Full approval!!!

12,171 Views | 136 Replies | Last: 3 yr ago by Zobel
L7 WEENIE
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superunknown said:

For what it's worth, a Trump supporter and conservative who works for me scheduled his 1st Pfizer shot today now that it's been FDA approved. So there's some anecdotal for you.


That's awesome!
Harry Stone
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Ryota Hayami said:

Kvetch said:

t - cam said:

The goalpost was already moved when people started claiming the FDA was a joke or somehow untrustworthy.


The FDA is untrustworthy. See their lack of action on viable therapeutics that are known to be safe.

Their push for vaccines over all else is 100% political.


Moving the goalposts but please at least read what actual scientists and epidemiologists are saying about the vaccine. Get your news from real sources that are cited with scientific research.


I own an mRNA company. We are small right now but the virus has considerably changed our trajectory. my sources are 99.99% better than everyone here, including all the articles that are linked here. I believe that mRNA vaccines are great, but I cannot stand people who get on here and scold people for not getting the shot. If your company requires it, then you have to make a choice on whats more important, your job or your principles.
L7 WEENIE
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Harry Stone said:

Ryota Hayami said:

Kvetch said:

t - cam said:

The goalpost was already moved when people started claiming the FDA was a joke or somehow untrustworthy.


The FDA is untrustworthy. See their lack of action on viable therapeutics that are known to be safe.

Their push for vaccines over all else is 100% political.


Moving the goalposts but please at least read what actual scientists and epidemiologists are saying about the vaccine. Get your news from real sources that are cited with scientific research.


I own an mRNA company. We are small right now but the virus has considerably changed our trajectory. my sources are 99.99% better than everyone here, including all the articles that are linked here. I believe that mRNA vaccines are great, but I cannot stand people who get on here and scold people for not getting the shot. If your company requires it, then you have to make a choice on whats more important, your job or your principles.


Thanks for chiming in. I would love to hear more about your opinions and data about the covid mRNA shots.

That specific comment about the shots was aimed at people who said they wouldn't get it because it wasn't fully approved but are still making different excuses now that it is approved.
AggieUSMC
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Quote:

Does that mean people can sue if they have adverse reactions now?
There's a reason why pharmaceutical commercials list the side effects of the drug. As long as patients are educated on the side effects and take the drug anyway, they are making an informed decision to assume the risk.
AggieUSMC
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Quote:

but I cannot stand people who get on here and scold people for not getting the shot.
I don't have any problem with people who simply choose not to take the shot because they have done their own cost/benefit analysis and chose to forgo the jab.
I do, however, have a problem with those who use terms like "garbage" or "poison" when describing the vaccine. Or they spread unfounded lies about it in an attempt to undermine it's safety or efficacy.
double aught
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superunknown said:

For what it's worth, a Trump supporter and conservative who works for me scheduled his 1st Pfizer shot today now that it's been FDA approved. So there's some anecdotal for you.
Glad to hear this. The more vaccinated, the better.

But the whole conservative, anti-vaxxer thing is just odd to me. Whether you like it or not, I think Trump deserves at least some credit for helping to speed along the vaccines and ushering them through. You'd think conservatives would be taking the opportunity to tout the vaccine as a triumph of his, but instead, for whatever reason, many are doubling down on an anti-vax stance.
aggierogue
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Ryota Hayami said:

You do you! I'm not throwing out "fear porn" just using data.

I'm not looking it up but getting struck by lightning twice is probably so unlikely it's statistically insignificant. The data on reinfections and breakthrough cases including those who get seriously ill are not statistically insignificant by any measure.
Why can't you just leave it at "you do you?"

That's what many of us want. Get your vaccine. Wear your masks, and leave other people alone.

