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  • Gamble1
    Member
    • Apr 2007
    • 7257

    I am going to share a concern I have for the vaccines being pushed out that use a viral vector system like in astrazenca, Jansen, sinovac and sputnek. Theses systems will have a difficult time adjusting to viral mutations in covid 19 that may require a booster shot in the future.

    The flaw in these systems is that they use a harmless virus to deliver the information to make the covid 19 spike protein to make antibodies against. What will happen is that our bodies will also make antibodies to these harmless viruses so you basically are immunizing people to the deliver system aka the virus vector. If you do that the efficacy goes down so you need to choose a different virus vector or increase the dosages.

    If the majority of the world gets these vaccines then we run the risk of prolonging the pandemic since the vaccine delivery system will become less effective the more times you use it in a person.

    Comment

    • vapacersfan
      Member
      • Apr 2006
      • 8614

      ​​​Side effect of Moderna vaccine may be a delayed skin rash, doctors warn

      An itchy rash may be a side effect of receiving the Moderna vaccine, doctors said.

      About 12 recipients in a 30,000-person trial have seen their arms turn red, sore, itchy or swollen about a week after receiving the first dose, according to a letter from doctors published Wednesday in the New England Journal of Medicine.

      Comment

      • vapacersfan
        Member
        • Apr 2006
        • 8614



        Julia Marcus, PhD, MPH
        @JuliaLMarcus

        J&J vaccine is rising to the occasion

        7:04 PM ? Mar 3, 2021



        Comment

        • dal9
          Can see thru wooden doors
          • Dec 2007
          • 17455

          Originally posted by vapacersfan
          ​​​Side effect of Moderna vaccine may be a delayed skin rash, doctors warn

          An itchy rash may be a side effect of receiving the Moderna vaccine, doctors said.

          About 12 recipients in a 30,000-person trial have seen their arms turn red, sore, itchy or swollen about a week after receiving the first dose, according to a letter from doctors published Wednesday in the New England Journal of Medicine.
          12 out of 30K is notable now?

          Comment

          • vapacersfan
            Member
            • Apr 2006
            • 8614

            I mean. 1 out of of the whole world is notable.

            We are literally still in the “trial” phase of a new vaccine. I heard on the radio tonight that a healthy man (I think in his 40’s or 50’s) died after getting his first vaccine. Perhaps its nothing - or perhaps its something.

            Also, 12 is the “reported” number to date. This could be happening to other folks and not been reported yet.

            Comment

            • Gamble1
              Member
              • Apr 2007
              • 7257

              Originally posted by vapacersfan

              Julia Marcus, PhD, MPH
              @JuliaLMarcus

              J&J vaccine is rising to the occasion

              7:04 PM ? Mar 3, 2021


              I really hate confusing graphs. If you normalize the serum levels based on negative covid serum test you should not place the efficacy at 65% from day one. I would need to look at the data to really know how they came up with that graph but after 30ish days from day 14 to day 43 you have an increase of 20% efficacy. That is not reassuring to me.

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              • Gamble1
                Member
                • Apr 2007
                • 7257

                Originally posted by vapacersfan
                I mean. 1 out of of the whole world is notable.

                We are literally still in the “trial” phase of a new vaccine. I heard on the radio tonight that a healthy man (I think in his 40’s or 50’s) died after getting his first vaccine. Perhaps its nothing - or perhaps its something.

                Also, 12 is the “reported” number to date. This could be happening to other folks and not been reported yet.
                In a clinical trial they have to report it and to my knowledge they are well past the recruitment phase for moderna so what you see is what you have for that stage 3 clinical trial.

                The median time to resolve the skin condition was 6 days so yeah not much of a concern overall.
                Last edited by Gamble1; 03-05-2021, 03:39 PM.

                Comment

                • Gamble1
                  Member
                  • Apr 2007
                  • 7257

                  Originally posted by vapacersfan
                  I mean. 1 out of of the whole world is notable.

                  We are literally still in the “trial” phase of a new vaccine. I heard on the radio tonight that a healthy man (I think in his 40’s or 50’s) died after getting his first vaccine. Perhaps its nothing - or perhaps its something.

