Certified Legendary Thread Corona, Jamaica ooh I wanna take ya (COVID-19 Information & Discussion Here) Part 2 "The Second Wave"

[ad victoriam]

I tried ordering online but it’s not available yet.

you will need to wait a few months before one is rolled out to the general public,
However, the Oxford Vaccine is in Production in Australia, in preparation for its approval, as it will take time to manufacture enough dose's to do any good.

 

[jenny61_99]

the Pfizer vaccine showing 90% efficacy.... but what they don’t tell you is it has to be stored at -94 degrees. That’s going to make distribution virtually impossible. Also that we don’t know who it works for... is it only those who get mild cases and not those with comorbidities? It’s no bloody good if it only works for those who won’t die from it anyway. Still way too much data needs to be gathered before they can roll ANYTHING out for mass distribution.

 

[ad victoriam]

the Pfizer vaccine showing 90% efficacy.... but what they don’t tell you is it has to be stored at -94 degrees. That’s going to make distribution virtually impossible. Also that we don’t know who it works for... is it only those who get mild cases and not those with comorbidities? It’s no bloody good if it only works for those who won’t die from it anyway. Still way too much data needs to be gathered before they can roll ANYTHING out for mass distribution.

Just some Info re the Pfizer vaccine that may help to answer your questions. From the Australian Government

Pfizer and BioNTech are jointly developing a vaccine for Coronavirus (COVID-19). If the vaccine is proven to be safe and effective, and is approved for use, it will be available in Australia from early 2021 as part of the Australian Government’s COVID-19 Vaccine and Treatment Strategy. The vaccine doses purchased by the Australian Government will be manufactured in the United States, Belgium and Germany

Large-scale human clinical trials (Phase 2/3), involving 44,000 participants, are underway in the United States, Germany, Argentina, Brazil and South Africa. The vaccine is being tested in adults 18-54 years of age, 55-85 years of age and adolescents 12-18 years of age. The Pfizer/BioNTech vaccine is the first COVID-19 vaccine to be tested in adolescents.

And If the Pfizer/BioNTech vaccine is successful:
• 10 million doses will be available from early 2021
• These doses will be manufactured offshore.

 

[mistylake]

Just some Info re the Pfizer vaccine that may help to answer your questions. From the Australian Government

Pfizer and BioNTech are jointly developing a vaccine for Coronavirus (COVID-19). If the vaccine is proven to be safe and effective, and is approved for use, it will be available in Australia from early 2021 as part of the Australian Government’s COVID-19 Vaccine and Treatment Strategy. The vaccine doses purchased by the Australian Government will be manufactured in the United States, Belgium and Germany

Large-scale human clinical trials (Phase 2/3), involving 44,000 participants, are underway in the United States, Germany, Argentina, Brazil and South Africa. The vaccine is being tested in adults 18-54 years of age, 55-85 years of age and adolescents 12-18 years of age. The Pfizer/BioNTech vaccine is the first COVID-19 vaccine to be tested in adolescents.

And If the Pfizer/BioNTech vaccine is successful:
• 10 million doses will be available from early 2021
• These doses will be manufactured offshore.

They clearly don’t consider cold storage logistics an issue, they would obviously be sorting this out in tandem with the vaccine development or its already in use now anyway.

 

[1970crow]

the Pfizer vaccine showing 90% efficacy.... but what they don’t tell you is it has to be stored at -94 degrees. That’s going to make distribution virtually impossible. Also that we don’t know who it works for... is it only those who get mild cases and not those with comorbidities? It’s no bloody good if it only works for those who won’t die from it anyway. Still way too much data needs to be gathered before they can roll ANYTHING out for mass distribution.

just keep barracking against it Jen, we understand.

 

[mistylake]

just keep barracking against it Jen, we understand.

Bali opening up to international travelers soon. It’s not going to be like in the past though there’s going to be pre-testing etc required. Plus hygiene, social distancing etc. vaccines are going to start rolling out. I think after Christmas/new year, things will rapidly change.
I only mention Bali because it was just on the news this morning.

