Coronavirus Outbreak

[Deleted member 3518]

I understand what your saying . I’m not an anti Vaxer at all . But we should have healthy conversations about it . Why not ? Even if the conversation is simply be to explain why it’s safe and the reasons for it .
These conversations have to be had . Not in the , “I know more than you , cause your dumb and don’t believe” belittling way. Especially if the only reason you believe is you lost a close family member .
There’s nothing wrong with discussing it . And people who think there is . Are the problem I’ve been posting about the last few days . If you know more , don’t be a douche to people who have reservations . Try and ease thier worry . Because thier concerns are fair enough IMO. I mean it’s not like a government had never tried to control the population through nefarious means before is it …

I don't know what the solution is in terms of broader communication. I have ongoing fears that society is generally becoming more and more skeptical even though there is an ever greater ability to do research via online resources. It's something like the fight between fear/opinion and evidence-based discussion.

My main concern, as voiced, is that there is a big difference between concern about an issue and rejection of the stated facts of an issue. Again - I am not saying anyone in this forum is doing this. Of course it's natural to have concerns regarding your personal health, and again it's probably best to discuss that with your doctor, with whom you hopefully share a long-term trusting relationship.

But then you say "who has the time to do that research mate?" That's highly concerning to me! If something like vaccination is serious to someone, they should find the time to do research. Because whilst social media tends to muddy the waters of popular opinion, there's also never been an easier time in history to get access to information online.

So for example your comment - having conversations about "why it's safe and reasons for it" - that involves research. Not difficult research, there are lots of fairly straight forward resources. In fact, I'd argue that COVID is being given the most energy and effort in terms of helping the wider population understand what's going on. For example most folks can name 2 or 3 vaccine candidates. Most folks now have some idea what the R value is in a pandemic. Everyone knows what social distancing is. You could not have said any of that 1.5 years ago.

The government can only do so much with mailbox drops and TV ads. I'm not aware of an Australian government trying to control the population, no. If the government / politicians concern you specifically then don't listen to the pollies, listen to scientists, the TGA (they are bipartisan), your doctor.

Everything your saying is perfect world . And I agree with it . But that’s not the world we live in .
Single mum Karen , picks the kids up from school , speaks to other Karen’s about covid , goes home gets dinner ready , gets the kids to bed , then sits down to have a few wines whilst going on a you tube spiral where she might messenger the other Karen’s , and so it goes .

Or you get people who just want to be an ostrich , and stick thier head in the sand and watch John wick 3 . They don’t want the burden of reading this stuff .
How can this shock you ? If you say you’re pragmatic like @mike did , then you kind of have to accept this as fact . I know it sux especially in a field , where you , and I guess the people you directly work with seem to have the best intentions , but to me , this is far from shocking .
It’s an overload for a lot of people . Like the real life equivalent of watching saw movies and no longer wincing when the dude chops his arm off . It’s desensitisation. Or it’s misinformation.
Much like in another life I used to live , it’s about hearts and minds. I know people SHOULD just listen to you . But they don’t know you , and , a side effect of all this lockdown , and everybody going into thier own ,I guess ,cocoon with thier family ,it’s fully bread distrust. I mean look at the pasta and toilet paper fiasco . The same emotion that spurred the “it’s the apocalypse, where the TP”, for many people is fueling the lack of desire to get the vaccine . DISTRUST. They don’t trust the person standing in the line , or the person next to them at the park , or the person telling them to get he vaccine . Especially if they’ve gone down a negative you tube spiral .

When push comes to shove I have more confidence in the majority of the Australian population making the positive choice and getting vaccinated.

Me too , I’m just stating where the trepidation comes from . Where the push back is coming from . Like I said , I don’t agree with it , I just understand it . And most people will tell the voice in rehire head , that says “don’t do it” to shut up , and get the jab.

 

[Tiger5150]

During the pandemic have we given away power to the government? Yes absolutely. Sometimes I think it is a bit over the top but the numbers don’t lie. Compared to most of the rest of the world Australia is the place to be. Can we refine the liberties we give away or is there better ways of coping with the Pandemic, probably and 20-20 hindsight is wonderful.

We can fall back on the fact that the Australian government is a democratically elected group that can be removed from power if required. I don't think anyone has ever suggested that our government isn't fairly elected. They might collectively act like morons from time to time, but we put them there.

And we know this because we have compulsory voting.


Agreed. They are also reliably human and incompetent which for me is a positive. Everytime I hear a full on conspiracy theory that the Govt is manipulating to control us for nefarious purposes here in Aus, my instinctive reaction is that they are not actually good enough to keep that together to the level required.

Basically the only government I believe that would be able to pull off a substantial conspiracy would be the Chinese as they are extremely competent and equally capable now.

