Governments throughout Europe, including Scotland, are now putting all their efforts for containing or suppressing COVID-19 into getting as many of their country’s population vaccinated as soon as possible. They are out-vying each other in claims about doses secured and numbers vaccinated.
But the deployment of the various vaccines (now three available in the UK) creates potential for yet another catastrophic failure by a Westminster Government that couldn’t run a beetle drive in a cockroach sanctuary. There is a very real fear that the vaccination programme will be found just as wanting as the “world beating” track trace and isolate system and other failed measures with the virus remaining “out of control” (M Hancock).
If we allow this to happen, we will be the only losers. Everyone needs to speak out now about our expectations of Government and what will constitute failure. More than at any time before, it is imperative to pose clear questions and create yardsticks of success.
A still small voice says go careful here. Whatever else confidence in vaccination must not be eroded because, with the new variant extant, we need an 80% take up. So yes, it is probable that the decision to extend the interval between the first and second dose to 12 weeks is a panic response to the escalation of the pandemic, a response which has been firmly rejected by other high incidence countries and the WHO. See here, here and here.
The UK dose interval policy is based on a balance of probabilities assessment of a limited amount of data which does not meet the required statistical standards of a clinical trial. But although the decision is a troubling gamble, it should not be allowed to dominate our concerns
Crucially, this sudden shift in vaccine policy almost certainly reflects anxieties about the level of supply of vaccine that will be achieved in the next few weeks in the UK and the robustness of the fledgling systems for vaccine deployment and distribution.
Fair wind in the sails or shipwreck?
Anxieties about vaccine supply are clearly reflected in Nicola Sturgeon’s caution when looking beyond the end of January. Just two months ago we were promised about 1 million vaccinations by the end of January, now both she and Jason Leitch refer to 900,000 doses being “available”. Without adducing evidence Boris Johnson suggested 13.9m doses could be delivered by mid-February if we “have a fair wind” though his (ever hapless) “vaccines” minister, Nadhim Zahawi, is talking airily of it as a done deal.
The Four Nation Governments have made commitments to publishing operational plans and monitoring data, with targets and outcomes available on a rolling basis. But what does this mean precisely? Can we trust these promises of transparency any more than earlier promises about testing?
The devil, as usual, will be in the detail or rather its sufficiency. Because we will almost certainly be confronted again with the kind of ambiguities that for weeks meant that the capacity for testing was substituted for the actual number of tests conducted or that the percentage of tests that were positive was not routinely available. An equivalent ambiguity in a vaccination programme will be the distinction between vaccinations offered and vaccinations given.
Comprehensive data is essential if the vaccination system is to be properly monitored. Given the urgency of an efficacious vaccine programme would it not be a travesty to discover when it is far too late that essential data is either not being collected or published.
In the coming weeks the main focus of attention will be on the number of people vaccinated. But there are other data crucial for monitoring the programmes and giving early warning of how well promises are being fulfilled. Data on supply and distribution both actual and predicted will provide the earliest indications of success or failure.
A possible draft set of essential data required to support monitoring is set out in FIg1 (below):
Options versus orders
Some dazzlingly large figures are quoted about the number of vaccine doses that are available to the UK. But it remains unclear the extent to which these numbers are based on options to purchase or on orders confirmed by both the Governments and the suppliers.
The distinction between firm orders and options to purchase should be made explicit in published data and statements. Weekly updates of these data are essential for understanding the likely timetable for delivery of Vaccine doses.
There is scope for a considerable disconnect between the pharmaceutical companies and Governments in the claimed supply of vaccine. This is because the supply chain has at least three stages – supply of vaccine, filling vaccine vials and batch testing of vaccine and the data for each stage will differ.
Published data must allow the distinction to be draw between vaccine doses manufactured, put into vials and successfully batch tested. These data must include future projections.
The supply chain will presumably require one or more intermediate distribution centres at UK and home nation level between the vaccine supplier and the vaccination centre or GP surgery (“vaccine hub”). This offers scope for ambiguity about how many doses have been distributed.
To avoid this data must allow a clear distinction to be drawn between the capacity of vaccination hubs to vaccinate people and the number of doses of vaccine delivered to hubs. Projections of the likely future delivery of vaccine doses to hubs are essential if we are to gauge how the future vaccination timetable may change.
Extending the interval between doses to twelve weeks only provides a one-off respite in the number of doses required. So, if 2m doses per week in the UK are required to meet targets, by mid-March this would need to be doubled if the momentum in vaccination is to be maintained. If this cannot be achieved available doses will have to be reserved for the more vulnerable groups and the roll out to other groups would be paused
If vaccine supply could not be maintained at even previous levels, there would be a risk that second doses could not be given when required. Thus, data on projected order, supply and distribution are of critical importance in determining how many vaccinations not only can but also should be given each week
Given the sudden change in dose interval policy, data on the interval between first and second dose and numbers who do not receive the second dose within the prescribed time would seem essential.
Because the extension of the period between doses is based solely on balance of probability assessments of available evidence, monitoring for any consequences of this should be put routinely into the public domain. The consequences of the change in vaccination policy can only be understood if data is collected on people who, because of COVID-19, are hospitalised or die in the interval between first and second doses.
In the failed SERCO track and trace system, an army of recruits logged in faithfully each day but were given nothing to do. Our information on this came not from data but from the anecdotes of the workers themselves.
The recruitment of an army of health care professionals and volunteers to support a vaccination programme is certainly essential but will not achieve its objectives if the choke point in the system is vaccine supply. That is why it is essential to have access to data permitting evaluation of the vaccine supply and distribution system.
Overall, considerable energy has been expended since March on a pass the parcel game of blame for what have been clear failures by Governments. But this time, given its critical importance, we cannot afford for success or failure of the vaccination programme to be similarly obscured.
The outcome is indeed so vital for us all that the progress of the vaccination programme is the one topic that cannot be kicked into the long grass of some future Inquiry – and this knowledge must be shared as fully and as often as possible.