The European Commission does not appreciate the delays in the delivery of vaccines against Covid-19. After having been relatively indulgent with Pfizer-BioNTech, with whom a compromise seems to have been found (see EUROPE 12640/1), the institution hardened its tone with AstraZeneca on Monday 25 January, which has also just announced problems with the delivery of its candidate vaccine.
The institution also proposed to Member States at a meeting of the Steering Board on Vaccine Advance Purchase Agreement (APA) that an export transparency mechanism be put in place as soon as possible.
AstraZeneca’s vaccine, not yet authorised, already overdue
At this stage, the vaccine produced by AstraZeneca, which is cheaper and more easily transportable than those produced by Pfizer-BioNTech and Moderna, the only two authorised for the moment, is not yet authorised in the European Union. The European Medicines Agency (EMA) is expected to deliver its opinion for a conditional marketing authorisation at its meeting on 29 January.
The doses negotiated this summer by the European Commission on behalf of the Member States (300 million, with an option for a further 100 million doses) should therefore have started to arrive on European territory on 15 February, in accordance with the orders placed by the Member States (see EUROPE 12547/7).
However, “the company AstraZeneca surprisingly informed the Commission and the European Union Member States that it intends to supply considerably fewer doses in the coming weeks, than agreed and announced”, explained Health Commissioner Stella Kyriakides.
According to a European source, the laboratory - which cites production problems in a Belgian factory run by its partner Novasep - could supply 60% fewer doses in the first quarter than initially planned.
At the midday meeting, a Commission spokesperson recalled that orders from the Member States were placed “as early as autumn” and that AstraZeneca was “supposed to start production before the authorisation is issued so that the doses can be distributed as soon as the green light is given”.
“This new schedule is not acceptable to us!”, Stella Kyriakides reacted, echoing a letter she had sent the day before to the Anglo-Swedish group and a telephone conversation held in the morning between the President of the Commission, Ursula von der Leyen, and the CEO of AstraZeneca, Pascal Soriot.
Towards an export transparency mechanism
In the face of these delays, the Commission is calling for transparency. “The EU has pre-financed the development of the [AstraZeneca] vaccine and its production and wants to see the return. We want to know exactly which doses have been produced, where, by AstraZeneca so far, and if or to whom they have been delivered”, Ms Kyriakides said.
The Commissioner was speaking at the end of the APA Steering Board meeting, which AstraZeneca also attended. She said that the “answers of the company have not been satisfactory” and therefore a second meeting of the steering board was to be held in the evening.
The European Commission is under fire because AstraZeneca is not the only laboratory to review its commitments. Last week, Pfizer-BioNTech had announced “three to four weeks” of delay, before committing to limit the delay to one week. And on Monday, Poland announced that Moderna would deliver its doses several days late.
Although Italy has already announced its intention to take legal action against Pfizer and the President of the European Council, Charles Michel, has said he is prepared to “use all legal means” available to the EU, the Commission believes it is too early to enter into a legal discussion. It intends to give priority to dialogue with companies.
However, to avoid further unpleasant surprises, the institution suggests that an export transparency mechanism be put in place as soon as possible. “We want clarity on transactions and full transparency concerning the export of vaccines from the EU”, said Stella Kyriakides. She suggested that, in the future, companies should be required to introduce early notification for any exports of vaccines to non-Member States, with the understanding that “humanitarian deliveries” would not be affected. (Original version in French by Sophie Petitjean)