The safety of the new vaccine

[Paul O Mahoney]

That seems a higher number than get similar responses to the flu vaccine... and perhaps the symptoms are more severe also.
I think it will have to be factored in, especially rollout to frontline staff, that you may have to writeoff the next 48 hours rather than just carry on as normal.

Like everything thing else with this virus " who knows " Personally finding a vein to get anything takes hours, I usually break out in something after the flu vaccine.
It will interesting to see what happens but a least the UK have approved the Pfizer Biontech vaccine and data will be available.

 

[Allpartied]

Like everything thing else with this virus " who knows " Personally finding a vein to get anything takes hours, I usually break out in something after the flu vaccine.
It will interesting to see what happens but a least the UK have approved the Pfizer Biontech vaccine and data will be available.

Most vaccines are injected Intra Muscular, because an IV injection would lead to the liver and spleen swamping the vaccine before it got a chance to generate anti-bodies.

I'm not sure how the new vaccines are being administered, but I would imagine they are IM too.

 

[joe sod]

I see an article in the independent that the state is to indemnify the pharmaceutical companies rolling out the vaccine in order to allow them to roll it out quickly. I bet the state will also tighten up the laws to prevent people trying to claim for spurious stuff. I think that's the real reason why vaccines normally take so long to roll out, companies have to ensure that they do not get caught with enormous litigation liabilities .

 

[odyssey06]

Explainer on The Journal about the emergency rollout of the Pfizer-BioNTech vaccine.

The UK has formally approved a vaccine against Covid-19 developed by Germany’s BioNTech and US giant Pfizer, becoming the first country to do so. ... The Guardian reports that the UK has bought 40 million doses of the vaccine, with a statement form the company saying that the first doses will arrive in the UK in coming days.

Explainer: How has a Covid-19 vaccine been approved so quickly in the UK?

The UK has formally approved the Pfizer/BioNTech vaccine against Covid-19.

www.thejournal.ie

 

[Purple]

Good explainer on what this vaccine is with some general info on mRNA vaccines on RTE

 

[odyssey06]

Not sure if it's the right thread to mention it, but what would certainly ease rollout is ensuring staff can take paid time off to get the vaccine. At the moment, my understanding is that paid leave for a scheduled medical appointment isn't statutory - as opposed to an unexpected illness or accident or emergency type situation.
So clarity, something unequivocal from the government on that would be good across the private and public sector.

 

[Purple]

Not sure if it's the right thread to mention it, but what would certainly ease rollout is ensuring staff can take paid time off to get the vaccine. At the moment, my understanding is that paid leave for a scheduled medical appointment isn't statutory - as opposed to an unexpected illness or accident or emergency type situation.
So clarity, something unequivocal from the government on that would be good across the private and public sector.

What system should the government use to compensate employers for having to provide that paid leave?

 

[odyssey06]

What system should the government use to compensate employers for having to provide that paid leave?

Good question, I was thinking of employers which already cover such leave - and ensuring that is treated in same way as emergency.
But for employers who don't cover it, there is a government scheme, which only kicks in after X days, but it only covers statutory payment not full wages.
Without such compensation somewhere - either to employers or employees, I can see vaccine uptake being significantly affected.
A repeat of the scenarios we had where people weren't getting tested as they would miss out on working time.

It would be in employer's interests to have all their staff vaccinated - and hopefully that would be done free of charge.

 

[Purple]

Good question, I was thinking of employers which already cover such leave - and ensuring that is treated in same way as emergency.
But for employers who don't cover it, there is a government scheme, which only kicks in after X days, but it only covers statutory payment not full wages.
Without such compensation somewhere - either to employers or employees, I can see vaccine uptake being significantly affected.
A repeat of the scenarios we had where people weren't getting tested as they would miss out on working time.

It would be in employer's interests to have all their staff vaccinated - and hopefully that would be done free of charge.

I hope that there will be private companies offering the vaccine. It would be great to get a site visit and just everyone vaccinated in one go. The cost would be far outweighed by the disruption avoided.
We've been using a private company for testing anyone who has symptoms. We pay for the test. We've also paid foreign employees who were stuck in their home countries but there are employers who can't afford to pay anything extra at the moment.

 

[odyssey06]

I hope that there will be private companies offering the vaccine. It would be great to get a site visit and just everyone vaccinated in one go. The cost would be far outweighed by the disruption avoided.
We've been using a private company for testing anyone who has symptoms. We pay for the test. We've also paid foreign employees who were stuck in their home countries but there are employers who can't afford to pay anything extra at the moment.

From personal experience, on site vaccinations for flu are a lot less hassle.

