Developing the Covid-19 vaccine

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shpalman
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Re: Developing the Covid-19 vaccine

Post by shpalman » Fri Mar 19, 2021 11:44 am

A journalist is indeed asking what they* know now that they didn't know on Monday.

* - Participants in the press conference are the Direttore Generale of AIFA, Nicola Magrini, the Direttore Generale della Prevenzione del Ministero della Salute, Giovanni Rezza, and the Presidente del Consiglio Superiore di Sanità, Franco Locatelli.
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Re: Developing the Covid-19 vaccine

Post by Herainestold » Fri Mar 19, 2021 3:12 pm

I was just listening to a podcast where Derek Lowe of In the Pipeline was interviewed.
He characterized the EMA as "very good", "not cowboys", "cautious and data driven".

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Re: Developing the Covid-19 vaccine

Post by tom p » Fri Mar 19, 2021 3:48 pm

Herainestold wrote:
Fri Mar 19, 2021 3:12 pm
I was just listening to a podcast where Derek Lowe of In the Pipeline was interviewed.
He characterized the EMA as "very good", "not cowboys", "cautious and data driven".
What was the podcast?

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Re: Developing the Covid-19 vaccine

Post by shpalman » Fri Mar 19, 2021 9:29 pm

https://twitter.com/DaveKeating/status/ ... 61803?s=09

A thread explaining how the UK (and the US) keep doses for themselves while the EU assumed everyone would share nicely.
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Re: Developing the Covid-19 vaccine

Post by badger » Sat Mar 20, 2021 8:34 am

So it seems that a fair number of EU countries are still pausing AZ even after EMA report.

This includes Norway, who say there is a causal link between AZ and blood clots, in a report published just after the EMAs report, and involves cases not considered by them.

https://www.ft.com/content/9424d00d-570 ... 519383b21a

Is it back to the drawing board for the EMA?

(Thanks for these updates Tomp et al, as has been expressed a few times on here it's great to have some insight from people at the coalface during this pandemic)

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Re: Developing the Covid-19 vaccine

Post by shpalman » Sat Mar 20, 2021 2:12 pm

Scientists at Greifswald teaching hospital claim they have discovered the cause of blood clots among a small number of AstraZeneca vaccine recipients. Doctors say a targeted treatment can now be used.
The researchers emphasized that treatment would only be possible in patients where blood clots appear, rather than as a preventative treatment.

The information has been shared with hospitals around Europe.

The Greifswald findings have not yet been published in a scientific journal and therefore have not been reviewed by independent experts. The Paul-Ehrlich-Institute in Germany is now looking into the scientists' work.
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Re: Developing the Covid-19 vaccine

Post by Herainestold » Sat Mar 20, 2021 2:46 pm

tom p wrote:
Fri Mar 19, 2021 3:48 pm
Herainestold wrote:
Fri Mar 19, 2021 3:12 pm
I was just listening to a podcast where Derek Lowe of In the Pipeline was interviewed.
He characterized the EMA as "very good", "not cowboys", "cautious and data driven".
What was the podcast?
North American talk radio. Derek Lowe starts about 3:30 lasts about ten minutes.

https://omny.fm/shows/afternoons-with-r ... of-first-v

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Re: Developing the Covid-19 vaccine

Post by badger » Mon Mar 22, 2021 8:07 am

Some more AZ results from US trials. Wonder if this US will release more if its stock now, or keep given the good results?

https://www.astrazeneca.com/media-centr ... point.html

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Re: Developing the Covid-19 vaccine

Post by tom p » Mon Mar 22, 2021 8:52 am

Herainestold wrote:
Sat Mar 20, 2021 2:46 pm
tom p wrote:
Fri Mar 19, 2021 3:48 pm
Herainestold wrote:
Fri Mar 19, 2021 3:12 pm
I was just listening to a podcast where Derek Lowe of In the Pipeline was interviewed.
He characterized the EMA as "very good", "not cowboys", "cautious and data driven".
What was the podcast?
North American talk radio. Derek Lowe starts about 3:30 lasts about ten minutes.

https://omny.fm/shows/afternoons-with-r ... of-first-v
thanks

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Re: Developing the Covid-19 vaccine

Post by Herainestold » Mon Mar 22, 2021 12:57 pm

badger wrote:
Mon Mar 22, 2021 8:07 am
Some more AZ results from US trials. Wonder if this US will release more if its stock now, or keep given the good results?

https://www.astrazeneca.com/media-centr ... point.html
.

