johngould21 Posted August 9, 2021 Share Posted August 9, 2021 How many of you would like to be in Sturgis ND about now??? EEEEEEEEEEEEEEEEEEEhaw! Link to comment Share on other sites More sharing options...
johngould21 Posted August 9, 2021 Share Posted August 9, 2021 1 hour ago, stawns said: Edit : shes 35, in Kelowna and very healthy Falls right into the 20-40 age group. 1 Link to comment Share on other sites More sharing options...
stawns Posted August 9, 2021 Share Posted August 9, 2021 1 hour ago, johngould21 said: Falls right into the 20-40 age group. Link to comment Share on other sites More sharing options...
ChuckNORRIS4Cup Posted August 9, 2021 Share Posted August 9, 2021 3 hours ago, EOTM said: That'd a news report not a scientific study right? That's a fox news out of Kansas editorial right? Honestly you seem like a nice person and you seem intelligent so why the willful ignorance? I didn't even know it was fox tbh I agree I'm not a fan of Fox, my mother sent it to me because she wants me to get vaccinated I'm going to get mad her actually because she knows better and even hates fox, but anyways regarding it being approved by the FDA are you acknowledging that part is true or ignoring it because it was a news report by fox? That is legit truth though the vaccine has never been actually approved, it was only emergency approved for panic use, here read the definition. What is an Emergency Use Authorization (EUA)? An Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives. Taking into consideration input from the FDA, manufacturers decide whether and when to submit an EUA request to FDA. I still don't understand how something that's not actually approved is not considered experimental, obviously the person over at Fox sees it like that, I see it like that, I question why is hard for others to see it like that tbh. Link to comment Share on other sites More sharing options...
ChuckNORRIS4Cup Posted August 9, 2021 Share Posted August 9, 2021 Also that video someone posted that claims to be a doctor, has anyone bothered to look at what's happening to Indonesia? I checked the world meter last week and looked for any countries that stood out Indonesia stood out because their deaths were really high, so check them again yesterday last night, it was a little alarming to read and see especially with what's happening to the kids actually, but hey that docotor on YouTube claims Delta isn't that serious... Seriously just google Indonesia and covid and take a look for yourselfs. Link to comment Share on other sites More sharing options...
ChuckNORRIS4Cup Posted August 9, 2021 Share Posted August 9, 2021 4 hours ago, stawns said: Not crazy, just ignorant Ignorant for worrying about injecting myself with a vaccine that's not even approved technically, okay then bud thanks for the info cheers. Link to comment Share on other sites More sharing options...
ChuckNORRIS4Cup Posted August 9, 2021 Share Posted August 9, 2021 (edited) 3 hours ago, 6of1_halfdozenofother said: You just conflated water with the virus. I'm pointing out that it's closer to the vaccine, with its associated risks, known issues, and the plethora of experiments ongoing with it. Well your making a claim how bad it is for us to drink water, so isn't the first thing to try and fix it? Isn't that what were doing with covid? Isn't that why a vaccine was developed to help fight it and fix the issue? So why wouldn't the same logic be used with water since you want to bring it up and compare it. Edited August 9, 2021 by ChuckNORRIS4Cup Link to comment Share on other sites More sharing options...
thedestroyerofworlds Posted August 9, 2021 Share Posted August 9, 2021 When the Pfizer vaccine gets full FDA approval soon (by Labour Day by some accounts) and the Moderna vaccine gets full approval later this year, will Chuck then stop calling them "experimental" or will Chuck come up with some other excuse? Just asking. Link to comment Share on other sites More sharing options...
