Developing the Covid-19 vaccine

[Squeak]

I for one would love to hear Tom p's view on this

I came scooting over here, direct from The Guardian app with exactly this thought in mind. I didn't even bother to finish reading the article.

Come on Tom, we know how much you love sloppy regulations and casual British xenophobia. Please don't let us down.

[shpalman]

Shocked I tell you that rushing it through leaves it half arsed

https://www.theguardian.com/society/202 ... care-homes

... an official source said the process of dividing up the vaccines had not yet been designed and would first need to be validated by the MHRA, which could take weeks

[Bird on a Fire]

NUMBER ONE IN EUROPE!!!

WE ARE THE BEST COUNTRY!!!!!!!

https://www.bbc.co.uk/news/uk-55176614

TWO WORLD WARS AND ONE VACCINE
DOO-DAH, DOO-DAH

[Millennie Al]

Shocked I tell you that rushing it through leaves it half arsed

https://www.theguardian.com/society/202 ... care-homes

... an official source said the process of dividing up the vaccines had not yet been designed and would first need to be validated by the MHRA, which could take weeks

What's so difficult about it? The clinical trial treated over 20,000 people - why not copy the logistics from that? Surely all of the participants didn't receiev it by going to where it was manufactured? It would be quite understandable if the goal was to provide a vaccine available everywhere, but the available stock is far too small for that.

[KAJ]

What's so difficult about it? The clinical trial treated over 20,000 people - why not copy the logistics from that? Surely all of the participants didn't receiev it by going to where it was manufactured? It would be quite understandable if the goal was to provide a vaccine available everywhere, but the available stock is far too small for that.

Reminded me of this:

[tom p]

How much do regulator's decisions influence each other? Does the MHRA decision affect the FDA or the EMA?
What kind of things could cause the vaccine to not be approved? Could any regulator resist the political pressure to approve this?

The decisions do not impact one another one bit.

The MHRA's decision affects the communications departments and senior management of the EMA, FDA, TGA, HelathCanada, Swissmedic, MHLW, ANSM, AIFA, MEB, PEI, INFARMED, AGEMED and in every other regulator in an industrialised democratic nation.
This is because all of them have to explain to their local media why this is a f.cking moronic bit of grandstanding, but they have to do so in a way that means they won't sound like Gavin Williamson.

The scientific staff, while obviously aware of the decision, will in no way be swayed by it.

The EMA had already announced in the morning of 1 December, before the panicky oversold limited approval from the UK government, that there would be a special CHMP meeting no later than 29 December to decide on the full application dossier, which was submitted to the EMA on 1 December. It might be earlier, but that depends on how soon the assessors in the 2 member states that are officially designated as Rapporteur & co-Rapporteur will feel confident that they can make a recommendation one way or another to the CHMP (the committee which makes the decisions).
Staff (scientific, administrative & IT) will be working through Christmas to ensure all the systems are functioning and data available and we can have a meeting any day necessary.

The rapporteurs will tell any politicians who want to rush them or who want a decision one way or another to f.ck right off.

[Bird on a Fire]

Portugal is releasing details of its distribution plan tomorrow afternoon: logistics, safety and the register. It will be free, optional and distributed through the national health service. https://www.publico.pt/2020/12/02/socie ... 1419#55154
<snip>

Plan is out. Vaccinating the population in 3 phases, with the goal of reducing mortality and internments in ICUs:

1. Care home workers and staff, healthcare professionals, and people over 50 with certain health problems (heart/lung/kidney issues that increase mortality). (950k people)

2. People over 65, plus people age 50-64 with other health problems (diabetes, liver function, obesity). (1.8 M people)

3. Everybody else. However, if the provision of vaccines is slower than anticipated the "everybody else" group will be further subdivided.


The national health service (SNS) is going to be proactively contacting people on its books who fall into these categories, but there will also be means for people to ring up and make their own appointment. Delivery will be through GP surgeries. https://www.publico.pt/2020/12/03/socie ... io-1941621

Sounds straightforward enough. Due to certain issues, quite a few people use private healthcare and rarely interact with the SNS, so some will fall through the cracks, but I suspect that everyone with health issues will be interacting with some healthcare provider often enough that the information can get to them. Reaching the 'healthy elderly' might be trickiest, and then we'll see what happens with stage 3.

