The safety of the new vaccine

Brendan Burgess

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42,198
I raised this in another thread but I think it's worth highlighting.

My concern was that two or three months of testing might not be long enough to determine if it had any long term negative side-effects.

However, this was dealt with by one of the experts on BBC's excellent new series:


In testing previous vaccines, the negative side-effects all showed up quickly, so they are not concerned about negative side-effects appearing after a longer period of actual use.

And while they couldn't be definitely ruled out, the risks from Covid are known and far higher. And indeed, some of the long-term effects of Covid seem quite serious as well.

So, I am going to fight my way to the top of the queue for vaccination.

Brendan
 

john luc

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457
Had a listen to this, 28 minutes long and a lot to digest. @ 4.15 they talk about RNA and give an explanation and @ 6.28 they discuss they risk factor of RNA treatment effecting your DNA. This is where I think people will be a bit afraid of this new method I think. @10.50 they talk about safety. Worth a listen to more than once to get a good understanding of what's being said.
 

Paul O Mahoney

Registered User
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133
Its new technology, old vaccines and some for covid take the virus and manipulate it either by changing its geneic make up in order for our immune system adapt and kill this virus.

This is different, mRna is our messenger and it lives outside the cell nucleus but is used by cells for the transmission of code.
Both vaccines manipulate mRNA to detect the Rna protein that covid uses to stick to our lung cells primarily, and attacks that Covid protein thereby not allowing covid to attach.
I believe that this will be the first time this technology is used in this way, cancer was primarily the research area.
For 30 years now mRna ideas were laughed at by the general scientific community, but many kept going.

Long term side effects are unknown, the vaccines are new and developed in 8/9 months of 2020, but as our mRna doesn't live inside the nucleus of our cells and doesn't cause us any harm now its thought that it won't cause harm in the future.

But who knows, we all need to ponder Schrodingers Cat experiment.

Obviously time and tracking of clinical trail volunteers over the next 2 years will tell us more.

My view, not a scientific person, just my understanding of available information, plus my attempts to understand how mRna is being used in cancer treatment.
 

Brendan Burgess

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42,198
Good summary Paul.

The only addition I would make is that we must compare the risk of taking the vaccine with the risk of being infected with Covid.

It seems that the long-term risk of illness due to taking the vaccine is very small.

The risk of serious illness if you get Covid is fairly high - depending on your personal profile.

Brendan
 

Paul O Mahoney

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133
Good summary Paul.

The only addition I would make is that we must compare the risk of taking the vaccine with the risk of being infected with Covid.

It seems that the long-term risk of illness due to taking the vaccine is very small.

The risk of serious illness if you get Covid is fairly high - depending on your personal profile.

Brendan
Agreed there has been some evidence that Covid does affect organs other than the lungs, for example the bowel and it has also been witnessed that some people seemly recover from an infection only to get a second dose even in isolation.
The view here is that the virus resides in the body, and its thought that it the bowel.
Apparently analysis of poo, highlighted this.

Its going to be a while before the full details of all effects of covid are known, if thats possible.
 

PM9999

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57
I'm certainly no anti vaxxer generally, but I do have reservations about the speed at which this has been developed/tested. Some of the peripheral govt. activities have increased my concern, not least the immunity from prosecution granted by the U.S. for any adverse effects of administering the new Covid vaccine.

There was also a very interesting tender issued last month by the U.K. for software to monitor "adverse drug reactions" arising from the new vaccine. I quote:

"Strictly necessary — it is not possible to retrofit the MHRA’s legacy systems to handle the volume of ADRs that will be generated by a Covid-19 vaccine. Therefore, if the MHRA does not implement the AI tool, it will be unable to process these ADRs effectively. This will hinder its ability to rapidly identify any potential safety issues with the Covid-19 vaccine and represents a direct threat to patient life and public health."

See https://ted.europa.eu/udl?uri=TED:NOTICE:506291-2020:TEXT:EN:HTML&tabId=1

I'm in my 60s, in reasonable health, and not hugely scared about the prospect of catching Covid 19. I'm not planning to be in the first wave of vaccine take up and should compulsion/mandatory vaccination come in (mooted as a possibility in the UK), I would regard that as a very negative development.
 

joe sod

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1,039
I'm not planning to be in the first wave of vaccine take up and should compulsion/mandatory vaccination come in (mooted as a possibility in the UK), I would regard that as a very negative development.
But what happens if you need a "vaccine passport" to go on holidays or to go to a crowded concert or bar , maybe there will be bouncers not checking for age but for your Covid passport. I see RTE have suddenly switched to discussing the arrival of the vaccine, I wonder why :).
Brendan O Connor actually revealed today that they were told not to discuss the vaccine for fear it would stop people obeying the lockdown.
 