ChuckNORRIS4Cup Posted August 9, 2021 Share Posted August 9, 2021 (edited) 3 hours ago, coho8888 said: Not sure what exactly you are asking. I have no concerns with the Long term effects of the Vaccine. I have been double vaxxed now for a month. I do know that I still stand a chance at getting Covid and having long term effects from it. But being fully vaxxed provides me a safety net and combined with my mask wearing and overall caution, I feel safe. I posted the video for info. I did not provide my comments. I did not say I agreed with everything the doctor said. He is also from the US where you can and could have gotten fully vaxxed much earlier. We still have some young people that are waiting for their second dose so I don't agree with opening everything up fully. Look you have made it clear that you have an issue with how these vaccines are fast tracked. No need to beat a dead horse. This is your opinion and you have no scientific basis to conclude that this is the case. Others have posted about how the process of testing took place and that it wasn't necessarily rushed. None of these people are expressing their opinions or gut feelings. They are giving you facts. I said forget about the vaccine long term effects then because that's what we were discussing and that it doesn't concern you at all, so that's why I said lets forget about it then so we don't go back and forth on it, and after watching the video you posted and seeing how upset a doctor is or supposedly a doctor is over people using a mask, then I asked if you care about long term effects of covid if you do catch it, because according to the video you posted he doesn't. So why post the video then if you yourself don't agree with everything.... This is now the part I don't understand at all, are you posting it to educate people on his opinion? Because that video is actually his opinion not facts. It doesn't make sense why post it then? Especially when you want to talk about facts... Edited August 9, 2021 by ChuckNORRIS4Cup Link to comment Share on other sites More sharing options...
-DLC- Posted August 9, 2021 Share Posted August 9, 2021 25 minutes ago, ChuckNORRIS4Cup said: Ignorant for worrying about injecting myself with a vaccine that's not even approved technically, okay then bud thanks for the info cheers. Again, one paragraph taken out of context. Here's the whole thing: https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained Quote What is an Emergency Use Authorization (EUA)? An Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives. Taking into consideration input from the FDA, manufacturers decide whether and when to submit an EUA request to FDA. Once submitted, FDA will evaluate an EUA request and determine whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to FDA. Are the COVID-19 vaccines rigorously tested? Yes. Clinical trials are evaluating investigational COVID-19 vaccines in tens of thousands of study participants to generate the scientific data and other information needed by FDA to determine safety and effectiveness. These clinical trials are being conducted according to the rigorous standards set forth by the FDA. Initially, in phase 1, the vaccine is given to a small number of generally healthy people to assess its safety at increasing doses and to gain early information about how well the vaccine works to induce an immune response in people. In the absence of safety concerns from phase 1 studies, phase 2 studies include more people, where various dosages are tested on hundreds of people with typically varying health statuses and from different demographic groups, in randomized-controlled studies. These studies provide additional safety information on common short-term side effects and risks, examine the relationship between the dose administered and the immune response, and may provide initial information regarding the effectiveness of the vaccine. In phase 3, the vaccine is generally administered to thousands of people in randomized, controlled studies involving broad demographic groups (i.e., the population intended for use of the vaccine) and generates critical information on effectiveness and additional important safety data. This phase provides additional information about the immune response in people who receive the vaccine compared to those who receive a control, such as a placebo. What safety and effectiveness data are required to be submitted to FDA for an EUA request for a vaccine intended to prevent COVID-19? COVID-19 vaccines are undergoing a rigorous development process that includes tens of thousands of study participants to generate the needed non-clinical, clinical, and manufacturing data. FDA will undertake a comprehensive evaluation of this information submitted by a vaccine manufacturer. For an EUA to be issued for a vaccine, for which there is adequate manufacturing information to ensure quality and consistency, FDA must determine that the known and potential benefits outweigh the known and potential risks of the vaccine. An EUA request for a COVID-19 vaccine can be submitted to FDA based on a final analysis of a phase 3 clinical efficacy trial or an interim analysis of such trial, i.e., an analysis performed before the planned end of the trial once the data have met the pre-specified success criteria for the study’s primary efficacy endpoint. From a safety perspective, FDA expects an EUA submission will include all safety data accumulated from phase 1 and 2 studies conducted with the vaccine, with an expectation that phase 3 data will include a median follow-up of at least 2-months (meaning that at least half of vaccine recipients in phase 3 clinical trials have at least 2 months of follow-up) after completion of the full vaccination regimen. In addition, FDA expects that an EUA request will include a phase 3 safety database of well over 3,000 vaccine recipients, representing a high proportion of participants enrolled in the phase 3 study, who have been followed for serious adverse events and adverse events of special interest for at least one month after completion of the full vaccination regimen. Part of FDA’s evaluation of an EUA request for a COVID-19 vaccine includes evaluation of the chemistry, manufacturing, and controls information for the vaccine. Sufficient data should be submitted to ensure the quality and consistency of the vaccine product. FDA will use all available tools and information, including records reviews, site visits, and previous compliance history, to assess compliance with current good manufacturing practices. What is the process that manufacturers are following to potentially make a COVID-19 vaccine available