COVID-19: Vaccine/antidote and testing procedures Megathread [Mod Warning - Post #1]

03-12-2020 10:25pm

hmmm wrote: »

Pfizer has run into problems with quality in its supply chain.
https://www.cnbc.com/2020/12/02/stock-market-futures-open-to-close-news.html

"Pfizer now expects to ship half of the doses it had previously planned this year after finding raw materials in early production that didn’t meet its standard, Dow Jones reported."

It's good to see that quality control is being maintained, even if it costs supply in the short-term.

This is great news. Standards are maintained throughout, and further evidence that as much as some think these companies are willing to release any old ****e, the systems in place are robust enough to ensure quality is maintained

ShineOn7 · 03-12-2020 10:28pm

hmmm wrote: »

"Pfizer now expects to ship half of the doses it had previously planned this year after finding raw materials in early production that didn’t meet its standard, Dow Jones reported."

That's just for their 2020 distribution though right?

hmmm · 03-12-2020 10:42pm

ShineOn7 wrote: »

That's just for their 2020 distribution though right?

Yes, the article says later on they are still planning 1.3 billion doses next year.

I wonder if this was the reason why we saw stock being flown to the US from Belgium.

Hmmzis · 03-12-2020 10:49pm

If you are wondering if two vaccines can be taken interchangeably then the latest blog post from Derek Lowe is worth a read:

https://blogs.sciencemag.org/pipeline/archives/2020/12/02/taking-two-different-vaccines

Interesting that it was done with polio vaccines with great results. The attenuated oral drops used first and then boosted later with the inactivated type giving a much better response than boosting with the same type.

There has been research done on viral vectors with protein vaccine boosters with similar efects observed, curiously enough after the viral vector prime the protein booster also increases the cellular response.

funnydoggy · 03-12-2020 10:58pm

Pasteur. wrote: »

There's too much optimism and good news overall with the vaccines

There's gonna be a shedload of problems next year

The vaccine itself , efficacy, supply ,distribution etc

OP :pac:

charlie14 · 03-12-2020 11:01pm

Pasteur. wrote: »

There's too much optimism and good news overall with the vaccines

There's gonna be a shedload of problems next year

The vaccine itself , efficacy, supply ,distribution etc

Your really not a glass half full type of individual are you.

hotmail.com · 03-12-2020 11:30pm

Interesting that Fauci in America said Britain rushed the vaccine approval and he then says the FDA is the best in the world.

Americans worse than the Brits for hyping their own country.

Pasteur. · 03-12-2020 11:32pm

charlie14 wrote: »

Your really not a glass half full type of individual are you.

Was posing the question

Not a statement

Water John · 03-12-2020 11:33pm

hotmail.com wrote: »

Interesting that Fauci in America said Britain rushed the vaccine approval and he then says the FDA is the best in the world.

Americans worse than the Brits for hyping their own country.

The key difference is Fauci is a science specialist making the claim, whilst in the UK it's politicians of the calibre of Williamson.

Sky King · 03-12-2020 11:36pm

hotmail.com wrote: »

Interesting that Fauci in America said Britain rushed the vaccine approval and he then says the FDA is the best in the world.

No he said its the gold standard, which it is.

hotmail.com · 03-12-2020 11:39pm

Sky King wrote: »

No he said its the gold standard, which it is.

It sort of sounds like something Trump would say.

hotmail.com · 03-12-2020 11:40pm

Water John wrote: »

The key difference is Fauci is a science specialist making the claim, whilst in the UK it's politicians of the calibre of Williamson.

A pretty amazing claim, to imply the FDA is the best in the world and better than what Britain has.

It's a Trump comment.

wes · 04-12-2020 12:04am

brisan wrote: »

By their own admission the HSEs IT systems are not fit for purpose and are currently being upgraded
To ask them to repurpose the PPS numbers would be stretching them a bit far

I have no clue about how old the HSE systems are, but if they can't be modified for something like this, then we are in trouble.

