3 ms·

Can you give a citation for that. The generally agreed figure is that it was done 3 months later. Bear in mind, the EU has still not even approved production fr

Can you give a citation for that. The generally agreed figure is that it was done 3 months later. Bear in mind, the EU has still not even approved production from the AZ Halix plant. EU has generally been doing things slower than the UK.

mr_aks 6y ago
The EU hasn't approved AZ Halix because AZ hasn't applied yet: https://www.ft.com/content/8e2e994e-9750-4de1-9cbc-31becd2ae0a8 https://www.ft.com/content/8e2e994e-9750-4de1-9cbc-31becd2ae... (apologies for the paywall). Relevant quote: Asked about the Halix situation, the commission said on Friday that the EMA was ready to fast-track authorisation of new production facilities once it received an application and the necessary information from AstraZeneca.
- cameronh90 6y ago
  I don't really understand what's going on with the Halix plant, but surely there must be more to it than that. There's presumably no way the EMA are just sitting there going "well we can't do anything until they mail us over the papers". Certainly the UK MHRA have been working closely with the companies to move the process along very quickly, as has been confirmed by both the government and the companies themselves. I'm curious to know what's really going on at the Halix plant.
  - tuukkah 6y ago
    How could EMA approve the certification of the factory if AZ does not want to and does not provide the necessary information?
    - thu2111 6y ago
      Knowing how these sorts of regulations work, there's probably considerable scope for speeding things up by parallelising. That's apparently how the MHRA went faster. Usually the regulator would demand a complete pack of information in specific formats, etc, so you have to wait for all the components to be ready before submission (which may well cost money, I'm not sure, but for corporate approvals like that it often does). In the absence of further guidance and given the EU's hostility to them so far, AZ may be waiting to ensure it has all its ducks in a row before submitting. In the UK the regulator was willing to do partial processing of applications in parallel with the project being executed, which isn't normal and poses obvious complexities, but can speed things up when latency is what matters most. If the EMA hasn't indicated any willingness to do that, and it's not the first time they've come up with this "we're waiting for submission" business, then it may be causing artificial delays.
      - tuukkah 6y ago
        It is in EMAs interest to do incremental processing and this is what they have been doing in other cases. It is in AZs interest to not start the process which would make the factory available for EU, where AZ is not willing to deliver at this time. (Instead, they ship doses even from the EU factories to UK and elsewhere.) Given this, you would need something concrete to back your speculation to the contrary.
        thu2111 6y ago
        Can you provide a citation for the EMA doing parallel processing because I have yet to hear about that and in fact read the opposite. It's not in AZ's interest to keep an expensive factory idled in an environment of unprecedented demand, obviously. They want to sell vaccine to whoever will take it. AZ is "unwilling" to deliver to the EU because it has signed contracts putting other countries first and they are able to consume the entire supply. Once the UK is done, they will suddenly become "willing" (if such a term makes sense when contracts are involved) to deliver to the EU as well. So to be clear, you are describing factual statements as speculation (which is wrong) and then making spurious claims about AZ/EMA's claimed interests instead of what they're actually doing.