What is the shelf life of the vaccine? It sounds like it will take a month to get FDA approval. The US has neighbours that could use it now, as well as Europe.

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Re: Developing the Covid-19 vaccine

Post by badger » Mon Mar 22, 2021 1:50 pm

Herainestold wrote:
Mon Mar 22, 2021 12:57 pm
badger wrote:
Mon Mar 22, 2021 8:07 am
Some more AZ results from US trials. Wonder if this US will release more if its stock now, or keep given the good results?

https://www.astrazeneca.com/media-centr ... point.html
.

What is the shelf life of the vaccine? It sounds like it will take a month to get FDA approval. The US has neighbours that could use it now, as well as Europe.
Buried in that link it says:
The vaccine can be stored, transported and handled at normal refrigerated conditions (2-8 degrees Celsius or 36-46 degrees Fahrenheit) for at least six months and administered without the need for preparation within existing healthcare settings.

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Re: Developing the Covid-19 vaccine

Post by Herainestold » Mon Mar 22, 2021 4:11 pm

badger wrote:
Mon Mar 22, 2021 1:50 pm
Herainestold wrote:
Mon Mar 22, 2021 12:57 pm
badger wrote:
Mon Mar 22, 2021 8:07 am
Some more AZ results from US trials. Wonder if this US will release more if its stock now, or keep given the good results?

https://www.astrazeneca.com/media-centr ... point.html
.

What is the shelf life of the vaccine? It sounds like it will take a month to get FDA approval. The US has neighbours that could use it now, as well as Europe.
Buried in that link it says:
The vaccine can be stored, transported and handled at normal refrigerated conditions (2-8 degrees Celsius or 36-46 degrees Fahrenheit) for at least six months and administered without the need for preparation within existing healthcare settings.
Thanks. I admit I didnt read the link, I read the one shpalman linked and I read the Stat piece. Which says the same thing.
Unlike the Pfizer and Moderna shots, which must be kept very cold, it can be stored for six months at between 2 to 8 degrees Celsius and administered without on-site preparation.
https://www.statnews.com/2021/03/22/ast ... u-s-trial/

So there appears to be lots of time for America to use it, hard luck for Mexico, Canada and Europe.

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Re: Developing the Covid-19 vaccine

Post by Brightonian » Tue Mar 23, 2021 5:39 am

AstraZeneca may have provided incomplete efficacy data from latest COVID-19 trial: NIAID

Is this something to worry about? Have things been fiddled and/or screwed up?

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Re: Developing the Covid-19 vaccine

Post by shpalman » Tue Mar 23, 2021 10:27 am

Brightonian wrote:
Tue Mar 23, 2021 5:39 am
AstraZeneca may have provided incomplete efficacy data from latest COVID-19 trial: NIAID

Is this something to worry about? Have things been fiddled and/or screwed up?
The vaccine developed with partner Oxford University was 79% effective in preventing symptomatic illness in the large trial that also took place in Chile and Peru, according to the data.
NO.

It was 79% effective according to a press release from AstraZeneca.

We haven't seen the data.
This AstraZeneca-led US Phase III trial included two doses administered at a four week interval.
Why? Isn't the one thing they learnt from messing up the previous Phase III trial that leaving a bigger gap is actually better (and not just a chance for the UK to put bigger numbers in its headlines).
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Re: Developing the Covid-19 vaccine

Post by tom p » Tue Mar 23, 2021 4:44 pm

tom p wrote:
Fri Mar 19, 2021 11:08 am
shpalman wrote:
Fri Mar 19, 2021 9:40 am
tom p wrote:
Fri Mar 19, 2021 9:19 am
I get your point, however there is a very good reason why there is zero chance of people outside ever being invited into these meetings to witness the discussions.
I wouldn't have expected that. I expected something more like the link you give below, except with some graphs or tables of data or something.

