Oxford-AstraZeneca coronavirus vaccine approved for use in UK
bbc.co.uk
bbc.co.uk
I think the only reason they're considering this in Belgium right now is because they are unprepared in the extreme. They have frankly pissed away their time instead of actually preparing for the vaccine, the past nine months.
The current vaccination rollout plan leaves healthcare workers unvaccinated until march. HEALTHCARE WORKERS.
https://www.brusselstimes.com/news/belgium-all-news/147133/c...
There's been some pretty severe backlash to that, and rightfully so (I don't know of any other country that isn't vaccinating its health workers in the very first phase alongside senior citizens). I ran some numbers the other day and if you're distributing the vaccines exclusively via the 40-ish Belgian hospitals that can store the Pfizer one (and only 6 in Brussels), then there is no way to achieve herd immunity before end of 2020. The only real solution to that is to allow for more widespread distribution via pharmacies. (Yes, medium-term storage is an issue, but AIUI the Pfizer vaccines can still move around after thawing for some time so short term redistribution is possible if you've prepared for it).
So they're trying whatever they can to compress the timeline. It's not necessarily a bad decision, but it's a workaround to a worse one.
Also I’ve read that “Belgium accounts for 25% of Europe’s biotech”. I wonder why there’s no domestic vaccine yet given such R&D capacity.
It looks really promising, but investigation is required.
(And, better outcomes overall, too)
Not sure how all of that wound up, but:
https://www.who.int/emergencies/yellow-fever/mediacentre/qa-...
edit: For clarity, there wasn't an outbreak in Canada, but just shortages if you wanted to travel, and needed the vaccine.
I had the yellow fever vaccine last year in America. I received an, otherwise identical, Europe-manufactured vaccine instead of an American one because the shortage is on-going.
Your response made me think back to my research a few years back. Mostly, because I am surprised that there are STILL shortages! For more than half a decade?!
Found this:
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-S...
Quote:
Sanofi Pasteur has YF-Vax multi-dose vials and single dose vials on back order and the company estimates product will be available in 2021.[1]
Sanofi Pasteur has worked with FDA to make another vaccine, Stamaril, available in the US under an investigational new drug program. Stamaril is yellow fever vaccine manufactured by Sanofi Pasteur in France. It is not licensed in the US.
This, I recall. I also recall some more research, which I cannot find now, in that there were different production methods between the two vaccines. Hence, the lack of quick approval. Yet Yellow Fever is crazy spreadable! And still the vaccine is not fully approved in the US/Canada?!
I recall reading a report, where one person with yellow fever was briefly in an airport lounge. 20 minutes later, a few people passed through, and most caught it! Just... it makes COVID look like a joke, yet here governments are dragging their heels over approvals due to production methods over the same strains?
And those production methods / that company has been making and administering that version for decades? To hundreds of millions?
It really makes you think a bit about COVID approvals. Talk about a change of heart.
https://www.businesstoday.in/current/economy-politics/oxford...
https://www.thetimes.co.uk/article/covid-vaccine-boost-for-m...
And the Jenner Institute in Oxford doesn't do preprints or press releases for data, they go for publications (so that takes more time).
That said, I expect the missing information to appear in MHRA's guidance notes.
That said it seems the group who received smaller doses by mistake was only 1300, not sure where they got the data on 12 weeks but presumably it’s also a small number or they’d be going with that for everyone.
Things should become clearer over time and I hope they can shift to the smaller doses first as it’d give us double the number of initial vaccinations when supplies are limited.
Now we have a new number out there, 90% if the two doses are given 3 months apart, does anyone here now what the trial-size was? the age distribution? The statistical significance for that finding?
By now it's clear that for all three vaccines regardless of the exact efficacy of the vaccine, the chances of getting a severe case is greatly diminished. It's at least plausible that getting a vaccine reducings the severity of an infection in general; specifically that it might push what would otherwise have been a mild case into the asymptomatic (but infected) category. I don't know how large that group is, but given how many mild cases there are, it could be quite sizable. And those cases would not have been included in moderna and biontech/pfizer's efficacy numbers, but would have been included in the oxford/AZ trial's numbers.