        tuukkah 6y ago
        > Can you provide a citation for the EMA doing parallel processing "Rolling review" is the term I've seen typically used for the process that you described, and Wikipedia has references for various rolling reviews by EMA starting with the following: "In October 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) started 'rolling reviews' of the vaccines known as COVID-19 Vaccine AstraZeneca (ChAdOx1-SARS-CoV-2) and Pfizer-BioNTech COVID-19 Vaccine (BNT162b2)." https://en.wikipedia.org/wiki/History_of_COVID-19_vaccine_development#European_Union https://en.wikipedia.org/wiki/History_of_COVID-19_vaccine_de...
        thu2111 6y ago
        Then I wonder how it has ended in a situation where a factory is apparently ready to go to produce but is waiting for regulatory approval, and the regulators are claiming they're waiting for paperwork to be submitted. That shouldn't be possible in a genuinely parallel review process.
sprafa 6y ago
Sure. Here you go - https://www.france24.com/en/20200613-covid-19-france-italy-g https://www.france24.com/en/20200613-covid-19-france-italy-g... The Vaccine Alliance did a contract with AstraZeneca before the UK. The Alliance was Germany, Italy, Netherlands and France. AstraZeneca says this "doesn't count". I believe this was around 1 month before the UK agreement was signed. Here's another article that goes over it https://www.politico.eu/article/europe-coronavirus-vaccine-s https://www.politico.eu/article/europe-coronavirus-vaccine-s... And here's the press release up on Reuters https://www.france24.com/en/20200613-covid-19-france-italy-g https://www.france24.com/en/20200613-covid-19-france-italy-g... https://uk.ambafrance.org/Inclusive-Vaccines-Alliance-reache https://uk.ambafrance.org/Inclusive-Vaccines-Alliance-reache... And in the French embassy.. You're being fed BS. AZ signed with the Alliance, that contract was turned over to the EU comission. AZ is most likely caught up in giving their vaccine to the UK first and they are lying constantly. See the controversy on their efficacy in the US.
- thu2111 6y ago
  Hmm. I did a quick scan read over the Politico article, but I'm confused. It doesn't seem to be about contracts and the words "contract" and "alliance" don't appear in it. Did you copy/paste the wrong link? I also tried the two France24 links. They're both 404 Not Founds. The final link is also a 404. That's a bit odd. Where are you getting these links from? At any rate, the result is you've not provided any evidence that AZ is lying, which is a very bold claim to begin with. Why would they do that? AZ is part Swedish and has a Greek CEO, it's not like they're a 100% pure British firm of tub-thumping Brexit supporting patriots who inexplicably don't want to supply Europe with vaccine. Although by now I wouldn't be surprised if they're thoroughly sick of the EU and its games. Meanwhile the EU has: a) The motive to lie. b) A track record of doing so repeatedly, a completely undeniable one. It's ridiculous how often the EU or leaders of members states have said totally untrue things about this vaccine or the UK, I made a list at some point (see my old comments) and within a week there'd been another two lies coming out of Europe. I'm not the one being fed BS here - in many of those cases Europe's leaders have already admitted they'd said untrue things!
  - sprafa 6y ago

