Vaccine Megathread - See OP for threadbans

funnydoggy

Interesting:
https://www.prnewswire.com/news-releases/romark-announces-initial-results-of-phase-3-clinical-trial-of-nt-300-tablets-for-the-treatment-of-covid-19-301268321.html

Romark Announces Initial Results Of Phase 3 Clinical Trial Of NT-300 Tablets For The Treatment Of COVID-19


TAMPA, Fla., April 14, 2021 /PRNewswire/ -- Romark announced today initial results of a Phase 3 clinical trial of its investigational new drug candidate NT-300 (nitazoxanide extended-release tablets, 300 mg) versus placebo as a treatment for mild or moderate COVID-19. Based on the findings, Romark is working with the U.S. Food and Drug Administration (FDA) and plans to seek Emergency Use Authorization (EUA).

In the analysis of the primary endpoint, median time to sustained response (a measure of recovery time) was similar for subjects treated with NT-300 compared with placebo (approximately 13 days). In the pre-defined subgroup of patients with mild disease, median time to sustained response was reduced by 3.1 days with NT-300 (10.3 days, n=116) versus placebo (13.4 days, n=129).

In the analysis of the key secondary endpoint, treatment with NT-300 was associated with an 85% (0.5% of NT-300-treated patients vs. 3.6% of patients treated with placebo) reduction in the progression to severe illness (shortness of breath at rest with SpO2 ≤93% on room air or PaO2/FiO2<300). Only one person treated with NT-300 progressed to severe COVID-19 disease. In the pre-defined subgroup at high risk of severe illness according to CDC criteria, 7/126 (5.6%) of placebo-treated subjects experienced severe illness compared to 1/112 (0.9%) of NT-300-treated subjects.

ACitizenErased

funnydoggy wrote: »

Interesting:
https://www.prnewswire.com/news-releases/romark-announces-initial-results-of-phase-3-clinical-trial-of-nt-300-tablets-for-the-treatment-of-covid-19-301268321.html

That's very impressive, wow

TomOnBoard

ACitizenErased wrote: »

That Pfizer news is absolutely huge. That's 250k more fully vaccinated people.

500,000 with a cohort average of 80+ effectiveness if they adopt a one shot strategy and get everyone covered, with a booster/2nd shot once all have got the 80+% protection.

Turtwig

An oral tablet that prevents severe disease. This thread has become positive again. Yays!

(prelims I know)

funnydoggy

Looking for emergency use with the FDA too. Things are progressing

is_that_so

Government expected to confirm changes to the vaccination programme later today.

https://www.rte.ie/news/coronavirus/2021/0414/1209769-cabinet-vaccination/

Doctor Jimbob

is_that_so wrote: »

Government expected to confirm changes to the vaccination programme later today.

https://www.rte.ie/news/coronavirus/2021/0414/1209769-cabinet-vaccination/

Nice to see that we'll have an updated plan so quickly.

Might be partly down to the good weather but with all the good news today I feel significantly more optimistic than I did this time yesterday

lbj666

TomOnBoard wrote: »

500,000 with a cohort average of 80+ effectiveness if they adopt a one shot strategy and get everyone covered, with a booster/2nd shot once all have got the 80+% protection.

We'll see i am hopefully they will but, this increased supply may not force them to go beyond 6 weeks dose interval as on the label.

This news does offset the AZ news for the most part, presuming they will keep going with the over 60s with it.

I presume at this point that our current allocation of Pfizer/Biontech will be used up by the time tweeked booster is available or the kids turn?

eoinbn

Van.Bosch wrote: »

We should really have a bank Holiday to honour the guys in Biontech who created the vaccine and the gang at Pfizer who produced it in huge numbers.

If/when we get out of this, that vaccine is going to have played a massive roll - and to think a few months ago AZ was considered the game changer

BioNtech have their own factory in German. That is where most of the extra doses will be coming from. It is capable of manufacturing close to 20m a week!
Great news. Didn't expect that.

stephenjmcd

TomOnBoard wrote: »

500,000 with a cohort average of 80+ effectiveness if they adopt a one shot strategy and get everyone covered, with a booster/2nd shot once all have got the 80+% protection.

Unlikely, they won't go off label.

I'd say a change to 6 weeks between doses more likely

is_that_so

eoinbn wrote: »

BioNtech have their own factory in German. That is where most of the extra doses will be coming from. It is capable of manufacturing close to 20m a week!
Great news. Didn't expect that.

Bayer are also helping them as will Sanofi and Novartis.

Goldengirl

bucketybuck wrote: »

It highlights a problem with our governments approach since the very start, they completely ignored the human element in all this.

The young people of this country have been treated disgracefully in this past year, they had everything taken away from them while never being treated as anything more than collateral damage. Their jobs, their education and their chances all taken away and then told to stop whining and "hold firm".

Now they are being told to take a vaccine that possibly could kill them to protect against a virus that doesn't hurt them, all to protect people that did nothing for them. And we wonder why they may have stopped giving a damn?

I'm not young and I'll have my vaccine in the next few weeks, but I can completely see how extremely poor messaging and communication this past year has led to a situation where a lot of people may no longer care how selfish they are or are not.

The opposite of your post , in fact , is true .
Again , the AZ vaccine has been stopped for those young people precisely because of the risks , and somewhat over cautiously being restricted to only those over 60 who have greater risk from Covid .
Sorry to ruin your rant with a fact .

funnydoggy

https://www.reddit.com/r/Coronavirus/comments/mnitdo/vaccine_faq_variants_chronic_conditions_nsaids/

A great link explaining lots about variants, efficacy etc.

