BobbyPhil1781 Posted January 5, 2021 Share Posted January 5, 2021 28 minutes ago, ramssuperbowl99 said: I think we will, but keep in mind the change will be slower than you'd like. We talked about this when the Phase 1 Pfizer/Moderna results came out, but when the FDA/OECD/MHRA approve a drug, they don't just blanket say "the Moderna vaccine is safe go nuts". They approve a specific regimen at a specific dose level to a specific population. So they applied for, and were granted an exception to give 2 doses, 28 days apart. We would need a separate approval for a single dose, just like we would need a separate approval if they wanted to dose pregnant women or children. There's no reason we couldn't get that now, but there's a lot of machinery that will have to grind out that change. How long will it take to get this approval assuming they're going to allow it? Link to comment Share on other sites More sharing options...
ramssuperbowl99 Posted January 5, 2021 Share Posted January 5, 2021 (edited) 9 minutes ago, BobbyPhil1781 said: How long will it take to get this approval assuming they're going to allow it? It depends on the specifics. They'll need single dose data showing similar efficacy. That will take ~28 days for dosing and then confirmation of an antibody response, plus time to get the study started, to analyze samples to confirm immunity, and result interpretation/submission. A few months seems like a reasonable starting point for a guess? @Shanedorf what do you think? Edited January 5, 2021 by ramssuperbowl99 Link to comment Share on other sites More sharing options...
BobbyPhil1781 Posted January 5, 2021 Share Posted January 5, 2021 (edited) 26 minutes ago, ramssuperbowl99 said: It depends on the specifics. They'll need single dose data showing similar efficacy. That will take ~28 days for dosing and then confirmation of an antibody response, plus time to get the study started, to analyze samples to confirm immunity, and result interpretation/submission. A few months seems like a reasonable starting point for a guess? @Shanedorf what do you think? I thought I read they've already done this in their phase 2 study though. https://imgur.com/8fJhCGy I thought this image showed that but I'm certainly not experienced enough to know what I'm looking at. Someone who seemed smarter than me pointed to this data though. Edited January 5, 2021 by BobbyPhil1781 Link to comment Share on other sites More sharing options...
WizeGuy Posted January 5, 2021 Share Posted January 5, 2021 (edited) On 3/20/2020 at 4:26 PM, Xmad said: This all sucks. What's the worst thing you've dealt with ya'll? Seeing a ton of people ventilated on Christmas Eve hit me pretty hard that night. It takes a toll. Edited January 5, 2021 by WizeGuy Link to comment Share on other sites More sharing options...
Deadpulse Posted January 5, 2021 Share Posted January 5, 2021 1 minute ago, WizeGuy said: Seeing a ton of people ventilated on Christmas Eve hit me pretty hard that night. It takes a toll. There is a shot going around the internet of a nurse in Egypt in the fetal position freaking out because almost her whole floor died due to a lack of oxygen tanks because their supply was stretched so then it snapped. As horrible as these scenarios are, they need to be shared everywhere. Some people need to see how real this is. 1 Link to comment Share on other sites More sharing options...
TVScout Posted January 5, 2021 Share Posted January 5, 2021 L.A. County first responders told not to bring patients to hospital if survival chances are low https://www.washingtonpost.com/nation/2021/01/05/coronavirus-covid-live-updates-us/ Link to comment Share on other sites More sharing options...
ramssuperbowl99 Posted January 5, 2021 Share Posted January 5, 2021 1 hour ago, BobbyPhil1781 said: I thought I read they've already done this in their phase 2 study though. https://imgur.com/8fJhCGy I thought this image showed that but I'm certainly not experienced enough to know what I'm looking at. Someone who seemed smarter than me pointed to this data though. Yeah we looked at this. I think we may have talked about whether the second dose was worth it when these results came out too. Funny seeing this stuff again a few months later. What this comes down to, fundamentally, is risk tolerance. Or, maybe a different way to think about is the difference between what we know and what we can prove. We already have safety data following one dose, so we're good there. The only question remaining is the efficacy. The data we have shows that a week after the first dose, there's a huge increase in COVID-19 antibodies. But remember, we don't calculate efficacy based on antibodies. We need to see people not getting infected, and the calculation for efficacy is the relative number of cases in each group. So, even though we know that following one dose there are antibodies and we (probably, >99% sure) think that is sufficient for immunity. But we can't prove it with just that data, because everyone included in the efficacy calculation got 2 doses. 2 Link to comment Share on other sites More sharing options...
mission27 Posted January 5, 2021 Share Posted January 5, 2021 On 1/2/2021 at 8:40 PM, Xenos said: Right now there’s nothing that can be done in CA. Restrictions are in place as much as they can be. This is just the limits of states trying to place restrictions on their own. Eventually people get pandemic fatigue and do whatever they want such as go to large indoor social gatherings without masks on. We’re seeing the results of Thanksgiving. And we’ll see Christmas and New Year’s soon. It doesn’t help that people are spreading misinformation about the deaths and hospitalization. As I said back May and June when Newsom was being a complete *** and closing beaches and ****, you act irresponsibly and dishonestly and expect too much out of people and you will not get cooperation down the road. It is sad but was incredibly predictable. Link to comment Share on other sites More sharing options...
