Johnson & Johnson’s single-shot vaccine approved by EU regulator

The European Commission (EC) approval of Johnson & Johnson’s vaccine has paved the way for EU nations to use the first single-shot jab authorised in the fight against COVID-19. J&J’s vaccine is the fourth to be licensed in Europe. The US, Canada and Bahrain have also authorised the J&J vaccine.

Johnson & Johnson today announced that the 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.

J&J to supply 200 million doses in 2021

J&J will now aim to begin the distribution of its vaccine to the EU in the second half of April and is committed to supplying 200 million doses in 2021. Johnson & Johnson’s COVID-19 vaccine is to be available on a not-for-profit basis for emergency pandemic use.

The authorisation follows a Positive Opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). The CMA is valid in all of the EU’s 27 member states, plus Norway, Iceland, and Liechtenstein.

Alex Gorsky, Chairman and Chief Executive Officer at Johnson & Johnson said:

“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. 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.”

Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson said:

“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. With this Conditional Marketing Authorization, we are proud to bring our single-shot vaccine to help protect millions of people across EU member states.”

The Phase 3 ENSEMBLE

The Phase 3 ENSEMBLE study data has shown that the Johnson & Johnson COVID-19 vaccine was well tolerated and demonstrated a 67% reduction in symptomatic COVID-19 disease in participants who received the vaccine in comparison to participants given the placebo. The onset of protection was observed from day 14 and was maintained 28 days post-vaccination. The data also demonstrated the vaccine was 85% effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalisation and death, beginning 28 days after vaccination.

J&J global vaccine rollout

J&J 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. Rolling submissions for J&J’s vaccine candidate have also been initiated in several countries worldwide, including South Africa.

J&J’s vaccine can be stored at -25 to -15°C for two years

The Johnson & Johnson COVID-19 single-dose vaccine is compatible with standard vaccine storage and distribution channels enabling delivery to remote areas. 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.

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