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Discussion Starter #101
^ Okay, she's a nurse working in paediatrics at the Portuguese Institute of Oncology and was one of the 538 workers of the institute that received the Pfizer-BioNTech vaccine. Let's see what Pfizer has to say.
Is there a more reputable source for this news event? The online sources I found for this don't seem reliable.
 

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Pfizer’s mRNA vaccine is STILL in phase III clinical trials- study completion date is 27th January 2023.
(Last page) The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
https://pfe-pfizercom-d8-prod.s3.am... Production Distribution Statement 121720.pdf
Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals - Full Text View - ClinicalTrials.gov
 

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Discussion Starter #105 (Edited)
Pfizer’s mRNA vaccine is STILL in phase III clinical trials- study completion date is 27th January 2023.
Interesting, thanks. I would like the health regulators to spell out for us what measures are being taken to analyze the results in 2021, since the actual clinical trials won't be complete until 2023.

For example do they bring together impartial (external) scientists and analyze the results on a monthly basis? Is there a schedule for the analysis?

Does the FDA or Health Canada review the partial results of the clinical trials + public vaccination?

Who is studying and overseeing the ongoing results, including adverse reactions in public vaccination? If there was a large number of adverse reactions, who would have that data, and who's job is it to flag the problem and stop the vaccinations?

During provincial vaccination, when there are adverse reactions, where do those reports go? Who's job is it to stay on top of that situation?
 

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Large Numbers Of Health Care And Frontline Workers Are Refusing Covid-19 Vaccine
Earlier this week, Ohio Gov. Mike DeWine said he was "troubled" by the relatively low numbers of nursing home workers who have elected to take the vaccine, with DeWine stating that approximately 60% of nursing home staff declined the shot.
The Los Angeles Times reported Thursday that hospital and public officials in Riverside, Calif., have been forced to figure out how best to allocate unused doses after an estimated 50% of frontline workers in the county refused the vaccine.
 

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Interesting, thanks. I would like the health regulators to spell out for us what measures are being taken to analyze the results in 2021, since the actual clinical trials won't be complete until 2023.

For example do they bring together impartial (external) scientists and analyze the results on a monthly basis? Is there a schedule for the analysis?

Does the FDA or Health Canada review the partial results of the clinical trials + public vaccination?

Who is studying and overseeing the ongoing results, including adverse reactions in public vaccination? If there was a large number of adverse reactions, who would have that data, and who's job is it to flag the problem and stop the vaccinations?

During provincial vaccination, when there are adverse reactions, where do those reports go? Who's job is it to stay on top of that situation?
I imagine Pfizer/Moderna/AstraZenaca etc. will be watching their own trial candidates for many, many years. There is still a lot of info from these people that will be very useful to know, but for now, our leaders needed to weigh the importance of that future knowledge against the cost in lives, to wait and obtain it. Hence the emergency use authorization.

If Covid-19 was not upon us there is no way these drug companies would have even entertained the idea of submitting for approval to the FDA, when they did. There is literally years of study that needs to be done to fully understand everything, but for now, all we need to understand is that no one is getting really really sick from the vaccine and it has proven to keep people from getting sick from Covid-19. That is about what we know.

We can wish for different circumstances, but we are in the mess we are in, and this vaccine is the best mess cleaner we have, at this time.
 

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Discussion Starter #108
Not sure if this was mentioned anywhere in this thread, but if the mRNA vaccines turn out to be safe and effective (and it's looking like they probably are) these same technologies could also offer breakthroughs in cancer treatment.

This Bloomberg article points out that the same mRNA technology can be used to fight cancers.

The better way to fight cancer, Sahin and Tureci realized, is to treat each tumor as genetically unique and to train the immune systems of individual patients against that specific enemy. A perfect job for mRNA. You find the antigen, get its fingerprint, reverse-engineer the cellular instructions to target the culprit and let the body do the rest.

Take a look at the pipelines of Moderna and BioNTech. They include drug trials for treating cancers of the breast, prostate, skin, pancreas, brain, lung and other tissues, as well as vaccines against everything from influenza to Zika and rabies. The prospects appear good.
I didn't know all this, and this is incredibly exciting. Sahin & Tureci, the scientists behind the BioNTech (Pfizer) vaccine, have been tackling cancer for a while. If the COVID vaccine works well, this R&D is going to accelerate and go into hyper-drive.

