In the midst of the budget turmoil (see separate article), the EU, on Monday 16 November, took advantage of some good news: it is preparing to authorise, from Tuesday 17 November, a new contract with the German start-up CureVac to pre-order up to 405 million doses of its candidate vaccine.
“This is our fifth contract with the pharmaceutical industry”, said the President of the European Commission, Ursula von der Leyen, in a pre-recorded video message. “We do not know at this stage, which vaccines will end up being safe and effective. The European Medicines Agency will only authorise it after a robust assessment. This is why we need to have a broad portfolio of vaccines”, she said.
The other four contracts are those signed with AstraZeneca, Sanofi, Johnson&Johnsonand Pfizer-BioNTech (see EUROPE 12600/5).
Moderna in good position
A sixth contract is also in the pipeline, this time with the American company Moderna. “We hope to finalise the contract soon“, said Mrs von der Leyen. The exploratory discussions finalised in August involved the purchase of 160 million doses (see EUROPE 12544/6).
On Monday 16 November, the European Medicines Agency also indicated that it was starting the ongoing review of non-clinical data issued by the Spanish branch of Moderna.
On the same day, the U.S. company published an interim analysis of its Phase III clinical trials, suggesting that its vaccine candidate is 94.5% effective. At this point, 90 participants in the placebo group reported Covid-19, compared to 5 in the vaccine group. However, a larger trial is still underway.
The previous week, the German-American alliance BioNTech/Pfizer announced that its candidate vaccine was 90% effective (see EUROPE 12598/12). The CEO of Pfizer had sold $5.6 million worth of shares in the US laboratory, triggering a wave of outrage.
Further steps expected at the Commission and EU Council on 18 and 19 November
On the other fronts, it should be recalled that the European Commission intends to present recommendations on rapid antigenic tests as well as on isolation and quarantine measures on Wednesday 18 November in view of the videoconference of European leaders the following day (see EUROPE 12594/3).
The recommendation on rapid tests should provide details on “the situations and criteria that countries will need to consider when using such tests and on the validation and mutual recognition of tests and their results”.
However, according to a report by the German Presidency of the EU Council of 12 November on the state of play regarding the coordination of the response to the Covid-19 pandemic at EU level, the Member States seem to be rather divided on this tool: “Many Member States would like to see greater harmonisation in the use of rapid antigen detection tests, including in relation to travel. However, a large number of Member States made it clear that they consider it premature to discuss minimum standards and common criteria, believing that more solid scientific data are still needed“, the minutes state.
It also states that “in IPCR (Integrated Political Crisis Response, editor’s note), some stressed that the use of rapid antigen tests is a Member State competence. A few have raised the need for caution in relation to using rapid antigen tests in connection with travel”. Link to the report: https://bit.ly/3nuw9z0 (Original version in French by Sophie Petitjean)