Sophrosyne

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1,181
@PM9999, you are probably right at present.

This article from The Lancet summarizes the position. The following is an extract:

“Unfortunately, the trials' results were announced via press releases, leaving many scientific uncertainties that will dictate how the vaccines will affect the course of the pandemic. Little safety data are available. How well the vaccines work in older people or those with underlying conditions and their efficacy in preventing severe disease are still unclear. Peer-reviewed publication should resolve these issues, but other questions will not be answerable for some time. For one, the duration of protection is unknown and will have a huge bearing on the practicalities and logistics of immunisation (will boosters be needed? How often?).

Whether the vaccines prevent transmission of SARS-CoV-2 or mainly just protect against illness is largely unknown too. If the latter, achieving herd immunity through immunisation becomes a difficult prospect. Pfizer and Moderna together project that there will be enough vaccine for 35 million individuals in 2020, and perhaps up to 1 billion in 2021. As a result, many millions of people at high risk of disease will not be immunised any time soon, necessitating the continued use of non-pharmaceutical interventions. There is a danger that the public might become complacent following the news of promising vaccines, but how much more difficult will it be to ensure adherence to guidance and restrictions when a vaccine is available to many but others remain unprotected?”
 

joe sod

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1,039
The lancet hasn't had a great reputation lately, this from the guardian only last june

"The Lancet is one of the oldest and most respected medical journals in the world. Recently, they published an article on Covid patients receiving hydroxychloroquine with a dire conclusion: the drug increases heartbeat irregularities and decreases hospital survival rates. This result was treated as authoritative, and major drug trials were immediately halted – because why treat anyone with an unsafe drug?

Now, that Lancet study has been retracted, withdrawn from the literature entirely, at the request of three of its authors who “can no longer vouch for the veracity of the primary data sources”. Given the seriousness of the topic and the consequences of the paper, this is one of the most consequential retractions in modern history."


I think they have also made other big mistakes from memory, maybe what they say about the vaccine is correct but they are not beyond repute themselves. They have basically said nothing bad about the vaccine because they have no data themselves but they are still trying to spread doubt without any data.
 

Sophrosyne

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1,181
They have basically said nothing bad about the vaccine because they have no data themselves but they are still trying to spread doubt without any data.
The key issue is that data concerned has not yet been made public. So one cannot make assumptions either way.

The article expresses the same view held by reputable scientists worldwide, including our own - cautious optimism while prudently awaiting more substantial information, which was not contained in press releases but critical to evaluation of efficacy and to ongoing pandemic management.
 

Brendan Burgess

Founder
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42,198
I do have reservations about the speed at which this has been developed/tested.
I don't think you need reservations on this aspect.

The companies halted most of the other research and threw everything at this. Which is why they have come up with some vaccines so quickly.

Likewise the approval process won't take shortcuts. But they have a team on standby to review this as soon as the application is submitted. It won't go to the back of a long queue of other drugs.

Brendan
 

Brendan Burgess

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42,198
But what happens if you need a "vaccine passport" to go on holidays or to go to a crowded concert or bar , maybe there will be bouncers not checking for age but for your Covid passport.
I don't think that the vaccine should be compulsory. But if someone chooses not to be vaccinated then they should not be allowed to go on a plane, go to a bar or any other crowded indoor space.

Brendan
 

Paul O Mahoney

Registered User
Messages
133
Just read a tweet from Katlin Karakoram who has been the person behind the Moderna vaccine and is as important in the story as the people in Biontech.

In the tweet she says that RNA being kept at lower temperatures actually remains stable for a long time at lower temperatures, and this has been known for a long time.
She goes on to say that storing it at higher temperature, reduces its shelf life.

Interesting tweet given that Moderna have said they can store their vaccine at much lower temperatures than Pfizers.

It's unusual for anyone who is involved in one vaccine to talk about another one, suppose it might indicate that this truly is a project that the main benefits are actually the human race. Or am I dreaming again?

Ps don't know how to link to twitter, I'm very much low techie techie
 

Paul O Mahoney

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133
I don't think that the vaccine should be compulsory. But if someone chooses not to be vaccinated then they should not be allowed to go on a plane, go to a bar or any other crowded indoor space.

Brendan
Very Monty Python. In Cork RTC in the 80s we were given 3 options but couldn't take the first 2.
 

