VACCINE NEWS-Keep your fingers crossed...

[markeb]

3 minutes ago, downsmead said:

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).

 

As the number of cases drop from other control measures, doing a Phase III efficacy study will get harder. And you'll probably need a mix of people who do and do not have pre-existing antibodies. The "with" arm would probably be deferred under normal circumstances, but if you're really going forward as fast as you can, and you know there's an unknown but significant fraction of the population that has been exposed and developed antibodies, you kind of need to know if the vaccine performs differently. Otherwise you could end up forced to label the product so that you have to test everyone before vaccinating. Coronavirus immunology generally worries me until you've got a lot of good data...

[Roger88]

Even if they come with a vaccine this year, it will take a sufficient amount of time for it to go through a proper testing and being produced in mass amounts to supply the entire world. Moreover these vaccines will be super expensive which is not a good thing for poor countries. I wonder if Bill Gates will somehow participate in it

[markeb]

Just now, Roger88 said:

Even if they come with a vaccine this year, it will take a sufficient amount of time for it to go through a proper testing and being produced in mass amounts to supply the entire world. Moreover these vaccines will be super expensive which is not a good thing for poor countries. I wonder if Bill Gates will somehow participate in it

 

Did you read any of this thread? It's all about expediting the testing, early production, production and distribution essentially at cost, and yes, the Gates Foundation is partnering on the production. All are mentioned in the thread and the posted links.

[K.T.B.]

This is encouraging news.  I seriously doubt AstraZeneca would go ahead with production if they weren't fairly confident in its effectiveness.  

[prish]

1 hour 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.

That’s right John, the vaccine is being developed by Oxford University, to be manufactured by AstraZeneca. AZ has just signed a contract with Serum Institute of India, the largest vaccine manufacturing facility in the world. Production has already started and they hope to have 2 billion doses ready by September, in anticipation of successful trials. Half the supply will go to low and middle income countries.
 

Apart from other concerns I have a sisterly interest here, my brother works for AZ and actively involved in this project!

 

 

[twins_to_alaska]

1 hour 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).

 

I'm not going to be jumping for one right away and I got both my Shingrix doses this year and always get a flu shot. I want to be pretty convinced safe and effective.

 

My husband's family has anti-vaxxers who definitely will never get this vaccine. His sister called up concerned he might one day get one. But she has weird conspiracy belief about mind control?!

[BP99]

48 minutes ago, markeb said:

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...)

 

 

Hi,

A "friendly" correction. They use whole adenovirus particles (expressing the 

covid 19 spike protein). They grow it in a mammalian cell line and then purify

the virus particles. They inject the purified virus particles into the muscle of

animals/humans. It will NOT replicate in humans. They plan to scale up

growth in 1000 litre cultures. Not as easy as growing influenza in chicken eggs. 

 

 

[markeb]

Just now, BP99 said:

Hi,

A "friendly" correction. They use whole adenovirus particles (expressing the 

covid 19 spike protein). They grow it in a mammalian cell line and then purify

the virus particles. They inject the purified virus particles into the muscle of

animals/humans. It will NOT replicate in humans. They plan to scale up

growth in 1000 litre cultures. Not as easy as growing influenza in chicken eggs. 

 

 

 

Thanks. I can't keep them straight anymore, and probably knew that at one point!

 

Also probably not as easy as making grams of recombinant protein. But it could be.

 

I guess that's my other caution as the two lead vaccine candidates right now use novel approaches. I know the FDA has never approved an mRNA vaccine, and I'm blanking right now on an approved adenovirus vectored vaccine as well (do you know if there is one?). Both methods have been used a lot in vaccine research, but the US FDA is nothing if not risk adverse!

[BP99]

33 minutes ago, markeb said:

 

Thanks. I can't keep them straight anymore, and probably knew that at one point!

 

Also probably not as easy as making grams of recombinant protein. But it could be.

 

I guess that's my other caution as the two lead vaccine candidates right now use novel approaches. I know the FDA has never approved an mRNA vaccine, and I'm blanking right now on an approved adenovirus vectored vaccine as well (do you know if there is one?). Both methods have been used a lot in vaccine research, but the US FDA is nothing if not risk adverse!

Hi,

There has never been an approved adenovirus vaccine for humans.

There is a rabies vaccine for animals that is adenovirus based and

approved. It is easier to get approval for animal vaccines than humans. 

However 3 major groups are trying them for covid-19. They have

problems that adenoviruses are a member of the cold virus group (as are coronaviruses) and many humans have antibodies to them. Booster shots

(if needed) may be problematic. 

