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Are they going to have the balls to go after the ones going to Israel?
Pretty pleased I did the Novavax trial now as its been a hassle at times! But it’s been worth it!!!
I wonder if they will unblind me?!
https://www.nytimes.com/interactive/2020/health/novavax-covid-19-vaccine.html is worth a read. Now compare that 89.3% including the half with the UK variant of concern with the OX/AZ 62.1% for SD/SD. The Novovax is the first of the more traditional vaccines that use protein subunits. and the efficacy looks a lot like mRNA. I hope they can make a lot of it. It's good news for more traditional technologies.
@FFJA they should offer you active after the trial if you received placebo, no?
The organisation i work for just released this video.
A bit weird. Not sure how i feel about it. Political showboating, or a genuine attempt to get people to hold on until vaccination starts (aiming for end Feb, early March)? There's a risk of being complacent.
That Novovax news does look promising.
Apologies as I suspect this question has been posed a few times... but...
The 'raw materials' for vaccines, how stressed is the supply side of that part of the manufacturing process?
Also, Great Barrington declaration, WTF is that still doing the rounds?
Oh, and Valveva. Does anyone know if they're likely to be looking for volunteers in the next couple of months?
Or any others tbh.
Edit, I'll just Google vaccine volunteers in the meantime
@FFJA the Oxford trial offered unblinding to volunteers at the point that they were offered an nhs vaccine. In order to not be disadvantaged by volunteering. I’d expect other trials to do the same.
Once again, thank you for this thread.
Back in March, I spent a lot of time searching the internet for information and getting all sorts of conflicting results. Over that time I have found myself googling less, instead, listening to the useful podcasts posted on here and soaking up the science based evidence.
To stay sane during this pandemic, someone like me with a poor education, (my own fault) has had to choose to 'hang their hat' somewhere. Thankfully for me I chose this thread. Lots of other people weren't so lucky and have 'hung their hats' somewhere else, so their information is a lot less factual.
My other half is on the Novavax trial and was told at her appointment this week that once the interim results were published they would be un-blinded and those on the placebo offered the vaccine and the booster 4 weeks after that
Some might find this interesting
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00183-5/fulltext
Headline;
Resurgence of COVID-19 in Manaus, Brazil, despite high seroprevalence
Not so much in South Africa though… Not safe until we are all safe and all that.
I'd say the opposite, good news for the likes of south africa and their variant, the Novavax has been tested against our own variant in trials, and responded well by the looks of it, so should give their government hope.
Wee question on these variants for folks, do they evolve in areas where the virus is rampant? Or is that cause of the rampant spread? SE England, Manaus, SA, California, all areas with high levels, all have more transmissible variants emerging.
If so, it reinforces the point @seosamh77 made in his post, we should be looking to vaccinated our vulnerable groups then move on to the rest of the planet, otherwise we become some kind of leper island with no one leaving or coming in?.
@docrobster thanks for that. I’ve been seconded with work to a vaccine hub to make cups of tea so I may give them a call as I don’t want to take a left over dose that could more usefully go to someone else.
The lancet paper is interesting and worrying. I hope they can get the extra data to identify which of the factors are driving it
Well I can't say this was a surprise...
BBC News - Covid: Data shows outbreaks in England's offices in lockdown
https://www.bbc.co.uk/news/uk-55843506
Nor the stats on here - MrsMC is a frontline social worker and got her first jab last Wednesday, after 10 months relying on a mask, hand gel, and people's vague grasp of what 2 metres is, including having to take a DV family for emergency medical exams in our car when the Police refused as it failed their risk assessment.
BBC News - Covid: Are teachers more at risk of dying?
https://www.bbc.co.uk/news/55841748
I’d say the opposite, good news for the likes of south africa and their variant
6% of the SA participants had HIV, when these were removed from the analysis, efficacy rose from 49% to 60% (1.3 times more likely not to work if HIV +ve). That's the same as the OX/AZ efficacy against a strain that presents a significant challenge. This is good news. It will never be a one-shot-and-done measles jab, but the time between vaccine changes (annual for influenza) is something that needs time to settle down as the virus becomes seasonal and endemic. That will take a few years.
Seriously, this is very good news for the first non-genetic (i.e., traditional) vaccine platform. The single shot J&J vaccine should read out next week.
Thanks FFJA You're a star.
My NHS nursing friend had her jab on Tues and was ill for about 24 hours, feeling a much better now. She also had C19 a year ago and still has the anti-bodies.
I think it was mentioned earlier that this seemed to be common, or was it dismissed as coincidence (that people who had had the virus got ill after their vaccination).
