Of note, Immunization, Obesity, Illiteracy and High School drop out are actual priorities worldwide!
When Vaccination Became Routine
Vaccine proponents felt that the failure of the vaccine was
explained by the immunization campaign being too little, too late. As a
result, in 1960, national health experts recommended, for the first
time, routine annual vaccination, with emphasis on high-risk groups,
including those over the age of 65 years and individuals with chronic
illness.
[13] By the early 1960s, routine influenza vaccination was generally adopted as a policy, with very little supporting evidence.
After several years of this policy, the CDC decided to evaluate its impact. In 1964,
Alexander Langmuir, MD, MPH, then the chief epidemiologist at the CDC, published a paper
[13]
that "reluctantly concluded that there is little progress to be
reported. The severity of the epidemic of 1962-1963...demonstrates the
failure to achieve effective control of excess mortality." The paper
questioned whether widespread influenza immunization "should be
continued without better evidence to justify the major costs to the
general public." Despite this, annual vaccination campaigns were
continued.
In 1968, the CDC finally performed a randomized, double-blind trial
[14]
to examine the effect of vaccination on morbidity and mortality. The
authors concluded that "Despite extensive use of influenza
vaccines...attainment of [improved morbidity and mortality] has never
been demonstrated." Nevertheless, flu immunization continued.
In 1976, H1N1 "swine flu" appeared, and a large-scale effort to immunize as many Americans as possible was launched.
[15]
However, the anticipated levels of disease did not appear, and an
epidemic of paralytic Guillain-Barré syndrome in recipients of vaccine
led to the program's cancellation. An analysis in 1977
[16]
by the CDC concluded that influenza control had been "generally
ineffective" and that statistically valid community trials were needed.
In 1995, a major review from the US Food and Drug Administration
acknowledged the ongoing "paucity of randomized trials" and warned about
serious methodological flaws in many existing flu vaccine studies.
[17]
In 2000, the CDC performed a placebo-controlled trial and found
that "vaccination [when compared to placebo] may not provide overall
economic benefit in most years."
[18]
Nonetheless, in 2004, the AAP recommended annual influenza
immunization for young children, household contacts, and healthcare
providers.
[19]
Vaccination coverage recommendations continued to expand, and now
during every flu season, we watch commercials by retail pharmacies
telling us about the importance of getting the flu shot. The fact that
the AAP recommends "mandatory" flu vaccination for healthcare providers
[20] means that eventually clinicians could be fired for not getting vaccinated.
Summing Up the Data
A 2012 systematic review and meta-analysis
[21]
examined the efficacy and effectiveness of licensed influenza vaccines
in patients with confirmed influenza illness. The authors confirmed that
the original "recommendation to vaccinate the elderly was made without
data for vaccine efficacy or effectiveness." The main message was that
we need a better vaccine and better studies to demonstrate its
effectiveness.
Despite the lack of high-quality data supporting the value of the
flu shot, widespread vaccination policy might still be reasonable if
observational studies consistently showed a benefit. However, the
observational studies cited by flu shot proponents are frequently
flawed.
[22-28]
In many studies, relevant clinical outcomes are ignored in favor of
immunogenicity (ie, the ability to elicit an antibody response).
"Influenza-like illness" (ie, cold symptoms) is frequently measured
instead of serious outcomes, such as pneumonia or death. When these more
serious outcomes are examined, there is often a failure to control for
healthy user bias—the propensity for healthier people to do such things
as receive annual check-ups, eat healthier foods, and get the flu shot.
So, although it's true that people who get flu shots live longer, it may
have nothing to do with actually getting the flu shot.
A 2005 study of a 33-season, national data set attempted to
reconcile the reduced all-cause morbidity and mortality found in some
observational studies of influenza vaccination with the fact that
"national influenza mortality rates among seniors increased in the 1980s
and 1990s as the senior vaccination coverage quadrupled."
[29] In this study, the authors conclude that:
"[Our] estimates, which provide the best available national
estimates of the fraction of all winter deaths that are specifically
attributable to influenza, show that the observational studies must
overstate the mortality benefits of the vaccine...[even during two
pandemic seasons] the estimated influenza-related mortality was probably
very close to what would have occurred had no vaccine been available."
The rationale for flu immunization as a national health priority
is that influenza is a disease with serious complications, such as
pneumonia, hospitalization, and death.
[5,13,28]
If the reason for influenza vaccination is that flu is such a serious
disease, then the relevant outcomes are whether vaccination improves
morbidity and mortality from flu. However, after decades of vaccine use,
it is hard to detect any public health impact. This is in stark
contrast to other routine vaccinations, such as polio and
Haemophilus influenzae type b, where introduction of the vaccine led to obvious decline of the disease.
We are pediatricians, and we believe in childhood immunizations.
Many vaccines have provided immense public health value. We simply
question whether the policy of routine influenza vaccination has
outpaced the data supporting its use.
Influenza vaccination now supersedes many other priorities of
public health (such as obesity, illiteracy, and high school dropout),
and we question whether so much time, effort, and money should be
dedicated to flu vaccination while these other national healthcare
priorities remain on the back burner.
