VACCINE NEWS-Keep your fingers crossed...

[boscobeans]

ASTRAZENECA announced 15 hours ago that the vaccine they have developed has been VERY safe and successful in OVER TEN THOUSAND patients.

 

To avoid any lag time between approval and delivery they are moving ahead with production and will, if approved, be able to ship 300 million doses to the United States in SEPTEMBER of this year, and 2 billion worldwide.

[Fouremco]

This BBC interview with the CEO indicates cautious optimism with full recognition that preparing so many doses with an unproven vaccine is financially risky. https://www.bbc.com/news/business-52917118 

 

Definitely keeping our fingers crossed!

[TeeRick]

Yes encouraging - if this vaccine turns out to actually be efficacious against infection by the virus.  The first studies of any vaccine are primarily Safety studies and some immune responses are recorded which are usually specific antibodies against the vaccine target sequence(s).  Later studies will try to somehow look at prevention against viral infection.  Good progress but we are still a way to go.

[VitaminSea53]

SAFE ..... OK but is it effective?

[bEwAbG]

Seems a bit speculative, but it will be wonderful if it comes to pass that soon (and it works).

[TeeRick]

Just now, VitaminSea53 said:

SAFE ..... OK but is it effective?

Yes that is the question.  Further studies and time will tell.

[marieps]

I believe front line workers will get any vaccine first.  We pray for them, and for the safety and efficacy of ANY vaccine candidate. 

[UnorigionalName]

did they... just like skip phase ii?  How long was their phase i to leapfrog moderna?  I was amazed at the proposed Moderna like 1 month phase ii geez.

[boscobeans]

... preparing so many doses with an unproven vaccine is financially risky.

 

The possibility of it not getting final approval is well understood and the odds are being accepted by AstraZeneca.

 

SAFE ..... OK but is it effective?

 

They claim a high level of Covid-19 antibody production

[MarkWiltonM]

1 hour ago, boscobeans said:

ASTRAZENECA announced 15 hours ago that the vaccine they have developed has been VERY safe and successful in OVER TEN THOUSAND patients.

 

To avoid any lag time between approval and delivery they are moving ahead with production and will, if approved, be able to ship 300 million doses to the United States in SEPTEMBER of this year, and 2 billion worldwide.

 

I don't see any information on this vaccine being proved safe and effective. AstaZeneca just started enrolling subjects in a combined Phase 2/3 trial on May 22.  I find it extremely unlikely (impossible) that they have results. The news today is that they have decided to ramp up production before they know if the vaccine works.

 

[markeb]

52 minutes ago, TeeRick said:

Yes that is the question.  Further studies and time will tell.

 

43 minutes ago, marieps said:

I believe front line workers will get any vaccine first.  We pray for them, and for the safety and efficacy of ANY vaccine candidate. 

 

11 minutes ago, UnorigionalName said:

did they... just like skip phase ii?  How long was their phase i to leapfrog moderna?  I was amazed at the proposed Moderna like 1 month phase ii geez.

 

Did they shortcut phase II and try to dive into phase III? 10,000 would be a huge phase II study! But still not big enough to actually understand how the vaccine stands up to wild type virus in an outbreak. But the phase IIb is where you optimize dose and dosing schedule.

 

I'm all for speed if safety is really there. And I agree completely frontline workers need an effective vaccine soonest, probably followed by high risk, then the general public.

 

Lost in all of this still is I haven't seen a proposed dosing schedule. Do they really mean 2 billion doses, or enough to vaccinate 2 billion people, which could be 4-6 billion doses, depending on the vaccine. And you need a year's worth of data to know if you get a year's immunity!

 

[marieps]

6 minutes ago, markeb said:

 

Lost in all of this still is I haven't seen a proposed dosing schedule. Do they really mean 2 billion doses, or enough to vaccinate 2 billion people, which could be 4-6 billion doses, depending on the vaccine. And you need a year's worth of data to know if you get a year's immunity!

 

These are two very crucial points, although something tells me no one is going to wait a year before deciding the beast is beaten, rightly or wrongly.  

Edited June 5, 2020 by marieps

[BP99]

Very preliminary data in monkeys is encouraging BUT not great.

Antibody levels are not high in all animals. Likely need a booster.

Some monkeys had a partial response.

The BIGGEST result was the positive affect on the lungs.

May not be a GREAT vaccine but if it is a partial response

(which it is) it MAYBE? good enough to eliminate DEATH in

humans (monkeys don't die from this virus). 

Do a google: Oxford covid vaccine Forbes etc. for more details.

I'm waiting to see how well humans respond (titres, cell mediated 

immunity etc). A vaccine will work but which one is BEST is

still to be determined. 

[Fly and Sail]

Yeah right. The speed in which this was developed is highly suspect.

 

In any case there is no need to produce that many doses of the product as the majority of the population likely won't take it, same like all the other vaccines.

[Fouremco]

2 minutes ago, Fly and Sail said:

Yeah right. The speed in which this was developed is highly suspect.

 

In any case there is no need to produce that many doses of the product as the majority of the population likely won't take it, same like all the other vaccines.

