Safety of Trivalent Inactivated Influenza Vaccine in Children 6 to 23 Months Old

[HuckleB]

http://jama.ama-assn.org/content/296/16/1990.abstract

"In the largest population-based study to date of the safety of trivalent inactivated influenza vaccine in young children, there were very few medically attended events, none of which were serious, significantly associated with the vaccine. This study provides additional evidence supporting the safety of universally immunizing all children 6 to 23 months old with influenza vaccine."


-------------

I'm posting this because there appears to be some misinformation being pushed on this particular topic, and it makes sense to get the most updated information out there.


As and addendum:
http://www.cidrap.umn.edu/cidrap/content/influenza/general/news/nov2410kids-br.html

[BeFree]

1. What?

They are injecting infants with a poison?

How did we ever survive this long without injecting infants with poison? It's a miracle!!

[trotsky]

2. The infants who died of flu aren't around today to tell you.

Pity, that.

[HuckleB]

3. More Data on Vaccine Safety Amid New Outbreaks

http://www.sciencebasedmedicine.org/?p=357

"Conclusion

This latest study adds to the consensus of existing evidence for a lack of association between thimerosal in vaccines and autism or other neurological disorders. It is not by itself definitive, like all studies there are open questions, but it shows a lack of a dose-response toxicity to thimerosal in a dosing range relevant to the vaccine schedule.

However, since the anti-vaccination movement is largely ideological and disconnected from the scientific evidence I do not anticipate that this will end the controversy. The response of Handley and Kirby was predictable and shows this to be true. Meanwhile outbreaks of vaccine-preventable diseases appears to be on the rise, highlighting the need for better public education about vaccines."

[TheWraith]

5. I'd like to inform you of the dangers of the chemical "dihydrogen monoxide."

I'd also like you to take an actual high school level science class, and pass it, before you start wandering around talking about how people get cancer because their humors are misaligned.

[BeFree]

24. Ahhh

You have all the secrets to the human immune system.

Please, oh wise one, tell the world!! Be our savior!! Bwahahaha

[HuckleB]

27. LOL!!!!!!

http://scienceblogs.com/insolence/2007/11/cries_the_antivaccinationist_why_are_we.php

[endless october]

4. it's obviously a conspiracy.

A conspiracy designed to prevent babies from getting the flu and dying.

[mhatrw]

6. Thanks for bringing this important issue to our attention!

http://vran.org/about-vaccines/specific-vaccines/influenza-vaccine-flu-shot/safety-of-influenza-vaccines-in-children/

Since publishing our systematic review of the effects of influenza vaccines in healthy children (Feb 26, p 773),1 we have completed our review of the published and unpublished safety evidence for these vaccines.2

We found only one safety study of inactivated vaccine in 35 children aged 12-28 months done nearly 30 years ago with an influenza B vaccine;3 all other safety studies of inactivated vaccine we found were in children aged 3 years or more. Three studies reported safety data of live vaccine in children aged 22 months or younger (combined denominator 827).4-6 Seven further studies included children younger than 2 years.7-13 Only one trial of live vaccine had serious adverse events as an outcome (measured up to 3 months after vaccine administration).8 The lack of reported trial safety data for inactivated vaccines in younger children is particularly surprising given that this vaccine is now recommended for healthy children aged 6 months and older in USA and Canada.1 ...

Although so far we have found no evidence to suggest a serious harmful effect of any of the vaccines in our review, we are concerned by our findings of limited clinical trial evidence for inactivated vaccines. In addition, the withholding of safety data for live attenuated vaccines makes it impossible to present a complete evidence base of their safety. Although a frequent practice, lack of reporting of non-significant outcomes raises the real possibility that our review may present a biased picture.17,18 Heterogeneity of outcome definition and reporting are additional problems in vaccine trials.19

An incomplete or fragmented evidence base could hinder identification of rare and serious adverse events. Given their rarity, these may not be identifiable from single studies but may require a complete data set, as was the case for intussusception and rotavirus vaccines.20

We believe all unpublished trial safety data should be readily accessible to both the regulatory bodies and the scientific community on request. Our evidence gives rise to a concern that lack of access to unreported data prevents published data being put into context and hinders full and independent review. This cannot be good for public confidence in these vaccines.

[HuckleB]

8. Thank you for showing everyone that you are spreading outdated information.

Thank you for the confession.

[mhatrw]

9. Here is the latest & greatest.

http://www.cochrane.org/podcasts/issues-1-3-january-march-2010/two-updated-reviews-influenza-vaccines

[HuckleB]

10. That addresses studies regarding flu vaccines in the elderly.

If you'd like to discuss flu vaccines in geriatric practice, it would probably make sense to start a new thread.

