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Are 90 Year Old Vaccine Ingredient Safety Studies Valid Today?

Risk Of ASD 20% Higher For Child If Mother Has Flu Vaccine In First Trimester

Dice no yes maybeNot even Kaiser Permanente have been able to completely fudge the association between the vaccine and autism in this study, after exchanges with Brian Hooker and Donzelli et al. Here is the abstract:-

JAMA Pediatr. 2017 Jan 2;171(1):e163609. doi: 10.1001/jamapediatrics.2016.3609. Epub 2017 Jan 2.

Association Between Influenza Infection and Vaccination During Pregnancy and Risk of Autism Spectrum Disorder.

Zerbo O1, Qian Y1, Yoshida C1, Fireman BH1, Klein NP1, Croen LA1.

Author information

Abstract

Importance:

Maternal infections and fever during pregnancy are associated with increased risk for autism spectrum disorders (ASDs). To our knowledge, no study has investigated the association between influenza vaccination during pregnancy and ASD.

Objective:

To investigate the association between influenza infection and vaccination during pregnancy and ASD risk.

Design, Setting, and Participants:

This cohort study included 196 929 children born at Kaiser Permanente Northern California from January 1, 2000 to December 31, 2010, at a gestational age of at least 24 weeks.

Exposures:

Data on maternal influenza infection and vaccination from conception date to delivery date, obtained from Kaiser Permanente Northern California inpatient and outpatient databases. Influenza infection was defined by the International Classification of Diseases, Ninth Revision, Clinical Modification codes or positive influenza laboratory test results.

Main Outcomes and Measures:

Clinical diagnoses of ASDs identified by International Classification of Diseases, Ninth Revision, Clinical Modification codes 299.0, 299.8, or 299.9 recorded in Kaiser Permanente Northern California electronic medical records on at least 2 occasions any time from birth through June 2015.

Results:

Within this cohort of 196 929 children, influenza was diagnosed in 1400 (0.7%) mothers and 45 231 (23%) received an influenza vaccination during pregnancy. The mean (SD) ages of vaccinated and unvaccinated women were 31.6 (5.2) and 30.4 (5.6) years, respectively. A total number of 3101 (1.6%) children were diagnosed with ASD. After adjusting for covariates, we found that maternal influenza infection (adjusted hazard ratio, 1.04; 95% CI, 0.68-1.58) or influenza vaccination (adjusted hazard ratio, 1.10; 95% CI, 1.00-1.21) anytime during pregnancy was not associated with increased ASD risk. In trimester-specific analyses, first-trimester influenza vaccination was the only period associated with increased ASD risk (adjusted hazard ratio, 1.20; 95% CI, 1.04-1.39). However, this association could be due to chance (P = 0.1) if Bonferroni corrected for the multiplicity of hypotheses tested (n = 8). Maternal influenza vaccination in the second or third trimester was not associated with increased ASD risk.

Conclusions and Relevance:

There was no association between maternal influenza infection anytime during pregnancy and increased ASD risk. There was a suggestion of increased ASD risk among children whose mothers received an influenza vaccination in their first trimester, but the association was not statistically significant after adjusting for multiple comparisons, indicating that the finding could be due to chance. These findings do not call for changes in vaccine policy or practice, but do suggest the need for additional studies on maternal influenza vaccination and autism.

PMID:

27893896

DOI:

10.1001/jamapediatrics.2016.3609

Comments

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Benedetta

Jeannette Bishop;
Thanks for the link. Her speech is so filled with information.

Benedetta

If a mother miscarries, that baby never goes on to develop autism.
I wonder if the CDC and pharma depends on such little things like that to help keep the numbers down and thus find no association between vaccines given to pregnant women, and autism.

As a matter of fact? Have they even looked at this before recommending flu shots, or DTaP to pregnant women?

Jeannette Bishop

https://www.focusforhealth.org/prenatal-flu-vaccine-asd-good-research-bad-conclusions/

John Stone

ndavis

Whatever, the Zerbo paper is on the face of it a much better sample than the Sheffield data you cite twice.

ndavis

John Stone,

"The final link - the association of green jelly beans with acne - shows you are not serious."

Actually, John, that clever cartoon is in fact quite serious--and it perfectly illustrates a critical topic related to your post: the necessity of correction for multiple tests.

Here's the problem: If 20 tests are considered, the probability of observing at least one result that appears to be significant at the P < 0.05 level is about 64% even if all of the tests are actually not signficant. For example, the Bonferroni-corrected P value for that situation, with 20 tests, is not P < 0.05 but P < (0.05/20), so a P < 0.05 result for a link between green jelly beans and acne is not signficant. The headline in the last panel of the cartoon slyly tweaks the public's ignorance of statistics: most people would misunderstand the significance of the results because, unlike the authors of the JAMA Pediatrics article, they fail to understand the need for a correction for multiple tests.

John Stone

ndavis

The final link - the association of green jelly beans with acne - shows you are not serious.

