Are vaccines the light at the end of the tunnel?

[pumpkin 11]

5 minutes ago, phoenix_dream said:

I tried to do the Ignore thing, but the person in question keeps showing up anyway.  Help!  Any idea what I could be doing wrong?  I'm fearful I won't be able to control myself one of these days and will have to respond with a comment that will get me blocked from Cruise Critic for good LOL.😎

Hey, you can say whatever you want to me. I promise I won't get offended. As for CC admin, who knows.

[phoenix_dream]

4 minutes ago, pumpkin 11 said:

Hey, you can say whatever you want to me. I promise I won't get offended. As for CC admin, who knows.

What makes you think I am talking about you??

[pumpkin 11]

Just now, phoenix_dream said:

What makes you think I am talking about you??

I don't, but just incase...

[npcl]

51 minutes ago, phoenix_dream said:

I tried to do the Ignore thing, but the person in question keeps showing up anyway.  Help!  Any idea what I could be doing wrong?  I'm fearful I won't be able to control myself one of these days and will have to respond with a comment that will get me blocked from Cruise Critic for good LOL.😎

Just make sure you check all of the options when you add them to your ignore list.

[Ken the cruiser]

40 minutes ago, phoenix_dream said:

I tried to do the Ignore thing, but the person in question keeps showing up anyway.  Help!  Any idea what I could be doing wrong?  I'm fearful I won't be able to control myself one of these days and will have to respond with a comment that will get me blocked from Cruise Critic for good LOL.😎

My son taught me something a little while ago that helped quite a bit when I would want to unload on someone for posting something I totally disagreed with. Here's what he said.

 

Type up a draft response with everything you would want to say. I mean unload it all. Then check your grammar and edit it until it's exactly what you want to say. Then, once you have it just right with all of your emotions included, DELETE it. You will be surprised how relaxed you will become once it disappears from the screen. I've done that a few times and just before hitting Submit, I think of what my son told me. Just a thought ...

[Fouremco]

@phoenix_dream, ignore really only works if everyone stops responding the poster. While you won't see the initial post, you'll still see your blocked poster's posts as part of others' responses. 

[K.T.B.]

1 hour ago, npcl said:

Not worth reading or responding to your posts. Finally found  a use for ignore.

 

A saying from Forrest Gump comes to mind.

 

 

 

I just joined you.  The "I" in their IQ definitely is the opposite of "intelligence".

[K.T.B.]

1 hour ago, phoenix_dream said:

I tried to do the Ignore thing, but the person in question keeps showing up anyway.  Help!  Any idea what I could be doing wrong?  I'm fearful I won't be able to control myself one of these days and will have to respond with a comment that will get me blocked from Cruise Critic for good LOL.😎

 

There are 4 buttons to click on, click on all 4.  

 

 

[junglejane]

Well, I too have just learned how to use the "ignore" function.   So happy I will no longer see someone's selfish, self-absorbed, impulsive, simpleminded and unhelpful posts!  

[pumpkin 11]

47 minutes ago, junglejane said:

Well, I too have just learned how to use the "ignore" function.   So happy I will no longer see someone's selfish, self-absorbed, impulsive, simpleminded and unhelpful posts!  

Wow simpleminded. I'm at least talking about real issue that effect real people and you're response isn't on issue it's on name calling. Sad

[Ken the cruiser]

Here is something interesting to consider. Take the Oxford University/AstraZeneca Stage 3 trials going on in and more importantly outside the US (since June 20th in the UK, Brazil and South Africa) right now. Also consider the UK has dibs on the first 30 million vials of their vaccine as soon as it's approved by the applicable UK authorities, possibly as early as Sep/Oct, with a potential efficacy rate between 70-80% if Prof Gilbert was correct in her early projections.

 

Question: Will the FDA only consider the Stage 3 data collected from the Oxford/AZ trials conducted in the US before making their decision or will they also consider the data collected in the other countries where the Oxford/AZ Stage 3 trials are being performed?

Edited August 2, 2020 by Ken the cruiser

[markeb]

Generally, AZ would be required to present all data, even third party data, to the FDA. And the FDA would generally consider all data it receives. 

