The EU Commission, acting with EU states and vaccine developers BioNTech-Pfizer, reached an agreement on 26 May to better address Member States’ assessment of evolving needs for COVID-19 vaccines.
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How was the agreement negotiated with BioNTech-Pfizer?
Negotiations followed the guidance provided by EU Member States in the Vaccine Steering Board. The objective being to reduce the number of doses and extend the delivery over the coming years as requested by Health Ministers during the EPSCO meeting on 9 December 2022.
Negotiations with BioNTech-Pfizer were conducted by a Joint Negotiation Team, consisting of representatives of the Commission and of experts from several Member States. This team negotiated with and on behalf of all Member States and under the guidance of the Vaccines Steering Board.
How does the conversion to optional doses work?
Purchase Agreements with vaccine developers, agreed by the participating Member States are legally binding and cannot be unilaterally changed.
That is why the conversion of originally contracted doses into optional orders has been agreed. To do so, a fee will be paid which is deductible from the price that Member States would have to pay per additional optional doses if Member States decide to activate such doses in the future.
What is the price of the doses?
The price of COVID-19 vaccines is considered a sensitive commercial information, and the signatories of the Purchase Agreement (PA) are contractually bound to confidentiality.
In general, the agreement ensures that the provisions from the amendment do not substantially deviate from what was initially agreed. This includes no variation of the price for the extended duration of the contract. Also, for the EU Vaccines Strategy the affordability of vaccines has always been a core principle.
How many doses should still be delivered under the contract?
On 20 May 2021, the European Commission acting with and on behalf of Member States signed a third contract with BioNTech-Pfizer. It committed the purchase of 900 million initial doses, with the option to purchase an additional 900 million doses. Of the 900 million initial doses, 450 million are scheduled to be delivered in 2021 and 2022 and 450 million doses in 2023.
Today’s amendment to the third contract with BioNTech-Pfizer foresees a reduction of doses compared to the originally contracted amount remaining to be delivered under the current contract.
Will these vaccines be adapted to future variants?
Member States will continue to receive the latest available versions of COVID-19 vaccines adapted for variants and authorised by regulators, should COVID-19 variants of concern appear in the future.
How many vaccines doses will Member States that have opted out receive?
Member States that opted out of the amendment will continue to be bound by current contractual obligations.
Do these opt-outs mean the end of the solidarity and joint approach of our vaccine strategy?
The EU Vaccines strategy has been successful in a way that very few thought possible back in 2020. Solidarity between Member States has been unprecedented and has allowed Member States to have equitable access to COVID-19 vaccines in quantities needed to protect EU citizens. Moreover, throughout the pandemic Member States have continuously acted in solidarity to respond to the evolution of the virus.
Today, the epidemiological situation has improved, and Member States continue to act together to reflect this situation in our COVID-19 vaccines contracts. The agreement reached with BioNTech-Pfizer, and which was negotiated by the Joint Negotiation Team, on behalf of Member States, is yet another example of EU solidarity. It is the result of negotiations with the companies and aimed at reaching the best possible outcome for all Member States collectively. Nevertheless, some Member States expressed they would have expected a different result and have therefore exercised their right to opt out of the proposed amendment, while allowing other Member States to still benefit from it. The Member States that opted out will continue to be bound by current contractual obligations.
Finally, the opt-out mechanism has always existed for all contracts concluded with vaccine developers. The fact that Member States make use of a mechanism which was jointly agreed with all Member States, illustrates that the joint approach works and is adapted to the needs of the Member States.
Has the Commission changed the liability rules? If so, how?
The COVID-19 vaccines contracts have not changed the EU liability rules and patients’ rights are fully preserved, including their ability to go to Court.
Safe COVID-19 vaccines for Europeans
Source: European Commission