by EUA? Vaccine manufacturers are undertaking a development process that includes tens of thousands of study participants to generate non-clinical, clinical, and manufacturing information needed by FDA for the agency to determine whether the known and potential benefits outweigh the known and potential risks of a vaccine for the prevention of COVID-19. When the phase 3 portion of the human clinical trial reaches a predetermined point that informs how well a vaccine prevents COVID-19, as discussed and agreed to in advance with FDA, an independent group (called a data safety monitoring board) will review the data and inform the manufacturer of the results. Based on the data and the interpretation of the data by this group, manufacturers decide whether and when to submit an EUA request to FDA, taking into consideration input from FDA. After FDA receives an EUA request, our career scientists and physicians will evaluate all of the information included in the manufacturer’s submission. While FDA’s evaluation is ongoing, we will also schedule a public meeting of our Vaccines and Related Biological Products Advisory Committee, which is made up of external scientific and public health experts from throughout the country. During the meeting, these experts, who are carefully screened for any potential conflicts of interest, will discuss the safety and effectiveness data so that the public and scientific community will have a clear understanding of the data and information that FDA is evaluating to make a decision whether to authorize a COVID-19 vaccine for emergency use. Following the advisory committee meeting, FDA’s career professional staff will consider the input of the advisory committee members and continue their evaluation of the submission to determine whether the available safety and effectiveness and manufacturing data support an emergency use authorization of the specific COVID-19 vaccine in the United States. Who are the FDA career professionals evaluating EUAs for vaccines? The FDA staff are career scientists and physicians who have globally recognized expertise in the complexity of vaccine development and in evaluating the safety and effectiveness of all vaccines intended to prevent infectious diseases. These FDA professionals are committed to decision-making based on scientifically driven evaluation of data. FDA staff are like your family - they are fathers, mothers, daughters, sons, sisters, brothers and more. They and their families are also directly impacted by the work that they do, and are exactly who you want making these important public health decisions for the United States. What are the plans for continued monitoring of COVID-19 vaccines authorized by FDA for emergency use? FDA expects vaccine manufacturers to include in their EUA requests a plan for active follow-up for safety, including deaths, hospitalizations, and other serious or clinically significant adverse events, among individuals who receive the vaccine under an EUA, to inform ongoing benefit-risk determinations to support continuation of the EUA. FDA also expects manufacturers who receive an EUA to continue their clinical trials to obtain additional safety and effectiveness information and pursue licensure (approval). Post-authorization vaccine safety monitoring is a federal government responsibility shared primarily by FDA and the U.S. Centers for Disease Control and Prevention (CDC), along with other agencies involved in healthcare delivery. Post-authorization safety monitoring during the COVID-19 pandemic vaccination program will aim to continuously monitor the safety of COVID-19 vaccines to rapidly detect safety problems if they exist. There will be multiple, complementary systems in place with validated analytic methods that can rapidly detect signals for possible vaccine safety problems. The U.S. government has a well-established post-authorization/post-approval vaccine safety monitoring infrastructure that will be scaled up to meet the needs of a large-scale COVID-19 vaccination program. The U.S. government – in partnership with health systems, academic centers, and private sector partners – will use multiple existing vaccine safety monitoring systems to monitor COVID-19 vaccines in the post-authorization/approval period. Some of these systems are the Vaccine Adverse Event Reporting System (VAERS), the Vaccine Safety Datalink (VSD), the Biologics Effectiveness and Safety (BEST) Initiative, and Medicare claims data. How will vaccine recipients be informed about the benefits and risks of any vaccine that receives an EUA? FDA must ensure that recipients of the vaccine under an EUA are informed, to the extent practicable given the applicable circumstances, that FDA has authorized the emergency use of the vaccine, of the known and potential benefits and risks, the extent to which such benefits and risks are unknown, that they have the option to accept or refuse the vaccine, and of any available alternatives to the product. Typically, this information is communicated in a patient “fact sheet.” The FDA posts these fact sheets on our website. How is it that COVID-19 vaccines have been developed so quickly? In public health emergencies, such as a pandemic, the development process may be atypical. For example, as demonstrated by the response to the COVID-19 pandemic, the U.S. government has coalesced government agencies, international counterparts, academia, nonprofit organizations and pharmaceutical companies to develop a coordinated strategy for prioritizing and speeding development of the most promising vaccines. In addition, the federal government has made investments in the necessary manufacturing capacity at its own risk, giving companies confidence that they can invest aggressively in development and allowing faster distribution of an eventual vaccine. However, efforts to speed vaccine development to address the ongoing COVID-19 pandemic have not sacrificed scientific standards, integrity of the vaccine review process, or safety. Recognizing the urgent need for safe and effective vaccines, FDA is utilizing its various authorities and expertise to facilitate the expeditious development and availability of vaccines that have met the agency’s rigorous and science-based standards for quality, safety, and effectiveness. Early in a public health crisis, FDA provides clear communication to the pharmaceutical industry pertaining to the scientific data and information needed to ensure development of vaccines and works quickly to provide advice on their proposed development plans and assessment of the data that are generated. Link to comment Share on other sites More sharing options...