[Ken the cruiser]

8 minutes ago, markeb said:

Generally, AZ would be required to present all data, even third party data, to the FDA. And the FDA would generally consider all data it receives. 

Makes sense. The more data the better.

[npcl]

1 hour ago, Ken the cruiser said:

Here is something interesting to consider. Take the Oxford University/AstraZeneca Stage 3 trials going on in and more importantly outside the US (since June 20th in the UK, Brazil and South Africa) right now. Also consider the UK has dibs on the first 30 million vials of their vaccine as soon as it's approved by the applicable UK authorities, possibly as early as Sep/Oct, with a potential efficacy rate between 70-80% if Prof Gilbert was correct in her early projections.

 

Question: Will the FDA only consider the Stage 3 data collected from the Oxford/AZ trials conducted in the US before making their decision or will they also consider the data collected in the other countries where the Oxford/AZ Stage 3 trials are being performed?

All must be submitted.  A drug sponsor cannot pick and choose what trial data it wants to submit. That is why a lot of care goes into trial design.

[Ken the cruiser]

22 minutes ago, npcl said:

All must be submitted.  A drug sponsor cannot pick and choose what trial data it wants to submit. That is why a lot of care goes into trial design.

That raises the question, would AZ be allowed to submit their data from the non-US trial to gain FDA emergency approval if the UK gives them emergency approval to distribute the vaccine in the UK in the Sept/Oct timeframe, or would they have to wait until they reach the same testing milestone and then submit the combined data gained from their US trial along with the other non-US trial data, which I believe hasn't started yet, delaying their FDA submission to the Oct/Nov timeframe? 

Edited August 2, 2020 by Ken the cruiser

[markeb]

Just now, Ken the cruiser said:

That raises the question, would AZ be allowed to submit their data from the non-US trial to gain FDA emergency approval if the UK gives them emergency approval to distribute the vaccine in the UK In September, or would they have to wait until they reach the same testing milestone from data gained in their US trial which I believe hasn't started yet? 

 

Assuming for the moment you mean an Emergency Use Authorization, a form of early and limited approval. There are some "terms of art" here that can get muddled pretty easy. The FDA so far has agreed to expedited review and fast track, which theoretically isn't emergency approval. Emergency use, like compassionate use for things like cancer treatments, is different from but mostly parallel to the actual approval and licensure process.

 

The guidelines on emergency use are "loose" to put it mildly. There has to be an emergency declared by the Secretary of HHS, some safety data, and some efficacy data. Good data is good data, but approval of an EUA in this case is hard to predict. And, I really think FDA would like to review as complete of a biological license application (BLA) as possible because there's still a very real chance of something going wrong. I think what you're going to see is expedited review of multiple candidates as their trials proceed. But, if AZ has data and files a pre-EUA packet, then FDA would almost certainly act on it.

 

Generally speaking, the clinical trials are clinical trials. I really don't think anyone views them as US trials, UK trials, Brazilian trials, etc. If the UK or EU approved the vaccine, and the US trial showed problems, the UK or CE status would be in jeopardy. Likewise, if the data from Brazil shows more or less effect, or brings out a safety problem, it will be considered by the US, Health Canada, the EU, etc. 

[Ken the cruiser]

10 minutes ago, markeb said:

 

Assuming for the moment you mean an Emergency Use Authorization, a form of early and limited approval. There are some "terms of art" here that can get muddled pretty easy. The FDA so far has agreed to expedited review and fast track, which theoretically isn't emergency approval. Emergency use, like compassionate use for things like cancer treatments, is different from but mostly parallel to the actual approval and licensure process.

 

The guidelines on emergency use are "loose" to put it mildly. There has to be an emergency declared by the Secretary of HHS, some safety data, and some efficacy data. Good data is good data, but approval of an EUA in this case is hard to predict. And, I really think FDA would like to review as complete of a biological license application (BLA) as possible because there's still a very real chance of something going wrong. I think what you're going to see is expedited review of multiple candidates as their trials proceed. But, if AZ has data and files a pre-EUA packet, then FDA would almost certainly act on it.

