COVID-19: Vaccine and testing procedures Megathread Part 2 [Mod Warning - Post #1]

BigMo1 · 12-02-2021 12:46pm

Water John wrote: »

One suspects the EMA will be a bit quicker now, having had a fire been lit under them.

I really hope so. The last few weeks have been embarrassing for them, some would say even damaging.

funnydoggy · 12-02-2021 12:55pm

Water John wrote: »

One suspects the EMA will be a bit quicker now, having had a fire been lit under them.

Fire?

Doc07 · 12-02-2021 1:13pm

There has been plenty of reasonable concern (and plenty of nonsense) about these new and ‘rushed’ RNA vaccines. As of yesterday, Approx 34million have received first dose mRNA vaccine in US and over 10million their second dose. Many millions more worldwide.
It is also now about 6 months since the many thousands in the trials received their first doses.

Ongoing vigilance and intensive safety monitoring will still be required and will be performed over next couple years but....no new important safety concern has been identified so far.

Have a nice weekend

eoinbn · 12-02-2021 1:32pm

is_that_so wrote: »

Piece on the numbers of vaccines on order - about 10bn.

https://www.nature.com/articles/d41586-020-03370-6

From November. Well out of date by this stage.

brickster69 · 12-02-2021 1:33pm

IRISHSPORTSGUY wrote: »

The Yanks have first dibs until April 1st because of Operation Warp Speed anyway. Apparently the EMA will receive the application near the end of the month, it'll take a couple of weeks to approve so on track for deliveries at the beginning of April.

Sounds like someone got the second dibs of 30 million

https://www.theguardian.com/world/2020/aug/14/uk-agrees-deal-90m-doses-two-potential-coronavirus-vaccines

They really started early on this vaccine development, good job really.

https://www.janssen.com/uk/road-vaccine

12-02-2021 1:37pm

brickster69 wrote: »

Sounds like someone got the second dibs of 30 million

https://www.theguardian.com/world/2020/aug/14/uk-agrees-deal-90m-doses-two-potential-coronavirus-vaccines

They really started early on this vaccine development, good job really.

https://www.janssen.com/uk/road-vaccine

EU have a deal for 400 million. And the are manufactured in Belgium. They will be here in April

IRISHSPORTSGUY · 12-02-2021 1:46pm

Deleted User wrote: »

EU have a deal for 400 million. And the are manufactured in Belgium. They will be here in April

And I think the difference here is there was a much longer wait for J&J's vaccine than AZ. It won't make much of a difference that the EU took longer to sign because capacity will be built up in the meantime.

hynesie08 · 12-02-2021 2:18pm

What's been the average turn around time from rolling reviews to applications to approval?

ACitizenErased · 12-02-2021 2:22pm

https://twitter.com/COVID19DataIE/status/1360216810013003777?s=20

irishlad. · 12-02-2021 2:22pm

https://docs.google.com/spreadsheets/d/1cUZy6AMCwuA2zhtRuKK7cqMVgmhdDsGsZrFWJTkw9DY/edit?usp=sharing

A difference of 4,931 since yesterday

hynesie08 · 12-02-2021 2:26pm

ACitizenErased wrote: »

https://twitter.com/COVID19DataIE/status/1360216810013003777?s=20

That second dose % is spectacular.

giveitholly · 12-02-2021 2:40pm

Well holy moly vaccines actually work

https://twitter.com/KarlBrophy/status/1360211937720680449?s=19

josip · 12-02-2021 2:40pm

titan18 wrote: »

What I find interesting there isn't so much UK but Serbia. Similar sized country outside the EU and in Europe and they're well ahead of us.

Sky King wrote: »

Aren't they using Sputnik V though?

chrisbonnie wrote: »

Something we should be doing to.

But as stated above, our "leaders" are too obedient to walk their own path.

titan18 wrote: »

If it works, good for them tbf.

It's Sinopharm that's doing the heavy lifting in Serbia and that's because there's a Serb high up in Sinopharm securing supplies for them ahead of other countries.

Like many other countries, they've received small amounts of Sputnik and even smaller amounts of BioNTech.

In Serbia you can choose and register to receive any of the 3 vaccines, but only the Sinopharm queue is moving right now.

caveat emptor · 12-02-2021 2:47pm

giveitholly wrote: »

Luke O'Neill is always good to keep the positivity going

https://twitter.com/laoneill111/status/1360157377484513280?s=19

That's amazing news. That clearly indicates that the single dose strategy of the UK was right after all. If it is accepted it's a no brainer and we should change strategy yesterday.

