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The impact of Covid in Africa has been, so far, remarkably low.     South Africa has the highest incidence, with over 120 cases per 100,000 people (Over 250/100K in UK).   The next country, Morocco, has less than half that number.     This is completely the opposite among BAME people in Europe, which may be seen as further evidence that the natives of Europe evolved an unpigmented skin to enable the asorbtion of more UV light to synthesise VitD.   But look at Latin America and the Caribbean! Their first wave was worse than Europe's, not helped by the Trumpist attitude of President Bolsonaro, in the most populous country of that continent, less than half of whose people classify themselves as "branco", white.

There are other, perfectly valid, reasons to account for Africa's light impact.      It may be due to it's undeveloped health systems and almost entire lack of testing, so that infections are undocumented, to its young population, that has an average age half that of Europe, or that this is another example of the "hygeine hypothesis" whereby excessive attention to cleanliness prevents normal development of the immune system in the First World.

John

 

 

 

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Edited by john.r.davies
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2 hours ago, Motorsport Mickey said:

Peter,

Being as they are members of the BAME community how do the Somalians in Somalia manage to acquire enough D3 when their skin colour is stripping the D3 out ? or is it a case of they have that much sun it just batters it's way through ?

I think Sweden has a largish Somali or other African community and they have suffered in a mirror image to your suggestion.  

Mick Richards

Hi Mick,

the nearer you are to the equator the more direct  the Sun's UV emissions get through the atmosphere 

As you move north/South the angle that the UV hits the atmosphere becomes shallower and shallower

So in our winter time we may get only a fraction of what we receive in June.

At any time Cornwall would get more than John o Groats.

So if you have dark skin you need to be where more nature put you - near the equator.

However D3 supplements will help out alll through the year if you need it.

So Why isn't the Gov't recommending it to our Norther friends with Dark skin.

Professor Pete's video clips over the last 6 months have pointed this out time and again.

 

Roger

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1 hour ago, john.r.davies said:

 

image.thumb.png.d3b97a0d419c6510c011a2ba2342f62b.png

That graph is from 1 Sep. Here is the 2 Nov update. The dramatic upswing in cases in Europe since Sep is stark. It must truly be said that no-one can reliably predict how this virus is behaving in different geographies/populations, or say why with anything other than speculation. Just too many moving parts.

image.thumb.png.820a7c762429a570ea88d58f25948d8b.png

 

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1 hour ago, RogerH said:

Hi Mick,

the nearer you are to the equator the more direct  the Sun's UV emissions get through the atmosphere 

As you move north/South the angle that the UV hits the atmosphere becomes shallower and shallower

So in our winter time we may get only a fraction of what we receive in June.

At any time Cornwall would get more than John o Groats.

So if you have dark skin you need to be where more nature put you - near the equator.

However D3 supplements will help out alll through the year if you need it.

So Why isn't the Gov't recommending it to our Norther friends with Dark skin.

Professor Pete's video clips over the last 6 months have pointed this out time and again.

 

Roger

Hi Roger,

It’s worse than you think, I have the Dminder App on my phone and it allows you to set alarms for time spent sunning and gives you advice linked to your latitude. It self adapts for the phones latitude and as you say apart from June July our northern situation reduces available sun markedly. So much so it now advis’s me that D isn’t available here for another 122 days ! 
pass the supplements.

Mick Richards

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8 hours ago, john.r.davies said:

 

There are other, perfectly valid, reasons to account for Africa's light impact.      It may be due to it's undeveloped health systems and almost entire lack of testing, so that infections are undocumented, to its young population, that has an average age half that of Europe, or that this is another example of the "hygeine hypothesis" whereby excessive attention to cleanliness prevents normal development of the immune system in the First World.

 

Al the above is true but there are many more reasons:

- Low population density 

- Underdevelopped communication infrastructure hence poor mobility

- Gregarious community-based life style - outsiders are rejected in times of crisis 

- Average temperature above the optimal temperature for virus spread

- ...No shoes at home.

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Thank you Bleednipple, for bringing the argument up to date and to Geko for other arguments to explain why Africa has been spared, when BAME people in Europe have not.

