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

is_that_so

Cork2021 wrote: »

I know it been posted already but fûck it!!!!

GET IN THERE!!!

https://twitter.com/ema_news/status/1361698219764445184?s=21

All good. Just a reminder that AZ took 17 days but they've been doing a rolling review on this since 1 Dec. That puts Janssen shots on the cards in March. Single vaccination will also push vaccinated numbers up very fast.

EDIT: Seems they are looking at the middle of March for a possible decision.

Sanjuro

What is a rolling review exactly? Would it be the equivalent of continual assessment, where as other vaccines are looked at only when the application is submitted?

darem93

That's great news, glad to hear something positive in regards to the vaccine!

I have to admit it's been hard living right on the border and seeing the pace of the North's rollout in comparison to ours. But hopefully with good news like this things might start to speed up.

is_that_so

Sanjuro wrote: »

What is a rolling review exactly? Would it be the equivalent of continual assessment, where as other vaccines are looked at only when the application is submitted?

They have 3 of them at present, now 2.

A rolling review is a regulatory tool that EMA uses to speed up the assessment of a promising medicine during a public health emergency. Normally, all data on a medicine’s or vaccine’s effectiveness, safety and quality and all required documents must be ready at the start of the evaluation in a formal application for marketing authorisation. In the case of a rolling review, EMA’s human medicines committee (CHMP) reviews data as they become available from ongoing studies. Once the CHMP decides that sufficient data are available, the company can submit a formal application. By reviewing the data as they become available, the CHMP can reach an opinion on the medicine’s authorisation sooner.

https://www.ema.europa.eu/en/news/ema-starts-rolling-review-curevacs-covid-19-vaccine-cvncov

ACitizenErased

Single shot is a game changer, great news

is_that_so

ACitizenErased wrote: »

Single shot is a game changer, great news

Yeah, and much as the expression has been abused, this really is one.

Deathofcool

Fantastic news. Hopefully approval doesn't take too long and there is some decent initial supply. Could change the whole outlook for the summer. It seems the good news keeps coming, cant wait to see it on RTE later.

josip

Yevon wrote: »

Did Luke O'Neill say approval of J&J would be within days of being received or that he was expecting the application from J&J within days?

I would imagine we will hear timelines for approval and delivery in the coming days. Brilliant news.

J&J. "No More Tiers"

Just a word of caution on the Luke O'Neill statement; "days" could mean any number between 2 and ∞.
It took the EMA 17 days to approve AZ despite a rolling review there also.
Hopefully it will be less for J&J.

lbj666

Is there any indication of what supply timelines would be, wasnt there doubts on initial capacity? confounded by them being on project Warp Speed like moderna.

ACitizenErased

EMA statement says approval by mid-March but I assume thats a pessimistic take

is_that_so

ACitizenErased wrote: »

EMA statement says approval by mid-March but I assume thats a pessimistic take

Original plan it seems was to deliver vaccines in April anyway, subject to approval.

ACitizenErased

Mental to have a one dose vaccine that's 85% effective against severe disease. If we said that'd be the case a year ago we'd be laughing.

Charles Babbage

Great news. What is the story with J&J production capacity? Are they ready to roll or even stockpiling at this stage? They could achieve significant public relations benefit by getting going immediately, in contrast to AZ.

Anyone know the status of J&J in the UK? It would be great if the EMA approved here first, if only to quieten a few

josip

My paranoid, conspiracy-theorist, nutjob inner-self thinks that if the EMA were to approve in 5 days, J&J would still be constrained by US export restrictions and the EU will be getting criticized (and rightly so) for shoddy oversight and naivety on the contracts.

Whereas if the EMA take 15 days to approve, that's an extra 10 days for J&J to continue supplying the US and to ramp up production.
They can defend a 15 day review; "These things can't be rushed, safety, etc.." but there's no defending not dotting the 'i's on a contract.

Assuming the J&J contract limitation theory is correct.
Total fruit loop stuff I know.

Deeper Blue

Deathofcool wrote: »

It seems the good news keeps coming, cant wait to see it on RTE later.

There's no way you kept a straight face while writing that

Deathofcool

Deathofcool wrote: »

Fantastic news. Hopefully approval doesn't take too long and there is some decent initial supply. Could change the whole outlook for the summer. It seems the good news keeps coming, cant wait to see it on RTE later.

