Q&A: Can we restart using the AstraZeneca vaccine, and is it safe?

What’s the latest on AstraZeneca?

The European Medicines Agency (EMA) has said that despite fears over reports of blood clotting in a small number of people who received it, the AstraZeneca vaccine is " safe and effective" and that its benefits "outweigh the risks".

So nothing to see here?

Not quite. The EMA said it cannot definitely rule out a link between the cases and the vaccine. Meanwhile, in Norway where four of the concerning cases were located, a group of medical experts have said they believe the vaccine caused the clotting.

However, according to infectious diseases specialist Sam McConkey, the EMA review was looking for patterns and prevalence and comparing the risk of administering the vaccine to the risk to vulnerable people from Covid.

“It’s not a binary thing – does this cause clots or not – it’s the rate (at which incidents occur). The rate is more important than the causality”.

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All systems go then, right?

On the balance of probability, yes. Senior sources in Government believe AstraZeneca could be given out by the weekend, a view shared by Prof McConkey.

But there's still a process to be followed: the National Immunisation Advisory Committee (Niac) is meeting with other similar European bodies, and then discussing the issue, probably on Thursday night and Friday morning, before issuing advice to deputy chief medical officer Ronan Glynn. He then issues advice to Minister for Health Stephen Donnelly, who in turn makes the policy decision and tells the Health Service Executive to implement it.

Any chance of a hiccup?

Probably not, but it can't be totally ruled out. The Niac called a halt last week on foot of concerning reports from Norway, rather than a diktat from EMA, while that agency's advice has consistently been that the shot should be given, notwithstanding the clotting concerns. Despite this, Ireland and other countries have persisted with the suspension. So it is possible the Niac could form a separate, independent view to the European Medicines Agency.

However, the EMA has now done an expert review of the cases, which had not happened when the initial call was made. So the fundamentals have changed somewhat. Italy, Latvia and Lithuania have already said they will resume giving the shot and it seems Spain will follow.

Will there be changes on the ground?

The EMA has said patient information will carry a warning of a very rare risk of clotting from now on. Presuming the Niac gives its approval, and that this is backed by Dr Glynn and Mr Donnelly, this could cause minor complications for the HSE if it requires new patient information to be drawn up or changes to be made to the consent form.

How quickly will it be back in action?

Again this presumes no objection from the Niac or Dr Glynn. But there are some doses in healthcare settings already where there are vaccinators working and people to receive the shot. This could happen pretty quickly; about 10,000 of this week’s 30,000 cancelled appointments were healthcare workers. These could be low-hanging fruit.

Those super-vulnerable people in cohort four might prove trickier. Only about 5,000 of these have been done so it’s a relatively new process for people who may have specific needs. Between the remaining 5,000 from last week’s target and the 20,000 who weren’t done this week, there’s now a sizable backlog.

It’s hard to say just how quickly this will be cleared and there may be a degree of hesitancy after this week’s events that could slow the process.

How many doses does the HSE have, and has ground been lost?

There is 49,100 doses in the Republic with 10,000 more due for delivery this week, according to HSE chief executive Paul Reid – that suggests just short of 60,000. So once the backlog is complete, there should be 25,000 doses "extra" to deliver, with no AstraZeneca now being held back in a buffer. How quickly that buffer is cleared, and how quickly the other 25,000 doses will be distributed, is hard to say. The HSE has said that the completion of first doses for cohort four will now not happen until "well into" April.

The HSE believes it can start administering within “a few days” of being advised to do so. Unfortunately, what isn’t hard to predict is that well-publicised problems with deliveries will continue, so it’s unlikely that 25,000 doses will have many more for company.

How quickly it is cleared may prove a limited road test of the HSE’s claim that the only constraint on the programme will be supply.

What’s the impact on targets?

All things being equal, probably manageable. But that doesn’t mean the target of getting 1.1 million doses into arms by the end of the month is any more achievable, and it certainly won’t help.