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    Originally posted by billyhoyle View Post
    It's really not that complicated. They are running a clinical trial in 30,000 people for each vaccine to test safety and efficacy. These are double blinded placebo controlled trials. Once the trial is complete, both you and I can read the results. Only once the trial is complete and safety/efficacy has been demonstrated will the vaccine be distributed. These are the best doctors and scientists in the world conducted these trials, and you will have the opportunity to read the results of their work. But for some reason you think corners are being cut before the results of the trial have even been published? Is this based off of your years of experience in the pharmaceutical industry? If not, I suggest listening to the experts when the trial is complete, as forgoing a safe/efficacious vaccine for COVID-19 could be a deadly decision both for you and those you encounter.
    Iím not worried about the scientists or the pharma companies. Iím worried about the FDA, who could simply ok a vaccine even if safety/efficacy arenít demonstrated to their usual standards.
    Russian warship, go **** yourself

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      Re: Covid-19

      Originally posted by JL25and3 View Post
      Iím not worried about the scientists or the pharma companies. Iím worried about the FDA, who could simply ok a vaccine even if safety/efficacy arenít demonstrated to their usual standards.
      People inside of Operation Warp Speed are worried about this too, which is what concerns me.

      I'd like to believe there would be enough public pushback from those involved if that were to happen, but I can't be sure because we're relying on a president who has constantly prioritized his own self interest above anything else and the pharmaceutical industry whose own lies are responsible for a massive opioid epidemic.
      Stay "We" my friends

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        Re: Covid-19

        Originally posted by JL25and3 View Post
        Iím not worried about the scientists or the pharma companies. Iím worried about the FDA, who could simply ok a vaccine even if safety/efficacy arenít demonstrated to their usual standards.
        The clinical trial data is going to be published, and you can read it yourself if you want. I donít see why you are spreading distrust of the vaccine development when this process is likely to save millions of lives around the world. I guarantee you that the FDA will not approve a vaccine that isnít both safe and effective-it would be pointless to do so. You are suggesting that they will prior to actually seeing the data-itís a completely baseless argument based on a conspiracy theory. So to summarize-even if you distrust the FDA, which you shouldnít, you can just go and read the study yourself.

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          Re: Covid-19

          Originally posted by Tyler Durden View Post
          People inside of Operation Warp Speed are worried about this too, which is what concerns me.

          I'd like to believe there would be enough public pushback from those involved if that were to happen, but I can't be sure because we're relying on a president who has constantly prioritized his own self interest above anything else and the pharmaceutical industry whose own lies are responsible for a massive opioid epidemic.
          We are relying on the ability to read a phase 3 clinical trial when it is published, not the president. If you can read, which you can, it will be clear whether the vaccine is safe/effective. Please wait and read the study prior to spreading distrust/misinformation about the vaccine. It’s very likely that there will be many conspiracy theories about the vaccine spread when it is approved, so anybody that amplifies this message is doing serious harm.

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            Re: Covid-19

            Originally posted by billyhoyle View Post
            We are relying on the ability to read a phase 3 clinical trial when it is published, not the president. If you can read, which you can, it will be clear whether the vaccine is safe/effective. Please wait and read the study prior to spreading distrust/misinformation about the vaccine. Itís very likely that there will be many conspiracy theories about the vaccine spread when it is approved, so anybody that amplifies this message is doing serious harm.
            I don't know you, but you've made me feel a lot better about this. Thanks.
            "Our work continues, the fight goes on, and the big dreams never die." -- Elizabeth Warren

            Comment


              Originally posted by billyhoyle View Post
              The clinical trial data is going to be published, and you can read it yourself if you want. I donít see why you are spreading distrust of the vaccine development when this process is likely to save millions of lives around the world. I guarantee you that the FDA will not approve a vaccine that isnít both safe and effective-it would be pointless to do so. You are suggesting that they will prior to actually seeing the data-itís a completely baseless argument based on a conspiracy theory. So to summarize-even if you distrust the FDA, which you shouldnít, you can just go and read the study yourself.
              Iím simply spreading distrust of the current occupant of the White House. He has consistently shown himself capable of subverting whatever government processes there are for his own political gain. If there are people within the FDA whom he canít bend to his will, he would certainly not be above replacing them with people who are more flexible. Politics >>>>> science every day. As a much smaller example, he got the NOAA to retroactively change their forecast to fit the nonsense he spewed about it.

              So it would not be pointless for the FDA to cut corners - the point would be Trump's re-election. Heís already risked people's lives for that, I donít know why he would stop now.

