https://www.nytimes.com/2020/11/09/h...ne-pfizer.html
Great news.
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Outstanding news.
Buy pfizer
This is as good as we could have hoped for. Now to implement it will require convincing half the population it is not a conspiracy tied to a hoax
Nice little peak in the price of the stock since Friday. It’s been languishing a bit recently. Trump did say we would get a vaccine. Russians must have helped time the announcement.
Just to be clear, the conspiracy/hoax thing is not political when it comes to a vaccine. Half the population does not trust a vaccine including many that I know. My wife and her family, a large family, will not receive any vaccine period. And of my family, also a large family an equal amount claim they will not either.
Most believe it is a government conspiracy not limited to any political party.)
I will consider taking a vaccine, but not initially and until I can see any problems that may appear during the initial application to the general population.
Attachment 9787
https://twitter.com/cullenroche/stat...51495724535813
Far from official, but still good to see as a possibility.
Much like the results of the Phase IIa trial, this is about as good of news as you can expect out of this stage. That being said, there are some caveats. The biggest, the data hasn't been through any sort of peer-review process and has only been announced via press release. Until this occurs, I am taking the numbers with a huge grain of salt (albeit very hopefully).Quote:
Originally Posted by KSRdallen
This is inline with both my own estimates (albeit from working in a related field) and from people I know much more knowledgeable about vaccines. I would expect Q2-Q3 timeframe, even if approved in Q1, the doses would be reserved for the most at risk populations (immunocompromised, elderly, etc.).Quote:
Originally Posted by KSRBEvans
In related news, a new treatment with some promise. This treatment administers loads of the ACE2 protein to the patient. The viruses then latch on to this free-floating protein and can't unbind, in essence deactivating the virus.
https://www.nature.com/articles/s41392-020-00374-6
This is what I waiting for while everybody else's been discussing the vaccine. Of course, the vaccine is great news and I am excited about it. But with a daughter who is a Covid-19 ICU nurse, I have been especially interested in medications and treatment for those seriously infected. They have already gotten better, better, and better at treating patients in her unit, with both treatment and drugs. But what you have posted is super-exciting. Fingers crossed that it comes to pass as well. With a combination of both, maybe we can get back to normal.Quote:
Originally Posted by PedroDaGr8
Awesome news! And Pfizer isn’t one of the pharmaceuticals that got the government funding amazingly enough.
News today that Moderna's vaccine is also >90% effective in trials:
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https://twitter.com/ScottGottliebMD/...12880006111237
Here’s an article on it. Great news.Quote:
Originally Posted by KSRBEvans
https://apnews.com/article/pandemics...39a5d234aba07b
Thanks very much to both Pedro and dallen. I appreciate you taking the time to share the info with us.
^Agreed, dallen.
Between the Pfizer and Moderna vaccines, 70,000,000 doses by the end of the year? Yes, please.
I would take it tomorrow, and think nothing of it. I know pfizer.Quote:
Originally Posted by suncat05
^This!Quote:
Originally Posted by Doc
Depends on what is in it. I have an egg white allergy and was advised against taking a flu vaccine 25 years ago.Quote:
Originally Posted by Doc
I really want to see Moderna's data. They have a bad reputation for playing with the numbers via press release. If legit then it is great news but, unlike Pfizer, they do not have a track record that warrants faith without the full data.Quote:
Originally Posted by KSRBEvans
These mRNA vaccines should be much easier for people to take since they don't typically require growth in other cells. Not to say there won't be stabilizers and what not which can cause an allergic reaction, just some of the big ones like eggs are unlikely to be used.Quote:
Originally Posted by KeithKSR
The Moderna vaccine is now rated at 94.5% affective and doesn’t require being refrigerated to -90 f.
I’m in the trust Pfizer camp, but the challenges to keep it at temperature before being administered seems mind boggling.
