severities. As
such, the CDC funded a study9 of 1,441 participants, both
vaccinated and unvaccinated, in 328 households. The study
evaluated the flu vaccine’s ability to prevent communityacquired influenza (household index cases) and influenza
acquired in people with confirmed household exposure
to the flu (secondary cases). Transmission risks were
determined and characterized.
In conclusion, the authors state: “There was no evidence
that vaccination prevented household transmission once
influenza was introduced.”9,10
Furthermore, a systematic review5 of 50 influenza vaccine
studies conducted for the Cochrane Library states:
“Influenza vaccines have a modest effect in reducing
influenza symptoms and working days lost. There is
no evidence that they affect complications, such as
pneumonia, or transmission.”
9 FLU VACCINE FACTS
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The flu vaccine increases people’s
risk of suffering from non-flu
respiratory illnesses. Common
non-flu viruses include rhinovirus,
enterovirus, respiratory syncytial
virus, and coronaviruses.2
Increased
Respiratory
Infections
A review of 52 clinical trials assessing the effectiveness of
influenza vaccines did not find a significant difference in
hospitalizations between vaccinated and unvaccinated adults.7
INFLUENZA (FLU) – VACCINE RISK STATEMENT (VRS)
4. THE FLU VACCINE FAILS TO PREVENT
THE FLU ABOUT 65% OF THE TIME.
The CDC conducts studies to assess the effects of flu
vaccination each flu season to help determine if flu vaccines
are working as intended.11 As circulating flu viruses are
constantly changing (primarily due to antigenic drift
mutations),12 flu vaccines are reformulated regularly based
on a “best guess” of which viruses might circulate during
the coming flu season.3
The CDC states: “CDC monitors
vaccine effectiveness annually through the Influenza Vaccine
Effectiveness (VE) Network, a collaboration with participating
institutions in five geographic locations… [A]nnual estimates
of vaccine effectiveness give a real-world look at how well
the vaccine protects against influenza caused by circulating
viruses each season.”13
Data from the CDC’s Influenza VE Network indicate a 65%
vaccine failure rate between 2014 and 2018 (Fig. 1).11
5. REPEAT DOSES OF THE FLU VACCINE
MAY INCREASE THE RISK OF FLU
VACCINE FAILURE.
Studies have observed that influenza vaccines have low
effectiveness in individuals who are vaccinated in two
consecutive years.9
A review of 17 influenza vaccine studies
published in Expert Review of Vaccines states, “The effects
of repeated annual vaccination on individual long-term
protection, population immunity, and virus evolution remain
largely unknown.”14
6. DEATH FROM INFLUENZA IS RARE
IN CHILDREN.
Before the widespread use of the influenza vaccine in
children, between 2000 and 2003, each year kids age 18 and
younger had about 1 in 1.26 million or 0.00008% chance of
dying from the flu.15 In a 2004 report, the CDC stated, “Deaths
from influenza are uncommon among children with and
without high-risk conditions.”16
7. THE FLU VACCINE DOESN’T REDUCE
DEATHS FROM PNEUMONIA AND FLU.
The National Vaccine Program Office, a division of the U.S.
Department of Health and Human Services (HHS), funded
a study17 to examine flu mortality over the period of 33
years (1968–2001). The study found that there has been
no decrease in flu mortality since the widespread use of
the influenza vaccine. The authors state: “We could not
correlate increasing vaccination coverage after 1980 with
declining mortality rates in any age group… [W]e conclude
that observational studies substantially overestimate
vaccination benefit.”
Furthermore, the National Institute of Health (NIH) funded a
study6
to measure the effect of seasonal influenza vaccination
on mortality among the elderly. The study analyzed 7.6
million deaths and found “a sharp increase in influenza
vaccination rates at age 65 years with no matching decrease in
hospitalization or mortality rates.”
8. PATIENTS DON’T BENEFIT FROM
THE VACCINATION OF
HEALTHCARE WORKERS.
A review18 of more than 30 influenza vaccine studies conducted
for the Cochrane Library states, “Our review findings have not
identified conclusive evidence of benefit of HCW [healthcare
workers] vaccination programs on specific outcomes of
laboratory-proven influenza, its complications (lower respiratory
tract infection, hospitalization or death due to lower respiratory
tract illness), or all cause mortality in people over the age of 60.”
The authors conclude, “This review does not provide reasonable
evidence to support the vaccination of healthcare workers
to prevent influenza.” In addition, “There is little evidence to
justify medical care and public health practitioners mandating
influenza vaccination for healthcare workers.”
9. FLU VACCINE MANDATES ARE NOT
SCIENCE-BASED.
A Cochrane Vaccines Field analysis19 evaluated studies
measuring the benefits of flu vaccination. The analysis,
published in the BMJ, concludes: “The large gap between policy
and what the data tell us (when rigorously assembled and
evaluated) is surprising… Evidence from systematic reviews
shows that inactivated vaccines have little or no effect on the
effects measured… Reasons for the current gap between policy
and evidence are unclear, but given the huge resources involved,
a re-evaluation should be urgently undertaken.”
© 2020 Physicians for Informed Consent, an independent 501(c)(3) nonprofit educational organization.
All rights reserved. For more information, visit physiciansforinformedconsent.org. Oct 2020.
These statements are intended for informational purposes only and should not be construed as personal medical advice.
All references are available at: physiciansforinformedconsent.org/flu-vaccine.
11
Figure 1: Centers for Disease Control and Prevention (CDC) data from the
U.S. Flu VE Network indicate that the flu vaccine has failed to prevent the flu
about 65% of the time.