Pasteur. · 04-12-2020 12:09am

wes wrote: »

I have no clue about how old the HSE systems are, but if they can't be modified for something like this, then we are in trouble.

We'll do what we've done up to now

Wait to see what everyone else is doing and try to copy it the best we can

Public sector tech is prehistoric here, that's a big problem

Gael23 · 04-12-2020 12:44am

Is it a big job to upgrade assuming cost is not an issue?

lbj666 · 04-12-2020 1:12am

Pasteur. wrote: »

We'll do what we've done up to now

Wait to see what everyone else is doing and try to copy it the best we can

Public sector tech is prehistoric here, that's a big problem

I know people love to think Ireland are alone with such issues.

https://www.independent.co.uk/life-style/gadgets-and-tech/news/nhs-cyber-attack-hospitals-hack-big-mistake-latest-news-a7733361.html

Remember when the UK and the pentagon had to ask microsoft maintain support for windows xp.

astrofool · 04-12-2020 1:22am

Gael23 wrote: »

Is it a big job to upgrade assuming cost is not an issue?

Cost is never the issue with the HSE, the issue is always with people who work for and take advantage of the HSE, undoing the herculean efforts of many of the frontline workers.

speckle · 04-12-2020 1:35am

yoouhooo anyone know why it has to be exactly -70 degrees and not say -50 etc did I miss on on a day when it was discussed on the thread?

nocoverart · 04-12-2020 2:04am

I haven’t got laid in quite a while, so if restrictions are loosened and it’s known that i received the vaccine could I pull a hot chick easier than before this madness?

Thanks

Nocoverart

MrMusician18 · 04-12-2020 2:26am

hotmail.com wrote: »

A pretty amazing claim, to imply the FDA is the best in the world and better than what Britain has.

It's a Trump comment.

The FDA is widely regarded as the best medicines regulator, where it goes, others usually follow. The FAA has a similar global reputation but that tbf has taken a hammering over the 737 max fiasco.

The FDA is 10x larger than MHRA.

joseywhales · 04-12-2020 4:12am

odyssey06 wrote: »

Billions spent on 2020 on presumptive vaccine development... parallel phases of development...
We didnt have to develop the vaccine but we should have build a presumptive IT system to keep track of multiple vaccine variants and doses. Ffs.

I mean one page of one spreadsheet meets the requirements

mandrake04 · 04-12-2020 6:44am

MrMusician18 wrote: »

The FDA is widely regarded as the best medicines regulator, where it goes, others usually follow. The FAA has a similar global reputation but that tbf has taken a hammering over the 737 max fiasco.

The FDA is 10x larger than MHRA.

True but not always the case.

I’ve been working in Medical Devices for over 23 years, FDA is notoriously difficult to get approval. I work in Australia and Asia, a lot of products are field tested in APAC and sometimes Europe before they seek FDA approval. I’m always ahead of my American counterparts in experience.

04-12-2020 9:06am

speckle wrote: »

yoouhooo anyone know why it has to be exactly -70 degrees and not say -50 etc did I miss on on a day when it was discussed on the thread?

Cold slows down the rate of chemical reaction, the colder the slower. RNA is very susceptible to degradation due to chemical reactions, therefore the colder the better. Now it may turn out that the efforts they have made to stabilise the RNA will mean it will be relatively stble at fridge temperatures also. So for example at 12 months in a Fridge it may be just as effective as straight out of the freezer. But to know that they have to prove it - eg. leave it 12 months in a Freezer and then test the effectivity again. It is easier go with Ultra cold and know its still effective, than wait to do the studies for storage at higher temperatures. These studies are likely ongoing as when more stable vaccines come to the market, BioNTech will be at a significant disadvantage

brisan · 04-12-2020 9:19am

wes wrote: »

I have no clue about how old the HSE systems are, but if they can't be modified for something like this, then we are in trouble.

