[acsinuk]

Now, Boris must get the vaccine approved by the medical regulators immediately as they are doing in America. Not just when the medical boards' next monthly meeting occurs.  This is a national emergency no fiddle fuddling about by a load of medical H&S gurus please. 

[alancalverd]

Must he, indeed?  Haven't we seen enough evidence of the harm done by policy-led evidence-making? It reached the stage in August when Public Health England, having abandoned all scientific credibility, actually took pride in redefining "death"!

Just for once, let the competent scientists decide whether the benefit/risk ratio is favourable, and keep "worldbeating moonshot" idiocies out of sight now that the Poison Dwarf has left Downing Street. Speaking as an occasional "medical H&S guru" I'm pleased to say that my colleagues have saved an awful lot of lives by using science instead of backing the first horse with more than two legs.

[evan_au]

Public Health England, having abandoned all scientific credibility, actually took pride in redefining "death"!

I was interested to see that in Victoria, Australia, there have been no new cases of community spread for 31 days (and counting).
- However, there was 1 death this week (December) - a 70-year old woman who caught COVID-19 around July 2020
- Apparently, the definition of COVID death in Australia is "did not recover since the COVID infection".

See: https://www.9news.com.au/national/coronavirus-victoria-update-31-consecutive-days-no-covid19-cases-one-new-death-latest-numbers-dhhs/aea4664a-aa81-4488-9d8e-6753fcd7fa87

[Bored chemist]

Now, Boris must get the vaccine approved by the medical regulators immediately as they are doing in America. Not just when the medical boards' next monthly meeting occurs.  This is a national emergency no fiddle fuddling about by a load of medical H&S gurus please.

It looks like they didn't need your "advice" because the relevant bunch of "medical H&S gurus" are more organised than Boris.
Mind you, I have seen primary school kids that meet that criterion...
Interestingly, the politicians tried to score political points by lying about it.

https://www.theguardian.com/world/2020/dec/02/hancock-brexit-helped-uk-to-speedy-approval-of-covid-vaccine

Note to Brexiteers; you won: you can stop lying about it now.

[evan_au]

Can someone please clarify what  "Emergency Use Authorization" means (and does it mean something different in the case of a COVID vaccine)?

I see that a pharmaceutical company has received "Emergency Use Authorization" for their vaccine, based on the early Phase 3 trial results.
- In the past I have heard this term used to authorize use of a medication in individual patients for whom all other therapies have failed, and who appears about to die
- Or does it mean we are in the middle of a pandemic emergency, and we have no really effective therapies?
- Or does it just refer to a fast-track approval process for a medication that hasn't yet been through a full review?

One of the things about vaccines is that by the time the patient is showing symptoms of severe COVID-19, it too late to give them the vaccine, because it takes a week or two to develop an immunity; they are likely to die before they receive the second dose.

What is the next type of approval, what does it authorize, and how long will it take to receive this approval?

PS: I imagine that answering the last question may require liberal use of crystal balls...

[acsinuk]

Well done Boris and the approvals board, a triumph in all respects.  It is lucky we were not in the EU as UK can approve without waiting for EU approval.  Grab as much first batch vaccine that you can as when Europe realises they have been gazumped by us they will quickly approve and restrict all supplies to German, France, Italy and Spain as first priority.   i.e No exports.
Anyway, by that time ? a week , the UK's  Zeneca vaccine can be approved and we are free for Christmas.
Priorities for NHS staff first I think but over 80's should be asked whether they would rather prefer to donate their free vaccination to the person who visit them regularly, instead of themselves.   

[Bored chemist]

Well done Boris

It was nothing to do with Boris.

Grab as much first batch vaccine that you can as when Europe realises they have been gazumped by us they will quickly approve and restrict all supplies to German, France, Italy and Spain as first priority.   i.e No exports.

That would be illegal on a number of fronts.

You seem to forget; it's the pro brexit side that breaks the law.

[Petrochemicals]

Well done Boris and the approvals board, a triumph in all respects. 

2020,  a _ _ _ _ _ _ _ in all respects.

[Bored chemist]

Well done Boris

His government has just announced a pay cut for the MHRA staff.
That's the only contribution he has made to the process.

It is lucky we were not in the EU as UK can approve without waiting for EU approval. 

It was approved under EU law.
Have you not heard- we are still in transition.
The legislation which allowed us to fast track it is EU law.

You just repeated the same stupid lie that Hancock told.



The real effect of Brexit will be in a month's time when we are trying to get supplies but all the ports are clogged up because we left the EU.

It's a mechanism for brexit to kill people, and yet you are somehow convinced brexit is a good thing.

Are you really trolling, or were you too dim to understand?

