On Mar. 11, 2021, Johnson & Johnson announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a Positive Opinion to recommend the Conditional Marketing Authorization for its single-dose COVID-19 vaccine candidate, developed by Janssen Pharmaceutical to prevent COVID-19 in individuals 18 years of age and older.

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. 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 is committed to making its COVID-19 vaccine available on a not-for-profit basis for emergency pandemic use.

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.^[1] The COVID-19 vaccine candidate has also been filed for an Emergency Use Listing (EUL) with the World Health Organization. Rolling submissions for our vaccine candidate have also been initiated in several countries worldwide.

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 authorization in Canada.