Probably agree with you with regards a government actor and it used to be that only government actors would be big and powerful enough to manipulate a populace. I do think however that we are starting to (or already) at a point where non government actors are large and powerful enough to influence and manipulate large populations.

Im pretty certain that we are all being manipulated its just a question of whether that manipulation is coordinated by a body for a purpose.

 

[Deleted member 3518]

During the pandemic have we given away power to the government? Yes absolutely. Sometimes I think it is a bit over the top but the numbers don’t lie. Compared to most of the rest of the world Australia is the place to be. Can we refine the liberties we give away or is there better ways of coping with the Pandemic, probably and 20-20 hindsight is wonderful.

We can fall back on the fact that the Australian government is a democratically elected group that can be removed from power if required. I don't think anyone has ever suggested that our government isn't fairly elected. They might collectively act like morons from time to time, but we put them there.

And we know this because we have compulsory voting.


Agreed. They are also reliably human and incompetent which for me is a positive. Everytime I hear a full on conspiracy theory that the Govt is manipulating to control us for nefarious purposes here in Aus, my instinctive reaction is that they are not actually good enough to keep that together to the level required.

Basically the only government I believe that would be able to pull off a substantial conspiracy would be the Chinese as they are extremely competent and equally capable now.


Probably agree with you with regards a government actor and it used to be that only government actors would be big and powerful enough to manipulate a populace. I do think however that we are starting to (or already) at a point where non government actors are large and powerful enough to influence and manipulate large populations.

Im pretty certain that we are all being manipulated its just a question of whether that manipulation is coordinated by a body for a purpose.

It’s really , really , really easy for the population to be manipulated . Especially in the digital age.
Look at the people in Facebook saying sack Madge , and bring back benji , because of a fox sports marketing campaign at the end of last season .

 

[jirskyr]

Furthermore, ***most, if not all,*** of the vaccines being applied to COVID ***are based on existing research/technologies***. So pharma companies didn't have to wait to ramp up their trial abilities: they had the technology available once COVID was profiled/mapped.

For example the ***Pfizer/BioNTech*** vaccine, they've been fooling around with the technology for years. Once they isolated COVID they were ready to go, and my company has a pre-existing partnership for managing Pfizer clinical trials, so they rolled out a protocol for my company to start work on. The protocol designs are usually very similar; you basically drop the study into the existing framework and get going.


Thank you @jirskyr for great, informative and rational post outlining many great points regarding the vaccine development and testing. Ive snipped a lot of it, but this part interests me. You mention that most of the vaccines including Pfizer are using existing technologies, but correct me if I'm wrong, but my understanding is before COVID, there has never previously been a vaccine injected into humans using lipid nanoparticles as a delivery mechanism? Am I wrong about this?

I looked around, I could not easily find confirmation of the mRNA technologies being administered in humans before the COVID vaccines. I did not find evidence that they weren't either.

The Pfizer/BioNTech vaccine definitely included a Phase 1 step, which means first-in-human safety assessment on a small number of people. But also this is normal for a vaccine because each individual vaccine, even if built on existing technology, is technically new and needs initial human safety assessment before proceeding.

However, the point I was making is that they've had the technology for some time, so they didn't need much time to ramp up to be ready for a clinical trial. It also helps when the government pitches money in and fast-tracks the approvals.

 

[cochise]

During the pandemic have we given away power to the government? Yes absolutely. Sometimes I think it is a bit over the top but the numbers don’t lie. Compared to most of the rest of the world Australia is the place to be. Can we refine the liberties we give away or is there better ways of coping with the Pandemic, probably and 20-20 hindsight is wonderful.

We can fall back on the fact that the Australian government is a democratically elected group that can be removed from power if required. I don't think anyone has ever suggested that our government isn't fairly elected. They might collectively act like morons from time to time, but we put them there.

And we know this because we have compulsory voting.


Agreed. They are also reliably human and incompetent which for me is a positive. Everytime I hear a full on conspiracy theory that the Govt is manipulating to control us for nefarious purposes here in Aus, my instinctive reaction is that they are not actually good enough to keep that together to the level required.

Basically the only government I believe that would be able to pull off a substantial conspiracy would be the Chinese as they are extremely competent and equally capable now.


Probably agree with you with regards a government actor and it used to be that only government actors would be big and powerful enough to manipulate a populace. I do think however that we are starting to (or already) at a point where non government actors are large and powerful enough to influence and manipulate large populations.

Im pretty certain that we are all being manipulated its just a question of whether that manipulation is coordinated by a body for a purpose.

We are already there, the non government actors have greater influence than most government actors.

