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Johnson & Johnson’s vaccine granted conditional marketing authorization in the EU

vaccine vial

The European Commission has granted a Conditional Marketing Authorization for the company’s single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen).

The CMA 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 27 member states of the European Union (EU), plus Norway, Iceland and Liechtenstein.

Phase 3 ENSEMBLE study

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, states the company in a press release. The onset of protection was observed from day 14 and was maintained 28 days post-vaccination. 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 hospitalization and death, beginning 28 days after vaccination.

“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,” says Alex Gorsky, Chairman and Chief Executive Officer at Johnson & Johnson in the press release. “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.”

The second half of April

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. 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.

Johnson & Johnson’s COVID-19 Vaccine

The Johnson & Johnson COVID-19 vaccine leverages the AdVac vaccine platform, a 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.

Photo: iStock