Pfizer revises storage temps.

[cabmandone]

Originally Posted by Mahler9th

My recent posts were not intended to address the storage temperature topic.

I was kind of commenting on this:

"I think that's kinda why the FDA said Nah, we'll keep the dose the same back in January. Essentially, we're better off having a smaller percentage fully vaccinated than a larger percentage half assed vaccinated."

Back to storage temp....

I am not sure who is paying for what, but in general, it is likely in the best biz interest of Pfizer to seek a change that would make legal less challenging storage requirements in the labeling.

I have had roles in exec management in companies and have led projects with such goals...

The business opportunities for Covid vaccines for companies like Pfizer, Moderna, J&J and Novavax are not likely limited to the US and present circumstances. I would hypothesize that all of them have many initiatives underway to grow their businesses.

I glanced at the Novavax ~one year stock price change ... yikes.

Meh... go back to page two. I covered dosing there with a link from the FDA. If ya wanna take part that's fine. But read over the posts and maybe look at a few links so we're not going over the same stuff multiple times.

[Mahler9th]

"There was talk back in January about Moderna possibly seeking authorization to go to one dose. The FDA shut that down."

"Shut that down" is not a term of art used by the FDA in this context.

Curious folks should learn about fed regulations for off label use...

For example, depending on the details, the FDA might not lawfully be able stop, say a doctor's office from giving all doses as first shots only. The details can matter.

Folks should consider that what they'd think should be simple situations and circumstances may not be so for myriad reasons. If we had a different form of government and/or socialized medicine, things might be different.

Frankly I am a little surprised to not see folks "up in arms" (pardon the pun) when they realize that some of these OWS companies have taken orders from other countries.

[red-beard]

Mike, there was at least one African Nation stating that the US should share the vaccines more equally with the rest of the world. The only reason US has them is the US paid a WHOLE bunch of money to the manufacturers to get going, develop, test and produce them.

Up in Arms: That is good! I will have to use it!

[Sooner or later]

Originally Posted by Mahler9th

"There was talk back in January about Moderna possibly seeking authorization to go to one dose. The FDA shut that down."

"Shut that down" is not a term of art used by the FDA in this context.

Curious folks should learn about fed regulations for off label use...

For example, depending on the details, the FDA might not lawfully be able stop, say a doctor's office from giving all doses as first shots only. The details can matter.

Folks should consider that what they'd think should be simple situations and circumstances may not be so for myriad reasons. If we had a different form of government and/or socialized medicine, things might be different.

Frankly I am a little surprised to not see folks "up in arms" (pardon the pun) when they realize that some of these OWS companies have taken orders from other countries.

Quit splitting hairs.

[cabmandone]

Originally Posted by Mahler9th

"There was talk back in January about Moderna possibly seeking authorization to go to one dose. The FDA shut that down."

"Shut that down" is not a term of art used by the FDA in this context.

Curious folks should learn about fed regulations for off label use...

For example, depending on the details, the FDA might not lawfully be able stop, say a doctor's office from giving all doses as first shots only. The details can matter.

Folks should consider that what they'd think should be simple situations and circumstances may not be so for myriad reasons. If we had a different form of government and/or socialized medicine, things might be different.

Frankly I am a little surprised to not see folks "up in arms" (pardon the pun) when they realize that some of these OWS companies have taken orders from other countries.

No sh.t Sherlock! Again... my words. Again! since you're struggling with reading comprehension today... There was talk back in January of reducing the dosage from two down to one. It was said that Moderna might seek a change to the EUA. The FDA shut that talk down with the statement they came out with that I linked on page two. Try to keep up or at least try to understand what's being discussed. Or just drop out of the conversation altogether. Your little "gotcha" statements are adding nothing to the conversation but you seem to revel in that and I don't for the life of me understand why.

[cabmandone]

Originally Posted by Sooner or later

Quit splitting hairs.

It's what he does. I don't get why but it's what he does. And he wonders why I labeled him over in PARF.

[Mahler9th]

Folks should realize that the clinical trials that these companies conducted had to be approved by FDA. I don't know for sure, but I would surmise that there was a lot of discussion about trial structure with respect to number of doses, BEFORE the trials were approved.

If that is so, and the trial structures were based on two-dose endpoints, then FDA did not "shut anything down."

They likely could not authorize nor approve a change in labeling as critical as dosing because the study was likely not structured in a way that would provide sufficient safety and efficacy data.