[mhatrw]

11. I thought you wanted the latest & greatest!

http://www.ncbi.nlm.nih.gov/pubmed/20614424

Conclusions:

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. WARNING: This review includes 15 out of 36 trials funded by industry (four had no funding declaration). An earlier systematic review of 274 influenza vaccine studies published up to 2007 found industry funded studies were published in more prestigious journals and cited more than other studies independently from methodological quality and size. Studies funded from public sources were significantly less likely to report conclusions favorable to the vaccines. The review showed that reliable evidence on influenza vaccines is thin but there is evidence of widespread manipulation of conclusions and spurious notoriety of the studies. The content and conclusions of this review should be interpreted in light of this finding.

[HuckleB]

12. Thus, when faced with a correction to the misinformation you've spread, you offer red herring.

Well, I guess you made that clear long ago.

[mhatrw]

13. LOL. Thank you for offering the usual misdirection. And a double misdirection at that!

The links provided have put that lame line of bs to rest already. You aren't providing any new bs, so why repeat what has already been debunked?

:rofl:

[HuckleB]

14. Wow! When you want to claim up is down and down is up, you really go for it.

But thanks for yet another stunning confession.

[mhatrw]

16. Awwwwww.

I'm sorry you have no response for actual science and the real world.

I guess life is hard when you're pushing a line of baloney.

[HuckleB]

17. And you're still pretending that up is down and down is up.

Apparently you think that repeating fictional nonsense over and over again makes it true.

Sure, that can convince people that it's true, but it doesn't make it true. It's an old propaganda technique. I suspect you know it very well.

You were caught pushing your usual anti-vax routine, using old, selected data to push your agenda. Offering up links about the elderly and adults in response to being caught pushing misinformation about safety data on children does not do anything but show everyone that you do think up is down and down is up. (BTW, you do know that those links show no issues with flu vaccine safety, right?)

Confess away!!!!

[mhatrw]

19. So, once again, red herrings are all you've got!

:rofl:

[HuckleB]

20. In other words, you really are trying to create your own reality.

Yes, that is actually funny. :rofl:

Please keep posting! You are doing more to harm the anti-vax movement than anyone else on this board could do.

[mhatrw]

21. LOL. More misdirection. Your concerns have been answered many times.

Everyone can see your obvious agenda here. It's over. Face scientific reality.

[HuckleB]

23. It appears that you really do think you can create your own reality.

You keep repeating the same BS in a very odd defense of the defenseless nonsense that you've posted.

Repeat all you want. It doesn't make your BS true.

[MineralMan]

15. From 2005? Medicine marches on, whether you are paying

attention or not, you know.

[mhatrw]

18. Yeah. One study was done since then which does provide some evidence that

for the safety of this vaccine. However, this study was a non-randomized retrospective analysis. Unvaccinated controls were not used. Outpatient medical events attended to on the day of vaccination were not included in the study. The claims of health are based on comparing the medically attended events 28-14 days before and after vaccination (the "control" periods) with the medical events attended to 1 to 14 days after vaccination (the "active" period). If babies were medically attended for the same reason in both the "active" period and either of the "control" periods, both medical events were ignored. Charts were manually reviewed and medical events determined to be caused by something other than vaccination were manually excluded. The specific ICD-9 codes that were screened for were selected by the experimenters.

It's an interesting study, and it does offer some evidence of this vaccine's safety assuming the devilish details were handled expertly, competently and in an unbiased manner. But it was not a randomized double blind study by any means. It was rather an arbitrary temporal comparison of historical medical event frequency.

[HuckleB]

33. Flu Vaccine Efficacy

http://www.sciencebasedmedicine.org/?p=2040

[HuckleB]

7. Study: Pediatric vaccinations have no affect on long-term neuropsychological outcomes

http://www.pri-med.com/PMO/NewsDetail.aspx?id=63

More...

More Data on Vaccine Safety Amid New Outbreaks
http://www.sciencebasedmedicine.org/?p=357

[HuckleB]

22. Spring-fall flu shots safe, protect children

http://www.innovations-report.com/html/reports/medicine_health/report-34308.html

[HuckleB]

25. Study: Flu shots safe for most egg allergic kids

http://childrenshospitalblog.org/study-flu-shots-safe-for-most-egg-allergic-kids/

[HuckleB]

26. Swine flu vaccines, adjuvants, equity, safety

http://scienceblogs.com/effectmeasure/2009/09/swine_flu_vaccines_adjuvants_e.php

[HuckleB]

28. Study supports flu vaccine efficacy in young children

http://www.cidrap.umn.edu/cidrap/content/influenza/general/news/nov2410kids-br.html

Yes, this study was in the OP, but it was ignored, apparently.