It's amazing that some of you guys are vaccinated, boast about the protection you have acquired, and live on this board to point their fingers at others who've chosen a different route.
Azeotroper
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My brother is a chemical engineer. Worked for ConocoPhillips or whatever it is now for 30 years. He told me today he will likely retire if they force a vaccine on him. I can't imagine a smarter guy or better employee for a company to have. And they likely will get rid of him/ force him out for making what should be a personal choice.
Do y'all who think it's cool to take away someone's livelihood to protect him from a virus with very little lethality for him? And in the future when some idiot bureaucrat wants to force you to give up your f250 to save you from dying a death induced by "climate change", are you ok with that?
Apparently in these crazy times, personal liberty is frowned upon. Precedents made today can likely be used to gore your ox in the future. But keep heart, as somebody will cheer the killing of your ox by telling you it's for your own good and to protect others. Your personal liberty be damned.
superunknown
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double aught said:

superunknown said:

For what it's worth, a Trump supporter and conservative who works for me scheduled his 1st Pfizer shot today now that it's been FDA approved. So there's some anecdotal for you.
Glad to hear this. The more vaccinated, the better.

But the whole conservative, anti-vaxxer thing is just odd to me. Whether you like it or not, I think Trump deserves at least some credit for helping to speed along the vaccines and ushering them through. You'd think conservatives would be taking the opportunity to tout the vaccine as a triumph of his, but instead, for whatever reason, many are doubling down on an anti-vax stance.


I always figured anti-vaxxers were granola-deodorant wearing hippie types and then the Jenny McCarty anti-vax stuff happened and there seems to be a louder (if at least not stronger) portion now coming from that intersection of Alex Jones and evangelical home schooling types. I don't quite understand it. I would have thought Trumps initiative towards cutting down red tape and giving the companies financial incentives would have been a great selling point and an example of cutting gov regulation that worked. Obviously I whiffed on that.
Zobel
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I don't think it's a good bet for companies to require vaccinations. I advocated strongly in my company for us to not do it, and we're not. People need to be responsible for their own health.

That being said, covid represents a significant business interruption risk.

It is also a morale issue regardless of which way you go. We have people on both sides of masks, social distancing, work from home, and vaccine issues at my company.

Private companies have to do what makes sense for them, what's best for them and their shareholders. They don't owe their employees jobs, especially not at the expense of profitability. Framing this as a personal liberty infringement is not correct. You aren't entitled to work there, and if you don't like their conditions you can seek gainful employment elsewhere. That's not just true for vaccines.

Sorry your brother has to deal with it. I do too - my customers in O&G space are starting to require people on their sites to be vaccinated, which puts us in a bind because we don't care to ask our employees. But that's also a business decision for us, ultimately.
double aught
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The company isn't taking away his livelihood or depriving him of liberty. They are (potentially) changing the conditions of employment. You may disagree with it or debate whether it's right or not, but there's a big difference.
cowenlaw
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Seersucker Ag 2011 said:

Does that mean people can sue if they have adverse reactions now?


Vaccine manufacturers are generally immune for liability. The federal government runs a vaccine compensation program for people who can prove they were injured by certain vaccines. I'm not sure whether the Pfizer vaccine is now part of that program.
Azeotroper
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I guess I'm not smart enough to understand that forcing you to take a medicine or lose your employment isn't depriving you of employment. Congratulations for the extra brain power I don't have.
And yeah he can retire no problem and can likely find employment elsewhere.
I'm so glad back in the day that I chose self employment.
petebaker
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https://instagr.am/p/CS68vf0AkF-
Zobel
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I recommend not weighting too highly medical info you get from a former local traffic and weather personality.

As for the claim.

The link to the trial is here.
https://clinicaltrials.gov/ct2/show/NCT04368728

If you read the end points for pre registry, some go on for 2 years. The primary outcomes that go on through 2 years are:
Confirmed COVID-19 in Phase 2/3 participants without evidence of infection before vaccination
Confirmed COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination

All of the safety / adverse event outcomes are completed after six months. This is why they were able to finish that portion of the study, report results, and submit for full FDA approval six months after the phase 3 trials.

The remaining questions in the study are - how long does the protection last. Not safety.
Harry Stone
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Ryota Hayami said:

Harry Stone said:

Ryota Hayami said:

Kvetch said:

t - cam said:

The goalpost was already moved when people started claiming the FDA was a joke or somehow untrustworthy.


