Astra Likely To Run Additional Global Vaccine Test, CEO Says (bloomberg.com) 45
AstraZeneca is likely to conduct an additional global trial to assess the efficacy of its Covid-19 vaccine, according to the company's chief executive officer, after current studies raised questions over its level of protection. From a report: The new trial would be run instead of adding an arm to an ongoing U.S. trial and would evaluate a lower dosage that performed better than a full amount in Astra's studies. The company's acknowledgment that the lower level was given in error fueled concerns.
"Now that we've found what looks like a better efficacy we have to validate this, so we need to do an additional study," CEO Pascal Soriot said in his first interview since the data were released. It will probably be another "international study, but this one could be faster because we know the efficacy is high so we need a smaller number of patients." Soriot said he didn't expect the additional trial to hold up regulatory approvals in the U.K. and European Union. Clearance from the U.S. Food and Drug Administration may take longer because the regulator is unlikely to approve the vaccine on the basis of studies conducted elsewhere, especially given the questions over the results, he said. Authorization in some countries is still expected before the end of the year, he said.
"Now that we've found what looks like a better efficacy we have to validate this, so we need to do an additional study," CEO Pascal Soriot said in his first interview since the data were released. It will probably be another "international study, but this one could be faster because we know the efficacy is high so we need a smaller number of patients." Soriot said he didn't expect the additional trial to hold up regulatory approvals in the U.K. and European Union. Clearance from the U.S. Food and Drug Administration may take longer because the regulator is unlikely to approve the vaccine on the basis of studies conducted elsewhere, especially given the questions over the results, he said. Authorization in some countries is still expected before the end of the year, he said.
This is completely normal in Drug Industry (Score:1, Insightful)
The FDA has the highest standards, and historically prefers domestic clinical trial over ones held in foreign countries. It's not that the FDA doesn't trust foreign trials, it just scrutinizes them more closely, since they need to assess the protocols closer - US trials are run according to FDA protocols.
But, of course, we have to act like this is a big surprise, that foreign drug trials have always been accepted at face value, this is an insult to our fellow nations, and that this delay will cost countless
Re:This is completely normal in Drug Industry (Score:5, Insightful)
Usually novel vaccines take about five years to reach Phase 1 clinical trials and then years after that to get approval. Going from initial concept to approval in under a year is unprecedented.
So if this takes a couple of more months I'm not looking to blame anyone. Nobody has ever conducted trials this quickly.
What I will blame Trump for is if the vaccine distribution and administration gets screwed up for want of preparation. We should have been going hammer and tongs on that since last April or May.
Re: (Score:2)
I believe the record before now is 5 years, held by smallpox vaccine. It's why in the 80s there was a huge push to vaccinate everyone and how for the most part, smallpox is effectively gone.
That includes places like India where you have to get the vaccine out to all the little communities.
It's funny when you think of it because more recent vaccines like HPV were only approved a few years ago but were in development and testing far longer. And there's a rush to get it out because HPV can lead to several canc
Key information: Half as much works better (Score:2)
The summary is missing the key information about what they are checking with a new study.
Based on the data from the study that is ending now, it looks like it probably works better if people get a "half dose", then later get a full dose. The primary dosing they were testing had both doses at the same level.
So it's just refining which dosage works best.
Re:Key information: Half as much works better (Score:4, Informative)
No it's not a refinement. The 1.5 dose approach was a mistake which Astra corrected mid-trial. As a result only about 3K people got the 1.5 dose approach, and all of them were 55 or younger. Hence the very high success rate (90% effective) of the 1.5 dose approach, is likely to be either unreliable, or skewed.
At this point Astra have only done a large scale trial for the 2 dose regimen, and its only 62% effective.
Re: (Score:2)
Whether they originally did the half then full dose in accident, because that was the original plan, or because Elvis told them too, it's still a question of refining exactly what the best dosing is.
How we got here doesn't change where we are - we're at figuring out exactly what the best dosing schedule is.
Re: (Score:2)
We can only have confidence in the 62% effective result for the 2 dose regimen. For all we know the 90% effective result for the 1.5 dose regimen is simply due to small numbers (only 3K people in the accidental trial), or due to the recipients all being under 55. Having said that, whether its more effective at 1.5 or 2 doses is a dosing schedule question.
But, whether the vaccine is safe at 1.5 doses versus at 2 doses is not a question of dosing schedule. At this point we have no idea how safe the 1.5 dos
Re: (Score:2)
> 1.5 doses versus at 2 doses is not a question of dosing schedule.
It does seem unlikely that a lower first would have more side effects than a larger dose. That's something to be confirmed.
Also it needs to be checked whether a lower initial dose is more effective in older patients - only people 55 and younger got the smaller initial dose so far.
What's more important, perhaps, is something I didn't realize when I wrote my first comment. The "over 90% effective" headline we saw last week is only for the l
Re: (Score:1)
> 1.5 doses versus at 2 doses is not a question of dosing schedule.