[Bored chemist]

- Or does it mean we are in the middle of a pandemic emergency, and we have no really effective therapies?

I don't know the legal definition; but that is our current situation.

[alancalverd]

As I understand it the EUA is a step up from the "named patient" exemption that allows experimental or off-label treatment of drugs and devices that do not have applicable market approval.

Named patient use requires individual benefit/risk analysis and informed consent. It can be "last ditch" medicine but can be used for early experimentation where it is theoretically better than the standard treatment.

The EUA presumes an acceptable level of benefit/risk ratio for a restricted cohort of patients, in this case predominantly the over-75s, with generic information as would be supplied with an openly marketed product. So I'm expecting to receive general information  on effects, side effects and contraindications uncovered by Phase 2 trials, and an invitation to receive a commercial vaccine with little if any personalised investigation and counselling.

Hearty cheers for the medical H&S gurus that acsin despises.

[evan_au]

Today's Coronapod from Nature discusses Emergency Use Authorizations.

Apparently, the US FDA gave an EUA to Trump's favorite Hydroxychloroquine (which they later withdrew).
- This time, the FDA is insisting on being transparent about their approvals (while being as fast as possible)...

Listen: https://www.nature.com/articles/d41586-020-03418-7

In contrast, Australia (currently with very low infection rates) is not planning to rush into vaccine rollout. They will watch and learn from the experiences in UK & USA, with mass vaccinations in Australia expected to start around March 2021.

[acsinuk]

We are late on getting the Emergency Use Authorization.  It should have been granted as soon as the second wave of infections became evident.  Use first on NHS staff and on the over 75's in care homes is an ideal way of proving the vaccine works and will highlight any side effects quickly or within 10 days or so.
Next patients to receive the vaccine should be volunteers in highest areas of infection until the R rate is driven below 1; mostly in northern counties plus Kent.  More general vaccinating .of general public can wait until level 1.  Should airline passengers be allowed to buy vaccinations to get the world moving again quickly do you think??

[alancalverd]

You can't get an EUA unless (a) you  are a loudmouthed idiot PUS who has sacked anyone who knows anything in CDC or FDA or (b) you have demonstrated the safety and efficacy of your product to MHRA.

The "second wave of infections" was entirely predictable and preventable. It began before any vaccine trial results were announced.

Proof of efficacy and preliminary sideffects are already documented.

There is no point in applying for an EUA until you can provably manufacture and deliver your product to an acceptable quality level in the required quantities - the authorisation applies at the point of sale.

The R rate depends entirely on human behavior until you have vaccinated over 50% of the population at random. That is too big a sample to be considered ethical for a Phase 2 trial.

The vaccine requires a second shot a couple of weeks later to become effective . You could require airline passengers to produce a certificate of full vaccination, as for yellow fever, but to do so would reduce the number of airline passengers for several months until your catchment population have all been vaccinated. A vaccine is not a cure for existing infection, nor is it certain whether it prevents anyone from becoming an asymptomatic carrier.

Decisive action is not the same as hysterical reaction.

[Bored chemist]

It should have been granted as soon as the second wave of infections became evident. 

Seriously; no, it should have been granted once we knew that the vaccine was reasonably safe and effective.

You don't decide on one thing- the vaccine- based on the behaviour of another thing- the virus (or, indeed, the covidiots).

To have done what you suggest would have been anti-scientific.

[acsinuk]

We needed the EUA in April.  This is a national emergency not a scientific long term endurance test. Every day we were procrastinate over H&S risk and nicety issues people were dying.  Thank goodness common sense has prevailed at last.

[alancalverd]

An EUA is a licence to place a real product on the open market. You can't get an EUA for a product that doesn't exist and doesn't have a prospective manufacturer. Try submitting a portfolio for fairydust made by unborn leprechauns.

And if backward countries had adopted sensible quarantine instead of idiotic politics in January, we wouldn't need the vaccine now.

[Bored chemist]

Every day we were procrastinate over H&S risk and nicety issues people were dying. 

Did you understand this bit?

Messing up what you stupidly call "H&S risk and nicety issues" kills people.
If you issue a bad vaccine, you kill even more people than the virus.
We only know it is safe because we have tested it.
We could not have known that before, so we could not have issued it before.
You may be suicidal, but that's not the assumption which ethics committees make.

[Bored chemist]

And if backward countries had adopted sensible quarantine

Notably the UK...

[evan_au]

FYI: Lyrics to 20/20 by George Benson: https://genius.com/George-benson-20-20-lyrics

Chorus:
If I knew back then what I know now
If I understood the what, when, why and how
Now it's clear to me
What I should have done
But hindsight is 20/20 vision