Developing the Covid-19 vaccine

[jdc]

I'm wondering what kinds of plans and scenarios are being developed for the rollout. It would be a bit embarrassing if after a vaccine is developed there's a chaotic unpleasant scramble within and between countries to vaccinate people.

That's easy. USA first, then other rich countries, then ROW. Different countries will have different strategies for vaccinating different sectors of the population. Within the UK it's cabinet ministers & tory donors first, then healthcare workers, then old plebs, then young plebs.

[discovolante]

I'm wondering what kinds of plans and scenarios are being developed for the rollout. It would be a bit embarrassing if after a vaccine is developed there's a chaotic unpleasant scramble within and between countries to vaccinate people.

That's easy. USA first, then other rich countries, then ROW. Different countries will have different strategies for vaccinating different sectors of the population. Within the UK it's cabinet ministers & tory donors first, then healthcare workers, then old plebs, then young plebs.

Weren't we told that young plebs aren't getting vaccinated at all unless they are sick young plebs?

[jdc]

I think "we've got a vaccine nearly ready" is such a huge claim that I want to wait for pretty strong evidence before I believe it, and instinctively I mistrust marketing statements from Big Pharma.

Depends what you mean by "nearly" and "ready", I suppose. I'll assume 'within weeks' for the nearly part seeing as that's where we came in.

They're already manufacturing vaccines but if you're using "ready" to mean "available to all" f.ck knows how long that'll take. No idea how far on they are with manufacturing the Oxford vaccine but they did say they were starting back in June: https://www.bbc.co.uk/news/business-52917118 Meanwhile, Novavax delayed the start of their phase 3 trial due to "delays in scaling up vaccine manufacturing".

Would emergency authorisation count, or would you be after full approval?

[jdc]

I'm wondering what kinds of plans and scenarios are being developed for the rollout. It would be a bit embarrassing if after a vaccine is developed there's a chaotic unpleasant scramble within and between countries to vaccinate people.

That's easy. USA first, then other rich countries, then ROW. Different countries will have different strategies for vaccinating different sectors of the population. Within the UK it's cabinet ministers & tory donors first, then healthcare workers, then old plebs, then young plebs.

Weren't we told that young plebs aren't getting vaccinated at all unless they are sick young plebs?

I hadn't heard that. How young is young?

I'm sure I'll be fine for a jab, mind. There's no way I count as young.

[discovolante]

That's easy. USA first, then other rich countries, then ROW. Different countries will have different strategies for vaccinating different sectors of the population. Within the UK it's cabinet ministers & tory donors first, then healthcare workers, then old plebs, then young plebs.

Weren't we told that young plebs aren't getting vaccinated at all unless they are sick young plebs?

I hadn't heard that. How young is young?

I'm sure I'll be fine for a jab, mind. There's no way I count as young.

https://www.ft.com/content/d2e00128-788 ... e51355a751

I suppose you might be over 50 by the time there's a vaccine.

[jdc]

Thanks. They're not being as clear as I'd like there.

There’s going to be no vaccination of people under 18. It’s an adult-only vaccine, for people over 50, focusing on health workers and care home workers and the vulnerable.

So no to under-18s, yes to over-50s, and no hint either way for 18-49.

The latest advice from the Joint Committee on Vaccination and Immunisation... health and social care workers would be a high priority... places older adults in care homes and care home workers at the top of its priority list and then all adults aged 50 to 80 next on the list, with older age groups first.

Suggests it's care home workers and over-50s and that's it. Nothing on under-50s.

The JCVI said there had not been a decision on who would be eligible for the vaccine.

So forget the previous quote because they're actually not sure yet.

The health department said it was looking at advice from the JCVI, adding that it wanted “as many people as possible to access a Covid-19 vaccine”

So definitely ignore that quote. The govt don't seem to be sure they'll even take the JCVI's advice if and when they do make up their minds.

f.ck it, it'll probably be available in Boots for £30 a shot at some point anyway. Be weird if I could pop down there for my flu vaccine every year but not get a covid jab.