What is an Emergency Use Authorization (EUA)? An Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives. Taking into consideration input from the FDA, manufacturers decide whether and when to submit an EUA request to FDA. Once submitted, FDA will evaluate an EUA request and determine whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to FDA. Are the COVID-19 vaccines rigorously tested? Yes. Clinical trials are evaluating investigational COVID-19 vaccines in tens of thousands of study participants to generate the scientific data and other information needed by FDA to determine safety and effectiveness. These clinical trials are being conducted according to the rigorous standards set forth by the FDA. Initially, in phase 1, the vaccine is given to a small number of generally healthy people to assess its safety at increasing doses and to gain early information about how well the vaccine works to induce an immune response in people. In the absence of safety concerns from phase 1 studies, phase 2 studies include more people, where various dosages are tested on hundreds of people with typically varying health statuses and from different demographic groups, in randomized-controlled studies. These studies provide additional safety information on common short-term side effects and risks, examine the relationship between the dose administered and the immune response, and may provide initial information regarding the effectiveness of the vaccine. In phase 3, the vaccine is generally administered to thousands of people in randomized, controlled studies involving broad demographic groups (i.e., the population intended for use of the vaccine) and generates critical information on effectiveness and additional important safety data. This phase provides additional information about the immune response in people who receive the vaccine compared to those who receive a control, such as a placebo. What safety and effectiveness data are required to be submitted to FDA for an EUA request for a vaccine intended to prevent COVID-19? COVID-19 vaccines are undergoing a rigorous development process that includes tens of thousands of study participants to generate the needed non-clinical, clinical, and manufacturing data. FDA will undertake a comprehensive evaluation of this information submitted by a vaccine manufacturer. For an EUA to be issued for a vaccine, for which there is adequate manufacturing information to ensure quality and consistency, FDA must determine that the known and potential benefits outweigh the known and potential risks of the vaccine. An EUA request for a COVID-19 vaccine can be submitted to FDA based on a final analysis of a phase 3 clinical efficacy trial or an interim analysis of such trial, i.e., an analysis performed before the planned end of the trial once the data have met the pre-specified success criteria for the study’s primary efficacy endpoint. From a safety perspective, FDA expects an EUA submission will include all safety data accumulated from phase 1 and 2 studies conducted with the vaccine, with an expectation that phase 3 data will include a median follow-up of at least 2-months (meaning that at least half of vaccine recipients in phase 3 clinical trials have at least 2 months of follow-up) after completion of the full vaccination regimen. In addition, FDA expects that an EUA request will include a phase 3 safety database of well over 3,000 vaccine recipients, representing a high proportion of participants enrolled in the phase 3 study, who have been followed for serious adverse events and adverse events of special interest for at least one month after completion of the full vaccination regimen. Part of FDA’s evaluation of an EUA request for a COVID-19 vaccine includes evaluation of the chemistry, manufacturing, and controls information for the vaccine. Sufficient data should be submitted to ensure the quality and consistency of the vaccine product. FDA will use all available tools and information, including records reviews, site visits, and previous compliance history, to assess compliance with current good manufacturing practices. What is the process that manufacturers are following to potentially make a COVID-19 vaccine available by EUA? Vaccine manufacturers are undertaking a development process that includes tens of thousands of study participants to generate non-clinical, clinical, and manufacturing information needed by FDA for the agency to determine whether the known and potential benefits outweigh the known and potential risks of a vaccine for the prevention of COVID-19. When the phase 3 portion of the human clinical trial reaches a predetermined point that informs how well a vaccine prevents COVID-19, as discussed and agreed to in advance with FDA, an independent group (called a data safety monitoring board) will review the data and inform the manufacturer of the results. Based on the data and the interpretation of the data by this group, manufacturers decide whether and when to submit an EUA request to FDA, taking into consideration input from FDA. After FDA receives an EUA request, our career scientists and physicians will evaluate all of the information included in the manufacturer’s submission. While FDA’s evaluation is ongoing, we will also schedule a public meeting of our Vaccines and Related Biological Products Advisory Committee, which is made up of external scientific and public health