COVID-19: Vaccine/antidote and testing procedures Megathread [Mod Warning - Post #1]

Hmmzis

NHP challenge data from Pfizer/BioNTech, this is the one they're doing phase 3 at the moment:

https://www.biorxiv.org/content/10.1101/2020.09.08.280818v1.full.pdf+html

Looks good to my eye, some viral replication in the nose on day 1 but seems that the immune response got that under control quickly enough. The AB titers seem comparable with what they had in the phase 1 results in humans.

iguana

hmmm wrote: »

Go on tell us what you've googled about myelitis, I know you're dying to tell us.

Umm, so from what I've googled about myelitis, I'm wondering how they can say at this stage that the patient is expected to make a full recovery?

Gael23

If they can’t prove conclusively that the illness was not caused by the vaccine it’s all over for Oxford.

is_that_so

Gael23 wrote: »

If they can’t prove conclusively that the illness was not caused by the vaccine it’s all over for Oxford.

It's not unusual for this to happen and it's protocol to pause.

Hmmzis

Gael23 wrote: »

If they can’t prove conclusively that the illness was not caused by the vaccine it’s all over for Oxford.

Not quite, it's a large trial, it's unlikely it'll be stopped entirely with the one severe adverse event. We still don't know if that person was in the vaccine group or the control group.

is_that_so

Not quite vaccines but very interesting research and potentially another tool in the arsenal as there are drugs for this.

COVID-19 should be viewed not as a respiratory disease first, some researchers say, but as a vascular illness.
The bradykinin hypothesis refers to a compound that’s affected directly by the virus, and which could lead to a “bradykinin storm” that can cause serious problems and lead to death.

https://bgr.com/2020/09/01/coronavirus-drugs-that-work-bradykinin-storms-icatibant/

Gael23

Hmmzis wrote: »

Not quite, it's a large trial, it's unlikely it'll be stopped entirely with the one severe adverse event. We still don't know if that person was in the vaccine group or the control group.

Will the regulators see it that’ way though?

seanb85

Hmmzis wrote: »

Not quite, it's a large trial, it's unlikely it'll be stopped entirely with the one severe adverse event. We still don't know if that person was in the vaccine group or the control group.

Do they not unblind that particular patient immediately so the treating physicians can rule out it being a reaction to the vaccine?

stephenjmcd

Gael23 wrote: »

Will the regulators see it that’ way though?

Yes, if they can prove efficency and safety procedures then yes they will.

Its an extremely large trial, 1 person is ill and that needs to be investigated, its the correct procedure and will help with regulation.

This isnt the first time Oxford has been paused either. It happened earlier in the summer and was found to be unrelated to the vaccine.

Hmmzis

seanb85 wrote: »

Do they not unblind that particular patient immediately so the treating physicians can rule out it being a reaction to the vaccine?

By now they would probably know it, not sure they had that info last night as I couldn't find any clear statements on that.
I think if they don't give an update today stating the person was in the control group, then we can be quite sure the person was in the vaccine group.

tobefrank321

There's pros and cons to the pause.
The pro is they've found an issue before its been rolled out to millions of people.
The con is it will likely delay the roll out of this vaccine by a month or two, pushing it into next year.

XsApollo

So what’s the pause?
It’s that they won’t be inoculating anymore people until they find out what happened? But they will still be gathering data from the people already part of the trial.
Depending how many people they have in the trial already it might won’t make much of a difference?

is_that_so

tobefrank321 wrote: »

There's pros and cons to the pause.
The pro is they've found an issue before its been rolled out to millions of people.
The con is it will likely delay the roll out of this vaccine by a month or two, pushing it into next year.

Well, these possible early dates that are being bandied about were always contingent on trials going without a hitch.

Hmmzis

XsApollo wrote: »

So what’s the pause?
It’s that they won’t be inoculating anymore people until they find out what happened? But they will still be gathering data from the people already part of the trial.
Depending how many people they have in the trial already it might won’t make much of a difference?

The US trial is the most affected by this as they started enrolling only 10 days ago. The UK, Brazil and South Africa trials should have the enrollment done by now. They will still be gathering data from the enrolled people, that part doesn't stop, the new enrollments stop.

IHaveTheFlag

Thierry12 wrote: »

Reddit Covid19

Only the most discriminating and legitimate of sources for you, eh Thierry?

Hego Damask

FutureTeashock wrote: »

This sounds really serious.


Zero chance of a vaccine in 2020 now.

Thank GOD!

