The company has also started discussions with other regulatory agencies around the world for the recombinant viral vector candidate.
In Europe, the rolling review allows the EMA to speed up assessment of vaccines during a public health emergency, with the agency able to start reviewing data as and when they become available from pre-clinical and ongoing studies, alongside information on ingredients and manufacturing.
AdVac platform already approved by European Commission
The Janssen COVID-19 vaccine candidate, Ad26.COV2.S (also known as JNJ-78436735) is a recombinant vector vaccine using a human adenovirus to express the SARS-CoV-2 spike protein in cells. It uses the company’s AdVac vaccine platform, which was used to develop and manufacture Janssen’s Ebola vaccine regimen - approved by the European Commission in July this year - and construct its Zika, RSV, and HIV investigational vaccine candidates.
The vaccine is estimated to remain stable for two years at -20 °C and at least three months at 2-8° C. This would make the vaccine candidate compatible with standard vaccine distribution channels, says J&J.
The company has reached a deal with the European Union to supply up to 400 million doses of the vaccine if approved.
The EMA application is based on a single-dose regimen: distinguishing it from most other front-runners in COVID-19 vaccine development. The vaccine is currently in Phase 3 trials (‘Ensemble’) with up to 60,000 people aged 18 years and older in the US, Argentina, Brazil, Chile, Colombia, Mexico, Peru and South Africa.
However, J&J has also started exploring the potential of the vaccine as a two-dose regimen in a second Phase 3 trial, which started this month in Ensemble 2.
The EMA is already assessing three other COVID-19 vaccines. Pfizer/BioNTech and Moderna have this week completed their rolling review with the submission of a Conditional Marketing Authorization application; while AstraZeneca's vaccine candidate is in an ongoing rolling review.