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Another comment indicates that AstraZeneca didn't apply for approval for the Netherlands plant until very very recently. OK, so pointing blame at them seems fa

by bradfa 6y ago

Another comment indicates that AstraZeneca didn't apply for approval for the Netherlands plant until very very recently. OK, so pointing blame at them seems fair then.

kmlx 6y ago
there could be some reasons behind this. no one knows why thou...
- SamBam 6y ago
  Does anyone have any insights as to why it seems like AZ has mismanaged everything from the start?
  - kmlx 6y ago
    the only guess going around is that they're not a traditional vaccine manufacturer. as such, they don't have the expertise for this kind of a roll out. but this is still a guess at this point.
    - SamBam 6y ago
      I was wondering that, but they seem to be a more mature company than Moderna, and have more experience with bringing out products in general. Did Moderna get more support from other companies/the government?
      - mrep 6y ago
        Moderna got 955 million for investment of their vaccine back in May, and an additional 1.53 billion back in August for the purchase of 100 million doses which has also further been increased to 300 million doses now: https://www.cnbc.com/2020/08/14/the-us-has-already-invested-billions-on-potential-coronavirus-vaccines-heres-where-the-deals-stand.html https://www.cnbc.com/2020/08/14/the-us-has-already-invested-...
        SamBam 6y ago
        And I guess the unstated conclusion is that they wisely spent a chunk of that money on hiring people with a long history of FDA compliance, regulatory guidelines, international export regulations, and product management? (I suppose my point is that I would have expected such teething problems from a young company like Moderna, but they seem to have done everything right.)
        mrep 6y ago
        Yes, that money came from the US government program literally codenamed "Operation Warp Speed" which was set up as a public–private partnership initiated by the United States government to facilitate and accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics: https://en.wikipedia.org/wiki/Operation_Warp_Speed https://en.wikipedia.org/wiki/Operation_Warp_Speed
  - throwaway19937 6y ago
    There's plenty of blame to go around. The EU started negotiating later and signed a contract with fewer remedies than the UK (https://www.politico.eu/article/the-key-differences-between-the-eu-and-uk-astrazeneca-contracts/ https://www.politico.eu/article/the-key-differences-between-...). It's not at all surprising that AZ is focusing their efforts on the UK.
    - SiempreViernes 6y ago
      Right, the contract with the EU alone explains why they fail to meet their commitments, have trouble with the manufacturing plant, screw up the dosing in the trials, and don't promptly provide proper paperwork to authorities during at basically all stages of the process. Must have been some contract...
- dathinab 6y ago
  Besides conspiracy speculations, it could be as simple as that in their planing they want to export 100% of Halix plains production and as such have no reason to seek regulatory improvement of the plant.
  - kmlx 6y ago
    but how can they export it since the EU requires export approval since January?
    - dathinab 6y ago
      They can't but they probably try to argue that since it's not "not a valid vaccine" in the EU it's "not affected by export controls". Through I think that isn't going anywhere outside of bureaucracy, it's still a valid export controlled vaccine just not produced in a valid way. But then if the pandemic would have been mostly over by now they would probably have gotten away with it.
- SiempreViernes 6y ago
  Given the quantity of doses stored, it seems likely AZ has been having them make doses that (likely) pass their own QA for some time so they should be in shape to receive approval for a comparable amount of time. To me one likely explanation for this is that AZ was holding off on applying to the EU in the hope that they could make these doses "in secret" and sell them outside the EU. Another, more mundane one, is that their back office is just a total shitshow with so much panic going on that somebody just didn't file it.
m12k 6y ago
If AZ until recently thought they were going to be shipping those doses to the UK, and the UK has approved that, then it's hard to fault AZ for not applying to have the plant approved in a jurisdiction that it wasn't intended to be used for anyway.
- SiempreViernes 6y ago
  Well, their delivery contracts to the EU also mention this exact plant so they really had no reason to think they could ship all its production to the UK...
  - m12k 6y ago
    Fair enough

by bradfa 6y ago

Another comment indicates that AstraZeneca didn't apply for approval for the Netherlands plant until very very recently. OK, so pointing blame at them seems fair then.

kmlx 6y ago

there could be some reasons behind this. no one knows why thou...

