Johnson & Johnson Announces Agreement with AVAT to Supply Up to 400 Million Doses of Single-Shot COVID-19 Vaccine Candidate to African Union Member States

Johnson & Johnson to Provide Up to 400 Million Doses of Single-Dose Candidate Vaccine to African Union Member States

Vaccine supply is contingent upon approval by national regulatory authorities.

Data show that candidate vaccines can prevent COVID-19-related hospitalizations and deaths across a wide geographic area, including regions where variants of concern are prevalent.

NEW BRUNSWICK, N.J., March 30, 2021 /PRNewswire/ -- Janssen Pharmaceutica N.V. (NYSE: JNJ), a subsidiary of Johnson & Johnson’s Janssen Pharmaceuticals (hereinafter referred to as the “Company”), has entered into an agreement with the African Vaccine Acquisition Trust (hereinafter referred to as “AVAT”) to supply up to 220 million doses of its single-shot COVID-19 vaccine candidate to the 55 member states of the African Union starting in the third quarter of 2021. Additionally, AVAT has the option to order an additional 180 million doses, bringing the total potential volume to 400 million doses by 2022. The supply of the vaccine candidate is contingent upon successful approval or authorization by the national regulatory authorities of the African Union member states.

Alex Gorsky, Chairman and Chief Executive Officer of Johnson & Johnson, stated, “From the outset of the pandemic, Johnson & Johnson has recognized that no one is safe until everyone is safe, and we have been committed to the equitable global access to new COVID-19 vaccines. Our support for the COVAX Facility, combined with our supplemental agreements with countries and regions, helps accelerate the end of the COVID-19 pandemic worldwide.”

Johnson & Johnson is committed to ensuring equitable global access to its single-dose COVID-19 vaccine candidate for emergency pandemic use on a not-for-profit basis. In December 2020, the company reached an agreement with Gavi, the Vaccine AlliancePrinciples Agreement, in order to support the COVAX Facility in meeting the primary vaccination needs of 190 participating economies, including many countries in Africa. The Company and Gavi, the Vaccine Alliance, expect to enter into an Advance Purchase Agreement (APA) to supply up to 500 million vaccine doses to COVAX by 2022.

Furthermore, Johnson & Johnson recognized the increasingly severe impact of the COVID-19 pandemic on Africa, as well as the emergence and sustained transmission of SARS-CoV-2 variants in the Republic of South Africa, which demonstrated increased transmissibility of the virus.

Data from the Phase 3 ENSEMBLE study indicate that the Johnson & Johnson COVID-19 vaccine was well tolerated, with a 67% reduction in the incidence of symptomatic COVID-19 among vaccinated participants compared to those in the placebo group. Protective efficacy was observed starting from day 14 and persisted through day 28 post-vaccination.

Relevant data also indicate that the vaccine demonstrated 85% efficacy against severe disease across all study regions, with protection against COVID-19-related hospitalizations and deaths observed starting 28 days post-vaccination in countries circulating different SARS-CoV-2 variants. Variants observed in ongoing analyses of the ENSEMBLE study include the B.1.351 variant, which was identified in 95% of COVID-19 cases in South Africa.

Production and Supply Chain Information
Johnson & Johnson has established a global COVID-19 vaccine production and supply network in collaboration with nine partners across four continents, including Aspen Pharmacare from South Africa. Aspen will support the delivery of vaccines to African Union member states and facilitate the global supply of vaccines.

Johnson & Johnson’s single-dose COVID-19 vaccine is compatible with standard vaccine storage and distribution channels, enabling vaccine delivery to remote areas. It is estimated that the vaccine remains stable for two years at temperatures between -25°C and -15°C, and can be stored stably for up to three months under conventional refrigeration conditions at 2°C–8°C. This allows the vaccine to be transported using the same cold chain technologies employed for other conventional medicines and vaccines.

Johnson & Johnson COVID-19 Vaccine
Johnson & Johnson COVID-19 Vaccine UsageAdVac^®Vaccine Platform: This vaccine platform is a proprietary technology used for the development and production of the Janssen Ebola vaccine regimen approved by the European Commission, as well as for constructing experimental Zika, RSV, and HIV vaccines.

Regulatory Approval
Johnson & Johnson’s Single-Dose COVID-19 Vaccine Was Included by the World Health Organization (WHO) on March 12Emergency Use List, granted by the European Commission on March 11Conditional Marketing Authorization, and was approved by the U.S. Food and Drug Administration on February 27, 2021Emergency Use Authorization. Meanwhile, the single-dose COVID-19 vaccine has also been approved in CanadaProvisional Order Authorization, and launched additional rolling review processes in multiple countries worldwide.

For more information on the Company’s multi-pronged approach to helping combat the pandemic, please visit:www.jnj.com/coronavirus。