They have been working on the modifications recently but still not finished
it was mentioned again on the tonight show last night

04-12-2020 9:25am

mandrake04 wrote: »

True but not always the case.

I’ve been working in Medical Devices for over 23 years, FDA is notoriously difficult to get approval. I work in Australia and Asia, a lot of products are field tested in APAC and sometimes Europe before they seek FDA approval. I’m always ahead of my American counterparts in experience.

I have found Australia seem to be the slowest. But its true to say a lot of Med Device companies go foe CE approval well in advance of submitting to the FDA.

Interestingly having experienced regulatory body audits by FDA, Korea, Japan, Brazil, China, Australia and a number of notified bodies, by far and away the toughest auditors are those from HPRA

Irish Stones · 04-12-2020 10:04am

ShineOn7 wrote: »

The Irish Times is a great resource if you want to keep it Irish

I was said the opposite...

Irish Stones · 04-12-2020 10:06am

hmmm wrote: »

Pfizer has run into problems with quality in its supply chain.
https://www.cnbc.com/2020/12/02/stock-market-futures-open-to-close-news.html

"Pfizer now expects to ship half of the doses it had previously planned this year after finding raw materials in early production that didn’t meet its standard, Dow Jones reported."

It's good to see that quality control is being maintained, even if it costs supply in the short-term.

Would this slow down the process of vaccination in the continent?

Irish Stones · 04-12-2020 10:08am

hotmail.com wrote: »

Interesting that Fauci in America said Britain rushed the vaccine approval and he then says the FDA is the best in the world.

Why does Fauci say that?
If the EMA or FDA are going to approve the Pfizer vaccine anyway, where's the problem to have it approved a couple of week earlier?

Irish Stones · 04-12-2020 10:13am

Deleted User wrote: »

Cold slows down the rate of chemical reaction, the colder the slower. RNA is very susceptible to degradation due to chemical reactions, therefore the colder the better.

I have read somewhere that this deep cold chain might be a problem in countries where technologies and power supply is a problem, like in certain villages or remote towns in Africa. The distances between towns are huge and the temperatures are higher than here, so it might be a real problem to maintain the cold chain for them.

Ashbourne hoop · 04-12-2020 10:23am

Irish Stones wrote: »

Why does Fauci say that?
If the EMA or FDA are going to approve the Pfizer vaccine anyway, where's the problem to have it approved a couple of week earlier?

Because there's still data coming in and being reviewed as far as I know. The UK have taken a "well we've seen most of the data and it's fine, the rest should be too" approach. It will, most likely, be fine, but the EMA and FDA have taken a slightly more cautious approach, rightly so imo.

Russman · 04-12-2020 10:29am

The health minister on TV last night was saying that the UK approval is for emergency use and that every batch of vaccine they get must be checked for quality, whereas he said the EU approval is for a different kind of authorisation for general use. Presumably if true this is why the EMA will take a little longer ?

NaFirinne · 04-12-2020 10:31am

Does anyone know how these new RNA vaccines actually work?

funnydoggy · 04-12-2020 10:33am

NaFirinne wrote: »

Does anyone know how these new RNA vaccines actually work?

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html

Fascinating stuff!

Hmmzis · 04-12-2020 10:38am

Moderna have sent in some interim longitudal data from phase 1 about the vaccine's durability:

https://www.nejm.org/doi/full/10.1056/NEJMc2032195

The graphs are looking quite good to me, the RBD ELISA values are rock solid. There are some decliners in the various neutralization assays but overall it's looking rather good to me.

This bit from their submission is rather interesting:

At day 119, the binding and neutralizing GMTs exceeded the median GMTs in a panel of 41 controls who were convalescing from Covid-19, with a median of 34 days since diagnosis (range, 23 to 54).

It's cautiously hinting at the vaccine providing a better immune response than a wild type infection, with the caveat that the cellular responses are still being investigated.