 

[kirky]

Bali opening up to international travelers soon. It’s not going to be like in the past though there’s going to be pre-testing etc required. Plus hygiene, social distancing etc. vaccines are going to start rolling out. I think after Christmas/new year, things will rapidly change.
I only mention Bali because it was just on the news this morning.

Bali may open up but that doesn’t mean we, Australians, will be able to go there. We will be lucky to go anywhere except NZ by mid next year.

Australia in talks to expand travel bubble to parts of Asia

Scott Morrison says Australia is still holding discussions with several Asian countries about expanding Australia's travel bubble, but radical changes are not expected for months.

www.abc.net.au

 

[Vader]

Bali may open up but that doesn’t mean we, Australians, will be able to go there. We will be lucky to go anywhere except NZ by mid next year.

Australia in talks to expand travel bubble to parts of Asia

Scott Morrison says Australia is still holding discussions with several Asian countries about expanding Australia's travel bubble, but radical changes are not expected for months.

www.abc.net.au

Most of Asia should be feasible - but not the Philippines or Indonesia, both of which are still CV-19 disaster areas.

I'm curious as to why Japan, Taiwan, China, Singapore and South Korea are constantly named as places where the bubble could be extended - but Thailand and Vietnam are both regularly ignored. Neither Thailand, nor Vietnam, have had any community transmission of CV-19 for a long time. Probably because Thailand and Vietnam are relatively poor countries which don't contribute significantly to Australia's inbound tourism - they are destinations for outbound Australian tourists.

mistylake really shouldn't be getting his hopes up. Even if one or more vaccines are approved early next year, they are unlikely to be widely available until the second half of the year.

Further, there are still a whole lot of questions they haven't answered, most notably regarding how long they remain effective and long-term side effects, neither of which can be identified in trials which have been going for less than 12 months. The issue of distributing the Pfizer vaccine, which requires storage at extremely low temperatures, represents a major challenge even in developed countries - it's almost completely useless for developing nations.

 

[mistylake]

Most of Asia should be feasible - but not the Philippines or Indonesia, both of which are still CV-19 disaster areas.

I'm curious as to why Japan, Taiwan, China, Singapore and South Korea are constantly named as places where the bubble could be extended - but Thailand and Vietnam are both regularly ignored. Neither Thailand, nor Vietnam, have had any community transmission of CV-19 for a long time. Probably because Thailand and Vietnam are relatively poor countries which don't contribute significantly to Australia's inbound tourism - they are destinations for outbound Australian tourists.

mistylake really shouldn't be getting his hopes up. Even if one or more vaccines are approved early next year, they are unlikely to be widely available until the second half of the year.

Further, there are still a whole lot of questions they haven't answered, most notably regarding how long they remain effective and long-term side effects, neither of which can be identified in trials which have been going for less than 12 months. The issue of distributing the Pfizer vaccine, which requires storage at extremely low temperatures, represents a major challenge even in developed countries - it's almost completely useless for developing nations.

All I need is a third country which I can transit through.
Once Bali opens to Asia I need to find a loop around, to to get to that opened location even if I can not go to Indonesia direct. Be that through a pacific nation or whatever. It changes day by day and I may get exempt travel by going for a 3 month period to. I’m currently too busy to go anyway but wet season in Cairns is looming and bloody horrible, so would be great to get the F out of here after new year, for a few months. My plan is to get married so I’m not just going on a holiday. It’s a lot more than that.

 

[kirky]

So Victoria has now had 12 days with zero cases and nearly 20,000 daily tests.

This will assist in getting the borders open to NZ without the need to quarantine upon arrival there.

 

[radiojake]

3 days with no community transmission in the entire country

first time since Feb that has happened

 

[jenny61_99]

just keep barracking against it Jen, we understand.

I'm not barracking against anything. What a ridiculous statement. I'm telling you, it will take more time!

 

[jenny61_99]

Just some Info re the Pfizer vaccine that may help to answer your questions. From the Australian Government

Pfizer and BioNTech are jointly developing a vaccine for Coronavirus (COVID-19). If the vaccine is proven to be safe and effective, and is approved for use, it will be available in Australia from early 2021 as part of the Australian Government’s COVID-19 Vaccine and Treatment Strategy. The vaccine doses purchased by the Australian Government will be manufactured in the United States, Belgium and Germany

Large-scale human clinical trials (Phase 2/3), involving 44,000 participants, are underway in the United States, Germany, Argentina, Brazil and South Africa. The vaccine is being tested in adults 18-54 years of age, 55-85 years of age and adolescents 12-18 years of age. The Pfizer/BioNTech vaccine is the first COVID-19 vaccine to be tested in adolescents.

