Vaccines and Related Biological Products Advisory Committee Meeting Background Material Porcine...

[ema-adama]

http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/ucm197728.htm

A very interesting read in light of the finding of PCV1 and 2 in the rotavirus vaccines last year.

The issue of informed consent I think is very

important. What is going to be extremely difficult,

particularly in the present atmosphere of all this, which has eased perhaps a little bit but not a lot, antagonism to vaccines in general, probably for not good reasons, and the amount of dis-information that is going to be out there about this and freely available to all is going to be as large if not larger than the amount of information.

So informed consent is going to be a major issue to be dealt with. I don't think there is any choice.

 

from pg 184.

We are talking about a theoretical risk versus a known benefit.

A different doctor on the committee shares the following opinion

While at the population level, looking at risks and

benefits is an easier story than it is when you start looking

at individuals who could potentially be affected.

I am impressed by the number of gaps in the science and in the

literature. There are a lot of gaps in evidence.

I think making assumptions around those gaps, and assumptions that

lead one to the conclusion that this is safe, and it is safe

for all infants, I think is potentially erroneous.

I think we will be putting some infants at risk.

 

[Marnica]

Very interesting...thanks for posting :)

[Mosaic]

Oy, my head is FULL! Loooots of interesting information in there, and a nice insight into how many of these decisions are researched, who is involved, how decisions are made, what factors are taken into consideration, etc. BTW, I read the transcript here, in case others were wondering where the quotes came from; but there are other interesting transcripts there as well.

Thanks for sharing!

[ema-adama]

Yes, lots of insight into the decision making process. Thanks for posting a direct link to the transcript.