[phoenix_dream]

Speaking to people actually getting the vaccine - the sad truth is that there have been some surveys done (sorry, don't have exact sources at this time) which state that many, many people will not get the vaccine, at least not for some time.  I think it was approximately a 60/40 split (can't recall which side the anti versus pro - sorry!).  Why?  Various reasons.  First you have the usual anti-vaxxers, then you have people who are afraid of any vaccine developed rapidly.  Then of course there is always a percentage of the population whose age (newborn) or medical conditions advise against certain vaccines.  Then you have the people who think the vaccine would give you the virus (just like you have for the flu virus - the ignorance is beyond comprehension in that case as the vaccine is not a live virus)! - not sure if that is the case for the Covid-19 vaccine).  Personally, I would rather risk a vaccine that has been reasonably tested, with reasonable antibody results than risk catching a disease that can kill me (at 68 I am in the high risk group).  Even if it provides limited antibody protection, anything that would help reduce the risk of me catching it, and even more important the risk of me dying from it, to me it is worth it.

Edited June 5, 2020 by phoenix_dream

[4774Papa]

3 hours ago, Fly and Sail said:

 

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...

The way our government in Washington is creating money, they will probably just print more money and everyone in the USA will get a free vaccine.   Many foundations as well as the USA focused on treating AIDS and come up with the money for the World, including Africa.

[UnorigionalName]

2 hours ago, Roger88 said:

Even if they come with a vaccine this year, it will take a sufficient amount of time for it to go through a proper testing and being produced in mass amounts to supply the entire world. Moreover these vaccines will be super expensive which is not a good thing for poor countries. I wonder if Bill Gates will somehow participate in it

 

If you read the article they are heavily participating.  What they've proposed from the beginning.  Usually the way things go is you go through phase i, ii, and iii trials, get approval from all relevant regulators, then start building your factories to ramp up production which takes a few months.

 

The gates foundation from the beginning said there's a lot of smart people already working on dozens of vaccines, so that part is well covered.  Let them do their thing.  But what we can do is throw huge piles of money and fund useless factories.

 

So the strategy now is as soon as something looks promising in late phase ii or phase iii, like this vaccine or moderna, gates foundation and the US government is funding to pay for factories and hundreds of millions of doses of the vaccine.  Knowing full well that most of it might be throwing money away.  The thought is if you do that for the first however many dozen vaccines that make it to phase ii until you run out of money, hopefully at least one will work out by the end, and the rest of the money you threw away (on purpose).

[Ken the cruiser]

Yay AstraZenica!!!

[drakes2]

2 hours ago, phoenix_dream said:

Personally, I would rather risk a vaccine that has been reasonably tested, with reasonable antibody results than risk catching a disease that can kill me (at 68 I am in the high risk group).  Even if it provides limited antibody protection, anything that would help reduce the risk of me catching it, and even more important the risk of me dying from it, to me it is worth it

I'm in full agreement with you. I just spoke to a friend older than me who said she will not take the vaccine. 

[npcl]

7 hours 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.

They started enrolling phase II in late May.  It looks like they might be doing a combined phase II/III approach running in parallel.

 

The phase II part of the study involves expanding the age range of people the vaccine is assessed in, to include a small number of older adults and children:

• Aged 56-69
• Aged over 70
• Aged between 5-12 years

For these groups, researchers will be assessing the immune response to the vaccine in people of different ages, to find out if there is variation in how well the immune system responds in older people or children.

 

The phase III part of the study involves assessing how the vaccine works in a large number of people over the age of 18. This group will assess how well the vaccine works to prevent people from becoming infected and unwell with COVID-19.

[Germancruiser]

Every step there is in the direction of a vaccine is important- and one in the right direction. The sooner we get the vaccine the better!

Nobody is  " forced" to get the vaccine- BUT if you want to board a ship- you have to be vacinnated- as easy at that. There was a heated discusion going in Germany  here-  if - when the vaccine is available - it should be mandatory to get vaccinated.

Edited June 6, 2020 by Germancruiser

[K.T.B.]

I do not get a flu shot as it makes me violently ill, but I will get a COVID vaccine.  Period.  My wife and I are considered "high risk".

[TeeRick]

17 hours ago, markeb said:

 

As the number of cases drop from other control measures, doing a Phase III efficacy study will get harder. And you'll probably need a mix of people who do and do not have pre-existing antibodies. The "with" arm would probably be deferred under normal circumstances, but if you're really going forward as fast as you can, and you know there's an unknown but significant fraction of the population that has been exposed and developed antibodies, you kind of need to know if the vaccine performs differently. Otherwise you could end up forced to label the product so that you have to test everyone before vaccinating. Coronavirus immunology generally worries me until you've got a lot of good data...

At this point places with high infection rates like Brazil might be the place to have a large trial.