 

[Tiger5150]

Furthermore, ***most, if not all,*** of the vaccines being applied to COVID ***are based on existing research/technologies***. So pharma companies didn't have to wait to ramp up their trial abilities: they had the technology available once COVID was profiled/mapped.

For example the ***Pfizer/BioNTech*** vaccine, they've been fooling around with the technology for years. Once they isolated COVID they were ready to go, and my company has a pre-existing partnership for managing Pfizer clinical trials, so they rolled out a protocol for my company to start work on. The protocol designs are usually very similar; you basically drop the study into the existing framework and get going.


Thank you @jirskyr for great, informative and rational post outlining many great points regarding the vaccine development and testing. Ive snipped a lot of it, but this part interests me. You mention that most of the vaccines including Pfizer are using existing technologies, but correct me if I'm wrong, but my understanding is before COVID, there has never previously been a vaccine injected into humans using lipid nanoparticles as a delivery mechanism? Am I wrong about this?

I looked around, I could not easily find confirmation of the mRNA technologies being administered in humans before the COVID vaccines. I did not find evidence that they weren't either.

The Pfizer/BioNTech vaccine definitely included a Phase 1 step, which means first-in-human safety assessment on a small number of people. But also this is normal for a vaccine because each individual vaccine, even if built on existing technology, is technically new and needs initial human safety assessment before proceeding.

However, the point I was making is that they've had the technology for some time, so they didn't need much time to ramp up to be ready for a clinical trial. It also helps when the government pitches money in and fast-tracks the approvals.

To be clear, Im not challenging anything you have said, and I understand and agree (to the extent it matters if I agree) that the requisite trials and tests have been done. Im also not questioning the mRNA aspect, but more the lipid nanoparticle delivery method.

I did some research after my first post and found plenty of research (I can trawl through and post if you like) that shows that lipid nonoparticles have been used only over the last few (less than 5) years for cancer therapy but never in a vaccine (I found one research paper from 1 year ago discussing the possibility). WHat does this mean? To me it simply means the delivery methods has not been tested longitudinally. Doesnt mean its bad (or good), just untested. That is why I am going to get the Oxford vaccine simply because the delivery method (viral vector) has been proven over a long time.

 

[jirskyr]

Press Club address just started on ABC TV or news channel on vaccines that some may find interesting.


Summary?

Only caught a some of the opening address along with less of the latter between phone calls regarding a course, then writing in the politics thread and elsewhere towards the end, with not much context when mostly missing questions during the program, so nothing concrete or significant to report.

Types, strains, origins, mutations and efficacy as a result etcetera, so doubt you missed anything of consequence. The ABC news channel normally just runs at low volume in the background for me when able and occasionally piquing my interest, so the program details were posted as more of a community announcement than anything.


No worries thanks. I am interested (and will do my own research) because I have been firmly of the opinion (for me and no one else) that Ill stick my arm out for the Oxford/Astra Zeneca vaccine, but not the others, simply because their have been longitudinal studies of the Oxford delivery mechanism but not the others. Thought I recently heard that the efficacy of the Oxford vaccine against the funky new English/South African strains was in question. Thought they may have addressed that.

I don't think that's entirely accurate, re longitudinal studies of the delivery mechanism.

The use of modified / attenuated viruses for vaccines (for example) has a long history, however that's not the same as saying this specific vaccine has had a long history of safety testing. It's like saying morphine and heroin have the same safety profile because they are closely related (and that's not true, they are subtly different but have very different responses). It is entirely possible that making certain modifications to a virus or vector or protein, for the purposes of inducing COVID immune response, actually has an impact on the safety profile.

If you get my meaning, there's the "technology" or concept behind the vaccine on one hand, and on the other hand there is the final product that gets injected into your arm. To say that the background of the technology gives confidence regarding safety outcomes is fine, but the COVID vaccine is still a new product that needs to be independently tested. I would not be saying "this vaccine is already known to be safe" because similar vaccines were safe. That's not scientifically valid, you have to rigorously test the product you actually have, not its family of products.

I am curious to understand how much safety data you, personally, require to conclude a vaccine is safe or not. This is not to accuse you of anything, just to understand where something crosses over from being safe to being risky.

 

[jirskyr]

To me it simply means the delivery methods has not been tested longitudinally.

Again this isn't entirely correct.

What is "longitudinal" testing? Longitudinal simply means data being revisited over time. So for example, blood pressure measurements taken every 4 weeks over the course of 6 months.

There is longitudinal data for the Pfizer/BioNTech vaccine - you can read the protocol online. They do ongoing safety assessments before and after every dose, then periodically up to 24 months. This is common. It is true to say that they are only part-way through their safety assessment period, and there's still safety data collected ongoing, however I can guarantee they've gone to the FDA with their interim safety data based on the period around the actual shots.