[HuckleB]

29. Safety of the Trivalent Inactivated Influenza Vaccine Among Children

http://archpedi.ama-assn.org/cgi/content/abstract/158/11/1031

[HuckleB]

30. Safety and Immunogenicity of Concurrent Administration of Live Attenuated Influenza Vaccine With ...

Safety and Immunogenicity of Concurrent Administration of Live Attenuated Influenza Vaccine With Measles-Mumps-Rubella and Varicella Vaccines to Infants 12 to 15 Months of Age
http://pediatrics.aappublications.org/cgi/content/abstract/121/3/508

[HuckleB]

31. It's interesting to note that some DUers unrec good research.

Apparently, even at DU, dishonesty is a plague.

[HuckleB]

32. How Effective Is the Flu Vaccine?

http://www.webmd.com/cold-and-flu/how-effective-is-flu-vaccine

[mhatrw]

35. LOL

WebMd or http://www.democraticunderground.com/discuss/duboard.php?az=show_mesg&forum=222&topic_id=99128&mesg_id=99128">The Cochrane Review?

[HuckleB]

37. Nice logical fallacy.

[mhatrw]

34. Effectiveness of trivalent inactivated influenza vaccine in children 6 to 23 months old

http://www2.cochrane.org/reviews/en/ab004879.html

Vaccines for preventing influenza in healthy children

...

The review authors found that in children aged from two years, nasal spray vaccines made from weakened influenza viruses were better at preventing illness caused by the influenza virus (82% of illnesses were prevented) than injected vaccines made from the killed virus (59%). Neither type was particularly good at preventing 'flu-like illness' caused by other types of viruses (33% and 36% respectively). In children under the age of two, the efficacy of inactivated vaccine was similar to placebo. It was not possible to analyse the safety of vaccines from the studies due to the lack of standardisation in the information given but very little information was found on the safety of inactivated vaccines, the most commonly used vaccine, in young children.

[HuckleB]

36. And you repeat your often repeated post of this one review.

That's all you can offer? The same thing over and over again?

[mhatrw]

40. ONE REVIEW? ONE REVIEW?

Do you even know what a Cochrane Review is?

Hint: It is a http://www2.cochrane.org/reviews/en/ab004879.html">comprehensive assessment of ALL existing studies published in peer reviewed medical journals around the world to date.

[HuckleB]

41. I clearly know much more about Cochrane, it's pros and it's cons, than you do.

I also know when that review was published, and I know that you've chosen to ignore everything else.

Cochrane reviews can be helpful, but they are not be all, end all, as you clearly want to believe, in this selective instance.

A couple of pieces that touch on some of the issues with such reviews:

Rambling Musings on Using the Medical Literature
http://www.sciencebasedmedicine.org/?p=10300

Divine intervention? A Cochrane review on intercessory prayer gone beyond science and reason
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2728094/

[mhatrw]

42. Clearly. LOL

A review is not a "single" thing by definition. It is a meta-analysis of many single studies. Do meta-analyses have their own problems? Sure. Garbage in = garbage out. But when it comes to most vaccine "science", garbage is all you have to go on. Is it the fault of the Cochrane Review that better vaccine studies from which to draw their reviews' conclusions have never been done?

Do you know of any other reviews of the efficacy of flu vaccination in 6 month to 23 month kids that conclude that flu vaccines ARE effective in this sub-group?

If so, why don't you link these reviews up for us so we can judge them for ourselves?

Of course, this is not to say that I automatically agree with with every review of multiple studies over every singular well-designed and executed study that shows results to the contrary. But where are these individual studies that show that flu vaccines are EFFECTIVE (rather than safe) in 6 month to 23 month kids?

If you know of any such studies, why don't you link these studies up for us so we can judge them for ourselves as well?

Thanks!

[HuckleB]

45. And the red herrings and clear decision to only use data that supports your preconceived notions ...

... continues.

I've posted numerous studies. The fact that you only want a review, because you are trying to defend a preconceived notion is ludicrous. You can spin and spin and spin, which is all you do, but, again, you've failed to defend your preconceived notions over and over and over again.

BTW, thank you for ignoring information that has been posted repeatedly, in order to pretend otherwise. I will not waste my time on your games. If you can actually begin to engage in honest discussion, then I might engage with seriousness.