So while I'm no expert in any of this, I think it's at least fair to say that it's not trivial to compare the efficacies reported from the two mRNA vaccines to that of the oxford/AZ vaccine, because of this difference in methodology. Including vs. mostly excluding asymptomatic cases will affect the numbers.
The point being? All of these trials have their limitations; the oxford/AZ trials may have had bumps (but nothing all that serious sounding), but they also have extra data in the form of asymptomatic cases. The comparison isn't straightforward.
(ref: https://www.thelancet.com/journals/lancet/article/PIIS0140-6... vs. e.g. https://www.nejm.org/doi/full/10.1056/NEJMoa2034577 )
Unless the vaccine or virus is very different from normal ones.
The data collection also includes the period of time that the body spends responding to the vaccine (so if you get the shot and get infected that day, the shot gets counted as not being effective).
And then on the other side of it, they don't have data on how long immunity from a single dose would last.
But it's likely that the Moderna and Pfizer vaccines have quite high effectiveness after the initial immune response.
The point about how long single dose immunity lasts is fair though.
So much so that airlines can oversell a substantial number of tickets on any given flight and usually the plane departs with empty seats?
Why do people get divorced?
Why do...
Dose Interval --> 28 days after dose 1 --> 28 days after dose 2
<6 weeks --> 8,734.08 --> 22,222.73
6-8 weeks --> 7,295.54 --> 24,363.10
9-11 weeks --> 7,492.98 --> 34,754.10
≥12 weeks --> 8,618.17 --> 63,181.59
from https://www.gov.uk/government/publications/regulatory-approv...
There was a lot of hope for the one-dose given the supply constraints or a retrial for the more promising half+full dose for greater efficacy.
I wonder if people will ask which vaccine they're receiving. 62% is kinda underwhelming when there's two 95% ones (Pfizer/Moderna), a 92% one (Gamaleya), and a 79-86% one (Sinopharm). With the latter two also not needing subzero temps.
https://www.bbc.co.uk/news/health-55308216
"""Unlike other vaccines being trialled, the Oxford team had been taking weekly swabs from all volunteers to check whether they were infected but showing no symptoms. If the vaccine could prevent silent transmission it could stop them from unwittingly passing on the virus. "That's a big deal. Because that means the virus could be stopped in its tracks," says Pollard.
Intriguingly, when the trial results came out, there were indications it may partly suppress transmission of the virus. But more evidence is needed."""
and
"""Crucially, no-one who got the vaccine was hospitalised or got seriously ill due to Covid. Whereas in the control group there were 10 serious cases and one death."""
Perhaps, regardless of immunity, it reduces symptoms to "not serious", and may reduce transmission, which the other vaccines do not? Which seems like a fair trade for high immunity percentages, and possibly better for the wider community.
Moderna is 95% at preventing symptoms (100% for serious symptoms in their trial but insufficient sample size). They also reported slightly lower efficacy for the elderly.
AstraZeneca is 62% for preventing symptoms (unknown for infection and spread).
So it's not quite a trade-off of spread prevention vs symptom prevention, because Pfizer claims to do both significantly better.
edit: reading the data in more detail, all 3 don't have sufficiently significant data to claim anything other than symptoms. So preventing spread is just PR-hype.
Cite, please. Pfizer's primary outcome measure was symptomatic infection. Only Oxford/AZ in the UK carried out weekly PCR tests to check for asymptomatic infections.
Side note, the more I read about the AZ trials in detail, the more it becomes obvious how messy their trial was compared to the Pfizer/Moderna ones. They have so many more methodologies and outcomes and much smaller samples.
[1] https://www.thelancet.com/journals/lancet/article/PIIS0140-6...
Typically, high levels of antibodies will suppress infection and thus transmission. But there isn't data to make a conclusive statement about it.
FTR, this only happened for one of the trials (the AZ results are actually from several trials combined) in England and Wales. In Brazil, for example, this was not done.
I can only imagine what it must be like for these researchers. You give some people a dummy and let them get seriously ill and one even dies.
