Mel, Thanks to you and all the EMRAP staff and faculty!
By looking at the safety data, about 60% of recipients get some systemic symptoms (not just local injection site reaction) on dose #1 and 70% get systemic symptoms (10% with fever) after dose #2.
If the 'front line' healthcare staff get the vaccine in the next week or so....already short staffed....and the vaccine causes COVID like symptoms (hopefully mild but many will be more than mild) ... and not yet protected from COVID...how safe is it to assume that the symptoms are vaccine related and not actually concurrent COVID? Will we be dealing with a symptomatic front line health care staff that cannot determine vaccine reaction symptoms from concurrent COVID-19 infection.
And higher rate of systemic symptoms from the vaccine dose #2 ... still not yet fully protected....probably going to be administered in mid to late January as we might face a potential spike from Christmas and NY gatherings .. and again be confronted with systemic symptoms and unable to distinguish vaccine reaction vs COVID disease.
And for you and your very smart faculty....if the vaccine induces RNA to DNA to make spike protein and cause the immune response... is there enough spike protein produced in the body that the PCR testing that use the S protein as the gene target could potentially give a 'false positive' in identifying the S protein produced by the vaccine?
Ed so many good questions. First I would say schedule you vaccine if possible at the beginning of a few days off. As you say a lot of peeps get fatigue and systemic symptoms. I think we just have to assume if you get symptoms after your vaccine it is the vaccine, but if could be COVID just by chance, but this will be rare.
mRNA does not go to DNA, but just right into the ribosomes to make spike protein. This is key, your DNA is not getting messed with. Can these cause a false positive PCR or antigen test - I will ask the experts.
Mel- Thank you for the info and all you do, greatly appreciated. Couple of questions... I'm wondering how they had so few infections in this study?? In a study with so few infections in either vaccine or placebo arm, it seems concerning that so many withdrew or were lost to follow up (Figure 1), Was there discussion anywhere of how they accounted for those numbers? What are your experts suggesting ER/ICU docs and nurses with MS do? I'm imagining just take the vaccine, as we won't know more until many more tens of thousands have died and risk of that for frontline staff is likely higher than debilitating MS flare etc? Heidi
I need Sanjay and Mike to spoon feed this to me.. Any way they can do that now instead of three months from now? Or will they be on Wednesday's update?
The low infection rate in the placebo arm is interesting but was expected and the power calculation was based on just 196 infections. The study is ongoing and sadly that number will go up. Feels like in LA right now we could get 196 infections in about 5 minutes with 196 enrolled!
I forward to Mike and Sanjay and see if they can do a deep dive soon.
I'm disappointed in the wholehearted acceptance of this vaccine. I'm not a conspiracy nut, I'm just a guy who remembers SEVERAL medications that were approved by the FDA then taken off the market shortly after the real world effects were seen. What other medication in the world has EMA (Or EM:RAP) spoken of this much without a healthy amount of criticism.
Mel says in the video that he can't wait to get his vaccine but that's probably because (sorry Mel) he's in the higher risk because he's not a kid anymore. What about all of the fit, healthy, no risk factor people out there who would do fine if they got COVID? A 25 year old resident is not the same as a 55 year old attending.
There is a risk to getting COVID and there's a risk to taking a brand new shiny (never before used on humans) drug. Where's THAT conversation?
Jim I agree - talked more it on the prior video. But at this stage the predominance of the evidence favors the vaccine over COVID in MOST groups. I do wonder about the young peeps, but if you want to get to heard immunity you have to include them I think. But there is MUCH to discuss here.
We will keep getting more data and the goal posts may move, and I sure HOPE we don't get a bunch of LATE side effects from the vaccine. But again I think for now, most of us need to get this vaccine...
Ed N. - December 11, 2020 9:59 AM
Mel,
Thanks to you and all the EMRAP staff and faculty!
By looking at the safety data, about 60% of recipients get some systemic symptoms (not just local injection site reaction) on dose #1 and 70% get systemic symptoms (10% with fever) after dose #2.
