Developing the Covid-19 vaccine

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Herainestold
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Re: Developing the Covid-19 vaccine

Post by Herainestold » Sat May 08, 2021 5:35 pm

The WHO was not so thrilled about Sinopharm's data on side effects.
GENEVA, Switzerland: World Health Organization experts have said they have "very low confidence" in data received from Chinese state-owned drugmaker Sinopharm on side-effects caused by its COVID-19 vaccine.

The WHO document spoke of "evidence gaps" in data that evaluates protection against side-effects.

"We have very low confidence in the quality of evidence that the risk of serious adverse events in individuals with comorbidities or health states that increase risk for severe COVID-19 following one or two doses of BBIBP-CorV is low," the document said, according to Reuters.
https://www.bignewsnetwork.com/news/269 ... covid-data
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Re: Developing the Covid-19 vaccine

Post by shpalman » Sun May 09, 2021 1:11 pm

Europe's medicines regulator is reviewing reports of a rare nerve-degenerating disorder in people who received AstraZeneca's (AZN.L) COVID-19 vaccine
... the safety committee of the European Medicines Agency (EMA), is analysing data provided by AstraZeneca on cases of Guillain-Barré syndrome.
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bob sterman
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Re: Developing the Covid-19 vaccine

Post by bob sterman » Sun May 09, 2021 4:47 pm

shpalman wrote:
Sun May 09, 2021 1:11 pm
Europe's medicines regulator is reviewing reports of a rare nerve-degenerating disorder in people who received AstraZeneca's (AZN.L) COVID-19 vaccine
... the safety committee of the European Medicines Agency (EMA), is analysing data provided by AstraZeneca on cases of Guillain-Barré syndrome.
That wouldn't be unprecedented - Guillain-Barré is a recognised rare side effect of some vaccines.

For the 1976 influenza vaccine there was apparently 1 additional case of GBS per 100,000 persons vaccinated. Down to 1-2 per million for the 2009 vaccine.

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Re: Developing the Covid-19 vaccine

Post by Woodchopper » Thu May 13, 2021 7:48 am

Adults are more likely to report mild and moderate side-effects after mixing doses of the AstraZeneca and Pfizer Covid vaccines, a study indicates.
Chills, headaches and muscle pain were reported more frequently when different vaccine doses were combined.
Any adverse reactions were short lived, with no other safety concerns.
https://www.bbc.com/news/health-57075503

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Re: Developing the Covid-19 vaccine

Post by shpalman » Thu May 13, 2021 8:31 am

Woodchopper wrote:
Thu May 13, 2021 7:48 am
Adults are more likely to report mild and moderate side-effects after mixing doses of the AstraZeneca and Pfizer Covid vaccines, a study indicates.
Chills, headaches and muscle pain were reported more frequently when different vaccine doses were combined.
Any adverse reactions were short lived, with no other safety concerns.
https://www.bbc.com/news/health-57075503
"The same real differences applied for other symptoms such as chills, fatigue, headache, malaise and muscle ache," Prof Snape, the trial's chief investigator, said.
adding that perhaps they could try the episkey spell if willow bark portion didn't do the trick.
"One things it's telling us is that you wouldn't want to vaccinate a ward full of nurses on same day [with mixed doses of different vaccines], because you might have more absenteeism absences the next day."
I hope this means that when I get my second AZ dose on Monday, it won't give me the same reaction that the first one did.
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Re: Developing the Covid-19 vaccine

Post by shpalman » Fri May 14, 2021 7:10 am

Those WHO vaccination cards...

Image

I can't figure out what words fit in a blanks?
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Re: Developing the Covid-19 vaccine

Post by headshot » Fri May 14, 2021 8:44 am

shpalman wrote:
Fri May 14, 2021 7:10 am
Those WHO vaccination cards...

Image

I can't figure out what words fit in a blanks?
Vaccines bring us closer to 5G zombie friends apocalypse.