I think with some of the vaccines on site vaccinations might be more challenging due to super cold storage requirements?
Maybe not the Oxford one?

There would still need to be a process for people who 'miss their day' onsite - there will always be someone not in the office that day.

Edited to clarify Oxford vaccine doesnt need super cold storage - Pfizer does

 

[Paul O Mahoney]

From personal experience, on site vaccinations for flu are a lot less hassle.

I think with some of the vaccines on site vaccinations might be more challenging due to super cold storage requirements?
Maybe not the Pfizer one?

There would still need to be a process for people who 'miss their day' onsite - there will always be someone not in the office that day.

Why is the temperature an issue? Ebola vaccine a few years ago had similar requirements and that seemed to be rolled out ok, and in Africa where normal "shelf life" is double that of other vaccines.

Most countries would have deep cold temperature equipment, OK getting them to maximum efficiency locations might initially difficult but once in situ thats it.
Like most vaccines they will all lyophilized in the future anyway and temperature won't be an issue.
It's a long way off before the ordinary Joe will be offered this vaccine anyway, Moderna doesn't have its own plant yet, and will be dependent on 3rd Party producers and all the risk involved in that.

But the most important thing is we have a vaccine and from here it gets better with all the others rolling in behind, but there will be issue's of varying degree of seriousness its part of the game.

 

[odyssey06]

Why is the temperature an issue? Ebola vaccine a few years ago had similar requirements and that seemed to be rolled out ok, and in Africa where normal "shelf life" is double that of other vaccines.
Most countries would have deep cold temperature equipment, OK getting them to maximum efficiency locations might initially difficult but once in situ thats it.

Actually it is the Pfizer one that needs the super cold storage.

It seems to be due to concerns about mRNA degrading... It's possible that Pfizer's vaccine could eventually be shown to be stable in somewhat warmer conditions — or for longer times out of the freezer.
But when running the tests they used super cold storage so that is what it would be approved for currently.

Pfizer has created a special transport box - the same size as a regular suitcase - which has a GPS tracker and can be filled with dry ice to maintain cold temperatures. The boxes can carry up to 5,000 doses at the safe temperature for up to 10 days and can be reused hundreds of times.
Once it has arrived at the facility, the drug must be stored in a specialist freezer or fridge - similar to a domestic appliance but with precise temperature controls and locks suitable for storing medicine. Storing the vaccine at -70C presents problems for care homes, GP surgeries, pharmacists and hospitals which do not have the freezer capacity to store the drug at the scale ministers would like it to be rolled out...
Asked about how it would affect the speed of the rollout, health secretary Matt Hancock told LBC the freezer requirements "are quite significant" and that it would be a "challenge" to meet the capacity needed for a rapid rollout.

What is the Pfizer/BioNTech Covid vaccine storage temperature and how will the UK store it? - LBC

 

[Paul O Mahoney]

Actually it is the Pfizer one that needs the super cold storage.

It seems to be due to concerns about mRNA degrading... It's possible that Pfizer's vaccine could eventually be shown to be stable in somewhat warmer conditions — or for longer times out of the freezer.
But when running the tests they used super cold storage so that is what it would be approved for currently.

Pfizer has created a special transport box - the same size as a regular suitcase - which has a GPS tracker and can be filled with dry ice to maintain cold temperatures. The boxes can carry up to 5,000 doses at the safe temperature for up to 10 days and can be reused hundreds of times.
Once it has arrived at the facility, the drug must be stored in a specialist freezer or fridge - similar to a domestic appliance but with precise temperature controls and locks suitable for storing medicine. Storing the vaccine at -70C presents problems for care homes, GP surgeries, pharmacists and hospitals which do not have the freezer capacity to store the drug at the scale ministers would like it to be rolled out...
Asked about how it would affect the speed of the rollout, health secretary Matt Hancock told LBC the freezer requirements "are quite significant" and that it would be a "challenge" to meet the capacity needed for a rapid rollout.

What is the Pfizer/BioNTech Covid vaccine storage temperature and how will the UK store it? - LBC

mRNA doesn't degrade, its the medium in the vile that can change when exposed to temperature increases. For example the medium will contain lipids which are normally clear even to high resolution microscope but some will change and be visible.
These changes do not degrade anything and they aren't a health risk but they do change the appearance of the vaccines.......its an ongoing issue with all vaccines.

 

[odyssey06]

mRNA doesn't degrade, its the medium in the vile that can change when exposed to temperature increases. For example the medium will contain lipids which are normally clear even to high resolution microscope but some will change and be visible.
These changes do not degrade anything and they aren't a health risk but they do change the appearance of the vaccines.......its an ongoing issue with all vaccines.

