sandeep Posted March 6, 2022 Share Posted March 6, 2022 @BacktoCricaddict or any others who have domain knowledge, any insight? Cynical view would be that this is a protectionist move aimed at preserving pfizer market share. Bharat Biotech's vaccine is not mRNA based, and would offer a proven effective, meaningful alternative to parents like me. https://www.nytimes.com/2022/03/04/world/fda-bharat-biotech-vaccine.html?searchResultPosition=5 Link to comment Share on other sites More sharing options...
rangeelaraja Posted March 6, 2022 Share Posted March 6, 2022 2 hours ago, sandeep said: @BacktoCricaddict or any others who have domain knowledge, any insight? Cynical view would be that this is a protectionist move aimed at preserving pfizer market share. https://www.nytimes.com/2022/03/04/world/fda-bharat-biotech-vaccine.html?searchResultPosition=5 https://www.reuters.com/business/healthcare-pharmaceuticals/fda-declines-pediatric-eua-ocugens-covid-vaccine-covaxin-2022-03-04/ Quote Covaxin, which is not cleared for any age group in the United States, is one of the two most widely used COVID vaccines in India and also has an emergency use listing from the World Health Organization. The cynical view is the correct view in this case. Under_Score 1 Link to comment Share on other sites More sharing options...
BacktoCricaddict Posted March 7, 2022 Share Posted March 7, 2022 My quick answer: Even Pfizer's vaccine is not EUA'd for <5 y.o. FDA has delayed it multiple times and is asking for more data. AFAIK Ocugen submitted Covaxin for approval later than Pfizer submitted their data for approval. Under those circumstances, I am not sure how they could approve something submitted much later for 2 y.o.? Link to comment Share on other sites More sharing options...
rkt.india Posted March 7, 2022 Share Posted March 7, 2022 Kids don't need these vaccines. I am still suffering side effects of vaccines. Why do you want kids to have these unsafe untested vaccines when Covid hasn't been dangerous for kids? EnterTheVoid 1 Link to comment Share on other sites More sharing options...
sandeep Posted March 7, 2022 Author Share Posted March 7, 2022 3 hours ago, BacktoCricaddict said: Under those circumstances, I am not sure how they could approve something submitted much later for 2 y.o.? They rejected for those under 18, not just under 2? Link to comment Share on other sites More sharing options...
EnterTheVoid Posted March 7, 2022 Share Posted March 7, 2022 1 hour ago, rkt.india said: Kids don't need these vaccines. I am still suffering side effects of vaccines. Why do you want kids to have these unsafe untested vaccines when Covid hasn't been dangerous for kids? What nonsense. Link to comment Share on other sites More sharing options...
Clarke Posted March 7, 2022 Share Posted March 7, 2022 (edited) Quote This decision follows a similar one in June last year, in which FDA officials rejected an EUA for Covaxin for adults. Instead, they asked Ocugen to conduct a local trial in the US first. https://science.thewire.in/health/fda-declines-emergency-use-approval-for-covaxin-for-paediatric-use/ Maybe that's all there is to it. Having said that, efficacy numbers for all vaccines designed on initial virus variants will be a different ball park with Delta/Omicron Edited March 7, 2022 by Clarke Link to comment Share on other sites More sharing options...
rkt.india Posted March 7, 2022 Share Posted March 7, 2022 4 hours ago, EnterTheVoid said: What nonsense. I am suffering from VITT. Need to keep taking blood thinners. Body just hasn't felt same since the vaccination. Covid has not affected kids much. So don't have any reason for kids to get vaccinated. Especially u12. Real McCoy and BacktoCricaddict 2 Link to comment Share on other sites More sharing options...
