Re: Coronavirus
 

Not to worry, I'm sure the Government are currently pushing through a lucrative deal with the CEO of the Cornish tin miner association to deliver thousands of perfectly safe and sterile plastic bags with filters ;)

Re: Coronavirus
 

Bring back carboys!

Depends on what you want to show. 6 women as opposed to 17million. Were they on any other medication regime, etc, etc. Why only women? Can statistics answer that? Sorry one man as well.

Statiscally how safe is the AZ vaccine in your opinion???

Re: Coronavirus
 

Well, I had the AZ vaccine, so there's my opinion...

re your questions - that may be why the EMA is reviewing the incidents, to obtain answers...

Re: Coronavirus
 

Again, can statistics answer that?

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I think some are missing the point that it's entirely appropriate and their role to investigate such matters.

While side effects are extremely rare. Why only women? A very good question. Were they on any other medication? Another good question.

If we could narrow such things down deployment can continue in a safer manner than now around the world. Surely something everyone would want given we have another 60 million or so doses to issue ourselves plus any "new variant booster" launched in the autumn.

Re: Coronavirus
 

There are two parallel questions really. 1. Should they investigate? (Obviously yes) and 2. Should they halt use while they investigate? (Depends).

In the present circumstances the precautionary principle is liable to kill more people than it saves. The number of people suffering these clots is vanishingly small. The number of people dying from them is even smaller. Covid itself is clearly the far greater and deadlier threat. Some national regulators seem to have inadequate investigative procedures for pandemic situations. Their basic premise (that it is safer to do nothing) is flawed.

The MHRA's far more sensible pandemic operating principle has been to allow use of the vaccine to continue while a thorough review of the evidence was conducted. It has now concluded that review and is unequivocal. There is no evidence of a causal link between the Ox-AZ vaccine and the cerebral thromboses reported to it (five of them, one fatal, from the 11 million vaccinations reviewed).

https://www.bbc.co.uk/news/health-56447367

What will be interesting to see now, is how quickly those national regulators that have ordered suspensions, will lift them. The MHRA has shown how quickly this sort of work can be done when an emergency situation demands it. Somehow, I suspect the regulators in some other countries still haven't twigged that this is a public health emergency and that they need to start behaving accordingly.

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Great post. Too many regulators appear to be in business as usual mode and not doing the maths.

Re: Coronavirus
 

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But what is the benefit in continuing to issue it for the EU?

AZ in the EU are miles behind in terms of deliveries and the bloc are months away from being in a position to meaningfully ease restrictions.

Right now the biggest (only?) real weapon in their arsenal is lockdown and other non-pharmaceutical interventions. A delay in issuing the AZ vaccine of a week to two weeks is neither here nor their for the vaccination programme as a whole.

The UK regulator isn't in the same boat, it's weighing up the ongoing availability of a large number of doses with inadequate contracts to meaningfully continue the vaccination programme as a whole. We'd be doing about 25% of the vaccinations throughout April if we were relying on Pfizer only. That puts the UK back months, hence the "it's safer to use it than not" is closer to black vs white.

Re: Coronavirus
 

Well they've signed it off now, so safe to use - until they find another reason not to use it.

Re: Coronavirus
 

None of that is within the remit of the national medicines regulators in any of the countries where decisions have been taken to pause rollout.

Unless you're suggesting that politicians in those countries are implementing decisions, and then using their regulators as cover to give an entirely different set of justifications? The regulators are not (or should not be) concerned with supply levels or other infection control measures. They should be concerned only with safety and efficacy.

Incidentally the EMA has also concluded its own review of the data, and states that the Ox-AZ vaccine is 'safe and effective.'

https://www.bbc.co.uk/news/world-europe-56440139

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I'm not sure how, in a pandemic, a regulator is supposed to isolate supply from their decision making. The whole point is surely to reduce both prevalence and transmission across the population. A drug where supplies are unable to significantly do either must factor into whether the benefits outweigh the risks because the benefits and risks are intrinsically linked to what non-pharmaceutical are required.

As for politicians and regulators my cynicism knows no geographic bounds.

Re: Coronavirus
 

This is why drug regulation is split up into strands. The first answers the question 'is the drug safe and effective'? This is the job of the MHRA, EMA, FDA, etc. The next questions is who can and can't have a drug, when and how? In most cases, the regulatory body such as the MHRA does this too. This is the Marketing Authorisation.

The third question is who are we going to give this to given the data of safety, effectiveness, side effects, costs, quality of life, etc. This is more a clinical decision. In the UK, NICE usually makes this decision though JCVI will in the case of vaccines.

My feeling is that the separation of these strands is important. With the safety and effectiveness being 'blind' and scientific and the clinical application being the more 'human' side.

Say for example, that the findings were that there was a slight increase in clotting issues. Then the Marketing Authorisation would be adjusted to state this and then the clinicians would take the risk/benefit decision. For example, if you have clotting issues, then the AZ vaccine is not the one for you.

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Just to add, investigating this was the right thing to do in my opinion. In vaccine sceptic groups, saying 'nah, it's fine' probably doesn't wash. Saying let's stop, have a look, check and act on the results is more likely to get past vaccine sceptics. Of course, it's not ideal as it slows down the roll out but one reports were out, it needed to be done

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Like they forgot to order it;)