Guest Author at Angry Bear is Professor Joel Eissenberg. Dr. Joel Eissenberg is a professor of Biochemistry and Molecular Biology and is probably a good person to ask questions concerning pandemics and bringing new vaccines to market. Ask questions . . . I am sure he will answer the same as he has commented in the Comments section. He also reviewed my layman’s piece on Moderna’s mRNA. I am hoping he will contribute at Angry Bear on healthcare from time to time. The Moderna trial has reached its enrollment goal of 30,000 subjects and at least 75% have already received both injections. This is not a challenge trial, but it is expected that many subjects in the vaccine and placebo arms will be infected and these will be tracked. Power calculations
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run75441 considers the following as important: Healthcare, Hot Topics, Joel, mRNA Vaccine, Pharmaceuticals, politics
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Guest Author at Angry Bear is Professor Joel Eissenberg. Dr. Joel Eissenberg is a professor of Biochemistry and Molecular Biology and is probably a good person to ask questions concerning pandemics and bringing new vaccines to market. Ask questions . . . I am sure he will answer the same as he has commented in the Comments section. He also reviewed my layman’s piece on Moderna’s mRNA. I am hoping he will contribute at Angry Bear on healthcare from time to time.
The Moderna trial has reached its enrollment goal of 30,000 subjects and at least 75% have already received both injections. This is not a challenge trial, but it is expected that many subjects in the vaccine and placebo arms will be infected and these will be tracked. Power calculations suggest that only a few dozen infections are necessary to determine whether there is a benefit to the vaccine over placebo. So far, the number of infected subjects is at or ahead of what they expected. The trial lasts two years, so there is plenty of time to collect data. There is, of course, understandable urgency to push out some vaccine ASAP.
I’m in the Moderna trial, which tests the efficacy of injecting the messenger RNA for the SARS-CoV-2 spike protein (the surface protein that gives coronaviruses their corona) directly into muscle. The protein is made in muscle cells and then (a) secreted and (b) presented to immune cells to stimulate the adaptive immune system. Technically, it is a double-blind trial, but so far, everyone in the vaccine arm experiences the short-term vaccine syndrome of headache, mild fever, muscle and joint ache after the booster. I did, and was able to get an antibody test confirming a robust response (IgG). I’ll continue to social distance and mask as before; I have no interest in testing just how effective the vaccine is or isn’t with my own body.
The big question for this and the other vaccines is how robust and durable is the protection. This could vary because of a number of factors, including virus dosage and co-morbidities, which is why the 30,000 figure was important. My co-morbidity is age (I’m 65); older folks have a less-robust immune response on average, and it is more poorly regulated. The phase I/II cohort skewed young.
One thing that is frequently overlooked in the COVID-19 pandemic is that most people who survive a frank infection have enduring pathologies after they recover from the acute phase. In this respect, COVID-19 isn’t like the flu, it’s more like polio. So it will be important not only to see whether vaccines reduce mortality, but also if they can blunt the long-term effects on lungs, vasculature, and other organs, as well as virus-induced autoimmunity.
Tony Fauci has prophesized that there will likely be a vaccine approved for emergency use by December or the first quarter of 2021, but that general vaccination of the public won’t be a thing until summer of 2021, and assuming that enough people are vaccinated (ca. 70%), some semblance of normality isn’t expected until 2022. Even then, boosters every year or two may be necessary. I agree with Fauci. Indeed, he may be optimistic.
What is becoming increasingly clear is that infection is no guarantee of long-term immunity after recovery. Herd immunity by natural infection is mass murder, and the survivors will likely have little to celebrate. Until a vaccine is vetted, maintain social distancing, minimize time of potential exposure and wear a mask indoors when others are present. The economic impact of this is severe, yes, but ignoring these practices only leads to new peaks. Be safe out there, peeps!