experts from throughout the country. During the meeting, these experts, who are carefully screened for any potential conflicts of interest, will discuss the safety and effectiveness data so that the public and scientific community will have a clear understanding of the data and information that FDA is evaluating to make a decision whether to authorize a COVID-19 vaccine for emergency use. Following the advisory committee meeting, FDA’s career professional staff will consider the input of the advisory committee members and continue their evaluation of the submission to determine whether the available safety and effectiveness and manufacturing data support an emergency use authorization of the specific COVID-19 vaccine in the United States. Who are the FDA career professionals evaluating EUAs for vaccines? The FDA staff are career scientists and physicians who have globally recognized expertise in the complexity of vaccine development and in evaluating the safety and effectiveness of all vaccines intended to prevent infectious diseases. These FDA professionals are committed to decision-making based on scientifically driven evaluation of data. FDA staff are like your family - they are fathers, mothers, daughters, sons, sisters, brothers and more. They and their families are also directly impacted by the work that they do, and are exactly who you want making these important public health decisions for the United States. What are the plans for continued monitoring of COVID-19 vaccines authorized by FDA for emergency use? FDA expects vaccine manufacturers to include in their EUA requests a plan for active follow-up for safety, including deaths, hospitalizations, and other serious or clinically significant adverse events, among individuals who receive the vaccine under an EUA, to inform ongoing benefit-risk determinations to support continuation of the EUA. FDA also expects manufacturers who receive an EUA to continue their clinical trials to obtain additional safety and effectiveness information and pursue licensure (approval). Post-authorization vaccine safety monitoring is a federal government responsibility shared primarily by FDA and the U.S. Centers for Disease Control and Prevention (CDC), along with other agencies involved in healthcare delivery. Post-authorization safety monitoring during the COVID-19 pandemic vaccination program will aim to continuously monitor the safety of COVID-19 vaccines to rapidly detect safety problems if they exist. There will be multiple, complementary systems in place with validated analytic methods that can rapidly detect signals for possible vaccine safety problems. The U.S. government has a well-established post-authorization/post-approval vaccine safety monitoring infrastructure that will be scaled up to meet the needs of a large-scale COVID-19 vaccination program. The U.S. government – in partnership with health systems, academic centers, and private sector partners – will use multiple existing vaccine safety monitoring systems to monitor COVID-19 vaccines in the post-authorization/approval period. Some of these systems are the Vaccine Adverse Event Reporting System (VAERS), the Vaccine Safety Datalink (VSD), the Biologics Effectiveness and Safety (BEST) Initiative, and Medicare claims data. How will vaccine recipients be informed about the benefits and risks of any vaccine that receives an EUA? FDA must ensure that recipients of the vaccine under an EUA are informed, to the extent practicable given the applicable circumstances, that FDA has authorized the emergency use of the vaccine, of the known and potential benefits and risks, the extent to which such benefits and risks are unknown, that they have the option to accept or refuse the vaccine, and of any available alternatives to the product. Typically, this information is communicated in a patient “fact sheet.” The FDA posts these fact sheets on our website. How is it that COVID-19 vaccines have been developed so quickly? In public health emergencies, such as a pandemic, the development process may be atypical. For example, as demonstrated by the response to the COVID-19 pandemic, the U.S. government has coalesced government agencies, international counterparts, academia, nonprofit organizations and pharmaceutical companies to develop a coordinated strategy for prioritizing and speeding development of the most promising vaccines. In addition, the federal government has made investments in the necessary manufacturing capacity at its own risk, giving companies confidence that they can invest aggressively in development and allowing faster distribution of an eventual vaccine. However, efforts to speed vaccine development to address the ongoing COVID-19 pandemic have not sacrificed scientific standards, integrity of the vaccine review process, or safety. Recognizing the urgent need for safe and effective vaccines, FDA is utilizing its various authorities and expertise to facilitate the expeditious development and availability of vaccines that have met the agency’s rigorous and science-based standards for quality, safety, and effectiveness. Early in a public health crisis, FDA provides clear communication to the pharmaceutical industry pertaining to the scientific data and information needed to ensure development of vaccines and works quickly to provide advice on their proposed development plans and assessment of the data that are generated.