Of course "BAME" includes 'Asian' and India has not been so lightly hit.

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21 hours ago, Bleednipple said:

Very dark skin is apparently not of itself a barrier to high Vit D uptake by people living in equatorial zones, given that Vit D studies frequently reference reports that Hadza and Maasai people living traditional lifestyles in Kenya tend to exhibit high serum levels. The emphasis here though is the lifestyle bit.

(Kenya of course is on the same latitude as southern Somalia. And I can tell you from personal experience that the sun intensity in NE Kenya is, well... intense.)

I saw another study in the Kenyan population that showed a substantial minority (15%+) as being D-deficient at <20 ng/ml. The presumption being that these studies included a high proportion of people living 'modern' lifestyles and livelihoods with much less opportunity for substantial daily sun exposure. They also suggested that higher body fat among the 'modern lifestyle' study subjects, especially the females, seriously affected their D take-up.

Nigel

Yes modern lifestyle and dress codes influence response to sunlight. The Maasai iiving a natural herdsman lifestyle have 25(OH)D 125 nmol/L compared to the urban dwelling Ubuntu  at 70 nmol/L. UVB is absirbed by glass.!

Peter

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18 hours ago, Motorsport Mickey said:

Hi Roger,

It’s worse than you think, I have the Dminder App on my phone and it allows you to set alarms for time spent sunning and gives you advice linked to your latitude. It self adapts for the phones latitude and as you say apart from June July our northern situation reduces available sun markedly. So much so it now advis’s me that D isn’t available here for another 122 days ! 
pass the supplements.

Mick Richards

Mick, interesting to hear the app works, as I dont have a smartphone. Does it allow the rise in 25(OH)D  to be estimated according to time of day and area of skin exposed ? Peter

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7 hours ago, Peter Cobbold said:

Mick, interesting to hear the app works, as I dont have a smartphone. Does it allow the rise in 25(OH)D  to be estimated according to time of day and area of skin exposed ? Peter

I've not fully configured the app for myself yet Peter, just banged in some typical variables and iu units taken etc to give feedback especially with regard to latitude and hours of D sun available.  Their laptop version here I think.

http://dminder.ontometrics.com/

Mick Richards

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This week's BMJ contains an interview by Fiona Godlee with our CMO, Chris Whitty.   I don't think non-members could read it on the BMJ website, but it is " is made freely available for use in accordance with BMJ's website terms and conditions", so I copy it here.     The horse's mouth is ever fresher than rumour and gossip.

 

The BMJ interview: Chris Whitty, England’s chief medical officer, on covid-19

Never has the role of chief medical officer (CMO) been under such scrutiny. In a rare interview, England’s CMO speaks to The BMJ’s editor in chief, Fiona Godlee, about the pandemic and what it’s like to be a physician in Whitehall

This interview was conducted on 28 October and has been edited for length and clarity

How are you, Chris?

I’m fine. To be honest, I’m much more concerned about everybody who’s working on the front line because that’s the really hard work. And as we look forward to what’s going to be an extremely difficult winter for the NHS—one that I suspect, unfortunately, will be unlike any we’ve seen in recent memory—I’m really concerned about the welfare and the morale of all the medical professionals who are working on this, because this is going to be a long and difficult slog.

I think all of us have huge admiration for what people did in the first wave. It was really extraordinary. And we’re going to have to do that again.

What do you think is likely to happen over the next two months as we head into winter?

This is a new virus. It may behave in ways we’re not expecting. From an epidemiological point of view, there’s minimal evidence of significant immunity at this stage. So, unfortunately, a lot of people could become infected.

I think we have to assume that this virus will benefit from the winter season, just as most other respiratory viruses like flu and adenovirus that we come across every winter in the NHS do. So, my expectation is that, even if we do exactly the same things as we did two or three months ago, rates of infection will be higher.

Even in a typical flu season about 7000 people a year in the UK die of seasonal flu. And in a bad flu year, which often goes quite unremarked, it can be north of 20 000 people dying. SARS-CoV-2 is significantly more lethal than flu, in every age group apart from maybe children. It’s extremely transmissible, as we’ve seen with these explosive outbreaks around the world. So, I think we have to assume that there will be significant outbreaks and, as a result, significant numbers of people in hospital, some of whom, sadly, will die. I don’t think I’m saying anything that will come as a surprise to anybody in the NHS.

