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-   -   Pfizer revises storage temps. (http://forums.pelicanparts.com/showthread.php?t=1086512)

cabmandone 02-19-2021 10:22 AM

Pfizer revises storage temps.
 
Kind of interesting and should be helpful going forward.
https://www.msn.com/en-us/health/medical/pfizer-says-vaccine-can-be-stored-in-normal-freezers/ar-BB1dPAfY?li=BBnb7Kz

Pfizer submitted data to the Food and Drug Administration (FDA) showing the vaccine is stable when stored between minus 13 degrees and 5 degrees Fahrenheit, temperatures commonly found in pharmaceutical freezers and refrigerators.

Sooner or later 02-19-2021 10:25 AM

Quote:

Originally Posted by cabmando (Post 11231605)
Kind of interesting and should be helpful going forward.
https://www.msn.com/en-us/health/medical/pfizer-says-vaccine-can-be-stored-in-normal-freezers/ar-BB1dPAfY?li=BBnb7Kz

Pfizer submitted data to the Food and Drug Administration (FDA) showing the vaccine is stable when stored between minus 13 degrees and 5 degrees Fahrenheit, temperatures commonly found in pharmaceutical freezers and refrigerators.

I think that is the same as the Moderna vaccine.

cabmandone 02-19-2021 10:34 AM

Quote:

Originally Posted by Sooner or later (Post 11231613)
I think that is the same as the Moderna vaccine.

That's what I was thinking too. I couldn't figure out why when the two were supposed to be very similar, one needed to be stored at much lower temps.

71T Targa 02-19-2021 11:41 AM

I don't understand why they can't warm it up a bit before giving the injection...
Maybe then it wouldn't feel like you've been hit with a baseball bat for two days. :D

unclebilly 02-19-2021 11:58 AM

How much has been thrown out that may have been ‘ok’ due to improper storage?

pavulon 02-19-2021 01:31 PM

Not to derail but received the second Pfizer dose about an hour ago. The RN administering it said one dose is being quoted as high 80's% effective in preventing severe disease now and the inside track is that one dose will soon be the recommendation.

PorscheGAL 02-19-2021 01:46 PM

Quote:

Originally Posted by pavulon (Post 11231853)
Not to derail but received the second Pfizer dose about an hour ago. The RN administering it said one dose is being quoted as high 80's% effective in preventing severe disease now and the inside track is that one dose will soon be the recommendation.

Wish I had known that a month ago

pavulon 02-19-2021 02:10 PM

Quote:

Originally Posted by PorscheGAL (Post 11231874)
Wish I had known that a month ago

Right. I got that news about 15 seconds before the injection but work in a designated COVID hospital so...too late now.

Chocaholic 02-19-2021 02:33 PM

Sure would feel better if all the R&D had resulted in stable information. How is the public supposed to have confidence in a rushed vaccine worth billions, if they keep changing how it is stored and administered. Two very critical components.

Sorry for being a skeptic but there has been NOTHING reliable about the experts and this virus...in any regard.

Sooner or later 02-19-2021 02:48 PM

Quote:

Originally Posted by Chocaholic (Post 11231941)
Sure would feel better if all the R&D had resulted in stable information. How is the public supposed to have confidence in a rushed vaccine worth billions, if they keep changing how it is stored and administered. Two very critical components.

Sorry for being a skeptic but there has been NOTHING reliable about the experts and this virus...in any regard.

Those were the temps they used in their trials. Moderna, with a similar process, had lower temps so they went back and reviewed their process. It would have been asinine to do otherwise.

They are about to drop production time from 110 days to 60. It also appears they are about to drop a bombshell on single doses to those that have already recovered from a case.

All of the above are positive developments, not negatives.

cabmandone 02-19-2021 04:19 PM

Quote:

Originally Posted by Chocaholic (Post 11231941)
Sure would feel better if all the R&D had resulted in stable information. How is the public supposed to have confidence in a rushed vaccine worth billions, if they keep changing how it is stored and administered. Two very critical components.

Sorry for being a skeptic but there has been NOTHING reliable about the experts and this virus...in any regard.

