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

Santy2015

Hmmzis wrote: »

Very, very much would like to see the results of this vaccine in humans. We have to keep in mind that this is intended to be a single dose shot (it can be boosted, but we want as many doses available as possible), so the numbers most likely will not rival the prime-boost candidates. If you're looking for numbers, all we need from it are nAB titers in the 1:30 region and overall titers to go to 1:320 or above (in line with Mt Sinai convalescent plasma research). If that is paired with a good T cell response, then it should offer solid protection for the average individual. If we don't see that, it's still not a big loss as even 1:8 nAB titers have shown reasonable results, add some decent T cell responses and we might see something that prevents people from needing hospital treatment and dying.

Even at the 1:8 would regulators/governments sign off on it and give the go ahead after phase 3? Even if we need boosters after a year like the flu vaccine.

Hmmzis

Santy2015 wrote: »

Even at the 1:8 would regulators/governments sign off on it and give the go ahead after phase 3? Even if we need boosters after a year like the flu vaccine.

Regulator approval is entirely dependent on phase 3 results. FDA have said that they'll approve anything with 50% or grater efficacy.
While we can measure antibody levels and do neutralisation assays, we can't quite predict how that will work in a human when exposed to the real deal. We can make some comparisons and extrapolations from convalescent serum studies and compare similar animal studies, at the end it's still only an educated guess.

is_that_so

This is an interesting piece on the work being done on new and existing testing methods.
https://www.nature.com/articles/d41586-020-02140-8

is_that_so

A paper on the immune profile of 50 COVID-19 patients. May have implications for treatments.

We performed an integrated immune analysis on a cohort of 50 COVID-19 patients with various disease severity. A unique phenotype was observed in severe and critical patients, consisting of a highly impaired interferon (IFN) type I response and an exacerbated inflammatory response.

https://science.sciencemag.org/content/early/2020/07/10/science.abc6027

Azatadine

Not vaccine but treatment related.

https://www.bbc.com/news/health-53467022

is_that_so

Azatadine wrote: »

Not vaccine but treatment related.

https://www.bbc.com/news/health-53467022

Good to see real world trials giving more weight to research studies.

Hmmzis

Azatadine wrote: »

Not vaccine but treatment related.

https://www.bbc.com/news/health-53467022

This ties in well with the study done in Hong Kong in April, they also used interferon beta, but as an injection. If I recall right, the ICU requirements dropped by about 50% in the study group compared to the controls. This nebulized version would look to be even better.
Great to see clinical trials yielding some positive results.

Gael23

Hmmzis wrote: »

Regulator approval is entirely dependent on phase 3 results. FDA have said that they'll approve anything with 50% or grater efficacy.
While we can measure antibody levels and do neutralisation assays, we can't quite predict how that will work in a human when exposed to the real deal. We can make some comparisons and extrapolations from convalescent serum studies and compare similar animal studies, at the end it's still only an educated guess.

The FDA will do what Trump orders them to do. Who has to give approval for this to be used in Europe?

Why are the UK ordering so many doses? https://www.rte.ie/news/business/2020/0720/1154313-britain-signs-deals-for-covid-19-vaccines/

Hmmzis

Gael23 wrote: »

The FDA will do what Trump orders them to do. Who has to give approval for this to be used in Europe?

Why are the UK ordering so many doses? https://www.rte.ie/news/business/2020/0720/1154313-britain-signs-deals-for-covid-19-vaccines/

In the EU it's the EMA (https://www.ema.europa.eu/en) doing drug and treatment approvals (including vaccines).

The UK, as most/all others are insuring themselves in case some vaccine candidates don't make it to market. The EU has made similar deals with Astra Zeneca and Johnson & Johnson.

ACitizenErased

Is Oxford data being released today?

Santy2015

ACitizenErased wrote: »

Is Oxford data being released today?

Yeah as far as I’m aware

Santy2015

https://www.google.ie/amp/s/www.timesnownews.com/amp/health/article/oxford-s-covid-19-vaccine-phase-1-data-expected-today-serum-institute-to-begin-human-trials-from-next-month/624044

Probably released later today..

Gael23

What volume can AstraZeneca produce quickly?

Hmmzis

While we wait on the Lancet release of phase I for ChAdOx1, here is an update of the phase I/II results from Pfizer/BioNTech:

https://www.medrxiv.org/content/10.1101/2020.07.17.20140533v1.full.pdf+html

This was done in Germany, the previous was done in the US. The German groups were dosed 1ug and 50ug in a prime-boost regimen. While 50ug of course is looking good across the board, the 1ug dose is looking shockingly good for what it is. It's 50x less antigen presented, but is not shabby looking at all, especially when looking at the T cell counts, CRP levels and lymphocyte counts. Makes me wonder if a 1ug prime-boost-boost regimen might be superior to the higher dosed prime-boost and very high dosed prime only regimens?

