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Old 12-30-2017, 08:03 PM
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Default Re: Parents, do your due diligence on vaccination! There are serious risks!!

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Originally Posted by ChuckF View Post
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Originally Posted by peacegirl View Post
Quote:
Originally Posted by Chuck
Hm, ok, peacegirl. I don't see how this is really "diversionary" as it directly addresses the exact points raised by the source that you cited. Anyway:

Which studies were too small? What were the sample sizes? What were the results? What are the statistical effects of the sample size on the results? What was the risk/benefit analysis used by EMA? How was that different from the analysis applied by FDA? What is an adequate sample size?
peacegirl, I will give you a hint: the EMA EPAR for Bexsero would be a great place to find the answers to these basic questions. It is kind of the very first place someone would look if they were doing their due diligence.
http://www.ema.europa.eu/docs/en_GB/...C500216767.pdf
Quote:
Originally Posted by Chuck
So that is an EMA document but is not the EPAR. It's a CSR assessment for a some of the Bexsero studies. There are quite a few more studies included in the EPAR. peacegirl, do you need help locating the EMA EPAR for Bexsero?

But it's progress - peacegirl, what does this document tell you? How does it support the argument you have made here? Which studies were too small? What were the sample sizes? What were the results? What are the statistical effects of the sample size on the results? What was the risk/benefit analysis used by EMA? How was that different from the analysis applied by FDA? What is an adequate sample size?
I have no interest in comparing the EMA with the FDA, or getting off onto a tangent that could go on ad nauseam. I believe Christina England's reasoning was sound based on her legitimate concerns. You must have missed this.

Dr. Mark Sawyer, an infectious disease specialist at Rady Children’s Hospital San Diego who has helped set national vaccination policy, said the meningitis decision is more nuanced than it is for more routine vaccinations that have been around for decades.

“Physicians are struggling with this because we do not have a precise guideline. I was just at a conference where there were over 500 pediatricians in attendance and we talked about this issue for more than a half-hour because this is a real gray area,” Sawyer said.

Doctors divided on merits, risks of meningitis B vaccine - The San Diego Union-Tribune



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Originally Posted by peacegirl View Post
Quote:
Originally Posted by Chuck
peacegirl, do you understand that the FDA and EMA are different agencies?
What are the main differences between the FDA and the EMA?
Yes, peacegirl, you have posted that link before, as it is assuredly the first thing you found on Google. Did you read it, peacegirl? Do you understand it?

How does it help you understand the reasons that the US Bexsero label may be different from the EU Bexsero label?
The labeling may be different, but the standards used for approval are similar.

1 INTRODUCTION

The United States and the European Union have distinct but overlapping schemes for the regulation of biologics, ranging from the definition of a biologic itself to the technical requirements for approval. In the United States, the definition of “biological product” was developed over time, and historical context continues to inform its interpretation. In the European Union, biologics are largely defined in terms of their active substances and methods of manufacture. Despite these differences, both jurisdictions recognize that biologics warrant special treatment because of their distinct characteristics, such as their complex structures and susceptibility to
variation during manufacturing. Whereas in the United States, Congress enacted a separate statute for biologics, in the EU, the general approval scheme and certain specific requirements apply to biologics. Nevertheless, US and EU authorities have undertaken harmonization efforts with respect to some technical requirements for biologics applications; thus, there is significant overlap in requirements imposed by both regions. This chapter provides an overview of the US and EU regulatory schemes, from nonclinical trials through clinical trials to approval. It then discusses considerations for global development of biologics, and it ends by discussing special issues for developing vaccines.

https://www.cov.com/-/media/files/co...and_europe.pdf
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Thanks, from:
ChuckF (12-30-2017)
 
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