I know what you mean. It's hard when there's one dose vs two or crazy low storage temps vs more "normal" storage temps. I think people need to understand that things are evolving. It was approved based on initial information. As things progressed, they found that it's still viable at lower temps. I think the one dose vs two argument is just people looking to increase available vaccines. I saw something last month about one of the two potentially asking the FDA to revise to one dose. This might be a case of too much information being available to the public.

cabmandone 02-19-2021 04:21 PM

Quote:

Originally Posted by Sooner or later (Post 11231960)
Those were the temps they used in their trials. Moderna, with a similar process, had lower temps so they went back and reviewed their process. It would have been asinine to do otherwise.

They are about to drop production time from 110 days to 60. It also appears they are about to drop a bombshell on single doses to those that have already recovered from a case.

All of the above are positive developments, not negatives.

They should be reviewing the dosage for people who have already been infected. Those people already have the "first dose" so to speak. Several people I've talked to have had Covid and received the vaccine. Each said the first dose hit them like a train. I wish I knew the people better because I'd ask them what their reaction to the second dose was.

unclebilly 02-20-2021 03:15 AM

Quote:

Originally Posted by Chocaholic (Post 11231941)
Sure would feel better if all the R&D had resulted in stable information. How is the public supposed to have confidence in a rushed vaccine worth billions, if they keep changing how it is stored and administered. Two very critical components.

Sorry for being a skeptic but there has been NOTHING reliable about the experts and this virus...in any regard.

Stop being a putz - this isn’t 1960 anymore. The polio vaccine took over 15 years to develop from 1935 to 1950.

If we can’t develop a vaccine in the course of a year 70 years later, there is something wrong. Obviously, (and is the case with any R&D project or new technology), you start off cautious with the implementation and gradually dial back the precautions as new information from the field becomes available and as more testing is conducted.

Nobody in their right mind would start off by pushing the limits in terms of dosage and storage precautions, this would benefit nobody.

Get your head out of your ass. If you aren’t comfortable taking the vaccine, don’t take it. For gods sake, quit spreading misinformation and I’ll formed opinions based on **** you’ve either read on social media or heard from a bunch of washed up old men in coffee shops.

Sorry to come off strong here but I’m tired of the same old rhetoric from a certain demographic along the lines of, ‘how can we trust a vaccine that was developed so quickly...’ The answer is that you can choose to live in this decade and recognize the advantages of technology and the benefits of teams working around the world TOGETHER on this as opposed to the 1940’s Polio vaccine development approach consisting of a few people working in separate facilities with little to no information sharing from lab to lab. The alternative is to live in the past and die in it too.

Chocaholic 02-20-2021 03:48 AM

Control your anger Billy. I spread misinformation? What misinformation did I spread? Are we to a point where questions may no longer be asked? Where blind faith must displace critical thinking? Will await an apology for your childish rant.

Chocaholic 02-20-2021 03:52 AM

Quote:

Originally Posted by cabmando (Post 11232049)
I know what you mean. It's hard when there's one dose vs two or crazy low storage temps vs more "normal" storage temps. I think people need to understand that things are evolving. It was approved based on initial information. As things progressed, they found that it's still viable at lower temps. I think the one dose vs two argument is just people looking to increase available vaccines. I saw something last month about one of the two potentially asking the FDA to revise to one dose. This might be a case of too much information being available to the public.

We also need to consider that there is a very lucrative business side to this. J&J is pending approval for the first single dose vaccine. Is it pure coincidence that Pfizer is changing theirs just prior to that release? Are we to assume that big pharma is above making money?

cabmandone 02-20-2021 04:12 AM

Quote:

Originally Posted by Chocaholic (Post 11232401)
We also need to consider that there is a very lucrative business side to this. J&J is pending approval for the first single dose vaccine. Is it pure coincidence that Pfizer is changing theirs just prior to that release? Are we to assume that big pharma is above making money?

Pfizer probably isn't too worried about a totally different type of vaccine. They are more likely testing against the Moderna vaccine which is the same type but doesn't require the same ultra low storage temp as the Pfizer vaccine.

Make no mistake, they're making money. But if they're saving lives, they damn well should make a lot of money. I hope they can not only safely increase storage temps, but make a sh.t ton of money making a vaccine that ultimately gets our economy rolling again.

cabmandone 02-20-2021 04:17 AM

Quote:

Originally Posted by unclebilly (Post 11232384)
Stop being a putz - this isn’t 1960 anymore. The polio vaccine took over 15 years to develop from 1935 to 1950.

