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Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.
Europe's leaders find themselves in a strange situation as their defense of their systematic approach to drug registration via the EMA has come under fire not only externally, but from some of their own politicians as well.
Europe's leaders find themselves in a strange situation this week, as their stout defense of their systematic approach to drug registration via the European Medicines Agency has come under challenge not only externally, from the launch of the first COVID vaccine in the UK and the US, but also internally, from some of Europe's own politicians, impatient for vaccination to start within their own countries. The EU's formal response to the situation has been schizophrenic, trying simultaneously to justify its painstaking review on safety grounds, while placating its critics by promising faster action to bring vaccines to patients.
The rumblings date back to early December, when news broke that the UK was allowing emergency use of the BioNTech/Pfizer vaccine—and German health minister Jens Spahn, in his role as the current president of the EU's health council, valiantly defended the EU's choice to go for a marketing authorization, with the full review of data and the post-marketing conditions that this entails, at the cost of more time. Getting it right was more important than getting it quick, he argued. But since then, with the FDA following the UK route to a fast release, and the pictures flashed around the world of citizens getting their first doses of the vaccine, the positions have changed.
In Germany—where BioNTech is based and did the work that led to the vaccine—the contrast was just too provoking, as smiling UK patients walked away from doctors' offices confident they had been given a life-saving jab, while German infection figures soared so sharply that Chancellor Angela Merkel effectively banned Christmas in a bid to hold back the spread. It was Spahn himself who broke the dam of restraint, openly complaining in social media and press interviews about the delay in EMA approval. Within days his angst had been echoed by politicians across Europe.
EMA, while still proclaiming its total independence from political pressure, advanced by a week the date for its decisive meeting on the vaccine—but even this was not enough to stem the flow of anger. By December 16, the health ministers of Germany, France, Spain, Italy, Belgium, the Netherlands and Switzerland announced that they would start vaccination on December 27—blatantly ignoring the possibility that EMA might not, in fact, reach a favorable opinion on the product. Members of the European Parliament—not always masters of understatement—accused the EU and EMA of falling behind schedule, of disarray and a lack of coordination, and of concealing their assessments and plans from proper scrutiny.
Even the European Commission hierarchy—President Ursula von der Leyen, vice-president Margaritis Schinas, and health commissioner Stella Kyriakides, all of whom had been adamant that safety would come first and that all must hang upon EMA's view, suddenly found that their earlier remarks could be ignored, and confidently pronounced that December 27 would be 'Vaccination Day', no ifs, no buts, and with a simultaneous roll-out across the 27 member states as the clear objective. Further attempts at mollification emerged late on Thursday, when EMA announced it was also going to advance the crucial meeting on the second candidate in line, the Moderna vaccine, from January 12 to January 16 "due to the incredible efforts of everybody involved in these assessments," said Emer Cooke, EMA executive director. Kyriakides immediately indicated her endorsement of the plan, "Every day and hour makes a difference," she tweeted.
It is an inglorious spectacle, where political expediency appears to be suddenly triumphing over the EU's much-vaunted attachment to evidence-based decision-making, and where last week's commitments seem to be disposable at the convenience of the moment.