Johnson & Johnson announced today that the European Commission (EC), acting on behalf of the member states of the European Union ( EU), approved an advance purchase agreement in which the Janssen Pharmaceutical Companies will provide 200 million doses of their vaccine candidate against COVID-19 to the member states, once approval or authorization is obtained from the entities regulators. EU member states also have the option of securing another 200 million additional doses.

"The COVID-19 pandemic continues to threaten communities around the world, and we have a responsibility to ensure access to our vaccine as soon as possible. We appreciate the support we have received from the Commission and member states. for our COVID-19 vaccine candidate and on our development efforts, "said Dr Paul Stoffels, vice chairman of the executive committee and chief scientific officer of Johnson & Johnson.

This contract comes after the conclusion of exploratory talks with the EC. The company is in discussions with other stakeholders, including national governments and global organizations, as part of its efforts to fulfil its commitment to making the vaccine candidate accessible globally, as long as it is proven to be safe, effective, and obtained the Approval or corresponding authorization by the regulatory entities.

Independent of the agreement with the EC, as part of a larger commitment by the company to act in the face of the COVID-19 pandemic, Johnson & Johnson also announced plans to allocate up to 500 million doses of the vaccine for international initiatives, seeking to ensure that low-income countries can have access to it, and with deliveries expected around the middle of next year, once approval or authorization is obtained from the regulators. Aware of the exceptional global demand for the COVID-19 vaccine, we are working tirelessly to further increase the number of doses available.

Johnson & Johnson is developing and evaluating Janssen's COVID-19 vaccine candidate in accordance with its customary rigorous ethical standards and sound scientific principles. The company is evaluating a single-dose regimen in its pivotal phase 3, large-scale, multinational trial (ENSEMBLE), which began in September. A second phase 3 study with a two-dose regimen is planned to begin later this year. The company is committed to transparency and sharing information related to the ENSEMBLE phase 3 study, including the study protocol.

Janssen's experimental COVID-19 vaccine is supported by Janssen's proprietary AdVac technology. This same technology was used to develop the EC approved Ebola vaccine regimen and is the basis for its candidate vaccines against HIV, RSV and ZIKA. To date, more than 100,000 people have received an AdVac based Janssen vaccine. Based on our knowledge of the stability of our vaccines, we anticipate that our COVID-19 vaccine candidate will be compatible with standard distribution channels, with no need for a new distribution infrastructure.