Here is a related quote from FDA:

"Those participants who did not receive two vaccine doses at either a three-or four-week interval were generally only followed for a short period of time, such that we cannot conclude anything definitive about the depth or duration of protection after a single dose of vaccine from the single dose percentages reported by the companies. "

Did Pfizer include a robust "single dose" arm in studies? If not, why wouldn't they?

Here is a link that may provide some context:

https://clinicaltrials.gov/ct2/show/NCT04368728

This appears to be public domain info on the Pfizer study-- at least a Pfizer study.

I am sure we will learn more.

If folks are interested in learning more about trial design for vaccines and FDA submissions for changes in labeling in this type of situation, I can ask an expert--- an old friend that happens to be married to one of the OWS vaccine company CEO's. She is an expert, accomplished and experienced professional in the design and implementation of clinical studies for vaccines. I used to drink beers with her in college.

[Mahler9th]

"And he wonders why I labeled him over in PARF."

No, I don't wonder. And I don't care!

I appreciate the inclusion of this link in the thread:

https://www.fda.gov/news-events/press-announcements/fda-statement-following-authorized-dosing-schedules-covid-19-vaccines

That is where they try to explain why they haven't done something that many folks have apparently asked about. Taking a deeper cut at that understanding is perhaps helpful to slow down the spread of misinformation.

[red-beard]

I appreciate your insight to the FDA. I do wonder why it took two weeks each to approve Pfizer and Moderna.

[Mahler9th]

Here is an educational resource provided by FDA:

https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/vaccine-development-101

One other thing that most folks don't realize is that the FDA regulates manufacturing processes.

I once had a highly-anticipated medical device approved by FDA in a very awkward situation with respect to manufacturing. We got our PMA on March 21, 2001. The story made every major evening news program and every major newspaper in the country. The Secretary of Health and Human Services issued a press release! Very, very rare at that time.

The company stock shot up.

I was responsible for all of the PR and reported to the COO. We used a big NY firm for PR execution. But I had to write the releases because there were subtleties.

So we first got approval based on studies in adults. We had to get follow-on approvals for pediatric labeling-- those studies were behind the adult studies. This made me/us turn down the opportunity to have our product in a feature film called Panic Room. The product concept was in the screenplay, but the story had a teenager using it. No bueno. I had to deliver the bad news to the studio.

We also couldn't start selling the product the day we were approved. I had all kinds of government and celebrity people calling to buy our device-- we could not sell it. Why? The product was approved, but we had 2-3 additional approvals related to manufacturing. So it was still not legal to sell.

All of those additional approval steps meant that it took about a year after the product was approved to fully commercialize.

[cabmandone]

Originally Posted by red-beard

I do wonder why it took two weeks each to approve Pfizer and Moderna.

https://www.biospace.com/article/why-is-the-fda-taking-so-long-to-review-a-covid-19-vaccine-/#:~:text=)%20News%20(942)-,Why%20is%20the%20FDA%20Taking%20So,Review%20a%20C OVID%2D19%20Vaccine%3F&text=According%20to%20the%20FDA%2C%20%E2%80%9CThis ,with%20the%20advisory%20committee%20members.%E2%8 0%9D

“This amount of time will allow the FDA to thoroughly evaluate the data and information submitted in the EUA request before the meeting and to be prepared for a robust public discussion with the advisory committee members.”

The thing that gets me about that statement is, it was my understanding that the FDA was "in the loop" through all trial phases. I don't know why they'd need additional time to review the data when they had been seeing the data in real time as part of the information sharing that was supposed to be involved with OWS.

[Sooner or later]

Originally Posted by red-beard

I appreciate your insight to the FDA. I do wonder why it took two weeks each to approve Pfizer and Moderna.

Pfizer applied on Nov 20th and was approved on Dec 11th

Request
https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-emergency-use-authorization

Approval
https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccine

J&J applied on Feb 4th. Review is scheduled this Friday. 26th

[Chocaholic]

You gents do realize that these were approved under an EUA, right? An EUA is not inclusive of the comprehensive process that Mike has linked.

[Sooner or later]

Yes. That is why both my links include emergency use.

[cabmandone]

Originally Posted by Chocaholic

You gents do realize that these were approved under an EUA, right? An EUA is not inclusive of the comprehensive process that Mike has linked.

Yep. So what's your point?

