Flu shots: 50% more costly this season; staff vaccinations have failed to protect nursing home residents; UK gov concedes swine flu shots caused narcolepsy; shots may make you sicker from flu: you do the math

You may have noticed that some flu shots are “stronger” this year, there are more brands available, and the newer ones cost more.  What should you know?


Stronger flu shots


This year the newer shots contain 4 antigens instead of 3 (2 each for influenza A and influenza B), although you can get shots with 3 antigens (2 flu A and 1 flu B) also.  You can also get a 4 antigen live virus vaccine sprayed up the nose (if you are aged 2-49 and not pregnant).  According to Reuters:

French drugmaker Sanofi, whose Sanofi Pasteur unit is the world’s biggest supplier of flu vaccines, with sales of 884 million euros ($1.2 billion) in 2012, says it expects a premium of some 50 percent or more (for the 4 antigen vaccines)

In Europe, roll out of the new vaccines will be slower as several products – including Sanofi’s four-strain Vaxigrip – are still awaiting approval, although GSK’s quadrivalent has a green light in Britain, Germany and France. 

A competing vaccine that is sprayed into the nose rather than injected, from AstraZeneca’s MedImmune unit, is also cleared in the United States but not yet in Europe

Does “stronger” mean better?  We don’t know.  Are there more side effects?  We don’t know. Why has approval been delayed in Europe?  We don’t know.


Flu vaccine for health care workers


Stronger than what?  If you multiply something times zero it is still zero.  If recent year (3 antigen) healthcare worker flu shots failed to prevent deaths and hospitalizations in elderly nursing home residents, will 4 antigen shots be any better?  According to a meta-analysis by the Cochrane Collaboration (the world’s most respected group performing meta-analyses of medical interventions), the older shots had ZERO benefit at preventing lab-confirmed influenza, pneumonia and hospitalizations in nursing home residents over 60 years old.  (In the US, it is CDC-recommended nursing home policy to vaccinate all nursing home residents as well as staff. Vaccinating both groups appears to have produced little.) The elderly comprise the target group for flu vaccinations: it is they for whom death from flu is most likely. Cochrane concluded:

There is
no evidence that only vaccinating healthcare workers prevents laboratory-proven
influenza or its complications (lower respiratory tract infection,
hospitalisation or death due to lower respiratory tract infection) in
individuals aged 60 or over in LTCIs and thus no evidence to mandate compulsory
vaccination of healthcare workers…

The University of Minnesota’s CIDRAP reviewed a similar study just out by CDC and an editorial that reviewed the same evidence and grudgingly concluded:

… that, for specific outcomes such as lab-confirmed influenza, the data showed little evidence of protection for patients. They agreed, though, that immunization is a good measure to take.

Why is it a good measure to take if it doesn’t do what it is meant to?  Because CDC is charged with working with flu vaccine manufacturers to decide how many doses should be manufactured yearly, is responsible for purchasing most of those doses, and for generating advertising and media interest to increase flu vaccine uptake, it can hardly be expected to draw independent conclusions about the net benefit, positive or negative, of flu vaccine. 


Furthermore, a linchpin of CDC’s flu strategy is to get Americans to think of a yearly flu shot the way they think about getting their teeth cleaned: you have to do it on schedule, forever.  (Here is one example of this propaganda.) Necessary to this strategy is minimizing information that gets out to the public on whether the vaccine  formulation is a good match to circulating flu strains (when it isn’t) and what the side effects turn out to be (if surveillance identifies any).


If vaccinating the elderly and their caregivers does not prevent flu infections or hospitalizations, why are we doing it, and even mandating flu shots?  Possibly the profit motive plays a part:

… Contracts struck with the U.S. Centers for Disease Control and Prevention (CDC) confirm a hefty price jump for the new four-strain flu vaccine, with GSK’s quadrivalent Fluarix, for example, costing $12.03 per dose against $8.08 for the standard version, according to the agency’s website.
Those price premiums may feed through to higher revenues and accelerated growth in a global flu vaccine market that research group Datamonitor Healthcare estimates at around $3.7 billion a year…

Dodgy numbers


UPDATE Sept 26:  CDC also has a funny habit of using bad data to estimate flu vaccine uptake. Instead of counting doses distributed and doses returned, or using statistics from the VSD database (collected on millions of Americans by their HMOs) which CDC pays to use, CDC prefers to call people by phone and ask if they have been vaccinated.  This is acknowledged to be the least accurate method for determining how many people get flu vaccines.  Using this method, CDC estimated that 45% of the US population received a flu shot last year.  However, had 45% of Americans actually been vaccinated, it would have required 5 million more doses of vaccine than existed in the US.


