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Coronavirus II, the Vitamin D-free discussion thread.


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14 hours ago, iain said:

For me I’d rather read the summary of efficacy and safety as on the licences when granted, the SMPC.( Summary of product characteristics. )

Iain
 

Indeed. There seems to be some credible suggestion that the Oxford/AZN press release glosses over some serious shortcomings in the trial protocols and it's even being mused that their vaccine may not get FDA approval for the States (which in turn would presumably cripple it for public acceptance and use in other territories, including maybe the UK.

I hope that's not so, but this Wired article makes disturbing reading:

https://www.wired.com/story/the-astrazeneca-covid-vaccine-data-isnt-up-to-snuff/ 

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Reading that, there is a lot of classic NIH. Not Invented Here. Complaining that it was not "a" trial as it was conducted in two locations: UK and Brazil. In my humble opinion, multiple locations are better than one. The more locations, the wider the scope of ethnicity, environment and application. I want to see all vaccines tested across the planet on a representative sample of the global population.

Mick

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Peter,

They tried to recruit me for the local arm of a vaccine trial, so our age group will be tested.     I failed the inclusion criteria, because I'm on a platelet inhibitor - presumably they feared 'bruising' as a side efect!!

The Pfizer vaccine is said to be effective in over-65s:  https://www.bbc.co.uk/news/health-54986208

The Oxford vaccine investigators showed " that older adults aged 56-69 and over 70 had a similar immune response to younger adults aged 18-55".   https://www.bbc.co.uk/news/health-54993652

You may say that is just from press releases, so look at https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32466-1/fulltext  This study included 200 over-70s and "Neutralising antibody titres after a boost dose were similar across all age groups (median MNA80 at day 42 in the standard-dose groups: 18–55 years, 193 [IQR 113–238], n=39; 56–69 years, 144 [119–347], n=20; and ≥70 years, 161 [73–323], n=47; p=0·40)"

So, looking good, despite the usual dterioration in immune response with age.

John

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5 hours ago, Bleednipple said:

Indeed. There seems to be some credible suggestion that the Oxford/AZN press release glosses over some serious shortcomings in the trial protocols and it's even being mused that their vaccine may not get FDA approval for the States (which in turn would presumably cripple it for public acceptance and use in other territories, including maybe the UK.

I hope that's not so, but this Wired article makes disturbing reading:

https://www.wired.com/story/the-astrazeneca-covid-vaccine-data-isnt-up-to-snuff/ 

IF....big IF the allegations made in that article are true, then we should have grave concerns.   However, I am deeply suspicious of the US regulatory system and also US medical journals alleged independence of Pharma. 

 

 

 

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I hope you are not suggesting that the article contents may have been influenced by Pfizer and Moderna, who might be driven by their desire to make a few $bn from their very expensive vaccines. Shock, horror, whatever next?

Mick

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From the Telegraph:

... AstraZeneca may run further trials to assess the efficacy of its Covid-19 vaccine, the company's chief has said, after experts raised concerns over the validity of its data.

AstraZeneca and Oxford University on Monday reported that a lower initial dose of the vaccine, followed by a full dose, produced a 90 per cent efficacy rate, compared with 62 per cent for two full doses.

However, Moncef Slaoui, the scientific head of the US's Operation Warp Speed - the programme to supply America with vaccines - told US reporters that the half-dose regime, which was discovered by accident, was only given to adults aged 55 and under - throwing the validity of the results into question...

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I am in no hurry to get vaccinated. I feel a little better now that Trump and his enablers will not be part of the process but the whole thing seems rushed to me and the AZ affair did not help. I'll wait and see how things go with the first few million people and maybe think about getting vaccinated in March or April if things are going well.  I can maintain the current face mask, social distance, hygiene thing for a long time.

The Pfizer and Moderna vaccines are both mRNA based, the AZ is a weakened cold virus that has been engineered to present the spike protein to your system. So I'm also curious to see the difference in how people react to the injections and if we will in fact have any choice.

