#WTAF? Has anyone confirmed this statement from @MattHancock?

Where is the #ClinicalEvidence for such a deviation from protocol, not to mention trashing systems & processes the NHS has set up?

@pfizer/ @BioNTech_Group have been VERY clear about the performance of their #vaccine: https://twitter.com/Smyth_Chris/status/1344312600578945026
And, frankly, @MHRA's statements on the @UniofOxford/ @AstraZeneca #vaccine are rather vague and evasive:

https://www.theguardian.com/society/2020/dec/30/oxford-astrazeneca-covid-vaccine-approved-by-uk-regulator

PUBLISH THE DATA, FFS!

The two vaccines are nothing like the same, and cannot be treated as if they are; whatever happened to " #FollowTheScience"?
And, frankly, @MHRA's statements on the @UniofOxford/ @AstraZeneca #vaccine are rather vague and evasive: https://www.theguardian.com/society/2020/dec/30/oxford-astrazeneca-covid-vaccine-approved-by-uk-regulatorPUBLISH THE DATA, FFS!The two vaccines are nothing like the same, and cannot be treated as if they are; whatever happened to " #FollowTheScience"?
And, frankly, @MHRA's statements on the @UniofOxford/ @AstraZeneca #vaccine are rather vague and evasive: https://www.theguardian.com/society/2020/dec/30/oxford-astrazeneca-covid-vaccine-approved-by-uk-regulatorPUBLISH THE DATA, FFS!The two vaccines are nothing like the same, and cannot be treated as if they are; whatever happened to " #FollowTheScience"?
Somewhat alarmingly, the latest "advice" of the Joint Committee on Vaccination and Immunisation (​ #JCVI) on the @pfizer/ @BioNTech_Group #vaccine...

https://www.gov.uk/government/news/jcvi-issues-advice-on-the-astrazeneca-covid-19-vaccine

...DIRECTLY CONTRADICTS the unequivocal statements of the companies themselves:
Somewhat alarmingly, the latest "advice" of the Joint Committee on Vaccination and Immunisation (​ #JCVI) on the @pfizer/ @BioNTech_Group #vaccine... https://www.gov.uk/government/news/jcvi-issues-advice-on-the-astrazeneca-covid-19-vaccine...DIRECTLY CONTRADICTS the unequivocal statements of the companies themselves:
Somewhat alarmingly, the latest "advice" of the Joint Committee on Vaccination and Immunisation (​ #JCVI) on the @pfizer/ @BioNTech_Group #vaccine... https://www.gov.uk/government/news/jcvi-issues-advice-on-the-astrazeneca-covid-19-vaccine...DIRECTLY CONTRADICTS the unequivocal statements of the companies themselves:
And *none* of the references cited provide #evidence or point to data which supports #JCVI's position that the @pfizer/ @BioNTech_Group vaccine will be effective if the second dose is given not 3 weeks but 3 MONTHS after the first: https://www.gov.uk/government/publications/priority-groups-for-coronavirus-covid-19-vaccination-advice-from-the-jcvi-30-december-2020/joint-committee-on-vaccination-and-immunisation-advice-on-priority-groups-for-covid-19-vaccination-30-december-2020#references
Joint Committee on Vaccination and Immunisation: advice on priority groups for COVID-19 vaccinati...

https://www.gov.uk/government/publications/priority-groups-for-coronavirus-covid-19-vaccination-advice-from-the-jcvi-30-december-2020/joint-committee-on-vaccination-and-immunisation-advice-on-priority-groups-for-covid-19-vaccination-30-december-2020#references
The paper #modelling "optimal vaccination strategy" deals only with three generic 'types' of vaccine, assumes "instantaneous vaccination" & doesn't consider 2 doses:

https://www.medrxiv.org/content/10.1101/2020.09.22.20194183v2.full.pdf

N.B. This is not a criticism of its authors, rather those citing it as if it's relevant!
This is NOT a situation where you can just 'suck it and see'!

The #vaccination programme is literally still also a ( #Phase4) clinical trial, and @MHRAgovuk approvals shouldn't have been given if protocols were going to be deviated from without clear evidence from Phases 1, 2 & 3
And finally for now, while appreciating the need for formal language, does #JCVI really only "advise" that you get the same #vaccine for both shots?!

Given the 2 currently available stimulate immune responses by completely different methods, mightn't it be better to REQUIRE it?
For an abundance of clarity (again) I still firmly believe you should take a #vaccine when offered it - I certainly shall - but we need a LOT more clarity around what is driving these decisions.

