Johnson & Johnson (J&J) has secured the European Commission (EC) conditional marketing authorisation (CMA) for the single-dose Covid-19 vaccine, developed by its pharmaceutical company Janssen.
EC authorised the vaccine candidate to prevent the Covid-19 in people aged 18 years and older, in all 27 EU member states, along with Norway, Iceland and Liechtenstein.
The EC authorisation follows a positive opinion from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP).
The vaccine was previously granted Emergency Use Authorisation (EUA) from the FDA and was also authorised in Canada, under an interim order.
Johnson & Johnson chairman and CEO Alex Gorsky said: “For more than a year, we have been working around the clock – leveraging the scientific minds, scale and resources of our global organization to bring forward a Covid-19 vaccine.
“We are thrilled with today’s 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.”
Janssen’s Covid-19 vaccine leverages the AdVac vaccine platform, a unique technology previously used in making EC-approved Ebola vaccine regimen and create investigational Zika, RSV, and HIV vaccines.
According to the Phase 3 ENSEMBLE study, the Johnson & Johnson Covid-19 vaccine was well tolerated and reduced the symptomatic Covid-19 disease by 67%, compared to placebo.
The vaccine was 85% effective in preventing severe disease across all regions and offered protection against Covid-19 related hospitalisation and death from 28 days after vaccination.
The company said that its single-dose Covid-19 vaccine is compatible with standard vaccine storage and distribution channels, for effective delivery in remote areas.
The vaccine would remain stable for two years at -25 to -15°C, and for a maximum of three months at routine refrigeration at temperatures of 2°-8°C.
J&J intends to deliver the single-dose Covid-19 vaccine to the EU in the second half of April and to supply 200 million doses to the EU, along with Norway and Iceland in 2021.
Janssen Research & Development global head Mathai Mammen said: “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 program, including our J&J team, our partners and study participants.
“We are delighted by today’s announcement and remain fully committed to continuing our Covid-19 vaccine clinical program as we strive to provide our single-dose Covid-19 vaccine to people all over the world.”