Sent from my iPhone using Tapatalk
There are trade-offs for both.Quote:
Originally Posted by blueboss
For the Pfizer vaccine:
It is expected to cost around $20/dose. This is within the realm of international subsidy for poorer countries. The biggest downside with the vaccine is the storage temperature of -90°C (-70°C). This isn't as difficult as it seems for developed countries. These are dry ice temperatures and -80°C freezers are VERY common in hospitals, biological research labs, etc. As such, your large scale labs, hospitals, and Departments of Health are not going to have any issues with this requirement. I could foresee doctors offices and clinics getting the doses and having to store them on dry ice. To me, the biggest question is how do you cheaply and affordably ensure the reliability of the entire ultra-cold chain. That being said, poorer countries which do not have this infrastructure readily available are going to have issues being able to get this vaccine.
For the Moderna Vaccine:
It is expected to cost around $40/dose which is cost prohibitive for poorer countries even with subsidy. That being said, it has the benefit that it can be stored at 2-8°C for 1 month, which makes it easier to dispense in poorer countries from an infrastructure perspective (if the cost can come down).
Pfizer update below. Trial ends at 95% effective. Clearance being sought within days.
https://apnews.com/article/coronavir...ee4df873ec1023
:sHa_clap2: :sHa_clap2:
This is absolutely HUGE news! My quick overview of the data (my comments in bold):Quote:
Originally Posted by KSRdallen
- Pfizer plans to file for FDA EUA within days. This filing will include clinical trial and manufacturing validation data - the latter is VERY surprising in a good way.
- Pfizer and BioNTech plan to submit the efficacy and safety data from the study for peer-review in a scientific journal once analysis of the data is completed. - This is a VERY important part of the process. The earlier they release the data, the quicker the data scientists and other experts can begin parsing the data.
- 43,000 participants enrolled with 41,000 receiving the second dose - this is a very solid number.
- 42% from diverse ethnic backgrounds - this dramatically reduces the risk of undiscovered side effects in various ethnic backgrounds.
- 41% between 56 to 85 years of age - considering this is the most at risk age ranges, good to see it well represented.
- The vaccine will be manufactured at four Pfizer plants: St. Louis, MO; Andover, MA; and Kalamazoo, MI in the U.S.; and Puurs in Belgium.
- 50 million doses by the end of 2020 and 1.3 billion doses in 2021.
- As expected, vaccine will be shipped on dry ice. - Exactly what I indicated a couple posts back.
- Specially designed container allows for temporary storage for up to 15 days by simply refilling with dry ice.
- Shipments will include GPS-enabled temperature loggers to ensure cold chain integrity.
- 170 total COVID Infections (10 severe) across all participants
- 162 COVID infections (9 severe) in placebo group
- 8 COVID infections (1 severe) in vaccinated group
- Immune Response, Efficacy, Side Effects
- Immugenicity starts at 28 days (7 days after second dose)
- Good immune response consistent across age, gender, race, and ethnicity
- Vaccine is 95% overall and 94% effective in those over 65 years of age
- Safety data review was performed by external and independent Phase III oversite committee
- No serious side-effects reported
- 2% of volunteers reported headaches and fatigue
- Potential Unknowns
- How long immunity lasts.
- If and/or how often periodic boosters will be necessary.
- How a roll-out would be accomplished, who would get the vaccine, etc.
- Exactly when the first shipments would start.
EDIT: Done
A question about the mRNA vaccines. My sister is concerned with DNA alteration side effects. Is there any justification for such long term health issues that are at least rumored to be a concern?
None at all.Quote:
Originally Posted by kingcat
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.
Anybody else hungry after reading this?Quote:
Originally Posted by PedroDaGr8
(j/k). Thanks for the great analogy, Pedro.
This is brilliant! Nicely done, Pedro.Quote:
Originally Posted by PedroDaGr8
Thank you very much
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.
Great analogy. Oddly I feel a need to re-watch Ratatouille tonight though. :)Quote:
Originally Posted by PedroDaGr8
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.
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:
- Is the data and Pfizers analysis of the data legit or are there issues which could indicate malfeasance/lack of competence?
- 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?
- Does the data sufficiently prove the vaccine is effective? How effective?
- 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.
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).
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.
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.
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?
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.
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
Thanks for the info great discussion