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Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.
The EU has its first COVID vaccine authorized.
So, they've done it —at last! The EU authorities eased some of the growing impatience in member countries to begin administering a COVID vaccine. The European Medicines Agency delivered its green light, as expected, this morning. By lunchtime it announced that its human medicines committee had completed its "rigorous evaluation of Comirnaty"—as the BioNTech/Pfizer product is now styled—and had recommended a formal conditional marketing authorization. By tea-time, the European Commission had rushed through the formalities, telescoping what is usually weeks of work with the member states into a few hours, and the president of the European Commission, Ursula von der Leyen, personally told the world that the EU now has its first COVID vaccine authorized.
Joy unconstrained greeted the announcement, briefly overcoming the resentment that had built up across the member states ever since the UK gave the vaccine its first go-ahead on December 2nd. Resentment that was felt all the deeper in Germany, where the vaccine was developed. And resentment that deepened with every announcement of similar approvals elsewhere—notably in the USA. The ultimate insult to EU pride was that Switzerland managed not only to endorse the product yesterday, but did so with a formal conditional marketing authorization, rather than the emergency-use permissions granted everywhere else.
Not only that, but the FDA has already jumped ahead again, by giving emergency-use permission for the Moderna vaccine—on which EMA is not scheduled to finalize its review (even on its recently-accelerated timetable) until January 6th.
Unsurprisingly, therefore, the EU announcements on Comirnaty (one day we will all know how it got that bizarre name) are emphasizing safety, to justify the relative delay in issuing an authorization. EMA insisted this morning on "concluding by consensus that sufficiently robust data on the quality, safety and efficacy of the vaccine are now available," and that this will "provide a controlled and robust framework to underpin EU-wide vaccination campaigns and protect EU citizens." Von der Leyen focused on the same theme: "This authorization follows a positive scientific recommendation based on a thorough assessment of the safety, effectiveness and quality of the vaccine." The European Commission "has verified whether all necessary elements—scientific justifications, product information, informational material to healthcare professionals, labelling, obligations to marketing authorization holders, conditions for use, etc.—were clear and sound."
Emer Cooke, executive director of EMA, was on message too, “Our thorough evaluation means that we can confidently assure EU citizens of the safety and efficacy of this vaccine and that it meets necessary quality standards." She went on to point out that "our work does not stop here. We will continue to collect and analyze data on the safety and effectiveness of this vaccine to protect people taking the vaccine in the EU.”
44,000 people were involved in the trial, and efficacy was calculated in over 36,000 people from 16 years of age (including people over 75 years of age) who had no sign of previous infection. The study showed a 95% reduction in the number of symptomatic cases in the people who received the vaccine (8 cases out of 18,198 got symptoms) compared with people who received a dummy injection (162 cases out of 18,325 got symptoms). The trial also showed around 95% efficacy in the participants at risk of severe disease, including those with asthma, chronic lung disease, diabetes, high blood pressure or a body mass index ≥ 30 kg/m2. The high efficacy was maintained across genders, racial and ethnic groups.
The EU pitch also gives a lot of attention to "solidarity"—that is, all 27 member states have equal rights under EU rules to provide the vaccine. "Doses of the vaccine approved today will be available for all EU countries, at the same time, on the same conditions," she said, describing the upcoming vaccination as "a great moment of unity." Health commissioner Stella Kyriakides said it is "a day of true European solidarity in action," providing access to safe, effective and affordable vaccines "at the same time for all member states." She said it demonstrated what can be achieved collectively "when we work together."
It would be churlish to suggest that the approval has not been fast. BioNTech and Pfizer made a formal application for a conditional marketing authorization on December 1st, following the analysis of their data in a ‘rolling review' by EMA as from October 6th. The rolling review allowed EMA to assess the application "very rapidly", while "ensuring that all requirements in terms of safety, effectiveness and quality of the vaccine are fully and thoroughly evaluated." The aim now is to deliver the first doses to health facilities on December 26th, so that the EU vaccination can start on December 27th. Distribution of the full 200 million doses is scheduled to be completed by September 2021, and EU authorities are now working to acquire the additional 100 million doses foreseen in the contract with the two companies. The problem that emerged was political rather than technical or scientific: other authorities moved faster—for good or ill—and the EU came under fire from its own politicians for taking it too leisurely. The legitimate defense that a conditional marketing authorization trumps an emergency-use permission is a difficult argument to win in the public sphere, because it requires a grasp of complexities—and the public don't care much for complexities. There are lessons to be learnt from this, for the EU and for the entire drug development community everywhere. And since—as von der Leyen promised today—other vaccines are on the way, the EU had better do some fast learning about communication.