SamBam 6y ago
Does anyone have any insights as to why it seems like AZ has mismanaged everything from the start?
- kmlx 6y ago
  the only guess going around is that they're not a traditional vaccine manufacturer. as such, they don't have the expertise for this kind of a roll out. but this is still a guess at this point.
  - SamBam 6y ago
    I was wondering that, but they seem to be a more mature company than Moderna, and have more experience with bringing out products in general. Did Moderna get more support from other companies/the government?
    - mrep 6y ago
      Moderna got 955 million for investment of their vaccine back in May, and an additional 1.53 billion back in August for the purchase of 100 million doses which has also further been increased to 300 million doses now: https://www.cnbc.com/2020/08/14/the-us-has-already-invested-billions-on-potential-coronavirus-vaccines-heres-where-the-deals-stand.html https://www.cnbc.com/2020/08/14/the-us-has-already-invested-...
      - SamBam 6y ago
        And I guess the unstated conclusion is that they wisely spent a chunk of that money on hiring people with a long history of FDA compliance, regulatory guidelines, international export regulations, and product management? (I suppose my point is that I would have expected such teething problems from a young company like Moderna, but they seem to have done everything right.)
        mrep 6y ago
        Yes, that money came from the US government program literally codenamed "Operation Warp Speed" which was set up as a public–private partnership initiated by the United States government to facilitate and accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics: https://en.wikipedia.org/wiki/Operation_Warp_Speed https://en.wikipedia.org/wiki/Operation_Warp_Speed
- throwaway19937 6y ago
  There's plenty of blame to go around. The EU started negotiating later and signed a contract with fewer remedies than the UK (https://www.politico.eu/article/the-key-differences-between-the-eu-and-uk-astrazeneca-contracts/ https://www.politico.eu/article/the-key-differences-between-...). It's not at all surprising that AZ is focusing their efforts on the UK.
  - SiempreViernes 6y ago
    Right, the contract with the EU alone explains why they fail to meet their commitments, have trouble with the manufacturing plant, screw up the dosing in the trials, and don't promptly provide proper paperwork to authorities during at basically all stages of the process. Must have been some contract...
dathinab 6y ago
Besides conspiracy speculations, it could be as simple as that in their planing they want to export 100% of Halix plains production and as such have no reason to seek regulatory improvement of the plant.
- kmlx 6y ago
  but how can they export it since the EU requires export approval since January?
  - dathinab 6y ago
    They can't but they probably try to argue that since it's not "not a valid vaccine" in the EU it's "not affected by export controls". Through I think that isn't going anywhere outside of bureaucracy, it's still a valid export controlled vaccine just not produced in a valid way. But then if the pandemic would have been mostly over by now they would probably have gotten away with it.
SiempreViernes 6y ago
Given the quantity of doses stored, it seems likely AZ has been having them make doses that (likely) pass their own QA for some time so they should be in shape to receive approval for a comparable amount of time. To me one likely explanation for this is that AZ was holding off on applying to the EU in the hope that they could make these doses "in secret" and sell them outside the EU. Another, more mundane one, is that their back office is just a total shitshow with so much panic going on that somebody just didn't file it.

m12k 6y ago

If AZ until recently thought they were going to be shipping those doses to the UK, and the UK has approved that, then it's hard to fault AZ for not applying to have the plant approved in a jurisdiction that it wasn't intended to be used for anyway.

SiempreViernes 6y ago
Well, their delivery contracts to the EU also mention this exact plant so they really had no reason to think they could ship all its production to the UK...
- m12k 6y ago
  Fair enough