Hmmzis

And here is the ChAdOx1 phase 1/2 publication:

https://marlin-prod.literatumonline.com/pb-assets/Lancet/pdfs/S0140673620316044.pdf


This is good for anyone who has already had the misfortune of contracting the virus:

High levels of neutralising antibody at baseline
seen in a small number of participants probably indicates
prior asymptomatic infection, as potential participants
with recent COVID-19-like symptoms or with a history of
positive PCR test for SARS-CoV-2 were excluded from
the study. Individuals with high titres on the day of
vaccination who received ChAdOx1 nCoV-19 were boosted
by vaccination.

On a quick glance, the results are far better than what they had for their MERS candidate, titers for nABs are good, overall T cell counts are good and it looks to be safe and well tolerated. Honestly, I was prepared to see way less, this is very encouraging.

ACitizenErased

Hmmzis wrote: »

And here is the ChAdOx1 phase 1/2 publication:

https://marlin-prod.literatumonline.com/pb-assets/Lancet/pdfs/S0140673620316044.pdf

Those are pretty impressive results

Icantthinkof1

Great news!
Out of interest; what will phase 3 consist of?
Excuse my ignorance on this but will phase 3 be the same study as phase 2 but will they be testing the vaccine on more people than they did in phase2 or will they test it on more vulnerable people like the elderly; those with underlying conditions?

Stark

Gael23 wrote: »

What volume can AstraZeneca produce quickly?

2 billion apparently https://medicalxpress.com/news/2020-06-astrazeneca-track-virus-vaccine-september.html . They've had a head start since earlier in the year.

Gael23

Icantthinkof1 wrote: »

Great news!
Out of interest; what will phase 3 consist of?
Excuse my ignorance on this but will phase 3 be the same study as phase 2 but will they be testing the vaccine on more people than they did in phase2 or will they test it on more vulnerable people like the elderly; those with underlying conditions?

Healthy volunteers I believe

marno21

Stark wrote: »

2 billion apparently https://medicalxpress.com/news/2020-06-astrazeneca-track-virus-vaccine-september.html . They've had a head start since earlier in the year.

Have they started manufacturing en masse already?

Given the results to date, it would be fantastic if manufacturing began now. The financial risk of it not working out is substantially less than the benefits of being able to have a mass rollout in the event the Phase III trials are successful.

Danzy

Gael23 wrote: »

What volume can AstraZeneca produce quickly?

400mn by end of the year ordered for the EU

D.Q

marno21 wrote: »

Have they started manufacturing en masse already?

Given the results to date, it would be fantastic if manufacturing began now. The financial risk of it not working out is substantially less than the benefits of being able to have a mass rollout in the event the Phase III trials are successful.

Think they've already started manufacturing

marno21

Superb. I'm no immunologist but I read The Lancet paper there and it does seem promising.

It will be quite an achievement if this works and they can get it rolled out before year end. Huge credit deserved to all involved.

hmmm

You wait forever for a bus, then three come at once. Here's the Cansino (Chinese) vaccine results.

https://marlin-prod.literatumonline.com/pb-assets/Lancet/pdfs/S0140673620316056.pdf

Some commentary https://www.statnews.com/2020/07/20/study-provides-first-glimpse-of-efficacy-of-oxford-astrazeneca-covid-19-vaccine/ - Cansino perhaps a bit underwhelming due to their choice of vector - I believe it was J&J who had a very similar vaccine candidate who are taking a different vector approach to avoid this problem. That's the advantage of having lots of different vaccine candidates.

Danzy

Seems the Chinese have given the military a vaccine already.

Guinea pigs.

Gael23

When they say the vaccine should be available in limited quantities towards the end of the year, do we know how limited?

seanb85

Danzy wrote: »

Seems the Chinese have given the military a vaccine already.

Guinea pigs.

Given the way they are treating the Uighur Muslims, I would be surprised if they're not secretly carrying out challenge trials.

LuckyLloyd

A tremendous piece of news, people can focus on the negatives and remaining hurdles as they see fit - but we saw more than we could have hoped for at this stage imo. Very positive results.

LiquidZeb

seanb85 wrote: »

Given the way they are treating the Uighur Muslims, I would be surprised if they're not secretly carrying out challenge trials.

Jesus they really are sinister bastards. I feel sorry for anyone living under that government.

is_that_so

Gael23 wrote: »

When they say the vaccine should be available in limited quantities towards the end of the year, do we know how limited?

It will go to those who are potentially higher risk first anyway, which would be in healthcare workers and probably care homes. 2021 is more realistic for the rest of the population.