Pfizer and BioNTech COVID Vaccine has 90% efficacy first look at data

[Miaminice]

@Host Jazzbeau @Germancruiser

 

🙂 Sometimes it all about "better safe than sorry" 🙂

People all over the world -not just the cruise community- are desperate for this pandemic to end.
So the first good news is of course the first bandwagon everyone is inclined to jump on.
Personally I love the good news, and it really is good news. I choose to be careful and not to jump on the first bandwagon which comes by. It´s usually not the best and only one - so simply too early to throw all caution overboard. That´s my "but"...

[gerelmx]

One problem with this vaccine is the cold storage needed

[TeeRick]

13 hours ago, nocl said:

I do not think any of them will have that label without additional trials.

Agreed. Need to finish the current trial and then start more specific trials. And look at data from other similar vaccine trials like Moderna.  And if there is an emergency authorization soon, there might be enough data generated in the expanded vaccinated population- with the right follow ups- to start to answer some of the questions that are being discussed here. Or to design next step trials.   But I still am happy about the early outcome no matter what.  Better than a poke in the eye as they say!  Questions are appropriate and would likely have been studied clinically and addressed in the normal time frame (5-10 years?) of vaccine development.  Of course none of this is normal.  But it is fascinating to watch in real time!

Edited November 10, 2020 by TeeRick

[TeeRick]

1 hour ago, Miaminice said:

@Host Jazzbeau @Germancruiser

 

🙂 Sometimes it all about "better safe than sorry" 🙂

People all over the world -not just the cruise community- are desperate for this pandemic to end.
So the first good news is of course the first bandwagon everyone is inclined to jump on.
Personally I love the good news, and it really is good news. I choose to be careful and not to jump on the first bandwagon which comes by. It´s usually not the best and only one - so simply too early to throw all caution overboard. That´s my "but"...

I definitely understand your caution and your "but"...😀  A lot could still happen.  I would not consider this really bandwagon jumping and there are a lot of horses still in the race.  Just excitement at the potential that a vaccine approach could be effective.  That was a big unknown until this first data was announced.  It might not be the best vaccine or the best data a few months from now.  But I am just very pleased to see a positive outcome even with all the caveats (mostly appropriate) that will be thrown in the next few days.  I am more confident of making my next cruise Aug 2021 than I was a day ago.  I was waiting for the new 2022 European itineraries to be announced so I could L&S.  But now I might wait just a bit.  I have just a wee bit more cruising optimism.  Probably not entirely warranted but it is all of a sudden there in my head!

[upwarduk]

12 minutes ago, TeeRick said:

I am more confident of making my next cruise Aug 2021 than I was a day ago.  I was waiting for the new 2022 European itineraries to be announced so I could L&S. 

My grandson is a project manager for a company in UK, who are conducting  trials on another vaccine. He assures me that we should be back to normal in the second half of 2021. Best Christmas present and something to look forward to in the New Year.

I will however refrain from booking my cruise.

[TeeRick]

1 minute ago, upwarduk said:

My grandson is a project manager for a company in UK, who are conducting  trials on another vaccine. He assures me that we should be back to normal in the second half of 2021. Best Christmas present and something to look forward to in the New Year.

I will however refrain from booking my cruise.

Please thank your grandson for his service to all of us wanting to stay healthy and wanting to cruise next year!

[Miaminice]

1 hour ago, upwarduk said:

My grandson is a project manager for a company in UK, who are conducting  trials on another vaccine. He assures me that we should be back to normal in the second half of 2021. Best Christmas present and something to look forward to in the New Year.

I will however refrain from booking my cruise.

 

That seems a bit too optimistic to me - at least the term "normal".
Change it to "things will be on the way back to normal" and I would agree. 

Also because of the logistical challenges of producing, distributing and administering millions and millions if not billions of doses - it´s going to take a while.

