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The agreement offers European Union member states the option of securing up to 200 million additional doses for a total of up to 400 million doses.
Johnson & Johnson announced on October 8, 2020 that the European Commission (EC), acting on behalf of the member states of the European Union (EU), has approved an Advance Purchase Agreement in which Janssen Pharmaceutical Companies will supply 200 million doses of its COVID-19 vaccine candidate to EU Member States after approval or clearance by regulators. EU member states also have the option of securing up to 200 million additional doses.
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 fulfill its commitment to make its candidate vaccine accessible globally, provided the vaccine has a good safety profile. , be effective and receive approval or authorization. of regulators.
Aside from the agreement with the EC, as part of the Company’s broader commitment to respond to the COVID-19 pandemic, Johnson & Johnson has also announced plans to allocate up to 500 million doses of vaccines to international efforts to ensure access. to lower income countries. and delivery will begin in the middle of next year after approval or clearance from regulators.
Johnson & Johnson is developing and testing Janssen’s COVID-19 vaccine candidate in accordance with its rigorous customary ethical safety standards and sound scientific principles. The Company is evaluating a single-dose regimen in its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) that began in September. A second phase 3 study with a two-dose regimen is scheduled to begin later this year. The Company is committed to transparency and the exchange of information related to Phase 3 of the ENSEMBLE study, including the study protocol. Janssen Investigational COVID-19 Vaccine Takes Advantage of Janssen’s AdVac® technology.
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