If we can’t develop a vaccine in the course of a year 70 years later, there is something wrong. Obviously, (and is the case with any R&D project or new technology), you start off cautious with the implementation and gradually dial back the precautions as new information from the field becomes available and as more testing is conducted.

Nobody in their right mind would start off by pushing the limits in terms of dosage and storage precautions, this would benefit nobody.

Get your head out of your ass. If you aren’t comfortable taking the vaccine, don’t take it. For gods sake, quit spreading misinformation and I’ll formed opinions based on **** you’ve either read on social media or heard from a bunch of washed up old men in coffee shops.

Sorry to come off strong here but I’m tired of the same old rhetoric from a certain demographic along the lines of, ‘how can we trust a vaccine that was developed so quickly...’ The answer is that you can choose to live in this decade and recognize the advantages of technology and the benefits of teams working around the world TOGETHER on this as opposed to the 1940’s Polio vaccine development approach consisting of a few people working in separate facilities with little to no information sharing from lab to lab. The alternative is to live in the past and die in it too.

You gotta take it down a notch or 10 man. I can understand the concerns by some about the vaccine. Wanting to KNOW that it's safe is completely understandable. Let's not forget, this is being administered under emergency use authorization. This isn't a vaccine that has been studied over a longer period to be safe and effective.

Ziggythecat 02-20-2021 04:28 AM

Quote:

Originally Posted by Chocaholic (Post 11231941)
Sure would feel better if all the R&D had resulted in stable information. How is the public supposed to have confidence in a rushed vaccine worth billions, if they keep changing how it is stored and administered. Two very critical components.

Sorry for being a skeptic but there has been NOTHING reliable about the experts and this virus...in any regard.

Calm down
We have Science back in charge

pavulon 02-20-2021 04:35 AM

Quote:

Originally Posted by cabmando (Post 11232422)
You gotta take it down a notch or 10 man. I can understand the concerns by some about the vaccine. Wanting to KNOW that it's safe is completely understandable. Let's not forget, this is being administered under emergency use authorization. This isn't a vaccine that has been studied over a longer period to be safe and effective.

Unless you're DOING the research, you're taking someone else's word for safety on everything. If people don't want it, fine, don't take it. But don't burn resources if you get sick and you're not gonna do your part. Stay home and take your lumps win or lose.
Liberty and responsibility are two sides of the same coin.

Chocaholic 02-20-2021 04:58 AM

Quote:

Originally Posted by pavulon (Post 11232438)
Unless you're DOING the research, you're taking someone else's word for safety on everything. If people don't want it, fine, don't take it. But don't burn resources if you get sick and you're not gonna do your part. Stay home and take your lumps win or lose.
Liberty and responsibility are two sides of the same coin.

So, there are two vaccines released and more to come. Is it not reasonable to research the options before deciding which one to choose for your family? Are you suggesting just take whatever comes first and simply have faith that this urgently released option is automatically the best?

Meanwhile...the case count and death count continue to fall.

Chocaholic 02-20-2021 05:01 AM

Quote:

Originally Posted by Ziggythecat (Post 11232430)
Calm down
We have Science back in charge

Very helpful. You realize all these vaccines were developed under the previous administration, right?

Ziggythecat 02-20-2021 05:14 AM

Yes
The only administration in History to have a working Pharma Lab in the basement of the White House
Between tweets, Don would often be found, in the lab, making doses of the tRump Vax

No doses, 2 x and poof...cured

Jonas Salk Don Trump

Heros

cstreit 02-20-2021 05:15 AM

Quote:

Originally Posted by Ziggythecat (Post 11232430)
Calm down
We have Science back in charge

Knock off the condescension. Science IS questioning. Denying questioning is cult territory. Which side are you on?

That’s a pretty significant change in guidance and given the ridiculous logistics of shipping it at minus 94, something they should have looked at earlier. Did so,etching change or did they just not get around to it. Given the extreme logistics that were needed to keep it at those temps, I would have thought this would have been a priority.

