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#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
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"?
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"?
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:
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
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!
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
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?
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.
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!
#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...)
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...
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.
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:
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
[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...
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...
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...
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?
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
"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.)
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...
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!
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
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:
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...
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...
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.
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
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
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:
![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=19Noting real risks; requirements on which UK Gov't consistently fails to deliver; and still no sign of research protocols:](https://pbs.twimg.com/media/Equavl4XcAYTJrh.jpg "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=19Noting real risks; requirements on which UK Gov't consistently fails to deliver; and still no sign of research protocols:")
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!
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
"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.
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.