 

Unless he meant the "new normal" which we all got used to already 🙂

 

Edited November 10, 2020 by Miaminice

[dani negreanu]

12 hours ago, markeb said:

And a few (Vioxx, for instance) that made it past this point and were actually approved, then were pulled from the market for significant adverse events.

 

My family, friends and I used Vioxx for all the period it was "allowed" with utmost satisfaction and excellent results. My BF worked for Merck at the time, and when it was removed from the market, all the workers took home the remaining batches.... She worked there until recently, and told me that in her co-workers and her opinion, the removal was "rushed", based on only a few sporadic cases....

 

I, for one, am much less satisfied with Vioxx "replacement" - Arcoxia 😕

[TeeRick]

15 hours ago, Host Jazzbeau said:

These threads take me back to Western Civ, Locke vs Hobbes.  You can tell who is who, even now.  Is there no good news that won't be countered by some Hobbesian 'but'...

Jazz- I love it!  Brings me back way too many years to freshman year.  Way too many years!

[BP99]

4 hours ago, gerelmx said:

One problem with this vaccine is the cold storage needed

Hi,

Yes -80C (rare ultra freezer)is needed for LONG term storage for

Pfizer and Moderna covid vaccines. However short term storage

(5 and 10 days) is fine at -20C (close to your home freezer).

This will create some? problems but hospitals and research

labs have -80C.

[Arizona Wildcat]

4 hours ago, TeeRick said:

Agreed. Need to finish the current trial and then start more specific trials. And look at data from other similar vaccine trials like Moderna.  And if there is an emergency authorization soon, there might be enough data generated in the expanded vaccinated population- with the right follow ups- to start to answer some of the questions that are being discussed here. Or to design next step trials.   But I still am happy about the early outcome no matter what.  Better than a poke in the eye as they say!  Questions are appropriate and would likely have been studied clinically and addressed in the normal time frame (5-10 years?) of vaccine development.  Of course none of this is normal.  But it is fascinating to watch in real time!

TeeRick - a comment that Moderna is recruiting more volunteers locally.  Looking for Hispanic, Native Americans and those with morbidity issues that are elderly.

Have seen multiple media reports for a January time frame for those most at risk followed in February for first responders and others in March and beyond.  Any thoughts?

Called Pfizer Investor Relations and asked about their plans to handle the distribution of their vaccine.  They indicated their proprietary shipping containers using just in time as needed.  20 day life from factory to injection.  Should pretty much eliminate the local storage issues if it works.

[zap99]

4 hours ago, upwarduk said:

My grandson is a project manager for a company in UK, who are conducting  trials on another vaccine. He assures me that we should be back to normal in the second half of 2021. Best Christmas present and something to look forward to in the New Year.

I will however refrain from booking my cruise.

Tell him to get a move on please. Our next cruise is on Eclipse to Alaska, mid June. Could you please ask him to aim for mid second quarter. As he lives in UK I promise to buy him a pint.🤣

[nocl]

18 hours ago, markeb said:

 

I've gone through the study plan a couple of times today, and I'm now stuck with your interpretation, not my original interpretation. The study would not catch asymptomatic infections that could be contagious. Unless their actual data is different, which seems unlikely. It's a study of disease prevention. The press release is exactly technically correct, but at this point the general public (it's a press release, not a technical paper) does not recognize the significant terminology difference between the use of SARS-CoV-2 (the actual virus and infection) and COVID19 (the disease that requires evidence of infection with SARS-CoV-2 and some subset of symptoms). We're now months into reporting "COVID19 cases" based purely on laboratory testing with or without symptoms. There's a "how not to" book waiting to be written on the terminology subject alone!

 

They are doing nasal swabs and PCR before each vaccine dose, but the next PCR requires symptoms. What's not clear to me (you'd need the actual data) is how many people with a URD that met the COVID19 symptom criteria received a swab and negative PCR and were not diagnosed with COVID19 (and whether those numbers were statistically significant between the vaccinated and placebo groups). That could possibly give you more insight into infection reduction, but that's not an endpoint of the study..

