J&J’s one-shot COVID-19 vaccine approved by European Commission

pharmafile | March 12, 2021 | News story | Medical Communications COVID-19, EMA, Johnson & Johnson 

The European Commission has granted Johnson and Johnson’s single-shot COVID-19 vaccine Conditional Marketing Authorisation (CMA), it was announced on Thursday.

J&J have committed to supply 200 million doses in 2021 and will begin delivery of the vaccine to the EU in the second half of April.

Data from the Phase III study showed that the one-shot vaccine caused a 67% reduction in symptomatic COVID-19 disease in participants who received the vaccine versus patients given the placebo.

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.

Alex Gorsky, Chairman and CEO at J&J, 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 CMA 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.”

J&J’s vaccine is the first single-dose jab available to the public and the fourth vaccine overall to be approved by the EMA.

Unlike other vaccines currently available, such as the Pfizer and Moderna vaccines, J&J’s vaccine can be stored for prolonged periods of time in most standard refrigerators at temperatures of between 2°C-8°C, simplifying the logistics of mass distribution and immunisation.

The CMA is valid in all 27 member states of the European Union, plus Norway, Iceland and Liechtenstein.

J&J previously received Emergency Use Authorisation in the US on 27 February, following a unanimous vote by the FDA’s Vaccines and Related Biological Products Advisory Committee. The vaccine has also been granted interim order authorisation in Canada.

Kat Jenkins

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