No idea what else we could possibly do, this is probably just how this must be for the greater good, but wow must that feel horrible for everyone involved. You have to tell the family "Sorry, she was in the control group!" Peak 2020 moment for everyone involved right there.
Outside of ethical concerns, it comes with other complications, like how to design infecting the challengers so that it would be representative of real world infection/viral load.
> Simulation experiments revealed that to prevent an epidemic (reduce the peak by >99%), the vaccine efficacy has to be at least 60% when vaccination coverage is 100% (reproduction number=2.5–3.5). This vaccine efficacy threshold rises to 70% when coverage drops to 75% and up to 80% when coverage drops to 60% when reproduction number is 2.5, rising to 80% when coverage drops to 75% when the reproduction number is 3.5.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7361120/
Also, it prevents hospitalisations completely which is crucial.
I asked elsewhere but seems this thread is the busiest:
Also, does anyone know - supposedly the Oxford vaccine had swab tests for the virus every week to catch cases even if trial participants weren’t showing symptoms, whereas for the Pfizer/BioNTech vaccine they were only swabbing if someone showed symptoms. Would that not have a large effect on efficacy numbers?
> Using Microsoft Excel, version 16, with the Crystal Ball add-in, the team developed a computational transmission, clinical, and economics outcomes model
I did not expect the simulation model to be written in Excel. Never heard of "Crystal Ball" before. From Oracle's website:
> Use Monte Carlo simulation to automatically calculate and record the results of thousands of different what–if cases
I’m not sure coding these things up is always a great idea. I’ve done various types of programming over the years but in Excel you get things like dependency tracing, error checking, UIs for every components, Excel does have advantages for a lot of work. The equivalent code these domain experts produce is usually pretty awful.
Tools like Excel and Matlab exist for a reason.
Excel? You'd be lucky if Excel N-2 can properly handle the file, much less an "alternative implementation" such as LibreOffice Calc.
The other big difference is the sample size is much bigger with Astrazeneca one and is across continents as well.
My understanding would be that 10% immunity for instance would push R down by 10%. Once we get it below 1.0, we effectively won.
I don't believe we yet have evidence that any covid vaccine provides this. I've only read that any vaccine prevents disease or hospitalization.
I'm a bit reluctant to vaccinating until I see some more tests on wider population and we could test for long term complications (e.g. reduced fertility which couldn't be tested earlier) and I'm a person that vaccinated my children (and myself) for all kinds of diseases.
So I assume there are more people like me (aside from the usual "anti-vaccination" crowd).
62% is about as bad as vaccines get, and in any other circumstance the manufacturer would retrial instead of seek approval. Even the WHO recommends a 70% minimum during pandemic times (with 50%+ being a measure of last resort, which I guess we're at now).
On the other hand, 95% is better than the best of the best.
Even if that’s all the vaccine can do for me, here’s my arm.
Remember the biggest threat is health care systems being overwhelmed. That’s when people will die at much much higher rates because they don’t get respirators/oxygen.
Extra oxygen is critical.
I listened to an ICU doctor on the radio this morning saying the problem is that ANY kind of illness with covid is problematic because even fairly mild cases often require some medical attention, even if it’s just a doctor to reassure you you’re OK, that’s fine a doctor could be spending doing something more life-saving.
Here in the UK with this nee strain, the NHS is running out of resources in hotspot areas so any kind of vaccine will help.
[0] https://www.gov.uk/government/news/oxford-universityastrazen...
I doubt you can have both (even if safe, it's not tested at all).
The hospitalised patients per day is probably a more reliable measure - that has not surpassed the first wave yet on either patients per day or patients in hospital, but it does look like it might surpass it in January.
UK deaths are nowhere near the first wave yet, though it may approach it in the coming weeks, however at present deaths are trending down as stricter measures were finally put in place again in December and we may be starting to see the impact of that. We will then of course in a few weeks see the impact of the government attempt to 'Save Christmas' so things will probably get worse again in January.
In England (and probably the rest of the UK) more patients are in hospital compared to the first peak.
https://www.independent.co.uk/news/health/england-hospitals-...
https://coronavirus.data.gov.uk/details/healthcare
The UK totals for patients in hospital on the 25th December hadn't passed the peak yet, though they are very close. Doesn't matter too much though, they will no doubt pass that total of 21.6k at some point in January if they haven't already, especially as fewer patients are dying this time round.