If the current rate of vaccination is maintained, vaccination of the first nine groups may be achieved before material numbers of second doses will become due (in early April, based on the current 12‐week dosing interval) which would begin to impact on the rate of further progress.
.......
The findings have several clear implications. First, that the impact of COVID‐19 on hospitals and in particular on ICU admissions will last considerably longer than the time taken to dramatically reduce deaths. Second, there is a large benefit from maintaining high vaccination rates beyond groups 1–4: vaccinating through groups 5–7 has a substantial impact on all three metrics including reducing hospital admissions by > 80% and ICU admissions by almost 70%. Third, it provides some support for the strategy of delaying the second dose of vaccine, as within approximately 3 months around half of the adult population can be vaccinated, and as all three slopes are relatively steep up to this point, this will optimise the impact on deaths and healthcare service pressures.

IrishStuff09 · 12-02-2021 3:14pm

Hub was updated with some more granular data on how much of each dose was given to each cohort, but it isn't displayed anywhere on there yet.

Bars are first dose/second dose.

Raw data available here

lbj666 · 12-02-2021 3:23pm

giveitholly wrote: »

Luke O'Neill is always good to keep the positivity going

https://twitter.com/laoneill111/status/1360157377484513280?s=19

Colm Henry mentioned in the news at 1 that the Astra Zeneca was proving to be more effective on the ground than the trials suggested. Mentioned something in lancet, anyone see it?

Not a surprise really, many suspected this once the gaps in their trial data started being filled.

Sky King · 12-02-2021 4:11pm

lbj666 wrote: »

Colm Henry mentioned in the news at 1 that the Astra Zeneca was proving to be more effective on the ground than the trials suggested. Mentioned something in lancet, anyone see it?

No but here is the RTE report on that
https://www.rte.ie/news/2021/0212/1196659-virus-ireland-covid/

Speaking on RTÉ's News at One, Dr Henry said that five in 100 people in Ireland have now got the vaccine and 1.7 individuals per 100 are fully vaccinated.

He also said the AstraZeneca vaccine is also very effective and is showing more protection than Phase 3 trials predicted.

A UK study has shown it has 72% protection with sustained protection for three months and an enhanced response after a second dose, he said.

IRISHSPORTSGUY · 12-02-2021 4:15pm

Good news.

ROME (Reuters) - The European Medicines Agency is expected to give its approval to the COVID-19 vaccine developed by Johnson & Johnson by March, the Managing Director of Janssen Italia, part of the J&J group, said on Wednesday.

Massimo Scaccabarozzi, who is also the head of Italy’s pharmaceutical company association Farmindustria, said in an interview with Italian daily Corriere della Sera the vaccine had been tested on almost 44,000 people, “hence shields us from variants”.

He added that, under a European Union agreement, Italy will be allotted 27 million shots, which require only one dose and no booster.

is_that_so · 12-02-2021 4:24pm

Skyfloater wrote: »

Is the EMA still waiting for J&J to submit their request for approval, and if so, it begs the question why? Surely the data they sent to the American FDA is the exact same for us Europeans. The EMA should be offering to fill out the paperwork for J&J, not passively waiting for the application to arrive in the post.

There is an EMA rolling review of J&J which has been ongoing since December so a decision should happen a lot faster. We might even see vaccines in late March.

caveat emptor · 12-02-2021 5:43pm

ACitizenErased wrote: »

I don't know if you know anything about statistics, because you're backing up the terrible South African study with an even worse Novavax study. Look at the confidence interval.

ACE the world health organisation (WHO) are now warning people about this. Do you want to revise your opinion or would you like to teach their chief scientist about confidence intervals and statistics? You were incredibly rude and dismissive and I didn't appreciate it given the seriousness of the subject.

https://twitter.com/DrEricDing/status/1360264581982093318?s=20

ACitizenErased · 12-02-2021 5:56pm

caveat emptor wrote: »

ACE the world health organisation (WHO) are now warning people about this. Do you want to revise your opinion or would you like to teach their chief scientist about confidence intervals and statistics? You were incredibly rude and dismissive and I didn't appreciate it given the seriousness of the subject.

https://twitter.com/DrEricDing/status/1360264581982093318?s=20

You're calling me rude? Not engaging.

PCeeeee · 12-02-2021 6:01pm

Skyfloater wrote: »

Is the EMA still waiting for J&J to submit their request for approval, and if so, it begs the question why? Surely the data they sent to the American FDA is the exact same for us Europeans. The EMA should be offering to fill out the paperwork for J&J, not passively waiting for the application to arrive in the post.

The paperwork is not a form. It is huge tranche of documentation. Including test results, rationales for every aspect of their testing. Discussion of results. Etc. It can't be just filled out.

caveat emptor · 12-02-2021 6:03pm

ACitizenErased wrote: »

You're calling me rude? Not engaging.