It does seem unlikely that a lower first would have more side effects than a larger dose. That's something to be confirmed.
The standard assumption in toxicology is that the higher the dosage the more likely the dosage is to be toxic -- i.e toxicity is monotonically increasing with dosage. But that is an assumption. It isn't necessarily universally true. There has been work showing (suggesting might be more accurate) that there are some situations where toxicity is biphasic and hence not monotonically increasing.
This is why we do clinical trials, to sort out such issues. So unfortunately Astra Zenica are probably going to hav
Re: (Score:1)
So re-reading this discussion I think there is an alternative approach that the FDA could take. While Astra runs another trial of the 1.5 dose regimen, the FDA could (should?) approve the 2 dose regimen of their vaccine. Astra have shown the 2 dose regimen to be safe and 62% effective. 62% isn't ideal, but it's a lot better than what we presently have, namely nothing, and combined with other public health measures could get countries to 70% immunity, which should then achieve herd immunity. Moreover in dev
Re: (Score:1)
The summary is missing the key information about what they are checking with a new study.
You mean this "key information":
The new trial would be run instead of adding an arm to an ongoing U.S. trial and would evaluate a lower dosage that performed better than a full amount in Astra's studies.
Re: (Score:2)
I don't know if the summary changed after I posted, or if my eyes skipped right over that in the summary. As you pointed out, it's there now.
Re: (Score:1)
No, they baked the study. They used YOUNGER people in the second study and ohh look it works best on the LEAST AT RISK, how fucking wonderful. The study SHOULD BE FUCKING BIASED to the most at risk the elderly not fucking against them. ZERO over 60s, the most at risk the most at need of the vaccine, the studies they have done as a result are utter shite.
No one has any idea what so ever of the impact in those most at risk over 70, will the vaccine kill many of them, don't know, none were tested. Now that is
Re: (Score:2)
Usually novel vaccines take about five years to reach Phase 1 clinical trials and then years after that to get approval. Going from initial concept to approval in under a year is unprecedented.
So if this takes a couple of more months I'm not looking to blame anyone. Nobody has ever conducted trials this quickly.
I laughed when I saw a comment a while ago saying that China was rushing out a vaccine and the Chinese will be forced to take unsafe vaccine shots. I pointed out that it was the US which most desperately needed a vaccine asap, while China is the only country in the world that can afford to wait and can choose to sell/donate their vaccine elsewhere for humanitarian/good will/bribe purpose depending on your viewpoint.
The US is now in a huge dilemma, over 1000 dying everyday, desperate for vaccine. Would the
Re: (Score:2)
It's still unprecedented. All of the SARS-2 candidate vaccines depend on work done over a couple decades on SARS-1 vaccines.
The problem is there's 5 vaccines in the pipe (Score:4, Insightful)
Donald Trump has repeatedly told people the pandemic is no big deal, even after he was caught lying about it, so you'll forgive me if I don't trust what comes out of his administration. Even if the FDA wants to act in the country's best interest when your boss is Donald Trump you're not going to be at your best. Mistakes will be made. Lives lost.
Re: (Score:2)
COVID is going to have a *long* tail (Score:2)
Re: (Score:2)
The current pre-orders will be blown through before we've even vaccinated everyone who's "essential".
Do you think that would be the case? Or would the vaccines go to everyone who's got the money first?
Don't forget that early on, when even front line nurse cannot get a covid test, the rich and famous can get tested simply because "they were worried".
Re: (Score:1)
Don't forget that early on, when even front line nurse cannot get a covid test, the rich and famous can get tested simply because "they were worried".
Well, the ability of a nurse in NYC to get a test is not impacted by the reality that a private practice in CA sold a test to a local resident.
Last week we administered nearly 2 million COVID tests in one 24 hour period [covidtracking.com] - testing isn't an issue anymore, it hasn't been for a long time.
Re: (Score:1)
There are multiple 100 million dose pre-orders, in round numbers how many "essential" workers do you think there are in America? Even allowing for a two dose regimen, cutting that number to 50 million, that works out to one-in-seven of all Americans being deemed "essential" - and ignores the fact there are multiple vaccines in the pipeline with similar 100 million dose advance orders, with all pharma's actively manufacturing doses in parallel to the clinical trials and approval process.
I don't fear running
WOW America first (Score:2)
I guess you are pretty ignorant to not realise that AstraZeneca is not a US company, it is Anglo-Swedish. The origin of the vaccine is Oxford University and funded by the UK government. The trials is overseen and funded by the UK NHS and the first production line to get rolling is in Melbourne Australia?
The Pfizer/BioNTech vaccines is also a global effort being produced in Pfizer facilities across the world. I'd expect the Moderna will also need to be global to scale.