If you click on the "Data" tab, it says for 28th Dec the total of 23,771.
I've no idea why the graph doesn't show that.
Are you sure? This is the data I'm looking at:
https://ourworldindata.org/coronavirus-data-explorer?zoomToS...
This link goes to "confirmed deaths" per million people, see also the "case fatality rate" setting. The former is about 6.8 now versus 13.8 at the peak in April; the latter is 3% versus 15% at the peak in April. There are half as many deaths and a fifth of the deaths per case. That's not even close to "rivaling it despite being geared up", at least from this data. Is this data wrong?
https://coronavirus.data.gov.uk/details/cases
https://coronavirus.data.gov.uk/details/deaths
Deaths are a bit lower. Cases are higher. Hospitalisations are about the same as the previous peek, but heading further up.
> No hospitalisations or severe disease observed in the vaccinated groups from three weeks after first dose
https://www.ox.ac.uk/news/2020-12-08-first-peer-reviewed-res...
If you're part of the elderly high risk group, long term isn't that much longer anyway. It's the people with most of their life ahead of them that has to pick between the long term damage of COVID vs the unknown potential of long term effects from mRNA/adenovirus.
They have distanced themselves from the US with the fastest approvals of Pfizer and Astrazeneca, the smartest targeting of the population (a focus on saving lives by targeting most vulnerable groups first), and the enormously helpful focus on getting some immunity first before worrying about second doses.
The UK is no longer constrained by manufactured doses or anything else. The faster they put that existing supply into people, the faster they are done. They could be done with the pandemic by the end of January.
There are only 500,000 doses available for the first week of Jan according to Hancock's statement in the commons a few minutes ago, so it will be a while before everyone gets their first dose.
“Where we stand today is we have four million doses available right now and we've got enough active that we think we will be able to make a further 15 million available to the UK by the end of this year. Subject to regulatory approval, it could actually be 19 million doses by the end of this year (to the UK)."
That seems like something has clearly gone wrong, if more than a month ago they were in that position and now we are so limited by available dosage.
> There are thought to be more than five million doses of the Oxford vaccine in the UK, but only just over 500,000 are ready for use.
> That is because vaccines have to be put into vials and batched and certified.
> Sources at the NHS expressed frustration at the situation. "The NHS is ready to go, but we can only go as quickly as supply allows," one said.
Can you elaborate on this?
IIRC the US recommendations take into account the population's chance of infecting others, rather than just solely the risk of death.
The Oxford vaccine is a more classical one so wasn't available quite as early, but apparently the mRNA ones were developed in a very short space of time (weeks - months) and future development could cut that even further (and preemptive vaccines for potential pandemic-causing viruses could be kept in stock) - perhaps introducing a Bayesian triage pre-approval could be an important strategy in fighting viruses in the future?
In any case this and the mRNA vaccines are really tremendous achievements and somewhat restores my faith in humanity after a terrible year...
The full equation is: P(death+injury|vaccine) < P(death|covid)
Before widespread testing, you don't know the severity of a treatment's side effects, especially in vulnerable subpopulations like children and elderly. The risk of severe complications for a novel drug are especially of concern when the immune system is involved, since it's often unstable or senescent in early and late age groups, and overreaction (e.g. cytokine storms) may prove toxic.
You don't want the cure to be worse than the disease unless the untreated mortality rate is sky high and no other therapy is viable, as it is for many cancers. In the case of Covid, with a 2-10% death rate (depending on age and region), such desperate measures are hard to justify, especially in low risk groups, until risk of injury is better known.
If you had e.g. a 75% chance of death but the vaccine had a 0.01% chance of killing or seriously impairing you, even taking into account all the issues and the risk of actually catching it the risk seems worthwhile.
However this discussion does make me think that the candidate range is going to be pretty narrow, and of course all concerned would have to be able and willing to give informed consent many of whom presumably would not.
And, anyway, I'm sure getting safety data from a large scale trial, where every vaccinated person is a data point is much faster than getting effectivity data, where only the people exposed to the virus count.
