ramssuperbowl99 Posted August 22, 2020 Share Posted August 22, 2020 (edited) On 8/21/2020 at 10:02 AM, BobbyPhil1781 said: "Pfizer says its COVID-19 vaccine is on track for regulatory review in October" https://fortune.com/2020/08/20/pfizer-covid-vaccine-regulatory-review-october/ Can someone tell me what this means (although I think my peanut brain can comprehend this part) and what the process will be after this in order to get it to our front line workers and most vulnerable (they should be the first to receive it)? I know we're not going through typical vaccine guidelines here so if it's totally unknown, that makes sense. This is good news. They're still on track means they've continued to administer this in much larger trials without any adverse events that would end the trials, so we don't have the numbers but that's encouraging news on the safety front. But the main piece is that they expect to have all of the trial data collected, analyzed, and reported on by the end of September or so, and then will submit an application to the FDA that will hopefully provide proof that the vaccine is safe and effective. The FDA has set timelines for how long it has to review the data, but given how urgent this is you'd expect them to exceed their standard turnarounds, and then they could respond by approving, rejecting outright, or respond with questions/request additional data to bolster the application. Once they approve, Pfizer/BioNTech are free to sell the vaccine in the US. That doesn't mean they can't start preparing the doses now, though, so this doesn't give us a whole lot of information on when we could expect 50 million or 100 million doses to be ready. We'd need to know more about where they are in the manufacturing steps and what their goal production rate is before we could start to estimate that. Still though, this is good news on the regulatory front. Edited August 22, 2020 by ramssuperbowl99 4 Link to comment Share on other sites More sharing options...
SwAg Posted August 22, 2020 Share Posted August 22, 2020 Where does the deep state fda fit into all that? 3 Link to comment Share on other sites More sharing options...
Shady Slim Posted August 23, 2020 Share Posted August 23, 2020 2 hours ago, SwAg said: Where does the deep state fda fit into all that? eagerly awaiting for FF's qanon corner to show itself 2 Link to comment Share on other sites More sharing options...
BobbyPhil1781 Posted August 23, 2020 Share Posted August 23, 2020 https://www.researchgate.net/publication/343797723_Emerging_of_a_SARS-CoV-2_viral_strain_with_a_deletion_in_nsp1 Emerging of a SARS-CoV-2 viral strain with a deletion in nsp1 Looks like this is suggesting this new strain is less severe albeit just as contagious. Link to comment Share on other sites More sharing options...
BobbyPhil1781 Posted August 23, 2020 Share Posted August 23, 2020 (edited) https://mobile.twitter.com/tompelissero/status/1297530842676449280?s=21 Apparently there were 10 false positives in the Jets organization alone as well. Probably could post this in the NFL News section but there's not a Misc News Thread and didn't feel this was thread worthy unless there's a covid megathread or something. Edited August 23, 2020 by BobbyPhil1781 1 Link to comment Share on other sites More sharing options...
BobbyPhil1781 Posted August 23, 2020 Share Posted August 23, 2020 Browns saying every positive test was a false positive now....... https://mobile.twitter.com/MySportsUpdate/status/1297598921758441473?s=19 ........... Link to comment Share on other sites More sharing options...
naptownskinsfan Posted August 23, 2020 Share Posted August 23, 2020 4 hours ago, BobbyPhil1781 said: https://mobile.twitter.com/tompelissero/status/1297530842676449280?s=21 Apparently there were 10 false positives in the Jets organization alone as well. Probably could post this in the NFL News section but there's not a Misc News Thread and didn't feel this was thread worthy unless there's a covid megathread or something. I got an alert from CBS and ESPN on my phone about this, so pretty sure it's threadworthy. 1 Link to comment Share on other sites More sharing options...
BobbyPhil1781 Posted August 23, 2020 Share Posted August 23, 2020 1 hour ago, naptownskinsfan said: I got an alert from CBS and ESPN on my phone about this, so pretty sure it's threadworthy. I always struggle with what is and isn't thread worthy lol. It's obvious that it will be a talking point over the course of the entire season as well. Link to comment Share on other sites More sharing options...
ramssuperbowl99 Posted August 23, 2020 Share Posted August 23, 2020 7 hours ago, BobbyPhil1781 said: https://mobile.twitter.com/tompelissero/status/1297530842676449280?s=21 Apparently there were 10 false positives in the Jets organization alone as well. Probably could post this in the NFL News section but there's not a Misc News Thread and didn't feel this was thread worthy unless there's a covid megathread or something. I want more details. Did the labs repeat the samples and they turned up negative and that's why they're false positives? Did they find a contamination issue (even if they did, good luck proving that)? Sample swap? Lot's of potential causes here. 1 Link to comment Share on other sites More sharing options...
BobbyPhil1781 Posted August 23, 2020 Share Posted August 23, 2020 3 minutes ago, ramssuperbowl99 said: I want more details. Did the labs repeat the samples and they turned up negative and that's why they're false positives? Did they find a contamination issue (even if they did, good luck proving that)? Sample swap? Lot's of potential causes here. I've barely looked bc I wanted the same info especially after the Browns had the same thing happen. I couldn't find anything but I'm not entirely sure if I found what I was looking for and just didn't notice. Too much of a coincidence I feel like Link to comment Share on other sites More sharing options...
kingseanjohn Posted August 24, 2020 Share Posted August 24, 2020 Just heard that my main employment place won’t be opening again until March/April timeframe at the earliest. I figured that would be the case but now it’s confirmed. It’s going to be real interesting to see how many go back when the time comes. Link to comment Share on other sites More sharing options...
Xenos Posted August 24, 2020 Share Posted August 24, 2020 FDA Authorizes Convalescent Plasma As Emergency Treatment For COVID-19 https://www.npr.org/sections/coronavirus-live-updates/2020/08/23/905277083/fda-authorizes-convalescent-plasma-as-emergency-treatment-for-covid-19 Link to comment Share on other sites More sharing options...
BobbyPhil1781 Posted August 24, 2020 Share Posted August 24, 2020 https://mobile.twitter.com/TomPelissero/status/1297711784044957699?s=20 77 false positives by the same lab. Link to comment Share on other sites More sharing options...
TVScout Posted August 24, 2020 Share Posted August 24, 2020 14 hours ago, Xenos said: FDA Authorizes Convalescent Plasma As Emergency Treatment For COVID-19 https://www.npr.org/sections/coronavirus-live-updates/2020/08/23/905277083/fda-authorizes-convalescent-plasma-as-emergency-treatment-for-covid-19 Link to comment Share on other sites More sharing options...
TVScout Posted August 24, 2020 Share Posted August 24, 2020 Not free unfortunately: China says it began public use of covid-19 vaccine a month ago, bypassing clinical trials Quote On Saturday, Chinese health officials said few people who were given the experimental vaccine so far had reported adverse effects, and none reported fevers. They did not give a number of how many have received the trial vaccines. https://www.washingtonpost.com/world/asia_pacific/china-coronavirus-vaccine-bypass-clinical-trials/2020/08/24/1813779a-e5be-11ea-bf44-0d31c85838a5_story.html Link to comment Share on other sites More sharing options...
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