Bad Jab? (UPDATED)
Australia’s chief medical officer, Jim Bishop has announced that children under five years old should not receive the flu vaccine. Apparently at least 60 children under the age of 5 have had high fevers and 23 have had convulsions shortly after receiving the vaccine. I have not heard any advisory from the New Zealand authorities yet, although Stuff says that doctors have been warned not to use Fluvax, the alleged culprit in Australia. Child and youth health chief advisor, Pat Tuohy, rambles on about how 4% of children with high temperatures have seizures, but that does rather seem to miss the point that we do not normally see this number of febrile convulsions (fever fits) after a vaccine.
This is no reason for anyone over the age of five not to get the vaccine
”It is possible that the swine flu component is causing this problem. We did not see febrile convulsions after the original, emergency swine flu vaccine, but that was a whole-virus vaccine. The current vaccines all contain broken-apart viruses to increase their antigenicity (the amount of immune system response that is made). It may be that this has exposed an antigen that causes an extreme immune response. This makes sense when you consider that the deadliness of the swine flu was that it occasionally causes massive immune responses in its victims. Otherwise, it was a fairly innocuous form of flu. The fact that this seems to be a problem mostly with Fluvax, suggests that CSL’s manufacturing process might be the one that specifically exposes this antigen. Interesting. And very scary for the parents whose children suddenly became ill.
Contrary to the entertaining frenzying of the anti-vaccine lobbies, this is no reason for anyone over the age of five not to get the vaccine. There does not appear to be any safety issue here (though I know of a number of people who swear they developed flu symptoms within 24 hours of receiving the vaccine). The very fact that the authorities have picked up this problem (of febrile convulsions in under fives), means that the systems are working fine. Note that, unlike long-term vaccines like Gardasil and MeNZB, it is not reasonable to expect the seasonal flu vaccine to undergo extensive safety trial each year. We would simply have no seasonal flu vaccine if this were the case as these trials would be prohibitively expensive and too lengthy to allow the vaccine to be produced every year. Therefore, the flu vaccine is monitored more stringently than other vaccines.
There has been some criticism of the response time of Western Australia’s public health system. Two weeks elapsed from the first case of febrile convulsions associated with the vaccine to the current warning. In fairness, however, there are many other causes of febrile convulsions and it takes time to investigate each case to determine the likelihood of the convulsions being caused by the vaccine. This is not to say that the current surveillance system is perfect – far from it. For a start, a decent monitoring system would actively contact recipients of the vaccine and check for reactions, rather than waiting for the patient to see a GP and for the GP to actually notify CARM (Centre for Adverse Reaction Monitoring). Only the most severe reactions, such as a febrile convulsion, make it through this process. If we knew the prevalence of minor reactions, we could be more alert for severe reactions, if there was a sudden jump in minor ones.
Flu vaccination saves a number of lives every year and reduces the flu burden on society and the associated costs to the economy. It is certainly still worth considering. But I will not be recommending preschoolers have the vaccine, regardless of the manufacturer or the indications.
UPDATE 1:
There is still some dispute as to whether the death of the toddler in Western Australia was vaccine related. I would be surprised if they can say definitively it was not related (and provide evidence). I have less surprise that the GP did not notify this as a possible vaccine death. The combination of the firm belief that vaccines are safe, plus the disincentive of the likely can of worms one is opening, reporting the case, makes most GPs very reluctant to report such things. It is therefore unsurprising that vaccine reactions are very underreported.
UPDATE 2:
Our practice received a fax from vaccination control last night warning us not to use the flu vaccines in the under 5s. I am wondering why it took FOUR DAYS for them to make up their mind after Australia issues a warning. Surely it should take no more than a few hours?
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Apr 24 10 1:12 am
Your comment seems to hold contradictions for me.
1. We agree it’s not safe for children under 5. What about 6, or 7? Is 5 just a statistical cut off point, or a genuine safe point as far as an individual is concerned?
2. “The system is working” only applies to thinking of people in the masses. It didn’t work for all those that had adverse reactions.
3. What process for reporting negative reactions in that people “swear” they got the flu after receiving the shots? Most of the time I see these reports, I get the impression they are just ignored. I don’t think they should be, it’s another adverse reaction and one that indicates it didn’t work.
4. “It may be that this has exposed an antigen that causes an extreme immune response. ” and yet the flu brochures I read claim the flu vaccine is 100% safe, and due to using inert viruses,. broken apart viruses, attenuated viruses etc and they say “you can’t get the flu” from it. Yet points 3 and 4 says otherwise.
5. “Two weeks elapsed from the first case of febrile convulsions associated with the vaccine to the current warning. In fairness, however, there are many other causes of febrile convulsions and it takes time to investigate each case to determine the likelihood of the convulsions being caused by the vaccine. ” Well, in fairness, I think ANY reaction needs to be reported and then acted upon in good faith, rather than setting in procedures where people try very hard to find some other possible cause. Even if the vaccine is merely a trigger for a pre-existing condition, then people need to know it is acting like that. Immediately.
