The European Commission has granted a conditional marketing authorisation for Johnson & Johnson’s (J&J) single-dose COVID-19 vaccine in individuals aged 18 years and older.
The authorisation closely follows a positive opinion issued by the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
“We are thrilled with [this] conditional marketing authorisation by the European Commission, which enables our single-dose vaccine to reach many more communities in need, as we continue to do everything we can to help bring an end to this pandemic,” said Alex Gorsky, chairman and chief executive officer of J&J.
The authorisation was supported by data from J&J’s Phase III ENSEMBLE trial, which demonstrated a 67% reduction in symptomatic COVID-19 disease in participants who received the vaccine compared to placebo.
The results also showed that the vaccine was 85% effective in preventing severe disease across all regions studied, and also demonstrated protection against COVID-19-related hospitalisation and death, 28 days after vaccination.
J&J said in a statement that it aims to begin delivery of the single-dose vaccine to the EU in the second half of April, and to supply 200 million doses to the EU (plus Norway and Iceland) in 2021.
“This latest major regulatory milestone would not have been possible without the hard work and dedication of everyone involved in our COVID-19 vaccine clinical trial programme, including our J&J team, our partners and study participants,” said Mathai Mammen, global head, Janssen research & development, J&J.