Coronavirus

[jfman]

Originally Posted by papa smurf

Switzerland bans AstraZeneca vaccine for ALL citizens as Europe declares war on UK jab


https://www.express.co.uk/news/polit...cine-uk-latest


The decision makes it the only country in Europe not to authorise doses of the Oxford-produced jab for use. The Swiss medical regulator claimed there was a lack of data to reach conclusions on the efficacy of the COVID-19 vaccine. Approval of the jab had been widely expected by many in Switzerland.

Notably not in the EU or part of the EU vaccination plan.

Toning down the nationalist rhetoric and reading the FT analysis they added:

SwissMedic said it was specifically waiting on results from two further clinical trials in North and South America. Once the data is available, it said it could come to a final decision swiftly.

https://www.ft.com/content/e20c3070-...f-87abe7778188

Also not specified is whether they have any and when they’d be due to get delivery. Otherwise there’s no rush.

---------- Post added at 16:15 ---------- Previous post was at 16:14 ----------

Originally Posted by 1andrew1

Where does that leave Switzerland then which has declined to authorise it entirely?

Yet.

[Sephiroth]

Originally Posted by jonbxx

Yeah, you're right, the numbers don't look good but check out the confidence intervals (last column) All over the place! However, there's no technical reason to suspect that the vaccines won't work and/or are unsafe in over 65s.

The release for vaccines for use by either the MHRA in the UK or EMA in the EU are being done under different frameworks. The UK has given the vaccines we're having now an 'Emergency Use Authorisation' (EUA) This is not an approval of the vaccine in the traditional sense but more of a 'go ahead but you're on your own' status during the COVID emergency. One day, if COVID is gone, the authorisation will be withdrawn.

The EMA is working on a Conditional Marketing Authorisation (CMA) which is a step above an EUA in terms of the robustness of the data needed. CMAs can be converted to a full authorisation often quite easily. CMAs are time limited to 1 year.

I think it's due to the lack of data that the vaccine isn't being recommended for older recipients rather than any firm reason to doubt safety or efficacy.

Of course, the UK is currently generating a HUGE data set for over 65s right now which I am sure will be used to convert the various flavours of interim drug licencing into full licences

I do quite a bit of statistical work in my line of business.
The confidence interval in the AZ data is entirely negative and that's because there is no range of results that could fall within the entirely negative interval. The 1/314 result of the study is of insufficient statistical significance.

It seems to me as a layman in the epidemiology business that 1/314 is heading in the right direction.


---------- Post added at 16:28 ---------- Previous post was at 16:25 ----------

Originally Posted by papa smurf

Switzerland bans AstraZeneca vaccine for ALL citizens as Europe declares war on UK jab


https://www.express.co.uk/news/polit...cine-uk-latest


The decision makes it the only country in Europe not to authorise doses of the Oxford-produced jab for use. The Swiss medical regulator claimed there was a lack of data to reach conclusions on the efficacy of the COVID-19 vaccine. Approval of the jab had been widely expected by many in Switzerland.

I presume that their decision is based on a different approach to medical approvals.

The UK's approval is emergency and thus temporary. I'm guessing that Switzerland doesn't need to give emergency authorisation and would prefer, as a matter of principle, to give permanent approval subject to the study results they are awaiting.

[jonbxx]

Originally Posted by Sephiroth

I do quite a bit of statistical work in my line of business.
The confidence interval in the AZ data is entirely negative and that's because there is no range of results that could fall within the entirely negative interval. The 1/314 result of the study is of insufficient statistical significance.

It seems to me as a layman in the epidemiology business that 1/314 is heading in the right direction.
[COLOR="Silver"]

Yeah, I (happily) left my statistics behind a looong time ago! I read the confidence interval as -1405 to 94.2%. Obviously a negative efficacy would mean that the vaccine made you more susceptible to COVID which isn't really where we want to be going with a vaccine.

The elephant in the room is the control group showing 1/319 against the 1/341 for the dosed group.

I think there's something missing datawise. If this is the total of the submitted data to the EMA/EU countries, I can understand the reasoning for the stopping of doses for the elderly - why give it to them if it doesn't work and there are alternatives. Unfortunately, regulatory submissions are very much not public domain

https://www.ggd.amsterdam.nl/coronav...ten/spironose/

Would you like to know within minutes that you are not infected with the corona virus? It is possible with the breath test SpiroNose, a new corona rapid test that is used in a test street of GGD Amsterdam.

The SpiroNose (also called electronic nose or e-nose) is a breath test. The device smells of the breath you breathe or you may be infected with the corona virus. This makes this test different from the other corona tests: the SpiroNose does not detect the virus itself, but the consequences of the infection in your body.

SpiroNose smells consequences of corona infection
An infection causes the body to work to fight the virus, and this affects the smell of your breath. A human nose cannot pick up this change of smell, but the electronic nose has been specially trained for this.

Breath test as a screening tool
The SpiroNose can determine with certainty that 70% of all people who take the breath test are not infected with the corona virus. They will receive the results immediately. For the remaining 30%, the device is not sure. These people can then take a PCR or a LAMP test in the test line to determine whether they may be infected.

Test result within minutes
The results of the SpiroNose will be known within a few minutes. This makes this breath test a great step towards making testing for the corona virus even more accessible. The breath test has been validated as a pre-screening test in people who have no or mild complaints. People who have drunk alcohol should pay attention: there must be at least 8 hours between the last glass and the test.

Sounds interesting.

[pip08456]

Originally Posted by Hugh

https://www.ggd.amsterdam.nl/coronav...ten/spironose/

Sounds interesting.