Strazdas

What is the new total delivery schedule for Pfizer in Q2 does anyone know?

Elessar

Strazdas wrote: »

What is the new total delivery schedule for Pfizer in Q2 does anyone know?

Add 500k to that for Pfizer, so taking out AZ and, presumably, J&J, leaves 3m doses between Moderna and Pfizer for Q2.

iamwhoiam

Look like I will soon get the AZ via the portal .
I have tried to make sense of the efficacy of Az and what it actually means
I would appreciate if anyone can explain how well I am covered after 1st dose please ?
Thanks in advance for any help in understanding it

Hurrache

dominatinMC wrote: »

I presume RTE will be leading with this story today then? :rolleyes:

Yes, top story on their new page and one of the first on their Radio 1 news bulletin.

I'm convinced lads on this forum are fairly detached from reality when they whinge that RTE are only interested in bad news and runs from the good.

adam240610

Elessar wrote: »

Add 500k to that for Pfizer, so taking out AZ and, presumably, J&J, leaves 3m doses between Moderna and Pfizer for Q2.

Except you shouldn't be taking out AZ and J&J... Should be well north of 4m doses

Strazdas

Elessar wrote: »

Add 500k to that for Pfizer, so taking out AZ and, presumably, J&J, leaves 3m doses between Moderna and Pfizer for Q2.

That's impressive by Pfizer : if they stretch out the four weeks second dose, we could see a hell of a lot of Irish people get it as an initial dose.

hmmm

Elessar wrote: »

Add 500k to that for Pfizer, so taking out AZ and, presumably, J&J, leaves 3m doses between Moderna and Pfizer for Q2.

That's 1.5m people fully vaccinated vs forecast 2.25m . We shouldn't underestimate what a big deal it would be to lose J&J (if that happens, and I hope it doesn't).

stephenjmcd

Elessar wrote: »

Add 500k to that for Pfizer, so taking out AZ and, presumably, J&J, leaves 3m doses between Moderna and Pfizer for Q2.

Wouldn't take out AZ or J&J out of it.

AZ will still be used, quite probably most of it's 800k doses, likewise would expect J&J to be used as well

bucketybuck

Goldengirl wrote: »

The opposite of your post , in fact , is true .
Again , the AZ vaccine has been stopped for those young people precisely because of the risks , and somewhat over cautiously being restricted to only those over 60 who have greater risk from Covid .
Sorry to ruin your rant with a fact .

I think you may have meant to quote somebody else, your post doesn't seem to have any relevance to the point I made.

lbj666

hmmm wrote: »

That's 1.5m people fully vaccinated vs forecast 2.25m . We shouldn't underestimate what a big deal it would be to lose J&J (if that happens, and I hope it doesn't).

Keep in mind we are not leaving all of the AZ allocation go to waste either far from it.

Stark

stephenjmcd wrote: »

Wouldn't take out AZ or J&J out of it.

AZ will still be used, quite probably most of it's 800k doses, likewise would expect J&J to be used as well

I think they were estimating somewhere between 200 and 300k AZ doses will go to waste (we still have carry over from March to use). Not disastrous given the recent Pfizer news though I really hope there's some pragmatism when it comes to J&J.

Some Curevac doses in June would be nice.

stephenjmcd

hmmm wrote: »

That's 1.5m people fully vaccinated vs forecast 2.25m . We shouldn't underestimate what a big deal it would be to lose J&J (if that happens, and I hope it doesn't).

Most of that AZ allocation will still also be used

1huge1

iamwhoiam wrote: »

Look like I will soon get the AZ via the portal .
I have tried to make sense of the efficacy of Az and what it actually means
I would appreciate if anyone can explain how well I am covered after 1st dose please ?
Thanks in advance for any help in understanding it

https://www.reddit.com/r/Coronavirus/comments/mnitdo/vaccine_faq_variants_chronic_conditions_nsaids/
This link a few posts up explains it well.

ddarcy

rm212 wrote: »

More could have been done re: boosting deliveries if that assistance with production capacity started last summer rather than January, for example. I do take the point though, that initially they weren't certain what would work - as I acknowledged in the original post, hindsight is 20/20.

Not really. Pfizer only thought they could do 1 billion doses this year. Personally I think they knew they could deliver more, but didn’t want to set high expectations if something went wrong. Instead of being like the sh!tshow that AZ has been, they only signed contracts covering this low figure. Pfizer more likely than not one they could have more produced, but didn’t want to have a PR disaster of being unable to deliver.

stephenjmcd

Stark wrote: »

I think they were estimating somewhere between 200 and 300k AZ doses will go to waste.

The head of the GPs association mentioned it but looking at the numbers I can't see that happening.

Need about 220k for 2nd doses and then I'm going to say the roughly 300k (could be more) in the 60-69 age group is going to be AZ as well. 2 doses there.

They'll use most of it factoring in some of the 60-69 will be vaccinated as part of the at risk groups with Pfizer or Moderna

dominatinMC

Hurrache wrote: »

Yes, top story on their new page and one of the first on their Radio 1 news bulletin.

I'm convinced lads on this forum are fairly detached from reality when they whinge that RTE are only interested in bad news and runs from the good.

Detached from reality would be assuming that RTE have done the public a service during this pandemic.

iamwhoiam

1huge1 wrote: »

https://www.reddit.com/r/Coronavirus/comments/mnitdo/vaccine_faq_variants_chronic_conditions_nsaids/
This link a few posts up explains it well.

Thank you .