ChuckNORRIS4Cup Posted August 9, 2021 Share Posted August 9, 2021 2 minutes ago, -DLC- said: Again, one paragraph taken out of context. Here's the whole thing: https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained Funny you know exactly where I got that from, yes one paragraph taken out of the report, nothing altered or changed, copied right from it. Link to comment Share on other sites More sharing options...
-DLC- Posted August 9, 2021 Share Posted August 9, 2021 1 minute ago, ChuckNORRIS4Cup said: Funny you know exactly where I got that from, yes one paragraph taken out of the report, nothing altered or changed, copied right from it. But you need to read on, not just extract one part to make a point because it fits your agenda. Copied from it "in part" and without important information. Matters. Are the COVID-19 vaccines rigorously tested? Yes. Clinical trials are evaluating investigational COVID-19 vaccines in tens of thousands of study participants to generate the scientific data and other information needed by FDA to determine safety and effectiveness. These clinical trials are being conducted according to the rigorous standards set forth by the FDA. Initially, in phase 1, the vaccine is given to a small number of generally healthy people to assess its safety at increasing doses and to gain early information about how well the vaccine works to induce an immune response in people. In the absence of safety concerns from phase 1 studies, phase 2 studies include more people, where various dosages are tested on hundreds of people with typically varying health statuses and from different demographic groups, in randomized-controlled studies. These studies provide additional safety information on common short-term side effects and risks, examine the relationship between the dose administered and the immune response, and may provide initial information regarding the effectiveness of the vaccine. In phase 3, the vaccine is generally administered to thousands of people in randomized, controlled studies involving broad demographic groups (i.e., the population intended for use of the vaccine) and generates critical information on effectiveness and additional important safety data. This phase provides additional information about the immune response in people who receive the vaccine compared to those who receive a control, such as a placebo. What safety and effectiveness data are required to be submitted to FDA for an EUA request for a vaccine intended to prevent COVID-19? COVID-19 vaccines are undergoing a rigorous development process that includes tens of thousands of study participants to generate the needed non-clinical, clinical, and manufacturing data. FDA will undertake a comprehensive evaluation of this information submitted by a vaccine manufacturer. For an EUA to be issued for a vaccine, for which there is adequate manufacturing information to ensure quality and consistency, FDA must determine that the known and potential benefits outweigh the known and potential risks of the vaccine. An EUA request for a COVID-19 vaccine can be submitted to FDA based on a final analysis of a phase 3 clinical efficacy trial or an interim analysis of such trial, i.e., an analysis performed before the planned end of the trial once the data have met the pre-specified success criteria for the study’s primary efficacy endpoint. From a safety perspective, FDA expects an EUA submission will include all safety data accumulated from phase 1 and 2 studies conducted with the vaccine, with an expectation that phase 3 data will include a median follow-up of at least 2-months (meaning that at least half of vaccine recipients in phase 3 clinical trials have at least 2 months of follow-up) after completion of the full vaccination regimen. In addition, FDA expects that an EUA request will include a phase 3 safety database of well over 3,000 vaccine recipients, representing a high proportion of participants enrolled in the phase 3 study, who have been followed for serious adverse events and adverse events of special interest for at least one month after completion of the full vaccination regimen. Part of FDA’s evaluation of an EUA request for a COVID-19 vaccine includes evaluation of the chemistry, manufacturing, and controls information for the vaccine. Sufficient data should be submitted to ensure the quality and consistency of the vaccine product. FDA will use all available tools and information, including records reviews, site visits, and previous compliance history, to assess compliance with current good manufacturing practices. 1 Link to comment Share on other sites More sharing options...
