So, does anyone know why Astra/Zeneca is not approved in the U.S.? Did they not try, or it's still ongoing, or did they have problems?
Germany pauses AstraZeneca vaccinations as a 'precaution'
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Re: Germany pauses AstraZeneca vaccinations as a 'precaution'
#202Maybe AZ should have charged €3 per shot instead of €2 and spent the extra € on a PR agency. They just seem to be constantly taking a hammering in the press, unfairly I’d say.
I really don't understand the "unfairness" about how AZ is being treated. This isn't an NGO that's doing their best with limited resources, it's a private company that is getting funded to expand their operations - this isn't charity, and I doubt anyone asked for charity.
EU is buying vaccines with profit margins, and those are delivering.
If that cost structure is proving to not be enough for AZ, then they shouldn't have accepted it, because clearly what they are doing now is borderline criminal, all while hiding behind a "best effort" clause in a contract, that's being stretched far beyond what is acceptable.
They messed up the trials, they set up production infrastructure that would have never worked to begin with (because of the UK contract not allowing exports of vaccines), giving notice of failed deliveries on short notice, and still make new promises of deliveries that are showing yet again not to be true. They are yet to file approval for other production facilities in EU that should have been working for MONTHS.
Now they dare to question independent regulators from different countries by saying their vaccines are fine - when they didn't seem to even have bothered to investigate any of the cases - it's like they looked at a spreadsheet and said "this anomaly is within these intervals", completely disregarding the type of cases, their local incidence, time window and age group. Ignoring the fact that these occurrences are 4x greater then the ones in the UK.
I understand that the EU doesn't want to file a lawsuit because it's counter productive, but at this point I think it's the only path - pull the funding, place it on other candidates, sue AZ. It's too much incompetence for such an endeavor, which makes you question if they are not simply cutting corners. Again, they seem to be pushing "best effort" to what is acceptable.
Re: Germany pauses AstraZeneca vaccinations as a 'precaution'
#203You do have to wonder if some of this is politically driven. Germany are losing hundreds of life's a day, while in the meantime the UK has administrated 23 million doses (not sure the ratio of those that were AstraZeneca) and not recorded a single fatality or adverse reaction and are seeing infection rates / deaths drop. I can understand caution under normal circumstances, but nothing is normal right now.
A problem with bureaucracies is that they often care deeply if people die from an action they are responsible for, but are fine if there are massive deaths due to inaction.
The solution is simple though: politicians simply ask experts how many people die if they do X versus Y, and make sure it is recorded (e.g. by journalists) so they can refer to it later.
Re: Germany pauses AstraZeneca vaccinations as a 'precaution'
#204I have seen 2 similar cases of immune thrombocytopenia in the news in US, one related to the Moderna vaccine, and one related to the Pfizer-BioNTech vaccine:
https://www.nytimes.com/2021/02/08/health/immune-thrombocyto... (alternative link: https://archive.is/RisZF)
https://www.seattletimes.com/nation-world/doctors-death-afte...
Re: Germany pauses AstraZeneca vaccinations as a 'precaution'
#205The deaths don't seem very high, I wonder if this is meant to be exactly the opposite of what they say: purely a political move to justify their slow vaccine rollout compared to the quick UK one (which used AZ).
Re: Germany pauses AstraZeneca vaccinations as a 'precaution'
#206Looks like this may be a bit more relevant than many of the snarky comments would suggest - the relevant German authority on this said that they have seen a unexpected increase in a specific type of blood clotting issue that usually is very rare: https://www.pei.de/DE/newsroom/hp-meldungen/2021/210315-voru...
> The EMA has said that as of March 10, a total of 30 cases of blood clotting had been reported among close to 5 million people vaccinated with the AstraZeneca shot in the European Economic Area, which links 30 European countries.
"The decision today is purely precautionary..." given this level of signal. We don't have details on the age groups involved and the normal rates expected but I can hazard a Fermi Estimate that the risk is minuscule compared to COVID-19 itself. I look forward to seeing the actual data in coming days/weeks. Precaution without downside is acceptable; this is not one of those cases, IMO. YMMV.
Re: Germany pauses AstraZeneca vaccinations as a 'precaution'
#207You do have to wonder if some of this is politically driven. Germany are losing hundreds of life's a day, while in the meantime the UK has administrated 23 million doses (not sure the ratio of those that were AstraZeneca) and not recorded a single fatality or adverse reaction and are seeing infection rates / deaths drop. I can understand caution under normal circumstances, but nothing is normal right now.
According to these reports hosted on gov.uk there are reports of fatalities and reactions. Pfizer: https://assets.publishing.service.gov.uk/government/uploads/... AstraZeneca: https://assets.publishing.service.gov.uk/government/uploads/... Disclaimer from UK.gov: Part of our monitoring role includes reviewing reports of suspected side effects. Any member of the public or health professional can submit suspected side…
I don't see any problem with reporting official information.
Can we please fucking stop the downvotes?
Re: Germany pauses AstraZeneca vaccinations as a 'precaution'
#208How many countries have stopped AZ fo far? - Denmark - Norway - Ireland - Netherlands - Iceland - Bulgaria - Romania (only partly, see child comment) Am I missing any?
South Korea is also facing huge public pressure to ban AZ
Re: Germany pauses AstraZeneca vaccinations as a 'precaution'
#209Looks like this may be a bit more relevant than many of the snarky comments would suggest - the relevant German authority on this said that they have seen a unexpected increase in a specific type of blood clotting issue that usually is very rare: https://www.pei.de/DE/newsroom/hp-meldungen/2021/210315-voru...
> The EMA has said that as of March 10, a total of 30 cases of blood clotting had been reported among close to 5 million people vaccinated with the AstraZeneca shot in the European Economic Area, which links 30 European countries. "The decision today is purely precautionary..." given this level of signal. We don't have details on the age groups involved and the normal rates expected but I can hazard a Fermi Estimate…
And the press statement says that this is based on new data compared to when they looked at it on the 11th. Hope we'll see what that is.
Re: Germany pauses AstraZeneca vaccinations as a 'precaution'
#210Looks like this may be a bit more relevant than many of the snarky comments would suggest - the relevant German authority on this said that they have seen a unexpected increase in a specific type of blood clotting issue that usually is very rare: https://www.pei.de/DE/newsroom/hp-meldungen/2021/210315-voru...
Is that the real reason? In times of crisis one must be wary of propaganda. AstraZeneca has recently announced they'd deliver even less to the EU because of Italy's interception of the delivery headed to Australia [0]... Europe having to halt the vaccinations with AstraZeneca due to none being in stock makes europe lose far more face than halting them because of quality concerns... [0]: https://www.wsj.com/articles/a…
The Paul Ehrlich Institut is an independent scientific institute, who make suggestions based on science.
Of course they are influenced by what they see in the news and questions by the government, but aren't a political player.