Interim SAGE/WHO recommendation supporting the use of the Johnson & Johnson COVID-19 Vaccine

Johnson & Johnson welcomes the interim recommendation by the Strategic Advisory Group of Experts (SAGE) on Immunization for the World Health Organization (WHO) supporting the use of Johnson & Johnson’s single-shot COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in persons aged 18 years and above.

SAGE advises WHO on global vaccine and immunization policies and its recommendations for use provide guidance on the use of vaccines supplied through the COVAX Facility, a global risk-sharing mechanism for pooled procurement and equitable distribution of COVID-19 vaccines to all participating countries. At this time, 190 countries have joined the COVAX Facility, including 92 low- and lower-middle-income countries.

Johnson & Johnson is committed to ensuring global access to the Johnson & Johnson single-shot COVID-19 vaccine candidate on a not-for-profit basis for emergency pandemic use. In December 2020, Johnson & Johnson entered into an agreement in principle with Gavi, the Vaccine Alliance (Gavi), in support of the COVAX Facility. Johnson & Johnson and Gavi expect to enter into an Advance Purchase Agreement (APA) that would provide up to 500 million doses of the Company’s vaccine to COVAX through 2022.

The SAGE recommendation was based on scientific evidence presented by Johnson & Johnson, including data from the Phase III ENSEMBLE study. Data from the Phase III 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 across countries with different variants, beginning 28 days after vaccination. Variants observed in an ongoing analysis in the ENSEMBLE study included the B.1.351 variant which was identified in 95 percent of the COVID-19 cases in South Africa. Today’s SAGE recommendation follows the WHO issuing Emergency Use Listing on March 12, the European Commission granting a Conditional Marketing Authorization on March 11, and Emergency Use Authorization issued by the FDA on February 27, 2021. The single-shot COVID-19 vaccine has also been granted Interim Order authorization in Canada, and additional rolling submissions have been initiated in several countries worldwide.The Johnson & Johnson COVID-19 single-shot vaccine is compatible with standard vaccine storage and distribution channels enabling delivery to remote areas.

The vaccine is estimated to remain stable for two years at -25° to -15°C, and a maximum of three months of which can be at routine refrigeration at temperatures of 2° to 8°C. Therefore, it may be shipped using the same cold chain technologies used today to transport other medicines and vaccines that are in routine use.