My local health centre is constantly overstretched and chaotic, mind you, so adding the necessity to vaccinate the entire population of the town by prior appointment to their workload is going to be "interesting". Staff at carehomes etc. will be empowered to deliver the vaccine themselves.

[tom p]

The UK has managed to quickly accept a vaccine made in Belgium developed by Turkish scientists working for an American company because “Well I just reckon we’ve got the very best people in this country...

“Much better than the French have, much better than the Belgians have, much better than the Americans have. That doesn’t surprise me at all because we’re a much better country than every single one of them, aren’t we.”

Tories becoming increasingly Trumpian on a daily basis.

I for one would love to hear Tom p's view on this

In the coming few days, the UK is going to be very reliant on good will from those other countries, the ones who a government minister reckons are crappier than the country that is committing a shameful act of economic self-harm (and harm to those countries too).
Specifically, HMG, in an act of economically retarded petty nationalism has decided that the fishing industry, employer of 12k people, is the single most important industry in the UK and that this is the most important possible win for brexshit britain. Unbeknownst to the f.cktarded cabinet minister, France also has a channel/north sea/atlantic fishing industry too. The France he said the UK is just better than. The France with a not particularly popular president that is going to have an election in 2022 and where the president would quite like a poll boost from giving a bl..dy nose to les rosbifs over something that speaks to la france profonde. That France. There's already next-to-no good will in the EU towards the UK, this will just reduce it further.

A charitable person would say he'd been sent out to say something stupid to distract from questions about the indecent haste & whether the government has pressured this supposedly fiercely independent agency (more on which later) into acting on a political basis, rather than a scientific one. But he's not nearly that clever. If he were sent out to say something stupid, he'd end up making the most diplomatic and statesmanlike statements ever, by accident.

An equally charitable person might call him a f.cking lying c.nt by claiming that this is down to brexshit, but again I don't think he knows enough to lie about it. He's almost certainly completely unaware that the UK is still bound by the EMA's rules and decisions (without being able to contribute to them) and that the MHRA could have made such a decision at any time it needed to since 1995 (when the EMA was founded) or before and didn't need a brexshit which hasn't come into effect yet. He's definitely going to also be completely unaware that any EEA member state could have done the same too; but countries which want to abide by the rule of law prefer to take the right amount of time to make the right decision based on the right amount of evidence, rather than bullying* a recently-appointed head of a supposedly independent agency into rushing a decision to grab headlines for jingoistic purposes.

As for the fierce independence of the MHRA which doorMatt Hancock claimed - the MHRA was probably the single most important and cooperative agency in the EEA medicines regulatory network. They set the standards for inspections, and when it comes to assessments (both pre & post-authorisation), they did about 1/3 of the work (for which they were paid) of the whole network. This from a country that makes up 1/25 of the member states and 1/8 of the population. The MHRA had always prioritised cooperation and, thanks to its geographical location, was very close to the EMA. June Raine was, until very recently the chair of the PRAC, one of the most important committees in the EU medicines regulatory network. To claim them as some kind of nationalist mavericks is to distort the truth in exactly the way we have come to expect from this shower of sh.t.

*I have no evidence of this, but I know June Raine moderately well, & she is a very capable, intelligent and sensible person who is (was) admired by her peers. I find it impossible top believe that she would have taken this decision without strong pressure from above. Unless, she was so concerned at the kill-a-granny-for-christmas policy that HMG is adopting that she wanted something to protect those most likely to die. An old person who is fit enough to visit their relatives (ie not in a care home) is exactly the sort of person who will be front of the queue for the vaccine and so it might be purely an attempt to urgently mitigate the murderously incompetent short-termist populist policies of this government

[tom p]

What's so difficult about it? The clinical trial treated over 20,000 people - why not copy the logistics from that? Surely all of the participants didn't receiev it by going to where it was manufactured? It would be quite understandable if the goal was to provide a vaccine available everywhere, but the available stock is far too small for that.

Reminded me of this:

Indeed.
Participants in a trial travel to the investigation sites. They will be reasonably centralised, but then the participants get paid 'expenses' for attending. That sort of money is loose change for a company like Pfizer. For an NHS which is overstretched and under-resourced and in a country about to hit the deepest recession for >300 years, it's impossible.
The logistics are totally different.
Arrogant ignoramuses should keep their worthless opinions to themselves.

[nezumi]

I've just come across this while browsing facebook, it's a friend of a friend and I want to be able to challenge it, respectfully, but I have no idea where to start, can the Hive Mind help?

