Pfizer COVID vaccine greater than 90% effective

[PedroDaGr8]

Oxford vaccine shows 70+% effectivity. That being said, this is a bit misleading because they had two cohorts. The cohort which involved an initial half dose followed by a full dose booster had 90+% effectivity, while the cohort which had an full initial dose followed by a full booster dose only showed a 62% effectivity. This is very unexpected! One theory about why this happened focuses on the fact that the Oxford vaccine uses a virus carrier (unlike Pfizer or Moderna). The hypothesis is the larger initial dose causes the immune system to inherently recognize the virus and eliminate it before it can inject its payload trigger an immune response to the spike protein. Another theory is the stepped dose more closely mimics the outcome of an actual COVID infection. Personally, I think the first theory is much more likely considering the Pfizer and Moderna vaccines used equivalent booster doses.

There is a high probability that the Oxford vaccine will be used in poorer countries. It has tried and true vaccine technology which can be rapidly and cheaply scaled up. It also doesn't have any abnormal temperature restrictions.

[CitizenBBN]

None at all.

I can understand the worry/confusion, as they are both nucleic acids. In spite of this, RNA and DNA serve entirely different purposes in the human body. Hopefully, my use of a commercial kitchen as an analogy, makes it easier to comprehend the difference. Please let me know if it helps since I have a feeling I will have to answer this for a lot with friends:

DNA is the official genetic record of a cell (the chef's recipe book). It contains a number of genes (recipes) and, to keep it safe, it remains securely locked in the nucleus (the chef's office).

mRNA is an active copy of a gene (think of it as a photocopy of a recipe) which is transferred by cellular machinery (chef's assistants) from the nucleus (the chef's office) to the cytoplasm (the kitchen) of the cell, where it can be used to make proteins (the dish in the recipe) by ribosomes (the cooks). Human cells lack the machinery (chef's assistants) to transfer mRNA (recipe photocopies) from the cytoplasm (kitchen) to the nucleus (chef's office). Additionally, even if the mRNA (the recipe photocopy) could somehow physically enter/re-enter the nucleus (the chef's office), the human body ALSO lacks the machinery (chef's assistants) to transcribe (physically insert) the RNA (the recipe photocopy) into the DNA (the chef's recipe book).

As such, despite them both being nucleotides, it is physically impossible for mRNA to alter DNA.

Great analogy. Oddly I feel a need to re-watch Ratatouille tonight though.

You may have to PM me on this, but at what stage in the manufacturing process does the NSA put in those tracker microchips that send thoughts directly to your brain stem? Asking for a friend. Sadly, asking for several of them.

[PedroDaGr8]

The UK just approved the Pfizer vaccine today. The main FDA meeting will take place on Dec. 10th. This meeting will likely determine whether it will be accepted or not (though it may take a few days for it to become official). Interestingly, I have heard that the FDA will livestream this meeting. I fully intend to watch it, if possible.

I have seen a lot of people asking why the FDA is taking so much longer than the UK. Quite simply, I think the UK rushed things and is potentially putting their population at risk. The FDA is not just sitting around and waiting; they distributed the raw data to a number of scientists, experts, etc on November 23rd. These people will pour over this data looking for anything important, questionable, good, etc. I can promise you, having known a few of these kinds of people, most of them did very little else over the Thanksgiving holiday and will do very little else between now and Dec. 10th.

The overall evaluation process can be roughly summarized as follows:

1. Is the data and Pfizers analysis of the data legit or are there issues which could indicate malfeasance/lack of competence?
2. What's the risk profile of the vaccine?
   
   • What issues, risk factors, unaddressed problems, etc. were evaluated as part of the trial?
   • Just as importantly, what were not? Did they miss something they should have analyzed (maybe they didn't analyze it intentionally)?
   • What is the potential likelihood, severity, detectability, etc. of any of these risk factors?
   • Do any of these risk factors require additional research or preclude the use of the vaccine in certain patients?
3. Does the data sufficiently prove the vaccine is effective? How effective?
4. Lastly, using all of this data, would approving the vaccine potentially create a worse situation than not approving the vaccine? This is the crux of how the FDA will make their decision, does the benefit justify the risks.