-DLC- Posted August 9, 2021 Share Posted August 9, 2021 At this point, Chuck...what's your point? Don't want the vaccine? Fine, don't get it. But don't use this platform to share half articles and stuff your mom sends you that you don't even know the source of to try to convince others. Science and medicine (along with stats) are showing us that the way to control this is through vaccination in a concentrated effort. If you aren't on board, you're part of the problem not the solution. Link to comment Share on other sites More sharing options...
coho8888 Posted August 9, 2021 Share Posted August 9, 2021 (edited) 15 minutes ago, ChuckNORRIS4Cup said: I said forget about the vaccine long term effects then because that's what we were discussing and that it doesn't concern you at all, so that's why I said lets forget about it then so we don't go back and forth on it, and after watching the video you posted and seeing how upset a doctor is or supposedly a doctor is over people using a mask, then I asked if you care about long term effects of covid if you do catch it, because according to the video you posted he doesn't. So why post the video then if you yourself don't agree with everything.... This is now the part I don't understand at all, are you posting it to educate people on his opinion? Because that video is actually his opinion not facts. It doesn't make sense why post it then? Especially when you want to talk about facts... This is the COVID thread where we discuss everything COVID related. I did not make any references to any of your posts when I posted that video. It was just for info to the group. It had nothing to do with Long term COVID vaccine effects but this thread isn’t called the “Long term COVID vaccine effects thread” is called the Coronaviirus Thread” Edited August 9, 2021 by coho8888 Link to comment Share on other sites More sharing options...
-DLC- Posted August 9, 2021 Share Posted August 9, 2021 "Covid is fast becoming a virus of the unvaccinated" (just stated on the news as they're showing a story about a 15 year old who contracted COVID last year who is still experiencing new symptoms...severe bruising all over her body). I'd say the virus is "experimental" and anyone unvaccinated is potentially a guinea pig. The Delta variant is creating all kinds of new issues, presenting in kids who are too young to be vaccinated. Sadly. 2 1 Link to comment Share on other sites More sharing options...
coho8888 Posted August 9, 2021 Share Posted August 9, 2021 (edited) 1 hour ago, ChuckNORRIS4Cup said: Also that video someone posted that claims to be a doctor, has anyone bothered to look at what's happening to Indonesia? I checked the world meter last week and looked for any countries that stood out Indonesia stood out because their deaths were really high, so check them again yesterday last night, it was a little alarming to read and see especially with what's happening to the kids actually, but hey that docotor on YouTube claims Delta isn't that serious... Seriously just google Indonesia and covid and take a look for yourselfs. FFS, that doctor did not say Delta was not serious. He said it was not serious for those that are vaccinated. That was the whole premise of his video. Indonesia has only 9.7% with one dose and 8.5% fully vaxxed which explains the high death rates. get vaccinated. Edited August 9, 2021 by coho8888 1 Link to comment Share on other sites More sharing options...
coho8888 Posted August 9, 2021 Share Posted August 9, 2021 11 minutes ago, -DLC- said: At this point, Chuck...what's your point? Don't want the vaccine? Fine, don't get it. But don't use this platform to share half articles and stuff your mom sends you that you don't even know the source of to try to convince others. Science and medicine (along with stats) are showing us that the way to control this is through vaccination in a concentrated effort. If you aren't on board, you're part of the problem not the solution. At this point he is looking more and more like a troll. Link to comment Share on other sites More sharing options...
ChuckNORRIS4Cup Posted August 9, 2021 Share Posted August 9, 2021 8 hours ago, coho8888 said: FFS, that doctor did not say Delta was not serious. He said it was not serious for those that are vaccinated. That was the whole premise of his video. Indonesia has only 9.7% with one dose and 8.5% fully vaxxed which explains the high death rates. get vaccinated. And how does he know if people who catch it with the vaccine won't have long term effects of covid after? Because he says it not serious for them.... GTFO Yes I am aware of Indonesia and the vaccine it's definitely hurting them, but it's the KIDS who are dying from Delta 5 and under, but you're just going to ignore that I guess, and just blame not getting vaccinated go figure. Link to comment Share on other sites More sharing options...