Myself as a researcher, the background / history of a product is fine, but if you have modified it in some way, you almost need to start your safety assessment from scratch. Of course they estimate safety outcomes based on previous scientific knowledge, followed by animal models, but you need to get that particular product into people and then see what happens.

If you get my meaning? For example viral vector vaccines exist for ebola, Zika virus, flu. They may use a range of different viral vectors, and I don't think it's accurate to say any one vector vaccine is "more safe" than another type of vaccine because the overall family of vaccines has been used for a long period.

 

[Deleted member 3518]

Press Club address just started on ABC TV or news channel on vaccines that some may find interesting.


Summary?

Only caught a some of the opening address along with less of the latter between phone calls regarding a course, then writing in the politics thread and elsewhere towards the end, with not much context when mostly missing questions during the program, so nothing concrete or significant to report.

Types, strains, origins, mutations and efficacy as a result etcetera, so doubt you missed anything of consequence. The ABC news channel normally just runs at low volume in the background for me when able and occasionally piquing my interest, so the program details were posted as more of a community announcement than anything.


No worries thanks. I am interested (and will do my own research) because I have been firmly of the opinion (for me and no one else) that Ill stick my arm out for the Oxford/Astra Zeneca vaccine, but not the others, simply because their have been longitudinal studies of the Oxford delivery mechanism but not the others. Thought I recently heard that the efficacy of the Oxford vaccine against the funky new English/South African strains was in question. Thought they may have addressed that.

I don't think that's entirely accurate, re longitudinal studies of the delivery mechanism.

The use of modified / attenuated viruses for vaccines has a long history, however that's not the same as saying this specific vaccine has had a long history of safety testing. It's like saying morphine and heroin have the same safety profile because they are closely related (and that's not true). It is entirely possible that making certain modifications to a virus for the purposes of inducing COVID immune response actually has an impact on the safety profile.

If you get my meaning, there's the "technology" or concept behind the vaccine on one hand, and on the other hand there is the final product that gets injected into your arm. To say that the background of the technology gives confidence regarding safety outcomes is fine, but the COVID vaccine is still a new product that needs to be independently tested. I would not be saying "this vaccine is already known to be safe" because similar vaccines were safe. That's not scientifically valid, you have to rigorously test the product you actually have, not its family of products.

I am curious to understand how much safety data you, personally, require to conclude a vaccine is safe or not. This is not to accuse you of anything, just to understand where something crosses over from being safe to being risky.

Hey mate , can I ask a question about big pharma . Is there any way for them to manipulate , and create the cure and the disease at the same time ( not a conspiracy theory ) . Like for example how the medical industry in the USA over prescribing opioid pain killers like oxy , and many doctors getting kickbacks from pharmaceutical companies , Not an issue here because of the laws around this stuff . Not an accusation or anything , I’m just curious if there’s an avenue for them to exploit this ?

 

[Tiger5150]

Press Club address just started on ABC TV or news channel on vaccines that some may find interesting.


Summary?

Only caught a some of the opening address along with less of the latter between phone calls regarding a course, then writing in the politics thread and elsewhere towards the end, with not much context when mostly missing questions during the program, so nothing concrete or significant to report.

Types, strains, origins, mutations and efficacy as a result etcetera, so doubt you missed anything of consequence. The ABC news channel normally just runs at low volume in the background for me when able and occasionally piquing my interest, so the program details were posted as more of a community announcement than anything.


No worries thanks. I am interested (and will do my own research) because I have been firmly of the opinion (for me and no one else) that Ill stick my arm out for the Oxford/Astra Zeneca vaccine, but not the others, simply because their have been longitudinal studies of the Oxford delivery mechanism but not the others. Thought I recently heard that the efficacy of the Oxford vaccine against the funky new English/South African strains was in question. Thought they may have addressed that.

I don't think that's entirely accurate, re longitudinal studies of the delivery mechanism.

The use of modified / attenuated viruses for vaccines has a long history, however that's not the same as saying this specific vaccine has had a long history of safety testing. It's like saying morphine and heroin have the same safety profile because they are closely related (and that's not true). It is entirely possible that making certain modifications to a virus for the purposes of inducing COVID immune response actually has an impact on the safety profile.

I think you and I are at 180deg opposites. I agree that modified/attenuated viruses have a reasonably long history but that is not what I'm talking about. You are talking about the payload, the RNA and that is the modified/attenuated virus. I am talking about the actual method of getting that RNA into the cell (Cytoplasm not nucleus) which in the case of the Pfizer/Novatus vaccines is a lipid nanoparticle which to my understanding and some research is completely novel whereas the Oxford uses a viral vector to get it into the cell which is old technology and therefore lots of longitudinal data.

