republished below in full unedited for informational, educational, and research purposes:
It’s that time again. Flu season. And with it, a constant barrage of reminders to get your annual flu shot. Interestingly enough, what you’re being told about the influenza vaccine’s effectiveness and the reality are two very different stories. In January 2015, U.S. government officials admitted that, in most years, flu shots are—at best—50 to 60 percent effective at preventing lab confirmed type A or B influenza requiring medical care.1
At the end of that same year, a Centers for Disease Control and Prevention (CDC) analysis2 of flu vaccine effectiveness revealed that, between 2005 and 2015, the influenza vaccine was actually less than 50 percent effective more than half of the time. I wonder if the reality might be even worse than that.
Research from 2011 shows just how easy it is to inflate efficacy rates simply by using different end points.3 At that time, they found that by using serologic measures, i.e., the increase in influenza antibodies identified in the blood, results in an overestimation of vaccine efficacy.
During the 2015/2016 flu season, FluMist, the live virus nasal spray that typically has been recommended for children in recent years, had a failure rate of 97 percent.4 Its failure was so epic, the Advisory Committee on Immunization Practices recommended FluMist be taken off the list of recommended flu vaccines for the 2016 to 2017 season, a recommendation CDC officials ended up heeding. There are many other examples of the influenza vaccine not protecting people as promised. So, what might we expect from the vaccine this year?
2017 Flu Vaccine LineupFlu vaccines are by their nature a tricky business because influenza viruses are constantly evolving and public health officials have to guess at least six months before the flu season starts which type A and B influenza virus strains will be predominantly in circulation so drug companies can manufacture the vaccines. When the strains chosen do not match the strains actually causing most of the disease in any given flu season, the vaccine’s failure rate significantly increases.
Even when there’s a good match, the flu vaccine’s effectiveness is estimated to be between 40 and 60 percent,5 meaning that, at best, public health officials believe you have a 60 percent lower chance of not getting sick with influenza if you get a flu shot. But it could be as low as 40 percent. Put another way, it is still a coin toss no matter which way you look at it.
Before reviewing influenza vaccines, it is important to remember that the majority of respiratory influenza-like illness that people experience during any given flu season is NOT type A or B influenza.6 When you get a sore throat, runny nose, headache, fatigue, low-grade fever, body aches and cough, most of the time it is another type of viral or bacterial respiratory infection unrelated to influenza viruses.7 There are several different types of influenza vaccines. This year, the available vaccine lineup includes:8 9
- A high-dose version for seniors over the age of 65, containing four times the amount of antigen as the regular dose of the standard vaccine
- An adjuvanted vaccine (Fluad) for seniors over 65, first available during the 2016 to 2017 season. It contains an adjuvant called MF59, described as an oil-in-water emulsion of squalene oil, added to hyper-stimulate a strong inflammatory response to try to strengthen artificial vaccine acquired immunity
- An intradermal flu vaccine for adults between 18 and 64
- An egg-free recombinant version approved for people over the age of 4 with an egg allergy
- A jet injector (needle-free) vaccine approved for adults between 18 and 64
New for the 2017 to 2018 season is a quadrivalent influenza vaccine (Flucelvax) for individuals over 4 years old that uses dog kidney cells (MDCK) for production.10 Traditionally, candidate vaccine strain influenza viruses, i.e., the viruses selected for inclusion in the vaccine, have been produced using fertilized chicken eggs.
The cell-based influenza vaccine viruses are grown in cultured animal cells instead of chicken eggs.11 Another relatively new technology uses insect cells to produce a recombinant quadrivalent influenza vaccine, Flublok, for individuals over 18 years old.12 13
Shoulder Damage Following Flu VaccinationIn October 2015, journalist Marlene Cimons wrote about her experience following a routine pneumonia vaccination.14 While she said the injection itself hurt more than most other vaccinations, that was nothing compared to the pain she developed in the days and months following. “Initially, I dismissed it as typical post-shot soreness,” she writes. “But it didn’t go away.” Months later, her left shoulder was still in pain. Her orthopedist diagnosed her with subacromial bursitis—chronic inflammation and fluid buildup in the bursa sac. Cimons writes:
I’m convinced this occurred because the nurse injected the vaccine too high on my arm. I had no symptoms before the shot, and pain has persisted since. The needle probably entered the top third of the deltoid muscle—which forms the rounded contours of the shoulder—and probably went into the bursa or the rotator cuff, instead of lower down, into the middle part of the muscle, missing the bursa and rotator cuff entirely.In a recent Facebook post, ABC Action News journalist Ashley Glass also complained of shoulder pain, saying she could “barely move my arm now,” following her flu shot.15 As it turns out, shoulder damage following vaccination16 is a known side effect of improper injection.
