Janssen's COVID vaccine application submitted to EMA
The European Medicines Agency (EMA) announced Tuesday that Janssen, a division of Johnson & Johnson, has submitted an application for conditional marketing authorization for its one-dose vaccine against COVID-19.The submission package now goes before EMA’s human medicines committee (CHMP) for an accelerated assessment. “The Committee could issue an opinion by the middle of March 2021, provided the company’s data on the vaccine’s efficacy, safety and quality are sufficiently comprehensive and robust,” said EMA in announcing its receipt of the Janssen application.
EMA has been considering preclinical and clinical data for Janssen’s COVID-19 vaccine as they become available under its rolling review scheme, which shortens the time for evaluation. The agency has already reviewed quality data, preclinical data on immunogenicity, and clinical safety data for the modified human adenovirus vector used in the vaccine.
The rolling review process has previously been used to speed CHMP’s recommendations for conditional marketing authorization for three other COVID-19 vaccines: the messenger RNA (mRNA) vaccine codeveloped by Pfizer and BioNTech as well as the mRNA vaccine developed jointly by Moderna and the US National Institutes of Health, as well as the chimpanzee adenovirus vector vaccine developed by AstraZeneca and the University of Oxford. (RELATED: EMA okays Europe’s second COVID vaccine, Regulatory Focus 07 January 2021)
Vaccine candidates under development by CureVac and by Novavax, as well as a therapeutic antibody combination being developed by Regeneron and Roche, were also taken into the rolling review scheme earlier this month.
Overall, EMA has explained that the rolling review, which happens in approximate 14-day cycles, can shave the usual 210-day timeline for marketing authorization approximately in half. Once conditional marketing authorization is granted to a vaccine or therapeutic under EMA’s rolling review process, the agency requires the marketing authorization holder to submit monthly safety reports, which are then publicly reported by EMA.
EMA