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[bobsworth] 26/11/2020 08:17

The Lancet Article – 30/10/2020

"The study will take place in the high-level isolation unit of the Royal Free Hospital, London, UK."

The Human Challenge Consortium consists of UK Government representatives and experts from the National Health Service (NHS), academia, and the private sector. The group has come together to explore the feasibility and ethics of human challenge trials that could potentially accelerate the development of vaccines to protect against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
The first study phase, which could begin in January, 2020 ( should read 2021 !!!! ), aims to discover the smallest amount of virus it takes to cause the infection in up to 90 healthy young people, aged between 18 and 30 years, who are at the lowest risk of harm from COVID-19. The study will take place in the high-level isolation unit of the Royal Free Hospital, London, UK.

DOI:

[pogue] 26/11/2020 07:57

The vaccine news is unraveling due to their cutting corners in testing what a surprise...



...But since unveiling the preliminary results, AstraZeneca has acknowledged a key mistake in the vaccine dosage received by some study participants, adding to questions about whether the vaccine’s apparently spectacular efficacy will hold up under additional testing.

Scientists and industry experts said the error and a series of other irregularities and omissions in the way AstraZeneca initially disclosed the data have eroded their confidence in the reliability of the results....

[supernumerary] 25/11/2020 23:46

warranty - trying too hard :)

[lhoskins] 25/11/2020 22:45

Not sure if posted before but very interesting and worth listening to.

[lhoskins] 25/11/2020 22:43

https://thevaccinepodcast.libsyn.com/8-human-challenge

[klosters65] 25/11/2020 17:56

710,000 shares traded at 3.39 pm for 25p. I have noticed recently that large trades are at asking price or better. May indicate an Institution is accumulating.

[warranty] 25/11/2020 17:31

Thought this might be interesting as it seems the vaccines have actually been in development for longer than we think in other forms.


Quoted on the Quora Digest Site: The resident experts comment on the speed of development of the new Covid vaccines.

1. There is a development run-up of at least 10 years on these vaccines. Science has been working quietly in the background since SARS 1. and later on, Ebola virus, and technology learned in this research has been utilised in the present developments. The work on Pfizer and Moderna vaccines is more recent than this, but similarly, work on these mRNA vaccines has been in development for some years now. The research done has now been repurposed for CV19.

2. The scientists working on the new vaccines are putting in unprecedented efforts to arrive at an early solution, given the global emergency. They are working very long shifts, on a 24/7 basis. In this regard it helps that their social life is restricted the same as everybody else’s, and they are able to devote more time to the research.Coupled with this, the drug and vaccine companies have largely sidelined R+D work on other projects to concentrate on CV 19.

3. There has been advanced recruitment available. Many more people than normal have been willing to come forward to join in given publicity worldwide for the necessity for this. There has been no shortage of volunteers: in fact a surfeit.

4. The pandemic has similarly had a beneficial effect on levels of volunteers for testing, for phase 3 tests . Normally, in research for past vaccines, development has been substantially delayed, sometimes for many years, until there has been sufficient level of infection in the general public to enable Phase 3 volunteers to encounter the virus in normal life at an acceptable pace.Given the pandemic, this has been no problem. Further, when the virus became suppressed in Europe over the Summer, developers were able to move their testing further afield.

5. Finally, the global emergency has meant enormous political will and funding, to back vaccine development. In rapid time.

[warranty] 25/11/2020 17:20

Pogue, thanks for the confirmation it wasn’t a wind up but I’ve been a bit bashed lately for suggesting the government might suspend or cancel their Covid CHIMs now that 3 very quickly assembled vaccines have been allowed to seek regulatory permission for use. I’m happy after Pierre and Trader3 posts that they won’t, so hopefully they’ll go ahead as normal? As one who has never taken a flu jab, or any other medication not needed, I’m also reluctant to take a Covid vaccine until it’s been tested properly and has had time to exhibit any resulting side effects. Hopefully this makes Challenge trials even more relevant?

