Johnson & Johnson Single-Dose COVID-19 Vaccine Granted Registration by South African Health Products Regulatory Authority

JOHANNESBURG, April 1, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson (the Company) today announced the South African Health Products Regulatory Authority (SAHPRA) has granted registration with conditions for its single-dose COVID-19 vaccine, to prevent COVID-19 in individuals 18 years of age and older.

Data from the Phase 3 ENSEMBLE study showed 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 hospitalisation and death, beginning 28 days after vaccination. In South Africa, the level of protection against moderate to severe COVID-19 infection was 57%, 28 days post-vaccination.

The growing presence of regional COVID-19 variants underscores the need to look at a pandemic response from a global perspective. In South Africa specifically, the emergent SARS-CoV-2 variant from the B.1.351 lineage has had a critically detrimental effect on the country’s healthcare system, beyond its impact in other parts of the world where it is now rapidly spreading.

Johnson & Johnson is committed to making its vaccine available on a not-for-profit basis for emergency pandemic use. The Company aims to begin delivery of 31 million doses of the Johnson & Johnson COVID-19 vaccine to South Africa over the course of 2021, with a first supply of 2.8 million doses during the second quarter, and the first delivery scheduled for the second half of April.

Manufacturing and Supply Chain Information

The Johnson & Johnson COVID-19 single-dose 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°C to -15°C, and a maximum of three months of which can be at routine refrigeration at temperatures of 2°C -8°C. This enables the vaccine to be shipped using the same cold chain technologies used to transport other medicines and vaccines in routine use.

To meet its global commitments, Johnson & Johnson has established a global vaccine supply network where multiple manufacturing sites are involved in the production of the vaccine across different facilities, sometimes in different countries and continents, before the vaccine can be distributed globally. In South Africa, one of Aspen’s wholly-owned South African subsidiaries, Pharmacare Limited (which trades as “Aspen Pharmacare”), is performing formulation, filling, and secondary packaging of the vaccine for supply to Johnson & Johnson.

South Africa Phase 3b Study

The Company has partnered with the South African Medical Research Council (SAMRC) on the investigator led collaborative Sisonke (TOGETHER) study, which commenced in February 2021. The ongoing study is an open label, single-arm Phase 3b vaccine implementation study of the investigational single-dose Johnson & Johnson COVID-19 vaccine among the country’s frontline healthcare workers. The purpose of the trial is to monitor the effectiveness of the single-dose Johnson & Johnson vaccine at preventing severe COVID-19, hospitalizations and deaths among healthcare workers as compared to the general unvaccinated population in South Africa. The study aims to enroll 300,000 participants who are health care workers in the public and private South African health care system, with the potential to go up to 500,000 participants.

Regulatory Filings

The single-dose Johnson & Johnson COVID-19 vaccine has been granted Emergency Use Listing by the World Health Organization, Conditional Marketing Authorisation by the European Commission and Emergency Use Authorization by the U.S. Food and Drug Administration. It has also received an Interim Order authorization from Health Canada. 

Commitment to Equitable Access

Equitable access is at the centre of Johnson & Johnson’s COVID-19 response. The Johnson & Johnson single-dose vaccine and its compatibility with standard vaccine distribution channels align with WHO’s recommendations for medical interventions in a pandemic setting, which emphasize ease of distribution, administration, and compliance.

The Company is committed to ensuring global access to the Johnson & Johnson single-dose COVID-19 vaccine on a not-for-profit basis for emergency pandemic use. In September 2020, Johnson & Johnson joined other life sciences companies and the Bill & Melinda Gates Foundation in signing an unprecedented communiqué which outlined a steadfast commitment to facilitating equitable access to the innovations being developed to fight the pandemic. Additionally, the Company recently announced that it has entered into an agreement with the African Vaccine Acquisition Trust (AVAT) to make available up to 220 million doses of its single-dose COVID-19 vaccine to African Union’s 55 member states with delivery beginning in the third quarter of 2021.

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About the Janssen Pharmaceutical Companies of Johnson & Johnson

At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension. Learn more at https://www.janssen.com/southafrica.

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding development of a potential preventive vaccine for COVID-19. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Janssen Pharmaceutical Companies, and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 3, 2021, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

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