<p> </p>
<p><a href="http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/ucm197728.htm" target="_blank">http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/ucm197728.htm</a></p>
<p> </p>
<p>A very interesting read in light of the finding of PCV1 and 2 in the rotavirus vaccines last year.</p>
<p> </p>
<p> </p>
<div>
<p> </p>
<div class="quote-container"><span>Quote:</span>
<div class="quote-block">
<div>
<div>The issue of informed consent I think is very</div>
<div>important. What is going to be extremely difficult,</div>
<div>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.</div>
<div>So informed consent is going to be a major issue to be dealt with. I don't think there is any choice.</div>
<div> </div>
</div>
</div>
</div>
<p>from pg 184.</p>
<p> </p>
<p>We are talking about a theoretical risk versus a known benefit.</p>
<p> </p>
<p>A different doctor on the committee shares the following opinion</p>
<p> </p>
<p> </p>
<div>
<p> </p>
<div class="quote-container"><span>Quote:</span>
<div class="quote-block">
<div>
<div>While at the population level, looking at risks and</div>
<div>benefits is an easier story than it is when you start looking</div>
<div>at individuals who could potentially be affected.</div>
<div>I am impressed by the number of gaps in the science and in the</div>
<div>literature. There are a lot of gaps in evidence.</div>
<div>I think making assumptions around those gaps, and assumptions that</div>
<div>lead one to the conclusion that this is safe, and it is safe</div>
<div>for all infants, I think is potentially erroneous.</div>
<div>I think we will be putting some infants at risk.</div>
<div> </div>
</div>
</div>
</div>
<p> </p>
</div>
</div>
<p><a href="http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/ucm197728.htm" target="_blank">http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/ucm197728.htm</a></p>
<p> </p>
<p>A very interesting read in light of the finding of PCV1 and 2 in the rotavirus vaccines last year.</p>
<p> </p>
<p> </p>
<div>
<p> </p>
<div class="quote-container"><span>Quote:</span>
<div class="quote-block">
<div>
<div>The issue of informed consent I think is very</div>
<div>important. What is going to be extremely difficult,</div>
<div>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.</div>
<div>So informed consent is going to be a major issue to be dealt with. I don't think there is any choice.</div>
<div> </div>
</div>
</div>
</div>
<p>from pg 184.</p>
<p> </p>
<p>We are talking about a theoretical risk versus a known benefit.</p>
<p> </p>
<p>A different doctor on the committee shares the following opinion</p>
<p> </p>
<p> </p>
<div>
<p> </p>
<div class="quote-container"><span>Quote:</span>
<div class="quote-block">
<div>
<div>While at the population level, looking at risks and</div>
<div>benefits is an easier story than it is when you start looking</div>
<div>at individuals who could potentially be affected.</div>
<div>I am impressed by the number of gaps in the science and in the</div>
<div>literature. There are a lot of gaps in evidence.</div>
<div>I think making assumptions around those gaps, and assumptions that</div>
<div>lead one to the conclusion that this is safe, and it is safe</div>
<div>for all infants, I think is potentially erroneous.</div>
<div>I think we will be putting some infants at risk.</div>
<div> </div>
</div>
</div>
</div>
<p> </p>
</div>
</div>
</p>