[discovolante]

I hope you're right, jdc. About whatever it is. But something a bit better than No Vaccine For You, anyway.

[Gfamily]

Weren't we told that young plebs aren't getting vaccinated at all unless they are sick young plebs?

Wasn't there a risk raised about possible adverse effects of a vaccine; meaning that the risk/benefit ratio varies depending on the risk of serious/long term side effects if you do get Covid19
So - by default, young people would be better off (in terms of risk) by not having the jab.

ETA - at least, until there is more awareness of adverse effects

[discovolante]

Weren't we told that young plebs aren't getting vaccinated at all unless they are sick young plebs?

Wasn't there a risk raised about possible adverse effects of a vaccine; meaning that the risk/benefit ratio varies depending on the risk of serious/long term side effects if you do get Covid19
So - by default, young people would be better off (in terms of risk) by not having the jab.

ETA - at least, until there is more awareness of adverse effects

Ah yes there was that too.

On the plus side, if us young'uns did get the vaccine, we'd have to wait until last so if it did cause all sorts of problems we'd probably find out first.

Long covid seems to be affecting quite a high proportion of people though.

[Bird on a Fire]

I think "we've got a vaccine nearly ready" is such a huge claim that I want to wait for pretty strong evidence before I believe it, and instinctively I mistrust marketing statements from Big Pharma.

Depends what you mean by "nearly" and "ready", I suppose. I'll assume 'within weeks' for the nearly part seeing as that's where we came in.

They're already manufacturing vaccines but if you're using "ready" to mean "available to all" f.ck knows how long that'll take. No idea how far on they are with manufacturing the Oxford vaccine but they did say they were starting back in June: https://www.bbc.co.uk/news/business-52917118 Meanwhile, Novavax delayed the start of their phase 3 trial due to "delays in scaling up vaccine manufacturing".

Would emergency authorisation count, or would you be after full approval?

Well I'm not going to pretend to be on top of the ins and outs of vaccine approval, and I suspect this one might be a special case anyway. I reckon it's likely to be offered to vulnerable groups with less thorough testing than usual, and that's probably ok as there'll be loads of surveillance.

I think I'm really just thinking about when they start giving it to members of the public outwith the context of a trial, so yeah emergency authorisation is probably in - it's still some kind of endorsement from an independent regulator rather than PR BS.

And I'm not convinced that'll happen this year. I wouldn't bet big money on next year either, but that might be unreasonably pessimistic of me.

[jdc]

I never bet big money. I'd bet small money on spring though if we're talking emergency auth. Even the slightly more pessimistic quotes from non-pharma bods seem to suggest it's fairly likely we'll have some efficacy data this year.

I wondered how long we'd need to add on for approval and from one of the April articles: "Hill said the best case scenario would be for regulators to grant it “emergency use approval” - something that could be achieved within six weeks beyond the point at which data show whether it is effective."

So, this year (ish) for phase 3 trials to give us a bit of data and add six weeks on for emergency approval, so Spring 2021. Willing to bet 5p on this if you fancy a wager. Actually, spring doesn't start till 20th March. I'll have 10p on spring and 5p on winter. I've another 5p that says Boots have it on offer by August 2021.

Ooh, this gambling lark's dangerously moreish you know. I think I'd better quit it.

[Bird on a Fire]

That seems reasonable put like that. I'm just anticipating unexpected stumbling blocks to emerge.

I'll take your bet - either we get a vaccine, or I get some money. 2021 is looking up.

[AMS]

Would the roll-out model be based on the annual flu vaccine programme? That seems an obvious starting point.

(Though I wouldn't put it past this government to f.ck it up via a Serco contract.)

[jdc]

Would the roll-out model be based on the annual flu vaccine programme? That seems an obvious starting point.

(Though I wouldn't put it past this government to f.ck it up via a Serco contract.)

Makes sense and it looks like this year's flu vaccine target may be the same as their prospective covid target. (One article said the normal flu jab take-up was 15m and this year they wanted to make it 30m. They've also quoted 30m for a covid vaccine.)