As with anything, the devil is always in the details. While you can make the actual act of performing the analysis easier/faster, nothing can replace getting numerous and diverse sets of eyes on the data. Quite simply, you need lots of people looking at it in a bunch of different ways. Furthermore, you need to allow them to “chew on” what they saw and perform a bit of additional data analysis if necessary. If the data is on the up-and-up and everything looks good, the approval will be quick and easy.

Considering it will only take a couple of extra weeks, at most, to do things properly, I just can’t see why the UK rushed things. It isn’t like a couple of extra weeks will change things appreciably in the long term (either economically or outcome wise). If we were talking months of delays, then the equation is different. Production has already been allocated well into next year, so it is unlikely to impact distribution in any appreciable way. I guess the only “good” thing is that very few countries look to the UK for guidance on medicine safety, so this decision will only screw the Brits.

For anyone who thinks we should dispense with even this rather basic risk review process, one only needs to look at thalidomide to see a worst case scenario of skipping/circumventing this process. Europe, at the time, bowed to political pressure and failed to properly evaluate the data/risk or act on it. The FDA on the other hand, empowered their experts to stick to their guns and trust the data. The FDA never* approved thalidomide despite the company requesting approval SIX times. As a result of these decisions, Europe was devastated by over 2000 infant deaths and severe birth defects in over 10,000. The USA had zero deaths and only around 17 cases of birth defects, almost all of which were due to clinical testing of the drug. As an aside, this clinical trial outcome (and how the company obfuscated things) lead in part to the modern multi-phase clinical trial system. In particular, the requirements of distinct external health & safety oversight and that manufacturers prove BOTH effectiveness and safety.

*A good example of the FDA balancing risk versus benefit, thalidomide was actually eventually approved by the FDA in the late 90s-early 00's for use in very specific kinds of cancer. That being said, it has not been, and never will be, approved for any sort of general use.

[PedroDaGr8]

The meeting for the Pfizer EUA request is currently wrapping up.

According to the agenda, the committee plans to vote for/against EUA approval in the next hour or so. If approved, it will then be passed on for final approve (likely in the next day or so).

[PedroDaGr8]

Update: Two individual had allergic reactions, both had previous reactions to other substances and/or medicines in the past. Both had Epipens with them because they knew it was a risk. That being said, a lot of STRONG wording to let Pfizer know that the FDA is going to expect them to look into these reactions and show they are not unique to the vaccine. Furthermore, investigate the common severe allergies to ensure there is no overlap.

[PedroDaGr8]

A lot of the discussion is how to ethically handle continued follow-up considering the placebo group is necessary but they are unvaccinated. Voting will occur after the next two questions.

[PedroDaGr8]

Voting begins now! The number of times that people have been muted while trying to speak is hilarious! I will update this as they vote. Lots of discussion on how to proceed with the analysis if this does get EUA, lots of discussion on if there is sufficient data to address the voting question(s). I have been through TOO many of these discussions, it is humorous to me to watch them from the outside.

Vote question 1:

Based on the totality of the scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 Vaccine outweigh its risks for use in individuals 16 years of age and older?

[PedroDaGr8]

Lots of pushback on the 16 and 17 year old age group in the approval.

If you want to see how risk/benefit balance works in the pharma industry. This back and forth is a great example of the discussion.

[PedroDaGr8]

Actually, now they will start voting. They were commenting on the question before.

They are now reciting the voting instructions.

https://www.youtube.com/watch?v=owve...ature=youtu.be

[Padukacat]

Thanks for the info great discussion

[KSRBEvans]

This is not good:

Capture 12-28-20.jpg

https://twitter.com/ashishkjha/statu...60144735645702

Faster, please.