 

Generally speaking, the clinical trials are clinical trials. I really don't think anyone views them as US trials, UK trials, Brazilian trials, etc. If the UK or EU approved the vaccine, and the US trial showed problems, the UK or CE status would be in jeopardy. Likewise, if the data from Brazil shows more or less effect, or brings out a safety problem, it will be considered by the US, Health Canada, the EU, etc. 

Thanks for taking the time to help us better understand this next phase of the process! I just want to thank both you and @npcl for your input throughout the life of this thread to help give us a more in-depth understanding of this complicated process.

[npcl]

1 hour ago, Ken the cruiser said:

That raises the question, would AZ be allowed to submit their data from the non-US trial to gain FDA emergency approval if the UK gives them emergency approval to distribute the vaccine in the UK in the Sept/Oct timeframe, or would they have to wait until they reach the same testing milestone and then submit the combined data gained from their US trial along with the other non-US trial data, which I believe hasn't started yet, delaying their FDA submission to the Oct/Nov timeframe? 

In most cases when phase 3 trials are planned there are discussions with the FDA about the trials and what would be needed.  The trials are then planned in total, even though they might be run in multiple countries, with the intent that all data is submitted to the regulatory authorities.  The planned clinical trials might include components that are run with a longer time frame than the initial set for approval.  An example of that is with the expected data collection time of 24 months in the Moderna trial. They will continue to collect data, even though it is not all required for the initial approval. Sometimes there are also what are called phase 4 (post marketing trials that are run after approval to get information for expanded use use in groups for which there might not be sufficient information in the phase 3 trials). Another example might be that the phase 3 trials might be designed for two doses to make sure that immune response is good.  After approval they might run a single dose trial to compare efficacy to the 2 dose approach.

 

In general the regulatory authorities are pretty similar in their requirements, but in discussions you may get some unique requirements getting thrown in.  There is a group (International Conference on Harmonization) that is set up to try and harmonize regulatory requirements between the FDA, the Japanese MHW and the EU equivalent. I represented FDA to one of the working groups for 10 years. Then went to the other side of the table and represented PhRMA to the same working group for another 5.

 

Here is a link to the CDC page describing the vaccines process

 

https://www.cdc.gov/vaccines/basics/test-approve.html

Edited August 2, 2020 by npcl

[Ken the cruiser]

45 minutes ago, npcl said:

In most cases when phase 3 trials are planned there are discussions with the FDA about the trials and what would be needed.  The trials are then planned in total, even though they might be run in multiple countries, with the intent that all data is submitted to the regulatory authorities.  The planned clinical trials might include components that are run with a longer time frame than the initial set for approval.  An example of that is with the expected data collection time of 24 months in the Moderna trial. They will continue to collect data, even though it is not all required for the initial approval. Sometimes there are also what are called phase 4 (post marketing trials that are run after approval to get information for expanded use use in groups for which there might not be sufficient information in the phase 3 trials). Another example might be that the phase 3 trials might be designed for two doses to make sure that immune response is good.  After approval they might run a single dose trial to compare efficacy to the 2 dose approach.

 

In general the regulatory authorities are pretty similar in their requirements, but in discussions you may get some unique requirements getting thrown in.  There is a group (International Conference on Harmonization) that is set up to try and harmonize regulatory requirements between the FDA, the Japanese MHW and the EU equivalent. I represented FDA to one of the working groups for 10 years. Then went to the other side of the table and represented PhRMA to the same working group for another 5.

 

Here is a link to the CDC page describing the vaccines process

 

https://www.cdc.gov/vaccines/basics/test-approve.html

More great info!! Thanks!!

[ldubs]

53 minutes ago, npcl said:

In most cases when phase 3 trials are planned there are discussions with the FDA about the trials and what would be needed.  The trials are then planned in total, even though they might be run in multiple countries, with the intent that all data is submitted to the regulatory authorities.  The planned clinical trials might include components that are run with a longer time frame than the initial set for approval.  An example of that is with the expected data collection time of 24 months in the Moderna trial. They will continue to collect data, even though it is not all required for the initial approval. Sometimes there are also what are called phase 4 (post marketing trials that are run after approval to get information for expanded use use in groups for which there might not be sufficient information in the phase 3 trials). Another example might be that the phase 3 trials might be designed for two doses to make sure that immune response is good.  After approval they might run a single dose trial to compare efficacy to the 2 dose approach.

