Are vaccines the light at the end of the tunnel?

[Homosassa]

14 hours ago, Ken the cruiser said:

 

A source close to the process told CNN this week the Vaccines and Related Biological Products Advisory Committee could make a decision at the end of the meeting about whether to issue an EUA.

Just a clarification for the FDA Advisory panel role in the approval process.

 

An advisory panel is just that, it only gives "advise" on whether to approve or disapprove a product. FDA can ignore the opinion of the advisory panel and do the opposite (approve or disapprove).

[TeeRick]

21 hours ago, Homosassa said:

Just a clarification for the FDA Advisory panel role in the approval process.

 

An advisory panel is just that, it only gives "advise" on whether to approve or disapprove a product. FDA can ignore the opinion of the advisory panel and do the opposite (approve or disapprove).

Yes correct.  Here are the members:

https://www.fda.gov/advisory-committees/vaccines-and-related-biological-products-advisory-committee/roster-vaccines-and-related-biological-products-advisory-committee

 

They actually do very much listen to the Advisory Panel and usually 90% of the time follow their recommendations. But FDA does make the final decision.    The Vaccine Advisory Committee Meeting for the Pfizer Vaccine is scheduled for Dec 10. 

[mimbecky]

36 minutes ago, TeeRick said:

The Vaccine Advisory Committee Meeting for the Pfizer Vaccine is scheduled for Dec 10. 

 

Not to be snarky, but we are in a pandemic.  Any reason why they aren't choosing to meet earlier?  This will be 3 weeks from when Pfizer applied. I guess it may not change much but 3 weeks closer is 3 weeks closer. 😏

 

[markeb]

7 minutes ago, mimbecky said:

 

Not to be snarky, but we are in a pandemic.  Any reason why they aren't choosing to meet earlier?  This will be 3 weeks from when Pfizer applied. I guess it may not change much but 3 weeks closer is 3 weeks closer. 😏

 

Just guessing here, but even with rolling data submission, there are probably thousands of pages of data to review before the actual meeting. That takes time. I’m amazed they’re meeting that early...

[TeeRick]

7 minutes ago, mimbecky said:

 

Not to be snarky, but we are in a pandemic.  Any reason why they aren't choosing to meet earlier?  This will be 3 weeks from when Pfizer applied. I guess it may not change much but 3 weeks closer is 3 weeks closer. 😏

 

Here is my best guess.  Even at "warp-speed" the Advisory Committee members need to get the data and review everything in quite a lot of detail.  Before the meeting.  So all of this is going to happen behind the scenes.  There is a lot at stake.  The meeting will be a public discussion and a recommendation but much of it is happening immediately.

[TeeRick]

1 minute ago, markeb said:

Just guessing here, but even with rolling data submission, there are probably thousands of pages of data to review before the actual meeting. That takes time. I’m amazed they’re meeting that early...

Yes as you can see I agree with you!

[mimbecky]

2 minutes ago, TeeRick said:

3 minutes ago, markeb said:

Just guessing here, but even with rolling data submission, there are probably thousands of pages of data to review before the actual meeting. That takes time. I’m amazed they’re meeting that early...

Yes as you can see I agree with you!

 

Thanks guys....didn't realize that they were already reviewing.  I assumed this would all take place at the meeting.  Good to know.

[markeb]

20 minutes ago, TeeRick said:

Yes as you can see I agree with you!

😀

[K.T.B.]

Not sure if this has been posted or not, but here's the prioritization list for people getting vaccinated.  My wife and I fall under "Phase 2".  Hopefully the FDA approves emergency use and we can begin to work our way back to a somewhat normal life for us.  Though it'll be a good 9-12 months before that happens I believe.

 

 

[Homosassa]

4 hours ago, markeb said:

Just guessing here, but even with rolling data submission, there are probably thousands of pages of data to review before the actual meeting. That takes time. I’m amazed they’re meeting that early...

It is not only the advisory panel members that need to review the data. 

 

There are also the reviewers in the FDA in various  areas (microbiology, toxicology, medical, biomedical engineering, chemistry, etc) that will do a review on their respective area, talk to fellow reviewers if another area may impact on their area, write a review which goes to the team leader for that submission to review and write a summary which includes a recommendation for approval or not.

 

The team leader's information will go up the line to the branch chief and for applications of this significance, will go further up through the division director, office director, center director and to the commissioner's office.

 

All the FDA's reviews will also be sent to the advisory panel members and the application's team leader will also present at the meeting.

 

Quite frankly, a December 10 meeting is really fast scheduling and many FDA employees will be working overtime on this to make sure the review is complete.