 

one of the studies is looking at blood samples that could give data on how many got infected but did not develop symptoms. that will give supporting data and some indication if the vaccine also prevents infection. The problem is that it is too early for such measures to be validated to be used as a measure for infection in a clinical trial.

[nocl]

4 hours ago, Arizona Wildcat said:

TeeRick - a comment that Moderna is recruiting more volunteers locally.  Looking for Hispanic, Native Americans and those with morbidity issues that are elderly.

Have seen multiple media reports for a January time frame for those most at risk followed in February for first responders and others in March and beyond.  Any thoughts?

Called Pfizer Investor Relations and asked about their plans to handle the distribution of their vaccine.  They indicated their proprietary shipping containers using just in time as needed.  20 day life from factory to injection.  Should pretty much eliminate the local storage issues if it works.

The company I worked for used similar containers for a frozen biologic Oncology drug 20 years ago, so nothing new.

[Arizona Wildcat]

16 minutes ago, nocl said:

The company I worked for used similar containers for a frozen biologic Oncology drug 20 years ago, so nothing new.

Was not aware of a shipping container that could maintain -70C for 20 days in 2000.  Frozen or -20C/0F Yes.  -70C is way different.

[BirdTravels]

13 hours ago, upwarduk said:

My grandson is a project manager for a company in UK, who are conducting  trials on another vaccine. He assures me that we should be back to normal in the second half of 2021. Best Christmas present and something to look forward to in the New Year.

I will however refrain from booking my cruise.

Whilst it may be possible to manufacture sufficient vaccine for the UK, the challenge is significantly larger for America. And the cruise lines will require sufficient number of passengers to may a full restart viable. 

[LGW59]

2 minutes ago, BirdTravels said:

Whilst it may be possible to manufacture sufficient vaccine for the UK, the challenge is significantly larger for America. And the cruise lines will require sufficient number of passengers to may a full restart viable. 

It will be all about the Benjamin's no matter the country we live in.

[nocl]

5 hours ago, Arizona Wildcat said:

Was not aware of a shipping container that could maintain -70C for 20 days in 2000.  Frozen or -20C/0F Yes.  -70C is way different.

sufficient dry ice and sufficient insulation. dry ice sublimates at -78c

 

Notice I said similar.

 

We only used them for direct ship and we could get the product anywhere in about 7 days so we used enough dry ice for 10 days. but we could have gone longer but no need to.

 

The biggest limit is how much dry ice can you ship on a plane. we ran into that restriction a few times.

 

It is not rocket science.

Edited November 11, 2020 by nocl

[TeeRick]

Pfizer already working on a dry powder stable formulation of this vaccine.  No surprise here.  But it will need to be retested in a new phase 3 "equivalency" type study most likely so it will be a while.

 

https://www.dailymail.co.uk/news/article-8936107/Pfizers-scientist-says-working-powder-form-COVID-19-vaccine.html

[TeeRick]

19 hours ago, Arizona Wildcat said:

TeeRick - a comment that Moderna is recruiting more volunteers locally.  Looking for Hispanic, Native Americans and those with morbidity issues that are elderly.

Have seen multiple media reports for a January time frame for those most at risk followed in February for first responders and others in March and beyond.  Any thoughts?

Called Pfizer Investor Relations and asked about their plans to handle the distribution of their vaccine.  They indicated their proprietary shipping containers using just in time as needed.  20 day life from factory to injection.  Should pretty much eliminate the local storage issues if it works.

About a month ago Moderna had to slow their trial a bit in order to recruit more subjects in minority groups.

https://www.cnbc.com/2020/10/06/moderna-vaccine-trial-contractors-fail-to-enroll-enough-minorities-sources.html

 

I would be really very surprised if the Moderna vaccine was not as effective as the Pfizer/BioNTech vaccine.  So we might be dealing with two vaccines getting emergency authorization by sometime in December.  Anthony Fauci yeasterday still projecting Q2 -2021 for broader distribution beyond essential health care workers, first responders, those most at risk.

