J&J to supply Europe with 200 million doses of COVID-19 vaccine
Posted: 9 October 2020 | Victoria Rees (European Pharmaceutical Review) | No comments yet
J&J has agreed that it will supply the EU with 200 million doses of its COVID-19 vaccine candidate following regulatory approval.
Johnson & Johnson (J&J) has announced that the European Commission (EC) has approved an Advance Purchase Agreement in which the Janssen Pharmaceutical Companies will supply 200 million doses of its COVID-19 vaccine candidate to EU member states following approval or authorisation from regulators. The EU states also have the option to secure up to 200 million additional doses.
“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 EC’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, J&J.
This contract follows the conclusion of exploratory talks with the EC. The company is also in ongoing discussions with other stakeholders, including national governments and global organisations, 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 authorisation from regulators.
Separate to the agreement with the EC, J&J has 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 approval or authorization from regulators.
The COVID-19 vaccine candidate is being evaluating in a single-dose regimen in its large-scale, pivotal, multi-country Phase III trial that started in September. A second Phase III study with a two-dose regimen is planned to start later this year.
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Clinical Development, Drug Manufacturing, Manufacturing, Vaccines