BacktoCricaddict Posted March 7, 2022 Share Posted March 7, 2022 6 hours ago, sandeep said: They rejected for those under 18, not just under 2? Its a blanket request for ages 2 to 18. If no vaccine is approved for under 5, how would a late entrant get it for 2, 3 and 4 y.o? Unfortunately, age slabs for vaccine clinical trials in the US and India dont match Link to comment Share on other sites More sharing options...
sandeep Posted March 7, 2022 Author Share Posted March 7, 2022 16 minutes ago, BacktoCricaddict said: Its a blanket request for ages 2 to 18. If no vaccine is approved for under 5, how would a late entrant get it for 2, 3 and 4 y.o? Unfortunately, age slabs for vaccine clinical trials in the US and India dont match I understand that, but couldn't the approval have been given for ages 5 and up, or 11 and up etc? Seems like a fig leaf for a decision made for marketshare reasons... Link to comment Share on other sites More sharing options...
BacktoCricaddict Posted March 7, 2022 Share Posted March 7, 2022 (edited) 3 hours ago, sandeep said: I understand that, but couldn't the approval have been given for ages 5 and up, or 11 and up etc? Seems like a fig leaf for a decision made for marketshare reasons... They can only review the application that Ocugen submitted. It is not their job to parse the data for the submitter. For all you know, they probably told Ocugen to do just that - split the data by our slabs and resubmit. I am just scratching my head that Ocugen asked for a blanket 2 to 18 approval, knowing that toddler approval is a steep hill to climb. As for adult authorization, Ocugen submitted in Aug 2021. It took longer than 6 months to grant full approval for Pfizer and Moderna. So it's not inordinate. And with where we are with the pandemic, an EUA for adult administration may not be necessary. All of this is Occam's razor conjecture based on 2 facts 1. It took a hell of a long time to grant full approval for Pfizer and Moderna adult vaccines. 2. FDA is still dragging its feet on Pfizer's toddler request. Not even EUA granted. If they really were batting for Pfizer, why would they do this? Edited March 7, 2022 by BacktoCricaddict sandeep 1 Link to comment Share on other sites More sharing options...
Real McCoy Posted March 7, 2022 Share Posted March 7, 2022 2 hours ago, rkt.india said: I am suffering from VITT. Need to keep taking blood thinners. Body just hasn't felt same since the vaccination. Covid has not affected kids much. So don't have any reason for kids to get vaccinated. Especially u12. What? you are on blood thinners ? For what? Is this after the vacc or before? What's your age btw? Also what is VITT? This gets stranger and stranger. Yeah I agree on children. In fact nobody NEEDS a vacc yet they are making it mandatory to travel across the world. Also most of the current cases of koweed are double vaccinated. I don't see the point Link to comment Share on other sites More sharing options...
sandeep Posted March 7, 2022 Author Share Posted March 7, 2022 27 minutes ago, BacktoCricaddict said: I am just scratching my head that Ocugen asked for a blanket 2 to 18 approval, knowing that toddler approval is a steep hill to climb. yeah seems like a process own goal - but from what little i know, the Bharat Biotech vaccine is 'old' tech right, conventional vaccine with inactive virus etc, so given adequate data set maybe they thought that they had a good shot at getting approval in one go? who knows. I am not one for quick belief in conspiracy theories, but I know that these decisions aren't as free from politics and lobbying as they are purported to be.... Link to comment Share on other sites More sharing options...
BacktoCricaddict Posted March 7, 2022 Share Posted March 7, 2022 1 hour ago, sandeep said: yeah seems like a process own goal - but from what little i know, the Bharat Biotech vaccine is 'old' tech right, conventional vaccine with inactive virus etc, so given adequate data set maybe they thought that they had a good shot at getting approval in one go? who knows. I am not one for quick belief in conspiracy theories, but I know that these decisions aren't as free from politics and lobbying as they are purported to be.... You are right, the technology is old, tried and tested. But that alone does not necessarily make for a good Covid19 vaccine. Each clinical study stands on its own legs - one can hypothesize, but not make conclusions, about safety and efficacy based on age of technology. sandeep 1 Link to comment Share on other sites More sharing options...