[TeeRick]

10 hours ago, Germancruiser said:

Every step there is in the direction of a vaccine is important- and one in the right direction. The sooner we get the vaccine the better!

Nobody is  " forced" to get the vaccine- BUT if you want to board a ship- you have to be vacinnated- as easy at that. There was a heated discusion going in Germany  here-  if - when the vaccine is available - it should be mandatory to get vaccinated.

Yes - it only matters here on Cruise Critic at least what the cruising population will do and if they are required to get the vaccine.  And if they can actually get the vaccine within their countries and when.  It will be initially limited and not likely that vacation travelers will get a priority.  

 

There are government mandates for a number of vaccines, particularly childhood/infant vaccines for school purposes - but not for influenza and travel vaccines.  That would be a new precedent. And all governments act differently on this issue.  But perhaps there might be a mandate for a COVID vaccine- that would not surprise me.  Neither would the significant percentage of the population who refused it.  Speculating for the US population.

[boscobeans]

18 hours ago, prish said:

That’s right John, the vaccine is being developed by Oxford University, to be manufactured by AstraZeneca. AZ has just signed a contract with Serum Institute of India, the largest vaccine manufacturing facility in the world. Production has already started and they hope to have 2 billion doses ready by September, in anticipation of successful trials. Half the supply will go to low and middle income countries.
 

Apart from other concerns I have a sisterly interest here, my brother works for AZ and actively involved in this project!

 

 

AS PER OXFORD"S WEBSITE.

The University of Oxford has today announced an agreement with the UK-based global biopharmaceutical company AstraZeneca for the further development, large-scale manufacture and potential distribution of the COVID-19 vaccine candidate currently being trialled by the Oxford Vaccine Group.

 

[cangelmd]

5 hours ago, TeeRick said:

At this point places with high infection rates like Brazil might be the place to have a large trial.

I read somewhere Teerick, that the Oxford trial was headed to Brazil.

At some point, I read an interview with one of the lead researchers who said they needed at least 50 people to get the virus to make the study valid, not sure if that was Phase II or III.

Do you know what the typical end-point is - is it a positive PCR test or is it symptoms and positive test? With the number of asymptomatic infections and the long incubation, I would hope that they periodically test the study subjects.

[madmacs]

My niece is working on the Oxford project (junior role). I am no expert on the project but as I understand it there is a high degree of confidence it will work. The biggest concern is proving it, as cases reduce in the UK it is more difficult to establish if it is working. As someone said,and they are apparently considering it may be worth running a trial in Latin America which is the latest hot spot. I wonder is President Bolsonaro will allow them in as Covid-19 is just a little flu. 

 

I understand that a number of governments including the UK are funding Astra Zenica. It seems to me eminently sensible to produce the vaccine on an industrial scale as that may save a few months time in counteracting the disease. Frankly the few $billion costs could save lives and many more $billions in lost production etc. Of course there is a risk the vaccine won't work but I think a risk worth taking.

 

 I doubt this will save my October cruise but maybe March will be ok.

[John182]

1 hour ago, madmacs said:

As someone said,and they are apparently considering it may be worth running a trial in Latin America which is the latest hot spot. I wonder is President Bolsonaro will allow them in as Covid-19 is just a little flu. 

Yes, the Brazilian Health Regulatory Authority approved the Oxford Vaccine for use in trials in Brazil earlier this week. Whether the politicians there get in the way is as you say another matter. 

[cangelmd]

3 hours ago, John182 said:

Yes, the Brazilian Health Regulatory Authority approved the Oxford Vaccine for use in trials in Brazil earlier this week. Whether the politicians there get in the way is as you say another matter. 

The politicians will likely take credit!

[TeeRick]

18 hours ago, cangelmd said:

I read somewhere Teerick, that the Oxford trial was headed to Brazil.

At some point, I read an interview with one of the lead researchers who said they needed at least 50 people to get the virus to make the study valid, not sure if that was Phase II or III.

Do you know what the typical end-point is - is it a positive PCR test or is it symptoms and positive test? With the number of asymptomatic infections and the long incubation, I would hope that they periodically test the study subjects.

The desired endpoint of course in a perfect world is 100% protection from infection.  But there is some serious talk about a benchmark of 50% infection protection to get approval.  I included a link below with a clinical endpoint discussion of vaccine efficacy and approval.  It is possible IMO that future SARS-CoV-2 vaccine candidates will be correlated with immune responses (initially a secondary endpoint in the first large trials) and if that is a strong correlation to protection then the trials would be much easier to run and evaluate.  All of the current speed and high risk is worth it but skipping the usual steps might come back to bite us in some cases.

 

https://www.clinicaltrialsarena.com/comment/covid-19-vaccine-efficacy-approval/