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<div dir="ltr" data-setdir="false">I don't have the exact numbers handy, but Pfizer BioNtech had about 40,000 participants in their study and Modern 30,000. </div><div dir="ltr" data-setdir="false"><br></div><div dir="ltr" data-setdir="false">All the companies spent weeks writing their test procedures and having them reviewed and approved both inside the company and by FDA. This included many many details like how many men and women? What racial groups? Storage and handling procedures. How will the data be collected? What will be the criteria for determining if the vaccine is "good". Pfizer decided to do the test with cryogenic freezers because that is what they had experience with in their laboratory work before COVID. Much later, they did another test to collect data to prove that their vaccine really didn't need to be kept that cold.</div><div><br></div><div dir="ltr" data-setdir="false">In past, many vaccines were developed using fetal cells. Were all of the COVID-19 vaccines developed using fetal cells? J&J I'm pretty sure, What about Pfizer and Moderna who have a very new process.</div><div dir="ltr" data-setdir="false"><br></div><div dir="ltr" data-setdir="false">Lastly, I recall a pleasant Sunday in spring standing in a long line with my family. Maybe an hour later we got to the head of the line where there were tables with sugar cubes. Take one and keep moving. No record keeping of any sort. This was the famous Sabin Oral Sunday, SOS.</div><div><br></div>
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On Sunday, May 16, 2021, 09:05:13 AM PDT, Rick Moen <rick@linuxmafia.com> wrote:
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<div>...</div><div>To illustrate what is required for an EUA, here's what J&J (Janssen) had<br clear="none">to do, to get FDA's EUA on Feb. 28th for its single-shot COVID-19<br clear="none">vaccine: <br clear="none"><br clear="none">Safety<br clear="none">------<br clear="none"><br clear="none">The available safety data to support the EUA included an analysis of<br clear="none">43,783 participants enrolled in an ongoing randomized,<br clear="none">placebo-controlled study being conducted in South Africa, certain<br clear="none">countries in South America, Mexico, and the U.S. The participants,<br clear="none">21,895 of whom received the vaccine and 21,888 of whom received saline<br clear="none">placebo, were followed for a median of eight weeks after vaccination.<br clear="none">The most commonly reported side effects were pain at the injection site,<br clear="none">headache, fatigue, muscle aches and nausea. Most of these side effects<br clear="none">were mild to moderate in severity and lasted 1-2 days.<br clear="none"><br clear="none">Effectiveness<br clear="none">-------------<br clear="none"><br clear="none">The effectiveness data to support the EUA included an analysis of 39,321<br clear="none">participants in the ongoing randomized, placebo-controlled study being<br clear="none">conducted in South Africa, certain countries in South America, Mexico,<br clear="none">and the U.S. who did not have evidence of SARS-CoV-2 infection prior to<br clear="none">receiving the vaccine. Among these participants, 19,630 received the<br clear="none">vaccine and 19,691 received saline placebo. Overall, the vaccine was<br clear="none">approximately 67% effective in preventing moderate to severe/critical<br clear="none">COVID-19 occurring at least 14 days after vaccination and 66% effective<br clear="none">in preventing moderate to severe/critical COVID-19 occurring at least 28<br clear="none">days after vaccination. <br clear="none"><br clear="none">Additionally, the vaccine was approximately 77% effective in preventing<br clear="none">severe/critical COVID-19 occurring at least 14 days after vaccination<br clear="none">and 85% effective in preventing severe/critical COVID-19 occurring at<br clear="none">least 28 days after vaccination.<br clear="none"><br clear="none">There were 116 cases of COVID-19 in the vaccine group that occurred at<br clear="none">least 14 days after vaccination, and 348 cases of COVID-19 in the<br clear="none">placebo group during this time period. There were 66 cases of COVID-19<br clear="none">in the vaccine group that occurred at least 28 days after vaccination<br clear="none">and 193 cases of COVID-19 in the placebo group during this time period.<br clear="none">Starting 14 days after vaccination, there were 14 severe/critical cases<br clear="none">in the vaccinated group versus 60 in the placebo group, and starting 28<br clear="none">days after vaccination, there were 5 severe/critical in the vaccine<br clear="none">group versus 34 cases in the placebo group. <br clear="none"><br clear="none"><br clear="none">Here is FDA's write-up about the EUA process, generally:<br clear="none"><a shape="rect" href="https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained" rel="nofollow" target="_blank">https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained</a><div class="ydp788aa194yqt1238156983" id="ydp788aa194yqtfd51689"><br clear="none"><br clear="none">_______________________________________________<br clear="none">conspire mailing list<br clear="none"><a shape="rect" href="mailto:conspire@linuxmafia.com" rel="nofollow" target="_blank">conspire@linuxmafia.com</a><br clear="none"><a shape="rect" href="http://linuxmafia.com/mailman/listinfo/conspire" rel="nofollow" target="_blank">http://linuxmafia.com/mailman/listinfo/conspire</a><br clear="none"></div></div>
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