Johnson & Johnson said Thursday the European Commission, acting on behalf of the European Union Member States, approved an Advance Purchase Agreement in which the Janssen Pharmaceutical Cos. will supply 200 million doses of its COVID-19 vaccine candidate to EU Member States.
They also have the option to secure up to 200 million additional doses from Johnson & Johnson.
“The COVID-19 pandemic continues to threaten communities worldwide and we have a responsibility to ensure access to our COVID-19 vaccine as soon as we can. We appreciate the Commission’s and the Member States’ support for our COVID-19 vaccine candidate and development efforts,” said Dr. Paul Stoffels, vice chairman of the executive committee and chief scientific officer, Johnson & Johnson.
This contract follows the conclusion of exploratory talks with the EC.
The company is in ongoing discussions with other stakeholders, including national governments and global organizations, as part of its efforts to meet its commitment to making its vaccine candidate accessible globally, provided the vaccine has a good safety profile, is efficacious and receives approval or authorization from regulators.
Separate to the agreement with the EC, Johnson & Johnson also announced plans to allocate up to 500 million vaccine doses toward international efforts to ensure access for lower-income countries, with delivery beginning in the middle of next year following approval or authorization from regulators.
Johnson & Johnson is developing and testing Janssen‘s COVID-19 vaccine candidate and 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 later this year.