6. “Flu vaccination saves a number of lives every year ” That would be hard to prove I suspect. The dreaded Swine Flu raged through Mexico, and the total number of deaths recorded were pretty close to normal for a population of 110 million, and they had no vaccine for it, and many deaths were attributed to it by default, until the investigation confirmed it (and numbers attributed to swine flu deaths were later lowered).
I’m not convinced of the overall safety, effectiveness and efficacy of these vaccines. So I’ll borrow another idea I think rather flimsy in the vaccine debate – herd immunity. Go forth fellow readers, and jab yourself. I’ve got nothing to lose.
.-= ZenTiger´s last blog ..The Nazi Pedophile Priest Scare =-.
Apr 24 10 1:31 am
Hi, Zen. Nice to see you so feisty at this early hour of the morning!
1. There are no reported cases above the age of 5. Seeing as febrile convulsions are very rare above this age anyway, this is not a surprise.
2. The system can never be designed that will prevent individual tragedies.
3. No report is “ignored”. But none of these minor problems will be reported to CARM – hence my suggestion that they need to do some active monitoring.
4. I bet you it doesn’t say “100% safe”. That would be a very large claim to make. Technically, even placebo is not 100% safe.
5. I think that all reactions are taken seriously. It is simply very hard to determine if this is a vaccine reaction or something else. To remove vaccines from circulation without good cause is to deny people the undoubted benefits of the vaccine.
6. Actually, it is quite easy to prove that flu vaccines save lives. There are a number of excellent studies that compare the rate of pneumonia deaths in vaccinated and unvaccinated elderly populations. Paediatric studies are a little more thin on the ground but indicate similar results.
I agree that herd immunity is a dubious idea. Frankly, I see no reason to look beyond the clear economic benefits of fewer immunised people getting sick.
Apr 24 10 1:34 pm
“6. Actually, it is quite easy to prove that flu vaccines save lives. There are a number of excellent studies that compare the rate of pneumonia deaths in vaccinated and unvaccinated elderly populations. Paediatric studies are a little more thin on the ground but indicate similar results.”
“Does the vaccine matter?”
http://www.theatlantic.com/magazine/archive/2009/11/does-the-vaccine-matter/7723/
“When Lisa Jackson, a physician and senior investigator with the Group Health Research Center, in Seattle, began wondering aloud to colleagues if maybe something was amiss with the estimate of 50 percent mortality reduction for people who get flu vaccine, the response she got sounded more like doctrine than science. “People told me, ‘No good can come of [asking] this,’” she says. “‘Potentially a lot of bad could happen’ for me professionally by raising any criticism that might dissuade people from getting vaccinated, because of course, ‘We know that vaccine works.’ This was the prevailing wisdom.”
Nonetheless, in 2004, Jackson and three colleagues set out to determine whether the mortality difference between the vaccinated and the unvaccinated might be caused by a phenomenon known as the “healthy user effect.” They hypothesized that on average, people who get vaccinated are simply healthier than those who don’t, and thus less liable to die over the short term. People who don’t get vaccinated may be bedridden or otherwise too sick to go get a shot. They may also be more likely to succumb to flu or any other illness, because they are generally older and sicker. To test their thesis, Jackson and her colleagues combed through eight years of medical data on more than 72,000 people 65 and older. They looked at who got flu shots and who didn’t. Then they examined which group’s members were more likely to die of any cause when it was not flu season.
Jackson’s findings showed that outside of flu season, the baseline risk of death among people who did not get vaccinated was approximately 60 percent higher than among those who did, lending support to the hypothesis that on average, healthy people chose to get the vaccine, while the “frail elderly” didn’t or couldn’t. In fact, the healthy-user effect explained the entire benefit that other researchers were attributing to flu vaccine, suggesting that the vaccine itself might not reduce mortality at all. Jackson’s papers “are beautiful,” says Lone Simonsen, who is a professor of global health at George Washington University, in Washington, D.C., and an internationally recognized expert in influenza and vaccine epidemiology. “They are classic studies in epidemiology, they are so carefully done.”
The results were also so unexpected that many experts simply refused to believe them. Jackson’s papers were turned down for publication in the top-ranked medical journals. One flu expert who reviewed her studies for the Journal of the American Medical Association wrote, “To accept these results would be to say that the earth is flat!” When the papers were finally published in 2006, in the less prominent International Journal of Epidemiology, they were largely ignored by doctors and public-health officials. “The answer I got,” says Jackson, “was not the right answer.”
How many times does it need to be said? Flu vax = crap.
Apr 25 10 12:22 am
When the papers were finally published in 2006, in the less prominent International Journal of Epidemiology, they were largely ignored by doctors and public-health officials.