In every winter season some hospitals come under very substantial pressure, and some even have to call for mutual support. And that’s even without covid. So, I anticipate significant pressures this year.

There are four ways this virus is going to kill people and cause long term morbidity, as well as mortality. First, there’s the direct effects of covid. And as we know, there are significant morbidity effects as well as mortality effects.

Second is where we have an over-running of the emergency services such that all emergency care stops. We fortunately avoided that in the first wave, but it’s not a given if we don’t take strong action.

Third, some people need urgent but not emergency care—elective care—which will be delayed further because the health service is under considerable strain.

And fourth, we all know that deprivation leads to serious long term ill health effects, life long in some cases, and generational impacts. The things we have to do to keep the virus under control have significant social and economic impacts.

We’re faced by all of these. Making things better for one of them can have a negative impact on the others. For example, freeing up bed space to ensure that we have emergency care puts greater pressure on the elective care system. Bringing in more societal measures will have a bigger impact on the economic effect while it brings down the covid numbers.

We’re in this very difficult tension where in every direction we go there are harms, and we’re trying to find the least harmful combination of things we can do. But this is going to be tricky to manage, and the health effects are going to spill well beyond those who get covid directly, although obviously there will be significant numbers of those.

There have been calls for more transparency about how the government balances the things you’ve mentioned with the advice from its advisers and committees such as SAGE [the Scientific Advisory Group for Emergencies]. Would more transparency help health professionals to feel confident in the strategy? And if so, how could that be achieved?

I’m very much in favour of transparency in all areas. I was really pleased that, for example, the SAGE minutes were published—I think that’s exactly as it should be. I can see no disadvantage to openness.

It’s important that people making very, very difficult political decisions have the time and space to be able to do that before this constant commentary on it. But I do think that transparency, wherever possible, is a good thing. And certainly on the science side, we’ve tried to be very open about what our advice is and how it’s given.

In mid-September SAGE advised the government to impose a two week circuit breaker rather than localised targeted restrictions. As I understand it, the circuit breaker would probably not in itself reduce the number of cases. What would be the point?

The concept of a circuit breaker is that you buy time; you wind back the clock from wherever you are by a few weeks, and that helps to slow down the rate of rise. But you still have to do things after you come out of it. It’s not something where you do it and then that’s a substitute for all the other things you have to do. Rather, it’s a way of trying to slow stuff down. But it comes obviously at a very significant impact in terms of the other societal things that we were talking about before. So, it’s not a panacea.

What SAGE was saying is that this is one of the tools that need to be considered. I think it was slightly overwritten [in the media] as saying that you’ve got to do this or nothing else will work. We need to do quite a lot of things, and this is one of the tools to think about.

How do you respond when it doesn’t seem that the government is going to follow what you consider to be important advice?

The thing to understand is that I’m only presenting the health advice. I passionately believe in the health side of things, and I strongly believe that good science leads to good political decisions. But the economic side [and] the societal issues are also important. The political leaders who have to represent the public have to balance all these different elements together.

Whenever I look at a problem, I generally decide whether it’s primarily technical, political, or a bit of both. If it’s primarily technical I’ll say, look, in my view, there’s only one technically correct solution. So: which kind of drugs should we be using to treat covid? That’s a technical decision. Politics should play no part in that. Equally, prioritisation or balance between different elements of the response—for example, health against education against wider societal aims—those are political questions.

There’s an extremely heated international debate on how countries should manage the pandemic. Where do you sit on the spectrum between suppression of the virus at one end and population immunity at the other?

Let’s start with “herd immunity,” as it’s sometimes called in the press, which was perhaps most represented by the Great Barrington Declaration.1 My view is that it’s wrong scientifically, practically, and probably ethically as well. [It’s] really a pretty minority view, but it’s been seen as a much wider view. It’s a perfectly respectable one—but the reason it’s wrong scientifically is that it starts from the assumption that you will get herd immunity and that this is how you control epidemics.

