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Coronavirus II, the Vitamin D-free discussion thread.


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Since the original "Coronavirus" thread has become the place for VitD advocacy, to the exclusion of all other aspects of the pandemic, I thought we needed another one.     If you think differently, then away and boil your head - a sovereign cure for the illness, as Mr.Trump will probably tell you.

If I may, I will start us off by relaying the thoughts of New Scientist, which you can read for yourself at https://www.newscientist.com/article/2259306-pfizer-covid-19-vaccine-is-it-the-breakthrough-weve-been-hoping-for/ but only if you're a subscriber.

First, the Pfizer study of its vaccine is very limited.   It does not tell us if it modifies the progress of an infection, or prevents severe illness.  Much bigger trials would be needed to detect effect in the few who get really ill.  Nor does it tell about infection in anyone other than fit young adults;  the immune response diminishes with age, which is why Covid is more lethal in the aged, but also may make a vaccine less effective.   This means that the intended roll-out of the first doses to the aged might be wasted, and overall the effectivity is less than the 90% claimed..

The trial continues, and will do so until there have been another 70 cases of Covid infection in trial subjects (recall that nearly 44,000 people have had either the Pfizer vaccine or placebo), a total of 164 infections.    If the rate at which these occur continues, that will be about Christmas time, whereupon the code will be broken for those cases and if the results  confirm the interim one then Pfizer will apply for the vaccine to be licenced for use.   Unless they apply for and are given an "Emergency use" licence then that would normally take two or more years, and Pfizer do not , yet, have enough safety data to make an emergency application possible.

We must recall that the Pfizer vaccine needs two doses, so the 40 million that the UK has ordered is enough for 20 milluion people, on an island where more than  60 million live.  And Pfizer say that they hope to make 50 million doses during 2020, which will be subject to competition and contracts from everywhere else on Earth  We will not get 40 million in the short term.    Nor does the study tell anything about people who may have already been infected, in terms of safety or effectiveness, or, when the other vaccines come online, if their use together is advantageous or detrimental.     Most of all, and because the side effects of vaccines although real are very rare, it will be impossible o exclude or even quantify them in a reasonably sized study.  That must await 'Phase4' the actual implementation of vaccination to the general public, which must be with diligent monitoring, so that side effects are noted and registered.

NS opines on the Pfizer vaccine by quoting Prof Suzanne Hodgeson of Oxford U's Jenner Institute, who is involved in the Oxford vaccine work, that "Even a partially effectve vaccine could have a really significant impact of the course of the pandemic".     And notes that another 46 vaccines are in clinical trial, seven of themn in Phase 3

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Nice summation John. Plenty for all to think about especially the licensing authorities.....who would want their job in the next few months? The combination of  political and public pressure will be immense, I just hope they can remain totally objective.

Iain

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13 hours ago, Tony_C said:

Yes Dr Razorback, plenty of room for all / both....... Therefore,  I’m in....... (caveat; so long as Mr - ex pres - Trump is not!)

Thank you, Tony, but a "Razorback" is a dog!

Senior gorillas are Silverbacks, rather like their human cousins!

Yes, mike39, that is what is meant by the Phase 4 trial, release and use with monitoring.  Rare side effects cannot be registered until many more people get vaccinated,by giving it to populations.   That is routine, with drugs as well as vaccines, and is where the 'ten year' time scale comes from.

Yes, the Pfizer vaccine is a new type, using mRNA.   But only minor side effects have been seen.

Edited by john.r.davies
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Some news that has been taken up by most of the UK media yet: https://investor.lilly.com/news-releases/news-release-details/lillys-neutralizing-antibody-bamlanivimab-ly-cov555-receives-fda

According to one source, although early days yet, trials of this therapeutic drug have demonstrated the potential to dramatically reduce the need for hospitalisation. The drug was developed and early batches produced at the Eli Lilly plant in Ireland then shipped to the parent company in the US.

Mick

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1 hour ago, john.r.davies said:

Thank you, Tony, but a "Razorback" is a dog!

Senior gorillas are Silverbacks, rather like their human cousins!