[jdc]

That seems reasonable put like that. I'm just anticipating unexpected stumbling blocks to emerge.

I'll take your bet - either we get a vaccine, or I get some money. 2021 is looking up.

Consolation betting - same thinking my dad used when he went to the bookies to put £200 on the UK voting for Brexit.

I think stumbling blocks have already been a factor in delaying the progress so far (not sure how unexpected they've been), in terms of things like Novavax having trouble scaling up or J&J/AZ pausing their trials. I suppose we could see more things cropping up but I'd have thought most of the opportunity for stumbling blocks would be past by now?

They've got through phase 1 and 2 trials, and are well on with phase 3 so various hurdles like problems finding enough recruits or not getting the hoped-for phase 1/2 results have already not cropped up. We've already been through some of the others (as above). What's left? Disappointing phase 3 results comes to mind (please no), or more of the adverse events that have briefly paused trials. After that isn't it mostly about passing regulatory checks? I don't know much about this element of vaccines, I'm usually reading about alleged problems with existing vaccines rather than the approval process for new jabs. Shame tomp isn't here, I bet he'd know.

[jimbob]

Thanks for keeping track of these, jdc.

I think "we've got a vaccine nearly ready" is such a huge claim that I want to wait for pretty strong evidence before I believe it, and instinctively I mistrust marketing statements from Big Pharma.

I'm wondering what kinds of plans and scenarios are being developed for the rollout. It would be a bit embarrassing if after a vaccine is developed there's a chaotic unpleasant scramble within and between countries to vaccinate people.

You wonder because you're not a paying guest for an event held by a company that employs the chair of the UK Vaccine task force:

https://twitter.com/Gabriel_Pogrund/sta ... 1010971649

EXC: The chair of the UK's vaccine task force showed “official sensitive” government documents to a $200-a-head event for elite US venture capitalists last week

Kate Bingham, a Boris Johnson appointee, showed guests a list of products which the government is set to invest in 1/

Bingham spent 1hr with the “networking event” for women in private equity held by a Massachusetts firm

Her PowerPoint included a sensitive internal breakdown of vaccines.

Blue: "We haven’t necessarily signed contracts with all of them so far. But they’re all in our sights.” 2/

Bingham combines the role with her job as managing director of SV Health Investors, a private equity firm

Like Dido Harding, she is married to a Conservative MP: Treasury Minister Jesse Norman.

She also went to school with Rachel Johson

3/

In her talk she said she expects all over-50s to have vaccine available by Easter

But she also showed docs predicting up to 40% may never take it

There's “concern” over whether vaccines will “actually work". There isn't “any data” on whether it works for those with flu 4/

As a result officials are mulling a major “three-visits” programme that will see vulnerable given on flu vaccine and two for COVID next year

She also disclosed that the government will “literally dispatch roving teams on motorbikes” to deliver the vaccine to the vulnerable 5/

There is an important “debate” to be had, she added, about whether or not to vaccinate children.

As it stands, it is "highly unlikely" we'll have legislation to make vaccines mandatory and, therefore, improbable there will be herd immunity

6/

Sir Alistair Graham, a former chairman of the Committee on Standards in Public Life, said it was “seriously ill-advised” to give. “It must raise a question as to whether she is a suitable person to be chairing a task force like that,” he said. /7

@JonAshworth
said: “‘There are serious questions here as to why this information was shared at an international online conference where attendees paid for access. We are in a public health crisis and this information that ministers should be shared with the public.” 8/

[Martin Y]

Would the roll-out model be based on the annual flu vaccine programme? That seems an obvious starting point.

(Though I wouldn't put it past this government to f.ck it up via a Serco contract.)

Makes sense and it looks like this year's flu vaccine target may be the same as their prospective covid target. (One article said the normal flu jab take-up was 15m and this year they wanted to make it 30m. They've also quoted 30m for a covid vaccine.)

I wonder if they can meet that demand. I got it after (vulnerable) Mrs Y got a date to come for one, she asked if I could have one too and they said yes.
Couple of weeks later I got my own appointment but soon after they cancelled that appointment as they had run out. A FB friend said he and his wife (older than us) couldn't seem to get it either.