Alreet Paul, this leaves a question in my mind tho pal, if they've adapted the covid vax from the sars vax which has not been issued to the world, how can it be deemed as safe?
I believe that Ferrets were used for the MHRN vaccine trials as they have a similar immune system to ourselves, I also read a while back that the vax was administered to them with little side affects, but when they introduced them to the virus in stage 2, their immune systems worked in the opposite way and assisted the virus attacking their body. I may have it wrong, but if you are a bit concerned, may be worth looking it up m8. Not trying to sway you or change your mind pal, just want everyone to be safe and sure in their own mind before they possibly make a mistake.

Sadly I'm having some side effects from tablets that leave me with major brain fog and the feeling that every thought is trying to swim through treacle. Help me please, cos I can't let this pass without scrutiny.

[bolo]

As China nears a coronavirus vaccine, bribery cloud hangs over drugmaker Sinovac

[Bird on a Fire]

I've just come across this while browsing facebook, it's a friend of a friend and I want to be able to challenge it, respectfully, but I have no idea where to start, can the Hive Mind help?

Alreet Paul, this leaves a question in my mind tho pal, if they've adapted the covid vax from the sars vax which has not been issued to the world, how can it be deemed as safe?
I believe that Ferrets were used for the MHRN vaccine trials as they have a similar immune system to ourselves, I also read a while back that the vax was administered to them with little side affects, but when they introduced them to the virus in stage 2, their immune systems worked in the opposite way and assisted the virus attacking their body. I may have it wrong, but if you are a bit concerned, may be worth looking it up m8. Not trying to sway you or change your mind pal, just want everyone to be safe and sure in their own mind before they possibly make a mistake.

Sadly I'm having some side effects from tablets that leave me with major brain fog and the feeling that every thought is trying to swim through treacle. Help me please, cos I can't let this pass without scrutiny.

Why is he talking about ferrets? They've all been tested on thousands and thousands of humans now.

[mediocrity511]

Portugal is releasing details of its distribution plan tomorrow afternoon: logistics, safety and the register. It will be free, optional and distributed through the national health service. https://www.publico.pt/2020/12/02/socie ... 1419#55154
<snip>

Plan is out. Vaccinating the population in 3 phases, with the goal of reducing mortality and internments in ICUs:

1. Care home workers and staff, healthcare professionals, and people over 50 with certain health problems (heart/lung/kidney issues that increase mortality). (950k people)

2. People over 65, plus people age 50-64 with other health problems (diabetes, liver function, obesity). (1.8 M people)

3. Everybody else. However, if the provision of vaccines is slower than anticipated the "everybody else" group will be further subdivided.


The national health service (SNS) is going to be proactively contacting people on its books who fall into these categories, but there will also be means for people to ring up and make their own appointment. Delivery will be through GP surgeries. https://www.publico.pt/2020/12/03/socie ... io-1941621

Sounds straightforward enough. Due to certain issues, quite a few people use private healthcare and rarely interact with the SNS, so some will fall through the cracks, but I suspect that everyone with health issues will be interacting with some healthcare provider often enough that the information can get to them. Reaching the 'healthy elderly' might be trickiest, and then we'll see what happens with stage 3.

My local health centre is constantly overstretched and chaotic, mind you, so adding the necessity to vaccinate the entire population of the town by prior appointment to their workload is going to be "interesting". Staff at carehomes etc. will be empowered to deliver the vaccine themselves.

Oof, you'd be a bit gutted if you were under 50 and had severe lung disease or were immunocompromised. I can understand prioritising older people with health conditions, but not deprioritising younger at risk people entirely.

[nezumi]

Why is he talking about ferrets? They've all been tested on thousands and thousands of humans now.

Well, quite, I asked for a ref and he sent me this article.

Which might take me some time to get through cos my eyes keep crossing involuntarily.

[tom p]

It's in mice. Less than 40 mice.
The COVID-19 vaccines (which weren't developed from old SARS vaccine left lying around) have been tested in 10s of thousands of people each (I think over 200k if you add them up).

It is inconceivable (yes, that word does mean what I think it means) that the people who had been vaccinated were not subsequently exposed to COVID-19 in the wild.

Since immunopathologic-type lung diseases were not observed in patients who had received the vaccine (else the trial(s) would have been stopped), the theory that it might happen has been disproved. Furthermore, I'm pretty sure that one of the consequences of getting COVID-19 for people who end up in intensive care is an immunopathologic-type lung disease (that's pretty much what the fat clown got innit?), so he's worried about getting a side effect that is caused by the disease anyway.

