European Union Member States have had a sluggish start to their vaccination campaigns after the European Commission gave the green light in December to the vaccine marketed by the BioNTech and Pfizer alliance. As of 4 January, only a few hundred thousand people had received their first dose across the EU, with wide variations evident between countries.
These figures contrast with those of China, the United States and Israel, who have already administered several million doses.
Facing criticism over this, the European Commission defended itself on Monday 4 January, arguing that it was not acting too timidly. However, it did indicate that it was in discussion with Pfizer/BioNTech to see “if it is possible to add additional doses to the number already agreed upon”.
The advance purchase agreement with the German-US alliance covers a total of 300 million doses.
“ Don't put all your eggs in one basket”
“The EU has managed to ensure a diversified portfolio of vaccines during a time of great uncertainty”, said the institution's spokesperson for health, Stefan de Keersmaecker, at the midday press briefing; he also added that the EU did not want to “put all of its eggs in one basket”.
It should be remembered that the European Commission negotiated a purchase option for 2 billion doses of six vaccine candidates, namely those from Pfizer/BioNTech, AstraZeneca, Johnson & Johnson, CureVac, Moderna and Sanofi-GSK. A 7th contract is also expected to be signed, after the conclusion of preliminary discussions, with Novavax (see EUROPE 12625/7).
At this stage, however, only the Pfizer/BioNTech vaccine has a conditional marketing authorisation in the EU-27 (see EUROPE 12627/3). The European Commission is also due to rule in the coming days on the vaccine candidate developed by Moderna, of which 160 million doses have been pre-reserved. It is awaiting the opinion of the EMA, which is expected to be published on Wednesday 6 January.
No other upcoming dates
There will be a need to be patient in respect of other vaccine candidates, since the EMA is still analysing the data provided by the companies.
This is also the case for the vaccine candidate developed by AstraZeneca, which has been administered in the UK since Monday. In a press release published on 30 December 2020, the EMA indicated that as part of its rolling review, it was still in the process of analysing the latest clinical data provided by the firm on 21 December.
“Additional scientific information on issues related to quality, safety and efficacy of the vaccine is deemed necessary to support the rigour required for a conditional marketing authorisation and this has been requested from the company. Further information from the ongoing clinical trials is also expected from January. Interim data from a large trial ongoing in the USA are expected in Q1 2021”, the EU agency explained.
The EU as a scapegoat?
Accustomed to taking blows, the European Commission has insisted that it has prioritised the safety and efficacy of vaccines. It also indicated that it was constantly in contact with manufacturers and Member States to see how improvements to production capacity could be made. However, it declined to comment on whether there was a possible lack of preparation on the part of some Member States, merely noting that its recommendations dated from mid-October (see EUROPE 12582/7).
Finally, regarding the news that the institution had declined Pfizer's offer of 500 million doses, Stefan de Keersmaecker again dodged the issue on Monday, insisting nonetheless that “in October, there were still doubts over technology that used messenger RNA”.
While the European process normally precludes bilateral contracts, the German Ministry of Health has confirmed to EUROPE that it has reserved 30 million additional doses from BioNTech, separate from the 300 million European doses, “since it is not certain that all current vaccine candidates will be approved”, said the German ministry. (Original version in French by Sophie Petitjean)