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Just Because It’s In Print, Doesn’t Make it True

March 10, 2011

Recently, another blogger reviewed Vaccine Epidemic. The blogger’s emphasis was on this quote taken from Allen Tate’s chapter, “The Greater Good”: “It is indisputable that the vaccination schedule has never been tested for safety in its entirety, or in the way that it is administered. In other words, while the government reviews, licenses, and compels individual vaccines, it does not test–or require vaccine makers to test–the safety and efficacy of vaccines given simultaneously or the cumulative effects of multiple vaccines” (83).

I left a comment at the blog (which was NOT posted) that perhaps the blogger might want to dig a little deeper, as this was inaccurate information. I even left a couple of helpful links, one of which was to CHOP’s page. If I’d realized the blogger wasn’t going to approve a mild comment offering information that directly countered Tate’s inaccuracies, I’d have copied and pasted my reply so that I could have placed it here. Silly me. I keep forgetting not everyone’s interested in accurate information.

Ah well, live and learn, right?

So let’s look at this single quote lifted from Vaccine Epidemic.

Tate writes, “It is indisputable that the vaccination schedule has never been tested for safety in its entirety, or in the way that it is administered.”

Really? But he offers no evidence for this extraordinary claim.

The CDC has a page on how vaccines are tested and approved. It’s not detailed enough for the concerned consumer, unfortunately, and perhaps they’ll fix that, as they realize that brief overviews are inadequate for those consumers who are ready to believe the worst of the US, the CDC, pharmaceutical companies, and the vaccine industry.

The FDA has a page, too. According to this page:

“Pre-marketing (pre-licensure) vaccine clinical trials are typically done in three phases, as is the case for any drug or biologic. Initial human studies, referred to as Phase 1, are safety and immunogenicity studies performed in a small number of closely monitored subjects. Phase 2 studies are dose-ranging studies and may enroll hundreds of subjects. Finally, Phase 3 trials typically enroll thousands of individuals and provide the critical documentation of effectiveness and important additional safety data required for licensing. At any stage of the clinical or animal studies, if data raise significant concerns about either safety or effectiveness, FDA may request additional information or studies, or may halt ongoing clinical studies.”

That’s not specific enough, is it? How are the vaccines tested? According to Dr. Paul Offit (email communication, quoted with permission), “Regarding vaccines, the non-inferiority rule is fairly specific. A new vaccine added to the schedule cannot decrease the level of the immune response by greater than 10 percent. And the existing vaccines cannot decrease the immune response of the new vaccine by more than 10 percent. This is actually a much stricter rule than that applied in Europe. Which is why they have more combination vaccines than we have.”

For an example of a study discussing specifically whether the non-inferiority rule was met or not, there’s a recent study from 2010 entitled “Evaluation of non-inferiority of intradermal versus adjuvanted seasonal influenza vaccine using two serological techniques: a randomised comparative study.” Horne et al. explain the non-inferiority rule as it relates to vaccines: “The goal of a noninferiority trial is to demonstrate that an investigational product is not inferior to a control product (usually an active product for the same disease indication) by a clinically important amount, with respect to the chosen end points.”

Let’s look at a specific example of concomittance, though: a study Offit was a part of on the rotavirus vaccine, from 2006. In this study, the only exclusion dealt with the oral polio virus vaccine. Otherwise, “Concomitant administration of other licensed vaccines and breast-feeding were not restricted.” Doesn’t sound like vaccines aren’t being studied as they’re given.

According to the website Vaccinate Your Baby, “Finally, all vaccines are subjected to concomitant studies before they are approved for use, meaning that all new vaccines must be tested in conjunction with existing ones to ensure there are no negative interactions. Regulatory agencies such as the Food and Drug Administration (FDA) are careful to look for any side effects associated with concomitant use before approving a new vaccine.”