And If the Pfizer/BioNTech vaccine is successful:
• 10 million doses will be available from early 2021
• These doses will be manufactured offshore.

I had NO questions. I'm telling you the issues with the Pfizer drug are thus: it requires storage at -94 degrees. This makes it problematic. While it looks very encouraging so far with 90% efficacy, what we don't know from these studies is WHO were the subjects that contracted the virus. WHO were the subjects that didn't (and their age/co-morbidity profiles etc). At the moment, we don't have enough information to make categoric statements about the viability of this drug.

 

[Vhaluus]

the 90% number is truly remarkable if it can match that in the general populous. That is enough to eliminate the virus entirely potentially.

Previously conjecture had been that we'd need a cocktail of multiple different vaccines to achieve a reasonable level.

One thing I'd be curious about is how long it is effective for. We've already seen cases of reinfection and indeed most of the literature seems to indicate that long term immunity from normal exposure is not likely, so I'd assume the same is true for the vaccine.

So this may be something where people require doses as often as once a year to keep it effective.

 

[Vader]

the 90% number is truly remarkable if it can match that in the general populous. That is enough to eliminate the virus entirely potentially.

Previously conjecture had been that we'd need a cocktail of multiple different vaccines to achieve a reasonable level.

One thing I'd be curious about is how long it is effective for. We've already seen cases of reinfection and indeed most of the literature seems to indicate that long term immunity from normal exposure is not likely, so I'd assume the same is true for the vaccine.

So this may be something where people require doses as often as once a year to keep it effective.

So many questions which need to be answered:

• How long does it remain effective?
• How often will we need "booster" shots?
• What are the long-term side effects of the vaccine?
• How effective is it for people with comorbidities, and other factors?

The answers to the 3rd question won't be known for years.

The Aust Govt has ordered 10m shots of this vaccine (they've also placed orders for several other potential vaccines). The Pfizer vaccine requires 2 shots, so they'll have enough for 5m people. Australia's population is currently 25m. You do the math...

 

[1970crow]

I had NO questions. I'm telling you the issues with the Pfizer drug are thus: it requires storage at -94 degrees. This makes it problematic. While it looks very encouraging so far with 90% efficacy, what we don't know from these studies is WHO were the subjects that contracted the virus. WHO were the subjects that didn't (and their age/co-morbidity profiles etc). At the moment, we don't have enough information to make categoric statements about the viability of this drug.

It requires storage at -94 degrees. It lives for 24 hours at 4 degrees, ie refrigerator temperature. -94 and +4 is a wide gap where existing logistical infrastructure can probably deliver with very little risk of damage to the product. Don't forget that a doctor can only administer so many jabs per day, they'll get the required doses with cold chain certification each morning and administer that day. And given this is a global pandemic, I'm sure a few ideas surrounding mass immunisation facilities will get thrown up.

What you need to find out is how long does it live at -20 degrees, which is what an off the shelf freezer container can operate at. Then you will have a reasonable idea of how problematic the storage temperature requirement is.

 

[ad victoriam]

I had NO questions. I'm telling you the issues with the Pfizer drug are thus: it requires storage at -94 degrees. This makes it problematic. While it looks very encouraging so far with 90% efficacy, what we don't know from these studies is WHO were the subjects that contracted the virus. WHO were the subjects that didn't (and their age/co-morbidity profiles etc). At the moment, we don't have enough information to make categoric statements about the viability of this drug.