No need to wait
https://www.rte.ie/news/2021/0216/1197496-j-j-vaccine-ema/

brickster69

Deleted User wrote: »

Anyone know the status of J&J in the UK? It would be great if the EMA approved here first, if only to quieten a few

Yes, the rolling review started a month ago and expecting approval this month. They were just waiting on some data to be received.

https://www.dailymail.co.uk/news/article-9122173/Single-dose-vaccine-Johnson-Johnson-rolled-Britain-month.html

Deathofcool

El Sueño wrote: »

There's no way you kept a straight face while writing that

Haha they are the gift that keeps on giving. Tbf their article is mostly positive with a caveat on the variants that haven't impacted us thankfully to date.

https://www.rte.ie/news/2021/0216/1197496-j-j-vaccine-ema/

With 2.2 million in the initial order even if we got 500k in Q2 it could make a massive impact.

brickster69

brickster69 wrote: »

Yes, the rolling review started a month ago and expecting approval this month. They were just waiting on some data to be received.

https://www.dailymail.co.uk/news/article-9122173/Single-dose-vaccine-Johnson-Johnson-rolled-Britain-month.html

So after the EMA started its rolling review. Have J&J submitted EUA yet though. Cant be approved without an application as far as I know

Stark

Deleted User wrote: »

So after the EMA started its rolling review. Have J&J submitted EUA yet though. Cant be approved without an application as far as I know

Was submitted today by the looks of it https://www.irishtimes.com/news/health/coronavirus/covid-19-single-shot-johnson-johnson-vaccine-could-be-cleared-for-use-in-weeks-1.4486609

Looks like they're targeting middle of March for a decision.

From what I've seen, EU has ordered 200 million (with option for 200 million more) and 100 million are expected to be delivered by end of June. Which would mean 1.1m extra people vaccinated in Ireland by end of June.

JacksonHeightsOwn

still no formal application by the Russians for the Sputnik V vaccine then?????

Why arent the EU approaching the russians ti try and get this thing sorted, its one of the only 3 vaccines with 90%+ efficacy. Start being proactive, please!!!!!!

ek motor

chrisbonnie wrote: »

still no formal application by the Russians for the Sputnik V vaccine then?????

Why arent the EU approaching the russians ti try and get this thing sorted, its one of the only 3 vaccines with 90%+ efficacy. Start being proactive, please!!!!!!

I suspect its politics

marno21

Janssen are delivering 100m doses by end of June.

That’s 1.1m to Ireland. Which covers 1.1m people.

So in Q2 we’ll have 1.1m Janssen + Pfizer/Moderna/AstraZeneca. I believe we’re getting 2.4m from Pfizer, so that’s 2.3m between Pfizer and Janssen in Q2 alone plus whatever else we can manage with AstraZeneca and Moderna

Absolute bizarre stuff Pascal Donohue saying no staycations this summer today.

is_that_so

ek motor wrote: »

I suspect its politics

It's more likely to be paperwork. They are in discussions with the manufacturers but good politics for Russia if they get it.

is_that_so

marno21 wrote: »

Janssen are delivering 100m doses by end of June.

That’s 1.1m to Ireland. Which covers 1.1m people.

So in Q2 we’ll have 1.1m Janssen + Pfizer/Moderna/AstraZeneca. I believe we’re getting 2.4m from Pfizer, so that’s 2.3m between Pfizer and Janssen in Q2 alone plus whatever else we can manage with AstraZeneca and Moderna

Absolute bizarre stuff Pascal Donohue saying no staycations this summer today.

It's just talking people down in February. I'd view it as let's not plan that far ahead just yet.

brickster69

Hungary gets it's first Sinopharm

https://twitter.com/dwnews/status/1361734592554745861

Stheno

marno21 wrote: »

Janssen are delivering 100m doses by end of June.

That’s 1.1m to Ireland. Which covers 1.1m people.

So in Q2 we’ll have 1.1m Janssen + Pfizer/Moderna/AstraZeneca. I believe we’re getting 2.4m from Pfizer, so that’s 2.3m between Pfizer and Janssen in Q2 alone plus whatever else we can manage with AstraZeneca and Moderna

Absolute bizarre stuff Pascal Donohue saying no staycations this summer today.

That would be almost 65% of the adult population vaccinated by the end of June, not including those already done

KrustyUCC

is_that_so wrote: »

It's just talking people down in February. I'd view it as let's not plan that far ahead just yet.

There's a degree of that alright but talk things down too much and you'll lose people's adherence to restrictions

KrustyUCC

Stheno wrote: »

That would be almost 65% of the adult population vaccinated by the end of June, not including those already done

Wouldn't that be great