[backwoodsman] 25/11/2020 17:20

My take was that the governments are relieved that they can reduce the huge cost of PCR testing by vaccination instead, but that in itself will be a significant burden so if they can have 2nd or 3rd generation vaccines that are effective for longer periods than these first ones then all to the good. Therefore development of vaccines, no doubt involving challenge studies as appropriate, will continue apace.

[malcolmmm] 25/11/2020 16:43

Also I thought that I heard Cathal say they the Pharma's were talking to him.

[trader_3] 25/11/2020 16:41

'You will join a talented group of clinical fellows, research nurses and scientists led by Dr Chris Chiu (www.imperial.ac.uk/people/c.chiu) in the Department of Infectious Disease, to characterise the response to SARS-CoV-2 during experimental human infection. This will enable investigation of COVID-19 pathogenesis and protection as well as permitting follow-on vaccine efficacy studies. In particular, you will focus on the biology of T cells generated during infection.'

hxxps://www.imperial.ac.uk/jobs/description/MED02149/research-associate-respiratory-virus-vaccine-immunology

Note the ' follow on vaccine efficacy studies' , confirming several vaccines initially identified for future investigation.

All great confirmatory information, that the planned Covid CHIMs are progressing well.

GLA

[malcolmmm] 25/11/2020 16:39

Arnt they? I am thinking that our government will oblige them to

[lhoskins] 25/11/2020 16:31

Im amazed the new vaccines arent going to be tested with a challenge study before being rolled out to the masses.

[pierre oreilly] 25/11/2020 16:28

Mal, I'm not sure pharmas can just go round putting chemicals into volunteers willy nilly. Surely they have to put a case and evidence of low risk to do a phase1, then evidence of a successful phase one to get permission to do a phase 2, ditto phase 3. So it's unlikely there'll be mass deaths from anything pharmas are allowed to do.

I think the ethics bit is a bit misunderstood (but this isn't my business, so could be wrong - be great if someone experienced in these things could comment). The ethics come about because drs. are intentionally infecting people, and they have previously promised not to, and gov sometimes think infecting people is wrong. But the uk says it's ok, many other countries say it's not, so can't do challenge studies (ironically, s Ireland can't). The authorisation we are waiting for, more or less a formality, just depends on getting the dosage and virus derivative developed and a rescue remedy - basically getting the model approved. Totally different from getting a vaccine approved of course.

[lhoskins] 25/11/2020 16:28

Thats a great find. Thanks for sharing.

[trader_3] 25/11/2020 16:23

Imperial College London recruiting for Covid CHIMs

‘We are looking for a highly motivated Research Associate to work on an innovative SARS-CoV-2 human infection challenge study, in the first instance. You will be part of a multi-disciplinary group focusing on human immunity against respiratory viral infections using exciting and unique studies of experimentally infection/vaccination of volunteers and hospitalised patients.’

hxxps://www.imperial.ac.uk/jobs/description/MED02149/research-associate-respiratory-virus-vaccine-immunology

[malcolmmm] 25/11/2020 16:17

Funny thing is that these untested vaccines could kill more of us than cure in the long run.

[pierre oreilly] 25/11/2020 16:06

I think the decision to vaccinate people is totally independent of the challenge studies. If the gov wanted a challenge study passed before vaccinating, then there'd be no point in the drug companies applying for emergency authorisation befoire a challenge study has been done and successful.

Why do people assume the vaccines the gov want to test are from the 3 who've reported a preliminary success? Maybe i missed it, but i don't think they've said which candidates are going to have one (or maybe all 3) of the challenge study reservations. Would the gov pay for a challenge study for a commercial pharma just so it could sell more vaccines? I don't know.

Maybe i'm alone in thinking the gov challenge studies are coming whatever the circumstances - whether we've been vaccinated by then or not. The evidence for the 3 vaccines atm is extremely flimsy, a 3 monthly report from something which usually takes 10 years. More evidence from wherever (in this case challenge studies) is obviously needed asap. The lady boss of the mhra seemed very unrushed to me and spoke very sensibly - the hoops to jump for covid are exactly the same as any other vaccine for any other illness as far as she is concerned. It's clear, i think, that covid won't go through 10 years of testing, but i doubt we'll be offered a jab this side of christmas. It matters not two hoots whether or not jabs are offered by then as far as orph and its covid, and other, challenge studies are concerned... in my view (which could be wrong of course).