If you get my meaning, there's the "technology" or concept behind the vaccine on one hand, and on the other hand there is the final product that gets injected into your arm. To say that the background of the technology gives confidence regarding safety outcomes is fine, but the COVID vaccine is still a new product that needs to be independently tested. I would not be saying "this vaccine is already known to be safe" because similar vaccines were safe. That's not scientifically valid, you have to rigorously test the product you actually have, not its family of products.

Agreed and my point of view is this:

Pfizer/Novatus - Payload = RNA - Novel. Tested and proven sufficiently safe in trials, no longitudinal studies of payload. No longitudinal studies of delivery methods (lipid nanoparticles).

Oxford = RNA payload Novel. Tested and proven sufficiently safe in trials, no longitudinal studies of payload. Delivery method is viral vector (approximately 50years of usage and longitudinal studies)/

I am curious to understand how much safety data you, personally, require to conclude a vaccine is safe or not. This is not to accuse you of anything, just to understand where something crosses over from being safe to being risky.

I solely rely on the clinical testing and I conclude that all of the available vaccines (lets be honest Im not trusting chinese or russian vaccines) have been proven to be safe in the short term within acceptable parameters, but none of them are tested longitudinally (payload). The delivery method of the Oxford Vaccine is approx 50years old and therefore is one less thing that is untested. If my turn comes, I an happy to put my arm out for the Oxford vaccine, less keen on the others. Plus the fact that the Oxford is manufactured in Aus and doesnt require the -70deg storage etc.

 

[Kul]

Thankyou @jirskyr for your unique insights and comments.
I love reading behind-the-scenes and factual info like that.

An update from over here:
12.6million vaccinated so far
They have now vaccinated over 90% of people aged 75 and approaching similar numbers with as the age decreases.
Clinically vulnerable people are being vaccinated now too, my mate who has bad diabetes got his shot last week. Hats off the UK government, they are ahead of schedule here and it's clearly working!

 

[Tiger5150]

To me it simply means the delivery methods has not been tested longitudinally.

Again this isn't entirely correct.

What is "longitudinal" testing? Longitudinal simply means data being revisited over time. So for example, blood pressure measurements taken every 4 weeks over the course of 6 months.

I agree totally. Longitudinal studies are studies of efficacy or safety over time. Pfizer is (less than 6 months) , the Oxford delivery mechanism is almost 50years old so there are 50years of longitudinal data for the Oxford delivery method, almost none for the others.

There is longitudinal data for the Pfizer/BioNTech vaccine - you can read the protocol online. They do ongoing safety assessments before and after every dose, then periodically up to 24 months. This is common. It is true to say that they are only part-way through their safety assessment period, and there's still safety data collected ongoing, however I can guarantee they've gone to the FDA with their interim safety data based on the period around the actual shots.


I am not questioning for a second that all of the safety data is being collected and assessed and is coming back as acceptable. The fact there is no longitudinal data of any of the payloads or the Pfizer delivery mechanism is not a "fault" or error, its a factor of time. I dont consider less than 6months a longitudinal study. Look at some the very old vaccines that we use routinely these days like the MMR/Polio. They are not the same now as they were 10 or twenty years ago. For a start they have taken the Hg out of them. The Oxford delivery mechanism is old and has MANY years of longitudinal data. That is not to say that in time the PFizer vaccine may not be shown to be the best and safest, the data just doesnt exist yet.

Myself as a researcher, the background / history of a product is fine, but if you have modified it in some way, you almost need to start your safety assessment from scratch. Of course they estimate safety outcomes based on previous scientific knowledge, followed by animal models, but you need to get that particular product into people and then see what happens.

If you get my meaning? For example viral vector vaccines exist for ebola, Zika virus, flu. They may use a range of different viral vectors, and I don't think it's accurate to say any one vector vaccine is "more safe" than another type of vaccine because the overall family of vaccines has been used for a long period.

Disagree with you totally on this. If a particular viral vector is used over many years and proves to be inert and safe then by definition it is more safe than one that has not been proven over time.

 

[jirskyr]

Press Club address just started on ABC TV or news channel on vaccines that some may find interesting.


Summary?

Only caught a some of the opening address along with less of the latter between phone calls regarding a course, then writing in the politics thread and elsewhere towards the end, with not much context when mostly missing questions during the program, so nothing concrete or significant to report.

Types, strains, origins, mutations and efficacy as a result etcetera, so doubt you missed anything of consequence. The ABC news channel normally just runs at low volume in the background for me when able and occasionally piquing my interest, so the program details were posted as more of a community announcement than anything.


No worries thanks. I am interested (and will do my own research) because I have been firmly of the opinion (for me and no one else) that Ill stick my arm out for the Oxford/Astra Zeneca vaccine, but not the others, simply because their have been longitudinal studies of the Oxford delivery mechanism but not the others. Thought I recently heard that the efficacy of the Oxford vaccine against the funky new English/South African strains was in question. Thought they may have addressed that.