Fair enough. You should get in touch with the WHO chief scientist. She looks like she's in need of some fact checking. She is probably a bit busy though so don't be surprised if she can't engage.

12-02-2021 6:15pm

caveat emptor wrote: »

ACE the world health organisation (WHO) are now warning people about this. Do you want to revise your opinion or would you like to teach their chief scientist about confidence intervals and statistics? You were incredibly rude and dismissive and I didn't appreciate it given the seriousness of the subject.

https://twitter.com/DrEricDing/status/1360264581982093318?s=20

All variants are capable of reinfection. That's not news. The more important question is their severity and frequency. While prior immunity may not protect against infection it should still broadly protect against disease.

ACitizenErased · 12-02-2021 6:16pm

Hardyn wrote: »

All variants are capable of reinfection. That's not news. The more important question is their severity and frequency. While prior immunity may not protect against infection it should still broadly protect against disease.

That thread also reinforces the idea of vaccinations. Surprised Ding is even backing it tbh but here we are.
https://twitter.com/DrEricDing/status/1360267831850450944?s=20

caveat emptor · 12-02-2021 6:27pm

Hardyn wrote: »

All variants are capable of reinfection. That's not news. The more important question is their severity and frequency. While prior immunity may not protect against infection it should still broadly protect against disease.

True true but I think the importance of the data was the probability of reinfection vs infection. The rate of reinfection could also be important. The attack rate for the novovax data point estimate was 3.9% in seropositive vs 3.9% in seronegative. Similar confidence intervals (3.0; 5.0) and (2.5; 5.6).

i.e those who were previously infected with an earlier strain were just as likely to get infected with the new strain.

Also great that vaccines work with efficacy shown to be ~50% on the S.A strain.
Not so great that it was ~89% effective vs the UK strain.

40% less effective is quite a drop and has real implications for reaching normality / immunity.

Hopefully it doesn't spread and / or dies out. If it protects agains hospitalisation ICU and death then that's still a big win.

embraer170 · 12-02-2021 6:42pm

I posted earlier in the thread that my father was given advance notice about a vaccine appointment next week. It has now now been confirmed for next Thursday (86, Kerry).

My mom is 74 (turning 75 at the of the month) so I wonder how many weeks she will have to wait.

caveat emptor · 12-02-2021 6:44pm

Very interesting small study pre print. Hopefully it's accurate. Will make the vaccines we get go further.

Abstract
An important question is arising as COVID-19 vaccines are getting rolled out: Should individuals who already had a SARS-CoV-2 infection receive one or two shots of the currently authorized mRNA vaccines. In this short report, we show that the antibody response to the first vaccine dose in individuals with pre-existing immunity is equal to or even exceeds the titers found in naïve individuals after the second dose. We also show that the reactogenicity is significantly higher in individuals who have been infected with SARS-CoV-2 in the past. Changing the policy to give these individuals only one dose of vaccine would not negatively impact on their antibody titers, spare them from unnecessary pain and free up many urgently needed vaccine doses.

https://www.medrxiv.org/content/10.1101/2021.01.29.21250653v1.full.pdf

12-02-2021 6:45pm

caveat emptor wrote: »

True true but I think the importance of the data was the probability of reinfection vs infection. The rate of reinfection could also be important. The attack rate for the novovax data point estimate was 3.9% in seropositive vs 3.9% in seronegative. Similar confidence intervals (3.0; 5.0) and (2.5; 5.6).

i.e those who were previously infected with an earlier strain were just as likely to get infected with the new strain.

Also great that vaccines work with efficacy shown to be ~50% on the S.A strain.
Not so great that it was ~89% effective vs the UK strain.

40% less effective is quite a drop and has real implications for reaching normality / immunity.

Hopefully it doesn't spread and / or dies out. If it protects agains hospitalisation ICU and death then that's still a big win.

The problem with the Novavax trial is that it was never designed to assess risk of reinfection. It is unlikely the seropostive and seronegative participants were suitably matched by risk and demographic. That could lead to biased results. On top of that the numbers were just too low to be conclusive with extremely wide confidence intervals. It would only take a couple of outliers to swing the results.

Long story short the study has limitations and we need more conclusive data.

stephenjmcd · 12-02-2021 6:46pm

embraer170 wrote: »

I posted earlier in the thread that my father was given advance notice about a vaccine appointment next week. It has now now been confirmed for next Thursday (86, Kerry).

My mom is 74 (turning 75 at the of the month) so I wonder how many weeks she will have to wait.

Likewise my 92 year old grandmother got her appointment today for next Thursday

COVID-19: Vaccine and testing procedures Megathread Part 2 [Mod Warning - Post #1]

Comments