The agreement announced today has secured the following adaptations to the existing contract:
- a reduction in the quantity of doses purchased by Member States under the contract. Following payment of a fee, originally contracted doses will be converted into optional orders;
- an extension in the length of time in which Member States will be able to take delivery of the vaccines – up to 4 years from now;
- the possibility to continue to have access to additional doses up to the original contracted volume until the end of the contract to meet needs, should cases rise, and the epidemiological situation deteriorate;
- continued access to vaccines adapted to new variants as soon as authorised by the regulators.
The amendment was reached following negotiations between the vaccine developers, Member States and the Commission to better align to vaccine strategies and the evolving public health needs in the Member States.
Background
As from 2020, and in line with ourEU Vaccines Strategy, the European Union invested heavily in the global production of COVID-19 vaccines. It was crucial to have vaccines as early as possible and at the scale needed, requiring important investments before knowing whether any of these vaccines would prove successful.
The implementation of our EU Vaccines Strategyexceeded all expectations: EU Member States had access to safe and effective vaccines from a broad portfolio of different technologies, and at the scale needed, allowing all EU citizens to be offered primary and booster vaccinations, saving lives and mitigating the impact the pandemic had upon social and economic life.
Moreover, a large number of these vaccines have been used in the global efforts to tackle the pandemic. Member States have shared 526 million doses of which around 494.4 million have already been delivered to recipient countries.
At the same time, Member States must continue to ensure they have the strategic stocks of vaccines they need to protect the vulnerable parts of their populations and deal with the potential epidemiological evolution of the COVID-19 virus.
The Commission, Member States and BioNTech-Pfizer have previously signed amendments to the contract which adapted delivery schedules to the needs of the Member States and established a central storage facility increasing storage capacity for Member States.
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Quotes
I warmly welcome the agreement reached with and on behalf of our Member States with BioNTech-Pfizer to adapt the COVID-19 vaccine supply in order to match evolving needs. We have brought the pandemic under control largely through our vaccines and vaccinations. And while COVID-19 is no longer a global health emergency, it remains a threat that is likely here to stay. It is crucial therefore that we are prepared for the years to come.
Q&A: EU Commission secures agreement with BioNTech-Pfizer on the delivery of vaccines
Brussels, 26 May 2023
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.
Have you 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.
More information
Safe COVID-19 vaccines for Europeans
HERA
Source – EU Commission