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I've been seeing a lot of discussion around the dosage gaps recommended by government for the Astra/Oxford & Pfizer/BioNTech vaccines. My thoughts on the potential benefits & risks of such an approach, and the need for much greater transparency around these decisions. Thread.

 The UK govt announced recently that both the Oxford & BioNTech vaccines would be now administered with a gap of between 4-12 weeks (so prioritise administration of first dose, given limited resources).

What is the basis of this?
The basis that's been discussed seems to be that
1) the first dose is likely to confer some degree of protection against disease, so better to roll this out as fast as possible, and
2) that for Oxford/Astra efficacy may be higher when the gap between doses is greater.
I discuss some of the technical details around the Oxford trial below for those interested in these. If you'd just like a summary of this, please skip to the summary tweet titled 'SUMMARY'.
What does published evidence show? The Astra/Oxford data are a bit messy because of protocol changes during the trial. This is because the trial was originally planned as a single dose trial, but a booster dose was added when developers realised that this would likely help.
This meant the 2nd dose was added months after the start of the trial. Because of the nature of the trial- younger people recruited into the trial first & older people recruited once it was decided that 2 doses should be used, younger participants were given the 2nd dose later.
To complicate matters there was an error early in the trial which meant that ~1,400 participants were given a low 1st dose by mistake. Given the first tranche of participants were <55 years, the low dose (1st dose)/standard dose (2nd dose) combination was only used in this group
So approximately 42% of participants <55 yrs had the lowdose/standard dose (LD/SD) combination, and all the older ones had the SD/SD combination. And the gap between doses was higher among <55 yr olds vs >55 yr olds, although I couldn't find the breakdown of this in the paper.
The efficacy results that are reported suggest an efficacy of ~60% in reducing disease for the SD/SD group, and ~90% for the LD/SD group. What is less clear is whether these differences are due to the lower first dose, younger participants, or longer gaps between doses.
So let's look at efficacy by age group and dose.
Vaccine efficacy among 18-55 yr olds SD/SD dosing was 59% vs LD/SD dosing at 90%.

Is this due to dosing, or differences in gaps between doses?
Differences in gaps don't appear to impact efficacy in this analysis.
Of course we can't evaluate this in ages >55 as they only had a short gap in dosing. So we don't have any data on longer gaps in >55 yr olds, at least in the data that are public.
I have seen reports that unpublished data support longer gaps between doses. But without seeing the data, I can't evaluate the basis for this. Presumably MHRA has evaluated the evidence before granting approval for the current dosage protocol.

https://t.co/9yaSAyHcKR
What about the efficacy after the first dose?
It looks like the first dose prevented all severe disease (although numbers were small) in the SARS-CoV-2 vaccine group compared to vaccine control after the first 21 days of vaccination, and <14 days after the 2nd dose.
SUMMARY: the Oxford/Astra trial examined dosing with gaps between 4-12 wks- although longer gaps appear to be limited mostly to younger participants. There was no difference reported in published data between these & efficacy from the 1st dose seems high for severe disease.
Given this, I can understand the plan for longer dosing gaps for this vaccine, although I do think that it's important that the unpublished data that support this are released for transparency & to build public trust which is essential at this point.
The application of the same principle to the Pfizer/BioNtech vaccine is more difficult to evaluate. This vaccine was studied with a strict protocol of 21 days between doses & the company has since issued a warning that they cannot ensure efficacy if protocol is changed
While the Pfizer trial shows reasonably high efficacy after the 1st dose of vaccine (~80%), the duration of this following 21 days is unclear. So there is a risk that this level may decline after this period, as we don't have direct data on this from trials.
However, there are also arguments for the approach the govt is taking, as outlined below. Essentially the thinking is that given the urgency, roll-out across double the numbers with 80% efficacy is better than rolling out half numbers with 95% efficacy.

https://t.co/966V4EYw13
The assumptions key to this argument are of course that:
1. Resources for roll-out are limited & fixed & we need to optimise how best to use them within limitations
2. There isn't significant decline in immunity after the 3 wk mark
3. Later dosing will not affect overall efficacy
I'm not a vaccinology expert so can't really comment on 2. and 3. From reading views from other experts, the general view seems to be that later dosing is unlikely to impact overall efficacy. What level of immunity lasts up to 12 weeks is less clear, I think.
I'm also not entirely clear about the impact of a longer period of partial immunity (if immunity declines following 3 wks) on viral adaptation. I know some experts have raised concerns about this. I think this is dependent on how much immunity declines prior to the 2nd dose.
Given a lot of this is conjecture, it's hard to know whether this is the right strategy for the Pfizer vaccine. I am naturally cautious about changing a protocol that's tried & tested to one where we don't have data on, particularly given the warnings issued by Pfizer.
I'm also concerned by the poor planning around this. Given these data were available for a while, it's not clear to me why this decision was made now, when hundreds of thousands have had their second appts booked in. Cancelling these is also time-consuming & undermines trust.
Irrespective of how and why the MHRA approved this, I think it's important to release the thinking & the data around it - to create transparency & build trust with the public, and with health-care workers. It's very clear that HCWs were not consulted in this, which led to chaos.
Such actions really risk undermining public trust, when it's already very low. We are counting on high vaccine uptake to be able to contain the pandemic - we can't afford to not take the public along on decisions such as this. Good communication & transparency is key.
Given the urgency of vaccine roll-out now, these are complex decisions. While there may be good scientific reasons for which these decisions have been made, it's important that these reasons are made clear & the public and HCWs are engaged in this decision-making process.
Just wanted to highlight one last point- it looks like the govt have released a document around this today.

