Contract Pharma Staff09.16.20
Valneva SE, a specialty vaccine company focused on prevention against diseases with major unmet needs, has partnered with the UK government for its inactivated COVID-19 vaccine, VLA2001.
Under the agreement, if vaccine development is successful, Valneva will provide the UK government with 60 million doses in the second half of 2021. The UK Government then has options over 40 million doses in 2022 and a further 30 million to 90 million doses, in aggregate, across 2023 to 2025. Revenue from these options could amount to almost €900 million ($1.1 billion).
The UK government is also investing up-front in the scale up and development of the vaccine, with the investment being recouped against the vaccine supply under the partnership. The agreement follows the initial intent to participate in the UK Government’s COVID-19 vaccine response announced in July.
The Vaccine Candidate
Valneva’s vaccine candidate, VLA2001, is based on a proven approach and will leverage the company’s existing manufacturing platform being used for its US FDA and EMA approved Japanese Encephalitis (JE) vaccine. VLA2001 is expected to enter clinical studies at the end of 2020 and, if the clinical development is successful, a first regulatory approval may be granted in the second half of 2021.
“Our proven track record and manufacturing capability in Scotland underpins this partnership. Through our recent discussions we’ve built a great working relationship with UK Government. I’d like to acknowledge the contributions of UK government task force and colleagues as well as other stakeholders including West Lothian, Scottish and UK politicians who are supporting the ongoing work. We see a fantastic spirit across all stakeholders to make this partnership succeed,” said David Lawrence, chief financial officer of Valneva.
Thomas Lingelbach, CEO of Valneva, commented, “We made the early decision to choose a proven and well-established inactivated vaccine approach which is further validated by this partnership. We are honored to have been chosen by the UK Government and are eager to partner with them to address this terrible ongoing pandemic. This is another transformational step for Valneva following the Lyme partnership we signed earlier this year and our chikungunya vaccine commencing Phase 3 clinical studies last week. ”
Valneva had previously announced an agreement in principle with the UK government for the supply of vaccine doses and a binding preliminary agreement to support expansion of its UK-based manufacturing facilities.
Under the agreement, if vaccine development is successful, Valneva will provide the UK government with 60 million doses in the second half of 2021. The UK Government then has options over 40 million doses in 2022 and a further 30 million to 90 million doses, in aggregate, across 2023 to 2025. Revenue from these options could amount to almost €900 million ($1.1 billion).
The UK government is also investing up-front in the scale up and development of the vaccine, with the investment being recouped against the vaccine supply under the partnership. The agreement follows the initial intent to participate in the UK Government’s COVID-19 vaccine response announced in July.
The Vaccine Candidate
Valneva’s vaccine candidate, VLA2001, is based on a proven approach and will leverage the company’s existing manufacturing platform being used for its US FDA and EMA approved Japanese Encephalitis (JE) vaccine. VLA2001 is expected to enter clinical studies at the end of 2020 and, if the clinical development is successful, a first regulatory approval may be granted in the second half of 2021.
“Our proven track record and manufacturing capability in Scotland underpins this partnership. Through our recent discussions we’ve built a great working relationship with UK Government. I’d like to acknowledge the contributions of UK government task force and colleagues as well as other stakeholders including West Lothian, Scottish and UK politicians who are supporting the ongoing work. We see a fantastic spirit across all stakeholders to make this partnership succeed,” said David Lawrence, chief financial officer of Valneva.
Thomas Lingelbach, CEO of Valneva, commented, “We made the early decision to choose a proven and well-established inactivated vaccine approach which is further validated by this partnership. We are honored to have been chosen by the UK Government and are eager to partner with them to address this terrible ongoing pandemic. This is another transformational step for Valneva following the Lyme partnership we signed earlier this year and our chikungunya vaccine commencing Phase 3 clinical studies last week. ”
Valneva had previously announced an agreement in principle with the UK government for the supply of vaccine doses and a binding preliminary agreement to support expansion of its UK-based manufacturing facilities.