                  Also, 12 is the “reported” number to date. This could be happening to other folks and not been reported yet.
                  They have a system in place called VAERS for deaths or serious adverse events. So far no connection to the vaccines.

                  https://www.cdc.gov/coronavirus/2019...D-19%20vaccine.

                  Comment

                  • vapacersfan
                    Member
                    • Apr 2006
                    • 8614

                    I think you maybe missed the humor of the graph

                    As far as your last post the key words are “so far” and “no connection”

                    I am going off of memory here but the radio said the guy died the next day of a stroke. I also think the reporter said he had gotten the AstraZeneca vaccine (which I have heard a lot of locals here talk trash about)

                    I sure as hope there are never any connections to anything bad and the COVID vaccines. I also understand the risk of taking said vaccines after limited trials

                    (I am not a doctor but just going out on a limb and guessing every other vaccine I have ever taken in my life was tested for many years before being FBI approved)

                    Comment

                    • Gamble1
                      Member
                      • Apr 2007
                      • 7257

                      Originally posted by vapacersfan
                      I think you maybe missed the humor of the graph

                      As far as your last post the key words are “so far” and “no connection”

                      I am going off of memory here but the radio said the guy died the next day of a stroke. I also think the reporter said he had gotten the AstraZeneca vaccine (which I have heard a lot of locals here talk trash about)

                      I sure as hope there are never any connections to anything bad and the COVID vaccines. I also understand the risk of taking said vaccines after limited trials

                      (I am not a doctor but just going out on a limb and guessing every other vaccine I have ever taken in my life was tested for many years before being FBI approved)
                      For sure other vaccines have been studied much longer but the process of that study is the same applied here in the United States. The clinical trial design the safety measure to reporting etc etc. The difference is in the licensure which companies still have to apply for and are expected to operate under or they no longer can distribute the vaccine.

                      For clinical trials in phase 3 the efficacy is the main hurdle for the licensure. The safety is tracked but no one is expecting that data to change from the clinical 1 and 2 trials since most safety concerns are addressed early on. To put it simply you can not move to stage three clinical trials without a clear evidence that the vaccine is safe. It simply isn't allowed.

                      So essentially the main difference between these vaccines and the vaccines of the past is not the safety profile but the efficacy profile. The vaccines of the past had better data for how long they worked for and with these vaccines the data is still coming in but even if they worked for 6 months to a year they still would save millions of lives.

                      Comment

                      • vapacersfan
                        Member
                        • Apr 2006
                        • 8614

                        Yes and no.

                        We know short term the vaccine is safe. However do we know there will not side effects in year 2, years 3, year 5 or year 10?

                        IMO the main difference, or at least one of the main differences, is that we had more time to study the vaccines of the past.

                        To be clear I agree with the rest of your post - and I will be curious to see if we end up needing a booster this year, next year, etc

                        Comment

                        • Gamble1
                          Member
                          • Apr 2007
                          • 7257

                          Originally posted by vapacersfan
                          Yes and no.

                          We know short term the vaccine is safe. However do we know there will not side effects in year 2, years 3, year 5 or year 10?

                          IMO the main difference, or at least one of the main differences, is that we had more time to study the vaccines of the past.

                          To be clear I agree with the rest of your post - and I will be curious to see if we end up needing a booster this year, next year, etc
                          I mean we can make arbitrary timelines for any vaccines. So sure we do not know 50 years if a vaccine is safe after 50 years. The question is what does the science say for vaccine safety and what are the biological mechanisms that could make a vaccine unsafe or risky.

                          So for example acutely anaphylactic shock is the concern. Long term the concern is some autoimmune disease. The trick here is that covid or really any serious viral infection can cause an autoimmune disease. What would cause a autoimmune disease for a vaccine is most likely a similar protein structure that host and virus share. So this use to be hard to know 20 years ago but now all the proteins of the human species are known and those sequences are compared well before vaccine development.

                          As for booster shots go yes everyone will probably need one to address the new variants that have emerged. The companies will use the same participants from the clinical trial 1/2 to study the booster shots. The design of the trial will look at age difference and the amount of increase in serum level antibodies produced.





                          Comment

                          • vapacersfan
                            Member
                            • Apr 2006
                            • 8614

                            Originally posted by Gamble1

                            I mean we can make arbitrary timelines for any vaccines. So sure we do not know 50 years if a vaccine is safe after 50 years. The question is what does the science say for vaccine safety and what are the biological mechanisms that could make a vaccine unsafe or risky.