Tracey RN

Working in the health care field and reading moms prenatal records when they come in to deliver , they have started to give the flu and Tdap around 30 wks.. I see lots of moms coming in with cramping and headaches or just feeling lousy. At 30-34 wks. I put a bug in a labor and delivery nurses ear, start asking when they received their flu and Tdap . She looked at me like" seriously " hopefully she does... I do know when these babies are born and then given the VitK and HepB they cry like they are in PAIN all night long.... When you change them or unwrap them they scream .. I have been in the field 30yrs and I have never seen babies cry like this .. It's heartbreaking ...

ndavis

John, you might be interested in these articles:

https://www.ncbi.nlm.nih.gov/pubmed/22914461

https://www.ncbi.nlm.nih.gov/pubmed/27033634

https://www.ncbi.nlm.nih.gov/pubmed/25607230

https://www.ncbi.nlm.nih.gov/pubmed/26572546

http://www.bmj.com/content/346/bmj.f393

https://www.clinicalkey.com/#!/content/playContent/1-s2.0-S0264410X17303730?returnurl=null&referrer=null

Of course the question arises as to how to adjust for multiple tests. Otherwise, you end up with something like William Thompson's results that suggest that early exposure to thimerosal improves certain measures of fine motor coordination, attention and executive function, or this:

https://www.xkcd.com/882/

John Stone

ndavis

Which other studies?

Basically, you are acknowledging a situation where there is a trade-off and the trade-off escalates as the number of vaccines increase, but for public consumption is denied.

Obviously, it is the value for p which is under dispute and it simply looks as if Zerbo et al adjusted it because they didn't like the result.

ndavis

Of course you're right, John--my back-of-the-envelope calculation was off. If you take the statistics at face value, influenza vaccination in the first trimester would cause over half as many additional cases of ASD as the number of stillbirths and neonatal deaths that the vaccine would prevent. There is a problem with taking those statistics at face value, though: even the uncorrected value for the increased cases of ASD is barely significant (the confidence interval nearly includes 1.0) while the values for other adverse effects are highly significant (e.g., for stillbirth, P < 0.006). Moreover, the results for stillbirth and neonatal death replicate the results of other studies, while this first indication of a potential increase in ASD stands alone--if it is not refuted by correction for multiple tests. It's too bad that this situation, like most of life, involves competing considerations.

Tim Lundeen

@ndavis The study you link to does not seem to include miscarriage rates post-vaccination. Without this information, we don't know what the whole-pregnancy risks are. For example, see http://www.thehealthyhomeeconomist.com/study-confirms-anecdotal-link-between-flu-vax-and-miscarriage/

John Stone

ndavis

If the overall rate is ~150 in 10,000 it is easy to calculate that an increase of 20% would be much more than 10 in 10,000.

One problem with the study you cite is that the vaccinated are relatively small group, receiving extra care if older (obviously the vaccinated were a little older in the autism study), but there isn't any data presented to suggest that stillbirth was associated with "vaccine preventable" flu strains.

Can we find some answer to the control of infectious diseases which doesn't involve widespread neurological damage to the survivors? The implication your comment is "only 1 in 1000". Oh dear!

ndavis

When I discussed this study with a pediatrician friend last week, she mentioned that other recent studies suggest that influenza vaccination in the first trimester signficantly reduced adverse events including death. Apparently, according to the 2017 study discussed above, vaccination in the first trimester would cause about 10 extra cases of ASD per 10,000 women vaccinated. My friend said that several studies show that the influenza vaccine significantly reduces the risk if stillbirth, including a study that I looked up, which as far as I can tell shows that for every 10,000 women who receive a flu shot in the first trimester about 5 premature deliveries, 30 stillbirths, and 20 neonatal deaths would be prevented. This is more complicated than I thought.

https://www.ncbi.nlm.nih.gov/pubmed/22914461

John Stone

Nancy, Betty

Yes, the whole thing is completely insane. It should be emphasised that the 20% higher risk is not based on some very low risk in the first place, it is based on an average incidence of 1 in 63.5. So it starts off by being high risk and makes it measurably higher. In their reply Zerbo, Klein and Kroen are still basing their claim of statistical insignificance on the entire pregnancy but they are not willing to reject the use of the vaccine which offers about as much protection against flu as an umbrella with its fabric removed does against the rain - they are posing a minute and remote temporary benefit against another say three in a thousand children being rendered autistic for life. They don't say "Oh dear, primum non nocere" they say bang on with program while they devise another study which may hide the damage better. Nothing to interfere with the thousand year Reich of Kaiser Permanente or their pensions.

Betty Bona

If you don't understand the significance of this article, simply click on the names (Brian Hooker and Donzelli) to see the recently published letters to the editor in relation to this Kaiser study. Both letters discuss the inappropriateness of using the Bonferroni principle with this data. This is a perfect example of what Robert Kennedy, Jr. states; that statistics don't lie, but statisticians do! Even when the paper was first published, there was a comment questioning the use of the Bonferroni principle. Thank you to Brian Hooker and Donzelli, et al for pursuing this statistical lie.

nhokkanen

I urge readers to view the pithy JAMA comment and response letters by Brian Hooker, PhD and Donzelli et al. linked in the first paragraph.
http://jamanetwork.com/journals/jamapediatrics/article-abstract/2617988
http://jamanetwork.com/journals/jamapediatrics/article-abstract/2617989

The latter letter urges use of the precautionary principle by refraining from vaccinating pregnant women. Hopefully the public health community has the common sense — and decency — to prioritize autism prevention over a flu vaccine whose efficacy is demonstrably minuscule.

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