 

Pfizer has developed their own shipping containers and validated methods.  But everybody seems to want to focus on this as a big issue.  IMO it really is not.  Do we really think if the world community has a 90% effective vaccine then they will let logistics of storage and distribution get in the way?  This will all be solved.

[Arizona Wildcat]

7 hours ago, TeeRick said:

About a month ago Moderna had to slow their trial a bit in order to recruit more subjects in minority groups.

https://www.cnbc.com/2020/10/06/moderna-vaccine-trial-contractors-fail-to-enroll-enough-minorities-sources.html

 

I would be really very surprised if the Moderna vaccine was not as effective as the Pfizer/BioNTech vaccine.  So we might be dealing with two vaccines getting emergency authorization by sometime in December.  Anthony Fauci yeasterday still projecting Q2 -2021 for broader distribution beyond essential health care workers, first responders, those most at risk.

 

Pfizer has developed their own shipping containers and validated methods.  But everybody seems to want to focus on this as a big issue.  IMO it really is not.  Do we really think if the world community has a 90% effective vaccine then they will let logistics of storage and distribution get in the way?  This will all be solved.

Shipping is a non event. Already solved.

A personal question.   DW is 70s with several health issues and a cancer survivor.  Would you suggest I enter her in the Moderna trial or not?  Like everyone else we are tired of staying at home. Again she would be eligible to be one of the first after vaccines (am sure there will be at least 3) are approved.

[upwarduk]

16 hours ago, BirdTravels said:

And the cruise lines will require sufficient number of passengers to make a full restart viable. 

There will be an order that the vaccine will be administered in UK:

Care home residents and workers

Over 80’s

Age below 80. 
I am surprised that Hospital workers are not on this list and certainly not people who wish to go on a cruise. 
This however is on our NHS, no mention of private treatment.

[nocl]

On 11/10/2020 at 9:39 AM, dani negreanu said:

 

My family, friends and I used Vioxx for all the period it was "allowed" with utmost satisfaction and excellent results. My BF worked for Merck at the time, and when it was removed from the market, all the workers took home the remaining batches.... She worked there until recently, and told me that in her co-workers and her opinion, the removal was "rushed", based on only a few sporadic cases....

 

I, for one, am much less satisfied with Vioxx "replacement" - Arcoxia 😕

When I was doing work for the FDA one of the comments around the agency was that if aspirin was a new drug filing for approval it would be denied due to its risk profile (gastrointestinal bleeding).  It was grandfathered in when the law established the modern drug approval system.

Edited November 12, 2020 by nocl

[zanderblue]

8 hours ago, upwarduk said:

There will be an order that the vaccine will be administered in UK:

Care home residents and workers

Over 80’s

Age below 80. 
I am surprised that Hospital workers are not on this list and certainly not people who wish to go on a cruise. 
This however is on our NHS, no mention of private treatment.

 

I had a discussion just yesterday with a friend about private treatment. She was trying to make the case that private patients allocation would not come from NHS quota, and as such would have no impact on availability to NHS. 

My position is that no one should be allowed to jump the queue just because they can afford to pay for it.

[TeeRick]

15 hours ago, Arizona Wildcat said:

Shipping is a non event. Already solved.

A personal question.   DW is 70s with several health issues and a cancer survivor.  Would you suggest I enter her in the Moderna trial or not?  Like everyone else we are tired of staying at home. Again she would be eligible to be one of the first after vaccines (am sure there will be at least 3) are approved.

I think the very first step would be to go to her primary physician and ask this question. 

The clinical trial protocols for any vaccine will have very specific inclusion and exclusion criteria for subjects where she might or might not qualify.

 

Among other ways you can search for clinical trials offered in your area.  Or go to the company's websites.

 

https://www.clinicalresearch.com/en/find-trials