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Re: Developing the Covid-19 vaccine

Post by shpalman » Fri May 14, 2021 6:00 pm

shpalman wrote:
Fri Feb 19, 2021 6:12 pm
The authorities have allowed it to enter Phase II

They're hoping to complete Phase III by the summer and start production in September.
Some other authority has blocked its funding for some reason.
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Re: Developing the Covid-19 vaccine

Post by Herainestold » Sat May 15, 2021 12:49 am

shpalman wrote:
Fri May 14, 2021 6:00 pm
shpalman wrote:
Fri Feb 19, 2021 6:12 pm
The authorities have allowed it to enter Phase II

They're hoping to complete Phase III by the summer and start production in September.
Some other authority has blocked its funding for some reason.
They will need a couple million subjects in phase III trials to make sure there are no blood clot issues
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Re: Developing the Covid-19 vaccine

Post by shpalman » Mon May 17, 2021 7:27 pm

Johnson & Johnson is also failing

That was the EU's great hope after AZ was teh fail. There's hardly any Modernas here either; turns out instead that only Pfizer, the new technology needing the special fridges, is really working out.
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Re: Developing the Covid-19 vaccine

Post by Herainestold » Mon May 17, 2021 7:37 pm

shpalman wrote:
Mon May 17, 2021 7:27 pm
Johnson & Johnson is also failing

That was the EU's great hope after AZ was teh fail. There's hardly any Modernas here either; turns out instead that only Pfizer, the new technology needing the special fridges, is really working out.
Whoda thunk it?

Whatever happened to Nova vax have they given up?
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Re: Developing the Covid-19 vaccine

Post by jdc » Mon May 17, 2021 9:06 pm

Herainestold wrote:
Mon May 17, 2021 7:37 pm
shpalman wrote:
Mon May 17, 2021 7:27 pm
Johnson & Johnson is also failing

That was the EU's great hope after AZ was teh fail. There's hardly any Modernas here either; turns out instead that only Pfizer, the new technology needing the special fridges, is really working out.
Whoda thunk it?

Whatever happened to Nova vax have they given up?
Delayed... https://www.pmlive.com/pharma_news/nova ... ne_1369844
Novavax has announced that it will not submit its COVID-19 vaccine to regulators in the US, UK and Europe until the third quarter of 2021

Erck said that issues with “getting all the manufacturing data put together [and] getting all the very complex biologic assays that we have to do developed” has taken longer than expected.

Novavax is also expecting data from a US-based phase 3 trial of its COVID-19 vaccine, involving 30,000 volunteers, in “a few weeks”, according to Erck. Erck added that this trial data will reveal how effective Novavax’s vaccine is against currently circulating variants in the US and Mexico

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Re: Developing the Covid-19 vaccine

Post by headshot » Tue May 18, 2021 10:56 am

The EMA says Pfizer can be stored outside the cold chain for longer than originally thought: https://www.theguardian.com/society/202 ... d-extended

Which is great for poorer countries without the resources...but it's still expensive per dose.

Also, Pfizer have said that there's no evidence the vaccine will need updating to protect against variants. *citation needed

https://www.theguardian.com/society/202 ... d-extended

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shpalman
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Re: Developing the Covid-19 vaccine

Post by shpalman » Tue May 18, 2021 11:01 am

headshot wrote:
Tue May 18, 2021 10:56 am
...Also, Pfizer have said that there's no evidence the vaccine will need updating to protect against variants...
... and there's no evidence that it doesn't? Or just evidence that the booster they want to sell everyone every year isn't necessary as long as you have a third shot or what?
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Re: Developing the Covid-19 vaccine

Post by headshot » Tue May 18, 2021 11:13 am

shpalman wrote:
Tue May 18, 2021 11:01 am
headshot wrote:
Tue May 18, 2021 10:56 am
...Also, Pfizer have said that there's no evidence the vaccine will need updating to protect against variants...
... and there's no evidence that it doesn't? Or just evidence that the booster they want to sell everyone every year isn't necessary as long as you have a third shot or what?
*adopts mock French accent* But of course!

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Re: Developing the Covid-19 vaccine

Post by Woodchopper » Thu May 20, 2021 9:07 pm


BioNTech SE Chief Executive Ugur Sahin said on Thursday the COVID-19 vaccine it developed with Pfizer Inc (PFE.N) is expected to be 70% to 75% effective in protecting against infections caused by the coronavirus variant first detected in India.