[HuckleB]

38. Flu Shots in Children Can Help Community

http://www.nytimes.com/2010/03/10/health/10flu.html

[HuckleB]

39. Study backs up flu shot advice for kids

http://www.usatoday.com/news/health/2008-11-02-flu-shot-kids_N.htm

[mhatrw]

43. Do you even read your own links?

Hint: I do. So maybe you should as well before you post them

http://www.usatoday.com/news/health/2008-11-02-flu-shot-kids_N.htm

In a two-year study of 2,500 children ages 6 months to 5 years, those who were fully vaccinated had half as many flu-related medical visits. Children under 9 need two shots — given one month apart — to be fully vaccinated. Older kids need just a single shot. Researchers found that "partly" vaccinated children got no protection.

So what this says is that a single flu vaccination is completely useless for kids between 6 months and 5 years old!

And here is what the actual crappy case-controlled study said it showed:

http://pediatrics.aappublications.org/cgi/content/abstract/122/5/911

METHODS. We conducted a case-control study with children with medically attended, acute respiratory infections who received care in an inpatient, emergency department, or outpatient clinic setting during 2 consecutive influenza seasons. All children residing in Monroe County, New York, Davidson County, Tennessee, or Hamilton County, Ohio, were enrolled prospectively at the time of acute illness and had nasal/throat swabs tested for influenza with cultures and/or polymerase chain reaction assays. Children with laboratory-confirmed influenza were case subjects and children who tested negative for influenza were control subjects. Child vaccination records from the parent and the child's physician were used to determine and to validate influenza vaccination status. Influenza vaccine effectiveness was calculated as (1 – adjusted odds ratio) x 100.

RESULTS. We enrolled 288 case subjects and 744 control subjects during the 2003–2004 season and 197 case subjects and 1305 control subjects during the 2004–2005 season. Six percent and 19% of all study children were fully vaccinated according to immunization guidelines in the respective seasons. Full vaccination was associated with significantly fewer influenza-related inpatient, emergency department, or outpatient clinic visits in 2004–2005 (vaccine effectiveness: 57%) but not in 2003–2004 (vaccine effectiveness: 44%). Partial vaccination was not effective in either season.

...

Children were classified as being fully vaccinated if they were vaccinated according to the ACIP guidelines for each season and received (1) 2 vaccine doses in the current influenza season that were administered ≥24 days apart, with the second dose given ≥14 days before ARI onset, or (2) ≥1 vaccine dose in a previous influenza season and 1 dose in the current season, administered ≥14 days before ARI onset. Children were classified as being partially vaccinated if they received (1) only 1 of 2 recommended vaccine doses during the current season, ≥14 days before ARI onset, or (2) 2 vaccine doses during the current season, with the second dose administered within 14 days before ARI onset or <24 days after the first dose. (Does this seem a bit arbitrary to anyone else?) ...
It should be noted that, beginning in the 2007–2008 season, children who received only 1 of 2 recommended vaccine doses during a previous season and 1 dose during the current season would not be considered fully vaccinated under ACIP guidelines. (Yeah, I guess they noticed it, too.)

'''

Vaccine Effectiveness

2003–2004 Influenza Season

Among children 6 to 59 months of age, neither full nor partial vaccination was associated with a significant reduction in influenza-related visits, compared with those who were unvaccinated at the time of the visit. ... VE estimates varied between age subgroups, but neither age group experienced a significant reduction in influenza visits, compared with unvaccinated children.

So one flu vaccination made no difference in either 2003–2004 or 2004-05, and even two flu vaccinations did not result in significantly fewer influenza-related inpatient, emergency department, or outpatient clinic visits in 2003–2004.

Anyone who understands case control studies knows that this study was weak sauce in terms of demonstrating the true efficacy of the flu vaccine among the population studies. The study did not directly compare the number of influenza-like illnesses of vaccinated kids against those of unvaccinated kid, nor did the study compare the number of lab confirmed influenza cases of vaccinated kids to unvaccinated kids. What this study did was statistically analyze the subset of kids suffering from influenza-like illnesses who had their illnesses tested and compare the number of sick kids who had their illnesses tested who had lab confirmed influenza and were "fully vaccinated" to the number of sick kids who had their illnesses tested who had lab confirmed influenza and were not "fully vaccinated".

[HuckleB]

44. Yes, I do.

Now, thank you for repeatedly using selective BS, instead of acknowledging the full evidence. This has been repeatedly pointed out, yet you continue to repeat the same nonsense. This is a good study, and your only actual defense is to discuss "partly vaccinated" kids and bring up something much older. It's all the same nonsense over and over again. Your repeats don't change reality.