[Darrell KSR]

This is not good:

No, it's not, but I was afraid to read past those 4 words, and relieved that it was just going more slowly than expected. We need it to go well, and swiftly, but well especially.

[KSRBEvans]

In terms of vaccination doses/100 people, the US (0.64/100) has vaccinated about half the number of the UK (1.18/100) and almost 1/9 the number of Israel (5.68/100).

https://twitter.com/Birdyword/status...352128/photo/1

Hurry up already.

[dan_bgblue]

No one has returned my calls asking for my dose

[KSRBEvans]

Meanwhile, we have this nonsense:

LOUISVILLE, Ky. —

A Louisville woman received the first dose of the COVID-19 vaccine after a handful were made available to the general public at a Walgreens.

Julie Dryden said she received a text from a friend on Christmas Eve alerting her that the Walgreens on Lime Kiln Lane was offering around a dozen doses of the vaccine to people in the store. Dryden and her husband rushed there and found out it was true.

"And so they were like, 'We've got two left, one, two,' and I was the last person," Dryden said.

https://www.wlky.com/article/at-risk...ublic/35084999

Maybe we should all start hanging out in drug stores on the off chance they have a few spare doses laying around.

[Darrell KSR]

Meanwhile, we have this nonsense:



https://www.wlky.com/article/at-risk...ublic/35084999

Maybe we should all start hanging out in drug stores on the off chance they have a few spare doses laying around.

That has to be a joke, right? Are you sure that's not The Onion?

I had an appointment with my ophthalmologist yesterday. I joked with him that I was trying to make sure I kept my BMI above 30 so that I might have a factor that would improve my chances of receiving the vaccination early. He looked at me in all seriousness and said he would do it, too, if he didn't already have access to the first batch. He asked me if he should call my wife and ask her to make sure she bakes more desserts for me. I told him I had that part covered.

[Darrell KSR]

I'm going to take a minute here, because I consider everybody that's part of this board a friend and I care for my friends. I know that some of my friends have different opinions than I do, and I am not going to get on a soapbox and try to change their minds. But as someone who has lost a 54-year-old family member to Covid, who has a daughter who treated those suffering from Covid of all ages, and who has often been the last face that those patients have seen in the world, please consider being vaccinated as soon as it is available to you.

For several months my daughter has advised me of their patients who were discharged from ICU, successfully, but had continuing, lingering problems for months. I now learned that there have been worldwide instances of psychosis developed from mild cases of Covid where they believe the body's immune response produced neurotoxins that continue to attack their own brain. These are healthy individuals in their 30s, 40s in which Covid was no big deal for them, until several months later when they experience something similar to schizophrenia and dementia. The interesting thing is that they were aware of their mental decline, unlike those suffering from schizophrenia and dementia. Anyway, there are things that we are still learning about the disease, and none of it is good.

As I have discussed with friends, we all have to weigh our risks in everyday life. I probably drive faster than a lot of people. I'm sure my eating habits are not the best. I am suggesting, however, that none of us should be taking unreasonable risks, and the light is at the end of this tunnel, and we can see it. It's frustrating, it's taking longer than we want, and we want to live our lives. But it's coming.

Be safe, everyone.

[PedroDaGr8]

Well said Darrell! You and I are very much in alignment when it comes to vaccination. There are a lot worse things than death both in life and with this virus.

That being said, I’ll get on a soapbox (without getting political)!

As you state, we all weigh our risks. Nothing (at least in this physical realm) is perfect. For example, seatbelts aren’t perfect at preventing death in an accident, but they do dramatically reduce your risk of injury and death in an accident. At this point, I doubt anyone still believes that not wearing them is better than wearing them for almost all normal situations encountered in a vehicle. Similarly, double layer cloth masks are not perfectly effective at preventing infection, but they do a good job of dramatically reducing the risk of SARS-CoV-2 infection and even greater job at preventing severe infections. This virus spreads almost entirely via airborne droplet dispersion with very small percentages of infection occurring via surface contact and/or true airborne (non-droplet) infection. Because almost all of the viral spread occurs via droplet dispersion, a standard double layer cotton cloth mask reduces your risk of infection by around 70%-80%.