Yes, mike39, that is what is meant by the Phase 4 trial, release and use with monitoring.  Rare side effects cannot be registered until many more people get vaccinated,by giving it to populations.   That is routine, with drugs as well as vaccines, and is where the 'ten year' time scale comes from.

Yes, the Pfizer vaccine is a new type, using mRNA.   But only minor side effects have been seen.

Apologies JOhn.... I’m mortified... it’s my dyslexia (need predictive text just to spell it!)....... Here’s hoping Senior, senior Silverbacks are rather NOT like some of their human cousins in harbouring grudges?

 

Moving swiftly on..... now we’ve got the benefit of all the expertise on here..... What’s this new marketing strategy all about?

 

48529443-E0A0-4C6E-B50B-B455C78C84FC.thumb.jpeg.172a6c4e017af54cac38dc4d0e5dbf65.jpeg

 

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The briefing by Prof Jonathan Van-Tam, Deputy Chief Medical Officer,  Dr June Raine, Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA) and  Professor Wei Shen Lim, Chair of the Joint Committee on Vaccination and Immunisation, was one of the better ones that has come from the Government and addresses some of the questions raised above.

Regarding the speed of developing vaccines, there is a commercial driver here which will have contributed. Instead of investing resources across a broad pipeline of potential pharmaceutical products, Pfizer et al will have shifted resources away from other product development to focus greater resources on vaccine development. Some might say that this also creates an environment in which corners might be cut. That is why we have independent regulators and others that must be satisfied before the product is approved. Again, some may be convinced that a government can influence the wide range of people and groups required to authorise a product. I am not one of those people. Ultimately, it is in no-ones interests to allow the marketing of a duff or dangerous product.

Regarding the speed of approval, the MHRA also has experience of adjusting its resources in order to respond promptly, but just as robustly, to time-sensitive demands. As explained in the briefing, development, trial phases and regulatory oversight has been approached on an overlapping tater than a serial approach.

A 90% effectiveness rate, even for a specific cohort of the population, is quite impressive. The annual flu vaccine is about 50% effective. Pfizer's product looks promising; others will not. As John correctly notes ultimately, Pfizer will not be the only vaccine available. There is likely to be a range of vaccines developed and approved over a period of time. In this way hopefully, there will be a product that is suitable for different cohorts of the population. This virus is not going away. We will need to live with it as we do 'flu. The Pfizer vaccine if approved will not be the universal solution. But it may be the start of regime in which we manage the virus and return to a normal life.

 

Miles

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Slightly off the main thrust, but our son, a GP, was talking to us this morning (at a distance!) of the logistical problem posed by the forthcoming programme.

The numbers cannot be handled at the surgery, so it seems likely that surgeries in an area need to group together to hire premises and staff. 

The premises need to be quite large, have car parking and public transport nearby for those without cars.  And so on - I don't need to spell out all of it.

A decision by the practice, whether (or not) to be involved, is required by Tuesday 17th November - not much time to tackle such an exercise on top of handling the existing work.

Ian Cornish

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Ianc,

Earlier this year, the Lancaster Medical Practice, which is a group including several surgeries, oganised a flu immunisiatioon programme.     This included drive-in jabs in our local University car parks.     The U was then empty, so they were empty too, but local students were employed as marshals to direct the punters.     The whole project was so well organised that while military input was denied, I am sure that senior practice members' Territorial Army experience influenced it.      I sat in my car in a queue for no more than five minutes, was waved into one of many bays on the car park, each separated by a 'gazebo' shelter, and was checked in, injected and driving away in seconds.       It could not have been more efficient and effective.     The  Practice also arranged 'walk-in' centres in town for the carless, and I have only heard of similar efficiency.

I know nothing of the funding or logistics of this project, but no doubt they will be able to perform as well for Covid vaccination.      Perhaps, if my intuition is correct, Dr.Cornish Jr. should consult the local Territorial barracks!

MilesA,

Another factor that will have speeded Covid vaccine development will have been guaranteed government finance.      To have contracts in place for delivery before a vaccine is produced is unheard of!

But I wonder at your confidence that governments cannot influence medicine licencing bodies.  Yesterday Trump told America that the vaccine would be available "in a few weeks", and whatever happens on January 20th, he is still POTUS until then!

