J&J submitted its application for Emergency Use Authorization in the US on Thursday (January 4), and expects to supply 100 million doses of the single-shot vaccine in the country in the first half of 2021.
A rolling review is already under way in Europe, with the company planning to submit a Conditional Marketing Authorization Application in the coming weeks. It has a supply agreement with the EU for up to 400 million doses (200 million with the option to secure 200 million additional doses).
“Our submission for Emergency Use Authorization [in the US] of our investigational single-shot COVID-19 vaccine is a pivotal step toward reducing the burden of disease for people globally and putting an end to the pandemic,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson. “Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping. With our submission to the FDA and our ongoing reviews with other health authorities around the world, we are working with great urgency to make our investigational vaccine available to the public as quickly as possible.”
At the end of January, J&J reported the vaccine is 66% effective at preventing moderate to severe COVID-19. The Janssen viral vector vaccine also demonstrated protection against multiple virus variants, including the South Africa B.1.351 lineage (15% of the study’s participants were based in South Africa). The company also champions the logistic advantages of a single-shot vaccine (most others currently authorized are two-dose vaccines) and thus its ability to protect more people more quickly.
The Janssen vaccine candidate is compatible with standard vaccine distribution channels. The vaccine is estimated to remain stable for two years at -20°C (-4°F), at least three months of which can be at temperatures of 2-8°C (36°F–46°F). The company will ship the vaccine using the same cold chain technologies it uses today to transport other medicines.
J&J says its anticipated manufacturing timeline remains on schedule and the company is on track to meet its 2021 supply commitments, including those signed with governments and global organizations.
The Janssen COVID-19 vaccine candidate uses the company's AdVac viral vector vaccine platform, which was also used to develop and manufacture Janssen’s European Commission-approved Ebola vaccine regimen and construct its Zika, RSV, and HIV investigational vaccine candidates.