Warranty, thanks and no probs mate - bbs are pretty bad for trying to guess someone's intention when posting.

[malcolmmm] 25/11/2020 16:02

Another reason for challenge studies-


Rapid Response:
Official doubletalk hides serious problems with flu shot safety and effectiveness
OFFICIAL DOUBLETALK HIDES SERIOUS PROBLEMS WITH FLU SHOT SAFETY AND EFFECTIVENESS

After weeks of brooding about the Donahue article linking flu shots to miscarriages (Vaccine 2017;35:5314) it was with a sense of relief that I read Rob Wipond’s narrative of media attempts to sweep a serious vaccine safety issue under the rug….He points out the hypocrisy (his words were “double standard”) of authorities who dismissed the Donahue paper because it was an “observational study.” Year after year they have quoted observational studies to announce, “…80% vaccine effectiveness…60% effectiveness…40% effectiveness…” They do not mention that these studies make no effort to look for adverse vaccine effects (e.g. narcolepsy, seizures, high fever, oculorespiratory syndrome). They do not mention “negative vaccine effectiveness”, the increase in risk of illness from influenza and non-influenza viruses associated with (or caused by) the vaccines. (Cowling, Clin Inf Dis 2012;54:1778) They do not mention that a vaccine “effectiveR21; in one season may increase influenza risk in a subsequent season. (Read about “antibody-dependent enhancement” to understand one explanatory mechanism). They do not mention that the observational studies they refer to are likely to exaggerate vaccine effectiveness in the first place because of the “healthy user effect” well known to epidemiologists.

Some history: 1960 Nobel Laureate and a primary developer of today’s influenza vaccine, Macfarlane Burnet, didn’t think it was worth much. (Br J Path 1936:17:282. Natural History of Infectious Disease 1972, page212)….In 2000 Kenneth McIntosh warned that we should not routinely give influenza vaccine to healthy children until multicenter randomized trials were done over several seasons to be sure that it was safe and effective. (Editorial, NEJM 2000;342:225) His advice was ignored….In 2004 a “Seven-Step Recipe” for using the media to boost demand for the vaccine was presented to the National Influenza Vaccine Summit, sponsored by the CDC and the AMA. The recipe included, “…statements of alarm by public health authorities…prediction of dire outcomes from influenza…continued reports that influenza is causing severe illness affecting lots of people…repeated urging of influenza vaccination…” (Doshi, BMJ 2005;331:1419) Sound familiar?

Peter Collignon and his colleagues have said this: “We need much larger, independent, and better-reporte

[malcolmmm] 25/11/2020 15:47

Also did you know because I didnt-
The yearly Flu Vaccine
The vaccine must be changed each year, in hopes of matching the ever-mutating viruses. And that's been a challenge. On average, it's been 40% effective, meaning it's prevented illness 40% of the time.2 Sept 2020

[malcolmmm] 25/11/2020 15:41

The government wants challenge studies hence the signed contracts. They need approval from the ethics committee, whoever they are . Funny thing though, a pharma can inject 40,000 volunteers with untried vaccines that presumable contain antibodies or a mild dose of the virus without recourse to anyone

[systagenix] 25/11/2020 15:36

Yo Pogue
HVivo will it you....

[pogue] 25/11/2020 15:23

M5
the government have absolved one pharma company of any legal cases from the vaccine it produced, forgot name, I assume all are the same hence there is no great incentives on the pharma companies to be ultra careful to confirm safety or effectiveness of the vaccines.
Its a conclusion of one way of looking at this there are others everything maybe fine or may not be all seems random as to which one will happened though.

SMTM
I have been adding last few days been selling other stuff to fund purchases.