The FDA is untrustworthy. See their lack of action on viable therapeutics that are known to be safe.

Their push for vaccines over all else is 100% political.


Moving the goalposts but please at least read what actual scientists and epidemiologists are saying about the vaccine. Get your news from real sources that are cited with scientific research.


I own an mRNA company. We are small right now but the virus has considerably changed our trajectory. my sources are 99.99% better than everyone here, including all the articles that are linked here. I believe that mRNA vaccines are great, but I cannot stand people who get on here and scold people for not getting the shot. If your company requires it, then you have to make a choice on whats more important, your job or your principles.


Thanks for chiming in. I would love to hear more about your opinions and data about the covid mRNA shots.

That specific comment about the shots was aimed at people who said they wouldn't get it because it wasn't fully approved but are still making different excuses now that it is approved.


theres so much that goes into this. both mRNA vaxxes use T7 polymerase systems, which reduces the error rate of transcription. some info is proprietary. but the data from israel might actually not be false if pfizer vaccine changed capping enzymes. if for instance they went from post transcriptional to co transcriptional capping, they could have a problem with translational efficiency if they are not getting a high yield. in order to produce a high volume of vaccines, switching to co trancriptional capping reduces one step of modifications, which saves on time and cost.

one important study we should be doing on the new surge isnt asking IF they took pfizer, it's asking WHEN they took pfizer. we have tested co vs post transcriptional capping using a registered capping enzyme and have seen a much lower translation of mRNA with this capping enzyme. i'm betting the people contracting delta who took pfizer actually got their vaccine sometime in mid february and beyond.
Zobel
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Isn't that the part of the mRNA sequence itself? Wouldn't that be a material change, and precluded under approval? That seems kinda major.
L7 WEENIE
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aggierogue said:

Ryota Hayami said:

You do you! I'm not throwing out "fear porn" just using data.

I'm not looking it up but getting struck by lightning twice is probably so unlikely it's statistically insignificant. The data on reinfections and breakthrough cases including those who get seriously ill are not statistically insignificant by any measure.
Why can't you just leave it at "you do you?"

That's what many of us want. Get your vaccine. Wear your masks, and leave other people alone.

It's amazing that some of you guys are vaccinated, boast about the protection you have acquired, and live on this board to point their fingers at others who've chosen a different route.


We are discussing on a message board.
Harry Stone
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Zobel said:

Isn't that the part of the mRNA sequence itself? Wouldn't that be a material change, and precluded under approval? That seems kinda major.


it is, yes, and should be precluded under approval, yes, and im sure it was under phase 1-3. but what if they switched to something like trilink cleancap technology after eua.

https://www.trilinkbiotech.com/cleancap/?utm_campaign=Capping&utm_medium=cpc&utm_source=google&gclid=Cj0KCQjwjo2JBhCRARIsAFG667UsxHAr-qeak3K274_VBeZGty5Pm3siyR0-Z4SHmMuRQ5mleOU5IqQaAorGEALw_wcB

Daddy-O5
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OP will be glad to know that my opinion hasn't changed since Trump was president, FDA approved or not.

Not politically motivated
Not anti vax

Hope that doesn't ruin anyone's preconceived notions about those who haven't gotten the jab.
t - cam
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J_Daddy05 said:

OP will be glad to know that my opinion hasn't changed since Trump was president, FDA approved or not.

Not politically motivated
Not anti vax

Hope that doesn't ruin anyone's preconceived notions about those who haven't gotten the jab.

You are one subset of those refusing the vax. There were many people waiting for the approval. Hope this makes them feel safe.

Daddy-O5
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superunknown said:

double aught said:

superunknown said:

For what it's worth, a Trump supporter and conservative who works for me scheduled his 1st Pfizer shot today now that it's been FDA approved. So there's some anecdotal for you.
Glad to hear this. The more vaccinated, the better.

But the whole conservative, anti-vaxxer thing is just odd to me. Whether you like it or not, I think Trump deserves at least some credit for helping to speed along the vaccines and ushering them through. You'd think conservatives would be taking the opportunity to tout the vaccine as a triumph of his, but instead, for whatever reason, many are doubling down on an anti-vax stance.


