Johnson & Johnson said that its single-dose COVID-19 vaccine candidate has received a positive opinion from the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency or EMA.
The CHMP has 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.
The vaccine will be the fourth to be authorized for use in the European union following the Pfizer/BioNTech, Oxford-AstraZeneca and Moderna COVID-19 vaccines.
Johnson & Johnson said that phase 3 ENSEMBLE study 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.
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.
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.
According to Johnson & Johnson, 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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