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

ACitizenErased

Szero wrote: »

Could Ireland lift our suspension tomorrow afternoon too if updated EMA guidance is issued then?

Depends on when NIAC have their meeting

seamus

It amuses me all of the armchair commentators throwing out these numbers about thrombosis, as if the medical authorities aren't aware of it. These people might rely on Twitter and Facebook for their information and think others haven't seen it, but the authorities don't.

Just because we may not see the events as being particular risky, doesn't mean that those responsible for approved & distributing vaccines should ignore it as well.

If there's something unexpected, you pause, you look at it, you confirm that you're still happy, you move forward.

It's really easy for someone online to go, "Ag shure fvck it, look 14 events out of ten million. Be grand, bull on there". If the actual health of 400 million Europeans rested on your shoulders, you would consider a small delay a worthy price to pay to make sure everything is OK.

ACitizenErased

seamus wrote: »

It amuses me all of the armchair commentators throwing out these numbers about thrombosis, as if the medical authorities aren't aware of it. These people might rely on Twitter and Facebook for their information and think others haven't seen it, but the authorities don't.

Just because we may not see the events as being particular risky, doesn't mean that those responsible for approved & distributing vaccines should ignore it as well.

If there's something unexpected, you pause, you look at it, you confirm that you're still happy, you move forward.

It's really easy for someone online to go, "Ag shure fvck it, look 14 events out of ten million. Be grand, bull on there". If the actual health of 400 million Europeans rested on your shoulders, you would consider a small delay a worthy price to pay to make sure everything is OK.

EMA tend to agree with those posters. The issue I have is the undermining of the EMA's advice. We either follow them or we don't.

Wolf359f

timsey tiger wrote: »

I don't think anybody has assigned a risk of thrombosis to any of the covid vaccines.

I think it's the brain clots that they are concerned about.
As it's been reported the risk of a blood clots are the same for vaccinated vs unvaccinated people.
Maybe brain clots are uncommon in young people, hence the precaution.

Hopefully the EMA just adds it as a rare side effect and we can get back to using it.

stephenjmcd

Szero wrote: »

Could Ireland lift our suspension tomorrow afternoon too if updated EMA guidance is issued then?

Could do but I believe the process is NIAC & HPRA look at whatever the EMA say and then make recommendations to Dept of Health & Government

JTMan

ACitizenErased wrote: »

Depends on when NIAC have their meeting

Surely the NIAC will move their meeting forward from Thursday to tomorrow.

If France and other countries resume AZ tomorrow, it would be embarrassing if the NIAC are not going to discuss until Thursday.

brickster69

ACitizenErased wrote: »

https://twitter.com/DarrenEuronews/status/1371488463112040454?s=20

Too many chefs spoil the broth.

stephenjmcd

EMA's Marco Cavaleri, head vaccines strategy, just briefed the European Parliament's health commitee: "The benefit/risk of the AstraZeneca vaccine is considered positive. And we will not see any problem in continuing with the vaccination campaign."

Doesn't sound like they'll be recommending anything other than continuing tomorrow

robinph

quartz1 wrote: »

As an Irish Citizen how long would I need to take up residency in Northern Ireland or England to qualify for a NHS vaccine . ....it's getting to the point where its clear our Government are running around in circles lol.

About as long as it takes you to fill in the online booking form for a vaccine.

If you are over the age that they are currently vaccinating then can't think of any reason it wouldn't just let you book straight away, might ask you for a postcode. If you have some medical condition that bumps you up the queue then it would probably go through simpler if you have an NHS number, but not essential. It's also not really necessary to have an address as they are vaccinating homeless people as a priority group as well, although I'd guess that is more by them finding the homeless people or going to shelters.

The process of booking might be the most complicated bit, but as an Irish citizen you are entitled to exactly the same as any UK citizen. If you all do it at the same time though the NHS might send a bill for the vaccines, but doubt they would notice.

brickster69

stephenjmcd wrote: »

Could do but I believe the process is NIAC & HPRA look at whatever the EMA say and then make recommendations to Dept of Health & Government

Yes, EMA gives guidance, NIAC gives guidance and Dept of Health just do the opposite

https://www.irishtimes.com/news/politics/no-one-in-government-has-appetite-to-push-back-against-holohan-1.4477368

ACitizenErased

EMA don't sound worried, again. Benefit outweighs the risk. Looks like it'll be given the all clear tomorrow.

ninebeanrows

Very disappointed NIAC were so weak on this tbh.

Does not bode well, appears we will jump at anything.

brickster69

brickster69 wrote: »

What after calling them all the names under the sun, now they want Sputnik. If i were Putin i would tell them to f..k off !

Posters on an Internet forum are not countries. Sputnik have applied for use so therefore can be approved if they meet requirements. Beforehand, they hadn't, co couldn't. I am sure Putin and cronies will have a nice little scheme to "share" profits from the vaccine, so will sell to anyone, once approved.

is_that_so

Wolf359f wrote: »

Exactly the same number of doses the UK are getting from India at about the same time. Looking more likely that AZ had no intentions of using that for EU supply.

They do seem to be doing an awful lot of ducking and diving with all of this, to the point that we can only believe what shows up in boxes.

is_that_so

ACitizenErased wrote: »

EMA don't sound worried, again. Benefit outweighs the risk. Looks like it'll be given the all clear tomorrow.

Hasn't it been suggested it will take 4-5 days to look at this particular situation?

ACitizenErased

is_that_so wrote: »

Hasn't it been suggested it will take 4-5 days to look at this particular situation?

