Vulcan Insight

EU approves second COVID-19 vaccine as criticism grows

8 January 2021

Following the European Medical Agency’s (EMA) approval of the first COVID-19 vaccine just before Christmas, on Wednesday EMA’s human medicines committee recommended the granting of a conditional marketing authorisation to the vaccine by U.S. start-up Moderna. Following final approval by the European Commission, the first batch of the 160 million ordered doses could be arriving in the coming days.

Despite the BioNTech/Pfizer vaccine having been available to all EU Member States since the start of the pan-European vaccination drive, so far, Member States significantly lag behind countries such as the United Kingdom and Israel in rolling out the jab to their populations. Incensed by the delay and fuelled by a virus that shows no sign of retracting, a tense political feud has broken out in Germany, with the public accusing both the Government and the European Commission of ordering too few doses of the German-developed BioNTech/Pfizer and ordering them too late.

The row, which is being propelled by a mixture of anti-lockdown sentiment, economic interests by the CEO of BioNTech and, undoubtedly, the early beginning of the German General election campaign, has now spread to other countries, with Irish and French Renew Europe MEPs Billy Kelleher and Pascal Canfin calling on the Commission and EMA to give evidence on the Commission’s management of the vaccine programme next week. While indeed, there are considerable transparency questions to be raised, particularly with respect to delivery timetables and commitments, the basis of the row seems to be based on national leaders attempting to distract from their distribution shortcomings and a flawed understanding of the EU’s vaccination strategy.

Primarily, the rising criticism revolves around the Commission’s alleged failure to procure enough BioNTech/Pfizer doses to inoculate all the EU’s population at the same time, as well as EMA’s slow progress in granting regulatory approval compared to their international counterparts.

On the latter, while it is true that the European Medicines Agenda has taken considerably longer in their assessment of both vaccines approved to date, it is important to acknowledge that, compared to the U.S. FDA or U.K. HMRA, EMA grants conditional, rather than emergency, approvals. Not only should conditional market authorisations ensure citizens’ trust in vaccines developed in record time, using the  brand-new mRNA technology, but also limit the EU and Member States legal responsibility in case of unforeseen side-effects and complications. In fact, prior to December, all EU27 governments and the vast majority of political commentators supported this approach on the basis of ensuring citizens’ buy in.

Meanwhile, throughout the past year while nobody yet knew about the success of any vaccination trials, the Commission engaged in negotiations with the relevant companies compiling a speculative portfolio of 2 million doses from six different manufacturers – enough for the entire EU population. In fact, at the time, nobody could have anticipated that the two vaccines based on the never-before used mRNA technology, BioNTech/Pfizer and Moderna, would so far be the only vaccines market ready. As a result, the Commission ordered up to 300 million and 160 million doses respectively. Huge 400 million doses orders are also placed with Johnson & Johnson, AstraZeneca and Germany’s Curevac, as well as a further 300 million with France’s Sanofi/GSK which will become available once they have finished clinical trials and gained regulatory approval.

Granted, while the Commission could have purchased more vaccines, it would not have changed the current supply bottlenecks, as they have always been expected in the early months while manufacturers aim to scale up their capacities. In fact, one of the underlying reasons why capitals chose to begin their vaccination campaigns with the most vulnerable and those above the age of 80, is also that it allows for a gradual rollout until the critical mass is available.

While all Member States have a certain supply of vaccines already available to them, it is now on local authorities to put in place the necessary and infrastructure to actually inoculate their people.