The past year has seen a lot of opening up of access, both in terms of real-time statistics on government websites, and in terms of preprints of scientific publications. Within the limits of industrial intellectual property protection and patient confidentiality I'd like to see the same from medicine regulators.

(The approval process seemed to go like "vaccine submitted to regulator and expected to be approved by [date]" "[date]: yep it's approved" as if the regulator just gives a meaningless rubber stamp to whatever the drug company says, and not a whole load of detailed rules and guidelines about how [and how not] to produce, transport, store, and administer the vaccine. Please explain this to us, because nobody else seems to be doing it.)
That's an interesting question.
Normally the expectedness of approval is far less certain. I will reply later about this, 'cos i want to give a full answer without writing too much.
Normal drug approvals process:
1. academic identifies possible cause of a disease - e.g. a dodgy receptor on a cell surface
2. companies read about this and rush to synthesise the faulty receptor & then run their massive banks of hundreds of thousands of chemicals & proteins against it. In parallel, they look at synthesising things which will mimic what should bind with it & then try those.
3. anything that shows some form of binding with the receptor is then (a) patented & (b) studied to death through many phases of pre-clinical trials (lab & then animals)
4. companies then look at what has been patented by others & copy that, but adding a slight twist & study that too
5. the top 100 or so candidates go into phase 1 trials with healthy volunteers (all youngish blokes: students, unemployed & backpacking aussies who are happy to swap a bit of blood to be paid 2 grand to spend a week playing playstation)
6. the top 10 or so go into phase 2 trials (hopeless cases who all other drugs have failed)
7. the top 1 to 3 go into phase 3 trials.
8. early phase 3 trial results whittle it down to the best 1
8a. if things are looking good, then company starts to focus on manufacturing and storage details. They were obviously caring about it before, but now it ramps up.
9. company sends all their data to the regulators (following the guidance here - summat the RDIF should have read, the dozy twonks) & crosses their fingers
10. bit of back and forth between regulators and company to clarify any questions the regulators have (here's a list of basic validation issues frequently found - the potential issues with the actual data are far greater)
11. committee meeting when the regulators decide whether or not to grant a license and, if so, under what conditions.

Steps 1-9 take 12-15 years and cost $250 to 1,000 million. Steps 10 & 11 take 9-18 months depending on how many questions the regulators have.
A far better & more thorough overview is available here
On top of all this, there are inspections and certification all along the chain: GLP, GCP, GMP &c.

A not insignificant number of applications are rejected each year, or have very strict restrictions placed on their use.

Companies who come to the EMA to use their scientific advice service have a far greater chance of getting approval. Sadly I can't find the figures right now for the % rejected with/without scientific advice.

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Re: Developing the Covid-19 vaccine

Post by shpalman » Tue Mar 23, 2021 6:06 pm

shpalman wrote:
Tue Mar 23, 2021 10:27 am
Brightonian wrote:
Tue Mar 23, 2021 5:39 am
AstraZeneca may have provided incomplete efficacy data from latest COVID-19 trial: NIAID

Is this something to worry about? Have things been fiddled and/or screwed up?
The vaccine developed with partner Oxford University was 79% effective in preventing symptomatic illness in the large trial that also took place in Chile and Peru, according to the data.
NO.

It was 79% effective according to a press release from AstraZeneca.