For the great majority of the infections I’ve dealt with—and I’m an infectious disease epidemiologist—you never get herd immunity. You don’t get it for malaria, you don’t get it for HIV, you don’t get it for Ebola. Secondly, it makes an assumption that immunity will be maintained, at least for some period of time. And this is not clear yet with covid. We certainly know, for example, that antibodies wane quite fast. So, I think scientifically it’s on very weak foundations.

Then there’s the practical question. Let’s say that it was possible to achieve immunity. It works on the assumption that you can identify all of the people who come to harm and completely exclude them for the remainder of the time that this virus is in circulation, or least in high circulation. Anyone who’s thought about this with this particular virus, which is incredibly easy to transmit, realises that this is extremely impractical as a solution. SAGE have looked at this twice and came to the same conclusion both times.

The third reason I personally have problems with it is that, ethically, it would lead to a significant number of people dying who otherwise would not have died of this virus. And it almost certainly would lead to much higher pressure on the NHS and therefore some of the indirect damage.

As for the other end of the spectrum—which is, why can’t we just eradicate this virus?—that’s also impractical for a variety of reasons. There are reasons why we have, to date, only managed to eradicate one human disease—smallpox—with two or three others that have been just on the edge for a long time. It’s very, very difficult to do.

What we’ve got to do is get this virus down as low as is practical at any point in time, using the tools we’ve got, and expect that we will get medical countermeasures. It might come in the form of vaccines. It might come in the form of drugs, as happened with HIV, for example: we don’t have an HIV vaccine, but we’ve got very good control in the UK on that. There are other possible technical solutions. So, we shouldn’t see that we’ll be in the current state for an indefinite period. I have an absolute belief in the ability of science to get us out of this hole. But it is going to take a while before we get to that point.

What’s your sense of the likelihood of a vaccine in the next year?

There’s the biggest effort to get vaccines that’s ever been seen. I think there’s a reasonably good chance that we will get a vaccine in the next year. But nobody should assume that, and nobody should put a date on it. You never know which one is definitely going to cross the finishing line first. Obviously, we would all hope that the first two or three vaccines that are leading will work, and if every single one of the vaccines worked that would be an outstanding result. But let’s see.

Recent data published by the Financial Times show that countries that have done worse in terms of covid deaths have also done worse economically, with the UK scoring badly on both counts. This suggests that it’s a false dichotomy to talk about health versus wealth and that we have to control the virus to restore our economy. Is that how you see things?

That is absolutely how I see things.

What can you say to local public health professionals who feel left out of the approach in terms of Track and Trace and other public health measures, who believe that it would be better with their involvement?

When I go to places like Harlow or Blackpool or so on, you see remarkable public health leaders doing the day job, [working on] all the other areas of public health on top of all the covid activity. Particularly in this second wave, which is much less of a national picture and where we have a lot more tools at our disposal, I have a lot of sympathy with the view that there should be local leadership and local ownership of many of the decisions. We’re very fortunate to have such good directors of public health—there’s a long tradition of that in the UK. And I think that trusting them to make good local judgments is very sensible.

The first wave was a slightly different situation because, firstly, the whole of the UK went through the wave almost the same way: it was very similar across the country, and we were starting out from an incredibly standing start with very few tools. But as we go through this second wave we have a much more varied picture, which is actually much more typical of what other countries, in Europe for example, had in the first wave.

I think that this makes the argument for local leadership and local decisions where possible. You can’t do it across the board, because the health system will be criticised for having a very confusing picture if we do things too differently and for being too monoculture if we do things all the same. There’s a balance between having some degree of a national approach and some degree of local. And I think that inevitably in the second wave the ratio is slightly different and should be slightly different.

The UK government seems to have preferred a more centralised approach, with commercial companies delivering many of the measures. Do you envisage a larger role for the public sector and local public health teams in the second wave?

I don’t think I’m saying anything about the public sector versus private sector, which is a debate I consider to be in the political delivery end rather than the public health end. Mine was more to do with local authorities, local directors of public health, and their considerable contribution compared with the national. It’s basically about using both. They don’t have the degree of specialisation; they don’t have the resources that you have centrally—but they do have local knowledge. They have local experience. They understand what’s happening locally.