Dodgy language


Here is a CDC webpage for clinicians on flu vaccine safety. Note how the language is imprecise or deliberately misleads.  Examples:

Because they have not been used in the general population yet, there are no post-licensure safety data for the new quadrivalent IIVs, ccIIV, and RIV. However, data from pre-licensure clinical trials indicate that these vaccines have similar safety profiles as trivalent IIVs.”  (But CDC fails to state what that safety profile actually is.  CDC also confuses us: first saying there are no post-licensure safety data, then saying prelicensure trials showed safety. Are the safety data adequate?  Statistically significant? Are they for older vaccines or this year’s vaccines? –Nass)

“In a study of more than 250,000 children aged below 18 years, the investigators did not identify risk for any clinically important adverse events after IIV.” (I have no idea what “did not identify risk” means.  CDC fails to state what it considers to be a clinically important adverse event. No real data are presented.  Then, CDC acknowledges that for 2 of the last 3 flu seasons, vaccinated children had more febrile seizures than non-vaccinated.  The implication is that CDC does not consider a febrile seizure a clinically important adverse event, unlike the parents, children and clinicians who have to deal with them–Nass)


Flu shot safety:  narcolepsy, Guillain Barre and increasing flu frequency or severity


Note that most of the studies reviewed by CDC and Cochrane failed to look at flu vaccine safety.


This week, the UK government conceded that the 2009 swine flu shot Pandemrix (GSK, adjuvanted with ASO3) did cause narcolepsy in some recipients.  About 25% of the European population is felt to be genetically susceptible to this autoimmune condition. Approximately 100 people in the UK are believed to have developed the disease after receiving Pandemrix, with the largest affected group being children and teens, though all ages were affected.

… The government U-turn (on compensation) follows a major study of four- to 18-year-olds by the Health Protection Agency which found that around one in every 55,000 jabs was associated with narcolepsy. A spokesman for GSK said it had details of around 900 people from 14 countries who had narcolepsy and were vaccinated…

Why did it take so long to make this determination?  And why did the government deny it initially?  Perhaps because it was the government, not the manufacturer, that was on the hook for damages.  Such is the new legal regime for pandemic flu vaccines.  And now such is the legal regime for all vaccines given in the US.  The risk of developing narcolepsy in the UK was increased after vaccination by a factor of 10-16 (or at least 1,000%) in the six months after the shot.  The legal standard to assign causality in many countries would be just a doubling of risk; this ten-fold plus risk increase should have been rapidly identified and acknowledged, especially given the “enhanced” surveillance in the US and Europe to which the pandemic vaccines were subjected in 2009.


What is enhanced surveillance?  According to US government scientists

“The vaccine safety datalink (VSD), which is the USA’s principal active surveillance system, was enhanced, several active surveillance systems that were at varying stages of growth were expanded rapidly (ie, databases from Medicare and the US Departments of Defense and Veterans Affairs), and new adverse event monitoring systems were developed specifically for monitoring of influenza A (H1N1) vaccination — ie, the emerging infections programme (EIP), and the post-licensure rapid immunization safety monitoring (PRISM) network.”

It begs the question of the effectiveness of routine flu vaccine adverse event surveillance when enhanced surveillance took 2-3 years following the mass vaccination program to yield actionable results despite a 1,000 plus percent increase in narcolepsy incidence.  We still have no information about changes in incidence for other conditions, apart from GBS, following pandemic swine flu vaccine. 

Guillain Barre Syndrome (GBS) was found to occur approximately 2-2.6 times as often as expected in the six weeks post US pandemic (nonadjuvanted) flu vaccinations, per independent researchers and per CDC, but not after Pandemrix.  This has been found in other years as well, in addition to 1976, when GBS occurred about 8 times as often as expected in the 6 weeks following swine flu vaccination.  However, CDC’s discussion of this subject obfuscates the fact that, when you look for it, risk for GBS remains higher than expected following flu shots most years.


Last month, CIDRAP discussed new evidence from a study in pigs that a preceding flu shot could lead to a more severe flu illness than the illness seen in unvaccinated pigs.  This added to observations made by several groups (especially in Canada) that 2008 flu shots increased the risk of 2009 swine flu disease by about a factor of 2.  The reason is that vaccination may induce antibodies that potentially block a normal immune response as well as enhance it.  Other vaccines have occasionally caused a similar effect, increasing the incidence or worsening the illness they were intended to prevent.


Because vaccine science is actually more art than science, and the creation of new vaccines and adjuvants remains a matter of trial and error, we don’t actually know until a vaccine is given to many thousands or millions of people whether potentially serious adverse events will occur.   See info on vaccine safety analysis from the American College of Physicians, CDC and FDA.


CDC acknowledges that:

Rare side effects and delayed reactions may not be evident until the vaccine is administered to millions of people.

All confirm that serious adverse events may only be discovered long after a vaccine has been marketed. Unfortunately, the science of vaccine adverse event detection is still at a very early stage.

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