We haven't seen the data.
This AstraZeneca-led US Phase III trial included two doses administered at a four week interval.
Why? Isn't the one thing they learnt from messing up the previous Phase III trial that leaving a bigger gap is actually better (and not just a chance for the UK to put bigger numbers in its headlines).
https://twitter.com/HelenBranswell/stat ... 3356769287
It's clear the DSMB told AZ the vaccine efficacy estimate they should be using was between 69% - 74%. The company used data from an interim analysis that pointed to 79%, didn't mention the more recent data.
ExLNNaCVIAoRTsT.png
ExLNNaCVIAoRTsT.png (28.09 KiB) Viewed 261 times
‘I was sort of stunned’: Fauci and U.S. officials say AstraZeneca released ‘outdated information’ from Covid-19 vaccine trial
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Re: Developing the Covid-19 vaccine

Post by Herainestold » Wed Mar 24, 2021 2:25 am

What is wrong with these people? I am going to give my dose back.

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Re: Developing the Covid-19 vaccine

Post by tom p » Wed Mar 24, 2021 11:10 am

tom p wrote:
Tue Mar 23, 2021 4:44 pm
tom p wrote:
Fri Mar 19, 2021 11:08 am
shpalman wrote:
Fri Mar 19, 2021 9:40 am


I wouldn't have expected that. I expected something more like the link you give below, except with some graphs or tables of data or something.

The past year has seen a lot of opening up of access, both in terms of real-time statistics on government websites, and in terms of preprints of scientific publications. Within the limits of industrial intellectual property protection and patient confidentiality I'd like to see the same from medicine regulators.

(The approval process seemed to go like "vaccine submitted to regulator and expected to be approved by [date]" "[date]: yep it's approved" as if the regulator just gives a meaningless rubber stamp to whatever the drug company says, and not a whole load of detailed rules and guidelines about how [and how not] to produce, transport, store, and administer the vaccine. Please explain this to us, because nobody else seems to be doing it.)
That's an interesting question.
Normally the expectedness of approval is far less certain. I will reply later about this, 'cos i want to give a full answer without writing too much.
Normal drug approvals process:
1. academic identifies possible cause of a disease - e.g. a dodgy receptor on a cell surface
2. companies read about this and rush to synthesise the faulty receptor & then run their massive banks of hundreds of thousands of chemicals & proteins against it. In parallel, they look at synthesising things which will mimic what should bind with it & then try those.
3. anything that shows some form of binding with the receptor is then (a) patented & (b) studied to death through many phases of pre-clinical trials (lab & then animals)
4. companies then look at what has been patented by others & copy that, but adding a slight twist & study that too
5. the top 100 or so candidates go into phase 1 trials with healthy volunteers (all youngish blokes: students, unemployed & backpacking aussies who are happy to swap a bit of blood to be paid 2 grand to spend a week playing playstation)
6. the top 10 or so go into phase 2 trials (hopeless cases who all other drugs have failed)
7. the top 1 to 3 go into phase 3 trials.
8. early phase 3 trial results whittle it down to the best 1
8a. if things are looking good, then company starts to focus on manufacturing and storage details. They were obviously caring about it before, but now it ramps up.
9. company sends all their data to the regulators (following the guidance here - summat the RDIF should have read, the dozy twonks) & crosses their fingers
10. bit of back and forth between regulators and company to clarify any questions the regulators have (here's a list of basic validation issues frequently found - the potential issues with the actual data are far greater)
11. committee meeting when the regulators decide whether or not to grant a license and, if so, under what conditions.

Steps 1-9 take 12-15 years and cost $250 to 1,000 million. Steps 10 & 11 take 9-18 months depending on how many questions the regulators have.
A far better & more thorough overview is available here
On top of all this, there are inspections and certification all along the chain: GLP, GCP, GMP &c.

A not insignificant number of applications are rejected each year, or have very strict restrictions placed on their use.