I don't think that's entirely accurate, re longitudinal studies of the delivery mechanism.

The use of modified / attenuated viruses for vaccines has a long history, however that's not the same as saying this specific vaccine has had a long history of safety testing. It's like saying morphine and heroin have the same safety profile because they are closely related (and that's not true). It is entirely possible that making certain modifications to a virus for the purposes of inducing COVID immune response actually has an impact on the safety profile.

If you get my meaning, there's the "technology" or concept behind the vaccine on one hand, and on the other hand there is the final product that gets injected into your arm. To say that the background of the technology gives confidence regarding safety outcomes is fine, but the COVID vaccine is still a new product that needs to be independently tested. I would not be saying "this vaccine is already known to be safe" because similar vaccines were safe. That's not scientifically valid, you have to rigorously test the product you actually have, not its family of products.

I am curious to understand how much safety data you, personally, require to conclude a vaccine is safe or not. This is not to accuse you of anything, just to understand where something crosses over from being safe to being risky.

Hey mate , can I ask a question about big pharma . Is there any way for them to manipulate , and create the cure and the disease at the same time ( not a conspiracy theory ) . Like for example how the medical industry in the USA over prescribing opioid pain killers like oxy , and many doctors getting kickbacks from pharmaceutical companies , Not an issue here because of the laws around this stuff . Not an accusation or anything , I’m just curious if there’s an avenue for them to exploit this ?

No it's not very plausible.

Maybe 30-40 years ago the Pharma companies did a lot of smooching of doctors and decision-makers to help sell products, things like free dinners, cruises, travel overseas for seminars etc. They'd all be under the guise of research or education, but you could probably be very good friends with the pharma rep, and whilst they never paid you directly, they'd make it worth your while to recommend their stuff.

And that's not necessarily to say that lots of doctors were corrupt, no more than in any other field; they probably already recommended the products anyway but were happy for the Pharma company to be aware of their support.

HOWEVER the laws have been tightened exceedingly high now. You say "no issue here because of the laws", but actually the US now has just about the toughest drug industry laws going around. Look up the "Sunshine Act 2010" - which says I can't even buy an investigator a sandwich and a cup of coffee (over USD 20) without being obligated to report it to the US authorities. In Australia it's not that strict, it's more like AUD $120, however many Pharma companies are US-based and beholden to the US regulations even when the specific operation is overseas.

So these days, anyone caught of getting kickbacks will be annihilated. And in the US it's double the risk, as they are such a litigation-minded culture, you then stand the risk of being chased down by your patients in court. And the Pharma companies, they would cop massive fines - they are big companies, but not as rich as some people might imagine.

Also just to be clear, I work in drug development not marketing/sales, so once a drug gets to market, it has nothing to do with me.

 

[jirskyr]

I solely rely on the clinical testing and I conclude that all of the available vaccines (lets be honest Im not trusting chinese or russian vaccines) have been proven to be safe in the short term within acceptable parameters, but none of them are tested longitudinally (payload). The delivery method of the Oxford Vaccine is approx 50years old and therefore is one less thing that is untested. If my turn comes, I an happy to put my arm out for the Oxford vaccine, less keen on the others. Plus the fact that the Oxford is manufactured in Aus and doesnt require the -70deg storage etc.

Nothing that you are saying is specifically wrong, I'm just pointing out that whilst being *similar* to other vaccines, the Oxford vaccine is its own independent product. When they are studying the Oxford vaccine they start from zero, they don't presume a certain amount of safety data based on other products, even if they have some confidence that they can predict the safety profile.

The Oxford vaccine may or may not have a similar safety profile to drugs that use the same sort of technology.

As far as I am aware, almost all, perhaps all vaccine technologies are rather benign compared with standard chemical drug therapies.

There are novel technologies being approved all the time in drug therapy, e.g. CAR-T, oncology immunotherapy, medical devices etc. It doesn't make new strategies inherently more risky or less safe.

You also have to understand that clinical trials are statistically designed to profile safety and/or efficacy. The idea is that when you have finished your study, you have very strong data regarding the safety profile of the product and you submit that to the authorities.

If the authorities review the data submission and approve a drug, it's highly likely the drug is actually quite safe. I wouldn't go around presuming to need more data or longer-term studies to be confident that the risks are well described.

 

[Tiger5150]

I solely rely on the clinical testing and I conclude that all of the available vaccines (lets be honest Im not trusting chinese or russian vaccines) have been proven to be safe in the short term within acceptable parameters, but none of them are tested longitudinally (payload). The delivery method of the Oxford Vaccine is approx 50years old and therefore is one less thing that is untested. If my turn comes, I an happy to put my arm out for the Oxford vaccine, less keen on the others. Plus the fact that the Oxford is manufactured in Aus and doesnt require the -70deg storage etc.