And, even though it will take time to get it, published #evidence to back them up.
For starters, and because it's too important for it NOT to be published, I would like to see the study #protocol (with #ethical approval) for #testing the extension from 3 weeks to 12 between doses of the #PfizerVaccine, including the #cohorts and #controls.

#ScienceMatters!
Oops, sorry! It seems I got my [Threads] mixed up. There's a bit more, picking up from here: https://twitter.com/EinsteinsAttic/status/1344622790733942788?s=19
And another sub-[Thread] that might also be of interest:

https://twitter.com/EinsteinsAttic/status/1344671984333021184?s=19

(Don't forget that at this point we're talking about just *two* #vaccines - others, including @moderna_tx's, are on their way...)
I'm far from alone in seeing this as a "real-time experiment" on (sections of) the British population:

https://twitter.com/Dereklowe/status/1344644939666358273?s=19

The thing is, no matter how desperate we are, there are still #rules around #HumanExperimentation that need to be followed. The consequences of...
..NOT following them (esp. if the gamble turns out to be wrong) could be truly devastating, cf. #Tuskegee & #AlderHey - not to mention fuelling #antivax sentiment.

Even in the so-called ' #permissive' environment of the pandemic, treating everyone as #GuineaPigs is deeply unwise.
Here's a letter from the Doctors' Association, detailing their "real and grave concerns" to @MattHancock today: https://twitter.com/TheDA_UK/status/1344641247806435330?s=19
And a statement from a doctor who has already received her first dose that suggests in postponing people's second doses the Government may not only be breaking clinical #protocols on the basis of insufficient evidence, but breaching patient #consent: https://twitter.com/farrell_katrina/status/1344688278361022470?s=19
And another good spot by @jmlw1, on the conditions for authorisation of the @Pfizer/ @BioNTech_Group #vaccine:

https://twitter.com/jmlw1/status/1344690341430128641?s=19

Noting also:
It looks like @MHRAgovuk reserves the right to vary the conditions, but if it does then surely it needs to issue a new authorisation - else who is #liable? Whither #accountability?
And then, of course, there's this:

[Thread] https://twitter.com/PaulBieniasz/status/1344459067717279744?s=19
Oh dear. This 'short statement' from #JCVI, rationalising its decision, raises far more questions than it answers:

https://twitter.com/drmarkporter/status/1344926628393181184?s=19

"calculated" & "expected" when relating to NO ACTUAL DATA amount to little more than "guess". It's a #theory, and an #unproven one until...
...the #HumanExperiments have been performed. So instead of doubling down & publishing 'justifications', WHERE ARE THE CLINICAL STUDY PROTOCOLS?

Also, last time I checked, the people taking these #vaccines will be living in the real world. So ignoring the first 14 days of the...
.. #efficacy data to conjure up a higher-seeming figure - and further assuming protection *stays* high, when the only info available is 108 days'-worth of data FOR A DIFFERENT VACCINE - flies in the face of determining real-world #effectiveness.
Any pharmaceutical company that...
...was shown to have cherry-picked the performance figures for one of its drugs like this would (justifiably) be fined to bits - with possible criminal charges for executives if people had died.

And what, precisely, does this 👇 mean?
👆 Does any less than "strong evidence" exist that the immune response from the #PfizerVaccine would "differ substantially"? (If so, not publishing it would be a cover-up.)

Or does simply NO EVIDENCE AT ALL exist for the performance of this new #type and #formulation of vaccine?
There is at least one helpful clarification on page 2, though:

"The rate of vaccine delivery in the UK is currently limited by vaccine #supply rather than by workforce #capacity"

i.e. those who are doing so can stop slagging off the NHS in this regard.

https://m.box.com/shared_item/https%3A%2F%2Fapp.box.com%2Fs%2Fuwwn2dv4o2d0ena726gf4403f3p2acnu
Again, none of this [Thread] should be read as criticism of the #vaccines or #vaccination itself - it's rather the politics and decision-making around them I'm concerned with.

If you are offered a #COVIDvaccine, please do take it. (I sure will.)
For the record, my suggestion would be to see through the second doses of those already given the #PfizerVaccine, per their informed consent.

While doing that, publish the protocol(s) for the required study/studies for extending the gap between doses, and recruit volunteers...
...as one thing's for sure: plenty of brave women and men will put themselves forward, as many already have.