In a 2011 report, “Adverse Effects of Vaccines: Evidence and Causality,”17 the Institute of Medicine acknowledged that shoulder injuries are one of the possible adverse effects of vaccine injections, stating it found “convincing evidence of a causal relationship between injection of vaccine … and deltoid bursitis, or frozen shoulder, characterized by shoulder pain and loss of motion.”
Injection Site Injuries Becoming More CommonAccording to Dr. G. Russell Huffman, associate professor of orthopedic surgery at the Hospital of the University of Pennsylvania (cited by Cimons), shoulder injury related to vaccine administration, also known as SIRVA, includes chronic pain, limited range of motion, nerve damage, frozen shoulder and rotator cuff tears, and are typically the result of the injection being administered too high on the arm.
Rather than being injected into the muscle, the vaccine is injected into the bursa or joint space and, since vaccines are designed to provoke an immune response, the immune system ends up attacking the bursa sac, leading to the effects just mentioned.
Part of the problem appears to be related to more people receiving their vaccinations outside of a clinical setting, such as in pharmacies and grocery stores. Many will simply pull down the top of their shirt, exposing only the upper part of their deltoid, thereby increasing their risk of getting the injection in the wrong area.
Whatever the cause, reports of SIRVA have definitely increased in recent years,18 as has SIRVA cases settled in the federal vaccine injury court. Between 2011 and 2015, 112 patients were compensated for SIRVA and over 50 percent of those cases were brought in 2015.19 20 In 2016, 202 SIRVA cases were awarded damages by the national Vaccine Injury Compensation Program (NVICP) created by Congress under the National Childhood Vaccine Injury Act of 1986.21
In July 2015, the Department of Health and Human Services proposed adding SIRVA to the NVICP Vaccine Injury Table (VIT), noting that, “The scientific evidence convincingly supports a causal relationship between an injection-related event and deltoid bursitis.” By adding it to the table, SIRVA cases brought before the government’s vaccine court will be easier and faster, allowing injured patients to receive compensation quicker.
SIRVA, as well as Guillain-Barre Syndrome (GBS), were two vaccine reactions officially added to the VIT earlier this year, and applies to petitions for compensation filed under NVICP on or after March 21, 2017.22 23 One of the first case studies24 to recognize SIRVA was published in 2006. Clusters of GBS cases were noted among U.S. military personnel receiving the H1N1 influenza vaccine as early as 1976.25
It took a decade to get SIRVA added to the NVICP’s injury table. If it takes that long for the government to acknowledge that vaccine injection site injuries are real, imagine what it takes to prove other vaccine injuries.
For GBS, it took more than four decades. Is it any wonder then that many very serious vaccine-related neurological problems still have not made it onto that list—and some have even been taken OFF the list by government officials reluctant to award compensation—considering the far-ranging ramifications it might have for the childhood vaccination program?26
The More Flu Vaccines You Get, the More Likely You’ll Get SickIt seems no matter how poor influenza vaccine effectiveness is, the national call for everyone to get a flu shot every single year remains. But is getting an annual flu shot really “the best way” to protect yourself against influenza? Research frequently suggests otherwise. A recent article in Science Magazine27 delves into some of the finer points about individuality and how people’s immune responses vary depending on a number of different factors, including the age at which you’re exposed to the flu for the very first time.
That exposure will actually influence how your immune system responds for the rest of your life. Knowing this, what kind of effects might one expect when the first exposure to influenza viruses are vaccine viruses? It’s a gamble that no one has the answer to as of yet. Other studies have shown that:
Study Suggests Flu Vaccination During Pregnancy Can Cause MiscarriageIn 2009, reports of miscarriage following administration of the pandemic H1N1 (pH1N1) swine flu vaccine started emerging.44 Dozens of women claimed they lost their babies hours or days after getting the pH1N1 vaccine, which had not been tested on pregnant women (if it was, the evidence was never published). Not surprisingly, these instances were passed off by health officials as coincidental. After all, miscarriages do happen, and for any number of different reasons.Study Suggests Flu Vaccination During Pregnancy Can Cause Miscarriage
Alas, scientific findings published September 25, 2017, in the medical journal Vaccine45 46 47 suggest this spike in miscarriage reports may not have been a fluke after all. Researchers found that women who had received a pH1N1-containing flu shot two years in a row were, in fact, more likely to suffer miscarriage within the following 28 days. While most of the miscarriages occurred during the first trimester, several also took place in the second trimester.
