Momentum builds for equitable procurement of COVID-19 vaccines as EU lays out strategy
EC launches EU-wide procurement strategy to ensure equitable access to COVID-19 vaccines in Europe
The push to secure supplies of COVID-19 vaccines gathered more steam Wednesday with the European Commission launching an EU-wide procurement strategy to ensure equitable access to COVID-19 vaccines in Europe.
The initiative is separate from the COVID-19 Vaccine Global Access global purchasing pool launched by a coalition of health organizations, national governments and private companies. The COVAX initiative is intended to procure vaccines for both wealthy and low-income countries, while the EU commitment aims to meet European demand before making vaccines available globally.
According to the EU Strategy for COVID-19 Vaccines published Wednesday, the European Commission will enter advanced purchase agreements directly with COVID-19 vaccine producers on behalf of EU member states. Using the EU’s existing €2.7 billion ($3 billion) Emergency Support Instrument, the EC would provide an advanced payment in exchange for the right to buy an agreed upon number of vaccine doses at a set price during a prespecified time frame.
The document makes no specific mention of the COVAX purchasing pool, which was established by the Access to COVID-19 Tools (ACT) Accelerator to ensure priority populations around the world have access to a COVID-19 vaccine (see “COVAX Created to Try and Avoid Global Bidding Frenzy for COVID-19 Vaccines”).
But the strategy does note that the EU’s advanced purchase agreements contribute to the global response by supporting and accelerating clinical trials of vaccines and de-risking manufacturing investments. These actions will “significantly increase the potential for the world to have access to an affordable vaccine sooner than would otherwise be the case,” the strategy document said.
The EC said it is ready to enter into advanced purchase agreements with all vaccine manufacturers that have either started or have concrete plans to start a clinical trial in 2020. The criteria for selecting which vaccine to purchase will include available data and the “soundness of the scientific approach and technology”; the ability to deliver sufficient quantities of vaccine this year and in 2021; cost; and production capacity within the EU.
The purchase agreements will target a variety of vaccine technologies.
There are 18 COVID-19 vaccines in clinical testing, according to BioCentury’s COVID-19 Resource Center, with CureVac AG becoming the latest entrant on Wednesday. The German biotech said it is starting a Phase I trial for its mRNA vaccine candidate, which targets the spike protein of SARS-CoV-2.
The EC said the agreements will also require manufacturers to commit to making future doses of vaccines available globally, and that the companies engage with EMA early with a view to submitting the vaccines for marketing authorization.
While the contracts will be negotiated by the EC directly, once a vaccine becomes available it will be left for EU member states to acquire the vaccine at the negotiated rates. Allocation of vaccine doses to member states will be done according to a population-based distribution key. All EU countries will be represented on a steering committee that will assist the EC in all aspects of the contract negotiations.
Should the €2.7 billion prove insufficient to cover the financing requirements, the EC and EU countries can agree to add capital to the Emergency Support Instrument. Alternatively, vaccine companies can tap the European Investment Bank for debt or equity-based financing options to support manufacturing scale-up or development costs. Last week BioNTech SE (NASDAQ:BNTX) received €100 million in debt financing to scale up European manufacturing of its COVID-19 mRNA vaccine candidate BNT162.
Beyond the procurement process, the EC said it is taking steps to shorten regulatory review time for COVID-19 vaccines. In addition to the existing regulatory mechanisms available to EMA such as conducting a rolling review of data and conditional authorization, the EC said it would shorten the period typically required to consult member states on a pending CHMP positive recommendation. It also would allow for the translation of documents into the full set of EU languages after authorization, rather than before. The result would cut the EC response time to one week from the nine weeks it typically takes.