Jon Worth Euroblog

EU analysis, cross-posted to Blogactiv

⚠ WARNING! Political communication is my area of expertise, NOT public health. This blog post is no recommendation as to what ought to happen from a health perspective! ⚠

🚨 This piece was written on 25.1.2021, i.e. before the decision for a Conditional Marketing Authorisation has been approved or not on 29.1.2021. Please bear this in mine in case you read this post after that date! It is possible that the EMA grants authorisation for ALL age groups – if this is the case then the fears expressed in this blog post are largely unfounded. 🚨

 

On 12 January the European Medicines Agency (EMA) finally received the application for conditional marketing authorisation (CMA) for the COVID-19 vaccine developed by AstraZeneca and Oxford University. The EMA’s scientific committee for human medicines (CHMP) will consider this application on 29 January – 5 days from now.

The problem?

There are questions as to whether the AZ Vaccine will be approved for over-55s, as Der Standard reports today. The story also quotes Austrian Chancellor Kurz who says that if the vaccine is not speedily approved it “würde ihm irgendwann der Geduldsfaden reißen” (he will run out of patience). What Kurz or the Austrian Government actually do were a partial authorisation or non-authorisation to come to pass is not stated, but one assumes that Austria could go its own way and unilaterally grant a temporary authorisation for the AZ vaccine (much the same as the way UK approved BioNTech/Pfizer faster than the EU did).

Were a partial authorisation to happen, it would also pose Germany a different problem – Spahn has said that German patients cannot choose which vaccination to get – but a lack of approval for over-55s for AZ would force that to be used on younger patients, and BioNTech/Pfizer and Moderna on older patients.

But back to the communication problem.

I understand Kurz’s frustration – he wants as many doses of vaccine as soon as possible, just as any government leader does – but there is a major issue at stake here: the trust in the AZ vaccine. Kurz is in no position to assess whether the judgment of the European Medicines Agency CHMP Committee is scientifically right or not – he is not a scientific expert, and so he would do best to keep his mouth shut.

But what can the CHMP Committee say? As the European Medicines Agency states:

A CMA guarantees that the approved medicine or vaccine meets rigorous EU standards for safety, efficacy and quality and is manufactured and controlled in approved, certified facilities in line with high pharmaceutical standards that are compatible with large-scale commercialisation.

If that standard is not reached, then no approval.

But here is where a justification becomes so important. Is it because of what is not known? i.e. with more and better data, approval for all age groups could be guaranteed at a later stage? (this is an interesting thread on this – but I do not know if this is right!) Or is it because there is a genuine problem? The difference between those is enormous – honesty about what is not known is, in its way, a reassurance too.

And then there comes the UK issue. The UK approved the AZ vaccine on 30 December – for all age groups. Were the European Medicines Agency to take a different view, how is that going to hold up – both in the countries of the European Union where critique is rising about the slow pace of vaccination (although manufacture problems are likely the largest part of this – for AZ and BioNTech/Pfizer), and in the UK – where fears about the safety of the AZ vaccine could rise among over-55s?

The communication of this is going to be complicated this week. Everyone has a duty to be as calm and careful as possible here. Politicians should not try to bounce scientists into unduly hasty decisions, or lambast processes they do not understand. Difference of view among scientists is normal and proper. If the EMA’s view on AZ is not the same as the UK’s, that is understandable, but needs careful explanation – both EU and UK side. Likewise the consequences of a decision being based on an absence of data being different to one based on negative data need to be explained carefully.

The post The EU’s impending communication headache: approval (or not) of the AstraZeneca COVID-19 Vaccine appeared first on Jon Worth Euroblog.

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