Shouldn't vaccines made with proven technology carry a somewhat high prior of efficacy?
(And, anyway, with all those problems people are finding on the trials, we are still green lighting them. What's only fair, because it's very likely that the problems aren't important. But why can we make that calculation now, but couldn't in June?)
Many drugs fail due to toxicity only during/after P3 when the number of subjects (often 1000 to 30,000) is sufficient to engage sufficient contraindication factors and power needed statistics to reveal detail in the edge cases.
Also, how long do we need to wait on P3 before we get the toxicity result?
A really rigorous answer is that we need several years because some problems appear very slowly. Yet, we are not waiting those years. We are declaring definitive success with incomplete information. What is very reasonable, because it is very unlikely that those vaccines will have long term toxicity... but then, why are we using that prior, but refuse to use the P2 or early P3 results to make a temporary decision?
Why we decided that it was ok to try the vaccine on 10s of thousands in June, but couldn't expand that number to 100's of thousands on July, or millions by August? The decisions were taken by calgo culting regulations, and caused a lot unnecessary harm.
The issue is less tangible and less quantative that that. It's about trust and public buy-in. If vaccine is rolled out despite not fully understanding its efficacy and safety and there are even minor side-effects, there will be fewer people who take the vaccine when they are asked to do so.
I think it's pretty clear from the past year that we need different tools and approaches to dealing with pandemics. One part is clearly faster vaccine development (mRNA seems very promising for this) and pre-emptive vaccine development, another might be permitting very much informed consent take up early on.
No, it would have to be P(death|vaccine) < P(death|covid) * P(covid) because not everyone would get covid during the pre-approval period. That's a far higher bar.
Also, let's not forget P(covid|vaccine). People would behave very differently once they had the vaccine and feel safe. So if the vaccine isn't effective, that could be catastrophic.
I still think the numbers would arguably work out well given the general safety especially of the mRNA vaccines (as I understand it).
It wouldn't be a simple or easy decision but it's one that should be considered (very carefully!)
Not sure, but I would think it comes down to hospitals not being overrun in the case of a widescale negative response to the vaccine. But since the whole thing is a game of probabilities, I do share your view.
Summing up the ethics part: Studies include volunteers in a controlled environment. Just administering un approved stuff to people means using people as guinea pigs. I don't want that, and it is doubtful we would have gained anything. Because now it is "simple" distribution and production problem.
The progress of the vaccine has been incredible compared to usual, but that doesn't mean more could have been done. Every death is a tragedy.
People are constantly used as guinea pigs... as long as there is informed consent as per the Nuremberg code it's fine. Not suggesting anybody would be forced or ill-informed.
So back to my argument - you can make a reasonable guess at estimating P(death|vaccine) vs. P(death|covid) and set a big margin, then offer people to VOLUNTARILY agree to take it who are most at risk of dying.
The average age of death in the UK is 82 mostly with co-morbidities. I am sure many of these dead would have been happy to take the chance.
And in the case of the mRNA vaccines this not some trivial difference - some were developed within weeks/months, but took nearly a year longer to pass all testing.
It's really obvious that pandemics need different handling than the 'lock down and loads of people die anyway, both from the virus and the consequences of lockdown while ruining the economy + wait 2yrs for a vaccine to be fully distributed' approach we've got.
I hope lessons are learned from covid (I'm actually optimistic they will be, in countries other than the one where the virus emerged anyway).
So you never asked anyone. The problem is, if you ignore ethics, which of course says a lot about your priorities, still two fold.
First, you have development. That was arguably the fastest vaccine development in history. Not sure what could have been done faster here.
Second, you have production and distribution. Ramping up these two doesn't make much sense before you know whether or not the vaccines work. Now they are ramped up really fast. Going "fast and breaking" things may have resulted in more people being vaccinated early on. But this small benefit would have caused tremendous issues in a couple of weeks / months. The goal is to get millions vaccinated, not just a few elderly so that some people can go out partying again without feeling bad.
This is offensive and I suggest you re-read my post (as well as the HN comment guidelines). I am not ignoring ethics, I specifically mention informed consent. I also have no idea what you mean by 'so you never asked anyone' - this is a hypothetical??