Shanedorf Posted January 5, 2021 Share Posted January 5, 2021 1 hour ago, ramssuperbowl99 said: It depends on the specifics. They'll need single dose data showing similar efficacy. That will take ~28 days for dosing and then confirmation of an antibody response, plus time to get the study started, to analyze samples to confirm immunity, and result interpretation/submission. A few months seems like a reasonable starting point for a guess? Sounds reasonable on the timelines and the longest part will be trying to determine if the lower doses create a durable immune response Are people going to have a durable immune response with a single, 1/2 dose vs (2) 1/2 doses vs (1) full dose or (2) full doses ? Is the 2nd priming dose just as critical as the initial dose ? Is that result the same for young and old ? If they only get a good short term response, then using the 1/2 dose strategy isn't a successful immunization program and might actually be worse I wonder if you can go back and re-test the antibody titers from the low-dose groups in previous clinical trials - those patients who were low-dosed 6+ months ago would give us useful data points and could potentially shave time off this effort. There's a puzzle here that needs to be solved and it will likley be the combination of looking at previous data, 1/2 dosing some patients + modeling to gain confidence in the results. These dose assessments are happening in parallel with working out the distribution logistics so IF this works you'd see a nice boost in immunizations in Spring due to a greater supply of vaccine and better distribution. fingers crossed 1 Link to comment Share on other sites More sharing options...
Shanedorf Posted January 5, 2021 Share Posted January 5, 2021 14 minutes ago, ramssuperbowl99 said: But remember, we don't calculate efficacy based on antibodies. We need to see people not getting infected good point and I forgot about that part of the efficacy equation Link to comment Share on other sites More sharing options...
ramssuperbowl99 Posted January 5, 2021 Share Posted January 5, 2021 5 minutes ago, Shanedorf said: good point and I forgot about that part of the efficacy equation Fundamentally, this is why I don't think we can model our way out of this. At some point, we need to translate antibody titers into real immunity. If the FDA isn't comfortable with that risk, we need direct data. 1 Link to comment Share on other sites More sharing options...
Xenos Posted January 5, 2021 Share Posted January 5, 2021 (edited) 57 minutes ago, mission27 said: As I said back May and June when Newsom was being a complete *** and closing beaches and ****, you act irresponsibly and dishonestly and expect too much out of people and you will not get cooperation down the road. It is sad but was incredibly predictable. And I disagree with you then. Just like I disagree with you now. The beaches were reopened. At the end of the day, blaming Newsom is a cop out at the highest order. Edit: it’s not like there is a Newsom in the other states that are blowing up right now also. So no, I push back against this false narrative. I should also point out that when beaches were reopened and a surge happened over the summer, Newsom was also blamed for letting the beaches reopen and letting people from other states travel to the beaches. Hilarious.... Edited January 5, 2021 by Xenos Link to comment Share on other sites More sharing options...
Dr LBC Posted January 5, 2021 Share Posted January 5, 2021 3 hours ago, mission27 said: As I said back May and June when Newsom was being a complete *** and closing beaches and ****, you act irresponsibly and dishonestly and expect too much out of people and you will not get cooperation down the road. It is sad but was incredibly predictable. In fairness, the level of entitlement for a number of people, especially in Southern California, was always going to predispose them to not cooperating with anything that inconvenienced them and to grasp at any justification to do whatever they wanted anyway. At some point we have to face the fact that the "inherency" of good in people is a fallacy and that people, especially in modern society, are inherently selfish. 4 Link to comment Share on other sites More sharing options...
Xenos Posted January 5, 2021 Share Posted January 5, 2021 51 minutes ago, The LBC said: In fairness, the level of entitlement for a number of people, especially in Southern California, was always going to predispose them to not cooperating with anything that inconvenienced them and to grasp at any justification to do whatever they wanted anyway. At some point we have to face the fact that the "inherency" of good in people is a fallacy and that people, especially in modern society, are inherently selfish. Link to comment Share on other sites More sharing options...
Xenos Posted January 5, 2021 Share Posted January 5, 2021 (edited) Right now every state except Hawaii and Vermont is feeling the pain. The top five hotspots are AZ, CA, RI, TN, and OK currently. https://www.npr.org/sections/health-shots/2020/09/01/816707182/map-tracking-the-spread-of-the-coronavirus-in-the-u-s Edited January 5, 2021 by Xenos Link to comment Share on other sites More sharing options...
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