Ah ok, but there must be some concern about how this relates to the effectiveness of the vaccine when delivered?
I can't imagine Pfizer went with super cold storage for appearance reasons only?

Edit: According to this NPR article
But even with the stabilized building blocks and lipid coating, the mRNA could still fall apart easily, which is why the vaccine is frozen.
"Everything happens more slowly as you lower the temperature," Liu says. "So your chemical reactions — the enzymes that break down RNA — are going to happen more slowly." It's the same idea as freezing food to keep it from spoiling.
Because the specific formulations are secret, Liu says, it's not clear exactly why these two mRNA vaccines have different temperature requirements.
"It just comes down to what their data is," she says of Moderna's vaccine. "If their data shows that it's more stable at a certain temperature, that's it."

Why Moderna And Pfizer Vaccines Have Different Cold Storage Requirements : Shots - Health News : NPR

 

[Paul O Mahoney]

Ah ok, but there must be some concern about how this relates to the effectiveness of the vaccine when delivered?
I can't imagine Pfizer went with super cold storage for appearance reasons only?

Edit: According to this NPR article
But even with the stabilized building blocks and lipid coating, the mRNA could still fall apart easily, which is why the vaccine is frozen.
"Everything happens more slowly as you lower the temperature," Liu says. "So your chemical reactions — the enzymes that break down RNA — are going to happen more slowly." It's the same idea as freezing food to keep it from spoiling.
Because the specific formulations are secret, Liu says, it's not clear exactly why these two mRNA vaccines have different temperature requirements.
"It just comes down to what their data is," she says of Moderna's vaccine. "If their data shows that it's more stable at a certain temperature, that's it."

Why Moderna And Pfizer Vaccines Have Different Cold Storage Requirements : Shots - Health News : NPR

Modernas medium is different thus the temperature difference., its called stability and as the word means the vaccine says more stable at lower temperatures.

The word breakdown really is not the right word effectiveness of the vaccine is reduced.

My wife is involved, but another vaccine prenvar protects children from pneumonia, and she was tasked with getting it into the WHO program for Africa, its "shelf life" in the western world is 15 days......production to patient. However in Africa people walk everywhere and 15 days isn't enough time, so she got her team and another team in Lyon to try and extend it to 30days, and lipids became and issue, so after a year and a half the WHO were happy with the fact that "effectiveness " wasn't overly reduced by the longer stability time. And the vaccines were shipped and still are...

Vaccines will be manipulated and made better as more data comes in, so while the temperature issue is causing a headaches now its a natural part of vaccine development, Prenvar is now available for adults, old people 70+ and teenagers, but the initial use was for children under 5 I think.

 

[Paul O Mahoney]

And also remember this is brand new biotechnology in its usage, research has been going on for 25 years.

There are going to be issues and she was explicitly told last night get your Christmas shopping done sooner rather than later.....to make 1.3bn doses next year is going be a huge ask, and thats just Pfizer, Moderna, J&J,Astrazeneca etc will also face issues.

This could be the way we create vaccines for HIV, Cancer and whatever else mutates and jumps species, it could be the age of new medicines as CRISPR is also showing that your DNA can be altered and people are taking about eliminating dementia, or genetic inherited cancers like Brac2.

 

[Paul O Mahoney]

Well that didn't take long, looks like the US aren't going to get its 100m doses this year, according to AP.
Anyone find the schoolyard stuff amusing , I'm mean senior politicians getting into spats over who's the best , I was surprised at the German Ambassador weighting in, more surprised at Fauci saying what he said.

I would say the political pressure that is going on behind the scenes must be intense.

 

[odyssey06]

Well that didn't take long, looks like the US aren't going to get its 100m doses this year, according to AP.
Anyone find the schoolyard stuff amusing , I'm mean senior politicians getting into spats over who's the best , I was surprised at the German Ambassador weighting in, more surprised at Fauci saying what he said.
I would say the political pressure that is going on behind the scenes must be intense.

Disappointing there will be less doses available - supply chain quality issues?

On the political side... more of this hopefully - Obama, Clinton, Bush & Biden have volunteered to be inoculated on camera... although it still won't convince everyone (they got a placedo etc)

 

[Sophrosyne]

Well that didn't take long, looks like the US aren't going to get its 100m doses this year, according to AP.

What's going on now?

 

[Paul O Mahoney]

Disappointing there will be less doses available - supply chain quality issues?

On the political side... more of this hopefully - Obama, Clinton, Bush & Biden have volunteered to be inoculated on camera... although it still won't convince everyone (they got a placedo etc)

Yeah Matt Hancock apparently said the same.