>The goal is to get millions vaccinated, not just a few elderly so that some people can go out partying again without feeling bad.
You're also strawmanning me pretty hard here.
> But this small benefit would have caused tremendous issues in a couple of weeks / months.
Not even sure how you come to this conclusion (you seem 100% certain that distributing the now-proven safe mRNA vaccine early would have caused tremendous issues, somehow).
You seem to want to be aggressive to me and strawman me as somebody who doesn't care about covid victims (my grandmother is 85 and has serious comorbidity risks thank you very much) so I am not going to respond further but I suggest you focus on arguments, not insults and dismissive comments. You can go to reddit and much of the rest of the internet for that.
I live in the UK and if they offer this, I'm taking it.
It may also play a role that asymptomatic carriers have lower chance of transmitting infection, so R0 in those countries is lower.
It's really good news all round.
I found eg this Wired article that talks a lot about the geopolitical maneuvering of Russia/China/India in Africa and South America: https://www.wired.co.uk/article/russia-covid-vaccine-sputnik...
But really, despite a lot of pejorative language in there -- “Once they have this relationship, they can extort whatever they want” -- it just sounds like the same strategy the UK has been attempting (both politically, and in terms of vaccine development and approval), except the Russian version sounds more successful so far.
Edit to add: apologies in advance for dragging politics into this! But it seems like politics and vaccines are unfortunately intertwined.
Their Phase 1/2 results were published in Lancet[1], which also printed an opinion about the politics of the vaccine[2]
They have reported their final data for their phase 3 study in a press releace which states they will be published in a journal soon [3].
1. https://www.thelancet.com/journals/lancet/article/PIIS0140-6...
2. https://www.thelancet.com/journals/laninf/article/PIIS1473-3...
3. https://sputnikvaccine.com/newsroom/pressreleases/the-sputni...
It sounds like much of the communication and release of scientific data has been bad, but in general the approach is sound and it’s likely to work well.
The same criticism about miscommunication could be (and has been) levelled at AZ, over the full-dose/half-dose mix-up.
You mean selling the COVID vaccine to 3rd world countries at cost/zero-profit, or others prior to this?
https://www.theguardian.com/global-development/2020/nov/23/o...
The key question would seem to be, who can produce and distribute those billions of doses first? Is the AstraZeneca vaccine being produced at a large enough scale already, and/or has the current capacity already been bought up by the EU and other rich countries?
From the BBC article(s) I believe the UK has ordered 100m doses. I have no idea who is producing those though, and how long it takes.
https://in.reuters.com/article/us-health-coronavirus-india-c...
As far as I can tell the data on the Chinese Sinovac and Russian Sputnik (which are of the same type) are consistent with the data for Oxford/AstraZeneca.
So politics aside, this is hopeful.
The UK really needs to roll this out fast because the current sudden growth in hospitalisation rates is a disaster, NHS is near full capacity again. I suspect there will be a full lockdown in January too.
Then there's things like only being allowed out of your house once a day for exercise.
And maybe if your work can't be done from home you're paid to stay home and not do it unless it's an essential service?
Key things are
1. This is only for a short and bounded time while we roll out vaccine 2. We need to get numbers down so that vaccine rollout isn't impinged
Secondly, this vaccine already prevents hospitalisation and severe illness! That's already a game-changer in and of itself. If you vaccinate the 20m or so who are the most vulnerable to COVID-19 and the most likely to require hospitalisation, then you immediately solve the hospitals-may-be-overflowing problem out of the pandemic (which is the only reason we go into lockdown in the first place). This will allow life to return to normal!
I did not look for better sources, but I read in this [1] CNN post that in 2021: AZ is producing 3 billion doses, Pfizer 1.3B and Moderna less than 1B.
So in total we are going to have 5 billion doses in 2021. Each person requires two doses. So we end up vaccinating around one third of the world's population. It seems to me even at the end of 2021 our lives will be still far from "normal".
Are there other promising vaccines on the way?
[1] https://us.cnn.com/2020/12/30/investing/premarket-stocks-tra...