mr_aks 6y ago

The EU hasn't approved AZ Halix because AZ hasn't applied yet: https://www.ft.com/content/8e2e994e-9750-4de1-9cbc-31becd2ae0a8 https://www.ft.com/content/8e2e994e-9750-4de1-9cbc-31becd2ae... (apologies for the paywall). Relevant quote: Asked about the Halix situation, the commission said on Friday that the EMA was ready to fast-track authorisation of new production facilities once it received an application and the necessary information from AstraZeneca.

cameronh90 6y ago
I don't really understand what's going on with the Halix plant, but surely there must be more to it than that. There's presumably no way the EMA are just sitting there going "well we can't do anything until they mail us over the papers". Certainly the UK MHRA have been working closely with the companies to move the process along very quickly, as has been confirmed by both the government and the companies themselves. I'm curious to know what's really going on at the Halix plant.
- tuukkah 6y ago
  How could EMA approve the certification of the factory if AZ does not want to and does not provide the necessary information?
  - thu2111 6y ago
    Knowing how these sorts of regulations work, there's probably considerable scope for speeding things up by parallelising. That's apparently how the MHRA went faster. Usually the regulator would demand a complete pack of information in specific formats, etc, so you have to wait for all the components to be ready before submission (which may well cost money, I'm not sure, but for corporate approvals like that it often does). In the absence of further guidance and given the EU's hostility to them so far, AZ may be waiting to ensure it has all its ducks in a row before submitting. In the UK the regulator was willing to do partial processing of applications in parallel with the project being executed, which isn't normal and poses obvious complexities, but can speed things up when latency is what matters most. If the EMA hasn't indicated any willingness to do that, and it's not the first time they've come up with this "we're waiting for submission" business, then it may be causing artificial delays.
    - tuukkah 6y ago
      It is in EMAs interest to do incremental processing and this is what they have been doing in other cases. It is in AZs interest to not start the process which would make the factory available for EU, where AZ is not willing to deliver at this time. (Instead, they ship doses even from the EU factories to UK and elsewhere.) Given this, you would need something concrete to back your speculation to the contrary.
      - thu2111 6y ago
        Can you provide a citation for the EMA doing parallel processing because I have yet to hear about that and in fact read the opposite. It's not in AZ's interest to keep an expensive factory idled in an environment of unprecedented demand, obviously. They want to sell vaccine to whoever will take it. AZ is "unwilling" to deliver to the EU because it has signed contracts putting other countries first and they are able to consume the entire supply. Once the UK is done, they will suddenly become "willing" (if such a term makes sense when contracts are involved) to deliver to the EU as well. So to be clear, you are describing factual statements as speculation (which is wrong) and then making spurious claims about AZ/EMA's claimed interests instead of what they're actually doing.
        tuukkah 6y ago
        > Can you provide a citation for the EMA doing parallel processing "Rolling review" is the term I've seen typically used for the process that you described, and Wikipedia has references for various rolling reviews by EMA starting with the following: "In October 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) started 'rolling reviews' of the vaccines known as COVID-19 Vaccine AstraZeneca (ChAdOx1-SARS-CoV-2) and Pfizer-BioNTech COVID-19 Vaccine (BNT162b2)." https://en.wikipedia.org/wiki/History_of_COVID-19_vaccine_development#European_Union https://en.wikipedia.org/wiki/History_of_COVID-19_vaccine_de...
        thu2111 6y ago
        Then I wonder how it has ended in a situation where a factory is apparently ready to go to produce but is waiting for regulatory approval, and the regulators are claiming they're waiting for paperwork to be submitted. That shouldn't be possible in a genuinely parallel review process.

sprafa 6y ago

Sure. Here you go - https://www.france24.com/en/20200613-covid-19-france-italy-g https://www.france24.com/en/20200613-covid-19-france-italy-g... The Vaccine Alliance did a contract with AstraZeneca before the UK. The Alliance was Germany, Italy, Netherlands and France. AstraZeneca says this "doesn't count". I believe this was around 1 month before the UK agreement was signed. Here's another article that goes over it https://www.politico.eu/article/europe-coronavirus-vaccine-s https://www.politico.eu/article/europe-coronavirus-vaccine-s... And here's the press release up on Reuters https://www.france24.com/en/20200613-covid-19-france-italy-g https://www.france24.com/en/20200613-covid-19-france-italy-g... https://uk.ambafrance.org/Inclusive-Vaccines-Alliance-reache https://uk.ambafrance.org/Inclusive-Vaccines-Alliance-reache... And in the French embassy.. You're being fed BS. AZ signed with the Alliance, that contract was turned over to the EU comission. AZ is most likely caught up in giving their vaccine to the UK first and they are lying constantly. See the controversy on their efficacy in the US.

thu2111 6y ago
Hmm. I did a quick scan read over the Politico article, but I'm confused. It doesn't seem to be about contracts and the words "contract" and "alliance" don't appear in it. Did you copy/paste the wrong link? I also tried the two France24 links. They're both 404 Not Founds. The final link is also a 404. That's a bit odd. Where are you getting these links from? At any rate, the result is you've not provided any evidence that AZ is lying, which is a very bold claim to begin with. Why would they do that? AZ is part Swedish and has a Greek CEO, it's not like they're a 100% pure British firm of tub-thumping Brexit supporting patriots who inexplicably don't want to supply Europe with vaccine. Although by now I wouldn't be surprised if they're thoroughly sick of the EU and its games. Meanwhile the EU has: a) The motive to lie. b) A track record of doing so repeatedly, a completely undeniable one. It's ridiculous how often the EU or leaders of members states have said totally untrue things about this vaccine or the UK, I made a list at some point (see my old comments) and within a week there'd been another two lies coming out of Europe. I'm not the one being fed BS here - in many of those cases Europe's leaders have already admitted they'd said untrue things!
- sprafa 6y ago