The median fetal term at the time of miscarriage was seven weeks. In all, 485 pregnant women aged 18 to 44 who had a miscarriage during the flu seasons of 2010/2011 and 2011/2012 were compared to 485 pregnant women who carried their babies to term. Of the 485 women who miscarried, 17 had been vaccinated twice in a row—once in the 28 days prior to vaccination and once in the previous year. For comparison, of the 485 women who had normal pregnancies, only four had been vaccinated two years in a row.
While study authors stated that direct causation could not be established, they called for more research to assess the link. Commenting on the study, which was funded by the CDC, Amanda Cohn, CDC adviser for vaccines stated:
I think it’s really important for women to understand that this is a possible link, and it is a possible link that needs to be studied and needs to be looked at over more [flu] seasons. We need to understand if it’s the flu vaccine, or is this a group of women [who received flu vaccines] who were also more likely to have miscarriages.At present, the CDC is not making any changes to its recommendation for pregnant women, which states they can and should get a flu shot at any point during their pregnancy, no matter which trimester they’re in.48 This is irresponsible public health policy at its worst, placing the health of women and their unborn children in danger so corporations can profit.
Remember, the former head of the CDC, Julie Gerberding, left the CDC in 2009 to later become president of Merck Vaccines, a position she held until December 2014, when she became Merck’s executive vice president of strategic communications, global public policy and population health.49 She’s a poster child for the revolving door between government and industry, and a clear example of how that door is working against protecting the public health and safety.
Fraudulent Advertising Is the Norm for Flu VaccinesNow we find out that the 2016 to 2017 influenza vaccine, which public health officials acknowledged was very well-matched to circulating viral strains and was hailed in February 2017 as “one of the most effective in years,”50 actually turned out to be another rather useless dud.
According to the CDC, 100 percent of circulating H1N1, 95 percent of the H3N2, 90.6 percent of the Victoria B lineage viruses and 100 percent of the Yamagata B lineage viruses were similar to the vaccine virus components for the 2016 to 2017 season.51
In other words, the match-up between the vaccine strains and the circulating strains causing type A or B influenza illness was about as good as you could ever hope for and, based on interim estimates in February, the CDC reported vaccinated individuals were 59 percent less likely to get sick than unvaccinated individuals.52
Dr. Joseph Bresee, CDC’s influenza division’s associate director of global health affairs, told NBC News this was “good news and underscores the importance and the benefit of both annual and ongoing vaccination efforts this season.”53 Fast-forward four months, and the good news turned into a report of last year’s seasonal flu shot being yet another dismal failure.
It turns out the 2016 to 2017 influenza vaccine had “no clear effect” in those between the ages of 18 and 49. Ditto for the elderly. In fact, influenza-related hospitalizations among seniors were the highest they’ve been since the 2014 to 2015 season, which was rated as “severe.”
Among young children, the effectiveness was about 60 percent.54 In older children and adults between the ages of 50 and 64, the overall effectiveness topped out at about 42 percent, in terms of preventing illness severe enough to send you to the hospital or doctor’s office.
As reported by U.S. News & World Report,55 “In four of the last seven flu seasons, influenza vaccine was essentially ineffective in seniors, past studies suggest. The worst performances tend to be in H3N2-dominant seasons.”
Last year, H3N2 type A influenza, which is associated with more severe illness and increased mortality among seniors and very young children, was the most prevalent influenza strain circulating in the U.S.56 So far, CDC influenza surveillance data indicates that H3N2 is the most prevalent strain circulating in the U.S. this year, as well.57
You can find a listing of adjusted vaccine effectiveness estimates for each influenza season going back to 2005 until 2016 on the CDC’s Seasonal Influenza Vaccine Effectiveness, 2005 to 2017 webpage.58 told U.S. News & World Report, “While it is clear we need better flu vaccines, it’s important that we not lose sight of the important benefits of vaccination with currently available vaccines.”
