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?
During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.
Do not refreeze thawed vials.
Vial Storage Prior to Use
Cartons of COMIRNATY multiple dose vials with gray caps and labels with gray borders will arrive frozen at ultra-cold conditions in thermal containers with dry ice.
Once received, frozen vials may be immediately transferred to the refrigerator [2ºC to 8ºC (35ºF to 46ºF)], thawed and stored for up to 10 weeks. The 10-week refrigerated expiry date should be recorded on the carton at the time of transfer. A carton of 10 vials may take up to 6 hours to thaw at this temperature.
Alternatively, frozen vials may be stored in an ultra-low temperature freezer at -90ºC to -60ºC (-130ºF to -76ºF). Do not store vials at -25°C to -15°C (-13°F to 5°F). Once vials are thawed, they should not be refrozen.
If cartons of COMIRNATY multiple dose vials with gray caps and labels with gray borders are received at 2°C to 8°C, they should be stored at 2°C to 8°C. Check that the carton has been updated to reflect the 10-week refrigerated expiry date.
Regardless of storage condition, the vaccine should not be used after the expiration date printed on the vial and cartons.
Vial Storage During Use
If not previously thawed at 2ºC to 8ºC (35ºF to 46ºF), allow vials to thaw at room temperature [up to 25ºC (77ºF)] for 30 minutes.
COMIRNATY multiple dose vials with gray caps and labels with gray borders may be stored at room temperature [8°C to 25°C (46°F to 77°F)] for a total of 12 hours prior to the first puncture. After first puncture, the vial should be held between 2ºC to 25°C (35°F to 77°F). Vials should be discarded 12 hours after first puncture.
Thanks for that. For something with such specific and precise handling, it seems unlikely to me (and difficult) that the shots that were being given at pop-up clinics, schools, churches, stadiums, police and fire stations, etc..were adhering of these protocols. Reading your explanation is very detailed and specific. This is just another piece of the puzzle that doesn't smell right. What happens if the vaccines are not stored at these temps? Do they become toxic, dangerous or simply ineffective? Not asking for an answer but just another piece of the puzzle that raises questions. Based upon the outlined protocols it would seem that every shot should have been given at hospitals with proper storage capabilities and experienced admins/nurses. Thank you for your Substack above as it was something I believe many have thought about. I am somewhat familiar with the drug development process and this doesn't seem to jive with the normal course and timeline. Just more questions and hopefully we get real answers one day.
the info was copied directly from the approved label so it is what PFE and FDA agreed on ... if pop up clinics didn't follow it for some reason, they needed to report it to PFE or FDA ... this is handled under the complaints system ; FDA is supposed to review sample complaints during their inspections of the manufacturing sites... hope this helps ...
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.
Frankly we don’t know what the extend of the prep work was ... so, it s hard to conclude that the substance would go bad n inactive with time ... too many unknowns but if anyone finds info, pls add here! Thx
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?
absolutely at sub-0 and deep ...
from the approved labeling:
During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.
Do not refreeze thawed vials.
Vial Storage Prior to Use
Cartons of COMIRNATY multiple dose vials with gray caps and labels with gray borders will arrive frozen at ultra-cold conditions in thermal containers with dry ice.
Once received, frozen vials may be immediately transferred to the refrigerator [2ºC to 8ºC (35ºF to 46ºF)], thawed and stored for up to 10 weeks. The 10-week refrigerated expiry date should be recorded on the carton at the time of transfer. A carton of 10 vials may take up to 6 hours to thaw at this temperature.
Alternatively, frozen vials may be stored in an ultra-low temperature freezer at -90ºC to -60ºC (-130ºF to -76ºF). Do not store vials at -25°C to -15°C (-13°F to 5°F). Once vials are thawed, they should not be refrozen.
If cartons of COMIRNATY multiple dose vials with gray caps and labels with gray borders are received at 2°C to 8°C, they should be stored at 2°C to 8°C. Check that the carton has been updated to reflect the 10-week refrigerated expiry date.
Regardless of storage condition, the vaccine should not be used after the expiration date printed on the vial and cartons.
Vial Storage During Use
If not previously thawed at 2ºC to 8ºC (35ºF to 46ºF), allow vials to thaw at room temperature [up to 25ºC (77ºF)] for 30 minutes.
COMIRNATY multiple dose vials with gray caps and labels with gray borders may be stored at room temperature [8°C to 25°C (46°F to 77°F)] for a total of 12 hours prior to the first puncture. After first puncture, the vial should be held between 2ºC to 25°C (35°F to 77°F). Vials should be discarded 12 hours after first puncture.
Thanks for that. For something with such specific and precise handling, it seems unlikely to me (and difficult) that the shots that were being given at pop-up clinics, schools, churches, stadiums, police and fire stations, etc..were adhering of these protocols. Reading your explanation is very detailed and specific. This is just another piece of the puzzle that doesn't smell right. What happens if the vaccines are not stored at these temps? Do they become toxic, dangerous or simply ineffective? Not asking for an answer but just another piece of the puzzle that raises questions. Based upon the outlined protocols it would seem that every shot should have been given at hospitals with proper storage capabilities and experienced admins/nurses. Thank you for your Substack above as it was something I believe many have thought about. I am somewhat familiar with the drug development process and this doesn't seem to jive with the normal course and timeline. Just more questions and hopefully we get real answers one day.
the info was copied directly from the approved label so it is what PFE and FDA agreed on ... if pop up clinics didn't follow it for some reason, they needed to report it to PFE or FDA ... this is handled under the complaints system ; FDA is supposed to review sample complaints during their inspections of the manufacturing sites... hope this helps ...
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.
Frankly we don’t know what the extend of the prep work was ... so, it s hard to conclude that the substance would go bad n inactive with time ... too many unknowns but if anyone finds info, pls add here! Thx
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.
the logistics is where I got to ...