Johnson & Johnson (J&J) is collaborating with the UK government on a global Phase 3 clinical trial to explore the two-dose regimen of Janssen’s SARS-CoV-2 vaccine candidate, Ad26.COV2.S.
This global study will run in parallel to the Phase 3 trial investigating the single-dose regimen of Ad26.COV2.S.
In addition, J&J has agreed in principle to supply the UK Government with doses of its SARS-CoV-2 vaccine candidate, Ad26.COV2.S.
The availability of the vaccine candidate is subject to its successful development and regulatory approval.
“We are delighted to work with the UK Government on the global Phase 3 clinical programme for our COVID-19 vaccine candidate, and to ensure it is made available to citizens around the world, if proven to be effective with a good safety profile,” said Paul Stoffels, Vice Chairman of the Executive Committee and Chief Scientific Officer at J&J.
The parties will negotiate a final advance purchase agreement in due course under which the UK Government would initially purchase 30 million doses of Janssen’s Ad26.COV2.S vaccine candidate on a not-for-profit basis for emergency pandemic use.
The agreement will also provide the option for an additional purchase by the UK Government of up to a further 22 million vaccine doses.
The Phase 1/2a first-in-human clinical trial of the vaccine candidate, Ad26.COV2.S, is underway in healthy volunteers in the United States and Belgium. Planning is underway for the Phase 3 programme which is subject to interim data of the Phase 1 trials and approval of regulators.