I had always understood that the CMO was the head of public health in the UK. But people are confused about where oversight or leadership of public health sits, given what’s happened with Public Health England and the new Joint Biosecurity Centre. People see you as the head of public health in the UK. Is that right?

I felt quite strongly when I came into this role, not just for public health, but for the medical profession as a whole, that we ought to have a collective leadership. I am definitely part of that collective leadership. But there are the royal colleges and, in the case of public health, obviously the Faculty of Public Health, and there are all the various NHS organisations in NHS England. There are the devolved nations, which have complete control over health decisions pretty well. And local authorities which have very significant influence, which you were talking about before. It’s neither right nor sensible that anybody says, “I am the person who just leads the whole thing.” I see this as a collective leadership, but the CMO role is and always has been a senior leader within that system.

Particularly going through this crisis at the moment, it’s been really important that the leaders talk very regularly to the presidents of the royal colleges, to the directors of public health, to the leaders of NHS England and PHE [Public Health England]. It’s important that we see ourselves as a collective leadership. I would actually see the editors of the major journals as part of that collective leadership of the profession: it doesn’t mean having to be brought into other people’s decisions, but you help influence how this goes, and I think that’s important. We see ourselves as a profession with a collective leadership, of which I am one, and many people who might be listening to or reading this are also leaders.

As a civil servant you’re accountable to the government, but how do you guard your own credibility, when that’s where your authority comes from among your colleagues and the wider world?

The CMO role is different from most civil service roles, in that I’m statutorily independent while being government. And so I feel that, no, I’m not bound by what the government’s view is. I give my own view straight. I hope people realise that I give my own view and I don’t feel constrained.

Where being a civil servant matters is that there’s an absolute statutory requirement, rightly, for impartiality and to stay out of party politics. So, if I think something is a political issue, I’m not going to engage publicly in it.

No one [in government] has ever said to me, ‘Gosh, you went a bit far there’ or ‘I want you to say this, and if you don’t there’s going to be trouble.’ They’ve always accepted that this role is an independent role, and it ceases to have use if people like me are having to cut our jibs just to suit the situation. It would no longer be helpful to the government. That’s the way it works, that’s the way it has always worked, and the way in my view it always should work.

After the Dominic Cummings incident you were asked at the press conference what your views were. It could seem that Boris Johnson rather quickly stepped in to stop you commenting . . .

I did think it was a party political issue at that point in time. I’ve been very careful across the board never to comment on individual people. At its extreme, I really strongly push back against journalists asking about individual patients, which they did near the beginning.

The UK lacks an independent organisation such as the Robert Koch Institute in Germany, which provides information, data, and analysis to the public. Do you think this is something the UK should aim to establish?

In this kind of pandemic, I don’t think it makes much difference where the advice is situated. I think it’s very important that public health advice is seen to be free of political interference. We can agonise rather a lot about exactly what form that should take. Some of those who were very exercised about the fact that PHE was no longer to be PHE were very exercised about PHE being created in the first place, saying it was disgraceful that it was being created out of otherwise independent organisations.

The general principle should be—as with all medical advice, so this is true for clinicians as well—you should give the advice you give professionally, independently, and without any sense that you’re cutting the advice according to what the person you’re talking to wants to hear. Any doctor who doesn’t abide by that general principle is not doing them, their patients, or the wider public if they’re in public health, any favours at all. So, independence is, in my view, a state of mind and a tradition that should be firmly adhered to. Organisational structures strike me as less important.

At the beginning of the pandemic politicians made it clear that they would follow the science, and they and you and Patrick Vallance, the chief scientific officer, presented a very united front. This seems to be less so recently, such as when you said that the three tier system wouldn’t be enough. Does the loss of unity worry you?

What I said [about the three tiers] was, if an area of the country has got such a high level of transmission already and is rising such that it needs to go into the tier 3 areas, the very base case of tier 3 would probably not be sufficient on its own to allow that area to turn the curve down. But within tier 3 there are multiple options on top of that, which will need to be added to. There will be some degree of local discretion as to what the right ones are. But if you think that you’ve got tier 3 and can just do the base case, that will be insufficient.

