Johnson & Johnson (J&J) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a Positive Opinion to recommend the Conditional Marketing Authorization (CMA) for its single-dose COVID-19 vaccine candidate, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), to prevent COVID-19 in individuals 18 years of age and older.
Data from the Phase 3 ENSEMBLE study showed that the Johnson & Johnson COVID-19 vaccine was well tolerated and demonstrated a 67 per cent reduction in symptomatic COVID-19 disease in participants who received the vaccine in comparison to participants given the placebo.1 The onset of protection was observed from day 14 and was maintained 28 days post-vaccination. The data also demonstrated the vaccine was 85 per cent effective in preventing severe disease across all regions studied and showed protection against COVID-19 related hospitalisation and death, beginning 28 days after vaccination.
“The European Medicines Agency’s recommendation is a landmark moment for Johnson & Johnson and for the world. Now, as we await a decision on the use of our single-dose COVID-19 vaccine in the European Union, we remain confident that the Johnson & Johnson vaccine will prove a critical tool for fighting this pandemic,” said Paul Stoffels, Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson.
In December 2020, the company announced that Janssen initiated a rolling submission with the EMA for its single-dose COVID-19 vaccine candidate, enabling an expedited CHMP review process.2 The COVID-19 vaccine candidate has also been filed for an Emergency Use Listing (EUL) with the World Health Organisation.
The company received emergency use authorisation (EUA) in the US on February 27. The Johnson & Johnson single-dose COVID-19 vaccine has also been granted Interim Order authorisation in Canada.