John

Edited by john.r.davies
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The Pfizer vaccine must be stored at -70 degrees C until just before it is administered. The new scarce resource and logistics issue will be the refrigeration equipment.

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5 hours ago, Mick Forey said:

Some news that has been taken up by most of the UK media yet: https://investor.lilly.com/news-releases/news-release-details/lillys-neutralizing-antibody-bamlanivimab-ly-cov555-receives-fda

According to one source, although early days yet, trials of this therapeutic drug have demonstrated the potential to dramatically reduce the need for hospitalisation. The drug was developed and early batches produced at the Eli Lilly plant in Ireland then shipped to the parent company in the US.

Mick

Yes, for those close to the realities of the many lines of research and development related to CV19 this EUA is very positive - in my view the reason Bamlanivimab hasn’t triggered the kind of publicity that media outlets drool over is because it is (currently) a niche therapy for particular patient-groups who have caught CV19, subsequently with elevated risk of becoming seriously unwell, it does not stop a person from catching it in the first place.

..... Andy 

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3 hours ago, foster461 said:

The Pfizer vaccine must be stored at -70 degrees C until just before it is administered. The new scarce resource and logistics issue will be the refrigeration equipment.

I believe the vaccine remains viable for a few hours at normal fridge temperatures.

Pete

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7 hours ago, john.r.davies said:

Thank you, Tony, but a "Razorback" is a dog!

Thats the wild boar. 
 

the dog is the ridgeback. 
 

At my “new” job I get to see the daily figures and individuals for a council area together with the hospital admissions and deaths.

I get to talk to many positive cases daily and concentrate on the business and higher education premises. 
 

laterly we can send officers round to addresses to ensure isolation compliance. 
 

it’s very busy at the moment. 
it’s a real thing, look after yourselves and only do things that are essential otherwise stay in.

please !

Edited by Hamish
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6 minutes ago, john.r.davies said:

Indeed, indeed, Hamish and TorontoTim!  My 'Doh!' !

John

No worries

neither should be confused with the intimidating Silverback :o

;)

Edited by Hamish
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4 hours ago, stillp said:

I believe the vaccine remains viable for a few hours at normal fridge temperatures.

Pete

I read that's up to five days in fact (Pfizer spokesman, reported by Reuters).

Nigel

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If it has to be stored at -70C then it needs to stored at -70C,

After an hour at room temp it will be at room temp.    It will need to be thereabouts to be injected!   But not left on the shelf for any longer than absolutely necessary.

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Long-term storage -70 to -80 degrees. When stored at the more common  -2 to -8 refrigeration it will spoil after 5 days.

Therefore - for some positive perspective - it remains viable to use for up to 5 days once moved to regular refrigerated storage - based on info at the current point in time.

....... Andy 

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:) fortunately it does not come out of long-term storage (-70) and straight into the recipient 

Edited by AndyR100
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4 hours ago, Hamish said:

Thats the wild boar. 
 

the dog is the ridgeback. 
 

At my “new” job I get to see the daily figures and individuals for a council area together with the hospital admissions and deaths.

I get to talk to many positive cases daily and concentrate on the business and higher education premises. 
 

laterly we can send officers round to addresses to ensure isolation compliance. 
 

it’s very busy at the moment. 
it’s a real thing, look after yourselves and only do things that are essential otherwise stay in.

please !

So nearly correct Hamish, I believe you've been mislead by the 1984 film of it's name Razorback which is a large boar

Razorback (1984).html

Whereas the Cambodian Razorback is a genuine 100% original dog,so John is correct with his reference to a Razorback. ,  

https://www.dogbreedinfo.com/c/cambodianrazorbackdog.htm#:~:text=The Cambodian Razorback is a,it is active and agile.&text=Coat%3A They have a long,as they do not overheat.

The Rhodesian Ridgeback is a different breed, the Dutch settlers crossed Mastiffs and a variety of other large European dogs with a half-wild native dog kept by the Khoikhoi, a pastoral people. This dog had a distinctive ridge of hair along its back, and breeders noticed that crosses who had this ridge tended to be excellent hunters.

Mick Richards

 

 

 

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