A neighbour's sister in law also quite ill after her jab, however I don't know if she had C19 or not.
My Missus has perked up today after her bad vaccination reaction. We're 90% sure she had Covid last Spring (not tested but colleagues were positive). Again, only anecdote.
OT in a way but interesting development in the EU/AZ dispute.
Council President Charles Michel has now outlined the legal possibilities for releasing the licences by means of Article 122. Article 122 can help us to take full advantage of market opportunities in vaccine production. The Corona crisis is justification enough to use this emergency article in the EU Treaty. Europe must now do all it can to expand vaccine production. AstraZeneca's vaccine can be produced by many other companies. We should make full use of global production capacities so that a vaccine can be made available to everyone in the world quickly. Indian producers, for example, have already offered to support production on several occasions. AstraZeneca should be generously compensated so that the vaccine can be transferred into the public domain and produced with all the forces of the market.
One of the conditions in the Oxford/Gates/AZ alliance was not for profit until later so generous compensation seems a bit extravagant but then its other people's money they are spending.
I seem to remember UVdL having form with contracts going pear shaped when she was defense minister in Germany. I think she got the EU gig to get her out of the way.
That is all just noise.
By the time the other companies are fully up and running (with approved production) we would be in aug or sept anyway i suspect. The vaccine has been licensed to a while load of places round the world anyway so what the EU think it would achieve other than a political statement i have no idea, it wouldn't change the current vaccine shortages anyway.
As tired said many pages back there is a limit on total global vaccine production anyway from a facilities and capacity stand point.
The EU have published a heavily redacted version of the AZ Vaccine contract:
Section 5 - Manufacturing & Supply, seems to support what AZ have been saying from the outset:
"5.1 AZ shall use its Best Reasonable Efforts to manufacture the Initial Europe Doses within the EU for distribution, and to deliver to the European Hubs after EU Marketing Authorisation"
The contract drafting is pretty poor on several counts:
- it's arguable that the manufacturing doesn't need to commence until AFTER the marketing authorisation - which to date has still not been given.
- the commencement date for manufacturing isn't specifically addressed
The contract does also refer to production sites in the UK but again, because 5.1 is poorly drafted the intent on either side isn't crystal clear.
In any event, AZ can legitimately say that "best and reasonable efforts" when their existing production capacity is completely utilised effectively allows them to deliver little or no finished goods until such time as there is capacity to make doses for the EU.
That is all just noise.
This!
I have huge sympathy for AZ here. Making stuff in BiotechLand is hard. My colleagues on the teams I work on tell us this all the time. But they come through and are largely taken for granted. On these unprecedented timescales nothing should be taken for granted. Do people not believe that everyone is making their "best and reasonable efforts". In every company? In all disciplines? And the regulators everywhere are doing the same, btw. The amount of interaction and advice they are delivering is also unprecedented.
I've just scanned the (indeed heavily redacted) contract and whilst it would clearly be helpful to see the UK one in order to get the full picture, on first read the EU's claims seem to be something of a stretch.
As above, there is no specific timeline for delivery of the "Initial Europe Doses" and in any event these are to be manufactured within the EU (whereas the vast majority of the UK ones are manufactured in the UK). The contract does explicitly envisage a situation whereby AZ is "unable to deliver on its intention to manufacture the Initial Europe Doses and/or Optional Doses under this Agreement in the EU" but the contractual resolution is not to divert from elsewhere but for the EU to make other potential manufacturing sites available to AZ.
I cant help but think the noise from the EU is intended for domestic politics as much as anything else.
I cant help but think the noise from the EU is intended for domestic politics as much as anything else.
I think so. They have a population which is watching other countries getting into double digit percentages of population vaccinated and starting to get highly miffed about it. Why not blame AZ, and by association, us? I'm sure our government wouldn't hesitate to do the same.
I have huge sympathy for AZ here.
AZ only got the license after Bill Gates intervened with Oxford.
The original intention was to make the vaccine available for production by anyone anywhere.
Looks like grandstanding from the EU. No doubt they would look to get some of the UK-bound vaccines through arbitration.
I cant help but think the noise from the EU is intended for domestic politics as much as anything else.
Yes. The media from their own member states have called them out, so now the are using the Brexit strategy to divert attention from their cock up(or own risk management strategy). Somewhat ironic.
Mariner - do you have any more reputable sources for that instead of some obscure South florida website?
Watch the BBC documentary that was in about the Oxford development, they explained why they chose az
I cant help but think the noise from the EU is intended for domestic politics as much as anything else.