An additional example of the way in which vaccines are studied can be found on the FDA’s website. The FDA provides a webinar on safety monitoring, as well. In addition to this webinar, the FDA provides a slide show on “Regulatory Perspective on Development of Preventive Vaccines for Global Infectious Diseases.” On one slide it discusses “Key clinical trial design parameters •Endpoints; dose & dosing; duration; concomitant meds/vaccines.”

Although there doesn’t appear to be a neat, concise bullet comment at either the FDA or the CDC that would succinctly rebut Tate’s argument, there is sufficient evidence readily available that suggests Tate, had he done a cursory review of the subject, should have known his statement was inaccurate.

If one did a little deeper digging, this article by Wang et al. would further explain how vaccines are studied:

“Once a correlate for disease protection has been established, immunogenicity trials with noninferiority/equivalence designs are widely used as economic and time-efficient alternatives to large efficacy trials in evaluating the effectiveness of a new or reformulated vaccine as compared to already licensed vaccines (Chan et al., 2003; Horne, 1995; Mehrotra, in press).

Noninferiority/equivalence designs are particularly useful in four common types of vaccine immunogenicity trials: vaccine bridging trials, combination vaccine trials, vaccine concomitant use trials, and vaccine consistency lot trials. Each of these trials serves a different purpose. For example, vaccine bridging trials are used because manufacturing processes or storage conditions may be changed after vaccine licensure to improve production yields and vaccine stability/shelf life. Vaccine bridging trials are often required to demonstrate that such changes do not have an adverse impact on vaccine effectiveness, by ruling out a clinically significant difference in immune responses between the modified vaccine and the current vaccine.

Combination vaccine trials are typically used to rule out clinically significant differences in immune responses between a combined vaccine and separate but simultaneously administered vaccines (Blackwelder, 1995; FDA, 1997; Horne et al., 2001). A combination vaccine is intended to prevent multiple diseases or to prevent one disease caused by different strains or serotypes of the same organism while reducing the number of injections required (Chan et al., 2003). Similarly, since the concomitant administration of multiple vaccines can reduce the number of vaccination visits, vaccine concomitant use trials are used to rule out clinicallysignificant differences in immune responses between the concomitant administration of two or more vaccines and the separate administration of each vaccine.”

Wang et al. continues, “The primary objective of a vaccine noninferiority/equivalence trial is to demonstrate that a new or modified vaccine is noninferior or equivalent to the current vaccine by ruling out a prespecified clinically relevant difference in the immune response.”

Let’s get back to Tate, though. The quote from Tate continues, essentially repeating himself and further distorting the reality: “In other words, while the government reviews, licenses, and compels individual vaccines, it does not test–or require vaccine makers to test–the safety and efficacy of vaccines given simultaneously or the cumulative effects of multiple vaccines.”

This isn’t true. It does review, it does license, but it does not compel vaccination. Local governmental bodies and states may require vaccination in order to participate in the public event. Private companies may require that individuals be vaccinated. But no one compels. And it appears to be patently not true that the vaccine makers aren’t testing the vaccines under real world conditions.

So while some readers might have found themselves moved to fear and distrust based on this simple quote from Tate, reasonable people, even with just the cursory glance at the evidence countering the contention, have to conclude that this was meant to make individuals reading it fearful and distrustful.


Works Cited

Wang, W. B., Mehrotra, D. V., Chan, I. F., & Heyse, J. F. (2006). Statistical Considerations for NonInferiority/Equivalence Trials in Vaccine Development. Journal of Biopharmaceutical Statistics, 16(4), 429-441. doi:10.1080/10543400600719251

Additional articles on vaccine studies can be found here. discusses concomitant vaccine administration

An example from the FDA:

“In a submission to the BLA dated January 31, 2006, the Applicant committed to conduct an adequately powered non-inferiority study of the concomitant administration of RotaTeq™ with acellular pertussis vaccine in which serological endpoints will be examined using a validated assay. The study will be powered sufficiently to detect a 1.5-fold difference in GMTs. A final concept sheet for this protocol will be submitted no later than May 3, 2006.”


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