I always figured anti-vaxxers were granola-deodorant wearing hippie types and then the Jenny McCarty anti-vax stuff happened and there seems to be a louder (if at least not stronger) portion now coming from that intersection of Alex Jones and evangelical home schooling types. I don't quite understand it. I would have thought Trumps initiative towards cutting down red tape and giving the companies financial incentives would have been a great selling point and an example of cutting gov regulation that worked. Obviously I whiffed on that.


Huge win. Trump deserves a significant amount of credit for doing so. As most of us figured after the election, some folks are attempting to give credit where none is due to the current admin.
Harry Stone
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Harry Stone said:

Zobel said:

Isn't that the part of the mRNA sequence itself? Wouldn't that be a material change, and precluded under approval? That seems kinda major.


it is, yes, and should be precluded under approval, yes, and im sure it was under phase 1-3. but what if they switched to something like trilink cleancap technology after eua.

https://www.trilinkbiotech.com/cleancap/?utm_campaign=Capping&utm_medium=cpc&utm_source=google&gclid=Cj0KCQjwjo2JBhCRARIsAFG667UsxHAr-qeak3K274_VBeZGty5Pm3siyR0-Z4SHmMuRQ5mleOU5IqQaAorGEALw_wcB




also, perhaps its not precluded here. perhaps its just a manufacturing distnction. is it purchasing any capping enzymes or specific capping enzymes. under these unique circumstances maybe there was leniency in fear of shortages.
Daddy-O5
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t - cam said:

J_Daddy05 said:

OP will be glad to know that my opinion hasn't changed since Trump was president, FDA approved or not.

Not politically motivated
Not anti vax

Hope that doesn't ruin anyone's preconceived notions about those who haven't gotten the jab.

You are one subset of those refusing the vax. There were many people waiting for the approval. Hope this makes them feel safe.


I'm not "refusing the vax" either. And I'm really responding to several specific posts on this page lumping all the folks who haven't gotten the vax into a mass collective of anti vax conservatives refusing it for political reasons.
The Big12Ag
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Posting this here because I am not sure where to share, in all honesty I don't want to share anywhere because it is unpleasant.

A friend has a girlfriend in health care, she works as a nurse in a hospital. As a result, my friend hangs out around a lot of the hospital staff (clerical, nurses, doctors) on a regular basis.

Neither he or I agree with their stance, but due to overwork and burnout I guess these hospital staff members openly express disdain for the unvaccinated with severe conditions. As in the gist is "they can go home and die for all I care I am sick of treating them". Many staff members have quit and there are insane bonuses to pick up extra shifts (like doubling of pay) due to the staff shortages and over limit ICU patients (some need ICU but are parked in ER or other beds since there is no ICU space). This, coupled with anecdotal stories that suggest good treatment is hard to come by unless you push and push and advocate for your loved one, has me worried for anyone I might know that would require hospitalization or ICU care.

Based on what I heard, I'd worry the most (at least at this one hospital) if I was an unvaccinated Covid patient. But anyone going in for any reason might experience worse care than ever. Stay healthy everyone!
Cyp0111
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that is similar to what most health care workers are saying privately.
Fenrir
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The Big12Ag said:

push and push and advocate for your loved one
Off topic, but I would advocate people do this regardless. There are enough bad (incompetent or malicious, doesn't matter) medical people out there, be as vigilant as you can on behalf of your loved one. The Duntsch's of the world don't have cartoon villain mustaches to easily identify them as ****ty practitioners.
Slicer97
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FDA approved ranitidine in 1983. How'd that work out?

I'll wait for the Novovax to come out.
Zobel
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Every time someone brings an FDA approved product that is later withdrawn up I have the same question. What should our pre-test probability be to assign a risk to the chance of some major problem?

So I did some looking and found this study from 2017.

There are three types of safety events. Withdrawals (pulled altogether), addition of a warning, and safety communication.

For the 222 new therapeutics approved by the FDA from 200 to 2010, there were 123 safety events on 71 of the drugs.