Sadly the RW press over here is also using it to grandstand to its audience. Sad to see the vaccine issues being weaponised on both sides.
Someone on legal twitter has just pointed out the EU deal has a Force Majeure clause which includes epidemics as a reason not to be liable for delays. Not so clever.
I'm with TiRed on this. Biologicals supply chains have a whole bunch of variables in play (quality, batch yield, consistency of batch yield and specific issues relating to small variations in equipment on similar lines) that typically take a long time to resolve. It typically takes anywhere from 9-18 months to optimise the end to end process to address these factors.
In this case AZ have achieved something at incredible pace.
They have been altruistic in their approach from the outset - their costs are open book, they've volunteered to take no profit and arguably could have sat back and kept their lines running to churn out something profitable.
It's absolutely appalling to see the way the Oxford / AZ partnership has been used as a political football by Brussels, inferring AZ's CEO has lied, AZ has been dishonest, AZ has reneged on binding commitments etc etc but I suppose it shouldn't surprise anyone - the Commission did the same with Brexit.
Hopefully this thing will go away sharpish once member states apply their own pressure.
The focus should be doing everything possible to support bringing all of the successful vaccine candidates to market - and ensuring we massively ramp up supply to the developed world. For its part, the UK looks like it will be donating 200m+ doses to other countries based on the positions we hold and the commitments made by government ministers.
I think we've also donated more to the global funding pool that any other country (or at least it was reported as such on the radio yesterday) so perhaps the EU could focus on that a bit as well.
EU do look to be shaky ground, looks like they had clauses they thought covered them
But will it end up in a Belgian court
?
https://twitter.com/GreatStrides65/status/1355122772763176960?s=19
AZ do add a warranty at the end to say they don't have any convicting orders for initial doses, which doesn't help their case & can see why EU might think they are being shafted
https://twitter.com/OSchonrock/status/1355122749354733569?s=19
In this climate, how would conflict be defined and such clause enforced? Given that AZ are producing as much as they can, do they expect all production to go to EU?. What is their endgame other than stirring up shit?
So Janssen single does comes in at 66% - how does that compare to a single dose of any of the others?
In this climate, how would conflict be defined and such clause enforced? Given that AZ are producing as much as they can, do they expect all production to go to EU?. What is their endgame other than stirring up shit?
Partly arse covering, but partly getting AZ to send more vaccine, including from UK as contract includes UK in EU vaccine source & says there's no other conflicts....
Be interesting to know if UK gov aware UK sites classed as EU manufacturing
UvDL does seem to be clutching at straws a bit. Allegedly her quote is that the "best intentions" bit only really applied when AZ weren't sure if they would even be able to create a vaccine. Now that they have created one that clause no longer has that meaning and they are due all the vaccines they want and AZ better pick it up. Yet the vaccine still isn't approved for use in the EU yet so not even sure what point she is trying to make
AZ do add a warranty at the end to say they don’t have any convicting orders for initial doses, which doesn’t help their case & can see why EU might think they are being shafted
It doesn't impact it at all, the Initial European Doses are clearly those from the EU factories -see 5.1. - UK factories not included. UK factories only included in 5.4 which is dealing with the wish for the vaccines generally (not just the intial ones) to be manufactured in the EU and UK.
Essentially the contract envisages the possibility of vaccines coming from the UK, but only commits the production from the EU plants, which is what AZ has been saying all along.
Sounds like a very complex dispute to resolve in courts, not just the contracts but in light of the material considerations that constitute the context.
It wouldn't seem reasonable, prima facie, that the EU get an iron-clad guarantee of vaccines vis a vis the UK who ordered first.
By the time it goes through the courts the pandemic will be over with!
I never wanted to leave the eu, but since they played hardball to ensure we got the minimum acceptable deal going, I think it's slightly ironic that the shoe is now well and truly on other foot
Personally, if we are going to give out stocks away, id rather it goes to a developing nation, rather than the eu which has a problem largely of its own making.
I would say mistaken, I think in the rush to report people have misread clause 5.4 as altering the definition of EU for the whole of the clause rather than just the sub clause.
how does that compare to a single dose of any of the others?
It says that they'll likely be testing a two-dose regimen. Response is the same as OX/AZ two standard doses, but a wider population. It's good enough to use and could be made better. That's positive. Only Merck has really thrown in the towel so far (The Queensland vaccine was a non-starter due to HIV test interference).
Extra confusing as further down 5.4 lumps in initial & additional doses
As being made in EU, which for terms of 5.4 includes UK