Why ?
You don't have to get it if you don't want it ..

Stark

Anti-vaxxers have hard-ons for viruses. They just love those "natural" adverse effects.

Hego Damask

Thierry12 wrote: »

Reddit Covid19

Stay clear of that cesspit reddit during all this - take that free advice!!

ACitizenErased

Hego Damask wrote: »

Stay clear of that cesspit reddit during all this - take that free advice!!

R/COVID19 is the science subreddit for COVID, you have to have a degree to post on there basically. Some really good discussion.

Away With The Fairies

Gael23 wrote: »

If they can’t prove conclusively that the illness was not caused by the vaccine it’s all over for Oxford.

Isn't phase 3 trials when they find out if it's not safe and often gets scrapped at this stage?

What are our options after the Oxford vaccine if it doesn't work out?

Hego Damask

ACitizenErased wrote: »

R/COVID19 is the science subreddit for COVID, you have to have a degree to post on there basically. Some really good discussion.

OK fair enough, I'll still stay away from it, I remember seeing some stuff on reddit about this when it all started and it was literally end of the world ****e,
They were going on how 100s of millions will die etc ....


f*ck that doom and gloom ****

Hego Damask

WHO beating the "Vaccine won't be available for 2 years" drum again, they really are just fear mongering assholes...

IHaveTheFlag

ACitizenErased wrote: »

R/COVID19 is the science subreddit for COVID, you have to have a degree to post on there basically. Some really good discussion.

R/Covid19 is a brilliant resource with professionals who patiently break stuff down into layman's terms. R/coronavirus on the other hand is an insane asylum where every discussion, no matter the topic or country rolls over into an anti Donald Trump rant or pure negative piss and misery.

Gael23

Is there history of this happening in the past and the vaccine eventually making it to market?

Micky 32

Gael23 wrote: »

Is there history of this happening in the past and the vaccine eventually making it to market?

As far as i know most pandemics didn’t last long enough.

Charles Babbage

Gael23 wrote: »

Will the regulators see it that’ way though?

If you have a large control group then people will get various medical conditions simply because a certain proportion of the population get these things regardless of having taken a vaccine.



One person in a large number getting a particular problem is not useful proof of anything.



However, I expect this kind of thing could delay the approval.

TFBubendorfer

Away With The Fairies wrote: »

Isn't phase 3 trials when they find out if it's not safe and often gets scrapped at this stage?

What are our options after the Oxford vaccine if it doesn't work out?

There are 9 vaccines in phase 3 trials at the moment, including the Oxford one. That's plenty of options.

https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html

ACitizenErased

The Serum Institute of India is continuing it’s Oxford trials. They say that the issue is not vaccine related.
Taken from Reddit:

Interesting that the Indian trials are continuing and the SII don't seem too concerned.

From Twitter

"We (Serum Institute of India) can't comment on reports of AstraZeneca pausing the trials in the UK, other than that they have been paused for review and shall restart soon. The Indian trials are continuing and we have faced no issues at all."

EDIT -

Adar Poonawalla also said this :

"This incident in the UK will have no impact on the Indian vaccine trial being carried out by Serum Institute," said Adar Poonawalla, CEO of Serum Institute of India, that is conducting trials on the Oxford vaccine AZD1222 (aka ChAdOx1 nCoV-19) in India also known as COVISHIELD.

Adar Poonawalla added, "The reaction that has been reported is not directly linked to the vaccine. The person who has had the reaction had an existing neurological condition. During a vaccine trial such events are common place."

"Our production timelines are on schedule as planned,"

Not sure if I can post the article bit it is titled "Oxford vaccine trial pause won't have impact on Indian trials: Serum Institute CEO" from the site India Today

Hego Damask

IHaveTheFlag wrote: »

R/Covid19 is a brilliant resource with professionals who patiently break stuff down into layman's terms. R/coronavirus on the other hand is an insane asylum where every discuss, no matter the topic or country rolls over into an anti Donald Trump rant or pure negative piss and misery.

OK, I must have been on /coronavirus one then, ill check /Covid19

tobefrank321

TFBubendorfer wrote: »

There are 9 vaccines in phase 3 trials at the moment, including the Oxford one. That's plenty of options.

https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html

Hopefully Oxford and AstraZenica publish details of the adverse reaction so that other vaccine makers can learn from it, and commercial considerations don't play a part.

Their vaccine was considered one of the front runners and probably the best option.

Large numbers of vaccine candidates often make it to phase 3 but the success rate at this stage drops dramatically.