COVID-19 — Coronavirus

[03 March 2002]

Squares with what I wrote yesterday, if rather more sensationally put.

The FDA wants full phase 3 data on the lower dose alone before deciding.

MHRA (and EMA) will probably approve using the data across both doses, but will need to choose which dose if that's the case.

No idea on the details, but a breakdown in relations with FDA seems very likely - there has to be a reason why they paused the trial for so much longer than any other agency.

AZ does, indeed have limited vaccine experience, just one (FLUMIST) on the market. Their part is more for clinical trials experience and manufacturing knowhow.

Note that even this article still expects approval in the US early next year.

My bottom line: that data in the lancet looks good and safe at either dose.

The lack of a wider vaccine portfolio is unfortunately a sign of the times. Typically diseases requiring vaccines affect the poorest countries and therefore the financial appetite is not there to develop those vaccines. MedImmune/AZ are more than capable of developing and delivering a vaccine from a technical and operational standpoint.

I'd echo your statements about breakdown of relationship with FDA. As we come to the end of this administration it's clear that people are getting fed up and just staying amicable until the next administration. Just recently Pfizer refused Trump's invitation to the WH to discuss vaccine approval.

I understand there is just one outstanding question from the MHRA, I don't know the nature of it but I'd guess it's down to the dosing situation.

Great post as usual.

 

[BlueAnorak]

Bad news on the Pfizer vaccine.
2 folks have had allergic reactions. But that happens quite a lot with vaccines. Nursing staff are ready to deal with it.
Folks with strong allergic reactions aren't normally allowed to have vaccines.

 

[BlueAnorak]

Squares with what I wrote yesterday, if rather more sensationally put.

The FDA wants full phase 3 data on the lower dose alone before deciding.

MHRA (and EMA) will probably approve using the data across both doses, but will need to choose which dose if that's the case.

No idea on the details, but a breakdown in relations with FDA seems very likely - there has to be a reason why they paused the trial for so much longer than any other agency.

AZ does, indeed have limited vaccine experience, just one (FLUMIST) on the market. Their part is more for clinical trials experience and manufacturing knowhow.

Note that even this article still expects approval in the US early next year.

My bottom line: that data in the lancet looks good and safe at either dose.

Its not American and it costs 5 times less!

 

[BlueAnorak]

sum of cases per 100k people, 7 moving window, up to 3rd Dec

seems to be a levelling off, from about the 26th Nov

View attachment 6436

Great graphs, Where are you getting them from?

 

[kevin horlocks wand]

Bad news on the Pfizer vaccine.
2 folks have had allergic reactions. But that happens quite a lot with vaccines. Nursing staff are ready to deal with it.
Folks with strong allergic reactions aren't normally allowed to have vaccines.

2 out of 5000

people are allergic to all sorts of things. It’s a new product so I would have thought they would accept some allergies and 2 out of 5000 doesn’t seem that bad news.

what’s the allergic reaction do you know , is it severe?

 

[artfuldodger]

Bad news on the Pfizer vaccine.
2 folks have had allergic reactions. But that happens quite a lot with vaccines. Nursing staff are ready to deal with it.
Folks with strong allergic reactions aren't normally allowed to have vaccines.

Just 2 and both NHS staff staff, who I assume would know what to do.

 

[twosips]

What classifies as 'significant'? We need clarity on this kind of thing. I've literally already had one sceptical friend whatsapp a group I'm in saying 'this is why I was concerned - i get bad hayfever'. Imagine how many others are saying the same kind of thing now? Incredibly frustrating.

Also, I really wish this was advised publicly beforehand if its common. Even if its totally normal it just fuels into the idea that it's rushed. Headlines like this barely 24 hours are so damaging.

Edit - this is a message in a group I'm in. See how easy scepticism spreads? The guy is a lovely intelligent fella too. Just anxious.

 

[twosips]

Apparently its people who have to carry adrenaline injectors around. So we're talking serious allergies. Not just hayfever etc. Apparently! Sure we'll hear more soon

 

[roubaixtuesday]

FDA published their review of the Pfizer jab yesterday

https://www.fda.gov/media/144246/download

Just the 92 pages to review for those here who like to make their own decisions on whether to take it or not ;-)

On the allergic reactions referred to above, in trials "After either BNT162b2 dose, no participant reported an immediate allergic reaction to vaccine."

On overall safety

The potential risks are based on the observed safety profile to date, which shows mostly mild reactogenicity, low incidence of severe or serious events, and no clinically concerning safety observations. The vaccine appears to be safe and well-tolerated across the safety population and within demographic subgroups based on age, sex, race/ethnicity, country, and baseline SARSCoV-2 status. The preponderance of severe cases of COVID-19 in the placebo group relative to the BNT162b2 group (9 of 10) suggests no evidence of VAED

 

[mosssideblue]

Great graphs, Where are you getting them from?