A key part of the rationale appears to be a bottleneck in vaccine supply (rather than roll-out).

https://t.co/mccavkBGeb

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I'm honestly at a loss as to understanding what our government is thinking & what evidence they're considering in enacting gravely negligent policies that will almost certainly lead to tens of thousands of deaths in the coming weeks. Thread.

To recap - NHS capacity is critical in many places. Hospitals have reported oxygen shortages, and doctors are talking about having to choose who to put on ventilatory support. We have rapidly rising case numbers, >50,000 daily reported cases & 981 deaths reported yesterday.

Let's remember that the impact of socialising over christmas hasn't even begun to show in our numbers yet. And that hospitalisations are indicative of infections that happened ~2-3 wks ago (since then we have been seeing exponential rises in cases).

This means even if we act today, and bring R to below 1 right now, hospitalisations will continue to rise for another 2 wks or so - in line with exponential rises in cases over the past 2 weeks. And deaths will continue to rise for 2-4 wks after we act.

Given current doubling periods, this means very conservatively, 20-30,000 deaths over the next 4 weeks or so, which we sadly can't do anything about now, because most of those who will die during this period have already been infected.
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This is the exact problem with our government's thinking & response- despite this strategy of 'tolerating deaths' and half-way measures having spectacularly failed, it's quite amazing that our govt still hasn't learned anything, & continues to promote a policy of death. Thread


Had we adopted an elimination strategy early on, rather than one of tolerating a certain level of infection, we wouldn't be here now. The reason we're here is because the govt never committed to elimination.

We eased lockdown in May when infection levels were much higher than when other countries in Europe did this. The govt was warned about this, but did this to 'help the economy'. Not only did this lead us into the 2nd wave, the need for further lockdowns harmed the economy further

It's very clear from global evidence that we cannot 'tolerate a level of community transmission' and maintain 'R at or just below 1', which has been our governments policy for a long time. This isn't sustainable & very rapidly gets out of control, leading to exponential rises

Coupled with late action to contain these surges, not only does this lead to many more deaths, and much more morbidity with Long COVID, it also creates a fertile ground for viral mutations to accumulate with a greater risk of adaptation, which is exactly what happened in the UK
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My thoughts on the govt announcement yesterday regarding a new viral strain potentially driving an increase in cases in London. The claim, at least from listening to the daily briefing seems to be based on the strain increasing in frequency more recently. 1/N

Cases have been rising exponentially in England- much of the increase being attributed to the South, although declines have slowed even in the North following easing of lockdown. Much of this is anticipated, and expected, given the behaviour of the virus. 2/N

SARS-CoV-2, like any other viruses mutates as it multiplies (albeit slower than influenza). Mutations occur randomly and most are 'neutral' - i.e. have little to no effect on transmission, ability to evade the natural or vaccine-related immune response

Having said that, few mutations have been shown to be less likely to be neutralised by plasma from patients infected by the usual (wild-type) virus. Whether this translates to a lower response to vaccines or higher risk of re-infection is unclear at the moment.

Also worth noting that just because a variant becomes more frequent in a region doesn't necessarily mean it offers a fitness advantage to the virus. Many mutations rise to different frequencies in different regions due to random processes. The frequency of strains varies globally
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@dgurdasani1
We've been falsely told 'schools are safe', 'don't drive community transmission', & teachers don't have a higher risk of infection repeatedly by govt & their advisors- to justify some of the most negligent policies in history. 🧵


data shows *both* primary & secondary school teachers are at double the risk of confirmed infection relative to comparable positivity in the general population. ONS household infection data also clearly show that children are important sources of transmission.

Yet, in the parliamentary select meeting today, witnesses like Jenny Harries repeated the same claims- that have been debunked by the ONS data, and the data released by the @educationgovuk today. How many lives have been lost to these lies? How many more people have long COVID?

has repeatedly pointed out errors & gaps in the ONS reporting of evidence around risk of infection among teachers- and it's taken *months* to get clarity on this. The released data are a result of months of campaigning by her, the @NEU and others.

Rather than being transparent about the risk of transmission in school settings & mitigating this, the govt (& many of its advisors) has engaged in dismissing & denying evidence that's been clear for a while. Evidence from the govt's own surveys. And global evidence.

Why?
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Thread on the recent report on the possible risk of increased death associated with the new UK variant (B117)- with a discussion of the evidence around this, and what this means.

First, there is strong evidence to support increased transmissibility of B117 - current estimates of increased transmissibility range between 30-70% - from epidemiological evidence examining the differential rate of growth of B117 with respect to other variants & increase in R

There is also evidence from PHE contact studies that the risk of transmission from those carrying the B117 variant is ~50% greater than with other non-B117 variants.

Increased transmissibility, even if a variant has the same fatality rate can increase deaths substantially, because the rate of growth of cases is higher- & more cases means more deaths.

Increased fatality rates also increase deaths- but do so


So how was risk of death with the variant studied?
We don't routinely sequence all samples for the virus. We've found that the variant has a particular deletion which means that some PCR tests on samples with the variant give a different read-out when the variant is present.
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