The European Commission, on behalf of the European Union, approved an advance purchase agreement in which J&J subsidiary Janssen Pharmaceutical, which is developing the vaccine candidate, would supply the doses to EU member states following approval or authorization.
Under the agreement, for which financial terms were not disclosed, the EU member states also have the option to secure up to 200 million additional doses, according to a news release. The U.S. Dept. of Health and Human Services and Defense Dept. agreed to a $1 billion deal for the vaccine candidate from Johnson & Johnson in August.
Janssen’s COVID-19 vaccine candidate is being evaluated in a single-dose regimen in a large-scale, pivotal, multi-country Phase 3 trial that began in September. An additional Phase 3 study with a two-dose regimen is slated for later this year.
Speaking during the virtual MedTech Conference by AdvaMed, J&J chief scientific officer Dr. Paul Stoffels said the first doses of Janssen’s COVID-19 vaccine could be available for frontline healthcare workers in January or February, but added the company isn’t rushing it.
Separate to the agreement and as part of J&J’s broader commitment to a COVID-19 response, the company said it is planning to allocate up to 500 million vaccine doses toward international efforts to ensure access for lower-income countries, beginning delivery in the middle of next year once approval is garnered.
“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,” Stoffels said in the release. “We appreciate the commission’s and the member states’ support for our COVID-19 vaccine candidate and development efforts.”