What was reported was that I was saying tier 3 was no good. Quite often I give a very precise answer, and people cut out the bit that they want to hear and just narrowly report that. It’s just like if you’re talking to a patient and you’re giving a long talk about all the pros and cons of the treatment and they choose to only hear one bit of it, and that’s what they report back. That’s what it feels like to me sometimes as a medical practitioner in the system.

What I said, I hope, was reasonably clear, and I would invite people to go back and listen to my words, which were carefully chosen and were, in my view, pretty accurate.

People may be surprised to learn that you’re still practising clinically. Tell us why that is and how it feels at this time

I self-identify primarily as a doctor, so to me it matters a lot. It’s also helpful to talk to colleagues all the way through the system—doctors, others, nurses, all of the other professionals. It grounds you in how the system is. So, there’s a win for the wider role.

This is the first job I’ve done where I haven’t actually done weekly clinics and done on-calls on a rota for acute medicine, because I didn’t think I could stay up to date with all the acute medical guidelines. I’ve kind of restricted it to infectious diseases, which is my own specialist area. But I’ve hugely benefited from doing it all the way through the time I’ve been working in government, which is now about a decade.

I’ve been a clinician throughout that time—I have to do it at times when parliament’s not sitting, in holiday times, but I really enjoy it, as well as thinking it’s something I should do. It is a real privilege to be a doctor. And I think that anyone who’s a clinician doesn’t realise quite how lucky they are until they try to do something else.

What do you think we’ve learnt from this pandemic that we’ll need to apply in the next one?

Unfortunately, we always say this at the end of every major epidemic: what this demonstrates is the need to get proper diagnostic capacity, proper public health systems properly rooted locally, because that’s what actually stands you in good stead when you have an emergency. That’s very easy to say during an emergency. Immediately afterwards, everyone will say it. And then the enthusiasm gradually wanes. And then you get to a situation where the next wave hits. This is a lesson you could have rewritten after several previous pandemics.

How will the pandemic end?

I don’t think that the virus is going to disappear. We’ll get medical countermeasures—drugs, vaccines, or other things—and they’ll help us de-risk it significantly. But I think we’ll have covid circulating, and it may become like seasonal flu. It may become like seasonal adenovirus. It might become something which is rather less seasonal. There are a variety of ways it could play out.

But I think that its impact on society, its impact on mortality, and its existential threat to medical practice in the wider sense—the stopping us from doing all the other elements of health—will fade, as we get on top of it with the medical countermeasures.

The medical countermeasures will make this a manageable problem, just as HIV is now a manageable problem. When I was a doctor in southern Africa a third of people my age had it, and it was 100% mortality. Now HIV is still a very serious threat, but it is much, much less a threat than it was. I’m not equating HIV and covid as diseases—they’re very different—but they are two infectious diseases that have had a massive impact on society, where medical science and medical practice will reduce the risk such that the impact on society will be much smaller—without being able to say that it’ll be completely gone. Because I don’t think “completely gone” is a realistic goal for this or most other infections.

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On 11/6/2020 at 3:36 PM, barkerwilliams said:

And another string to Vitamin D

https://www.studyfinds.org/eczema-symptoms-reduced-vitamin-d/

I am surprised by low Vit D in Egyptian sufferers in winter, but I suppose it is the winter clothing.

 

Alan 

They regard <20 ng.ml as deficient. Thats 50 nmol.L. Mean winter UK level is around there .

Its a good dose 1600 IU pd.  However it is surprisng it works  within 3 months as it takes a couple for the  serum level to rise.

Peter

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If not the beginning of the end...maybe the end of the beginning...