A successful Pfizer vaccine will bring a huge amount of $, new scientific brainpower, and new legitimacy to the mRNA technique.

Seriously folks... this is a very exciting time. Wow.
 

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Not sure if this was mentioned anywhere in this thread, but if the mRNA vaccines turn out to be safe and effective (and it's looking like they probably are) these same technologies could also offer breakthroughs in cancer treatment.

This Bloomberg article points out that the same mRNA technology can be used to fight cancers.
I'll just point out that research for usage in cancer treatment has been going on for years. It's just that the COVID vaccines have brought it out into the spotlight.
 

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A while back I mentioned, on another thread, about the new technology of Immuno Therapy and how that has come closer then anything so far in a cure for cancer. Immuno therapy, for anyone not familiar with it, is the idea that since cancer attack cells and our immune system is supposed to protect our cells, why then does our immune system not protect us against cancer?

It was discovered that our immune system has switches. It switches on when serious threats are found and off when there is something that is perceived not to be a threat. For some reason, cancer tumors turn off our immune system and hence we have no defense against it. Just recently a man named Jim Allison won a nobel prize for developing a drug, which we now call immuno therapy, that turns our immune system back on against the threat of cancer. Once that happens, our immune system attacks the tumor directly and immediately and presto, no more tumor, no more cancer.

When I first brought the information about immuno therapy to this board, I also mentioned that I saw no reason why someday in the future, we could not come up with a vaccine to prevent cancer completely. I can't talk much about what is involved, I am sure quite a lot and I am not even sure if it is needed, if a cure is available, but the only point I want to make is that we do live in interesting times when it comes to this serious disease. I am kind of surprised at how little discussion and information about this technology has been brought up by the public and the media. It is not a full on cure yet, since more work and study is involved, but for the people it has cured already, it certainly beats the heck out of chemotherapy. I would think people would be more interested in that.

But hey, NHL hockey is back. I do know that. lol
 

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A while back I mentioned, on another thread, about the new technology of Immuno Therapy and how that has come closer then anything so far in a cure for cancer. Immuno therapy, for anyone not familiar with it, is the idea that since cancer attack cells and our immune system is supposed to protect our cells, why then does our immune system not protect us against cancer?

It was discovered that our immune system has switches. It switches on when serious threats are found and off when there is something that is perceived not to be a threat. For some reason, cancer tumors turn off our immune system and hence we have no defense against it. Just recently a man named Jim Allison won a nobel prize for developing a drug, which we now call immuno therapy, that turns our immune system back on against the threat of cancer. Once that happens, our immune system attacks the tumor directly and immediately and presto, no more tumor, no more cancer.

When I first brought the information about immuno therapy to this board, I also mentioned that I saw no reason why someday in the future, we could not come up with a vaccine to prevent cancer completely. I can't talk much about what is involved, I am sure quite a lot and I am not even sure if it is needed, if a cure is available, but the only point I want to make is that we do live in interesting times when it comes to this serious disease. I am kind of surprised at how little discussion and information about this technology has been brought up by the public and the media. It is not a full on cure yet, since more work and study is involved, but for the people it has cured already, it certainly beats the heck out of chemotherapy. I would think people would be more interested in that.

But hey, NHL hockey is back. I do know that. lol
Here's one of the stories on Immunotherapy. There are many more.
In 2009, Maureen was 62 and had stage 4 lung cancer. Her options were really to die in 12 to 14 months or die in 12 to 14 months. I think most of us know how lung cancer usually turned out. This interview was given in 2015.

She enrolled in immunotherapy trials in 2010.

What was the treatment like?

Maureen
: My infusions were once every two weeks, with scans every eight weeks. Even before I had my first scan I was starting to feel much better. I didn’t have any side effects. The chemo was leaving my body, and I was starting to feel like myself again. I was getting stronger. I was looking better. And the first scan showed that I had a dramatic response to the treatment in all areas of the disease. So we continued with treatment. The next set of scans showed even further reductions and no new growth.
What were you thinking as you were getting these results?