From my link above;

"For the COVID-19 vaccines, Pfizer and Moderna are still collecting data from Phases I and II. Phase III trials for COVID-19 vaccines are scheduled to run for about two years, although some trials are longer. Because those Phase I, II and III trials aren’t complete, (robust) reviews haven’t happened,” she said. “Safety and efficacy data were reviewed a few weeks after the initial vaccinations, but VRBPAC probably will have additional efficacy data when it meets.”

[Sooner or later]

Originally Posted by cabmando

Yep. So what's your point?

Emergency use=scary

[cabmandone]

Originally Posted by Sooner or later

Emergency use=scary

To a certain degree it is. I'm not 100% comfortable with having the stuff injected in my arm. I did it because if it helps get us past this I view it as a good thing. If I pay for it in the future should they find something wrong? Oh well! I put enough stuff in my body over the years that could kill me so what's one more? I smoked, did Cope, drink beer, did autobody repair as a teen and inhaled all kinds of fumes, probably exposed to asbestos as a HVAC tech. What's one more thing to add to the list?

[Sooner or later]

Originally Posted by cabmando

To a certain degree it is. I'm not 100% comfortable with having the stuff injected in my arm. I did it because if it helps get us past this I view it as a good thing. If I pay for it in the future should they find something wrong? Oh well! I put enough stuff in my body over the years that could kill me so what's one more? I smoked, did Cope, drink beer, did autobody repair as a teen and inhaled all kinds of fumes, probably exposed to asbestos as a HVAC tech. What's one more thing to add to the list?

You have to look at both sides of the equation.

On the vaccine positive side:
Faster opening of the economy/schools
Near elimination of hundreds of thousands of deaths
Near elimination of millions of hospitalizations
Near elimination of longer term covid symptoms

On the vaccine negaive side
A fairly high rate of mind symptoms
A very low rate of more serious symptoms
A near zero rate of deaths or hospitalizations
Unknown long term consequence

The positives far outweigh the negatives. Only the long term consequences are not a slam dunk for the vaccine. There is nothing to suggest that there is any significant risk that those long term consequences will approach the death, hospitalizations, and long term health issues of covid itself.

[Mahler9th]

FDA has some perspective on EUA on their web site. I have not made any effort to understand details of EUA.

It may help to remember that 21st century molecular biology is probably more advanced than 20th century molecular biology. And that current regulatory systems and processes have likely lagged. So legacy timelines may not be the best comparison.

And then there is all of the big data tech that can help crunch risk-related numbers. Again, century 21 might afford humankind better tools in this regard than those available 10-30 years ago.


I believe that there is a lot at stake, and the key players in industry have already done a lot to ensure transparency. For example several of them have released their protocols, which is not typical. That may be a big deal.

The gubmint has had a big family of challenges on their hands because, because, well the system is complex and while some aspects can be de-risked and priorities elevated, some cannot. It is complex at least in part because... well, it is the gubmint!

Difficult for them to parse through all of that in ways that the public can digest.

Based on my experience, the system is likely to have extreme bias on the safety side of the equation. I think that the stakes are far too high for public companies and gubmint to not have that bias. We have things we can do on the efficacy side.

One question that folks might ask is the role of statistics in all of this. The study sizes used are designed to deliver statistical power. It is possible that under "normal" circumstances, the companies would not invest in the achievement of that level of power so early on and in such a short time window-- due to costs and in general biz risk.

OWS might be translated as "brush clearer/biz de-risker." I heard a director on an OWS company Board say that in a webinar back last Fall.

I hope that in a few years I can have a cocktail with the best experts in my personal network to look back and get into this level of detail. But they are really busy so t I ain't a gonna bother them now!

Meanwhile, perhaps of interest:

https://www.bbc.com/future/article/20210114-covid-19-how-effective-is-a-single-vaccine-dose

ttps://www.reuters.com/article/us-health-coronavirus-vaccine-novavax/novavax-expects-to-produce-150-million-vaccine-doses-per-month-as-early-as-may-ceo-idUSKBN29Y2WP

What would happen in say March , the world's supply of some key ingredient common to all of these vaccines was grabbed up by the North Korean gubmint?

Dang.

[Chocaholic]

Originally Posted by Sooner or later

Emergency use=scary

No. But EUA = Reasonable to evaluate mRNA vs adenovirus methods to decide which way to go.

Lighten up. No one is out to get you. Maybe 10 years from now we’ll know who was right. Hopefully we both are.