Nothing that you are saying is specifically wrong, I'm just pointing out that whilst being *similar* to other vaccines, the Oxford vaccine is its own independent product. When they are studying the Oxford vaccine they start from zero, they don't presume a certain amount of safety data based on other products, ***even if they have some confidence that they can predict the safety profile***.

Exactly and of course they have to start from scratch to test and prove the Oxford vaccine in its entirety, but there is 50yo evidence that the delivery mechanism is safe (the safety profile that you speak of) where there is no longitudinal evidence of the safety (or otherwise) of lipid nanoparticle delivery. Its one less aspect that needs longitudinal testing.

The Oxford vaccine may or may not have a similar safety profile to drugs that use the same sort of technology.

As far as I am aware, almost all, perhaps all vaccine technologies are rather benign compared with standard chemical drug therapies.

There are novel technologies being approved all the time in drug therapy, e.g. CAR-T, oncology immunotherapy, medical devices etc. It doesn't make new strategies inherently more risky or less safe.

Agreed totally however if there are two technologies side by side, both proven to be safe (within parameters) in the short term, but one has long term testing of the delivery method and the other one hasnt, then that method has longitudinal testing and the other hasnt. Doesnt necessarily mean one is safer, just one has that aspect tested over time.

You also have to understand that clinical trials are statistically designed to profile safety and/or efficacy. The idea is that when you have finished your study, you have very strong data regarding the safety profile of the product and you submit that to the authorities.


Agreed you have every strong data regarding the immediate or short term safety profile of the product. Clinical trials can only test over the period of the clinical trial. Its a finite limitation. Its not to say that its safer or less safe, there is simply no longitudinal data for the payload of ANY of the vaccines and no long data of all but the Oxford delivery mechanism.

If the authorities review the data submission and approve a drug, it's highly likely the drug is actually quite safe. I wouldn't go around presuming to need more data or longer-term studies to be confident that the risks are well described.

Then why do long term longitudinal studies on drugs? Why have they changed the formula of all of the currently accepted (jabbed into me and my kids, Im not an antivaxer) vaccines. They have ALL been altered over time due to longitudinal studies, Hg taken out for example.

We've probably gone around it enough, Im not challenging you or disagreeing that the vaccines have been proven safe in the short term. Im merely saying that in one of the vaccines the delivery mechanism has 50years of data whereas the others are brand new and therefore I feel more comfortable with that one.

I recognise that you work in the field and are knowledgable in this field. FWIW, I hold AQF 8 (Grad Cert) Uni quals in Biological Sciences and have worked with viruses (Im NOT a virologist or an epidemiologist or a Doctor).

 

[jirskyr]

I agree totally. Longitudinal studies are studies of efficacy or safety over time. Pfizer is (less than 6 months) , the Oxford delivery mechanism is almost 50years old so there are 50years of longitudinal data for the Oxford delivery method, almost none for the others.

I believe the technology is only about 25 years old, since the first publication? Here: Smith, G. L., Mackett, M. & Moss, B. Infectious vaccinia virus recombinants that express hepatitis B virus surface antigen. Nature 302, 490–495 (1983).

I did some more research, there has been research with mRNA vaccines for cancer in humans since 2008. I can't say how closely the cancer mRNA vaccines match or predict antivirus vaccines for COVID.

The other thing I'll note with the COVID vaccine candidates is the data is maturing very quickly, given the urgency and the caseload from which to recruit subjects.

 

[jirskyr]

Then why do long term longitudinal studies on drugs? Why have they changed the formula of all of the currently accepted (jabbed into me and my kids, Im not an antivaxer) vaccines. They have ALL been altered over time due to longitudinal studies, Hg taken out for example.

Well obviously it's good science to continue to assess therapies. They are still doing studies on aspirin despite billions and billions of doses having been taken. I'm not advocating not assessing long-term safety data, I'm just cautioning that in my opinion, a new technology or an older technology don't necessarily infer greater or worse safety outcomes on any given therapy.

For example with viral vectors, they may slightly change the vector or the way they attenuate it, and you get a new product. It may indeed be very much like a similar product, but as I said before, there are very many chemicals / therapies / technologies that are similar in concept or approach, but that don't necessarily have the same safety profile.

 

[Tiger5150]

I agree totally. Longitudinal studies are studies of efficacy or safety over time. Pfizer is (less than 6 months) , the Oxford delivery mechanism is almost 50years old so there are 50years of longitudinal data for the Oxford delivery method, almost none for the others.

