J&J and Europe agree on Janssen Covid-19 vaccine candidate, subject to regulatory okay

The European Commission (EC), acting on behalf of the European Union (EU) member states, has approved an advance purchase agreement in which the Janssen Pharmaceutical Companies will supply 200 million doses of its Covid-19 vaccine candidate following approval or authorization from regulators.

The member states also have the option to secure up to 200 million additional doses, according to an announcement issued today by Johnson & Johnson.

The investigational Covid-19 vaccine leverages Janssen's AdVac technology that was used to develop Janssen's EC-approved Ebola vaccine regimen and is the basis for its HIV, RSV and Zika vaccine candidates.

The Covid-19 vaccine, if successful, is estimated at launch to remain stable for two years at -20°C and at least three months at 2-8°C, according to a September 23 company release that noted, “This makes the vaccine candidate compatible with standard vaccine distribution channels and would not require new infrastructure to get it to the people who need it.”

The Covid-19 contract follows the conclusion of exploratory talks with the EC. The company said it is in ongoing discussions with other stakeholders, including national governments and global organizations, as part of its efforts to meet its commitment to make 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 mid next year following required regulatory acceptance.

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 later this year.

Johnson & Johnson previously announced it has been scaling up its manufacturing capacity and remains on track to meet its goal of providing one billion doses of a vaccine each year.