              Obviously, Iíll wait until it happens, and Iíll take the vaccine of available. But Trump sees a vaccine as a political goal, not a public-health goal, and that worries me. A lot.
              Russian warship, go **** yourself

              Comment


                Re: Covid-19

                Originally posted by billyhoyle View Post
                We are relying on the ability to read a phase 3 clinical trial when it is published, not the president. If you can read, which you can, it will be clear whether the vaccine is safe/effective. Please wait and read the study prior to spreading distrust/misinformation about the vaccine. Itís very likely that there will be many conspiracy theories about the vaccine spread when it is approved, so anybody that amplifies this message is doing serious harm.
                Where can I find phase three clinical trials when they are published? I want to look at some older ones and see how easy it will be for a layperson to make an accurate assessment.

                Comment


                  Re: Covid-19

                  Originally posted by Texsahara View Post
                  Where can I find phase three clinical trials when they are published? I want to look at some older ones and see how easy it will be for a layperson to make an accurate assessment.
                  Here is the phase 3 clinical trial result for the antiviral Remdesivir, which was shown to be effective in decreasing time requires for recovery from infection, although not a statistically significant improvement on CFR. Still, the antiviral activity is still likely a good thing for overall outcome.
                  https://www.nejm.org/doi/full/10.1056/NEJMoa2007764

                  If you cannot understand the way scientific results are published, I recommend asking questions to doctors/scientists that you know when the vaccine trial results are published. They will be very easy to find, since these are the most anticipated clinical trial results in history.

                  I know this discussion isn’t about my opinion, but based on the phase 1 data, I am very optimistic. I also think that the fact that the candidates are not live virus means that it is unlikely that many adverse events will occur. All the vaccine does is trick our immune system into thinking it is infected, without actually having any type of replicative capability. The phase 1 trials optimized the dosage-and I’m hopeful that the one moving forward will only cause a fever at worst (this is a consequence of our immune system developing defense against the vaccine, not actually because we are sick).

                  When it’s over, I think operation warp speed will be comparable only to the Manhattan project and moon landing in terms of the ability to redefine what was thought to be scientifically feasible (in this case vaccine development timeline). In this case though, the entire world will benefit. I think the investment will save millions of lives around the world in record time, since the J&J vaccine is expected to be cost effective enough to produce the billions of doses required to do so.

                  By the way, I also expect results on a very promising monoclonal antibody therapy from Regeneron in the next couple of weeks. I am hopeful that it will decrease both CFR and time to recovery-and it may also be used prophylactically for front line workers as a type of “temporary vaccine.”

                  Comment


                    Re: Covid-19

                    Originally posted by billyhoyle View Post
                    Here is the phase 3 clinical trial result for the antiviral Remdesivir, which was shown to be effective in decreasing time requires for recovery from infection, although not a statistically significant improvement on CFR. Still, the antiviral activity is still likely a good thing for overall outcome.
                    https://www.nejm.org/doi/full/10.1056/NEJMoa2007764

                    If you cannot understand the way scientific results are published, I recommend asking questions to doctors/scientists that you know when the vaccine trial results are published. They will be very easy to find, since these are the most anticipated clinical trial results in history.

                    I know this discussion isnít about my opinion, but based on the phase 1 data, I am very optimistic. I also think that the fact that the candidates are not live virus means that it is unlikely that many adverse events will occur. All the vaccine does is trick our immune system into thinking it is infected, without actually having any type of replicative capability. The phase 1 trials optimized the dosage-and Iím hopeful that the one moving forward will only cause a fever at worst (this is a consequence of our immune system developing defense against the vaccine, not actually because we are sick).

                    When itís over, I think operation warp speed will be comparable only to the Manhattan project and moon landing in terms of the ability to redefine what was thought to be scientifically feasible (in this case vaccine development timeline). In this case though, the entire world will benefit. I think the investment will save millions of lives around the world in record time, since the J&J vaccine is expected to be cost effective enough to produce the billions of doses required to do so.

                    By the way, I also expect results on a very promising monoclonal antibody therapy from Regeneron in the next couple of weeks. I am hopeful that it will decrease both CFR and time to recovery-and it may also be used prophylactically for front line workers as a type of ďtemporary vaccine.Ē
                    What kind of work do you do? Do you work with vaccine development? I'm just curious because you seem quite knowledgeable.
                    "Our work continues, the fight goes on, and the big dreams never die." -- Elizabeth Warren

                    Comment


                      Re: Covid-19

                      Originally posted by jlw1980 View Post
                      What kind of work do you do? Do you work with vaccine development? I'm just curious because you seem quite knowledgeable.
                      Not vaccines specifically, but research involving immunology. And unsurprisingly, i've been following the vaccine development process for this very closely because of how impactful it is for all of us.