"So far we've had the chance to test our vaccine against more than 30 variants of the virus. It has proven effective against mutations so far," said Sahin, a German scientist with Turkish parents, speaking Turkish in televised comments.

Tests this week have focused on the India variant, he said. "We expect (our vaccine) to protect against infections by 70% to 75%," he said after virtually attending the Turkish government's science council meeting.

[...]

A BioNTech spokeswoman said lab tests show that when the blood of vaccinated people is exposed to the Indian variant, 25% to 30% fewer antibodies were binding to the virus than would have been the case with the original coronavirus.

That suggests protection against the variant, whether symptomatic or not, is a bit lower but still 70% to 75%.

It is about 95% effective against the original version of the virus.
https://www.reuters.com/business/health ... 021-05-20/

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Re: Developing the Covid-19 vaccine

Post by Woodchopper » Fri May 21, 2021 8:29 am

Pfizer, Moderna vaccines effective against Indian variants: study
https://www.france24.com/en/live-news/2 ... ants-study

The lab-based study was carried out by the NYU Grossman School of Medicine and NYU Langone Center and is considered preliminary because it has not yet been published in a peer-reviewed journal.

"What we found is that the vaccine's antibodies are a little bit weaker against the variants, but not enough that we think it would have much of an effect on the protective ability of the vaccines," senior author Nathaniel "Ned" Landau told AFP on Monday.

The researchers first took blood from people who were vaccinated with either of the two shots, which are predominant in the United States and have been given to more than 150 million Americans.

They then exposed these samples in a lab to engineered pseudovirus particles that contained mutations in the "spike" region of the coronavirus, which were particular to either the B.1.617 or B.1.618 variants, first found in India.

Finally, that mixture was exposed to lab-grown cells, to see how many would become infected.

The engineered pseudovirus particles contained an enzyme called luciferase, which fireflies use to light up. Adding it to the pseudovirus makes it possible to tell how many cells are infected, based on light measurements.

Overall, for B.1.617 they found an almost four-fold reduction in the amount of neutralizing antibodies -- Y-shaped proteins the immune system creates to stop pathogens from invading cells. For B.1.618, the reduction was around three-fold.

"In other words, some of the antibodies now don't work anymore against the variants, but you still have a lot of antibodies that do work against the variants," said Landau.

"There's enough that do work that we believe that the vaccines will be highly protective," he added, because the overall levels remain well above those found in samples taken from people who recovered from infection with earlier unmutated virus.

But this kind of lab investigation cannot predict what the real world efficacy might look like -- that will have to be investigated through other studies.

The coronavirus is known to latch on to a particular receptor on human cells called ACE2, which it uses to force its entry.

Landau's team showed the Indian variants were able to bind more tightly to this receptor, like other variants of concern. This might be linked to its increased transmissibility compared to the original strain.

"Our results lend confidence that current vaccines will provide protection against variants identified to date," the team concluded.

However, they do not preclude the possibility that newer variants that are more resistant to vaccines will emerge -- highlighting the importance of widespread vaccination at the global level.

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Re: Developing the Covid-19 vaccine

Post by basementer » Fri May 21, 2021 10:09 am

Woodchopper wrote:
Thu May 20, 2021 9:07 pm

BioNTech SE Chief Executive Ugur Sahin said on Thursday the COVID-19 vaccine it developed with Pfizer Inc (PFE.N) is expected to be 70% to 75% effective in protecting against infections caused by the coronavirus variant first detected in India.

"So far we've had the chance to test our vaccine against more than 30 variants of the virus. It has proven effective against mutations so far," said Sahin, a German scientist with Turkish parents, speaking Turkish in televised comments.

Tests this week have focused on the India variant, he said. "We expect (our vaccine) to protect against infections by 70% to 75%," he said after virtually attending the Turkish government's science council meeting.

[...]

A BioNTech spokeswoman said lab tests show that when the blood of vaccinated people is exposed to the Indian variant, 25% to 30% fewer antibodies were binding to the virus than would have been the case with the original coronavirus.

That suggests protection against the variant, whether symptomatic or not, is a bit lower but still 70% to 75%.