Paul O Mahoney

Registered User
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133
I don't think you need reservations on this aspect.

The companies halted most of the other research and threw everything at this. Which is why they have come up with some vaccines so quickly.

Likewise the approval process won't take shortcuts. But they have a team on standby to review this as soon as the application is submitted. It won't go to the back of a long queue of other drugs.

Brendan
Just to add to this, the vaccines will still have to get licences from all various Regulatory agencies globally, like all other vaccines that we now have.

The emergency usage will be only for a few months.

Not pulling anyone up but production on all other medicines has continued as have inspections by regulators, but nearly all development other medicines and vaccines were severely curtailed.
 

Paul O Mahoney

Registered User
Messages
133
The key issue is that data concerned has not yet been made public. So one cannot make assumptions either way.

The article expresses the same view held by reputable scientists worldwide, including our own - cautious optimism while prudently awaiting more substantial information, which was not contained in press releases but critical to evaluation of efficacy and to ongoing pandemic management.
The FDA and EMA , the UK regulator all have the data, and that is more important than the Lancet.
The Lancet aren't a regulatory agency and they are still hugely important but are also stuck in the past, this is emergency approval they'll get the data when full licencing is sought.
 

Paul O Mahoney

Registered User
Messages
133
@PM9999, you are probably right at present.

This article from The Lancet summarizes the position. The following is an extract:

“Unfortunately, the trials' results were announced via press releases, leaving many scientific uncertainties that will dictate how the vaccines will affect the course of the pandemic. Little safety data are available. How well the vaccines work in older people or those with underlying conditions and their efficacy in preventing severe disease are still unclear. Peer-reviewed publication should resolve these issues, but other questions will not be answerable for some time. For one, the duration of protection is unknown and will have a huge bearing on the practicalities and logistics of immunisation (will boosters be needed? How often?).

Whether the vaccines prevent transmission of SARS-CoV-2 or mainly just protect against illness is largely unknown too. If the latter, achieving herd immunity through immunisation becomes a difficult prospect. Pfizer and Moderna together project that there will be enough vaccine for 35 million individuals in 2020, and perhaps up to 1 billion in 2021. As a result, many millions of people at high risk of disease will not be immunised any time soon, necessitating the continued use of non-pharmaceutical interventions. There is a danger that the public might become complacent following the news of promising vaccines, but how much more difficult will it be to ensure adherence to guidance and restrictions when a vaccine is available to many but others remain unprotected?”
All the answers are available in the public domain.
Both vaccines are two dose, boosters are a unknown now.

Also Pfizer and Moderna aren't the only cowboys at the Rodeo.
Johnson and Johnson, Astrazeneca, GSK the worlds biggest vaccine producer , and many others are at various stages of development.

Qtr1 of 2021 will be exciting as more vaccines will be close to market.
 

Paul O Mahoney

Registered User
Messages
133
I'm certainly no anti vaxxer generally, but I do have reservations about the speed at which this has been developed/tested. Some of the peripheral govt. activities have increased my concern, not least the immunity from prosecution granted by the U.S. for any adverse effects of administering the new Covid vaccine.

There was also a very interesting tender issued last month by the U.K. for software to monitor "adverse drug reactions" arising from the new vaccine. I quote:

"Strictly necessary — it is not possible to retrofit the MHRA’s legacy systems to handle the volume of ADRs that will be generated by a Covid-19 vaccine. Therefore, if the MHRA does not implement the AI tool, it will be unable to process these ADRs effectively. This will hinder its ability to rapidly identify any potential safety issues with the Covid-19 vaccine and represents a direct threat to patient life and public health."

See https://ted.europa.eu/udl?uri=TED:NOTICE:506291-2020:TEXT:EN:HTML&tabId=1

I'm in my 60s, in reasonable health, and not hugely scared about the prospect of catching Covid 19. I'm not planning to be in the first wave of vaccine take up and should compulsion/mandatory vaccination come in (mooted as a possibility in the UK), I would regard that as a very negative development.
OK I saw this too, and on further research the UK system needs to be updated as the pure volume of vaccination is going to dwarf anything that has gone before.

Personally I think this is a good thing as data needs to be collected. This is new technology and its the first time it has been made and used in the population. It would be unthinkable that the results wouldn't be tracked.

PS all vaccines are tracked and the WHO needs this data too, like the data on the virus itself.

And the companies will be tracking too, they have to.
 

Sophrosyne

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Messages
1,181
@Paul O'Mahony, are you saying that the Pfizer Phase III trials have been concluded and have been published?
 
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