What exactly those “important benefits” are was left unsaid. Personally, I cannot think of a single one. I can, however, point to a number of well-documented risks of harm and failure associated with influenza vaccine, which people take year after year, while apparently getting virtually no benefit at all.
2 CDC, December 21, 2015 Influenza Vaccine Effectiveness: How Well Does the Flu Vaccine Work?
3 Center for Infectious Disease Research and Policy March 11, 2011.
4 STAT News September 28, 2016.
5 CDC.gov, Vaccine Effectiveness.
6 CDC.gov, Feb. 19, 2016. Update: Influenza Activity – United States Oct. 4, 2015-Feb. 6, 2016.
7 WebMD. Mar. 14, 2017. “Flu-Like” Illnesses Spread Misery Nationwide.
8 CDC.gov, Flu Information for 2017-2018.
9 Live Science August 15, 2017.
10 FDA.gov. Flucelvax Quadrivalent. April 2017.
11 CDC.gov. Cell-Based Flu Vaccines.
12 CDC.gov. How Influenza (flu) Vaccines Are Made.
13 FDA.gov. March 2017. Flublok Quadrivalent – Protein Sciences Corp.
14 Washington Post October 26, 2015.
15 March Against Monsanto October 23, 2017.
16 CBS News March 6, 2017.
17 Institute of Medicine, Adverse Effects of Vaccines: Evidence and Causality.
18 AAP News September 1, 2017.
19 Wall Street Journal August 24, 2015.
20 Wired September 3, 2015.
21 See Footnote 18.
22 Myvaccinelawyer.com August 7, 2017.
23 HRSA.gov, Vaccine Injury Table, applicable on or after March 21, 2017.
24 Vaccine 2007; 25: 585-587 (PDF).
25 World Health Organization, Guillain-Barre Syndrome and Influenza Vaccine (PDF).
26 National Vaccine Information Center (NVIC). Aug. 27, 2014.
27 STAT News September 28, 2016.
28 Vaccine December 1998;16(20):1929-32.
29 STAT News November 11, 2015.
30 Clinical Infectious Diseases 2014; 59 (10): 1375-1385.
31 CIDRAP April 6, 2010.
32 Science Daily May 20, 2009.
33 STAT News October 29, 2015.
34 SeeFootnote 4.
35 Journal of Infectious Disease October 28, 2015.
36 The Cochrane Library July 7, 2010.
37 Cochrane Database of Systematic Reviews 2012; Issue 8.
38 FDA. 94th Meeting of Vaccines and Related Biological Products Advisory Committee Transcript. Feb. 20, 2003.
39 CDC Seasonal Influenza Q&A. Aug. 15, 2014.
40 CDC 2014-2015 Influenza Season Week 51 Ending December 20, 2014.
41 JAMA Intern Med 2013; 173(11): 1014-1016.
42 Vaccine 2006 Oct 30;24(42-43):6468-75.
43 International Journal of Epidemiology April 1, 2006; 35(2): 337-344.
44 Organic Health November 11, 2009.
45 Vaccine September 25, 2017; 35(40): 5314-5322.
46 Nola.com September 14, 2017.
47 Fortune September 13, 2017.
48 U.S. News September 13, 2017.
49 Business Wire December 10, 2014.
50 NBC News February 24, 2017.
51 CDC.gov, FAQ 2016-2017 Influenza Season.
52 CDC.gov Morbidity and Mortality Weekly Report February 17, 2017; 66(6): 167-171.
53 See Footnote 50.
54 US News June 21, 2017.
56 See Footnote 51.
57 CDC.gov. Oct. 27, 2017. Weekly US Influenza Surveillance Report.
58 CDC.gov, Seasonal Influenza Vaccine Effectiveness, 2005-2017.
republished below in full unedited for informational, educational, and research purposes:
The U.S. Food and Drug Administration (FDA) recently expanded the age indication for Seqirus’ Afluria Quadrivalent influenza vaccine to include patients aged five years or older.1
Like the trivalent version of Afluria, the quadrivalent version is available in pre-filled syringes, as well as multi-dose vials.1
The Centers for Disease Control and Protection (CDC) had previously recommended against the use of Afluria for anyone younger than nine years, but changed its recommendation to be in line with the new FDA indication.2
2 Lowes, R. Flu Vaccine Efficacy Slips From Prior Estimate, CDC Says. Medscape June 23, 2017.