[Fouremco]

47 minutes ago, K.T.B. said:

Not sure if this has been posted or not, but here's the prioritization list for people getting vaccinated.  My wife and I fall under "Phase 2".  Hopefully the FDA approves emergency use and we can begin to work our way back to a somewhat normal life for us.  Though it'll be a good 9-12 months before that happens I believe.

 

 

You state that this is "the prioritization list", but the document you've posted only states "How the COVID-19 vaccine could be rationed". Do you know if the list has now been approved as the official US list?

[K.T.B.]

55 minutes ago, Fouremco said:

You state that this is "the prioritization list", but the document you've posted only states "How the COVID-19 vaccine could be rationed". Do you know if the list has now been approved as the official US list?

 

My error.  Should not have used "the" but rather "a".  However, from everything that I've read so far, both in the news and officially (i.e. CDC), that list seems to be accurate and it makes sense.

[markeb]

1 hour ago, Homosassa said:

It is not only the advisory panel members that need to review the data. 

 

 

I'm not sure I'd want to be working data review at CBER right now...

 

I haven't done this, but I'm assuming something like this, especially with two coming in almost at the same time, will pretty much be all hands on deck? As someone with a lot of familiarity, but always outside this process, this seems almost like they've got a near complete BLA to review for the EUA (other than the longer term safety data they've talked about). And they're coming close to reviewing it like it was a BLA!

[Ken the cruiser]

So I have a question. Once an EUA is issued by the FDA for a COVID vaccine, does that mean the petitioner, in the case Pfizer, get to keeping distributing their vaccines in the US as long as they have a supply, or is there a target audience strictly defined in the EUA?

 

And if there is a defined audience in the EUA, does the petitioner at some point have to then go through another FDA approval process to gain authorization to allow them to distribute their vaccine to the general public?

[markeb]

21 minutes ago, Ken the cruiser said:

So I have a question. Once an EUA is issued by the FDA for a COVID vaccine, does that mean the petitioner, in the case Pfizer, get to keeping distributing their vaccines in the US as long as they have a supply, or is there a target audience strictly defined in the EUA?

 

And if there is a defined audience in the EUA, does the petitioner at some point have to then go through another FDA approval process to gain authorization to allow them to distribute their vaccine to the general public?

It depends. I haven’t read Pfizer’s request. The could ask for a limited population. The FDA could grant the EUA for a limited population. That could be age limited, risk limited, or almost anything. It probably won’t be for everyone, but it could be. 
 

The FDA could expand the EUA as more data comes in, or it could move to act on the BLA for full licensure. There will likely be significant post-marketing requirements, and the licensure could still limit use pending more data and an amended BLA.

 

Lots of possibilities at this point. 
 

 

[lyndarra]

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

Not sure if this has been posted or not, but here's the prioritization list for people getting vaccinated.  My wife and I fall under "Phase 2".  Hopefully the FDA approves emergency use and we can begin to work our way back to a somewhat normal life for us.  Though it'll be a good 9-12 months before that happens I believe.

 

 

Good graph. I'd like to see a realistic roll-out  time line alongside it. By realistic I mean somewhere between a best case/worst case scenario. I'm also guessing that, ATM, it would be very difficult in light of non-cooperation of the outgoing government so far as federal planning (if any) and also not ignoring states' approval and readiness. Tall order?

Edited November 22, 2020 by lyndarra
punctuation error

[Homosassa]

1 hour ago, Ken the cruiser said:

So I have a question. Once an EUA is issued by the FDA for a COVID vaccine, does that mean the petitioner, in the case Pfizer, get to keeping distributing their vaccines in the US as long as they have a supply, or is there a target audience strictly defined in the EUA?

 

And if there is a defined audience in the EUA, does the petitioner at some point have to then go through another FDA approval process to gain authorization to allow them to distribute their vaccine to the general public?

There is no way of knowing in advance what restrictions may be in the EUA if it is approved.  

 

We will all find out when the authorization is finalized and released.

 

As far as further review, besides and data requirement reporting contained in the EAU, the vaccine at some point in the future will have to undergo a normal BLA  (Biologic License Application) submission, review and approval for marketing.

 

A drug in the past where the clinical results in the trials showed such life changing results that the drug,  trastuzumab (Herceptin),  was allowed to be used in an expanded access program (given to patients outside a clinical trial) and the clinical trial was halted early in Stage 3 and permission to give the drug  was authorized for Stage 4 HER2 positive breast cancer patients.

 

Use was later expanded to Stage 3 patients and, finally in 2006, stage one and two patients.

 

Before Herceptin, a diagnosis of HER2 Positive breast cancer was a death sentence no matter how early the cancer was found.

Edited November 23, 2020 by Homosassa
Changed NDA to BLA. LOL - I am showing my IDE/PMA (devices) and IND/NDA (drug ) review background.