Key personnel do have the Data, They have the records of all the volunteers undergoing the trials, you do understand that is a basic requirement.
They also have regular reports on every individual.
I can honestly say that TGA has up to date information, And every day they are getting more information,
But while that's going on some are working on distribution and getting Vaccination on the ground in Australia for immediate roll out once approval has been given,
Australia has Purchase 10million dose of Pfitzer, Novavax will supply 40 million vaccine doses (note These are 2 dose vaccinations)
And Currently producing 30million of the Oxford- AstraZeneca Vaccine in Australia,

The Pfitzer requires a -70 degree long term storage, Also at this time the vaccine remains stable at 2 to 8 degrees Celsius for five days,
And there are urgent discussion among airlines, freight companies, and governments around the world now taking place on how much dry ice and deep freezers can be safely accommodated on various aircraft, The Problem is not getting the required Temperature but the quantity allowed., Airlines have strict limits about dry ice because it produces carbon dioxide and there are estimates that only around one-tenth of a plane’s cargo space could accommodate the vaccine.
However Miltary plane's have different rules, and the Globemaster may come into play, in Australia,

 

[jenny61_99]

Key personnel do have the Data, They have the records of all the volunteers undergoing the trials, you do understand that is a basic requirement.
They also have regular reports on every individual.
I can honestly say that TGA has up to date information, And every day they are getting more information,
But while that's going on some are working on distribution and getting Vaccination on the ground in Australia for immediate roll out once approval has been given,
Australia has Purchase 10million dose of Pfitzer, Novavax will supply 40 million vaccine doses (note These are 2 dose vaccinations)
And Currently producing 30million of the Oxford- AstraZeneca Vaccine in Australia,

The Pfitzer requires a -70 degree long term storage, Also at this time the vaccine remains stable at 2 to 8 degrees Celsius for five days,
And there are urgent discussion among airlines, freight companies, and governments around the world now taking place on how much dry ice and deep freezers can be safely accommodated on various aircraft, The Problem is not getting the required Temperature but the quantity allowed., Airlines have strict limits about dry ice because it produces carbon dioxide and there are estimates that only around one-tenth of a plane’s cargo space could accommodate the vaccine.
However Miltary plane's have different rules, and the Globemaster may come into play, in Australia,

The data, as yet, has not been reviewed by peers. There are still many aspects to be addressed.

 

[ad victoriam]

The data, as yet, has not been reviewed by peers. There are still many aspects to be addressed.

So you're telling us the Australian Government has Purchase a supply of Drugs, without anyone reviewing the available Data,

The Data is continually being updated, and has been available for the various select department to review, Whether the people in these departments are Peers in your eyes is another thing, but they are pretty high up the decision-making ladder.
Yes, The complete data has not been finalized, but the progress reports and regular updates have been made available.
You do not authorize and do the level of work that is happening, to prepare for the Vaccines for immediate rollout once full approval is given, without a lot of decision making base on solid groundwork.
They are not Producing Oxford- AstraZeneca in Australia on a Whim, they are not laying the groundwork to fly in Pfitzer and Novavax vaccines on a whim, They are basing their decision on sound advice, and yes sound advice from people in your industry.

 

[jenny61_99]

So you're telling us the Australian Government has Purchase a supply of Drugs, without anyone reviewing the available Data,

The Data is continually being updated, and has been available for the various select department to review, Whether the people in these departments are Peers in your eyes is another thing, but they are pretty high up the decision-making ladder.
Yes, The complete data has not been finalized, but the progress reports and regular updates have been made available.
You do not authorize and do the level of work that is happening, to prepare for the Vaccines for immediate rollout once full approval is given, without a lot of decision making base on solid groundwork.
They are not Producing Oxford- AstraZeneca in Australia on a Whim, they are not laying the groundwork to fly in Pfitzer and Novavax vaccines on a whim, They are basing their decision on sound advice, and yes sound advice from people in your industry.

In all cases, they have purchased the rights to access when/if the vaccine is licensed and approved for distribution. They haven't purchased the actual vaccine because - shock horror - there IS NO approved vaccine at the present moment. Pfizer have reported these favourable results but they have AS YET, not been peer reviewed. Also, they haven't answered the questions relating to who (age profile/comorbidity) got sick, who appeared to be protected etcetc. It is no good if the vaccine only protects 30 year olds who aren't at risk of death/dying should they get the disease. This is in data yet to be presented for peers to review. You are chomping at the bit... but like I've said to you MULTIPLE times, there will be no vaccine distributed this year (as you predicted) and I doubt very much we'd see anything for mass distribution before mid year next year (more likely end of year). I've been consistent in this.

