COVID-19: Vaccine and testing procedures Megathread Part 3 - Read OP

timsey tiger

ujjjjjjjjj wrote: »

Luke O'Neill is pretty unambiguous about NIAC's decision..........they ain't trusting the science...................

An abundance of caution also can be described as scared of your own shadow.................

We have a country next door to us with over 11 million doses issued and they are banging away. We have used 120,000 odd AZ vaccines and nothing untoward. One document from Norway and we panic.

Luke O'Neill doesn't have to worry about anti-vaxxers and lawyers. It's not like we are getting so much AZ that we can't recover the back log in a couple of days.

That said, I personally think that they shouldn't have paused the roll out.

mick087

is_that_so wrote: »

It's not panic to await the outcome of data review, it's a choice a number of countries have made. Glynn and the rest will happily take the hit for possible overreaction so it's not much of a target.

Delays and excuses.

No issues in Ireland but again more delays more excuses.

Miike

The pausing of the roll-out is fairly standard procedure. It sets in motion a mechanism to ensure everything is as it should be. Yeah, it's annoying, it knocks us back a bit of time and it's really less than ideal but if they DIDN'T suspend the AZ vaccine and it turns out something is detected - You'd all be screaming about that too. There is no winning when drugs/therapies are developed with this level of public watch. This more than likely won't be the last time one of the vaccines is suspended either, just to prepare some of you for next time.

is_that_so

mick087 wrote: »

Delays and excuses.

No issues in Ireland but again more delays more excuses.

Most delays are not of our making but we may even have more AZ to use at the end of this! It's up to 30K people, which the system has shown it can comfortably deal with inside a week.

mick087

is_that_so wrote: »

Most delays are not of our making but we may even have more AZ to use at the end of this! It's up to 30K people, which the system has shown it can comfortably deal with inside a week.

Yes Ireland can comfortably deal with this inside a week and us Irish will take the vaccine.
The damage to vaccine roll out in parts of Europe this will do will not be described as cautious in time but as a disaster.

timsey tiger

is_that_so wrote: »

Most delays are not of our making but we may even have more AZ to use at the end of this! It's up to 30K people, which the system has shown it can comfortably deal with inside a week.

More would be great, how would this work?

Fitz*

Call me a cynic but I suspect that those in charge of the vaccine roll out in Ireland wanted a reason to suspend the rollout.

They are under severe pressure because of the speed of their roll out, so any sort of a chance they can get to pause will be welcomed. This gives an opportunity to take a break, recheck their internal stock levels of needles etc, keep up to date on the admin side, maybe get more doses in and then continue the vaccine roll out again. Again, the reason of the slow roll-out can be blamed on external factors, which suit their narrative.

Targets won't be met again this week or next week but the excuse given this time will be the suspension. I wonder what the next excuse will be?

Renault 5

Fitz* wrote: »

Call me a cynic but I suspect that those in charge of the vaccine roll out in Ireland wanted a reason to suspend the rollout.

They are under severe pressure because of the speed of their roll out, so any sort of a chance they can get to pause will be welcomed. This gives an opportunity to take a break, recheck their internal stock levels of needles etc, keep up to date on the admin side, maybe get more doses in and then continue the vaccine roll out again. Again, the reason of the slow roll-out can be blamed on external factors, which suit their narrative.

Targets won't be met again this week or next week but the excuse given this time will be the suspension. I wonder what the next excuse will be?

I think the same. But thats just my opinion man:cool:

I think I’m going to ring the doctors and get my housebound 82 yr old father onto the next round of Pfizer. I’ll get a private disabled taxi/ambulance to bring him.

My only concern is he has a tracheotomy so a face mask doesn’t cover that. I don’t know if it should be covered at all tbh.

stephenjmcd

Strawberry Milkshake wrote: »

I think I’m going to ring the doctors and get my housebound 82 yr old father onto the next round of Pfizer. I’ll get a private disabled taxi/ambulance to bring him.

My only concern is he has a tracheotomy so a face mask doesn’t cover that. I don’t know if it should be covered at all tbh.

If he's housebound then NAS will be visiting to administer the vaccine. It'll take time for them to get to everyone.

iamwhoiam

Strawberry Milkshake wrote: »

I think I’m going to ring the doctors and get my housebound 82 yr old father onto the next round of Pfizer. I’ll get a private disabled taxi/ambulance to bring him.

My only concern is he has a tracheotomy so a face mask doesn’t cover that. I don’t know if it should be covered at all tbh.

You could put the filter on the trachy , when in the surgery put a surgical mask over the trachy leaving the bottom ties loose .Scroll down to see the photo



https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7394613/

Hector Savage

So the EU are still saying it's on track to have the vast majority vaccinated and pandemic under control by end of 2021, what are they basing this on ?

It's on a snails pace and at this rate will take 2+ years to vaccinate the majority ..

stephenjmcd

stephenjmcd wrote: »

If he's housebound then NAS will be visiting to administer the vaccine. It'll take time for them to get to everyone.

Doctor was out last week to change catheter and said housebounds were getting the AZ vaccine.

