On 06/03/2021 13:21, N_Cook wrote:


What is an appropriately qualified or proper scientist?
Recently we've had proper French and German scientists, presumably
appropriately qualified ,advising their governments that there was
absolutely no proper science behind the notion of Oxford/Pfizer covid
vaccination of the over 65s. But Macron's psuedo scientists , in the UK,
decided the experience with chicken egg vaccine technology was
transferable to the totally new technology MRNA vaccines without any
direct evidence to back up that hunch. A strange old world,
serendipitously, 1:0 to the pseudo-scientists.


It's seriously OT here, but that summary is quite a mangling of what's
actually happened:

Regulatory approval for new medicines (including vaccines) has always,
as far as possible, tried to minimise risk. That typically means
requiring _explicit_ evidence of low-risk and efficacy in the groups to
be treated. Circumstantial evidence is usually not acceptable for a new
medicine.

The debate is not about the Pfizer and Moderna mRNA vaccines, but
specifically about the AZ virally vectored vaccine, which is not a mRNA
vaccine. It is perfectly true that the 65+ age-group was
under-represented in the AZ trial. (Actually, and strictly in my
personal opinion, I think it's wrong to call it the AZ trial, rather it
should be the Oxford trial - I suspect AZ would have made a much better
job of designing the trial, which has all sorts of holes in it.)

The MHRA (the UK regulator) took a calculated risk in approving the AZ
vaccine for use in all adults, but a risk which could easily have
backfired on them. Fortunately it didn't (at least not so far as we know
at present - it's still very early days). So the MHRA took a gamble and
thankfully it seems to have paid off.

The EMA (Europeans) and the FDA (US regulators, where the AZ vaccine is
still not approved) took a more traditional stance and needed more
rigorous evidence of safety and efficacy, which has now been supplied
thanks to the early evidence from the UK vaccination campaign. In
effect, the MHRA allowed a massive extension of the AZ Phase III trial
and all the early UK vaccinees were unwitting participants in that trial.

So I really don't think it's a matter of pseudo-scientists, whatever
that might be. It's more that the UK MHRA were prepared to take more of
a gamble than other major regulators around the world. Or to put it
another way, their risk appetite was higher than other regulators.
That's not necessarily a good model in general for medicines regulators
in the future - it's vital that new medicines are low-risk, but arguably
it was justified in present 'wartime' circumstances.

On Saturday, 6 March 2021 at 15:14:45 UTC, JGD wrote:
On 06/03/2021 13:21, N_Cook wrote:


What is an appropriately qualified or proper scientist?
Recently we've had proper French and German scientists, presumably
appropriately qualified ,advising their governments that there was
absolutely no proper science behind the notion of Oxford/Pfizer covid
vaccination of the over 65s. But Macron's psuedo scientists , in the UK,
decided the experience with chicken egg vaccine technology was
transferable to the totally new technology MRNA vaccines without any
direct evidence to back up that hunch. A strange old world,
serendipitously, 1:0 to the pseudo-scientists.

It's seriously OT here, but that summary is quite a mangling of what's
actually happened:

Regulatory approval for new medicines (including vaccines) has always,
as far as possible, tried to minimise risk. That typically means
requiring _explicit_ evidence of low-risk and efficacy in the groups to
be treated. Circumstantial evidence is usually not acceptable for a new
medicine.

The debate is not about the Pfizer and Moderna mRNA vaccines, but
specifically about the AZ virally vectored vaccine, which is not a mRNA
vaccine. It is perfectly true that the 65+ age-group was
under-represented in the AZ trial. (Actually, and strictly in my
personal opinion, I think it's wrong to call it the AZ trial, rather it
should be the Oxford trial - I suspect AZ would have made a much better
job of designing the trial, which has all sorts of holes in it.)

The MHRA (the UK regulator) took a calculated risk in approving the AZ
vaccine for use in all adults, but a risk which could easily have
backfired on them. Fortunately it didn't (at least not so far as we know
at present - it's still very early days). So the MHRA took a gamble and
thankfully it seems to have paid off.

The EMA (Europeans) and the FDA (US regulators, where the AZ vaccine is
still not approved) took a more traditional stance and needed more
rigorous evidence of safety and efficacy, which has now been supplied
thanks to the early evidence from the UK vaccination campaign. In
effect, the MHRA allowed a massive extension of the AZ Phase III trial
and all the early UK vaccinees were unwitting participants in that trial.

