Can you explain the storage and transport side. If you recall when these were released there was lots of hype about them needing to be stored and delivered at sub-freezing temps. Subsequently, read that they don't need to stored at sub freezing temps anymore. Seems odd such a significant change midway through rollout?
My layman's summary is, these shots were ready for deployment long before Covid? Or, they were produced in such a slipshod fashion that of course they failed? But if they were slipshod, why aren't they inert rather than dangerous? Thank you for your article.
Great article. I have experience in small molecule drug development and my thoughts were, how could the API (active pharmaceutical ingredient, in this case the mRNA molecule used in the formulations) have possibly been scaled up so quickly and in accordance with FDA protocols on all other agents (i.e., validation of synthetic process, development and validation of purification and analytical protocols)? Short answer: it cannot as something of this scale and within the time frame has never been done before. Your excellent post focuses on the formulation but there is also the issue of the mRNA, which makes it even worse. It seems the only way the manufacturing process could have been ramped up so quickly is that much or most of the work had already been completed well ahead of approval of the jabs. The people who did the work know the answers. Would be very interesting to hear from some of them....
Doesn’t the shear scale of the vaccinations ( over 11 billion worldwide to-date ) suggest a running start? Something isn’t making sense to me. It’s not just the vaccines but the logistics involved in the entire rollout. From needles, to dry ice, to packaging, to extremely cold storage, to training etc. all the way down to the paperwork for recording all vaccinations and developing the QR travel pass. Is this simply a monumental achievement enabled by the “warp speed” initiative or something far more involved that began long before the initial release of the virus. A
Can you explain the storage and transport side. If you recall when these were released there was lots of hype about them needing to be stored and delivered at sub-freezing temps. Subsequently, read that they don't need to stored at sub freezing temps anymore. Seems odd such a significant change midway through rollout?
My layman's summary is, these shots were ready for deployment long before Covid? Or, they were produced in such a slipshod fashion that of course they failed? But if they were slipshod, why aren't they inert rather than dangerous? Thank you for your article.
Great article. I have experience in small molecule drug development and my thoughts were, how could the API (active pharmaceutical ingredient, in this case the mRNA molecule used in the formulations) have possibly been scaled up so quickly and in accordance with FDA protocols on all other agents (i.e., validation of synthetic process, development and validation of purification and analytical protocols)? Short answer: it cannot as something of this scale and within the time frame has never been done before. Your excellent post focuses on the formulation but there is also the issue of the mRNA, which makes it even worse. It seems the only way the manufacturing process could have been ramped up so quickly is that much or most of the work had already been completed well ahead of approval of the jabs. The people who did the work know the answers. Would be very interesting to hear from some of them....
Loved your article. Thank you.
Doesn’t the shear scale of the vaccinations ( over 11 billion worldwide to-date ) suggest a running start? Something isn’t making sense to me. It’s not just the vaccines but the logistics involved in the entire rollout. From needles, to dry ice, to packaging, to extremely cold storage, to training etc. all the way down to the paperwork for recording all vaccinations and developing the QR travel pass. Is this simply a monumental achievement enabled by the “warp speed” initiative or something far more involved that began long before the initial release of the virus. A
Craig Corcoran.