Companies who come to the EMA to use their scientific advice service have a far greater chance of getting approval. Sadly I can't find the figures right now for the % rejected with/without scientific advice.
I've realised I didn't fully answer your question.
The difference this time, and why it may have looked like rubber-stamping is that from step 1 the vaccine manufacturers have been in discussions with the EMA. All fees for scientific advice for developing a COVID vaccine or treatment were waived and there was more discussion and meetings and requests for COVID-related advice than for anything ever. Plus the EMA and FDA cooperated to ensure that advice was not clashing and that a trial that data would be good enough for both markets. The companies were able to set up and run trials that they already knew were sufficiently powered for regulators' requirements and that the endpoints would be accepted.
Furthermore, the EMA performed a rolling review of the data, so that from step 5 onwards there was an ancillary step of 'send the latest data to the regulators, and that included sending in stability info, agreeing preliminary storage conditions, certifying manufacturing & agreeing all the tiny details about solvents, adjuvants, bottles, needles, syringes, stoppers and even what the boxes & bottles would look like.
It's lucky that the vaccines (particularly Pfizer & Moderna) are far more effective than anyone expected and so they were able to stop after fewer infections and get their vaccines approved earlier than anticipated. In fact, it was so fast that one of the important but usually quite mundane administrative steps (getting the international name for the substance approved) wasn't done before authorisation (which is unheard of).
The EMA website is teeming with details about the approvals.

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Re: Developing the Covid-19 vaccine

Post by shpalman » Wed Mar 24, 2021 11:43 am

shpalman wrote:
Tue Mar 23, 2021 6:06 pm
shpalman wrote:
Tue Mar 23, 2021 10:27 am
Brightonian wrote:
Tue Mar 23, 2021 5:39 am
AstraZeneca may have provided incomplete efficacy data from latest COVID-19 trial: NIAID

Is this something to worry about? Have things been fiddled and/or screwed up?
The vaccine developed with partner Oxford University was 79% effective in preventing symptomatic illness in the large trial that also took place in Chile and Peru, according to the data.
NO.

It was 79% effective according to a press release from AstraZeneca.

We haven't seen the data.
This AstraZeneca-led US Phase III trial included two doses administered at a four week interval.
Why? Isn't the one thing they learnt from messing up the previous Phase III trial that leaving a bigger gap is actually better (and not just a chance for the UK to put bigger numbers in its headlines).
https://twitter.com/HelenBranswell/stat ... 3356769287
It's clear the DSMB told AZ the vaccine efficacy estimate they should be using was between 69% - 74%. The company used data from an interim analysis that pointed to 79%, didn't mention the more recent data.
ExLNNaCVIAoRTsT.png

‘I was sort of stunned’: Fauci and U.S. officials say AstraZeneca released ‘outdated information’ from Covid-19 vaccine trial
Since we don't really know anything I'm going to have to keep making stuff up.

What we do know, from the press release, is that there were 32449 participants of which 21583 received "at least one dose of the vaccine" and that there were 141 symptomatic cases of covid in total.

Something like 41-42 cases in the vaccine group and 99-100 cases in the control group would, according to wot I reckon, give something which rounds to 79% efficacy if I've calculated it right.

To get down from there to 72% (in the middle of the 69-74% range the DSMB gets when looking at the full data) you'd need about 12 extra cases in the vaccine group assuming no new cases in the control group.

So we don't really seem to be talking about 1-2 more cases...

Of course, I'll stop wot I reckoning once they publish the f.cking data instead of bullshitting about it.
molto tricky

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Re: Developing the Covid-19 vaccine

Post by Bird on a Fire » Wed Mar 24, 2021 2:42 pm

It's really nuts that the data hasn't been published yet.

I assume that the EMA has seen it, at least. But the ongoing confusion and contradiction around the real numbers isn't very encouraging, and given the public's lack of faith in the AZ vaccine specifically I can't help but think that publishing the numbers would be a good PR move (unless...)
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Re: Developing the Covid-19 vaccine

Post by shpalman » Wed Mar 24, 2021 2:45 pm

~72% would have been fine. It's only their habitual fuckery that led them to want to publish a slightly higher number and bring this sh.t down on themselves.
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Re: Developing the Covid-19 vaccine

Post by Herainestold » Wed Mar 24, 2021 4:29 pm

shpalman wrote:
Wed Mar 24, 2021 2:45 pm
~72% would have been fine. It's only their habitual fuckery that led them to want to publish a slightly higher number and bring this sh.t down on themselves.
Yup. Now the Americans are indicating that they are pissed off with AZ and may delay authorization while they go over the data with a fine toothed comb. They are producing a shitload of the mRNA vaxes and waiting for J&J to come on stream, so they feel they may not need AZ. Meanwhile they sit on a stockpile of 20 million AZ doses, after shipping 4m to their neighbours. Countries waiting for the one shot J&J vax from America, may be out of luck as America uses that one in preference to the unapproved AZ.