D3 to Vulnerable people.docx

 

Mick Richards

Edited by Motorsport Mickey
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Watch this space for a substantial press release, the campaign is at long last on a roll, making waves. Maybe this week, still collecting signatories.  Peter

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10 hours ago, Peter Cobbold said:

Watch this space for a substantial press release, the campaign is at long last on a roll, making waves. Maybe this week, still collecting signatories.  Peter

Well done, at last Peter.;) 

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1 hour ago, kiwican said:

Here's the official Pfizer news release:  https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-vaccine-candidate-against

But you will recall I posted (on the previous page) about the surprisingly small numbers, double figures only, when the studies recruit thousands of subjects, that are 'required' to allow the double blinding code to be broken.    The new release itself says thet they conducted "the first interim analysis at a minimum of 62 cases".     So always bear that in mind.

Also remember that this says nothing about the persistence  of immunity, and that for all other corona-viruses, persistence is poor.

The woods still surround us.

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Hence the Pms strenuous messaging this evening, long way to go

Storage through distribution could also be a tad challenging....-94F !

Edited by iain
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Indeed.     And no Cassandra, me.    New Scientist reports the Pfizer results:

https://www.newscientist.com/article/2259306-pfizer-covid-19-vaccine-is-it-the-breakthrough-weve-been-hoping-for/#ixzz6dK1EY200

As they say, the “end point” of this trial – the criterion against which success or failure is judged – is almost the bare minimum.

John

Read more:

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1 hour ago, john.r.davies said:

Indeed.     And no Cassandra, me.    New Scientist reports the Pfizer results:

https://www.newscientist.com/article/2259306-pfizer-covid-19-vaccine-is-it-the-breakthrough-weve-been-hoping-for/#ixzz6dK1EY200

As they say, the “end point” of this trial – the criterion against which success or failure is judged – is almost the bare minimum.

John

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John,we have to subscribe to be able to read the article in full and your second link is not working for me.

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Sorry, Suzanne, nowt I can do about you reading it, unless I can copy and post it???

The second link, wasn't.  Just my emphasis.

Let's try copy'n'paste

US drug maker Pfizer and its German partner BioNTech have today released some positive-looking results from a clinical trial of their experimental covid-19 vaccine BNT162b2.

The headline figure is “90 per cent effective”. But that may not be quite as good news as it first appears.

What did Pfizer and BioNTech find?

The results are from a phase III clinical trial, the final stage of testing whether a vaccine or drug is both safe and effective. The companies gave the vaccine or a placebo to 43,538 participants in a double-blinded study, meaning that about half were dosed with the real thing and half with the placebo but nobody knows who got what. They then waited until there were 94 confirmed cases of covid-19. As of 8 November, 38,955 participants had received two doses.

An independent committee then “unblinded” the study and found that about 90 per cent of the cases were in the placebo group. The raw numbers haven’t been released, but back-of-the-envelope calculations suggest 85 cases in the placebo group and nine in the vaccine group.

Does this mean we are on the brink of a successful vaccine?

Not yet. It is an interim verdict, not a final one. And the “end point” of this trial – the criterion against which success or failure is judged – is almost the bare minimum. It merely looks at whether people are protected from being infected by the virus, not whether the vaccine prevents severe illness or death.

Of course, people who don’t catch the virus cannot get very ill or die from it. But if 10 per cent of vaccinated people remain vulnerable, that could still add up to a lot of illness and death. The trial isn’t big enough to pick that up. “The studies do not have adequate numbers of patients in them to be able to reliably tell us if they prevent severe disease,” says Susanne Hodgson at the University of Oxford’s Jenner Institute, which researches vaccines, who spoke to New Scientist about covid-19 vaccine trials in general not Pfizer’s in particular. “We will need to give these vaccines to much larger populations in order to collect that kind of data.”

Hodgson has been working on the UK clinical trials of the SARS-CoV-2 candidate vaccine being developed by the University of Oxford and AstraZeneca but has no links to the Pfizer/BioNTech vaccine.

Another thing to bear in mind, says Hodgson, is that vaccine effectiveness in the real world can be lower than found in clinical trials. That may be because vaccines don’t work very well in older people, but are usually tested in younger ones. Pfizer and BioNTech haven’t released specific details of the age profile of their study.

So we still have to wait for the final result?