Maureen
: It was like having a second chance. I was diagnosed with stage 4 lung cancer. I was told I had twelve to fourteen months to live. I thought that I was going to die. That I was going to leave my family behind. It’s quite an emotional roller coaster. So I was thrilled beyond words that they actually found something that worked.

I was cautiously optimistic. I didn’t want to get crazy happy, because I didn’t want to be let down again if it stopped working. There was nothing to fall back on.
What’s the status of your cancer now?

Maureen:
The tumors have shrunk down to essentially nothing. There’s a little bit left on scans, but whether it’s calcifications or scar tissue, they won’t know unless they go in and look. But everything has remained stable through the end of the trial in June 2012.
There are lots of these stories now. It is a bloody miracle.
 

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Not sure if this was mentioned anywhere in this thread, but if the mRNA vaccines turn out to be safe and effective (and it's looking like they probably are) these same technologies could also offer breakthroughs in cancer treatment.

This Bloomberg article points out that the same mRNA technology can be used to fight cancers.



I didn't know all this, and this is incredibly exciting. Sahin & Tureci, the scientists behind the BioNTech (Pfizer) vaccine, have been tackling cancer for a while. If the COVID vaccine works well, this R&D is going to accelerate and go into hyper-drive.

A successful Pfizer vaccine will bring a huge amount of $, new scientific brainpower, and new legitimacy to the mRNA technique.

Seriously folks... this is a very exciting time. Wow.
... got to read this exciting news in details. Thanks for sharing!
 

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This idea of switches that are part of our immune system, that we might be able to control someday, should have very interesting and useful benefits in the future. We talked about Cancer above and of course the research on that is far from complete.

Going back to Covid-19, there was an interesting observation during the AstraZeneca trials that I can't seem to shake out of my mind. It could just be clinical trial error. It could be laboratory noise. Or it could be quite significant. It was the observation of efficacy, within 3 groups of participants. Within the entire group, AstraZeneca says that their vaccine is 70% effective. Within the group that actually represents the majority of participants AND is what we plan to implement, their efficacy is said to be around 62%. That group got 2 full doses of vaccine between 4 and 12 weeks apart.

The really interesting observation was with 3,000 participants that accidently only received 1/2 the recommended dose for their 1st dose and the full dose for their 2nd dose. They had an efficacy rate of 90%. So what might be going on here. Unfortuneately, whatever one surmises with this, it will unfortuneately be an unproven theory, because we actually do not know. I would have thought that all the body should need is one big whack of covid-19 to wake it up and get it's immune system to respond with the full power of its entire capabilities. But is that what should always happen?

If a military threat came from an unknown enemy towards the US, would they really activate every single soldier. Every single Navy ship. Put every fighter jet and bomber they have into the air, and put all nuclear stations and subs on alert, no matter what the size that threat actually is? Of course not. That actually would put them at a disadvantage in many ways. They would respond with the minimum force they need to be absolutely positive of eliminating the threat at hand. This response would get activated by different military commands. Lets call them switches. Kind of like defcon 1 and defcon 2.

Our immune systems would have some of the same issues the military would have. Is Covid-19 the only possible threat going on, that our bodies are concerned with, on a given day? Of course not. Can one immune response possibly get in the way of the other. Kind of like a runway being bogged down with planes carrying infantry and therefore restricting the ability for fighter planes to land so they can to be armed and put into action. Basically, the infantry is getting in the way of the air force.

It's possible that our immune system, not only has an on and off switch depending on whether an invader is perceived to be a threat or not, but also that it might even have a different switch depending on what level of threat it perceives the invader to be. If it is a lower level threat, like a low dose of Covid-19, it might switch on its 1st immune response. If it is seen as a higher threat, like a much higher dose of Covid-19, it might switch on another level of response.

So think about this. When we give a person a big dose of covid-19 vaccine, the body sees this as a big threat and implements a higher level response. Since most higher level responses take a little longer to organize and get going, this can have some negative implications to your outcome. What you really want to do, is implement your response in the proper stages. Perhaps the 1/2 dose followed by a full dose, gets all the switches activated. Low, medium, and high and whatever else there might be. Low probably being quicker but less effective and high being more effective but a little slower to get going. Not much different then our military. Combined, however, you probably get the best and quickest total response against a new infection of Covid-19.

