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

hmmm wrote: »

Wow, there's rumours that the FDA may be about to grant Emergency use authorisation to the Oxford vaccine.

Might be complete rubbish, but we'll see.

If that is the case we might hope that phase 3 data is very strong. Fingers crossed

Santy2015 wrote: »

Going by the amount of tweets about it the last couple of hours. Seems legit..
what impact will that have by stopping phase 3 and going with EUA?

he can do a EUA all he wants, but he would still need the oxford group to allow them to use it in this way, which i'm sure they will not.

Has any phase 3 data been published by Oxford yet?

the FDA has a pretty good reputation worldwide. their audits are feared by pharma and food companies alike the world over. i hope they don't throw it all down the toilet by helping trump win an election.

Doc07 wrote: »

No, as fast and all as the Oxford/Astrazeneca development has been it will be another couple of months away at least before phase 3 results

Understood they said September at the earliest.

New research on how Covid affects cells in the heart:
https://mobile.twitter.com/berteroale/status/1300294273334534149

Even as the death rate falls as treatments improve over time, the increasing evidence of secondary impacts will mean no let-up in developing vaccines.

Reputable source

https://twitter.com/SaskiaPopescu/status/1300475035598028800

AdamD wrote: »

For...America?

Yes.

The only one I would have any notion of taking so quick is the oxford one.

They have been working on sars and Mers and reading a few things from them suggest

Gael23 wrote: »

Who is the regulator for Ireland?

The HPRA I believe

The US phase 3 trial of Oxford's ChAdOx1 vaccine candidate started today.

https://www.astrazeneca-us.com/media/press-releases/2020/development-of-covid-19-vaccine-azd1222-expands-into-us-phase-iii-clinical-trial-across-all-adult-age-groups-08312020.html

They'll be giving participants a prime-boost regimen four weeks apart with 20k in the vaccine group and 10k in the control group.

Further trials are planned in Peru, Chile, Russia and Japan. The total number of participants in all of them is aimed to be 50k people. Results from the later stages are expected later this year.

Thierry12 wrote: »

Why such confidence in Oxford one?

People do realise they are untested and a longshot?

Adenoviral vaccines have been tried for 30 years and we have never got one to work effectively

Oxford vaccine will be the first commercialy available adenoviral vaccine for humans in history

It is relatively new, that's correct. It won't be the first one to market though, the J&J Ebola vaccine would have that one squared off - https://johnsonandjohnson.gcs-web.com/static-files/1c979f4f-cad3-4f8b-9a22-69aaac503570

I guess the efficacy (one way or another) of these we're going to find out soon enough.

I know I’ve seen it a few times and thought I’d give a bit of insight on all the “rushed” clinical trials excuses for not wanting to take it. So I’ll give you my Phase III experience from the US and how things can be sped up.

1. Patients - most Phase III trials require a large number of patients. This can take anywhere from what I’ve seen of between 6-18 months to get to.

In the case of this vaccine, they have a queue out the door. As a matter of fact they are using way more than typical Phase III studies.

2. The study- depending on the drug being tested, the patient in the study will need to be evaluated over a specific time period. Typically it’s 1 month, but I’ve been in a few heart medications that are 24 month studies.

Vaccines are typically a month, there are exceptions but I’ll get to that point later on review.

3. Data collection - each patient needs to have all results out into a usable format to be analysed. This can take 6 months to do. Is very manual work and there are a lot of regulations ensuring mistakes are not made.

With these vaccine tests, the likes of Astra Zeneca and others will have all everyone working on this. So instead of a team of 12, they will have 120 doing this. Literally this is checking/ double checking and other verification works. So this can remove significant time. Typically I have to wait for this to be done before analysing.

4. Analysis and write up- this isn’t too complicated, but I always found that doctors/ nurses went missing to get this done and delaying it. You can bet they won’t be working on anything else but this.

5. Government review- the system is in order of receipt. So that blood pressure drug submitted before your trial is given priority, etc. The government are skipping this to the front of the queue for review. This takes anywhere from 6-12 months of waiting. Literally the results are on someone’s desk waiting their turn. Typically the review takes a few weeks to go through once it’s in front of the reviewers.

6. Results Ad Hoc- during the review questions will be asked. Some could be based on Adverse Events / serious adverse events. Others could be on the data presented. So more analysis may be needed. This rarely occurs with vaccines, but still could happen. Heart related medications it almost always happens and is built into the timelines.

So from all that, you can, without jeopardising the study, cut years off an approval. So by my calculations, they are cutting year off the patient , a year off being in the queue to be reviewed, up to a year for the data to be collected and analysed, obviously these are all worst case scenarios.

So my calculations on this is that it should be up for approval by end of October and November a decision. But there are a lot of caveats there. Something may be found and need to be re investigated or it may not work. All of this does happen.