                            So for example acutely anaphylactic shock is the concern. Long term the concern is some autoimmune disease. The trick here is that covid or really any serious viral infection can cause an autoimmune disease. What would cause a autoimmune disease for a vaccine is most likely a similar protein structure that host and virus share. So this use to be hard to know 20 years ago but now all the proteins of the human species are known and those sequences are compared well before vaccine development.

                            As for booster shots go yes everyone will probably need one to address the new variants that have emerged. The companies will use the same participants from the clinical trial 1/2 to study the booster shots. The design of the trial will look at age difference and the amount of increase in serum level antibodies produced.
                            I am not trying to be a smart *** but I find the bolded part kind of....I don’t know the right word.....insulting isn’t right...maybe cynical.

                            You really want to call a “1 year” study arbitrarily......

                            Surely other vaccines (some? Most? All?) had been studies for years and years. In this case we are talking about 12 months. Perhaps a little over 12 months at this point

                            Look, you are talking to someone who is pro vaccine. However, I totally understand folks who feel like “the world” is in a giant trial with these vaccines and lord forbid bad effects come in in X years they don’t want to be part of that. If you don’t agree then I dont know what to say - except I respectfully disagree that we know 100% sure “there will not be side effects” in the future from these vaccines

                            Comment

                            • vapacersfan
                              Member
                              • Apr 2006
                              • 8614

                              Originally posted by Gamble1
                              As for booster shots go yes everyone will probably need one to address the new variants that have emerged. The companies will use the same participants from the clinical trial 1/2 to study the booster shots. The design of the trial will look at age difference and the amount of increase in serum level antibodies produced.
                              I agree.

                              This may be a stupid question but I remember at some point someone (maybe CNN?) said the companies were going to tell folks “You got the real COVID vaccine or you got the placebo”

                              Is there any impact to folks knowing who got the real shot and a vaccine that addresses the variant? Does that matter at all?

                              Comment

                              • Gamble1
                                Member
                                • Apr 2007
                                • 7257

                                Originally posted by vapacersfan

                                I am not trying to be a smart *** but I find the bolded part kind of....I don’t know the right word.....insulting isn’t right...maybe cynical.

                                You really want to call a “1 year” study arbitrarily......

                                Surely other vaccines (some? Most? All?) had been studies for years and years. In this case we are talking about 12 months. Perhaps a little over 12 months at this point

                                Look, you are talking to someone who is pro vaccine. However, I totally understand folks who feel like “the world” is in a giant trial with these vaccines and lord forbid bad effects come in in X years they don’t want to be part of that. If you don’t agree then I dont know what to say - except I respectfully disagree that we know 100% sure “there will not be side effects” in the future from these vaccines
                                I understand why you think it is cynical and to be honest this word is used in research and arguments believe it or not. Some of the timelines in research are arbitrary.

                                The clinical study designs for vaccines are heavily monitored and the study designs all have red tape guidance from the NIH and FDA. Clinical trials typically run 1 to 4 years but it almost always boils down to the statistical power of the study to give a conclusive result. So how many people enlisted and what benchmarks are expected to be meet. The clinical trial will have stages of updates or reporting dates during the duration of the trial. The trials timeline can be heavily influenced by volunteers and recruiting.

                                What you saw with covid 19 vaccines was when they hit that first reporting date they applied for the EUA. That date was not set by the company but by the NIH and FDA guidance to even apply for the EUA. It had to meet the statistical power parameters of determining efficacy of the vaccines.

                                The clinical trials will have an estimated date of completion and that will be 3 years or so. They can amend the reporting dates or timelines though or cancel it all together like Merc did.

                                So on one hand yes other vaccines have been around longer but that does not mean they have been studied longer for safety. Most of the safety concerns are addressed early on and the efficacy is the major benchmark being addressed. Safety is always followed by the fda but the endpoints of the clinical trials are not 5 to 10 years.

                                For example this Novavax one goes for 2 years.

                                https://clinicaltrials.gov/ct2/show/...&draw=2&rank=7


                                Last edited by Gamble1; 03-07-2021, 03:47 PM.

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