It is quite clear the second dose is a booster. My guess is what they are REALLY saying is that the first does is *good enough* that as a society it’s better to get more people one dose, than half of us two doses. Also an interesting question. ...or did something change?

cabmandone 02-20-2021 05:16 AM

Jesus Christ zig, can't you keep politics out of anything? GTFOOH

There's no reason for this to end up in PARF but your jackassery is going to get it moved there.

cabmandone 02-20-2021 05:17 AM

I came across this article this morning. I thought it was an interesting take.
https://www.msn.com/en-us/health/medical/a-johns-hopkins-professor-predicts-the-us-will-reach-herd-immunity-by-april-but-many-experts-arent-so-optimistic/ar-BB1dRhJZ?li=BBnb7Kz

pavulon 02-20-2021 05:35 AM

Quote:

Originally Posted by Chocaholic (Post 11232456)
So, there are two vaccines released and more to come. Is it not reasonable to research the options before deciding which one to choose for your family? Are you suggesting just take whatever comes first and simply have faith that this urgently released option is automatically the best?

Meanwhile...the case count and death count continue to fall.

No problem. The road to success is paved with flat squirrels who couldn’t make up their mind.

Chocaholic 02-20-2021 05:45 AM

Quote:

Originally Posted by pavulon (Post 11232521)
No problem. The road to success is paved with flat squirrels who couldn’t make up their mind.

Being under 65 and not yet eligible for the shot...why wouldn’t a person assess the options?

The road to success is paved with squirrels who weren’t concerned about what was coming.

cstreit 02-20-2021 05:53 AM

Quote:

Originally Posted by pavulon (Post 11232521)
No problem. The road to success is paved with flat squirrels who couldn’t make up their mind.

All the more reason we need some more consistent information to decide..

..at this point I dont think anyone has the option of one vaccine vs. the others. It is my understanding that the two dose Phizer has had a higher effective rate against some of the variants and at this point would be my "choice" if I got one, but I'd like to understand more...

cstreit 02-20-2021 05:56 AM

Quote:

Originally Posted by cabmando (Post 11232487)

It makes logical sense on some level. Given the number of asymptomatic cases out there its very possible that more people were infected than we thought, and simply didn't go out and get tested. In fact we've been reading for months that the infection rates were much higher than we know... (Usually some media outlet trying to pronounce doom)

...but then it begs the question as to whether these folks developed an an immunity and how long it will last. Certainly not all will - maybe only a few. I've seen data that suggests an asymptomatic case may not bring immunity.

Chocaholic 02-20-2021 06:17 AM

Quote:

Originally Posted by cstreit (Post 11232548)
It makes logical sense on some level. Given the number of asymptomatic cases out there its very possible that more people were infected than we thought, and simply didn't go out and get tested. In fact we've been reading for months that the infection rates were much higher than we know... (Usually some media outlet trying to pronounce doom)

...but then it begs the question as to whether these folks developed an an immunity and how long it will last. Certainly not all will - maybe only a few. I've seen data that suggests an asymptomatic case may not bring immunity.

It’s frustrating how unreliable every bit of information is regarding this entire fiasco. As such, I’m struggling to assume the vaccine info is any better. And now with significant changes only weeks later. As you say above....you’ve seen data that suggests an asymptomatic case may not...

Nothing remotely conclusive. Heck...has there been data to confirm the immunity from the vaccine will last any longer?

cstreit 02-20-2021 06:47 AM

Quote:

Originally Posted by Chocaholic (Post 11232579)
It’s frustrating how unreliable every bit of information is regarding this entire fiasco. As such, I’m struggling to assume the vaccine info is any better. And now with significant changes only weeks later. As you say above....you’ve seen data that suggests an asymptomatic case may not...

Nothing remotely conclusive. Heck...has there been data to confirm the immunity from the vaccine will last any longer?

I doubt we’ll have any definitives in situations like this. Especially when the media focuses on fringe cases and supposition to generate interest.

red-beard 02-20-2021 07:23 AM

The UK (Astro Zeneca) and now Pfizer have been back checking the data from the vaccine studies and is finding that a single dose is "good enough". Now we can double the number of people vaccinated with the same infrastructure. This is good news.

On the temperatures, Pfizer was being very cautious. And they have had a few months to work on the effectiveness with less severe refrigeration. And note, the "normal freezer" temps are only allowed for storage for two weeks. You have to keep it at -94F if you want to keep it stored for multiple months or transport.

Pfizer I believe also has a shorter life in the bottle once warmed up to injection temps.

Texas Center for Drug Development is running three vaccine studies in our area: Pfizer, Moderna and Novavax. I was there yesterday getting my second "real" Moderna injection. I chatted with one of the nurses and the Novavax study is done. They are compiling the data and will be doing the FDA submittal soon.