 

In general the regulatory authorities are pretty similar in their requirements, but in discussions you may get some unique requirements getting thrown in.  There is a group (International Conference on Harmonization) that is set up to try and harmonize regulatory requirements between the FDA, the Japanese MHW and the EU equivalent. I represented FDA to one of the working groups for 10 years. Then went to the other side of the table and represented PhRMA to the same working group for another 5.

 

Here is a link to the CDC page describing the vaccines process

 

https://www.cdc.gov/vaccines/basics/test-approve.html

 

By harmonize, I'm going to think that means standardized regulatory req's.  Kind of like International Organization of Standards.   Great idea.  After 15 years I hope was there some headway?  

 

And X2 - thanks for sharing.  

 

 

 

  

[Ken the cruiser]

10 hours ago, npcl said:

Here is a link to the CDC page describing the vaccines process

 

https://www.cdc.gov/vaccines/basics/test-approve.html

Thanks for also posting this link. It was very helpful describing the overall step-by-step approval process. 

[TeeRick]

20 hours ago, phoenix_dream said:

I know I shouldn't take the bait, but sometimes I can't help myself.  First of all, you absolutely can't know that you will recover, and even if you do you may have long-lasting damage to your heart or other organs.  There have been a number of news stories about perfectly healthy individuals with no underlying conditions who have died from the virus.  So your chances of recovery may be better, but unless you have a crystal ball you cannot be sure you will recover.

 

Secondly, there are a number of people who cannot take the vaccination due to health issues or being newborns.  If you catch it you are putting their lives at risk by not being vaccinated.  It's sad you could live with that on your conscience.  I know I couldn't.

pheonix_dream and others.  Close your eyes.  Repeat. Just don't take the bait.  Just don't take the bait.  Just don't take the bait.  😀

[TeeRick]

11 hours ago, npcl said:

In most cases when phase 3 trials are planned there are discussions with the FDA about the trials and what would be needed.  The trials are then planned in total, even though they might be run in multiple countries, with the intent that all data is submitted to the regulatory authorities.  The planned clinical trials might include components that are run with a longer time frame than the initial set for approval.  An example of that is with the expected data collection time of 24 months in the Moderna trial. They will continue to collect data, even though it is not all required for the initial approval. Sometimes there are also what are called phase 4 (post marketing trials that are run after approval to get information for expanded use use in groups for which there might not be sufficient information in the phase 3 trials). Another example might be that the phase 3 trials might be designed for two doses to make sure that immune response is good.  After approval they might run a single dose trial to compare efficacy to the 2 dose approach.

 

In general the regulatory authorities are pretty similar in their requirements, but in discussions you may get some unique requirements getting thrown in.  There is a group (International Conference on Harmonization) that is set up to try and harmonize regulatory requirements between the FDA, the Japanese MHW and the EU equivalent. I represented FDA to one of the working groups for 10 years. Then went to the other side of the table and represented PhRMA to the same working group for another 5.

 

Here is a link to the CDC page describing the vaccines process

 

https://www.cdc.gov/vaccines/basics/test-approve.html

Everything you say here is very accurate and true for the typical vaccine clinical trial and approval process which pretty much takes years.  I am cautious by trying to be hopeful that FDA, EMEA and worldwide regulatory authorities are having discussions now together to at least some extent.  But I have not heard of this happening yet.  And they need to coordinate with manufacturing and supply chain of multiple sources and countries.  And possibly several vaccines of dissimilar technologies will be developed and approved.  Perhaps by different countries.  All of this is truly needed but highly unprecedented.  And it will be confusing to most.

[hcat]

17 hours ago, K.T.B. said:

 

I just joined you.  The "I" in their IQ definitely is the opposite of "intelligence".

We are going that route as well..

Too many posts  have been wasted on one person and their opinions,

[WrittenOnYourHeart]

9 minutes ago, hcat said:

We are going that route as well..

Too many posts  have been wasted on one person and their opinions,

 

Yep, I've had them on mine for a few weeks as well. Only issue, as has been pointed out, is that when people reply to them by quoting them, I see their inane posts still.