BacktoCricaddict Posted March 7, 2022 Share Posted March 7, 2022 (edited) @sandeep As for me, I am going to fight for the freedom to get a 4th dose, even though I am not diagnosed as being immunocompromised. Heck, I work among 1000s of 18-22 year old college students who get around in the world and could be walking virus incubators. I feel like, by dragging their feet on approving the 4th dose for anyone who wants it, the US Govt/FDA is preventing me from protecting myself in the best way possible. If the benefit-risk ratio for 3 doses has proven to be exceedingly high, how bad can a 4th dose be? I want the right to be vaccinated as many times as I think necessary. My body, my shot - and the evidence so far is in my favor. Bloody Babus. Edited March 7, 2022 by BacktoCricaddict Link to comment Share on other sites More sharing options...
rkt.india Posted March 7, 2022 Share Posted March 7, 2022 (edited) 2 hours ago, Real McCoy said: What? you are on blood thinners ? For what? Is this after the vacc or before? What's your age btw? Also what is VITT? This gets stranger and stranger. Yeah I agree on children. In fact nobody NEEDS a vacc yet they are making it mandatory to travel across the world. Also most of the current cases of koweed are double vaccinated. I don't see the point After first dose, I had to regularly take blood thinners. Would feel black out time to time, aspirin would help. My diastolic bp also increased and having persistent headache. I am 37. Got lipid profile done which is fine. VITT is vaccine-induced thrombotic thrombocytopenia. Edited March 7, 2022 by rkt.india Link to comment Share on other sites More sharing options...
Real McCoy Posted March 7, 2022 Share Posted March 7, 2022 7 minutes ago, rkt.india said: After first dose, I had to regularly take blood thinners. Would feel black out time to time, aspirin would help. Now taking statins. My diastolic bp also increased. I am 37. Got lipid profile done which is fine. VITT is vaccine-induced thrombotic thrombocytopenia. what do you mean by black outs. becoming unconscious for a while? Dude that's damn serious. Isn't thromobo whatever related to blood clots. So VITT is basically the same and you are preventing clots with blood thinners? statins IIRC are for cholestorel. wtf have you gotten into So if you get cured of VITT, does the thinners and statins also come off or they stay? How long since the first dose and have you gotten the second dose. Link to comment Share on other sites More sharing options...
Real McCoy Posted March 7, 2022 Share Posted March 7, 2022 21 minutes ago, BacktoCricaddict said: @sandeep As for me, I am going to fight for the freedom to get a 4th dose, even though I am not diagnosed as being immunocompromised. Heck, I work among 1000s of 18-22 year old college students who get around in the world and could be walking virus incubators. I feel like, by dragging their feet on approving the 4th dose for anyone who wants it, the US Govt/FDA is preventing me from protecting myself in the best way possible. If the benefit-risk ratio for 3 doses has proven to be exceedingly high, how bad can a 4th dose be? I want the right to be vaccinated as many times as I think necessary. My body, my shot - and the evidence so far is in my favor. Bloody Babus. Its your body and your shot but don't force it onto others. I don't know whether you are trolling or being serious or pushing an agenda here. freedom to get your shot Nobody's stopping you. Don't place the blame on college students to get your way. You are basically blaming the non vacced people and want it to be made compulsory Link to comment Share on other sites More sharing options...
rkt.india Posted March 7, 2022 Share Posted March 7, 2022 21 minutes ago, Real McCoy said: what do you mean by black outs. becoming unconscious for a while? Dude that's damn serious. Isn't thromobo whatever related to blood clots. So VITT is basically the same and you are preventing clots with blood thinners? statins IIRC are for cholestorel. wtf have you gotten into So if you get cured of VITT, does the thinners and statins also come off or they stay? How long since the first dose and have you gotten the second dose. Statin as a combination to keep BP in control along with lisinopril plus amlodipine. I have taken both doses. Second was in October end. Have no idea about anything else. Hopefully, this effect will wear off as vaccine antibodies reduce with time. Link to comment Share on other sites More sharing options...
Real McCoy Posted March 7, 2022 Share Posted March 7, 2022 1 hour ago, rkt.india said: Statin as a combination to keep BP in control along with lisinopril plus amlodipine. I have taken both doses. Second was in October end. Have no idea about anything else. Hopefully, this effect will wear off as vaccine antibodies reduce with time. Are you still taking those statin and other bp medications. am I right in assuming you were not under any medication before this shot? Link to comment Share on other sites More sharing options...
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