A couple reasons that's not a concern (Score:3)
The world will need a couple BILLION doses, so as long as a company has some for sale by March-May they'll be buyers. Some buys are already guaranteed by contract (subject to the vaccine being approved).
Also, it looks like most likely the first vaccine to be approved needs to be shipped and stored at -70 Celsius. That's very cold, colder than a standard freezer can manage. The next one up is -20C, which a regular freezer can do. Given this needs to be delivered to everyone in the world, they'll be a huge d
I'm aware (Score:2)
In short the incentive to get to market fast is still there and it makes me nervous. I'm anxious for a vaccine, but if one gets out and hurts people it'll be a disaster. Even if it's only 1 out of 5.
I know! (Score:1)
Let's hold up the vaccines that are further along in development so the other vaccine makers can catch up! Then the profit driven race to get to market first won't be a factor, things would be "fair", the little guys won't get beat up by the big guys, and delaying will make all the vaccines safer (especially the ones that finished testing first).
We can't have these rushed, dangerous, vaccines being pushed on an unsuspecting populace by giant faceless corporations. People are going to be hurt. Phase I t
Re: (Score:2)
Just fyi, when I agree to with the point you are making, it really annoys me that you discredit the point with your tone and your stalking of rsilvergun.
Any ideas associated with your behavior lose credibility by that association - they become "things crazy stalkers say".
If you're going to be an asshole stalker, I wish you would say things that are NOT true, because having you say them, in the way that you say them, makes the ideas seem less credible.
Less of a concern (Score:2)
My subject line referencing "not a concern" should have said "less of a concern". Your point isn't meritless.
For better or for worse, we'll get another 2-3 months of data, and many more data points, as the elderly and those at greatest risk are vaccinated first.
A concern I have is if something related to the vaccine, maybe truckload that gets thawed out in some third-world country, kills 8 people. Then a bunch of people won't get vaccinated.
Covid has killed roughly 1.4 million people. If it kills ANOTHER
14 Billion doses (Score:2)
The world will need close to 14 billion doses to completely eradicate COVID-19. A couple of billion will barely vaccinate the developed world.
At current production rates it is expected that about 40 million doses of mRNA vaccines can be produced by the end of 2020 and this can be increased to about 1 billion doses by the end of 2021. That is a big short fall.
The AstraZeneca vaccine is far easier to produce than mRNA vaccines so is expected to cost about an eighth of mRNA vaccines and it can be produced in e
Re: (Score:2)
Yes, right now it is about production capacity (and probably price). The AstraZeneca vaccine cost 1/10th of the Moderna vaccine. If it is also 10x easier to produce, you could inocculate 10 people with the AstraZeneca vaccine instead of just 1 with the Moderna vaccine, over the same time period. That gives 6-7 protected people people instead of just one.
My guess is that governments will use whatever vaccine at whatever price that they can get their hands on to protect important people like healthcare worker
Re: (Score:2)
and the worry is that whoever's last to market will miss out on a huge payday, giving them incentive to push it through.
Fortunately for us then this is a global pandemic. Due to the issues you've noted, I have no doubt that the approval agencies in places like the UK, EU, Australia, Canada etc will all be taking their own very close look at the data. If they unanimously approve, I'm not going to have any concerns about regulatory capture issues.
We are already seeing this pressure with this Oxford Vaccine. While Boris was bleating on about how incredible this 'homegrown' vaccine was, the rumbling out of the USA was that the d
Re: (Score:2)
I'm confused. Is that a vaccine to cure capitalism or to cause it?
Re: (Score:2)
I'm confused. Is that a vaccine to cure capitalism or to cause it?
Yes!
So if I got this right... (Score:2)
So, in short... Europe gets more vaccines, earlier?
Thank you for your screwup, AstraZeneca :)
Re: (Score:2)
Unless they can really show robust data for the 90% efficacy in the half dose use (there were no over 55s in that group for example), then countries that go for the mRNA vaccine will probably get better results quicker anyway. The UK would have to essentially inoculate everyone to build any sort of herd immunity if the efficacy is only 60%. Even putting aside the thorny issue of mandatory inoculation, that will take a long time and lots of people will die from the virus while you're doing this.
With the mRNA
Re: (Score:3)
Herd immunity is no goal at all early on. Early on, the goal is to get some protection in place for the most vulnerable, any protection, since right now, those who haven't get gotten infected (most people) have no immunity whatsoever to it.
It'll be well into the spring before one can even detect the impacts of herd immunity.
Re: (Score:3)
That's foolishness. This would have been a horrible year however it was approached, and the US, e.g., would never have adopted the method that Vietnam adopted, which unsurprisingly worked. It involved massive quarantine right at the start, and rigid quarantines for smaller groups later. And the quarantine being ENFORCED!!!. We can't even get people to reliably wear masks *OR* to reliably socially distance. (And either alone is insufficient.)
That said, yes, Trump made it a lot worse than it had to be.
NOT SHARING TRIAL RESULTS (Score:2)