Johnson & Johnson's Single-dose COVID-19 Vaccine Gets Conditional Marketing Authorization In EU

Johnson & Johnson (JNJ) said Thursday that the European Commission has granted a Conditional Marketing Authorization for its single-dose COVID-19 vaccine.

The authorization comes hours after receiving a positive opinion from the European Medicines Agency's the Committee for Medicinal Products for Human Use or CHMP for the vaccine.

The CHMP earlier today recommended Conditional Marketing Authorization for the vaccine candidate, developed by Johnson & Johnson's Janssen Pharmaceutical, to prevent COVID-19 in individuals 18 years of age and older.

Johnson & Johnson's single-dose COVID-19 vaccine is the fourth authorized vaccine available in the European union following two-dose vaccines developed by Pfizer/BioNTech, Oxford-AstraZeneca and Moderna.

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

According to Johnson & Johnson, phase 3 ENSEMBLE study data showed that its 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. The onset of protection was observed from day 14 and was maintained 28 days post-vaccination.

Johnson & Johnson said 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.

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, plus Norway and Iceland in 2021.

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 with the World Health Organization.

Johnson & Johnson's single-dose COVID-19 vaccine received Emergency Use Authorization in the United States on February 27. The vaccine has also been granted Interim Order authorization in Canada.

The company noted that the COVID-19 single-dose vaccine candidate is compatible with standard vaccine storage and distribution channels with ease of delivery to remote areas. The vaccine is estimated to remain stable for two years at minus 15 degree celsius to minus 25 degree celsius and a maximum of three months at routine refrigeration at temperatures of 2 degree celsius to 8 degree celsius.

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