Actually there have been a great many additional papers on confounding bias of observational and cohort vaccine studies. The latest one can be found here
Unfortunately for your conspiracy theory, there have been a number of recent papers that have addressed this issue and found that, on eliminating the confounding errors there is still a clear benefit for the elderly in both reduced mortality and reduced hospitalizations. Examples are here (“most studies confirm the benefits of vaccination among the elderly for reducing hospitalization and death”), here (“After taking unmeasured confounding into account, influenza vaccination is still associated with substantial reduction in mortality risk.”) , here (“Although our estimate of 4.6% vaccine effectiveness against all-cause mortality during flu season may seem disappointing, it amounts to approximately 47% of a plausible target: the rise in mortality that would have occurred during flu season had none of the elderly been vaccinated.”) and here (“Influenza but not pneumococcal vaccination was associated with a reduced risk of all-cause mortality in COPD.”)
This is not a global warming debate, where the “science is settled” and further truth is not forthcoming. The people doing the studies made a note of the valid observations of Dr Jackson and others and addressed the issue. The conclusion is that, although the results of vaccinating the elderly are not as spectacular as originally suggested, they are still significant results. At risk older folk, especially those in nursing homes, should all get the flu jab. The benefits greatly outweigh the risks.
Apr 26 10 1:20 am
Well, the conspiracy theories are actually those of Dr Lisa Jackson from the Atlantic article, which I repeated. Furthermore, in her latest study, published October ’09, she states,
“Furthermore, a 2003 study by contemporary CDC epidemiologists [2] found that national influenza-related mortality rates among seniors increased in the 1980s and 1990s as the senior vaccination coverage quadrupled. That apparent lack of effect of increased vaccination could not be explained by adjusting for aging and viral circulation patterns [3], but many simply cited the inherent inferiority of trends studies to brush this observation aside. Although trends studies do have limitations, they are frequently celebrated when they seem to confirm vaccination program benefits for childhood diseases such as measles, Hib, pertussis, varicella and most recently rotavirus.
Such opposing views about the benefits of influenza vaccination in the elderly have been suppressed for quite some time. In fact, immunologists often use influenza vaccination as a model system in experimental studies of immune senescence (see reviews [4] and [5]). Ironically, a recent NEJM paper recapitulated similar astonishing cohort study findings of 50% VE published many times since the 1980s [6] almost simultaneously with our review of the flaws and how cohort studies could be improved”.
Influenza vaccination and mortality benefits: new insights, new opportunities.
http://www.ncbi.nlm.nih.gov/pubmed/19840664
(with full text under “Linkout”)
I also note that a recent review in the BMJ concluded that “Publication in prestigious journals is associated with partial or total industry (ie pharmaceutical company) funding, and this association is not explained by study quality or size”. ie a crap study would be published ahead of a good one if the crap one was pharma funded. Are you sure that the studies you cited are to a high standard and free from bias? Are you also confident that Dr Jackson would be satisfied by the approach taken by the authors of these studies in order to address her concerns? If you are, then do share how.
Relation of study quality, concordance, take home message, funding, and impact in studies of influenza vaccines: systematic review.
http://www.bmj.com/cgi/content/abstract/338/feb12_2/b354
Personally I would like to see Dr Jackson’s take on this latest round of research to see if her concerns were really addressed adequately, because as at October ’09 her view is that, “A way forward includes a new generation of unbiased studies with laboratory endpoints, and requires an agreement that the evidence base was flawed”.
Apr 26 10 1:37 am
You are misreading Dr Jackson’s article. She is not saying that there is no effect in the elderly but that seroconversion rates are not as high as we first thought and the actual protection from mortality is not the very rosy 50% that it was once thought to be . It is more of the order of 5%. This is still a worthwhile endeavor.
Dr Jackson’s article is NOT a study BTW, but a critique. But even she notes “We do not suggest that seniors should not be vaccinated”
And I wholeheartedly agree with her that better studies on this matter are needed.
Apr 25 10 5:46 pm
Thanks for the response, MacDoctor.
.-= ZenTiger´s last blog ..Lest We Forget =-.
Apr 27 10 11:29 pm
MacDoctor, how do you take the news that a baby has died within 24 hours of receiving the flu jab? The father is convinced it is related, how will it be recorded though?
Also, of interest, I checked the flu notice on the wall at work. It actually used the word “impossible”, as in “it is impossible to get the flu from the vaccine”. I mentioned this to a friend who said he got the flu jab for the first time this year, and has never been sicker, and three of his friends (not all working in the same place) who went with him to get the jab have all come down with hard cases of the flu. I guess if they associate together, they might get sick together, but it’s put him off the jab.
.-= ZenTiger´s last blog ..Traders and Warriors =-.
Apr 28 10 1:17 am
The father is probably right.
Most of the symptoms of what we call “the flu” is actually the body’s immune response against the disease, including the high fever and the muscle aches and pains. The flu vaccine consists of entirely denatured viruses (broken into little bits), so you can’t really get the disease from it (those posters are right). What people are experiencing is the immune response. Unfortunately, with the swine flu, that immune response is large, particularly in people who have been exposed to the virus already (but who may have had a mild form of the disease that time).
This is probably what is happening to those sick children. They have been unknowingly previously exposed and are now mounting a vast immune response in the form of a high fever. Some will have fever fits. Rarely, children will die from this. children who die from this almost invariably have some other medical illness and die from complications of that, rather than a fever fit, but there is no doubt that the vaccine is a contributing factor.