Of these there were 3 withdrawals (valdecoxib, tegaserod for heart events, and efalizumab for risk of progressive leukoencephalopathy whatever that is but it sounds real bad). Average time to withdrawal was 4.2 years.

There were 61 boxed warnings on 43 of the drugs. Time to warning was 4 years.

There were 59 safety communications on 44 of the drugs. Average time to safety communication was 4.9 years. By ten years, 30% of the therapeutics had 1 or more safety event.

Ok, so we might say that the pre-test probability of any of the vaccines being withdrawn is roughly 1.3% (3/222). You might also say that we should expect something like a 19% chance there's a box warning added to any of them (43 / 222) and about the same chance that a safety communication goes out.

I'm not sure the time to problem is relevant in this case, because I bet dollars to donuts these vaccines have more uses than any of those drugs. And in this case, the ~20% chance of a warning label has happened (myocarditis within 7 days of the second dose).

I also think that this is a kind of test of the ability of the FDA to evaluate the safety of drugs during the approval process, and isn't particular to any kind of drug. So all of those risks apply just as much to Novavax or anything else approved by the FDA.
Harry Stone
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Zobel said:

Isn't that the part of the mRNA sequence itself? Wouldn't that be a material change, and precluded under approval? That seems kinda major.
I found some really good reading materials for you. it does look like pfizer uses co-transcriptional capping. it's a much cheaper method with one less purification step. we have seen less translational efficiency with a trinucleotide than Cap 2-O-Methyltransferase and VCE, but it is still effective just not consistent, which could effect the lots.

another note is the company, Precision Nanosystems mentioned in Lipid Nanoparticle Assembly, very well as we have done work with them. at least one of Moderna or Pfizer uses their microfluids device and Precision redirected much of their operations towards LNP vaccine production to formulate the LNP with the mRNA for stability.

https://blog.jonasneubert.com/2021/01/10/exploring-the-supply-chain-of-the-pfizer-biontech-and-moderna-covid-19-vaccines/#fn:6

this is the EU public assessment report. It's a long read but i find it fascinating, especially beginning with section 2.2. pfizer went from a PCR product to IVT, which allows them to increase the length of the Poly-A tail and create more stability of the mRNA. Typically PCR based products max out at a 130 base poly-A tail whereas IVT can max out at 180-190 in many cases. PCR is just easier to amplify and replicate, so oftentimes it becomes the preferred choice for that reason.

https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf

this document looks like the msds for their EUA filing, and it was harder to find.

https://www.onesourcedocs.com/wp-content/uploads/2020/12/Pfizer_SDS_BioNTech_COVID_19_Vaccine_v1_02_202011_nr-1.pdf

this next document is more than likely the MSDS they used to file their BLA.

https://safetydatasheets.pfizer.com/MyDocuments/DownloadSingleFile?content=E87D8763-BDFF-4631-A957-B9D8E52AFBD9_PDF

here is their fact sheet. interestingly they don't require a list of the ingredients of the mRNA such as the enzymes.

https://www.fda.gov/media/144414/download

pfizer was able to file a priority review bla to expedite approval

https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine

moderna's came 3.5 months later so i'm guessing their vaccine will get approved just before christmas.

https://investors.modernatx.com/news-releases/news-release-details/moderna-completes-submission-biologics-license-application-us



Zobel
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Wow - awesome, thanks.

Quick question - I was under the impression that the poly-A tail had a sort of diminishing returns as to length. At some point you don't more benefit from making it longer. Is that true? Does it change the relevance of PCR vs IVT?
Harry Stone
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Zobel said:

Wow - awesome, thanks.

Quick question - I was under the impression that the poly-A tail had a sort of diminishing returns as to length. At some point you don't more benefit from making it longer. Is that true? Does it change the relevance of PCR vs IVT?
In a sense, maybe. for the most part, longer is usually more beneficial. however, certain cell types, like some myoblasts, may actually induce hyperadenylation. but typically the more stable the mRNA, the more the control of deadenylation.
Zobel
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Haha, first sentence I follow, the second and third went right by me. But thanks. Reading your links now.
 
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