You could point out to him that the SARS from 2002 was much worse than this year's model & so you would expect worse results, as well as the fact that ~200k humans challenged with the actual vaccine he would get is a far better model for what might happen to a human than 36-39 mice (what his paper is based on) challenged with a different vaccine for a worse disease.

You might also want to point out to him that not only are researchers who develop vaccines able to read literature articles, but so are the ethics committees and other bodies who approve trials and regulators too. We know about this sort of stuff and the drugs companies would have been required to demonstrate that this issue wasn't present in mice & ferrets before the vaccine was even allowed into a single human.

[Gfamily]

Also, they used two types of vaccine

inactivated whole virus vaccine in ferrets and nonhuman primates and a virus-like-particle vaccine in mice

, and I'm not sure if either is like the RNA vaccines being rolled out.

[nezumi]

Thanks guys I'll use all of that in my considered response, I must say it's refreshing to be discussing science on facebook.

[FairySmall]

At this point, can I just say thanks to tomp for his knowledge of this and his willingness to share it with us random forum peeps*.

I'd love to say he's made me reassured about the vaccine. In fact he's made me deeply uncertain, but it's the uncertainty of greater info rather than blissful ignorance. So thanks for making me more concerned, genuinely.

I think at this point I'm meant to call you a c*nt or something, just to balance it out, right?

* tomp isn't the only one I'd like to thank. I've been really valuing the expertise of many of this forum. Mikeh is one example but he's by no means the only one. But I run the risk of sounding like an Oscar acceptance speech...

[Stephanie]

I too am glad to see Tom back.

I will prod mikeh back eventually, but I think he's busy getting his beard in various media.

(I do take the piss a lot, but I genuinely enjoy folk sharing their expertise, otherwise it would just be me occasionally googling sh.t).

[Millennie Al]

Participants in a trial travel to the investigation sites. They will be reasonably centralised, but then the participants get paid 'expenses' for attending. That sort of money is loose change for a company like Pfizer. For an NHS which is overstretched and under-resourced and in a country about to hit the deepest recession for >300 years, it's impossible.
The logistics are totally different.

The Pfizer/Biontech vaccine study that had 43998 participants has registered 155 study locations which include 39 U.S. states, including Hawaii, as well as Argentina, Brazil, Germany, South Africa, and Turkey. There must have been a lot learned about the logistics to achieve that.

The NHS is not expected to pay for this from its usual budget. I don't know how it can have escaped your attention, but the country is already spending hundreds of billions of pounds as a result of this coronavirus, so money will be found - especially as it's such a highly visisble expense.

Arrogant ignoramuses should keep their worthless opinions to themselves.

And you could do with toning down that superciliousness.

[Millennie Al]

I've just come across this while browsing facebook, it's a friend of a friend and I want to be able to challenge it, respectfully, but I have no idea where to start, can the Hive Mind help?

Alreet Paul, this leaves a question in my mind tho pal, if they've adapted the covid vax from the sars vax which has not been issued to the world, how can it be deemed as safe?
I believe that Ferrets were used for the MHRN vaccine trials as they have a similar immune system to ourselves, I also read a while back that the vax was administered to them with little side affects, but when they introduced them to the virus in stage 2, their immune systems worked in the opposite way and assisted the virus attacking their body. I may have it wrong, but if you are a bit concerned, may be worth looking it up m8. Not trying to sway you or change your mind pal, just want everyone to be safe and sure in their own mind before they possibly make a mistake.

Sadly I'm having some side effects from tablets that leave me with major brain fog and the feeling that every thought is trying to swim through treacle. Help me please, cos I can't let this pass without scrutiny.

As well as the facts already mentioned by others, it may be worth considering that citing this may be more a symptom than the disease and if you refiute it you'll only face another one. The underlying cause may be an unease at apparent overenthusiasm for a vaccine whereby any risks are ignored or dismissed. This is likely to be the case for someone who gets their information from politicians and celebrities, who (like anyone) have a tendency to adopt extreme views. Actual experts know that nothing is perfectly known and there can be unecpected risks. In the case of a vaccine, it should be obvious that you have to balance the risk of the disease against the risk of getting vaccinated. In the case of Covid-19, the risk to an individual is typically quite small, but high enough that lots of people are dying. Any approved vaccine will be evaluated to see what its risks are. This is where it's worth trying to find information directly from the experts, and you'll find that studies used to evaluate vaccines report any problems and the problems are taken seriously. While it's always possible that some unexpected problem appears, if you test on over 10,000 people it must be very rare. It seems that the risk of dying if you catch Covid-19 is at least 1 in 1000, so as an individual it makes sense to get vaccinated unless you think that you are very unlikly to catch it (any why would that be the case?) or the vaccine is likely to have some major problem that has not yet shown up and the experts cannot predict.