I also understand that human beings (as a whole) are social creatures. For most of us, it is extremely difficult to do without face-to-face social interaction; not meeting with others carries its own risks of mental impacts. As such, mitigate your risks: wear a mask when you are outside your home, clean your mask regularly, keep your distance from others, keep meetings with others truly outdoors if possible (ideally two walls maximum on a tent, a heater is fine), and limit the numbers of DIFFERENT people you meet over a two-week period (the fewer branches a node has the slower the virus spreads).

Quick aside about N95 masks: Most people assume that an N95 mask is the only option because it is the gold standard. The truth is that real N95 masks can be VERY uncomfortable to wear long term (10x worse than a cloth mask). Additionally, most of the public has never been properly fitted for an N95 mask nor knows how to wear/remove them properly. Because of this, they end up compromising the effectiveness of the mask, rendering them AT BEST only as good as a double layer cloth mask and often times much worse (despite being way less comfortable).

*Steps off soapbox*

I wanted to give some context to this statement:

they believe the body's immune response produced neurotoxins that continue to attack their own brain.

These chemicals are called cytokines and aren't neurotoxins per se; they are molecules which the immune system uses to induce inflammation. On their own cytokines and the inflammation they induce are highly beneficial. For example, when you have an active infection in one part of the body, you want this inflammation to bring immune cells from around the body to come fight this infection and swelling to restrict blood flow away from the site to prevent it from spreading. Cytokines only become a problem when the amount produced becomes so large (as with an acute SARS-CoV-2 infection) that they spread throughout the body in high amounts. This triggers a broad scale inflammation responses throughout the entire body. Something which your body (especially your brain) isn't designed to handle. These wide spread inflammation response can wreak havoc with all sorts of biological pathways. Even worse, these molecules can actually preclude some of the other immunological pathways from functioning properly, preventing the immune system from properly fighting the virus.

Oddly enough, this cytokine response is the reason for the random occasional news stories about Vitamin D and COVID-19. Interestingly, one of the functions of Vitamin D is to down regulate the production of cytokines (via a complex immunological pathway). We have seen some statistically significant data indicating that patients with low serum Vitamin D levels are significantly more likely to become infected and to experience a severe case of the disease. There is still a lot of research to be done on this topic, as low Vitamin D levels are not uncommon, but it does appear likely that increased Vitamin D levels do provide at least some protective benefit.

[kingcat]

Just visited with an 81 year old man who received his vaccination at Walgreens. A nursing home had returned (or whatever) two injections which were not used and while he was in Walgreens they offered the injection because of his health situation and age.
A real nice fellow who was very happy to have luckily received it.

[Darrell KSR]

Well said Darrell! You and I are very much in alignment when it comes to vaccination. There are a lot worse things than death both in life and with this virus.

That being said, I’ll get on a soapbox (without getting political)!

As you state, we all weigh our risks. Nothing (at least in this physical realm) is perfect. For example, seatbelts aren’t perfect at preventing death in an accident, but they do dramatically reduce your risk of injury and death in an accident. At this point, I doubt anyone still believes that not wearing them is better than wearing them for almost all normal situations encountered in a vehicle. Similarly, double layer cloth masks are not perfectly effective at preventing infection, but they do a good job of dramatically reducing the risk of SARS-CoV-2 infection and even greater job at preventing severe infections. This virus spreads almost entirely via airborne droplet dispersion with very small percentages of infection occurring via surface contact and/or true airborne (non-droplet) infection. Because almost all of the viral spread occurs via droplet dispersion, a standard double layer cotton cloth mask reduces your risk of infection by around 70%-80%.