IRISHSPORTSGUY

Hector Savage wrote: »

So the EU are still saying it's on track to have the vast majority vaccinated and pandemic under control by end of 2021, what are they basing this on ?

It's on a snails pace and at this rate will take 2+ years to vaccinate the majority ..

Because more vaccines will be available and the vaccines currently available will be scaling up production.

This time next month the J&J deliveries will be starting and the yield from Pfizer's new factory in Germany will be coming through.

zuutroy

Hector Savage wrote: »

So the EU are still saying it's on track to have the vast majority vaccinated and pandemic under control by end of 2021, what are they basing this on ?

It's on a snails pace and at this rate will take 2+ years to vaccinate the majority ..

Actually at this rate it would take 5 years, but this rate doesn't matter.

Apogee

Friday: 17312 administered. Over 600K total doses. Mon-Fri: 76,462. Cohort 4: 3295

astrofool

Fitz* wrote: »

Call me a cynic but I suspect that those in charge of the vaccine roll out in Ireland wanted a reason to suspend the rollout.

They are under severe pressure because of the speed of their roll out, so any sort of a chance they can get to pause will be welcomed. This gives an opportunity to take a break, recheck their internal stock levels of needles etc, keep up to date on the admin side, maybe get more doses in and then continue the vaccine roll out again. Again, the reason of the slow roll-out can be blamed on external factors, which suit their narrative.

Targets won't be met again this week or next week but the excuse given this time will be the suspension. I wonder what the next excuse will be?

Everything arriving is going straight into arms, the system is purely supply constrained, the vaccination roll out data also confirms this is the case. This has been explained to people over and over.

AZ was also being administered in hospitals which is the easier location to roll out from, vs. Pfizer which is being kept in a cold supply chain to GP's for administering.

If this was an excuse for a pause, it's the most stupid possible way to do it, and anyone believing such a thing is probably not that bright either.

astrofool

Strawberry Milkshake wrote: »

Doctor was out last week to change catheter and said housebounds were getting the AZ vaccine.

That's good to hear, means advice change about over 70's has been followed (of course doesn't help them much this week, but it'll catch up).

NeuralNetwork

It’s clearly not an excuse but I think we also have to look at Ireland in terms of how we operate around medical negligence claims too.

What would you think might happen here if a group of regulators who would be deemed to be very competent all pause and the Irish regulator didn’t & then something turned out to actually be problematic?

There would inevitably be legal and political fallout.

They’re not in a position where they can say “sure it’s probably grand!”

Multiple countries have paused based on the flags raised, so I think we have no option but to take it seriously.

That’s good in many ways as it keeps our systems airing on the side of safety all the time, but it’s also always going to mean we will never throw caution to the wind for the sake of speed either.

Mitch Connor

Mitch Connor wrote: »

Not proof, anecdotal, but my sister in law was quite ill after her AZ jab (dose 1) the other day. Vommiting, hot an cold flashes, migrane. She was much better the following day though.

No thrombosis or PE then?

ACitizenErased

astrofool wrote: »

Sorry to go back to an old post, but this stuck with me, vaccines are approved for use based on their own safety data, the risk of catching the disease that the vaccine prevents are not part of the approval. There is no "balance of risks" to the approval.

This is why we can trust the health authorities when medicines are approved, and it's also why when we see something severe that doesn't match previous data that it must be investigated. It's also why people with a much less chance of catching the disease and having complications can trust taking the vaccine.

Yes there is.


Look at the EMA update just the other day:

The position of EMA’s safety committee PRAC is that the vaccine’s benefits continue to outweigh its risks and the vaccine can continue to be administered while investigation of cases of thromboembolic events is ongoing

https://www.ema.europa.eu/en/news/covid-19-vaccine-astrazeneca-prac-investigating-cases-thromboembolic-events-vaccines-benefits



And the actual definition of a CMA from the EMA approval press release..

CMAs allow for the authorisation of medicines that fulfil an unmet medical need on the basis of less complete data than normally required. This happens if the benefit of a medicine or vaccine’s immediate availability to patients outweighs the risk inherent in the fact that not all the data are yet available.

https://www.ema.europa.eu/en/news/ema-recommends-covid-19-vaccine-astrazeneca-authorisation-eu

Hector Savage

IRISHSPORTSGUY wrote: »

Because more vaccines will be available and the vaccines currently available will be scaling up production.

This time next month the J&J deliveries will be starting and the yield from Pfizer's new factory in Germany will be coming through.

So do people think by end of 2021 EU will be in a good position vaccine wise ?
I'm genuinely curious, have not been back to the old sod since December 2019 and don't know if it will ever be possible - seriously.

NeuralNetwork

Hector Savage wrote: »

So do people think by end of 2021 EU will be in a good position vaccine wise ?
I'm genuinely curious, have not been back to the old sod since December 2019 and don't know if it will ever be possible - seriously.

I’d say more likely by the end of the summer.

I think you’ll see the US and UK compete by early summer and EU likely by a he end of the summer / early autumn.

There are very big volume boosts due for BioNTech and Janssen / J&J comes on steam very soon also Moderna volumes are increasing.