Also many countries have the capacity to produce a similar vaccine. For example here is a feel good story from RT about Venezuela buying Russia's similar Sputnik vaccine:
https://www.rt.com/news/511063-sputnik-vaccine-venezuela-dea...
10 m. doses to be delivered within 3 months. How long time would it have taken Venezuela to procure a similar amount of mRNA vaccines from Pzifer or Moderna?
While they have been tested in trials for long, all of the adenovirus-based vaccines are new. There is only 1 commercially approved adenovirus vaccine, for rabies in wild animals.
Whilst Oxford had the (generic) basis of the vaccine ready to go, prior to the COVID outbreak, it was the removal of all bureaucracy in this, and other, vaccine trials, that has allowed them to go from r&d to approved in 10 months or so.
Which is apparently what researchers will tell you is the 'real' time it takes to develop a vaccine. No time writing proposals and rewriting them when they get rejected, no awaiting someone to approve the proposal, no applications and waiting for grant money, no time spent waiting for volunteers for clinical trial groups, and so on.
Regarding the dosage, more information here: https://www.bbc.co.uk/news/health-55308216
(edit) and the time to develop here: https://www.bbc.co.uk/news/health-55041371
From https://nymag.com/intelligencer/2020/12/moderna-covid-19-vac...:
> "Moderna’s mRNA-1273, which reported a 94.5 percent efficacy rate on November 16, had been designed by January 13. This was just two days after the genetic sequence had been made public"
I don't want to be that person who thinks a really complicated thing should be trivial, so: Can anyone suggest why it would take weeks to approve these vaccines? What might the regulator actually be doing in this time?
They're clearly going to know that the request is urgent, and know when it's going to be arriving in their inbox; they could ask for anything apart from final data ahead of time to check everything is as they want it. I don't see why they can't have made sure they were happy with everything else ahead of receiving the final data.
If you compare the data between Pfizer[1] and AstraZeneca[2]. The AZ trials were significantly more complicated, with variations in methodology between phases and locale and much smaller sample sizes. It looks like they had to massage data and combine phases and explain differences, why they were doing it, and why it should still be considered safe.
Pfizer just submitted a giant sample size homogeneous trial result.
I would imagine it's way easier explaining and approving the one methodology/result with a giant sample size from Pfizer than the four methodologies/trials with small sample sizes and different doses within those trials given by mistake from AZ.
[1] https://www.nejm.org/doi/10.1056/NEJMoa2034577 [2] https://www.thelancet.com/journals/lancet/article/PIIS0140-6...
Means they didn't get the vaccine at all.
It has been developed at a pace that would have been unthinkable before the pandemic.
The new vaccine approval comes after Public Health England said the country was facing "unprecedented" levels of infectionshttps://blogs.sciencemag.org/pipeline/archives/2020/12/30/va...
Not only have AZ lied about their test plans (claiming that the two differing dose was deliberate in the first press releases), lied about who was at fault with dosing errors (they insisted that the Italians where at fault), "pooled" results with different populations to try and make a argument they were not testing for (which critically didn't include people over 55) - they just managed to get the UK to approve a dosing strategy that they never even tested.
It's a pandemic - and the UK has invested a lot in both loves and national prestige in this vaccine. But the shortcuts here may come back to haunt. Or it may be what stops this disease in it's tracks.
it's a hell of a gamble either way..
If we want the best possible vaccine, wait 6 months. If we want a safe vaccine that can end the pandemic as quickly as possible, this is the vaccine for the job.
"However, unpublished data suggests that leaving a longer gap between the first and second doses increases the overall effectiveness of the jab."
That may well help too. But at the end of the day, the world needs a lot of vaccine. It's better to have Pfizer/Moderna and the Oxford vaccine at our disposal, particularly when the latter is also much cheaper and easier to store (this will be crucial in developing countries and/or rural populations). What matters is having fewer people get sick or die, not ensuring everyone is given the vaccine with the greatest efficacy.
* Cost of vaccine
* Ease of manufacturing
* Ease of distribution
* Prevention of severe cases and hospitalisations
It seems all vaccines currently approved so far prevent hospitalisations completely. It won’t stop the epidemic completely depending on coverage but it’s enough to stop killing people.
