The deal also includes an option that allows supply of up to 200 million additional doses to the EU member states.
This agreement was signed after the conclusion of exploratory talks with the EC.
Separately, J&J intends to supply up to 500 million vaccine doses to lower-income countries from mid next year following approval or authorisation from regulators.
Janssen’s Covid-19 vaccine is being developed and evaluated by J&J in line with its ethical standards of safety and scientific principles.
J&J is studying a single-dose regimen in its large-scale, pivotal and multi-country phase 3 ENSEMBLE study, which was commenced last month. The company plans to start a second phase 3 study with a two-dose regimen by the end of this year.
The investigational Covid-19 vaccine is said to leverage Janssen’s AdVac technology, which is the same technology utilised to develop its EC-approved Ebola vaccine regimen.
It also served as the basis for the company’s HIV, RSV and Zika vaccine candidates. Janssen AdVac-based vaccine had been already used for over 100,000 individuals.
Johnson & Johnson executive committee vice chairman and chief scientific officer Dr Paul Stoffels said: “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.’
In September, Janssen Pharmaceuticals partnered with injectable contract development and manufacturing organisation (CDMO) Grand River Aseptic Manufacturing (GRAM) to produce its SARS-CoV-2 vaccine candidate.