Be open about your cohorts & control groups - the situation's only going to get more complex as more vaccines become available.

Stay #consensual, #safe and #transparent!
Hmm. Latest @PHE_uk advice, published yesterday, despite there being *no evidence* on the #interchangeability of different types of #COVID19vaccine suggests it is "reasonable" to 'mix and match' them:

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/949063/COVID-19_vaccination_programme_guidance_for_healthcare_workers_December_2020_V3.pdf
And bizarrely, though it is the most contentious change, the newly-added section on the #scheduling of doses doesn't even merit a mention in the document revision information:
And bizarrely, though it is the most contentious change, the newly-added section on the #scheduling of doses doesn't even merit a mention in the document revision information:
And bizarrely, though it is the most contentious change, the newly-added section on the #scheduling of doses doesn't even merit a mention in the document revision information:
In a rapidly-evolving situation, 'guidance' so ambiguous as to set up #random, but not #RCT, experiments on even a tiny number of patients (i.e. two doses of different vaccines, possibly at intervals beyond what the manufacturer recommends) is unconscionable.

I'm not saying...
...that such experiments shouldn't be done - indeed, they should!

But ONLY in a properly controlled, tightly-managed trial situation, NOT left in the 'lap of the gods' - exposing those most vulnerable to the vagiaries of a still-stabilising supply chain.

These are difficult...
...times, and even more difficult decisions - but that is no reason to throw the baby out with the bathwater!

Please, please! will someone publish proper protocols for what are now self-evidently a bunch of new *live human* experiments.

And make sure they are managed properly.
HT @patrickseurre for pointing to the @CDCgov recommendations, which state even the two #mRNA vaccines (i.e. the ones from @pfizer and @moderna_tx, @AstraZeneca's being of a different 'viral vector' type) are "NOT interchangeable":

https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html
N.B. For those wishing to follow along with the changing @PHE_uk guidance, archived versions are here:

v 01.00, Nov 27:
http://web.archive.org/web/20201127101758/https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/938999/COVID-19_vaccination_programme_guidance_for_healthcare_workers.pdf

v 02.00, Dec 4:
http://web.archive.org/web/20201208013202/https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/941236/COVID-19_vaccination_programme_guidance_for_healthcare_workers_December_2020_V2.pdf

v 02.1, Dec 11:
http://web.archive.org/web/20201214130006/https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/943589/COVID-19_vaccination_programme_guidance_for_healthcare_workers_December_2020_V2.1.pdf

v 3, Dec 31:
https://web.archive.org/web/20210102003646/https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/949063/COVID-19_vaccination_programme_guidance_for_healthcare_workers_December_2020_V3.pdf
Measured [Thread] of [Threads] explaining why the decision to extend period between doses may be "justifiable" in the circumstances:

https://twitter.com/rvenkayya/status/1345026156257550339?s=19

Noting real risks; requirements on which UK Gov't consistently fails to deliver; and still no sign of research protocols:
VG post by @petermbenglish explaining why *in some circumstances* he'd support delaying the second dose:

http://peterenglish.blogspot.com/2021/01/delaying-second-dose-of-covid-19.html

...pointing out the vital importance of getting other mitigations (e.g. schools & universities) right as well.

We're not just gambling on vaccines!
VG post by @petermbenglish explaining why *in some circumstances* he'd support delaying the second dose: http://peterenglish.blogspot.com/2021/01/delaying-second-dose-of-covid-19.html...pointing out the vital importance of getting other mitigations (e.g. schools & universities) right as well.We're not just gambling on vaccines!
VG post by @petermbenglish explaining why *in some circumstances* he'd support delaying the second dose: http://peterenglish.blogspot.com/2021/01/delaying-second-dose-of-covid-19.html...pointing out the vital importance of getting other mitigations (e.g. schools & universities) right as well.We're not just gambling on vaccines!
Welcome clarification (to those who have received & read the letter) from NHS CEO, NHS Medical Director & SRO Vaccine Deployment on 'mix and match' between vaccines:

"Each person’s second dose must be from the same manufacturer as their first dose":

https://www.england.nhs.uk/coronavirus/wp-content/uploads/sites/52/2020/12/C0994-System-letter-COVID-19-vaccination-deployment-planning-30-December-2020.pdf
If these people 👇 can be clear on this crucial point, why was @PHE_uk's guidance (updated a day later) not equally clear?

You'd hope that in a crisis, current medical advice and the communication of it would at least be consistent.
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