And also, problems with "vaccines" are like problems with "people". There are many different instances in each category. Just as Boris Johnson is different to Stormzy, one vaccine can be completely different to another and has to be evaluated as an individual.

[sTeamTraen]

I have no knowledge of physiology, so this may be a silly question: Do vaccines, in general or in particular, reduce a person's infectivity during the asymptomatic period?

For example, let's say that vaccine A works by "preventing the virus from doing something nasty to you as it runs around inside you" (top sciencing here, I know) whereas vaccine B works by preventing the virus from reproducing. (Those two may very well be the same thing. Rarely have I written a post for which I would be so happy to be called an idiot.) Then maybe if lots of people get vaccine A, versus B, there could be a risk of increased spread during the asymptomatic period.

The concern is that you could have a large number of vaccinated people walking around who, while not going to get (bad) symptoms themselves, would be potential spreaders to the unvaccinated, of whom there will be many, if only because the whole operation takes time. And since getting vaccinated is being sold as a way to get back to normal, it's going to be hard to get those people to continue to wear masks or not attend large sex parties in Brussels. So you could have the ironic effect of making the effective R rate go up rather than down.

Once more, I hope that this is a very silly argument and the response will be "having the vaccine means in all cases that the virus hardly reproduces in your body, so even in the asymptomatic period you will not be shedding lots of it". Or some other reassuring virological/epidemiological explanation.

[sTeamTraen]

Duplicate

[shpalman]

It has been discussed in the thread, but I think that in this case we just don't know, since the studies are looking at who in the trial is getting infected (the Pfizer trial just tested people who had symptoms, the Oxford trial regularly swabbed everybody to pick up also the asymptomatic cases), not who in the trial goes on to infect other people (which would be a lot harder to study). This is why the first doses are going to those who are most at risk from either catching it (health care providers) or suffering the worst effects (older people, especially those either hospitalized or requiring out-patient treatment, care home residents)* rather than young super-spreaders.

* - of course depending on whether it can be distributed, and how much actually arrives, because I keep hearing contradictory things i.e. it can stay in a fridge for a week vs. an entire batch of 975 has to be used within 6 hours of opening it and can't be moved more than once or something. So health care workers have been de-prioritized but it's still not clear to me if it can actually be delivered to care homes. Except in Scotland where they interpreted the cold-chain rules differently. Or maybe it's just because it's colder up there.

Long term data in a well-vaccinated population in which there are few enough infections to do contact tracing but still a high enough number of infections to get decent statistics will eventually answer this to some extent. Or at least, enough of an extent.

I may have mentioned that

the Oxford vaccine reduces asymptomatic transmission

but we need to wait for them to actually publish their results properly.

I previously raised the point that

if it leads to the same amount of infectivity but fewer symptoms then you'll get more asymptomatic spread.

but of course we don't know if it reduces "amount of infection" overall, such that a severe case would instead be a mild case, a mild case would instead be an asymptomatic case, and an asymptomatic case would not be a case at all, or if it cuts out all of the severe cases and a lot of the mild cases but leaves the asymptomatic cases.

Also bear in mind that swabs can still pick up extremely low levels of "dead" viral RNA being shed after your body has fought off the infection.

You idiot.

[AMS]

I'm not an proper expert in this either, but the vaccine should reduce your ability to spread a virus, otherwise the concept of herd immunity doesn't work.

The big thing you want from a vaccine *for infectivity* is to generate a strong T-cell response. These are the part of the immune response that recognise and kill off infected cells. Infected cells are the "factories" for producing more virus, so shutting them down quickly is key to stopping viral replication. So that will reduce the amount of virus you're producing and therefore able to breathe out and pass on. Whether that's enough to eliminate transmission to others, I don't know, but it will definitely reduce the chances.

(Antibodies also matter but are more about blocking the virus from infecting more cells. People talk about them more because they are much easier to measure from a blood sample.)