It is about 95% effective against the original version of the virus.
https://www.reuters.com/business/health ... 021-05-20/
"THE BLOOD OF." It's in vitro looking at antibodies, not in vivo looking at people, and I'm sure you know there's an xkcd for that.
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Re: Developing the Covid-19 vaccine

Post by tom p » Fri May 21, 2021 10:18 am

basementer wrote:
Fri May 21, 2021 10:09 am
Woodchopper wrote:
Thu May 20, 2021 9:07 pm

BioNTech SE Chief Executive Ugur Sahin said on Thursday the COVID-19 vaccine it developed with Pfizer Inc (PFE.N) is expected to be 70% to 75% effective in protecting against infections caused by the coronavirus variant first detected in India.

"So far we've had the chance to test our vaccine against more than 30 variants of the virus. It has proven effective against mutations so far," said Sahin, a German scientist with Turkish parents, speaking Turkish in televised comments.

Tests this week have focused on the India variant, he said. "We expect (our vaccine) to protect against infections by 70% to 75%," he said after virtually attending the Turkish government's science council meeting.

[...]

A BioNTech spokeswoman said lab tests show that when the blood of vaccinated people is exposed to the Indian variant, 25% to 30% fewer antibodies were binding to the virus than would have been the case with the original coronavirus.

That suggests protection against the variant, whether symptomatic or not, is a bit lower but still 70% to 75%.

It is about 95% effective against the original version of the virus.
https://www.reuters.com/business/health ... 021-05-20/
"THE BLOOD OF." It's in vitro looking at antibodies, not in vivo looking at people, and I'm sure you know there's an xkcd for that.
That XKCD is not really relevant here.
It's a perfectly valid first study - a surrogate endpoint to give an expected range of efficacy so that later studies can be adequately powered

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Re: Developing the Covid-19 vaccine

Post by basementer » Fri May 21, 2021 10:25 am

tom p wrote:
Fri May 21, 2021 10:18 am
basementer wrote:
Fri May 21, 2021 10:09 am
"THE BLOOD OF." It's in vitro looking at antibodies, not in vivo looking at people, and I'm sure you know there's an xkcd for that.
That XKCD is not really relevant here.
It's a perfectly valid first study - a surrogate endpoint to give an expected range of efficacy so that later studies can be adequately powered
I'll disagree with you. The quoted or touted in vivo range, 70 to 75 percent efficacy, is way too precise to extrapolate from this.
Be extrapolated from, sorry
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Re: Developing the Covid-19 vaccine

Post by shpalman » Fri May 21, 2021 10:36 am

The point about that XKCD is that lots of things can kill cancer cells, but the difficult part is to kill the cancer cells without killing the person they're in.

AstraZeneca kept saying that their vaccine should work in older subjects, despite not having Phase III data on them, because they demonstrated the same antibody response as younger people (in Phase II). I mean, you still need to actually try it in lots of people, but you've got to at least know it's not going to be a waste of time. I did complain about that at the time though, I mean, what's the point of Phase III if you're just going to insist on rolling out the vaccine based on the Phase II results. You're basically doing an uncontrolled experiment on the entire population. The UK is lucky that it was the right call.
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Re: Developing the Covid-19 vaccine

Post by tom p » Fri May 21, 2021 11:09 am

shpalman wrote:
Fri May 21, 2021 10:36 am
The point about that XKCD is that lots of things can kill cancer cells, but the difficult part is to kill the cancer cells without killing the person they're in.
What you do, grandma, is you take the shell off the eggs first & then pop them in your mouth...
shpalman wrote:
Fri May 21, 2021 10:36 am
AstraZeneca kept saying that their vaccine should work in older subjects, despite not having Phase III data on them, because they demonstrated the same antibody response as younger people (in Phase II). I mean, you still need to actually try it in lots of people, but you've got to at least know it's not going to be a waste of time. I did complain about that at the time though, I mean, what's the point of Phase III if you're just going to insist on rolling out the vaccine based on the Phase II results. You're basically doing an uncontrolled experiment on the entire population. The UK is lucky that it was the right call.
Yes, you need to do the studies. BioNtech's boss is just giving a rough range of where the results are expected to end up.
Whilst biology can be a tricky bugger, there are certain relationships that we do understand reasonably well and sometimes surrogate biomarkers can be very helpful. Unsurprisingly, however, nobody is taking his word for it & real world data studies are being commissioned and run to try and get better data based on what is really happening.
It is, however, useful preliminary information because it helps us to know how many people should need studying & it suggests that, while the Indian variant is of concern, there's no need to panic just yet.
What it doesn't mean is that work on improving the vaccines to add important variants will just stop.

