That's two! After the Pfizer-BioNTech vaccine, it is now the Moderna one which received a conditional marketing authorisation from the EU on Wednesday 6 January (see EUROPE 12627/3). The European Commission has thus followed the recommendations of the European Medicines Agency (EMA) made public a few hours earlier.
In total, the EU has ordered 160 million doses from the US biotech company, to be delivered between the first and third quarter of 2021. This approval should give a boost to vaccination campaigns in the EU, which are considered to be too slow compared to what is being done in the United States or the United Kingdom (see EUROPE 12628/2).
However, the European ordering procedure has been under strain since Germany confirmed that it has bilaterally booked 30 million doses with BioNTech.
Moderna: 94.1% efficiency
The green light obtained by Moderna is far from being a surprise. The U.S. company, which filed an application for conditional approval with the EMA at the same time as Pfizer-BioNTech, uses the same technology (messenger RNA) and has achieved results that are as good as those achieved by the competing alliance.
In phase III clinical trials, in which 30,000 people participated, the vaccine demonstrated 94.1% efficacy. Of the 14,134 people who received it, only 11 developed symptoms of Covid, compared with 185 of the 14,073 who received the placebo. The trial also showed an efficacy of 90.9% in participants at risk of severe forms of Covid, such as those with chronic lung disease or obesity.
The European Commission in trouble
At the Commission's midday briefing, however, journalists' questions focused more on the Pfizer-BioNTech vaccine and Germany's compliance with the rules.
Earlier this week, Berlin had claimed to have concluded a bilateral memorandum of understanding with BioNTech in September, one month before the Commission sealed a contract on behalf of all Member States. Article 7 of the Annex to the Commission Decision establishing the European procedure explicitly provides that a Member State is not allowed to negotiate separately.
Embarrassed, the Commission reiterated that “according to its understanding” the German order was indeed part of the European procedure. It recalled that the EU ordered 300 million doses from Pfizer-BioNTech, i.e. 200 million at the outset and 100 million through a call option exercised more recently in light of the good results of clinical trials. These 100 million doses, it explains, have yet to be distributed and this is what the German order is all about.
An unconvincing explanation, at a time when the German authorities have explicitly confirmed to EUROPE that this was a separate order.
However, the Commission is currently negotiating with Pfizer-BioNTech for a new order. Negotiations which, if successful, might solve the problem. This would make the pill easier for other Member States to swallow. (Original version in French by Sophie Petitjean)