Pasteur. · 04-12-2020 10:39am

Irish Stones wrote: »

Why does Fauci say that?
If the EMA or FDA are going to approve the Pfizer vaccine anyway, where's the problem to have it approved a couple of week earlier?

It was a bad idea to come out with that after UK approval

hmmm · 04-12-2020 10:42am

NaFirinne wrote: »

Does anyone know how these new RNA vaccines actually work?

I'm not an expert, but in simple terms RNA is a delivery mechanism for vaccines to help your body recognise the virus and respond to it.

In the past vaccines have often been either viruses with the dangerous element deactivated, or have been very mild versions of real virus.

The Oxford vaccine is delivered on the back of another mild virus. This is newish technology but has been used in Ebola vaccines which are working well.

mRNA is simpler still. The vaccine makers study the virus, identify the small bit which is important for the immune system to recognise, and then sends your body a blueprint of what that piece looks like. Your body generates small amounts from this blueprint, and your immune system recognises it as foreign and learn to defeat it. It's very simple technology ultimately, but it needed a few breakthroughs. They hope the same technology can be used to train your body to recognise cancers in the future.

Stark · 04-12-2020 10:48am

mRNA (messenger RNA) is a sequence of genes with instructions for ribosomes in your cells to make a certain protein. In the case of the vaccine, the "spike protein" that the virus uses to enter cells. This triggers the immune system to create antibodies against the spike protein.

timsey tiger · 04-12-2020 11:14am

ShineOn7 wrote: »

Can we, for love of all that is holy, stop sending RTE traffic?

The Irish Times is a great resource if you want to keep it Irish

And, although it's not Irish, the Guardian website is superb

It is a bit tiresome reading stuff in the IT, having read it a week before in the Guardian. Esp. when paying for the IT and the app. has no search function.

Micky 32 · 04-12-2020 11:17am

I see that president elect Joe Biden and Obama, Bush and Clinton are going to get inoculated on camera to help ease peoples fears of the vaccine safety.

iguana · 04-12-2020 11:18am

And as far as I understand it, the scope with mRNA vaccines is enormous. Not just for infectious diseases, but a very powerful tool in fighting cancer. I suspect that in the future when this pandemic is looked back on, the acceleration of mRNA vaccine technology will be viewed as a major positive to come out of it.

BrianD3 · 04-12-2020 11:22am

This must be the questionnaire that I referred to earlier. There were two - ECDC and HSC, we didn't respond to the latter.

https://www.ecdc.europa.eu/sites/default/files/documents/Overview-of-EU_EEA-UK-vaccination-deployment-plans.pdf

On 16 November 2020, the Health Security and Vaccination unit of the EC’s Directorate-General for Health and
Food Safety sent a survey using the EU Survey online tool to Members of the HSC for an update on EU Member
States’ implementation of the Commission Communication on Preparedness for COVID-19 Vaccination Strategies
and Vaccine Deployment. The survey included a total of 18 closed and open-ended questions on technical and
logistical aspects of country vaccine deployment plans

Twenty five of 27 EU Member States responded to the HSC survey (Austria, Belgium, Bulgaria, Czechia, Croatia,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden).

I have only very quickly skimmed through the linked document - as we didn't respond to the HSC questionnaire there appear to be fewer details in the document regarding our preparations compared to other countries. Some alarm bells going off here.

NaFirinne · 04-12-2020 11:24am

hmmm wrote: »

I'm not an expert, but in simple terms RNA is a delivery mechanism for vaccines to help your body recognise the virus and respond to it.

In the past vaccines have often been either viruses with the dangerous element deactivated, or have been very mild versions of real virus.

