Coronavirus (COVID-19)

[djchapsticks]

7 hours ago, welshbairn said:

And the problem of keeping it at -80c for distribution and storage will be huge I'd have thought, especially in the 3rd World. 

Not even remotely. The company I work for has a dry ice machine and routinely packs goods at these sorts of temperature every day. 

We also regularly supply to Pfizer so you can bet your bottom dollar that Pfizer also have this process in place for goods they produce and ship onwards. 

Edited November 10, 2020 by djchapsticks

[WhiteRoseKillie]

FFS, @welshbairn. OK, it's not a magic bullet tied up with tinsel and ready to get everybody and everything back to normal for Christmas. In fact, in the cold light of day, after the soundbite-laden announcement with the Chief Squaddie showing his presentation skills, it appears to be a pretty small light at the end of a long ol' tunnel..

..but d'you know what? After the year we've had, I'll fucking take that. Especially as there appear to be seveeral other viable vaccines coming after Pfizer's* headline-grabber.  Feeling a wee bit better this morning.

* As an aside, I really do hope they delayed the announcement simply to deny tangoman the chance to claim credit in the US election campaign. A massive fúck you to the ManBaby, and top trolling besides.

[budmiester1]

1 hour ago, Granny Danger said:

I know a guy who works on the busses and is used to such temperatures.

 

 

He’s a super conductor.

 

Boom Tish!! LOL

[LongTimeLurker]

30 minutes ago, WhiteRoseKillie said:

FFS, @welshbairn. OK, it's not a magic bullet tied up with tinsel and ready to get everybody and everything back to normal for Christmas...

If the 90% thing holds up and this starts to get implemented by the end of this month, the end is very much in sight once medical professionals, care homes and most people in high risk groups get immunised over the following few months. Once that's taken care of and if the IFR drops another order of magnitude to around 0.02% by that point, there should be no conceivable reason for any lockdowns and anything beyond an advisory to keep up hand sanitising practices because they are generally a good move.

Edited November 10, 2020 by LongTimeLurker

[welshbairn]

1 hour ago, LongTimeLurker said:

Would be better if the resident alarmists would stop parroting this sort of stuff when they clearly don't understand the issue in question. Dry ice and liquid nitrogen are used routinely for this sort of cooling, so there is nothing hugely challenging about this. It's a bit of a nuisance factor rather than an insurmountable obstacle.

 

I would take that from most people when I clearly got the wrong gist from a brief piece on Newsnight, and am ignorant on the basics, but not from someone who thinks global warming isn't an issue because we're past peak oil.

[Paco]

If the 90% thing holds up and this starts to get implemented by the end of this month, the end is very much in sight once medical professionals, care homes and most people in high risk groups get immunised over the following few months. Once that's taken care of and if the IFR drops another order of magnitude to around 0.02% by that point, there should be no conceivable reason for any lockdowns and anything beyond an advisory to keep up hand sanitising practices because they are generally a good move.

It’s hard to know how it plays out, isn’t it? And it probably still depends on the progress of further vaccines. Yesterday’s news is monumental but the doses might not quite be available when we want them and it could be a long slog vaccinating those most in need before we can crack on.

The more cautious side of me still thinks life could be virtually normal come summer, you might not be counting how many household groups you’re mingling with at the pub but equally you’re not going to be able to cram into one with standing room only, you’ll be able to go on holiday but wearing a mask on the plane and probably still testing at airports, and you can go to the football but maybe still not quite in unrestricted numbers.

I just can’t see us loosening the shackles as quickly as some, including scientists, seem to be proclaiming this morning. Vaccinating those most at need takes time and you’d still be causing problems for the 10% for whom the vaccine doesn’t work if you just let it run around the rest of the population.

We now know how this ends but still a long way to go, I think. If the Oxford vaccine can be used simultaneously, I’ll feel a lot more confident.

[D.A.F.C]

Absolute scenes when pubs & football reopen, exclusively for over 70s who've been vaccinated.

Basically just a bunch of folk complaining at games then.
[emoji38]

[Aladdin]

Basically just a bunch of folk complaining at games then.
[emoji38]

George Fox stand up to full capacity at Tannadice by April.

The vaccine, if the data holds up, is a pretty remarkable scientific feat. It shows how far the technology has come over the last 20 years.

