… but approval not expected before month end
Reuters reports this morning that Europe’s drugs regulator will review AstraZeneca and Oxford University’s COVID-19 vaccine this month under an accelerated timeline, after the British drugmaker submitted an application for conditional approval, the watchdog said on Tuesday.
The European Medicines Agency (EMA) said it would fast-track the assessment of the application and could issue an opinion on a conditional marketing authorisation by January 29 at a meeting of its human medicines committee.
EuroNews reports that the EU approved its second COVID-19 vaccine this week, giving the green light to the Moderna jab. But the website observes that bloc’s authorisation process has not been as fast as other countries, such as the UK, which approved its first vaccine on December 2. By contrast, the EU’s first approved vaccine did not come until December 21.
London has since added a further two vaccines to its portfolio: the Oxford–AstraZeneca one on December 30 and Moderna today (January 8).
Why has the EU been slower in approving a vaccine?
The Amsterdam-based European Medicines Agency (EMA) is responsible for approving all new drugs and vaccines across the 27 EU member states, Iceland, Liechtenstein, and Norway. It is roughly equivalent to the US Food and Drug Administration.
Professor Stephen Evans, a former independent expert member of the drug safety and risk assessment committee at the EMA, the answer for its slower approach comes down to two things: the science and the administration.
He told Euronews on Friday that the science involves looking at all the data from basic laboratory data — including animal studies and the first few human volunteers — up to the more advanced phase three. “Those processes tend to be almost exactly the same, whether they are done in Europe or the US or anywhere else,” he said.
Vaccine needs approval by each member state
But under EMA rules, Prof Evans added, a vaccine still needs to be approved by representatives of every EU member state — and the European Commission — before it can enter general circulation in the bloc.
That means it is “probably fair to say” that administrative delays are the reason the EMA is taking longer to approve vaccines — rather than, for example, because their process is more or less robust.
“There’s no doubt that the EMA process is rigorous,” said Prof Evans. “But it is inevitable that in sharing out the workload among the 27 member states that, in order to involve all of them in all the decisions, they divide it up so that there will be two member states that take the principal load of assessing the data. But the authorisation and the advice on authorisation has to be shared by all 27 member states.”
COVID-19 in Madeira: daily updates can be found on an earlier post.