But when I see '<70%' effectiveness compared to 95% effectiveness with the Pfizer-BioNTech and Moderna vaccines, the Oxford-AstraZeneca vaccine looks very disappointing and far from the top standard I have expected.
That is not good enough.
Hell, it's even more complex than that, because even given a type of vaccine, even subtle stuff such as dose size and time between the two doses seem to play a huge role, and this is again something that needs to be tweaked over time, using long phase 3 trials. I would attribute it much more to luck than actual skills here.
The sample size of Astrazeneca is much bigger as well.
With Moderna one, some people are loosing antibodies with in weeks.
That's... how vaccines work? Your anti-bodies don't stick around forever, and they're not supposed to. The purpose of the vaccine is to prime your memory B/T cells so that when the actual virus is introduced to your body the antibodies are produced much more rapidly, enough to kill the virus before it can take hold.
That’s the 60% effective version.
This is disappointing, hopefully they are working on getting approval for the 90% effective regime.
They could vaccinate far more people that way.
> The MHRA’s decision was based on ... _interim_ analysis of the Phase III programme
> Additional safety and efficacy data for the vaccine will continue to accumulate from _ongoing_ clinical trials.
https://www.astrazeneca.com/media-centre/press-releases/2020...
So the summary metric is the Vaccine Efficacy, calculated as 1-relative risk, where relative risk is the incidence of infection in the vaccine group relative to the incidence of infection in the control group.
So with N = 75 the targeted number of post-dose infections, and V = # vaccinated out of the N, P = # placebo out of the N, are they saying that 100*(1-V/N) is the efficacy ? Then if it's 50%, it actually means you have no benefit over the placebo.
The government has had almost a year to plan for the rollout. Obviously there are some different logisitics for storing the various vaccines, however the last mile infra is exactly the same.
There is a plan to train 30k st johns ambulance volunteers, however if they want a smooth rollout, they should have been trained already. This hasn't happened yet.
Getting the jabs in the people is only part of the problem, the jab needs to be prescribed, but doctor time is rare (as they are all being hoovered up to provide 45% extra intensive care beds)
Not only that, after the jab, you need to watch the patient for anaphylactic shock. This requires nurses, again very much lacking in numbers.
Normal vaccinations you just go through some questions on risk factors before the nurse gives you the shot, usually on egg allergy, any past reactions and the like. No reason this would be any different.
> Normal vaccinations you just go through some questions on risk factors before the nurse gives you the shot
there are nurse prescribers, that have the power to prescribe a limited number of things. That aside, the prescription doesn't need to be done with the patient present. it can be pre-filled with the nurse/other arranging the dispensing.
this doesn't mean that the rules can't be changed. I suspect that in time there will be special dispensation given to allow non medical staff to prescribe, dispense and administer jabs. However until the first million or so have been done, they'll want to keep an eye on things and monitor the number of "yellow card" incidents that occur.
https://www.reuters.com/article/us-health-coronavirus-astraz...
So, there is no reason to force down our throats the dubious vaccine from Pfiser which requires -70 C storage facilities. Not to mention of course the its creator has not been vaccinated yet. He said he did not want to take someelse's place.. What a horseshit.
What's this got to do with Brexit?
For the past few months, the government has been using every opportunity to justify Brexit. The vaccine approval process being one of those.
> The reporting around it has always sounded a bit nationalistic.
The press have certainly reported that it's British developed, and why not? I'd say they equally reported that the Moderna vaccine was developed by Turkish Germans/German Turks.
Matt Hancock, secretary of state for department of health and social care: "It is absolutely clear that because we’ve left the EU I was able to change the law so that the UK alone could make this authorisation decision. So because we’ve left the EU, we’ve been able to move faster."
See also Jacob monumental fucking bellend Rees-Mogg and Nadine Dorries who made similar claims.
If Rees-Mogg, Dorries, and Hancock are wrong, then demonstrate it.
The full summary is below. But the short answer is the regulators who did the work are saying it makes no difference
Well, with the obvious exception that happened this year (Brexit).