INFLUENZA (FLU) – VACCINE RISK STATEMENT (VRS)
© 2020 Physicians for Informed Consent, an independent 501(c)(3) nonprofit educational organization.
All rights reserved. For more information, visit physiciansforinformedconsent.org.
1. Dierig A, Heron LG, Lambert SB, Yin JK, Leask J, Chow MY, Sloots
TP, Nissen MD, Ridda I, Booy R. Epidemiology of respiratory viral
infections in children enrolled in a study of influenza vaccine
effectiveness. Influenza Other Respir Viruses. 2014 May;8(3):293-
301. Epub 2014 Jan 31.
2. Rikin S, Jia H, Vargas CY, Castellanos de Belliard Y, Reed C,
LaRussa P, Larson EL, Saiman L, Stockwell MS. Assessment of
temporally related acute respiratory illness following influenza
vaccination. Vaccine. 2018 Apr 5;36(15):1958-64.
3. Centers for Disease Control and Prevention. Washington, D.C.:
U.S. Department of Health and Human Services. Selecting
viruses for the seasonal influenza vaccine; [cited 2020 Aug 17].
https://www.cdc.gov/flu/prevent/vaccine-selection.htm.
4. Demicheli V, Jefferson T, Al-Ansary LA, Ferroni E, Rivetti A, Di
Pietrantonj C. Vaccines for preventing influenza in healthy adults.
Cochrane Database of Syst Rev. 2014 Mar 13;(3):CD001269.
5. Jefferson T, Di Pietrantonj C, Rivetti A, Bawazeer GA, Al-Ansary
LA, Ferroni E. Vaccines for preventing influenza in healthy adults.
Cochrane Database Sys Rev. 2010 Jul 7;(7):CD001269.
6. Anderson ML, Dobkin C, Gorry D. The effect of influenza
vaccination for the elderly on hospitalization and mortality: an
observational study with a regression discontinuity design. Ann
Intern Med. 2020 Apr 7;172(7):445-52.
7. Demicheli V, Jefferson T, Ferroni E, Rivetti A, Di Pietrantonj C.
Vaccines for preventing influenza in healthy adults. Cochrane
Database Syst Rev. 2018 Feb 1;2(2):CD001269.
8. Joshi AY, Iyer VN, Hartz MF, Patel AM, Li JT. Effectiveness of
trivalent inactivated influenza vaccine in influenza-related
hospitalization in children: a case-control study. Allergy Asthma
Proc. 2012 Mar-Apr;33(2):e23-7.
9. Ohmit SE, Petrie JG, Malosh RE, Cowling BJ, Thompson MG, Shay
DK, Monto AS. Influenza vaccine effectiveness in the community
and the household. Clin Infect Dis. 2013 May;56(10):1363.
10. Physicians for Informed Consent. Newport Beach (CA):
Physicians for Informed Consent. Vaccines: what about
immunocompromised schoolchildren? Dec 2019. https://
physiciansforinformedconsent.org/immunocompromisedschoolchildren/rgis/.
11. Centers for Disease Control and Prevention. Washington, D.C.:
U.S. Department of Health and Human Services. CDC seasonal
flu vaccine effectiveness studies; [cited 2020 Apr 17]. https://
www.cdc.gov/flu/vaccines-work/effectiveness-studies.htm.
12. Centers for Disease Control and Prevention. Washington, D.C.:
U.S. Department of Health and Human Services. How the flu
virus can change: ‘drift’ and ‘shift’; [cited 2020 Aug 17]. https://
www.cdc.gov/flu/about/viruses/change.htm.
13. Centers for Disease Control and Prevention. Washington, D.C.:
U.S. Department of Health and Human Services. How flu vaccine
effectiveness and efficacy are measured; [cited 2020 May 14].
https://www.cdc.gov/flu/vaccines-work/effectivenessqa.htm.
14. Belongia EA, Skowronski DM, McLean HQ, Chambers C, Sundaram
ME, De Serres G. Repeated annual influenza vaccination and
vaccine effectiveness: review of evidence. Expert Rev Vaccines.
2017 Jul;16(7):723,733.
15. Centers for Disease Control and Prevention. Washington, D.C.:
U.S. Department of Health and Human Services. CDC wonder:
about underlying cause of death, 1999-2018; [cited 2020 May
2]. https://wonder.cdc.gov/ucd-icd10.html; query for death from
influenza, 2000-2003. Between 2000 and 2003, there were 61
annual deaths from influenza out of 77 million children age 18
and younger, about 1 death in 1.26 million.
16. Harper SA, Fukuda K, Uyeki TM, Cox NJ, Bridges CB; Centers
for Disease Control and Prevention (CDC) Advisory Committee
on Immunization Practices (ACIP). Prevention and control of
influenza: recommendations of the Advisory Committee on
Immunization Practices (ACIP). MMWR Recomm Rep. 2004 May
28;53(RR-6):1-40.
17. Simonsen L, Reichert TA, Viboud C, Blackwelder WC, Taylor
RJ, Miller MA. Impact of influenza vaccination on seasonal
mortality in the US elderly population. Arch Intern Med. 2005 Feb
14;165(3):265-72.
18. Thomas RE, Jefferson T, Lasserson TJ. Influenza vaccination for
healthcare workers who care for people aged 60 or older living in
long-term care institutions. Cochrane Database Syst Rev. 2016
Jun 2;(6):CD005187.
19. Jefferson T. Influenza vaccination: policy versus evidence. BMJ.
2006 Oct 28;333(7574):912-5.
REFERENCES
*Estimates presented to the Advisory Committee on Immunization Practices on June 27, 2019

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