Johnson & Johnson Announces that Janssen’s COVID-19 Investigational Vaccine Candidate Prevents Severe Clinical Disease in Pre-clinical Studies

Janssen’s lead SARS-CoV-2 investigational vaccine candidate, Ad26.COV2.S, prevented severe clinical disease in Syrian golden hamsters, upon challenge with SARS-CoV-2, the virus that causes COVID-19 in people. The data, published today in Nature Medicine, demonstrated that the Company’s investigational adenovirus serotype 26 (Ad26) vector-based vaccine elicited an immune response as demonstrated by “neutralizing antibodies” and prevented severe clinical disease – including weight loss, pneumonia and mortality – in Syrian golden hamsters upon challenge.

This publication follows Johnson & Johnson’s recent announcement that its vaccine candidate elicited an immune response in a pre-clinical study in non-human primates (NHP), that correlated with protection against SARS-CoV-2, providing complete protection against viral replication in the lungs. The latest research tested the vaccine candidate in Syrian golden hamsters, as they are more susceptible to clinical disease than NHPs, which typically do not get severe disease.

“This pre-clinical study further validates our confidence in our SARS-CoV-2 vaccine candidate,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. “With our Phase 3 trials planned to start this month, we remain committed to expanding our manufacturing and distribution capabilities to enable global access to our SARS-CoV-2 vaccine candidate should it prove to be safe and effective in humans.”
The pre-clinical studies were conducted by researchers from Beth Israel Deaconess Medical Center (BIDMC) in collaboration with the Janssen Pharmaceutical Companies of Johnson & Johnson and others as part of its ongoing collaboration to accelerate the development of a SARS-CoV-2 vaccine.

In the pre-clinical study, researchers first immunized Syrian golden hamsters with a single injection of the Ad26-based SARS-CoV-2 vaccine, which induced neutralizing antibodies in all the vaccinated animals. Four weeks later, the animals were exposed to a high dose of SARS-CoV-2 virus. These vaccinated animals lost less weight and had less virus in their lungs and other organs than unvaccinated control animals. Mortalities were absent in vaccinated animals. Moreover, the researchers found that neutralizing antibody responses were inversely correlated with weight loss and viral replication in the lung.

Ad26.COV2.S is currently being evaluated in clinical studies to establish the performance of the vaccine candidate in humans.

Notice to Investors 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 potential preventive and treatment regimens 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 December 29, 2019, 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.

Source: Johnson & Johnson