If the 'front line' healthcare staff get the vaccine in the next week or so....already short staffed....and the vaccine causes COVID like symptoms (hopefully mild but many will be more than mild) ... and not yet protected from COVID...how safe is it to assume that the symptoms are vaccine related and not actually concurrent COVID? Will we be dealing with a symptomatic front line health care staff that cannot determine vaccine reaction symptoms from concurrent COVID-19 infection.
And higher rate of systemic symptoms from the vaccine dose #2 ... still not yet fully protected....probably going to be administered in mid to late January as we might face a potential spike from Christmas and NY gatherings .. and again be confronted with systemic symptoms and unable to distinguish vaccine reaction vs COVID disease.
And for you and your very smart faculty....if the vaccine induces RNA to DNA to make spike protein and cause the immune response... is there enough spike protein produced in the body that the PCR testing that use the S protein as the gene target could potentially give a 'false positive' in identifying the S protein produced by the vaccine?
ERN
Mel H. - December 11, 2020 10:06 AM
Ed so many good questions. First I would say schedule you vaccine if possible at the beginning of a few days off. As you say a lot of peeps get fatigue and systemic symptoms. I think we just have to assume if you get symptoms after your vaccine it is the vaccine, but if could be COVID just by chance, but this will be rare.
mRNA does not go to DNA, but just right into the ribosomes to make spike protein. This is key, your DNA is not getting messed with. Can these cause a false positive PCR or antigen test - I will ask the experts.
Heidi B. - December 11, 2020 9:42 PM
Mel-
Thank you for the info and all you do, greatly appreciated. Couple of questions...
I'm wondering how they had so few infections in this study??
In a study with so few infections in either vaccine or placebo arm, it seems concerning that so many withdrew or were lost to follow up (Figure 1), Was there discussion anywhere of how they accounted for those numbers?
What are your experts suggesting ER/ICU docs and nurses with MS do? I'm imagining just take the vaccine, as we won't know more until many more tens of thousands have died and risk of that for frontline staff is likely higher than debilitating MS flare etc?
Heidi
Ian L. - December 13, 2020 11:24 PM
Paracetamol and non sedating antihistamines may blunt the adversity of the reaction . Paracetamol at least would not affect the immune response
Stephen R. - December 14, 2020 10:03 AM
I need Sanjay and Mike to spoon feed this to me.. Any way they can do that now instead of three months from now? Or will they be on Wednesday's update?
Stephen R. - December 14, 2020 10:23 AM
Also notable that infectivity overall seems extremely low even in placebo group 8/18198 0.04% versus 162/18325 0.88%. What's with that?
Mel H. - December 14, 2020 10:38 AM
The low infection rate in the placebo arm is interesting but was expected and the power calculation was based on just 196 infections. The study is ongoing and sadly that number will go up. Feels like in LA right now we could get 196 infections in about 5 minutes with 196 enrolled!
I forward to Mike and Sanjay and see if they can do a deep dive soon.
Jim J. - December 16, 2020 1:51 PM
I'm disappointed in the wholehearted acceptance of this vaccine. I'm not a conspiracy nut, I'm just a guy who remembers SEVERAL medications that were approved by the FDA then taken off the market shortly after the real world effects were seen. What other medication in the world has EMA (Or EM:RAP) spoken of this much without a healthy amount of criticism.
Mel says in the video that he can't wait to get his vaccine but that's probably because (sorry Mel) he's in the higher risk because he's not a kid anymore. What about all of the fit, healthy, no risk factor people out there who would do fine if they got COVID? A 25 year old resident is not the same as a 55 year old attending.
There is a risk to getting COVID and there's a risk to taking a brand new shiny (never before used on humans) drug. Where's THAT conversation?
Mel H. - December 16, 2020 3:20 PM
Jim I agree - talked more it on the prior video. But at this stage the predominance of the evidence favors the vaccine over COVID in MOST groups. I do wonder about the young peeps, but if you want to get to heard immunity you have to include them I think. But there is MUCH to discuss here.
We will keep getting more data and the goal posts may move, and I sure HOPE we don't get a bunch of LATE side effects from the vaccine. But again I think for now, most of us need to get this vaccine...
Mel H. - December 16, 2020 3:21 PM
But on the therapeutics front, I think most of the drugs we are using will ultimately be proven not to work.