Read back, France has said EMA is issuing guidance tomorrow

is_that_so

brickster69 wrote: »

What after calling them all the names under the sun, now they want Sputnik. If i were Putin i would tell them to f..k off !

Pretty sure all they said was that some the testing was non-standard and that there was not much data on it. Any vaccine maker who wants to can submit an application to the EMA.

ixoy

ninebeanrows wrote: »

Very disappointed NIAC were so weak on this tbh.

Does not bode well, appears we will jump at anything.

As would Germany, France, Netherlands, Thailand, Denmark, etc etc. Let's not put this as a "timid little Ireland" thing. A lot of countries want to be sure - they're 95% sure, maybe more, but this way they can be closer to 100% and, if nothing else, it'll stop situations like: "Huh, Germany and France have halted this but Ireland says it's okay? Stephen Donnelly clearly doesn't care about the health of his citizens in a rush to send out the vaccine! :mad: JOKESHOP!"

brickster69

Sounds promising

https://www.businesswire.com/news/home/20210315005197/en/UK-Clinical-Trial-Confirms-SaNOtize

is_that_so

brickster69 wrote: »

Sounds promising

https://www.businesswire.com/news/home/20210315005197/en/UK-Clinical-Trial-Confirms-SaNOtize

Interesting. And we're heading towards a head cold!:D

Irish Stones

It's clearly unlikely that these deaths are related to the vaccines.
We all know that each patient is held under observation for 15 minutes post jab, in the case of ADR's. When in this forum I had asked why they do not extend this observation time to, say, 30 minutes, someone here told me that 15 minutes is the typical time during which any ADR shows up, past that time it is unlikely something may happen.
Given that all these deaths post AZ vaccine occured one day or even a week after the vaccination, it is clear that they are not related.

robinph

Irish Stones wrote: »

It's clearly unlikely that these deaths are related to the vaccines.
We all know that each patient is held under observation for 15 minutes post jab, in the case of ADR's. When in this forum I had asked why they do not extend this observation time to, say, 30 minutes, someone here told me that 15 minutes is the typical time during which any ADR shows up, past that time it is unlikely something may happen.
Given that all these deaths post AZ vaccine occured one day or even a week after the vaccination, it is clear that they are not related.

The whole hanging around for 15 minutes thing only happened because a couple of nurses with extreme allergies such that they carried epipens on them seemed to forget that detail and took the Pfizer vaccine despite the instructions saying "not for people with severe allergies".

Irish Stones

robinph wrote: »

The whole hanging around for 15 minutes thing only happened because a couple of nurses with extreme allergies such that they carried epipens on them seemed to forget that detail and took the Pfizer vaccine despite the instructions saying "not for people with severe allergies".

Well, it seems this waiting applies to all vaccines (not only Pfizer), despite all the checks done before the jab and the consent form filled.

silverharp

they will be getting smug up there soon

https://twitter.com/KarlBrophy/status/1371425603228930048

iamwhoiam

robinph wrote: »

The whole hanging around for 15 minutes thing only happened because a couple of nurses with extreme allergies such that they carried epipens on them seemed to forget that detail and took the Pfizer vaccine despite the instructions saying "not for people with severe allergies".

I got the flu vaccine for the last 6 years and we were asked each time to wait around for 15 minutes . Its pretty standard after a vaccine

ACitizenErased

EMA have released a statement
https://twitter.com/DarrenEuronews/status/1371505078104903683?s=20

ACitizenErased

“Many thousands of people develop blood clots annually in the EU for different reasons. The number of thromboembolic events overall in vaccinated people seems not to be higher than that seen in the general population”

stephenjmcd

ACitizenErased wrote: »

EMA have released a statement
https://twitter.com/DarrenEuronews/status/1371505078104903683?s=20

Interesting line there also. France might have jumped the gun with a decision tomorrow, looks like all data in by tomorrow with conclusion Thursday. Still doesn't look like they'll change guidance though.

"EMA’s safety committee (PRAC) will further review the information tomorrow (Tuesday) and has called an extraordinary meeting on Thursday 18 March to conclude on the information gathered and any further actions that may need to be taken."

Cork2021

Back on track by Friday

https://twitter.com/ema_news/status/1371509979388243969?s=21

funnydoggy

thehungryhippocrite on reddit re: the paper claiming increased lethality in the B117 variant:

I am suspicious of this study or more specifically its use to suggest that B117 is deadlier for the following reason:

The key assumption used in the methodology is as follows:
"Absolute risks of death (case fatality rate) within 28 days were estimated by age group and sex using data on individuals tested during August–October 2020; this is referred to as the baseline risk"

Yes, the CFR rose a lot from this period, which is attributed to the 117 variant in this study.

But I) CFRs are currently falling, why? https://www.cebm.net/covid-19/recent-falls-in-age-specific-estimates-of-the-case-fatality-ratio-in-england/

And ii) the CFR fell massively from c. Apr20 through to Aug20. Like enormously: https://www.cebm.net/covid-19/the-declining-case-fatality-ratio-in-england/

Why is it that the rise is so easily attributable to the new variant, but a fall is unexplained and investigated. In a relative sense that fall was much more significant than the rise (although much of the fall is explained by changes in testing)?

The following note in the discussion is really important, but it will be missed in reporting: "We do not identify any mechanism for increased mortality here. B.1.1.7 infections are associated with higher viral concentrations on nasopharyngeal swabs, as measured by Ct values from PCR testing (Extended Data Fig. 6). Higher viral load could therefore be partly responsible for the observed increase in mortality; this could be assessed using a mediation analysis."

I think similar arguments can be made regarding the R number findings of this study. I really wonder whether it will be looked back on as using a really unfortunately timed and underexplored baseline for comparison.