While the European Commission on Monday approved Pfizer-BioNTech’s vaccine against the coronavirus, most citizens in the EU member states are still in the dark about the vaccination programmes and when they will be vaccinated.
The Commission has referred to confidentiality clauses in the contracts with the vaccines producers when asked about the prices paid for the vaccines but has also declined to disclose the number of doses to be delivered in the first batches to the member states.
According to a new list of Questions & Answers, the Commission is negotiating intensely to build a diversified portfolio of vaccines for EU citizens at fair prices. By now it has secured a portfolio of more than 2 billion doses, enough for four times the population in the EU.
Contracts have been concluded with AstraZeneca (400 million doses), Sanofi-GSK (300 million doses), Johnson and Johnson (400 million doses ), BioNTech-Pfizer 300 million doses, CureVac (405 million doses) and Moderna (160 million doses). The Commission has also concluded exploratory talks with the pharmaceutical company Novavax with a view to purchasing up to 200 million doses.
Only the vaccine developed by BioNTech and Pfizer has by now been given conditional marketing authorisation following EMA positive assessment by the European Medicines Agency (EMA) of its safety and efficacy. It is now waiting for EMA's opinion on the possible authorisation for the vaccine by Moderna, which should be provided by 12 January at the latest.
No other vaccine producer has formally applied for a marketing authorisation to EMA. In order to accelerate the process, EMA has started rolling reviews on the vaccines produced by Johnson and Johnson and AstraZeneca.
Should all vaccines candidates turn out to be safe and effective, member states have the possibility to donate part of their doses to lower- and middle-income countries.
The safety and effectiveness of vaccines which have received conditional marketing authorisations will be rigorously monitored, as for all medicines, through the EU's established medicines monitoring system.
First deliveries of the BioNTech and Pfizer vaccine are expected within days of authorisation and first vaccinations would take place in the context of the EU vaccination days of 27-29 December.
All member states will have access to COVID-19 vaccines at the same time on the basis of the size of their population. The overall number of vaccine doses will however be limited during the initial stages of deployment and before production can be ramped up.
For most contracts concluded, the majority of delivery is foreseen to be completed in 2021. Under some contracts, first deliveries are expected to already start in the first quarter of 2021.
The Commission has been asking national authorities to prepare as early as possible for organising the fast and accessible deployment of vaccines, according to national vaccination plans and has issued guidance on the large-scale vaccination deployment, but the vaccination plans have not been published.
Instead, the Commission is referring to an overview published by the European Centre for Disease Prevention and Control (ECDC) on 2 December of where the member states are with the development of their vaccination plans. ECDC is also working on a modelling exercise on prioritisation to support member states. This report should be published before Christmas, according to the Commission.
M. Apelblat
The Brussels Times