Stan

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If the 1/2 dose group were all <50 yrs old ( as DT reported) and that achieved 90% efficacy becuase of their age ( rather than becuase of dose) then the 62% efficacy in Brazil must have been pulled down from 90% because of the oldies in the test. That means that effciacy in oldies may be mcuh lower than 62%. 

Indeed , we must see the full age-profile of efficacy.

Peter

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Looks like the UK and the USA are taking a similar approach to vaccinations starting with healthcare workers and people in elder care homes. I figure by the time they get to most of us it will be March/April and by then a bazillion old people will have been vaccinated and we will have an idea of what to expect when it is our turn.

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A rather interesting-sounding development regarding the safety of the vaccines, including apparently a problem with the animal testing:

https://2020news.de/en/dr-wodarg-and-dr-yeadon-request-a-stop-of-all-corona-vaccination-studies-and-call-for-co-signing-the-petition/

Edited by RobH
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Dr.Wodarg has been a specialist in the problems of seafarers, but since 1994 he has been a Member of Germany's Bundestag, and prominent in the SDP.    

Dr. Yeadon, former Vice President and a Chief Scientist of Pfizer Pharmaceutical, left in 2012, taking with hin four other Pfizer employees to start Ziarco, a clinical stage biotechnology company which focuses on inflammatory and allergic diseases.    He has many academic papers to his credit.    Recently he has been a vociferious critic of SAGE, and has said that, "There is absolutely no need for vaccines to extinguish the pandemic. I’ve never heard such nonsense talks about vaccines. You do not vaccinate people who aren’t at risk from a disease. You also don’t set about planning to vaccinate millions of fit and healthy people with a vaccine that hasn’t been extensively tested on human subjects.  ...The pandemic is effectively over and can easily be handled by a properly functioning NHS (National Health Service). Accordingly, the country should immediately be permitted to get back to normal life.”  

 

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2 hours ago, RobH said:

A rather interesting-sounding development regarding the safety of the vaccines, including apparently a problem with the animal testing:

https://2020news.de/en/dr-wodarg-and-dr-yeadon-request-a-stop-of-all-corona-vaccination-studies-and-call-for-co-signing-the-petition/

Tks Rob, I would have missed it.

The 70% immune reaction  to PEG sounds an alarm- it may compromise the use of a range fo drugs that are "PEGylated" to improve efficacy. List here

https://www.biochempeg.com/article/58.html

It will be interesting to see if GPs are advised not to use the RNA vaccines on pts taking pegylated drugs.

ADE also  raises questions, as only 90 people in the trial caught C-19.  It may take thousands to be infected to see one adverse ADE, narcolepsy etc.  So to me it is a question of how unlucky do I feel ?

Peter

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I had never heard of PEGylation in pharmacology!     So I looked it up, and I feel no shame!   

It is used to make drugs less likely to stimulate an allergic resposne, by masking the drug from the immune system, not suppressing it, and from enzymes that would breaks themn down, so prolonging their action.    The Wiki lists the following as 'commonly used'PEGylated drugs:

Pegvaliase (Biomarin) – PEGylated recombinant phenylalanine ammonia-lyase for the treatment of Phenylketonuria, approved by the FDA for the US in May 2018.[17][18]
Adynovate – PEGylated Antihemophilic Factor VIII for the treatment of patients with hemophilia A. (Baxalta, 2015)[19]
Irinotecan liposome (Onivyde) – PEGylated liposomal irinotecan hydrochloride trihydrate for the treatment of metastatic pancreatic cancer in adults proceeding treatment with gemcitabine-based therapy. (Ipsen, 2015)
Plegridy – PEGylated Interferon Beta-1a for the treatment of patients with relapsing forms of multiple sclerosis. (Biogen, 2014)
Naloxegol (Movantik) – PEGylated naloxol for the treatment of opioid-induced constipation in adults patients with chronic non-cancer pain (un-pegylated methadone can cause adverse gastrointestinal reactions). (AstraZeneca, 2014)
Peginesatide (Omontys) – once-monthly medication to treat anemia associated with chronic kidney disease in adult patients on dialysis (Affymax/Takeda Pharmaceuticals, 2012)
Pegloticase (Krystexxa) – PEGylated uricase for the treatment of gout (Savient, 2010)
Certolizumab pegol (Cimzia) – monoclonal antibody for treatment of moderate to severe rheumatoid arthritis and Crohn's disease, an inflammatory gastrointestinal disorder (Nektar/UCB Pharma, 2008)
Methoxy polyethylene glycol-epoetin beta (Mircera) – PEGylated form of erythropoietin to combat anemia associated with chronic kidney disease (Roche, 2007)
Pegaptanib (Macugen) – used to treat neovascular age-related macular degeneration (Pfizer, 2004)
Pegfilgrastim (Neulasta) – PEGylated recombinant methionyl human granulocyte colony-stimulating factor for severe cancer chemotherapy-induced neutropenia (Amgen, 2002)
Pegvisomant (Somavert) – PEG-human growth hormone mutein antagonist for treatment of Acromegaly (Pfizer, 2002)
Peginterferon alfa-2a (Pegasys) – PEGylated interferon alpha for use in the treatment of chronic hepatitis C and hepatitis B (Hoffmann-La Roche, 2002)
Peginterferon alfa-2b (PegIntron) – PEGylated interferon alpha for use in the treatment of chronic hepatitis C and hepatitis B (Schering-Plough/Enzon, 2000)
Doxorubicin HCl liposome (Doxil/Caelyx) – PEGylated liposome containing doxorubicin for the treatment of cancer (Alza, 1995)
Pegaspargase (Oncaspar) – PEGylated L-asparaginase for the treatment of acute lymphoblastic leukemia in patients who are hypersensitive to the native unmodified form of L-asparaginase (Enzon, 1994). This drug was recently approved for front line use.
Pegademase bovine (Adagen) – PEG-adenosine deaminase for the treatment of severe combined immunodeficiency disease (SCID) (Enzon, 1990)

You will note that they are almost all for rare or severe conditions, in people who might be considered to be in a "vulnerable" group and so eligable for early vaccination, but not in large numbers, so might be excluded, while being pprotected by the eventual 'herd immunity we all hope to acquire.    

Edited by john.r.davies
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Not just wrong vitamin, wrong disease!

See: "Reversal of the Pathophysiological Responses to Gram-Negative Sepsis by Megadose Vitamin C",  Yugeesh, Peiris et al, Critical Care Medicine: November 25, 2020

  https://journals.lww.com/ccmjournal/Abstract/9000/Reversal_of_the_Pathophysiological_Responses_to.95417.aspx

This paper describes an animal study in sheep, that were given intravenous E.Coli infusions to induce septic shock .    The rationale is that the VitC acts as an antioxidant to help reverse the oxidative stress of sepsis.     The VitC, ascorbic acid, is NOT acting as a vitamin, and this paper neither is nor seeks to be evidence that megadose vitamins can have a more general helath benefit.

John

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Ascorbate can act as an anti-oxidant or pro-oxidant. In combination with ferrous iron it can generate highly reactive hydroxyl radicals through the Fenton reaction. It is conceivable that these OH* can destroy pro-inflammatory cells and even cytokines involved in sepsis.

Howere OH radicals  are usually regarded as pathogenic and chronic large doses of vitC are to my mind best avoided.

Peter

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https://medicalxpress.com/news/2020-12-uk-probing-allergic-reactions-linked.html

A very quick and honest response by regulators.

The vaccine mRNA is coated with PEG, polyethylene glycol.  In other words, polymerised antifreeze.

Peter

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39 minutes ago, john.r.davies said:

But Peter, as I found out (above) in response to your mention of PEGylation, it used as a way of reducing the likelyhood of an allergic reaction.  Did I misread that?

Hi John, Big molecules such as monoclonal antibodies will be powerful antigens, and probably more so than the PEG used to coat them. The vaccine uses PEG to stabilise the mRNA and their antigenicity should  have been uncovered in the trials, except that these excluded allergy-prone volunteers. It is early days, and the second jab may throw up surprises if the first acts as a sensitizer. In short I am happier at present to rely upon the hormone this thread must not mention !

Peter

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