Johnson & Johnson announces that Janssen's COVID-19 investigational vaccine candidate prevents severe clinical disease in pre-clinical studies

Johnson & JohnsonJanssen'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 in Nature Medicine, demonstrated that the Company's investigational adenovirus serotype 26 (Ad26) vector-based vaccineJanssen'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.

About Johnson & Johnson

At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly-based health care company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity.

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.

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.

About Johnson & Johnson

At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly-based health care company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity.

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.

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