Johnson & Johnson Single-Shot COVID-19 Vaccine Granted Conditional Marketing Authorization by European Commission
Data have demonstrated vaccine protects against COVID-19 related hospitalisation in broad geographic regions, including those with emerging variants
Decision follows the European Medicines Agency recommendation of the J&J COVID-19 vaccine
The Company aims to begin delivery of its vaccine to the EU in the second half of April and is committed to supply 200 million doses in 2021
Johnson & Johnson (NYSE: JNJ) (the Company) announced that the European Commission (EC) has granted a Conditional Marketing Authorization (CMA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), to prevent COVID-19 in individuals 18 years of age and older.
The CMA follows a Positive Opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).2The CMA is valid in all 27 member states of the European Union (EU), plus Norway, Iceland and Liechtenstein.
Data from the Phase 3 ENSEMBLE study showed that the Johnson & Johnson COVID-19 vaccine was well tolerated and demonstrated a 67 percent reduction in symptomatic COVID-19 disease in participants who received the vaccine in comparison to participants given the placebo.2 The onset of protection was observed from day 14 and was maintained 28 days post-vaccination.1 The data also demonstrated the vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalisation and death, beginning 28 days after vaccination.1
“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 is committed to making its COVID-19 vaccine available on a not-for-profit basis for emergency pandemic use. The Company aims to begin delivery of its single dose COVID-19 vaccine to the EU in the second half of April and to supply 200 million doses to the EU,3 plus 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, M.D., 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 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. The COVID-19 vaccine candidate has also been filed for an Emergency Use Listing (EUL) with the World Health Organization. Rolling submissions for our vaccine candidate have also been initiated in several countries worldwide.
“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, M.D., Ph.D., 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.”
The Company received Emergency Use Authorization (EUA) in the United States on February 27, following a unanimous vote by the U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee on February 26, 2021. The Johnson & Johnson single-dose COVID-19 vaccine has also been granted Interim Order authorisation in Canada.
Manufacturing and Supply Chain Information
The Johnson & Johnson COVID-19 single-dose vaccine is compatible with standard vaccine storage and distribution channels enabling delivery to remote areas.6 The vaccine is 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. The Company will ship the vaccine using the same cold chain technologies it uses today to transport other medicines.6
Johnson & Johnson’s COVID-19 Vaccine
The Johnson & Johnson COVID-19 vaccine leverages the AdVac® vaccine platform, a unique and proprietary technology that was also used to develop and manufacture Janssen’s European Commission-approved Ebola vaccine regimen and construct its investigational Zika, RSV, and HIV vaccines.
Phase 3 ENSEMBLE Study Design
The Phase 3 ENSEMBLE study is a randomised, double-blind, placebo-controlled clinical trial in individuals 18 years of age and older. The study was designed to evaluate the safety and efficacy of the Company’s vaccine candidate in protecting against both moderate and severe COVID-19 disease, with assessment of efficacy as of day 14 and as of day 28 as co-primary endpoints. The study enrolled a total of 43,783 participants.6
The trial, conducted in eight countries across three continents,11 includes a diverse and broad population including 34 percent of participants over age 60.1 Forty-one percent of participants in the study had comorbidities associated with an increased risk for progression to severe COVID-19.1
For more information on the Company’s multi-pronged approach to helping combat the pandemic, visit: https://www.janssen.com/emea/our-focus/infectious-diseases-vaccines/respiratory-infections/covid-19.