J&J single-dose Covid-19 vaccine approved in EU

Johnson & Johnson’s single-dose Covid-19 vaccine has been granted a Conditional  Marketing Authorization (CMA) by the European Commission (EC).

The decision was made following data from the company’s Phase 3 Ensemble study, which enrolled a  total of 43,783 participants to evaluate the safety and efficacy of the company’s vaccine candidate.

Data from the study show that Johnson & Johnson’s vaccine was 67% effective in preventing Covid-19 compared to participants who had received a placebo. Protection from Covid-19 was observed after 14 days and then maintained for 28 days following vaccination. Data also show that the vaccine was 85% effective in preventing severe disease and also protection against Covid-19 related hospitalisation and death.

The vaccine was developed using the company’s proprietary AdVac platform, which was used to develop Janssen’s Ebola vaccine regimen and its investigational Zika, RSV and HIV vaccines. 

“For more than a year, we have been working around the clock – leveraging the scientific  minds, scale and resources of our global organisation to bring forward a Covid-19 vaccine,” said Alex Gorsky, chairman and chief executive officer at Johnson & Johnson. “We are  thrilled with today’s Conditional Marketing Authorization 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.”  

Johnson & Johnson has stated its commitment to making its Covid-19 vaccine available on a not-for-profit basis for emergency pandemic use. The company is aiming to begin deliveries of the vaccine to the EU in the second half of April. Johnson & Johnson intends to supply 200 million doses to the EU, including Norway and Iceland in 2021.

“This vaccine is the result of more than a decade of investment in research and development and deep commitment by our scientists. We appreciate the collaboration and the support of the European Commission in this monumental effort,” said Paul Stoffels, vice chairman of the Executive Committee and chief scientific officer at Johnson & Johnson. “With this Conditional Marketing Authorization, we are proud to bring our single shot vaccine to help protect millions of people across EU member states.” 

In terms of transportation, Johnson & Johnson’s Covid-19 vaccine is able to be stored and distributed using standard vaccine technologies, enabling delivery to remote areas more easily. It’s estimated to remain stable for two years at -25 to -15°C, and a maximum of three months of which can be at routine refrigeration at temperatures of 2°-8°C. 

“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,” added Mathai Mammen, global head, Janssen Research & Development, Johnson & Johnson. “We are  delighted by today’s announcement and remain fully committed to continuing our Covid-19  vaccine clinical programme as we strive to provide our single-dose Covid-19 vaccine to  people all over the world.”