Equally, it also shows how its only when a disease is rampant throughout the Western world and the dollar signs start flashing that pharmaceutical companies get the finger out.

[Marshmallo]

Is this more or less detrimental to education than blended learning?

[Honest_Man#1]

3 minutes ago, Marshmallo said:

Is this more or less detrimental to education than blended learning?

Seriously, what are all of these teachers and pupils doing visiting nail bars in their spare time outside of schools? This sort of reckless behaviour should be punished.

[effeffsee_the2nd]

George Fox stand up to full capacity at Tannadice by April.

The vaccine, if the data holds up, is a pretty remarkable scientific feat. It shows how far the technology has come over the last 20 years.

Equally, it also shows how its only when a disease is rampant throughout the Western world and the dollar signs start flashing that pharmaceutical companies get the finger out.

It’s not the money to be made that got them moving in jig time ( although that helps no doubt) it’s the money that the mega rich would lose via a long term shutdown that has them throwing money at a solution

[LongTimeLurker]

14 minutes ago, Paco said:

It’s hard to know how it plays out, isn’t it? And it probably still depends on the progress of further vaccines....

The good news on that front appears to be that several of the other vaccines are using a similar overall approach to Pfizer so are highly likely to also be OK on safety if the Pfizer one is. The -80°C storage angle appears to be a case of a trade off made by Pfizer related to trying to rush this onto the market first and the subsequent vaccines are likely not to have this issue apparently.

[Honest_Man#1]

15 hours ago, welshbairn said:

Nobody on here has said schools are safe, nobody has said schools should be closed. It will be remembered as the great masks versus blended war, and nobody will know what that means.

The point is that the government have, repeatedly.

[welshbairn]

Thought I better educate myself a bit on this vaccine thing, veering towards cautious optimism. From the New Scientist behind a firewall.

Quote

Pfizer covid-19 vaccine: Is it the breakthrough we've been hoping for?
Pfizer and its partner BioNTech say their coronavirus vaccine is 90 per cent effective in phase III trials. How excited should we be about the news, and what questions remain unanswered?

HEALTH 9 November 2020
By Graham Lawton

 

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.

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.

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.

 

 

Edited November 10, 2020 by welshbairn

[Donathan]

[Donathan]

[Todd_is_God]

1 hour ago, Paco said:

Vaccinating those most at need takes time and you’d still be causing problems for the 10% for whom the vaccine doesn’t work if you just let it run around the rest of the population.

 

I'm not convinced restrictions are required for *any* infection that only 10% of a population are susceptible to.

Surely the idea behind having 90% not susceptible is that the virus finds it difficult to find a viable host to spread?

Add in an IFR of just over 0.1% and, in Scotland, then even if every single one of those 10% somehow managed to get themselves infected, you'd be looking at a maximum of around 600 deaths in total, or the equivalent of 4 days.

In reality, even that would be extremely unlikely.

[LongTimeLurker]

4 minutes ago, Todd_is_God said:

I'm not convinced restrictions are required for *any* infection that only 10% of a population are susceptible to....

Depends on the IFR. Think there definitely would be restrictions for an Ebola virus outbreak under those circumstances, but with COVID there comes a point with a reasonably effective vaccine in place when it is undeniably in normal flu season territory on mortality and people will be told very firmly to get a grip.

[Todd_is_God]

17 minutes ago, LongTimeLurker said:

Depends on the IFR. Think there definitely would be restrictions for an Ebola virus outbreak under those circumstances, but with COVID there comes a point with a reasonably effective vaccine in place when it is undeniably in normal flu season territory on mortality and people will be told very firmly to get a grip.

Fair point. It's not an issue with covid, though.

[welshbairn]

4 hours ago, djchapsticks said:

Not even remotely. The company I work for has a dry ice machine and routinely packs goods at these sorts of temperature every day. 

We also regularly supply to Pfizer so you can bet your bottom dollar that Pfizer also have this process in place for goods they produce and ship onwards. 

How long can they stay sufficiently cooled in dry ice? Not arguing with you but this article suggests some difficulties, especially outside the 1st World.

https://abcnews.go.com/Health/pfizer-win-covid-vaccine-race-distributing-matter/story?id=72862724