Even after the submittal, we're still in the trial. They take blood and see how the antibodies develop and then track overtime the loss. I signed up for the Moderna Booster trial as well. We will see when that comes around.

J&J is days away from approval. That will add a HUGE amount of vaccine to the USA and the world. J&J says they can supply a billion doses this year. Maybe not as effective as the new guys. But better to get good vaccines out than wait for the others to produce.

Chocaholic 02-20-2021 07:33 AM

Agree. I’m interested in the J&J iteration. Developed for single dose using a similar technology to other vaccines (HIV and tuberculosis). And...this being a multi-billion dollar business, one has to wonder about Pfizer’s motives to also become approved for single use with J&J’s drug on the horizon.

cabmandone 02-20-2021 08:08 AM

Quote:

Originally Posted by Chocaholic (Post 11232703)
Agree. I’m interested in the J&J iteration. Developed for single dose using a similar technology to other vaccines (HIV and tuberculosis). And...this being a multi-billion dollar business, one has to wonder about Pfizer’s motives to also become approved for single use with J&J’s drug on the horizon.

IIRC Moderna and Pfizer showed high enough efficacy to be used as a single dose but because trials were done using a two dose regimen, that's what they had to seek authorization for. There was talk back in January about Moderna possibly seeking authorization to go to one dose. The FDA shut that down.

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

"Until vaccine manufacturers have data and science supporting a change, we continue to strongly recommend that health care providers follow the FDA-authorized dosing schedule for each COVID-19 vaccine."

VillaRicaGA911 02-20-2021 09:31 AM

Interesting topic, not sure how many here work in healthcare. Both my wife and I work in healthcare, she in patient care in radiology me in sales radiology/surgery. I can back up the COVID numbers falling off a cliff at least locally to us. I think the public at large misunderstands FDA review/approval protocols which by and large unless you are really into that kind of stuff who cares.
It makes sense that both Pfizer and Moderna went ultra conservative in testing and what data was submitted for review, keep in mid both companies had a ton at stake with what in the business is called at risk manufacturing (doses ready to go into arms as soon as given the green light). You want that to go right or its untold millions down the tubes. The manufacture I sell equipment used in surgery and many others use at risk manufacturing, then as more data is compiled product refinements are made. These sometimes result in the need to resubmit data to FDA for approval sometimes not. This at risk manufacturing had a huge role in how quickly this vaccine was produced.

pavulon 02-20-2021 10:10 AM

Quote:

Originally Posted by Chocaholic (Post 11232703)
Agree. I’m interested in the J&J iteration. Developed for single dose using a similar technology to other vaccines (HIV and tuberculosis). And...this being a multi-billion dollar business, one has to wonder about Pfizer’s motives to also become approved for single use with J&J’s drug on the horizon.

There is no HIV vaccine.

Chocaholic 02-20-2021 10:51 AM

Quote:

Originally Posted by pavulon (Post 11232898)
There is no HIV vaccine.

What are adenovirus-based vaccines?
To date, several adenovirus-based vaccines are in clinical and pre-clinical trials. Vaccines developed against HIV, Ebola virus, influenza virus, Mycobacterium tuberculosis, and Plasmodium falciparum are currently under human clinical trials. Moreover, there are vaccines under preclinical trials developed against rabies virus, dengue virus, and middle east respiratory syndrome coronavirus.

Sooner or later 02-20-2021 10:53 AM

Quote:

Originally Posted by Chocaholic (Post 11232947)
What are adenovirus-based vaccines?
To date, several adenovirus-based vaccines are in clinical and pre-clinical trials. Vaccines developed against HIV, Ebola virus, influenza virus, Mycobacterium tuberculosis, and Plasmodium falciparum are currently under human clinical trials. Moreover, there are vaccines under preclinical trials developed against rabies virus, dengue virus, and middle east respiratory syndrome coronavirus.

Even if they get approved I wouldn't take them because of unknown long term consequences...

Chocaholic 02-20-2021 11:58 AM

Quote:

Originally Posted by Sooner or later (Post 11232952)
Even if they get approved I wouldn't take them because of unknown long term consequences...

Save your trolling for PARF. :rolleyes:

Sooner or later 02-20-2021 12:13 PM

Nothing about the statement is parf. You can use that as a concern though I can't?


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