AstraZeneca is only at most 20% of supply.

I think though there’s an element of demand dumping going on. The EU has been supplying numerous countries, including US’ neighbours Canada & Mexico and a raft of other countries including the U.K., Israel etc etc all through this. So the burden of supply has been very much carried by EU plants as opposed to US ones that have been entirely focused domestically.

For all anger over the EU export regulations, the EU has been the region that’s been keeping supplies flowing to many countries, and arguably at its own expense, as it could have just closed off exports of vaccines until EU demand was met, which is exactly what the USA did, but it would mean places like Canada waiting until 2022 to begin serious programmes.

There’s been a very unfair burden sharing between the US and EU on this and they are both huge global suppliers of vaccines and pharmaceuticals generally.

average_runner

stephenjmcd wrote: »

Any proof of that ?

Anecdotally I know people who've had AstraZeneca & others who've had Pfizer. Both sets reported pretty much the same experience 24hrs post vaccination, a bit of fatigue, aches and pains but not a bother on them the next day.

All your advised possible side effects in both. It was compared to a hangover.

Yeah, i know people who have gotten it.
Severe headaches, temps and a hangover feeling for 2 days!!!

astrofool

ACitizenErased wrote: »

Yes there is.

I would bold the end part as well:

This happens if the benefit of a medicine or vaccine’s immediate availability to patients outweighs the risk inherent in the fact that not all the data are yet available.

This is saying that that the approval will be given based on the risk that the dataset might be incomplete, not that there is a risk with the medicine based on the data being submitted.

It's a subtle difference, but it is a difference.

This also means that when data comes in, that data can effect the approval, sometimes with updated guidelines and side effects.

As of right now there is no known severe side effects to the vaccine, the data causing the latest pause is weak, and some authorities are pausing and some are not as it's highly probable that it's not an issue.

This is not a case of "COVID causes 1% death, but the vaccine only causes 0.00001% death so take it", it's currently 0% death with the vaccine if administered according to the guidelines.

ACitizenErased

astrofool wrote: »

I would bold the end part as well:


This is saying that that the approval will be given based on the risk that the dataset might be incomplete, not that there is a risk with the medicine based on the data being submitted.

It's a subtle difference, but it is a difference.

This also means that when data comes in, that data can effect the approval, sometimes with updated guidelines and side effects.

As of right now there is no known severe side effects to the vaccine, the data causing the latest pause is weak, and some authorities are pausing and some are not as it's highly probable that it's not an issue.

This is not a case of "COVID causes 1% death, but the vaccine only causes 0.00001% death so take it", it's currently 0% death with the vaccine if administered according to the guidelines.

Which is exactly what I posted above. The EMA recommended "that the vaccine’s benefits continue to outweigh its risks and the vaccine can continue to be administered while investigation of cases of thromboembolic events is ongoing"
That is literally their AZ statement.

stefanovich

ACitizenErased wrote: »

Yes there is.


Look at the EMA update just the other day:

https://www.ema.europa.eu/en/news/covid-19-vaccine-astrazeneca-prac-investigating-cases-thromboembolic-events-vaccines-benefits



And the actual definition of a CMA from the EMA approval press release..

https://www.ema.europa.eu/en/news/ema-recommends-covid-19-vaccine-astrazeneca-authorisation-eu

Is the risk collective or individual? In other words, could an individual be put at greater individual risk if the collective effect was positive?

crossman47

Leinster90 wrote: »

I hate this phrase “an abundance of caution”. We need to take some more risks at this stage regarding vaccines and re-opening. Keep distributing the AZ vaccine to those who want it. Nobody is being forced to take it. It has already been given to millions of people.

Why do we always have to take the most conservative, low-risk approach as if there are no negative knock-on effects?

Fear of litigation? You know what this country is like.

astrofool

stefanovich wrote: »

Is the risk collective or individual? In other words, could an individual be put at greater individual risk if the collective effect was positive?

ACitizenErased, posters like this is the reason why severe side effects are unacceptable (unless specifically called out in the documentation, as clearly some medicines, such as chemotherapy do cause issues in cases where the patient is already ill anyway, vaccines are intended for the healthy public), and it's why I brought it back up this morning, as the difference in approval is subtle, but it is there. Medicines such as vacines get approved for everyone, if used according to the guidelines, there will be no risk of severe side effects.

ACitizenErased wrote: »

Which is exactly what I posted above. The EMA recommended "that the vaccine’s benefits continue to outweigh its risks and the vaccine can continue to be administered while investigation of cases of thromboembolic events is ongoing"
That is literally their AZ statement.

You are understanding what this means wrongly.

stephenjmcd

average_runner wrote: »

Yeah, i know people who have gotten it.
Severe headaches, temps and a hangover feeling for 2 days!!!

But you said the side affects of AZ were worse than the others which isn't the case. You can get those with any of the vaccines, Pfizer, Moderna or AZ.

People have had those symptoms with them all & some have had no side effects. Everyone's different but the possible effects are the same. Most common being fatigue, temp and chills, sore arm etc