ChuckNORRIS4Cup Posted August 9, 2021 Share Posted August 9, 2021 Look yesterday I decided to really voice my honest opinion here and explain why someone like myself who isn't vaccinated and still isn't getting it, in the past I've come here occasionally and posted an article or something of a new study that has come out regarding the vaccine, not to stop people from taking the vaccine but to help inform them of recent information that does come out, people still have a right to know this information whether the news channel wants to show it or not because it doesn't fit their narrative all of a sudden, people still have a right to know if even it is a small amount, no information should be kept from anyone. I knew it would create a response it's something I've actually tried to avoid here because I knew this exactly would happen, I've read in here so I do know how many feel here, but I felt I have a right to my opinion and heck maybe some people might actually enjoy talking and digging up my mind a bit to really figure out why he doesn't want to get the vaccine. To see that I'm being labeled as this troll now or this anti vax fake news conspiracy or whatever people are calling it heck I don't even know. My opinion has been like this since day one when Pfizer tried to make the claim their vaccine was 90% effective then days later after Moderna said theirs was 94.5%, then Pfizer was now 95%, I never trusted this hence when my skepticism started on this vaccine and on top of it the rush and quickness with emergency panic use. I didn't need no fake news or people influencing my opinion I made this opinion up on my own from the start, and as this virus and vaccine has gone on my opinion still hasn't change this is why I addressed it with so many posters in here when they quoted me, I wanted to show you why I'm making this choice. I'm not here telling you or anyone to not take the vaccine, never once have I said this or will. Now everyone knows my stance, I will also add I haven't ruled out taking the vaccine completely but for the moment I'm not taking it, I think I voiced my opinion on why I am skeptical still, and I am well aware of what everyone responded to me with to help change my view on the matter, the same stuff I've been receiving and reading from family members. I've seen how the vaccines are definitely helping in the reduce of deaths I'm not denying any of that information, like I've stated I know their intent is to help people and not hurt them, it's obvious they're still learning as this goes on and how effective the vaccine is dealing with mutations and such, or other side effects that people may encounter with the vaccine, even if it is small their still learning. I think I'd be more comfortable once they have determined and found out all the side effects of the vaccine. Personally though before the vaccine came out and when we were first dealing with this virus, I wanted the whole world to literally shut down for 2-4 weeks. I felt this would of been the best way to deal with it to eliminate it at the beginning, but of course the way the world works they felt financially this wasn't pratical and can't be done, I'd argue yes it would of hurt financially a bit, but it would of been much less of a hit then trying to live with it for 2 years and lockdown multiple times in between to hurt financially way more. Anyways that can be an argument for a different day. I will step out of this topic, but if I do read something that comes up that imo people have a right to know then I will come back here and post it to show them, and I understand some or many may not agree with it because it may not fit the narrative that's going on at the moment, but if it's a study even if it's a small amount of people it effects, I will let people know especially for the ones who have got vaccinated because you do have a right to know, even if the News channel doesn't tell you, and just because the News didn't say or show it doesn't mean it's fake, there is some stuff they decide not to say or show still, they're not all as bad as Fox News, but they have their secrets to don't think they're all perfect now. 1 Link to comment Share on other sites More sharing options...
johngould21 Posted August 9, 2021 Share Posted August 9, 2021 7 hours ago, ChuckNORRIS4Cup said: I didn't even know it was fox tbh I agree I'm not a fan of Fox, my mother sent it to me because she wants me to get vaccinated I'm going to get mad her actually because she knows better and even hates fox, but anyways regarding it being approved by the FDA are you acknowledging that part is true or ignoring it because it was a news report by fox? That is legit truth though the vaccine has never been actually approved, it was only emergency approved for panic use, here read the definition. What is an Emergency Use Authorization (EUA)? An Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives. Taking into consideration input from the FDA, manufacturers decide whether and when to submit an EUA request to FDA. I still don't understand how something that's not actually approved is not considered experimental, obviously the person over at Fox sees it like that, I see it like that, I question why is hard for others to see it like that tbh. How about reading the post from Stawns, and the situation his friend in Kelowna is in, then go get vaccinated. You say you're not an anti-vaxxer, believe in science, etc., yet you go on and on for a week on these theories. 1 Link to comment Share on other sites More sharing options...
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