Media Statement | UPDATED: Johnson & Johnson Statement on Supply of COVID-19 Vaccine to the African Union and Government of South Africa
UPDATED: Johnson & Johnson Statement on Supply of COVID-19 Vaccine to the African Union and Government of South Africa
UPDATE ADDED June 17, 2021
Johnson & Johnson confirms that doses of its single-shot COVID-19 vaccine will arrive in South Africa on Thursday, 17 June. These doses build on the 500,000 doses provided in support of the Phase 3b Sisonke (TOGETHER) study being conducted in frontline healthcare workers. Additional deliveries are expected through the end of 2021 in line with the Advance Purchase Agreement between Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and the Government of the Republic of South Africa.
Johnson & Johnson continues to be fully committed to the African Union and the Government of South Africa to deliver its single-shot COVID-19 vaccine to address the current pandemic and is engaging with them to ensure early and meaningful access to its vaccine.
The Company fully supports the important quality and regulatory processes of health authorities across the world and, in alignment with the precautionary measures outlined by the South African Health Products Regulatory Authority (SAHPRA) and other regulatory authorities, and out of an abundance of caution, the Company confirms it will not release specific batches of its COVID-19 vaccines produced with drug substance manufactured by Emergent BioSolutions.
Johnson & Johnson is working with authorities to accelerate the production and delivery of additional COVID-19 vaccine drug substance from its global supply chain network and the manufacturing of filled and finished vaccines at Aspen’s manufacturing site in Gqeberha, South Africa. In addition, the Company is actively evaluating how it may supply new vaccines for immediate use from its global network for deployment on the African continent.
The United States Food & Drug Administration and SAHPRA have also authorised the release of unaffected batches of vaccines produced with Emergent BioSolutions drug substance under the Emergency Use Authorization. We will work closely with the South African Government to provide this released supply of vaccines where these doses can provide immediate impact.
Johnson & Johnson also notes that doses previously distributed to South Africa as part of the Sisonke Study have met all product specifications and requirements for quality, safety, and efficacy.
The Company continues to substantially expand its global supply chain network, including its important partnership with Aspen, as it works with regulatory and health authorities to supply its vaccine worldwide. We believe that a single-shot, easy to distribute COVID-19 vaccine is an essential tool to combat the pandemic globally.
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 Company, any of the other 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.