                      It's an interesting perspective to have, I think, because it has opened my eyes a bit to just how unknowledgeable the general public (and even some of the "expert" doctors that go on TV) is to basic scientific knowledge. Even MLB, which should have experts on hand, aren't requiring their teams to take the necessary measures to limit/prevent spread-it's not that complicated.

                      Comment


                        Re: Covid-19

                        Originally posted by billyhoyle View Post
                        Not vaccines specifically, but research involving immunology. And unsurprisingly, i've been following the vaccine development process for this very closely because of how impactful it is for all of us.

                        It's an interesting perspective to have, I think, because it has opened my eyes a bit to just how unknowledgeable the general public (and even some of the "expert" doctors that go on TV) is to basic scientific knowledge. Even MLB, which should have experts on hand, aren't requiring their teams to take the necessary measures to limit/prevent spread-it's not that complicated.
                        And what do you think about how Trump has handled this pandemic? Do you think if he provided a more consistent message, both visually and audibly, that people would've taken to mask-wearing as being the 'cost of being American?' and maybe thousands of lives wouldn't have been needless wasted?
                        ďNobody teaches life anything.Ē - Gabriel GarcŪa MŠrquez

                        Comment


                          Re: Covid-19

                          A lot of knowledge and a lot of interesting stuff.

                          Also a lot of naivety about how incredibly politicized and unconventionally cluster****ed this administration has made this pandemic.

                          I'm glad you're so optimistic but please take your faith in the scientific process winning out with a big ol' chunk of salt. What once would have been overlooked as batty conspiracy theories about the Pres/govt are now just factual reports since 2016.

                          Comment


                            Re: Covid-19

                            America certainly has had a rather craptastic attempt against the virus no doubt, but living in Asia I'm starting to think that a bigger lingering effect will not be the death directly due to COVID, but death indirectly due to COVID which a vaccine won't help as much. First of all, the vaccine isn't going to pop out tomorrow, or next week, or next month...heck, all things going well I'd be overjoyed with it being complete within this year. But even if that miraculously saves 99.9999% of the would-be-dying future patients, that won't save the countless number of jobs and businesses that were/will be lost and the economy being toast until the vaccine is made. Those won't be easily recovered even with a new President being elected in November, unfortunately.

                            Using Japan as an example because I live here, they have already started moving on to the "everyone be very careful and live with COVID and go on with life until someday a vaccine will hopefully be made"-phase. I mean, so far they have had about a 1000 death directly due to COVID but just within the last half year or so already over a hundred small/individual businesses have filed for bankruptcy and overall economy has been royally hurt, enough that the government determined more death will come from financial suicide over COVID patients if they continue to suppress the economy.

                            Will be really interesting what the new presidential regime will decide to do in 2021.

                            Comment


                              Re: Covid-19

                              Originally posted by ojo View Post
                              And what do you think about how Trump has handled this pandemic? Do you think if he provided a more consistent message, both visually and audibly, that people would've taken to mask-wearing as being the 'cost of being American?' and maybe thousands of lives wouldn't have been needless wasted?
                              Trump has done an awful/incompetent job and the CDC and NIAID have also done awful jobs under his watch. Most people donít understand how easy it should have been to have a test ready/mass produced in early March given that the sequence of the virus was published in late January. The equipment/facilities were already in place to carry out RT-PCR..It was just a matter of producing the kits. I was also furious with the mixed messages at first regarding masks from both the CDC and WHO-it was obvious from day 1 that masks both limit spread and viral load upon infection. I also think the governors were ill prepared to respond to this in March, and once again I blame the CDC for this, since it isnít really the job of De Blasio or Cuomo to be public health experts and know that their week of inaction in March cost tens of thousands of lives-but it did. And then some Governors around the county seem to just want people to die-the whole thing is insane.

                              I really think the best responses can be seen in South Korea and Germany.

                              Comment


                                Re: Covid-19

                                I trust the science and the scientists.

                                I have zero trust that the current President and federal govt will do anything well unless it coincides with them personally making money.
                                Bring tea for the Tillerman; Steak for the son; Wine for the woman
                                who made the rain come; Seagulls sing your hearts away;
                                'Cause while the sinners sin, the children play ...

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