@gordonchree The Edinburgh University data adds NO justification to the 12 week strategy for the Pfizer vaccine.

We know the 1st dose has an immediate effect that is measurable 12 days after vaccination.

We do NOT know for how long it is sustained.
We do NOT know what effect a 2nd dose will have when given after 12 weeks, if the 1st dose has declined significantly.

Pfizer have opposed the UK strategy and Pfizer should know a thing or two about the vaccine they designed and tested.
There is no evidence relating to sustained efficacy of a single Pfizer dose to 84 days.

An earlier Pfizer paper (in Nature) shows the 2nd dose (given at Day 21) boosts antibody levels by 900% or 1800% (according to dose), by Day 28.

A single dose declined by 30% by Day 28.
Additionally, neutralising antibodies only appeared in any significant numbers days AFTER the 2nd Pfizer dose was given.
Pfizer analysis on the FDA website shows a MUCH weaker immune response among the 65-85 age group, relative to the 18-55 age group.

It also shows the 2nd dose (at Day 21) has a much stronger effect on the 65-85 age group.
Dr Paul Offit, who is on the FDA Vaccine Advisory Committee.
There IS data to support a 12 week delay for the Ox-AZ vaccine.

mRNA vaccines are new, they should be used with caution, especially where the lives of the most vulnerable are concerned.
See also this recent article in @TheLancet


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More from @KennyMathieson

20 Feb
It's depressing that so many journalists (and some academics) are easily distracted by shiny objects (in the form of newly reported Pfizer efficacy "studies"), without (apparently) having read the source data and understanding the implications and limitations. 🙄
Last night @CNN reported (with almost breathless excitement), that a new Pfizer study in the @NEJM showed that a single dose of Pfizer vaccine is 92% effective.

Is that a fact?
This "new" study, contains NO new data.

It is a letter, NOT a paper.

It simply repeats the same statistical "trick" the JCVI did, calculating the efficacy of the 1st dose only after ignoring the data from the first 14 days after it was given.

No shit, Sherlock.
Read 22 tweets
18 Feb
If one believes the official statistics (and the associated interpretation being made by politicians), there is currently dramatic evidence that vaccination is vastly reducing deaths in Scottish care homes.

Is this interpretation based on solid data?

In both my training as a scientist and during my professional career in IT, I looked at a LOT of data.

A key requirement in both of these fields is the need for "interesting" results, to be reproducible.

If results can't be reproduced, that suggests a systemic error.
For example, if one was conducting clinical trials of a new vaccine across two countries, which had similar background infection rates, but the results showed:

Vaccine in Country A has 95% efficacy
Vaccine in Country B has 25% efficacy

One would need to ask serious questions.
Read 34 tweets
1 Feb
A thread on how the UK strategy relating to Pfizer vaccine rollout (i.e. 12 weeks between doses, rather than the 3 weeks followed in the Phase 3 clinical trial), places the most vulnerable in society, at PARTICULAR risk.

#FAO @JDBakewell
I was looking through the FDA website (as one does, for...um, FUN) for documents related to the Pfizer vaccine.

I found a briefing document, which has significant implications for the UK Pfizer strategy...and by "strategy", I mean, "reckless gamble". 🙄

On Page 26:

"Overall, BNT162b2 elicited HIGHER antigen-binding and neutralizing responses in YOUNGER participants (Figure 6) than in older participants (Figure 7). The BOOST effect AFTER receiving Dose 2 was MOST PRONOUNCED at the 30 μg dose level for OLDER participants."
Read 24 tweets
12 Jan
The "hope" that @krishgm mentions is forlorn, in this case.

A thread in which I prove (using ONLY published Pfizer trial data) that the UK CMOs and JCVI have not so much ignored the science, as left it bleeding at the roadside.


Read on.

From the moment, the decision was announced to delay 2nd vaccine doses, I've felt uneasy.

This is not my field of expertise, but I trained as a scientist (two chemistry degrees), worked professionally in IT, and understand the importance of testing.
My principal concern was about the Pfizer vaccine.

As vaccines go, it's "new tech", the first mRNA vaccine and the results are stunning.

Perhaps one should be cautious about deviating from a clinical trial procedure, at least until there is greater experience of mRNA vaccines?
Read 68 tweets
5 Jan
Since the UK plan to delay the 2nd Covid vaccine from 3 weeks to 12 weeks was announced, I've felt VERY uneasy.

My concerns are principally related to the Pfizer vaccine.

Having now read the original paper in the New England Journal of Medicine, I'd like to set out my concerns.
It has been suggested that there is unpublished data for the Oxford-AstraZeneca vaccine to support a 12 week gap between doses.

Accordingly, I reserve judgement on that vaccine until this data appears, but I do want to see that data.
Over the course of the last few days, I've read many helpful Tweets and Twitter threads by such as:

@farrell_katrina @BMAScotland @Tanya_Marlow @PaulBieniasz @helenamckeown @EmergMedDr @HelenRSalisbury @StFilansDream @krishgm @Nicola_Yeo @doctorcaldwell @toca63 & @DoctorChrisVT
Read 27 tweets
5 Jan
@patrickharvie I’ve read the Pfizer vaccine paper in the New England Journal of Medicine, which is here:

The paper states:

“The study was not designed to assess the efficacy of a single-dose regimen.”

This is the key graph related to vaccine efficacy.
The key numbers are at the bottom of that graph.

The 52.4% figure relates to efficacy after the 1st dose and before the 2nd dose.

However, there are 95% confidence intervals associated with that figure and the lower end is only 29.5%.
Read 14 tweets

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