So I really don't think it's a matter of pseudo-scientists, whatever
that might be. It's more that the UK MHRA were prepared to take more of
a gamble than other major regulators around the world. Or to put it
another way, their risk appetite was higher than other regulators.
That's not necessarily a good model in general for medicines regulators
in the future - it's vital that new medicines are low-risk, but arguably
it was justified in present 'wartime' circumstances.

That seems a good summary to me.

However, the 2nd AZ jab could turn out to be more problematic. A close relation of mine who works in A&E tells me they have had several A&E admissions recently due to reactions to the 2nd jab. One of them, last week, was my 92 year old father who developed a dangerously high temperature (he had no reaction to the 1st jab). Thankfully he's back home now. He has other health issues, as do virtually all 80s.

The 1st large scale trial of the 2nd jab is just beginning.

Graham
Penzance

On 06/03/2021 15:14, JGD wrote:
On 06/03/2021 13:21, N_Cook wrote:


What is an appropriately qualified or proper scientist?
Recently we've had proper French and German scientists, presumably
appropriately qualified ,advising their governments that there was
absolutely no proper science behind the notion of Oxford/Pfizer covid
vaccination of the over 65s. But Macron's psuedo scientists , in the
UK, decided the experience with chicken egg vaccine technology was
transferable to the totally new technology MRNA vaccines without any
direct evidence to back up that hunch. A strange old world,
serendipitously, 1:0 to the pseudo-scientists.


It's seriously OT here, but that summary is quite a mangling of what's
actually happened:

Regulatory approval for new medicines (including vaccines) has always,
as far as possible, tried to minimise risk. That typically means
requiring _explicit_ evidence of low-risk and efficacy in the groups to
be treated. Circumstantial evidence is usually not acceptable for a new
medicine.

The debate is not about the Pfizer and Moderna mRNA vaccines, but
specifically about the AZ virally vectored vaccine, which is not a mRNA
vaccine. It is perfectly true that the 65+ age-group was
under-represented in the AZ trial. (Actually, and strictly in my
personal opinion, I think it's wrong to call it the AZ trial, rather it
should be the Oxford trial - I suspect AZ would have made a much better
job of designing the trial, which has all sorts of holes in it.)

The MHRA (the UK regulator) took a calculated risk in approving the AZ
vaccine for use in all adults, but a risk which could easily have
backfired on them. Fortunately it didn't (at least not so far as we know
at present - it's still very early days). So the MHRA took a gamble and
thankfully it seems to have paid off.

The EMA (Europeans) and the FDA (US regulators, where the AZ vaccine is
still not approved) took a more traditional stance and needed more
rigorous evidence of safety and efficacy, which has now been supplied
thanks to the early evidence from the UK vaccination campaign. In
effect, the MHRA allowed a massive extension of the AZ Phase III trial
and all the early UK vaccinees were unwitting participants in that trial.

So I really don't think it's a matter of pseudo-scientists, whatever
that might be. It's more that the UK MHRA were prepared to take more of
a gamble than other major regulators around the world. Or to put it
another way, their risk appetite was higher than other regulators.
That's not necessarily a good model in general for medicines regulators
in the future - it's vital that new medicines are low-risk, but arguably
it was justified in present 'wartime' circumstances.

I'm sure all fair comment.
I also mangled it by misremembering Macron referred to
"quasi-ineffective vaccine" , not quasi-sceince let alone pseudo-science.

Nearer to this thread . When this story was in the news I was in
conversation with the Welsh prof, as similar happens with marine
flooding, as far as depth of inundation rather than wave damage.
https://www.aber.ac.uk/en/news/archive/2015/12/title-177495-en.html
In the academic world , if there is no official tide-gauge record of a
surge event , then it didn't happen . They use their statistical package
for the "return year" periods. Then those outputs used as the design
criteria for multi-million pound flood defense projects.
Knowigly ignoring the GIGO situation that tide gauges often fail in the
more extreme events.
In clockwork days , limit stops for the pen not going over the edge of
the drum and a slip clutch or whatever ,so going out of calibration but
at least a useable image remains, just a matter of determing the offset
by the next tide cycle and hopefully less perterbation around.
These days its worse because of firmware filters and no record of any sort.
The usual ones are bubblers and to avoid jitter (from too much pump
pressure) in the record the bubbler air pressure is set to a minimum for
any likely rate of increase in normal tide level plus a little. But not
enough to counter a lot of surge situations. The stream of bubbles stop
and the firmware says its an error and the whole thing stops outputting
or storing anything.
So is it better science to at least attempt to fill in the known missing
"records" via newpaper reports , epigraphic records etc and lessen the
GIGO?

--
Global sea level rise to 2100 from curve-fitted existing altimetry data
http://diverse.4mg.com/slr.htm