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Re: Developing the Covid-19 vaccine

Post by shpalman » Fri May 21, 2021 11:41 am

tom p wrote:
Fri May 21, 2021 11:09 am
shpalman wrote:
Fri May 21, 2021 10:36 am
The point about that XKCD is that lots of things can kill cancer cells, but the difficult part is to kill the cancer cells without killing the person they're in.
What you do, grandma, is you take the shell off the eggs first & then pop them in your mouth...
Thanks but I'm backing you up not disagreeing with you or trying to explain it to you in particular. For anyone saying that well actually an in-vitro test of a surrogate endpoint is useless regarding eventual in-vivo efficacy regarding disease outcomes.

And then trying to pretend that I'm not being inconsistent since I criticised AstraZeneca for insisting their vaccine could be given to older subjects despite the lack of Phase III data...
tom p wrote:
Fri May 21, 2021 11:09 am
shpalman wrote:
Fri May 21, 2021 10:36 am
AstraZeneca kept saying that their vaccine should work in older subjects, despite not having Phase III data on them, because they demonstrated the same antibody response as younger people (in Phase II). I mean, you still need to actually try it in lots of people, but you've got to at least know it's not going to be a waste of time. I did complain about that at the time though, I mean, what's the point of Phase III if you're just going to insist on rolling out the vaccine based on the Phase II results. You're basically doing an uncontrolled experiment on the entire population. The UK is lucky that it was the right call.
Yes, you need to do the studies. BioNtech's boss is just giving a rough range of where the results are expected to end up.
Whilst biology can be a tricky bugger, there are certain relationships that we do understand reasonably well and sometimes surrogate biomarkers can be very helpful. Unsurprisingly, however, nobody is taking his word for it & real world data studies are being commissioned and run to try and get better data based on what is really happening.
It is, however, useful preliminary information because it helps us to know how many people should need studying & it suggests that, while the Indian variant is of concern, there's no need to panic just yet.
What it doesn't mean is that work on improving the vaccines to add important variants will just stop.
Well, I'm sure Pfizer would be really happy to be able to sell every adult a dose of the vaccine every year so they need to find a way to balance "yes it works against variants" now but also "we need to tweak it to work better against new variants and you need to get that new dose".

(I'm rather hoping that if anything we'll need a strategy a bit like the seasonal 'flu vaccination but better organized, plus vaccinating the children who arrive into the eligible age range every year, but even that latter might not be useful depending on how long protection actually lasts.)
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Re: Developing the Covid-19 vaccine

Post by shpalman » Fri May 21, 2021 3:01 pm

The Novavax coronavirus trial has descended into chaos as exasperated volunteers threaten to drop out because they cannot prove they are fully vaccinated on the NHS app, leaving them unable to travel to Europe.

A similar but smaller problem has been created in Italy for the 600 volunteers trialing the Reithera vaccine whose development appears to have been blocked.
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Re: Developing the Covid-19 vaccine

Post by Herainestold » Fri May 21, 2021 6:42 pm

shpalman wrote:
Fri May 21, 2021 3:01 pm
The Novavax coronavirus trial has descended into chaos as exasperated volunteers threaten to drop out because they cannot prove they are fully vaccinated on the NHS app, leaving them unable to travel to Europe.

A similar but smaller problem has been created in Italy for the 600 volunteers trialing the Reithera vaccine whose development appears to have been blocked.
Have they unblinded the trial? Or do trial participants who may have received the placebo think they should be certified as being fully vaxed?
How do you run a late stage covid vaccine phase III trial anyway? Do you use Pfizer instead of a placebo, and where do you test it, India? That would actually be good as we would know it works against the Indian variant.
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