Yes. The trial will go on until there have been 164 confirmed infections, with another interim assessment after 120 infections. But the chances of the result flipping are vanishingly small. A bit like vote counting in the US presidential election, the case numbers in the placebo group have already reached a level that cannot be surpassed by the vaccine group, and are approaching the threshold needed to “win”, at least according to criteria laid out by the Word Health Organization (WHO) in its official assessment of what would constitute a safe and effective covid-19 vaccine. That threshold is 50 per cent reduction of relative risk, which in this trial would mean no more than 54 cases in the vaccine group from a total of 164 across both groups.

Read more: What is a vaccine and how do they work? Find out in Science with Sam

When might we reach that end point?

Extrapolating from the study so far, quite soon. The trial began on 27 July and racked up 94 cases in around three months. It needs just 70 more to get to the magic number of 164. And with cases soaring in many parts of the world – the trial is global with many volunteers in the US –  that could happen before Christmas.

What happens then?

If the numbers are still good, the companies could decide to apply to a regulator such as the US Food and Drug Administration (FDA) for approval, or what is technically called “licensure”. The FDA has said it won’t cut any corners. It hasn’t put an estimated timescale on the approval process, but says that it will adhere to standard procedure: review the data itself, seek advice from the Vaccines and Related Biological Products Advisory Committee, and open up a period for public comment. It may ask for further data from the companies.

According to the World Economic Forum, vaccine approval usually takes one to two years. But the FDA has also said it will expedite the process without shortcutting it. “The FDA will not authorize or approve any COVID-19 vaccine before it has met the agency’s rigorous expectations for safety and effectiveness,” said FDA commissioner Stephen Hahn in a statement on 29 September.

And then we are home and dry?

No. Even if a regulator says yes, there are hurdles to overcome, not least limited supply. “We expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021,” the companies said in a press release announcing the result. Around 14 billion doses are required to vaccinate everyone, allowing for inevitable wastage and the fact that each person would need two doses.

Vaccines also require careful post-licensure evaluation, often called phase IV trials, because adverse reactions may be too rare to be picked up in clinical trials but serious enough to make the vaccine unsuitable for widespread use, says Hodgson. Some adverse reactions may take months or even years to be detected, she says.

No serious safety concerns have been seen in the present trial, the companies said. But the vaccine is of a type that has never been approved before – it is an RNA vaccine that uses messenger RNA from the virus to elicit an immune response, rather than the usual attenuated virus or viral proteins – so there may yet be surprises. The companies say that trial participants will be monitored for two years after receiving their second dose.

Read more: How do vaccines work?

What about approval for emergency use?

That is a distinct possibility. The FDA has a procedure called emergency use authorisation (EUA), which can grant temporary approval to unproven medicines in an emergency situation. Pfizer and BioNTech say they intend to apply for one for their vaccine but don’t yet have enough safety data. They are gathering that data and could have enough in the third week of November. The FDA has already issued five EUAs for covid-19 therapies. The WHO also has an emergency use process, called emergency use listing criteria, though Pfizer and BioNTech haven’t announced plans to go through it.

Are there any other negatives?

Yes. The vaccine requires two doses, which the WHO regards as less than ideal. Single-shot vaccines are better because you need to make fewer doses and people cannot possibly miss the booster shot.

Another downside is that the results exclude people who have been infected with the virus before. A successful vaccine will inevitably be given to people who have had the disease, so we need to know its effect on them too. Again, the companies say they have data on this and will continue to investigate it as the trial runs on.

There is also the fact that the results were released by press release, not in a scientific paper, so the fine details are hard for scientists to evaluate. Pfizer and BioNTech say they will submit the data to a peer-reviewed journal.

We also don’t know at this stage how long any protection from the vaccine would last.

What is the state of play with other vaccines?

According to the WHO, there are currently 46 other candidate vaccines in clinical trials, seven of them in phase III.

But overall this is good news, right?

Yes. “Even a partially efficacious vaccine could have a really significant impact on the course of the pandemic,” says Hodgson.



Read more: https://www.newscientist.com/article/2259306-pfizer-covid-19-vaccine-is-it-the-breakthrough-weve-been-hoping-for/#ixzz6dKURrDZn

 

YAY!  Online lives!

 

 

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