Microsoft Xl :)

 

[somapop]

I shall await the barrage from the flat earthers re the allergic reactions.
Like clockwork that lot.
Got it after the Swiss commented on the UK's authorisation timescale. They cannot wait for someone to melt into globules of fried atoms to 'prove' they were right all along.
Imagine being like that.

As an aside, I though the media rollout of the vaccinations were done very well yesterday. Lots of boxed ticked.
I'm almost certain that those vaccine boxes are purposely designed like pizza boxes due to our nations love of takeaway pizzas...clever that ;)

 

[BlueHammer85]

What classifies as 'significant'? We need clarity on this kind of thing. I've literally already had one sceptical friend whatsapp a group I'm in saying 'this is why I was concerned - i get bad hayfever'. Imagine how many others are saying the same kind of thing now? Incredibly frustrating.

Also, I really wish this was advised publicly beforehand if its common. Even if its totally normal it just fuels into the idea that it's rushed. Headlines like this barely 24 hours are so damaging.

Edit - this is a message in a group I'm in. See how easy scepticism spreads? The guy is a lovely intelligent fella too. Just anxious.

View attachment 6440

Wait till the first death...

sorry to be cold. But it is just a matter of time before a big sky breaking news headline reports a death partially related to the vaccine jab.

I will of course take it with a pinch of salt as i have full confidence in the vaccine, but i suspect others won't.

 

[artfuldodger]

What classifies as 'significant'? We need clarity on this kind of thing. I've literally already had one sceptical friend whatsapp a group I'm in saying 'this is why I was concerned - i get bad hayfever'. Imagine how many others are saying the same kind of thing now? Incredibly frustrating.

Also, I really wish this was advised publicly beforehand if its common. Even if its totally normal it just fuels into the idea that it's rushed. Headlines like this barely 24 hours are so damaging.

Edit - this is a message in a group I'm in. See how easy scepticism spreads? The guy is a lovely intelligent fella too. Just anxious.

View attachment 6440

It is understood that both the staff members had a significant history of allergic reactions - to the extent where they need to carry an adrenaline auto-injector with them.

They developed symptoms of “anaphylactoid reaction” shortly after receiving the vaccine and both have recovered after the appropriate treatment.

 

[shemnel]

Great graphs, Where are you getting them from?

dashboard data plus my design

 

[Scottyboi]

Stupid headlines purposely meant to cause panic and hysteria the scumbags.

 

[twosips]

Wait till the first death...

sorry to be cold. But it is just a matter of time before a big sky breaking news headline reports a death partially related to the vaccine jab.

I will of course take it with a pinch of salt as i have full confidence in the vaccine, but i suspect others won't.

Oh yeah guaranteed. It's mega frustrating as I've got to convince my parents! My brother is a staunch anti-vaxxer/flat earth conspiracy theorist, and he's in one ear waffling shite to them constantly, whereas im in the other trying to make them see sense. They know he's prone to bollocks, but headlines like this just don't help at all. They feed the idiots!

 

[mosssideblue]

Oh yeah guaranteed. It's mega frustrating as I've got to convince my parents! My brother is a staunch anti-vaxxer/flat earth conspiracy theorist, and he's in one ear waffling shite to them constantly, whereas im in the other trying to make them see sense. They know he's prone to bollocks, but headlines like this just don't help at all. They feed the idiots!

I hate comments like that arbitrarily thrown out. Some, me included have real concerns about what the vaccine may do to me or my children - we are far from idiots!

Not everyone is safe from vaccines, please consider this demographic before trying to look big

 

[mexico1970]

I hate comments like that arbitrarily thrown out. Some, me included have real concerns about what the vaccine may do to me or my children - we are far from idiots!

Not everyone is safe from vaccines, please consider this demographic before trying to look big

What condition prevents someone from being vaccinated? The fella was pointing out the strange subset of flat earthers who use the anti-vaxing handle in tandem.

 

[mosssideblue]

What condition prevents someone from being vaccinated? The fella was pointing out the strange subset of flat earthers who use the anti-vaxing handle in tandem.

There are several severe auto immune conditions which totally fuck with your bodies immunity
Do you know of anyone, let alone a family member die from a reaction to a vaccine which was deemed safe?

 

[twosips]

I hate comments like that arbitrarily thrown out. Some, me included have real concerns about what the vaccine may do to me or my children - we are far from idiots!

Not everyone is safe from vaccines, please consider this demographic before trying to look big

I didn't say everyone who isn't sure about the vaccine is an idiot. I said headlines like this feed the idiots. My brother is an idiot - he's one of those obsessed with conspiracy theories.