1 billion doses for global distribution is probably insufficient. With a world population of just under 7.6 billion, if only 1/3 of people want the vaccine they'd need 2.5 billion. If booster shots are required, you can double it to 5 billion.

[Fly and Sail]

12 minutes ago, Fouremco said:

1 billion doses for global distribution is probably insufficient. With a world population of just under 7.6 billion, if only 1/3 of people want the vaccine they'd need 2.5 billion. If booster shots are required, you can double it to 5 billion.

 

We all know that something like this will never be global or reach the poor. China and India are already 3 Billion combined. They'll do their own thing. Then countries such as Pakistan and Bangladesh. Africa as a whole...

[John182]

3 hours ago, boscobeans said:

ASTRAZENECA announced 15 hours ago that the vaccine they have developed has been VERY safe and successful in OVER TEN THOUSAND patients.

 

AstraZeneca did not develop the vaccine. That was done by the University of Oxford, based upon an existing vaccine that was under development for another virus, I think it was SARs but I may be wrong, that was put on hold. AstraZeneca are manufacturing the vaccine in conjunction with two partner organisations in the world.

[boscobeans]

8 minutes ago, John182 said:

 

AstraZeneca did not develop the vaccine. That was done by the University of Oxford, based upon an existing vaccine that was under development for another virus, I think it was SARs but I may be wrong, that was put on hold. AstraZeneca are manufacturing the vaccine in conjunction with two partner organisations in the world.

AstraZeneca and Oxford University announce landmark agreement for COVID-19 vaccine.

Sorry, I am not as informed as you as to what each party has done to lay claim to the vaccine.. 

[John182]

1 minute ago, boscobeans said:

Sorry, I am not as informed as you as to what each party has done to lay claim to the vaccine..

 I didn't mean to sound critical. It's just that one of my sons is a member of the University research team so I just went a bit parental there 😀

[MamaFej]

1 hour ago, Fly and Sail said:

Yeah right. The speed in which this was developed is highly suspect.

 

In any case there is no need to produce that many doses of the product as the majority of the population likely won't take it, same like all the other vaccines.

I have always been under the impression that anti-vaxers are a minority, albeit a very vocal one. Do you have a source you could point me to, please, for evidence that the majority won't take all the other vaccines?

 

Tone does not come across well online. II want to make it clear that  am not being snarky, I'm genuinely curious about where your information comes from. TIA

[marieps]

Hard to believe with the relentless media coverage that most people wouldn't take a vaccine, especially since they may believe it will help get life back to normal (no matter the efficacy).

[cangelmd]

2 hours ago, MarkWiltonM said:

 

I don't see any information on this vaccine being proved safe and effective. AstaZeneca just started enrolling subjects in a combined Phase 2/3 trial on May 22.  I find it extremely unlikely (impossible) that they have results. The news today is that they have decided to ramp up production before they know if the vaccine works.

 

The article says results by August. I think the idea is to be ready to package and ship ASAP after that.

As we have painfully seen with testing and swabs, you can overwhelm the supply of things you take for granted- in the case I’ve heard they are worried about adequate supplies of the special glass to make the vials to put vaccine in. One interview I saw they were considering multi dose vials to conserve glass.

[cangelmd]

9 minutes ago, marieps said:

Hard to believe with the relentless media coverage that most people wouldn't take a vaccine, especially since they may believe it will help get life back to normal (no matter the efficacy).

Ha, I believe it, people are not logical or predictable.

Earlybon, my housekeeper said she never gets a flu shot - those are bad for you, did you know that?- but she would definitely get a covid vaccine. Now she doesn’t want any vaccine.

[downsmead]

It is interesting that some reports in the UK press from , I believe, someone involved in the development of the vaccine, that due to the UK getting Covid-19 ‘under control’, that there may not be sufficient people to test it on here!

https://www.thetimes.co.uk/article/oxford-vaccine-team-chases-virus-to-brazil-89zwtqtp2 
Testing may be carried out in countries where the infection rate is still high e.g Brazil is mentioned in the article above (apologies it may not be accessible to all).

[markeb]

Having thought about this a little more, with just a little cynicism involved, going forward with production is probably a genius move.

 

1) They need production quality material for the Phase III trial.

2) They have to demonstrate a consistent production method at scale for licensure.

3) If they essentially go straight to scale, they've already accounted for risk to scale up.

4) I'm betting they've settled on a very large production process in the first place, so 2B doses (of the actual protein, not vialed product) may not be much material at all. So it sounds really good that they're driving forward and risking manufacturing material that fails, but they have to do that anyway.

 

Likely as not great PR for doing something they more or less have to do. It's possible they're doing modular production where scale is just add more modules, but it's equally likely they (and others) are doing gram-level or higher (kilogram?) production runs, and need micrograms or less of purified protein per vaccine dose. You could get to 2B doses from your consistency runs if you're really scaling at that level!

 

(For those who've never been around this, I once encountered a vaccine program where the production method produced twice the demand per production run. If you get lucky, or the university you partnered with got really lucky, you can end up with a lot of material to purify, assay, and vial...)