 

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Just keep in mind that there was at least one cancer mRNA vaccine was in a phase two trial that started in 2019 so it's not like there is a dependency between with the started in 2020 covid mRNA vaccine. Or that the covid mRNA is the source of looking into mRNA cancer vaccines.

Plus Moderna's partners for this are MercK for this one (i.e. they aren't on their own).


There's no mention of BioNTech working with a partner for their mRNA cancer vaccine in this article but since they partnered with Pfiser for their covid one, it may be a similar partnership for the cancer one.


Having the covid mRNA ones prove safe will likely boost confidence in the cancer ones that were already in progress. It will be interesting to see if it speeds up the approval process.

Cheers


PS
I'm not downplaying how promising it is. I'm just saying that cancer mRNA vaccines were in progress before the need for a covid mRNA vaccine showed up.
 

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Discussion Starter #116

The US CDC is reporting statistics on allergic reactions to the Pfizer shot. Data on Moderna's is not available yet.

In a conference call with reporters, the U.S. public health agency said Wednesday allergic reactions are occurring at a rate of 11.1 per one million vaccinations. That compared with flu vaccines, in which such reactions occur at a rate of 1.3 per one million shots.
So currently the SEVERE allergic responses are about 8x the level of normal flu vaccine. That's a pretty significant increase in occurrence versus the regular flu shot; you should care, because those are potentially fatal if not treated immediately.

This emphasizes the fact that you should not stray too far away from medical personnel when you get the shot. I think you should stay close to medical facilities for 30 minutes after getting the shot, perhaps even longer. When I eventually get the shot, I am planning to linger near the medical building (perhaps walk around outside) for a good 45 to 60 minutes before going home.

Anybody like me who lives alone should take additional emergency precautions in case anaphylaxis occurs while we're alone at home. Perhaps even go hang out in a public area for a few hours in case the anaphylaxis comes with a time delay.
 

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So currently the SEVERE allergic responses are about 8x the level of normal flu vaccine. That's a pretty significant increase in occurrence versus the regular flu shot; you should care, because those are potentially fatal if not treated immediately.
Yup, those that have a history of allergies or allergic reactions should definitely have someone monitor them after getting the vaccine. Good to see it is a still a rare event though.
 

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This emphasizes the fact that you should not stray too far away from medical personnel when you get the shot. I think you should stay close to medical facilities for 30 minutes after getting the shot, perhaps even longer. When I eventually get the shot, I am planning to linger near the medical building (perhaps walk around outside) for a good 45 to 60 minutes before going home.
It had always been mentioned that those with severe allergies should take precautions with these vaccines. Basically, if your reaction to bee stings or flu vaccines are normally severe, you should be bringing an epi-pen with you for the COVID vaccine.
 

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Discussion Starter #119
It had always been mentioned that those with severe allergies should take precautions with these vaccines. Basically, if your reaction to bee stings or flu vaccines are normally severe, you should be bringing an epi-pen with you for the COVID vaccine.
Yes carrying an epi pen is a good precaution for someone with a history of allergic reactions. Though the rate of severe reaction is much higher than the regular flu shot, it's still a very low risk -- in absolute terms.

I exchanged text messages with two friends who are US doctors. One of these guys has already received both Pfizer shots (he's a surgeon, high priority). The other doc is a chief medical scientist at a biotech firm. He also plans to get the Pfizer shot for himself and his whole family as soon as he can.

Meanwhile, Canada has secured another 20 million Pfizer doses. We will be getting 80 million doses, enough to vaccinate 40 million people. That covers our entire population. The government has shifted from Moderna (cancelled some orders) to Pfizer (added more), which I think is great. My medical friends believe the Pfizer vaccine is better and safer.

Just want to clarify in case anyone misreads my posts above. I absolutely DO intend to get the Pfizer shot, myself.
 

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That covers our entire population.
37 millions minus 7 millions underaged, minus allergies (Among allergy sufferers, roughly 3.6 million people. (42.8%) reported being allergic to multiple allergens.), minus people on the fence (like myself), minus people that don’t want/don’t need the vaccine.
A surplus going to be probably 50% of the 80 m doses.
p.s I am not selfish and totally fine if government wants to donate my dose of vaccine to some older people in greater risk in other countries.
 
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