The Oxford vaccine is delivered on the back of another mild virus. This is newish technology but has been used in Ebola vaccines which are working well.

mRNA is simpler still. The vaccine makers study the virus, identify the small bit which is important for the immune system to recognise, and then sends your body a blueprint of what that piece looks like. Your body generates small amounts from this blueprint, and your immune system recognises it as foreign and learn to defeat it. It's very simple technology ultimately, but it needed a few breakthroughs. They hope the same technology can be used to train your body to recognise cancers in the future.

Stark wrote: »

mRNA (messenger RNA) is a sequence of genes with instructions for ribosomes in your cells to make a certain protein. In the case of the vaccine, the "spike protein" that the virus uses to enter cells. This triggers the immune system to create antibodies against the spike protein.

Understanding how it works is key for me ....being my paranoid self when I see things like RNA - I automatically wonder is this similar to genetic engineering and I guess having to trust the companies that it's not going to alter my cells in a negative way, so while they can generate the antibodies it doesn't stop them from performing all there other functions or possibly make the body even more suseptible to the next virus that comes out.

So for me to get the reassurance I need to try an understand a more about the technology I guess and how it works.

They way you describe it there is sounds like a great technology to be utilised as long as it's not abused.

ShineOn7 · 04-12-2020 11:36am

Micky 32 wrote: »

I see that president elect Joe Biden and Obama, Bush and Clinton are going to get inoculated on camera to help ease peoples fears of the vaccine safety.

I see they left out himself

I think it'd be good to get him on board though as his supporters will definitely be mostly ant-vaxxers. They just seem to have that kind of intelligence

Irish Stones · 04-12-2020 11:51am

Pasteur. wrote: »

It was a bad idea to come out with that after UK approval

Fauci or me?
Genuine question.

Loafing Oaf · 04-12-2020 11:52am

ShineOn7 wrote: »

I see they left out himself

I think it'd be good to get him on board though as his supporters will definitely be mostly ant-vaxxers. They just seem to have that kind of intelligence

Are they going to vaccinate people who have already had it?

Irish Stones · 04-12-2020 11:53am

Micky 32 wrote: »

I see that president elect Joe Biden and Obama, Bush and Clinton are going to get inoculated on camera to help ease peoples fears of the vaccine safety.

How do we know that it isn't just a saline solution?

Water John · 04-12-2020 11:54am

This article gives a great understanding of the history of the discovery of mRNA tech:
https://www.statnews.com/2020/11/10/the-story-of-mrna-how-a-once-dismissed-idea-became-a-leading-technology-in-the-covid-vaccine-race/

Katalan Kariko is a great bet for a Nobel Prize for Chemistry, if any bookie would give you odds.

Irish Stones · 04-12-2020 11:55am

Loafing Oaf wrote: »

Are they going to vaccinate people who have already had it?

Do you mean "people who have already had the covid"?

From an Italian newspaper, which most of users of Boards do not trust much
https://www.lastampa.it/cronaca/2020/12/03/news/ippolito-chi-ha-avuto-il-covid-non-deve-vaccinarsi-1.39614023

is_that_so · 04-12-2020 12:03pm

Irish Stones wrote: »

Do you mean "people who have already had the covid"?

From an Italian newspaper, which most of users of Boards do not trust much
https://www.lastampa.it/cronaca/2020/12/03/news/ippolito-chi-ha-avuto-il-covid-non-deve-vaccinarsi-1.39614023

Using Google Translate the gist seems to be that they will not be considered initially and that they will need to look at the level of antibodies first. Nothing startling there.

is_that_so · 04-12-2020 12:05pm

Africa finally doing widescale trial of common drugs for COVID but they are starting with hydroxychloroquine.

Now, researchers on the continent are mounting a large effort to try to answer a crucial question that has gotten relatively little attention: Could cheap, widely available drugs prevent patients with mild illness from becoming severely sick?

https://www.sciencemag.org/news/2020/12/first-its-kind-african-trial-tests-common-drugs-prevent-severe-covid-19

COVID-19: Vaccine/antidote and testing procedures Megathread [Mod Warning - Post #1]

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