I also understand that human beings (as a whole) are social creatures. For most of us, it is extremely difficult to do without face-to-face social interaction; not meeting with others carries its own risks of mental impacts. As such, mitigate your risks: wear a mask when you are outside your home, clean your mask regularly, keep your distance from others, keep meetings with others truly outdoors if possible (ideally two walls maximum on a tent, a heater is fine), and limit the numbers of DIFFERENT people you meet over a two-week period (the fewer branches a node has the slower the virus spreads).

Quick aside about N95 masks: Most people assume that an N95 mask is the only option because it is the gold standard. The truth is that real N95 masks can be VERY uncomfortable to wear long term (10x worse than a cloth mask). Additionally, most of the public has never been properly fitted for an N95 mask nor knows how to wear/remove them properly. Because of this, they end up compromising the effectiveness of the mask, rendering them AT BEST only as good as a double layer cloth mask and often times much worse (despite being way less comfortable).

*Steps off soapbox*

I wanted to give some context to this statement:


These chemicals are called cytokines and aren't neurotoxins per se; they are molecules which the immune system uses to induce inflammation. On their own cytokines and the inflammation they induce are highly beneficial. For example, when you have an active infection in one part of the body, you want this inflammation to bring immune cells from around the body to come fight this infection and swelling to restrict blood flow away from the site to prevent it from spreading. Cytokines only become a problem when the amount produced becomes so large (as with an acute SARS-CoV-2 infection) that they spread throughout the body in high amounts. This triggers a broad scale inflammation responses throughout the entire body. Something which your body (especially your brain) isn't designed to handle. These wide spread inflammation response can wreak havoc with all sorts of biological pathways. Even worse, these molecules can actually preclude some of the other immunological pathways from functioning properly, preventing the immune system from properly fighting the virus.

Oddly enough, this cytokine response is the reason for the random occasional news stories about Vitamin D and COVID-19. Interestingly, one of the functions of Vitamin D is to down regulate the production of cytokines (via a complex immunological pathway). We have seen some statistically significant data indicating that patients with low serum Vitamin D levels are significantly more likely to become infected and to experience a severe case of the disease. There is still a lot of research to be done on this topic, as low Vitamin D levels are not uncommon, but it does appear likely that increased Vitamin D levels do provide at least some protective benefit.

A second time today I have really wanted a "Like" button. Awesome information.

[MickintheHam]

Thanks, Pedro.

[KSRBEvans]

A23FAEBC-8717-4A17-8251-1ED52CB35B19.jpg

https://twitter.com/ashishkjha/statu...47089121337345

[CitizenBBN]

Pedro, can I pick your brain? Would you (or anyone else) have any insight into what is the best option for a Vitamin D supplement.

I am low on D and on B12. I take both, but both are (from what I've read) hard to take as a supplement and translate into actual improved levels. I got a prescription for both at one time, but now I have to go back in for blood work to get another one.

It's amazing what you can get without question and what they want you tested to give you. I have to f-ing about beg for D and B12, but when I broke out in hives I got anti-inflammatories and other stuff with no questions asked.

just wondering if there's a decent OTC option.

[PedroDaGr8]

FYI I just wanted to say I have read this and am trying to find some reliable info on this. It is a bit out of my expertise, other than my company makes, meaning I support the mamufacture of, a very popular Vitamin D assay for testing patients.

Sent from my SM-N986U using Tapatalk

[CitizenBBN]

Thanks. Would love your insights but don't want to put you out either. I know when I got a prescription for D it was just a megadose thing, but for reasons that allude me I would have to go back and get blood work over and over to get another dose. Obviously something OTC would be more convenient, but it needs to be absorbed.

I could also go outside I suppose, and I would, but in January in Lexington I doubt it will do a lot of good.

