⚠️ 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.

[UPDATE 25.1.2021, 1510]
This BusinessInsider piece gives a useful overview of why the AZ vaccine is not yet approved in the USA. There are also concerns in Australia. Before anyone in any EU country jumps up and down to attack the EMA please bear those in mind too.

4 Comments

  1. Full marks to the EU for introducing politics into the Covid situation. The hero of the Bundeswher strikes again. 39/128 Eurofighters. 2.77%/13.95% Vaccines. Promoted beyond abilities doesn’t really cover it.

  2. “……..As of Friday, more than 11% of the UK population had been vaccinated compared with 2.3% in Germany and 1.8% in France. These figures give a stark measure of relative EU incapacity. At the end of a week that saw a grim milestone of 100,000 Covid deaths in Britain, the UK’s vaccine success story is a bright star in a gloomy firmament. Incompetence in Brussels must by no means be allowed to obstruct this encouraging progress. As for the EU, it should get its house in order – quickly.”

    No that wasn’t me. It was from the leader in The Observer today, a paper usually so glued to the liberal left that it would roll over let even Michel Barnier tickle its tummy.

    Things must be bad.

  3. William Horwood

    A rather convoluted post, which is unusual for you. Maybe because the issue IS so from an EU perspective, struggling as it must with so many unknowns. I had my AZ vaccine first dose yesterday – in Oxford, England. This place, and particularly my part of it, is riddled with talkative doctors, virologists, and epidemiologists to the same degree that Bruxelles is crawling with monosyllabic Eurocrats. Some of these medics and scientists are good friends of mine. Trust me, Jon, I have spent a lot of time these past few months weighing up, with this expert help, whether or not to take the vaccine. I was initially against. In the end, anyone who goes through this exercise, will realize that it’s a risk assessment that cannot be based on hard scientific research into this vaccine (none can yet exist) but on probabilities based on past performances of similar vaccines versus the risk of getting Covid and dying a very unpleasant death. Added to which I take seriously the herd immunity argument. I doubt very much that the UK’s approval process is any worse or better than the EU’s, which we can safely predict will give the go-ahead. Meanwhile the UK is muddling through, like it does, and on this occasion doing it a lot faster than the EU. To which I, like so many in my speedy and efficient vaccination line yesterday, could only say, ‘Thank goodness!’.

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