EU OKs Purchase of J&J’s COVID-19 VaccineBy
Johnson & Johnson has announced that the European Commission (EC), acting on behalf of European Union (EU) member states, has approved an advance purchase agreement in which the Janssen Pharmaceutical Companies will supply 200 million doses of the company’s COVID-19 vaccine candidate to EU member states following approval or authorization from regulators. The EU member states also have the option to secure up to 200 million additional doses
The 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 organizations, 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 its 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 (2021) following approval or authorization from regulators.
The company is evaluating a single-dose regimen of its COVID-19 vaccine candidate in a large-scale, multi-country Phase III trial that started in September (September 2020). A second Phase III study with a two-dose regimen is planned to start later this year (as reported on October 8, 2020).
Janssen’s investigational COVID-19 vaccine uses Janssen’s AdVac technology, which uses an adenovirus as a vector (a carrier), which has been genetically modified so that it can no longer replicate in humans and cause disease. The technology was also used to develop and manufacture the company’s Ebola vaccine, which has been approved by the EC, and for the constructs of its vaccine candidates respectively for Zika, respiratory syncytial virus, and HIV.
Source: Johnson & Johnson