The European Commission (EC) has recently approved an Advance Purchase Agreement in which the Janssen Pharmaceuticals will supply 200 million doses of its COVID-19 vaccine candidate to the EU member states following approval or authorization from regulators, announced Johnson & Johnson.
The EU member states also have the option to secure up to 200 million additional doses, said the company.
The company has also announced plans to allocate up to 500 million vaccine doses toward international efforts to ensure access for lower-income countries, with delivery beginning mid-2021 following approval or authorization from regulators. “Recognizing the unique global demand for COVID-19 vaccines, we are working tirelessly to further expand the number of available doses,” stated Paul Stoffels, MD, Vice-Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson.
The company is evaluating a single-dose regimen in its large-scale, pivotal, multi-country phase 3 trial (ENSEMBLE) that started in September. A second phase 3 study with a two-dose regimen is planned to start towards the last of 2020.
Janssen’s investigational COVID-19 vaccine leverages Janssen’s AdVac technology, based on the development and production of adenovirus vectors. The same technology was used to develop Janssen’s EC-approved Ebola vaccine regimen and is the basis for its HIV, RSV and Zika vaccine candidates, said the company.