Answer given by Ms Kyriakides on behalf of the European Commission

The advance purchase agreements, on which the EU Vaccines Strategy[1] is based, were concluded with vaccine producers having promising COVID-19 vaccine candidates as well as the potential to deliver doses at the necessary scale and speed, and taking the selection criteria listed in the strategy into account.

A Steering Board — composed of representatives of all Member States — steered the Commission and the Joint Negotiation Team on the negotiation of the advance purchase agreements. Furthermore, as stated in the agreement between the Commission and Member States, which forms the basis of the strategy, ‘In order to launch negotiations with a specific manufacturer, there needs to be support from at least four participating Member States’.

When the strategy was developed, nobody knew which of the many COVID-19 vaccines under development worldwide would be successful.

This is why the Commission aimed for a broad portfolio of vaccine candidates, representing different technologies. Concerning the BioNTech-Pfizer vaccine, the Commission has now secured up to 600 million doses, acknowledging the success of the mRNA technology. The Commission signed the agreement following a positive outcome of a negotiated tender procedure based on objective criteria.

In order to authorise any medicinal product, the European Medicines Agency needs to have and assess robust information on its safety, efficacy and pharmaceutical quality, with safety being of the utmost importance. The safety requirements for COVID-19 vaccines remain as high as for any other vaccine in the EU, the context of a pandemic does not change this.

• [1] https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1597339415327&uri=CELEX:52020DC0245