[KentuckyWildcat]

Update: Two individual had allergic reactions, both had previous reactions to other substances and/or medicines in the past. Both had Epipens with them because they knew it was a risk. That being said, a lot of STRONG wording to let Pfizer know that the FDA is going to expect them to look into these reactions and show they are not unique to the vaccine. Furthermore, investigate the common severe allergies to ensure there is no overlap.

Thoughts on someone with a seafood and tomato allergy? Severe seasonal allergies as well. Obviously, I'll talk to my doctor, but more opinions (information) are better. I've never had any real reactions with medicine. Some problems with anesthesia, but I think they gave me too much because I was fighting them.

[Darrell KSR]

Update: Two individual had allergic reactions, both had previous reactions to other substances and/or medicines in the past. Both had Epipens with them because they knew it was a risk. That being said, a lot of STRONG wording to let Pfizer know that the FDA is going to expect them to look into these reactions and show they are not unique to the vaccine. Furthermore, investigate the common severe allergies to ensure there is no overlap.

Thought this was something to keep in mind as well.

[PedroDaGr8]

Thanks. Would love your insights but don't want to put you out either. I know when I got a prescription for D it was just a megadose thing, but for reasons that allude me I would have to go back and get blood work over and over to get another dose. Obviously something OTC would be more convenient, but it needs to be absorbed.

I could also go outside I suppose, and I would, but in January in Lexington I doubt it will do a lot of good.

The blood work is to monitor your current levels and to make sure the high doses aren't causing damage to other organs. One of those sunlamps for Season Affective Disorder typically are capable of generating some Vitamin D when going outdoors is not reasonable.

Thoughts on someone with a seafood and tomato allergy? Severe seasonal allergies as well. Obviously, I'll talk to my doctor, but more opinions (information) are better. I've never had any real reactions with medicine. Some problems with anesthesia, but I think they gave me too much because I was fighting them.

To be honest, you will have a higher potential risk of adverse reaction. Right now, we just don't know for sure what is causing this allergic reaction. I would definitely work with your doctor on this. I imagine anywhere immunizing people will necessarily have an epipen on the ready but from what I hear it is NOT fun thing to go through.

Thought this was something to keep in mind as well.

I will add the context that these numbers will occur IRRESPECTIVE of if we vaccinate or not. Just pick 10 million people, these are the numbers that will occur.

[Darrell KSR]

I will add the context that these numbers will occur IRRESPECTIVE of if we vaccinate or not. Just pick 10 million people, these are the numbers that will occur.

Oops. I thought the context was obvious, but I realize now some might have thought it was connected.

Basically, when you hear about somebody dying after receiving a Covid-19 vaccine, guess what--people die for all kind of reasons every day. People get cancer, etc.

In other words...
10 million people who are vaccinated will have those events occur.
10 million people who are not vaccinated will have those events occur.

(I stole that from an epidemiologist I am friends with here from UAB...)

[CitizenBBN]

Pedro, I know it's to monitor the levels, and I get that, but the chance of a Vitamin D overdose is extremely slight, as is a b12 for that matter, my levels were severely low, and everything I read said that multiple such doses would be needed. The risk/reward of going into get blood work in the current situation versus prescribing at least a moderate dose of vitamins I can get OTC seems a clear decision. The dosages required to effectively do damage are far above what would be prescribed. I've seen research showing that 50K-100K IU/Wk didn't approach toxic levels, far beyond what I would have been prescribed.

Don't want to hijack, but when I can get prescribed muscle relaxers and pain meds for a tweaked back with no in person check up (video conference), but can't get Vitamin D and B12 in any quantity without one, I find that funny. I get the reasoning as you walk along the road, but when you look from 30,000 feet it's not really logical. Esp. during covid, when I really don't care to be going in for bloodwork right now.

I did like the video meeting though. That's the future, not having to go and check in and wait and be in the office unless really necessary. I just disagree about what is really necessary in this case.