 

[Vader]

So you're telling us the Australian Government has Purchase a supply of Drugs, without anyone reviewing the available Data,

That's exactly what they've done. They've pre-purchased large batches of several vaccines, long before their trials have been completed and the reports peer reviewed. They have done so in order to ensure that Australians will have access to these drugs, and that they won't be too far back in the queue if/when the vaccines become available.

No doubt the TGA will be reviewing all of the data before authorising their use in Australia, but the initial purchase (10 million units) has already happened - long before the TGA has had time to complete its review.

 

[Vader]

In all cases, they have purchased the rights to access when/if the vaccine is licensed and approved for distribution. They haven't purchased the actual vaccine because - shock horror - there IS NO approved vaccine at the present moment.

This part is not true. The Aus Govt has pre-emptively purchased 10 million units of the Pfizer vaccine, and ~160 million units of CV-19 vaccines in total. They haven't just purchased manufacturing licenses - they have purchased millions of units of unapproved vaccines.

However, they won't be injecting Australians with those vaccines until the TGA has reviewed all of the data and given their approval for the vaccines to be used.

 

[ad victoriam]

In all cases, they have purchased the rights to access when/if the vaccine is licensed and approved for distribution. They haven't purchased the actual vaccine because - shock horror - there IS NO approved vaccine at the present moment. Pfizer have reported these favourable results but they have AS YET, not been peer reviewed. Also, they haven't answered the questions relating to who (age profile/comorbidity) got sick, who appeared to be protected etcetc. It is no good if the vaccine only protects 30 year olds who aren't at risk of death/dying should they get the disease. This is in data yet to be presented for peers to review. You are chomping at the bit... but like I've said to you MULTIPLE times, there will be no vaccine distributed this year (as you predicted) and I doubt very much we'd see anything for mass distribution before mid year next year (more likely end of year). I've been consistent in this.

Jenny Not chomping at the Bit I am working on Data I have seen and allowed to mention,
The groundwork required to plan for these vaccines to come to Australia is not done on a Whim, and take planning they do not do this without serious groundwork,
The Groundwork require to start producing a vaccine in Australia take considerable more work,

As for the Age groups re Pfitzer The vaccine is being tested in adults 18-54 years of age, 55-85 years of age, and adolescents 12-18 years of age. The Pfizer/BioNTech vaccine is the first COVID-19 vaccine to be tested in adolescents. and the ongoing paperwork is available, I have mentioned this before,

As for mass production, I am sorry to say it has started, Just waiting for Approval before being rolled out, Approval which at this time is expected without problems,
We will have Vaccines available for some early next year, well before winter hits,
You may not agree but it is Happening as I speak,

 

[ad victoriam]

That's exactly what they've done. They've pre-purchased large batches of several vaccines, long before their trials have been completed and the reports peer reviewed. They have done so in order to ensure that Australians will have access to these drugs, and that they won't be too far back in the queue if/when the vaccines become available.

No doubt the TGA will be reviewing all of the data before authorising their use in Australia, but the initial purchase (10 million units) has already happened - long before the TGA has had time to complete its review.

No they did not make this decision without talking to competent officials,
TGA will make the Final Call, but due to emergency the Drug Trials have been open and sharing their findings, and I can grantee The People who are going to make the decision have access to this data,
We need to be proactive, as mention a while back the Biggest issue Australia was facing was how to get the vaccine out to the public in a timly fashion, this is the process, and it is not done on a whim,
We are dealing in unprecedented times, the way forward is differant than in the past.

 

[jenny61_99]

No they did not make this decision without talking to competent officials,
TGA will make the Final Call, but due to emergency the Drug Trials have been open and sharing their findings, and I can grantee The People who are going to make the decision have access to this data,
We need to be proactive, as mention a while back the Biggest issue Australia was facing was how to get the vaccine out to the public in a timly fashion, this is the process, and it is not done on a whim,
We are dealing in unprecedented times, the way forward is differant than in the past.

We will agree to disagree as you know everything, apparently.

What I will say is... that yes, indeed unprecedented times, unprecedented money being spent, but doesn't change the fact that safety WILL be compromised if a vaccine is released too quickly.