Clover Biopharmaceuticals (Clover), a global clinical-stage biotechnology company developing novel vaccines and biologic therapeutic candidates to address the world’s most life-threatening diseases and public health threats, today announced an advance purchase agreement (APA) with Gavi, the Vaccine Alliance, to provide up to 414 million doses of its protein-based COVID-19 vaccine candidate for procurement through the COVAX Facility. Pending an Emergency Use Listing (EUL) from the World Health Organization (WHO) for Clover’s COVID-19 vaccine candidate, Clover will make an initial 64 million doses available for procurement through the COVAX Facility in 2021. Gavi also retains options to procure up to an additional 350 million doses to be delivered in 2022. The agreement also contains the opportunity to access Clover variant-adapted COVID-19 vaccine candidates.

• Pending WHO EUL for its COVID-19 vaccine candidate, Clover is committed to providing 64 million doses in 2021 and Gavi has options for an additional 350 million doses in 2022
• Clover will receive a significant upfront payment, a payment upon positive Phase 2/3 data, potential payments upon option exercise and additional payments upon delivery of the doses based on a tiered pricing schedule

In exchange for these commitments, Clover will receive a significant upfront payment, a payment upon positive Phase 2/3 data, and additional advance payments upon Gavi’s exercise of options for doses to be delivered in 2022. Gavi will allocate Clover’s COVID-19 vaccine doses to the AMC (Advanced Market Commitment)-eligible and self-financing participants under a tiered pricing schedule. Clover will further receive additional payments upon the delivery of the doses of its COVID-19 vaccine at all pricing tiers, including doses being delivered to the AMC-eligible participants.

Joshua Liang, Chief Executive Officer of Clover Biopharmaceuticals said, “We are grateful for the support from Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI), and other COVAX partners in our joint pursuit of supporting global equitable access of COVID-19 vaccines and helping protect at-risk groups in participating countries. This pandemic continues to have a profound impact on the world, and we remain dedicated to expediting the availability of our COVID-19 vaccine candidate for procurement and global distribution.”

“The pandemic continues to evolve, and in order to be best prepared, COVAX’s actively managed, diverse portfolio will be critical to meeting countries’ needs, and protecting against risks such as regulatory delays, variant and supply constraints,” said Dr Seth Berkley, CEO of Gavi. “Today’s agreement with Clover Biopharmaceuticals is yet another important step in that direction.”

Dr. Richard Hatchett, CEO of CEPI said, “Today’s announcement of an advanced purchase agreement between COVAX and Clover will secure hundreds of millions of doses—pending an Emergency Use Listing from WHO—for globally fair allocation and will further support low-income and middle-income countries so that they can protect the most vulnerable members of their societies against this deadly virus. CEPI moved with urgency early on in the pandemic to accelerate the R&D needed to develop safe and effective COVID-19 vaccines, at speed. By late Spring 2020, CEPI had established nine COVID-19 vaccine programmes, including an early investment in Clover Biopharmaceuticals to advance their promising protein-based adjuvanted vaccine candidate and to enable equitable access to vaccine output funded by CEPI’s investment.”