I think something got lost in the translation. The companies web site is in English.

https://www.breathomix.com/science-technology/

[Sephiroth]

Originally Posted by jonbxx

Yeah, I (happily) left my statistics behind a looong time ago! I read the confidence interval as -1405 to 94.2%. Obviously a negative efficacy would mean that the vaccine made you more susceptible to COVID which isn't really where we want to be going with a vaccine.

The elephant in the room is the control group showing 1/319 against the 1/341 for the dosed group.

I think there's something missing datawise. If this is the total of the submitted data to the EMA/EU countries, I can understand the reasoning for the stopping of doses for the elderly - why give it to them if it doesn't work and there are alternatives. Unfortunately, regulatory submissions are very much not public domain

Ah yes - of course. Nevertheless, a sample result of 1 cannot provide a sensible confidence level unless there were other corroborative data.

Originally Posted by pip08456

I think something got lost in the translation. The companies web site is in English.

https://www.breathomix.com/science-technology/

The COVID-19 page isn’t, unfortunately - but a quick Google translate gives this -

https://www.breathomix.com/covid-ademtest/

Rapid breath test to rule out COVID-19 contamination

Pleasant test with immediate results

The Breathomix breath test has been tested for a number of months at the Amsterdam test streets in North and in the RAI, and will now be used in the rest of the Netherlands.

The OMT recommends using the breath test as the first test to rule out a COVID-19 infection. If that is not possible, a PCR test will follow immediately. This test is taken at the same location, in the same appointment.

The entire process from measurement to result can be realized within 2 minutes

How does the breath test with the SpiroNose work?
The SpiroNose, the electronic nose, measures the complete mixture of substances in the exhaled air. This is done via sensors inside the nose. The breath profile is sent directly to an online analysis platform, where it is compared with thousands of other breath profiles of people with and without a COVID-19 diagnosis.

Originally Posted by papa smurf

Switzerland bans AstraZeneca vaccine for ALL citizens as Europe declares war on UK jab

Originally Posted by Hugh

Pretty sure Europe hasn't declared a "war" on the British-Swedish jab, sounds like the Excess is trying to inflame passions.

Presumably it would be a good thing for us (UK) if they actually did- all the more for us

Typical of the EU, moan like hell they are not getting the vaccine, then decide they dont want to give to a load of people anyway.

[jfman]

Originally Posted by Paul

Presumably it would be a good thing for us (UK) if they actually did- all the more for us

Typical of the EU, moan like hell they are not getting the vaccine, then decide they dont want to give to a load of people anyway.

If we had a similar order as their Pfizer vaccine we’d likely do the same. However we don’t, we are all-in on the AstraZeneca vaccine either way. To that extent I don’t blame the Government for rolling the dice in the absence of data as it’s the only dice we have. Sitting around waiting for now emerging data would only delay the inevitability that they didn’t have a meaningful choice.

[Pierre]

Originally Posted by jfman

If we had a similar order as their Pfizer vaccine we’d likely do the same. However we don’t, we are all-in on the AstraZeneca vaccine either way. To that extent I don’t blame the Government for rolling the dice in the absence of data as it’s the only dice we have. Sitting around waiting for now emerging data would only delay the inevitability that they didn’t have a meaningful choice.

We’re not exactly “all in” on the AZ vaccine. It’s the one we’ve backed and ordered most of.

100 million.

But we also have ordered 300million further vaccines from other manufacturers.

https://www.itv.com/news/2021-02-01/...more-than-400m

So given we’ve ordered enough vaccines to immunise the nation several times over I think HMG are doing alright.

Certainly we’re not constrained to the one vaccine.

[jfman]

Originally Posted by Pierre

We’re not exactly “all in” on the AZ vaccine. It’s the one we’ve backed and ordered most of.

100 million.

But we also have ordered 300million further vaccines from other manufacturers.

https://www.itv.com/news/2021-02-01/...more-than-400m

So given we’ve ordered enough vaccines to immunise the nation several times over I think HMG are doing alright.

Certainly we’re not constrained to the one vaccine.

Yes, but these would incur (significant) delays to the schedule, well into later this year and next.

As someone keen to get out of lockdown I’m sure you’d appreciate that even without elements of data, unless there was evidence that the vaccine was dangerous in it’s own right, even at lower efficacy it’d be better than doing nothing.

However that may be to reduce the R number, rather than deliver a return to normal and “herd immunity” by the middle of June as I’ve seen claimed elsewhere. If (or when) this isn’t achieved higher performing or a newer version of the vaccine will be required although I take comfort that they say this is deliverable by Autumn. We will have well developed distribution chains that it shouldn’t take too long to deliver to the requisite number of the population beyond then.

[Pierre]

Originally Posted by jfman

As someone keen to get out of lockdown I’m sure you’d appreciate that, even without elements of data, unless there was evidence that the vaccine was dangerous in it’s own right, even at lower efficacy it’d be better than doing nothing.
.

Oh, you won’t get any objection from me.

[nomadking]

Have there been any other examples where a vaccine has actually been shown to be less effective in the over-65s? If not, then saying use in over-65s is not proven, is a bit flimsy. If there have been examples where a vaccine has been found to be less effective, then caution might make more sense.

I think their point is they dont have much in the way of examples/data at all.

Much the same was as they could not recommend it for pregnant women - not becasue it wont work, or is less effective, but simply because they had no data on it.

To think it will suddenly become less effective on your 65th birthday is just random nonsense though.

[nomadking]

Originally Posted by Paul

i think their point is they dont have much in the way of examples/data at all.

Much the same was as they could not recommend it for pregnant women - not becasue it wont work, or is less effective, but simply because they had no data on it.

I was referring to vaccines in general. If no other vaccine that has ever been used, has been found to have differences in effectiveness based upon age, there is little to expect this one will.
Unless there is a further breakdown by age for the under 65s, it might be possible that it isn't effective eg on the over 50s. The 60-64 group might also be small compared to the 65+ group.