[jdc]

They certainly seem to have struggled, yes.

GPs in England left waiting up to a month for flu vaccine supplies

GPs forced to pay for own flu jabs due to ‘massive’ stock shortages

Major wholesaler says all its vaccination stock is taken for flu season

Meanwhile, according to https://www.which.co.uk/news/2020/10/fl ... d-to-know/, the government insists there are no shortages. Which? go on to say that:

Boots has suspended bookings and walk-in appointments for flu shots for the under 65s. Lloyd’s, Well and Tesco pharmacies have all suspended online booking for the paid-for flu jab. When we checked, we were also unable to book an appointment on the Superdrug website. Meanwhile, some GP surgeries are reporting waiting times of up to a month. Flu vaccinations are being prioritised for those who need them most, so if you are in this group you should be able to access one. If you don’t fall into this category and are having trouble getting a vaccine, don’t panic – it should get easier to arrange one over the coming weeks.

[gosling]

I'm taking part in the Phase 3 trials of the Novovax vaccine - testing for efficacy and if it can be combined with the flu jab. First dose last Monday, second in two weeks' time, then follow up tests in 3, 6 and 12 months. It's not going to be quick.

Oh, and absolutely no reaction so I think I got the saline placebo.

[shpalman]

Scientists have found the strongest evidence yet that people who recover from Covid may mount a much faster and more effective defence against the infection if they encounter the virus again

So possibly not a total waste of time to develop a vaccine.

[bob sterman]

In relation to the mutated strain of SARS-CoV-2 recently found in mink in Denmark...

https://www.theguardian.com/world/2020/ ... be-worried

Some have suggested that we don't need to worry too much about implications for vaccine effectiveness as vaccines can be "tweaked" like influenza vaccines.

But surely new strains pose a major problem for the Oxford vaccine in particular? They are using a chimpanzee adenovirus vaccine vector to induce a recipient's own cells to produce SARS-CoV-2 spike proteins to generate an immune response. Sure you could tweak this to modify the exact nature of the SARS-CoV-2 spike proteins being produced - but my understanding was that the recipient could also generate an immune response to the specific adenovirus vector used to deliver the spike protein code.

So if you wanted to vaccinate a second time, against a slightly different spike protein, then you'd need to use a different adenovirus as the vector. Which surely puts you back to needing early safety testing? Particularly since the chosen adenovirus would need to be different enough to the original to evade the immune response.

Obviously not a problem for other vaccine technologies - but this Oxford vaccine doesn't sound like it's something that can be easily tweaked.

Or maybe recipient immunity against the vector is not such a big deal for non-replicating viral vectors? And only a real problem for replicating vectors? Anyone know?

[AMS]

I'm not sure of the answer, but it's a good question.

One point to note is that the spike protein is big - over 1000 amino acids - and your immune response will be spread around that surface. One or two amino acid changes won't abolish very much of that response if it's sufficiently diverse. Neutralising antibody epitopes around the ACE2 binding site are more critical, but these might be more functionally constrained for the virus, but it's something people will be watching closely.

(I'm not sure if the full spike is in the vaccine anyway. 1000 aa = 3000 bp of DNA, which is a lot to fit into a viral genome. )

[Millennie Al]

(I'm not sure if the full spike is in the vaccine anyway. 1000 aa = 3000 bp of DNA, which is a lot to fit into a viral genome. )

I don't know either, but obviously SARS-CoV-2 fits it in (and there are bigger viruses).

[Rich Scopie]

BBC News is reporting that Pfizer are claiming 90% efficacy for their version of an mRNA COVID-19 vaccine in preliminary results of third phase testing. Cautious good news. Safety testing data should be available in a couple of weeks.

[Woodchopper]

BBC News is reporting that Pfizer are claiming 90% efficacy for their version of an mRNA COVID-19 vaccine in preliminary results of third phase testing. Cautious good news. Safety testing data should be available in a couple of weeks.

Here’s some info from the company: https://investors.pfizer.com/investor-n ... fault.aspx