Every country should make their own vaccines. Except San Marino.

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Re: Developing the Covid-19 vaccine

Post by jdc » Wed Mar 24, 2021 6:51 pm

shpalman wrote:
Wed Mar 24, 2021 2:45 pm
~72% would have been fine. It's only their habitual fuckery that led them to want to publish a slightly higher number and bring this sh.t down on themselves.
Yep. Is there anything that AZ have been involved with over the last 12 months that hasn't been in some way problematic? And it's always them, the other vaccine mfrs don't seem to be shooting themselves in the foot.

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Re: Developing the Covid-19 vaccine

Post by Grumble » Wed Mar 24, 2021 7:16 pm

Herainestold wrote:
Wed Mar 24, 2021 4:29 pm
shpalman wrote:
Wed Mar 24, 2021 2:45 pm
~72% would have been fine. It's only their habitual fuckery that led them to want to publish a slightly higher number and bring this sh.t down on themselves.
Yup. Now the Americans are indicating that they are pissed off with AZ and may delay authorization while they go over the data with a fine toothed comb. They are producing a shitload of the mRNA vaxes and waiting for J&J to come on stream, so they feel they may not need AZ. Meanwhile they sit on a stockpile of 20 million AZ doses, after shipping 4m to their neighbours. Countries waiting for the one shot J&J vax from America, may be out of luck as America uses that one in preference to the unapproved AZ.

Every country should make their own vaccines. Except San Marino.
Are “the Americans” saying this? There’s not been anything from the FDA, as there wouldn’t be, and I would expect them to go over the data with a fine toothed comb anyway, just as I’d expect any regulator to.
I know this is vitriol, no solution, spleen venting, but I feel better having screamed, don’t you?

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Re: Developing the Covid-19 vaccine

Post by Herainestold » Thu Mar 25, 2021 12:34 am

Grumble wrote:
Wed Mar 24, 2021 7:16 pm
Herainestold wrote:
Wed Mar 24, 2021 4:29 pm
shpalman wrote:
Wed Mar 24, 2021 2:45 pm
~72% would have been fine. It's only their habitual fuckery that led them to want to publish a slightly higher number and bring this sh.t down on themselves.
Yup. Now the Americans are indicating that they are pissed off with AZ and may delay authorization while they go over the data with a fine toothed comb. They are producing a shitload of the mRNA vaxes and waiting for J&J to come on stream, so they feel they may not need AZ. Meanwhile they sit on a stockpile of 20 million AZ doses, after shipping 4m to their neighbours. Countries waiting for the one shot J&J vax from America, may be out of luck as America uses that one in preference to the unapproved AZ.

Every country should make their own vaccines. Except San Marino.
Are “the Americans” saying this? There’s not been anything from the FDA, as there wouldn’t be, and I would expect them to go over the data with a fine toothed comb anyway, just as I’d expect any regulator to.
It was the National Institute of Allergy and Infectious Diseases that was annoyed enough that they issued a special statement in the middle of the night over this kerfuffle. It was internet randos who were speculating that the FDA might not be in a huge hurry to approve this vaccine as the US seems to be on track to meet their vaccination goals without AZ. I am sure there are going to be a lot of questions and it may not go quite as smoothly as AZ had hoped. The problem in America is distribution, not vaccine supply, so the sense of urgency is absent.I dont know how meticulous the FDA is, I tend to think of American regulators as rather slapdash as compared to the professionals at the EMA.

You are right, I didn't phrase my comment correctly, by Americans , I meant American commentators genereall,y not official agencies such as the FDA.

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