I believe the technology is only about 25 years old, since the first publication? Here: Smith, G. L., Mackett, M. & Moss, B. Infectious vaccinia virus recombinants that express hepatitis B virus surface antigen. Nature 302, 490–495 (1983).

I did some more research, there has been research with mRNA vaccines for cancer in humans since 2008. I can't say how closely the cancer mRNA vaccines match or predict antivirus vaccines for COVID.

My question is not necessarily with the mRNA (payload) but the lipid nanoparticles. Anyway, Im also not saying they are or are not safe and toget back to your original point I trust and dont doubt any of the existing data, its the data that doesnt exist, that doesnt exist and for that factor alone, I would prefer the Oxford.

I think you and I are really in the weeds now. I appreciate the detailed discussion without needing to getting into win/lose or debate. Thank you, I enjoy it.

 

[Tiger5150]

I solely rely on the clinical testing and I conclude that all of the available vaccines (lets be honest Im not trusting chinese or russian vaccines) have been proven to be safe in the short term within acceptable parameters, but none of them are tested longitudinally (payload). The delivery method of the Oxford Vaccine is approx 50years old and therefore is one less thing that is untested. If my turn comes, I an happy to put my arm out for the Oxford vaccine, less keen on the others. Plus the fact that the Oxford is manufactured in Aus and doesnt require the -70deg storage etc.

Nothing that you are saying is specifically wrong, I'm just pointing out that whilst being *similar* to other vaccines, the Oxford vaccine is its own independent product. When they are studying the Oxford vaccine they start from zero, they don't presume a certain amount of safety data based on other products, ***even if they have some confidence that they can predict the safety profile***.


Exactly and of course they have to start from scratch to test and prove the Oxford vaccine in its entirety, but there is 50yo evidence that the delivery mechanism is safe (the safety profile that you speak of) where there is no longitudinal evidence of the safety (or otherwise) of lipid nanoparticle delivery. Its one less aspect that needs longitudinal testing.

The Oxford vaccine may or may not have a similar safety profile to drugs that use the same sort of technology.

As far as I am aware, almost all, perhaps all vaccine technologies are rather benign compared with standard chemical drug therapies.

There are novel technologies being approved all the time in drug therapy, e.g. CAR-T, oncology immunotherapy, medical devices etc. It doesn't make new strategies inherently more risky or less safe.

Agreed totally however if there are two technologies side by side, both proven to be safe (within parameters) in the short term, but one has long term testing of the delivery method and the other one hasnt, then that method has longitudinal testing and the other hasnt. Doesnt necessarily mean one is safer, just one has that aspect tested over time.

You also have to understand that clinical trials are statistically designed to profile safety and/or efficacy. The idea is that when you have finished your study, you have very strong data regarding the safety profile of the product and you submit that to the authorities.


Agreed you have every strong data regarding the immediate or short term safety profile of the product. Clinical trials can only test over the period of the clinical trial. Its a finite limitation. Its not to say that its safer or less safe, there is simply no longitudinal data for the payload of ANY of the vaccines and no long data of all but the Oxford delivery mechanism.

If the authorities review the data submission and approve a drug, it's highly likely the drug is actually quite safe. I wouldn't go around presuming to need more data or longer-term studies to be confident that the risks are well described.

Then why do long term longitudinal studies on drugs? Why have they changed the formula of all of the currently accepted (jabbed into me and my kids, Im not an antivaxer) vaccines. They have ALL been altered over time due to longitudinal studies, Hg taken out for example.

We've probably gone around it enough, Im not challenging you or disagreeing that the vaccines have been proven safe in the short term. Im merely saying that in one of the vaccines the delivery mechanism has 50years of data whereas the others are brand new and therefore I feel more comfortable with that one.

I recognise that you work in the field and are knowledgable in this field. FWIW, I hold AQF 8 (Grad Cert) Uni quals in Biological Sciences and have worked with viruses (Im NOT a virologist or an epidemiologist or a Doctor).

Cant work out why someone would bother to down vote that post ?

 

[Tim Sheens]

Thankyou @jirskyr for your unique insights and comments.
I love reading behind-the-scenes and factual info like that.

An update from over here:
12.6million vaccinated so far
They have now vaccinated over 90% of people aged 75 and approaching similar numbers with as the age decreases.
Clinically vulnerable people are being vaccinated now too, my mate who has bad diabetes got his shot last week. Hats off the UK government, they are ahead of schedule here and it's clearly working!

Good to see the government there at least getting this part right along with other decisions of late after what I would call multiple policy failures over many months.

Over here the government have scheduled announcements of further announcements to move on from other announcements on vaccines. Pretty sure they announced we were not only at the head of the queues, but also that we would have 4 million vaccinated by March.