[Ken the cruiser]

Thanks @markeband @Homosassa. From the way It sounds every EUA is different, so we'll just have to sit back and see what limitations, if any, each resulting COVID vaccine EUA will have.

[LuAnn]

Perhaps I missed this along the way of reading posts but do you all think that the Covid immunization will be required to sail with Celebrity and/or any cruise lines? 

[Ken the cruiser]

4 minutes ago, LuAnn said:

Perhaps I missed this along the way of reading posts but do you all think that the Covid immunization will be required to sail with Celebrity and/or any cruise lines? 

Hope so. But my guess is we'll probably have to wait until X and/or any of the other cruise lines actually post their preboarding requirements, especially for their initial start-up cruises. But as far as I know, no cruise line planning to sail into or out of US ports have released their specific requirements yet.

[nocl]

11 hours ago, mimbecky said:

 

Not to be snarky, but we are in a pandemic.  Any reason why they aren't choosing to meet earlier?  This will be 3 weeks from when Pfizer applied. I guess it may not change much but 3 weeks closer is 3 weeks closer. 😏

 

Because it takes time for the FDA to do its own analysis of the data.  The FDA will get the complete raw data set from the pharmaceutical company and will do its own analysis, it does not depend upon the companies analysis (though the company will provide a summary).  Three weeks is actually a quite remarkable time frame for the FDA to analyze the data and prepare its information for the advisory committee meeting.

 

 

[nocl]

3 hours ago, Ken the cruiser said:

So I have a question. Once an EUA is issued by the FDA for a COVID vaccine, does that mean the petitioner, in the case Pfizer, get to keeping distributing their vaccines in the US as long as they have a supply, or is there a target audience strictly defined in the EUA?

 

And if there is a defined audience in the EUA, does the petitioner at some point have to then go through another FDA approval process to gain authorization to allow them to distribute their vaccine to the general public?

Each EUA is unique depending upon the perceived risk and the unmet medical need. Usually an EUA comes with a set of restrictions.  Would not be surprised if it requires enhanced monitoring for adverse events. 

 

As far as authorized use it could go either way.  

 

The public vaccines advisory committee meeting should give us an idea of the direction that the EUA will take.

[TeeRick]

Oxford/AZ vaccine efficacy results just released.  This is the monkey adenovector vaccine.  One dosing protocol resulted in 90% efficacy.  That as a 1/2 dose followed by a full dose at 30 days.

 

Of interest- two full doses a month apart gave only 62% efficacy.  So what leads to these differences?  And why different from the two mRNA vaccines?  Lot's of possibilities starting with immune moderating effects of the adenovector itself.  There are human adenovector versions of this vaccine in phase 3 so we shall see soon if this was a species-related result (monkey vs human).  That has happened before with the vaccines for rotavirus.   We shall see.  It is nice that their are multiple approaches.  

 

https://www.cnbc.com/2020/11/23/oxford-astrazeneca-covid-vaccine-is-70percent-effective-trial-shows-.html

[mimbecky]

13 hours ago, LuAnn said:

Perhaps I missed this along the way of reading posts but do you all think that the Covid immunization will be required to sail with Celebrity and/or any cruise lines? 

 

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

Not sure if this has been posted or not, but here's the prioritization list for people getting vaccinated

 Could get interesting.  Hubby and I are in the very LAST phase.  I still have 2 cruises scheduled.  If they require immunization yet phase 4 has yet to transpire,  I wonder how Celebrity will handle THAT situation. Doubt they will issue 100 percent refund.  Then I have a TA deposit, insurance etc.

[mimbecky]

10 minutes ago, TeeRick said:

Oxford/AZ vaccine efficacy results just released.  This is the monkey adenovector vaccine.  One dosing protocol resulted in 90% efficacy.  That as a 1/2 dose followed by a full dose at 30 days.

 

Of interest- two full doses a month apart gave only 62% efficacy.  So what leads to these differences?  And why different from the two mRNA vaccines?  Lot's of possibilities starting with immune moderating effects of the adenovector itself.  There are human adenovector versions of this vaccine in phase 3 so we shall see soon if this was a species-related result (monkey vs human).  That has happened before with the vaccines for rotavirus.   We shall see.  It is nice that their are multiple approaches.  

 

https://www.cnbc.com/2020/11/23/oxford-astrazeneca-covid-vaccine-is-70percent-effective-trial-shows-.html

I heard this when I woke up.  Funny I was going to specifically ask YOU why this could be so.  It seems counter intuitive that a first 1/2 dose would be more effective than 2 full doses. Do you know when that human adenovector data is due?  Or Johnson and Johnson (isn't that a human adenovirus?) data?

Fascinating stuff -