Johnson & Johnson today announced that its lead vaccine candidate protected against infection with SARS-CoV-2, the virus that causes COVID-19, in pre-clinical studies. The data, published in Nature, show the Company's investigational adenovirus serotype 26 (Ad26) vector-based vaccine elicited a robust immune response as demonstrated by "neutralizing antibodies," successfully preventing subsequent infection and providing complete or near-complete protection in the lungs from the virus in non-human primates (NHPs) in the pre-clinical study. Based on the strength of the data, a Phase 1/2a first-in-human clinical trial of the vaccine candidate, Ad26.COV2.S, in healthy volunteers, has now commenced in the United States and Belgium.

"We are excited to see these pre-clinical data because they show our SARS-CoV-2 vaccine candidate generated a strong antibody response and provided protection with a single dose. The findings give us confidence as we progress our vaccine development and upscale manufacturing in parallel, having initiated a Phase 1/2a trial in July with the intention to move into a Phase 3 trial in September," said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson.

The robust Janssen COVID-19 clinical trial program, including the Phase 1/2a clinical trial and the Phase 3 clinical trial program, will evaluate both one- and two-dose regimens of Ad26.COV2.S in parallel studies. The Phase 1/2a trial will evaluate the safety, reactogenicity (expected reactions to vaccination, such as swelling or soreness), and immunogenicity of Ad26.COV2.S in over 1,000 healthy adults aged 18 to 55 years, as well as adults aged 65 years and older. Planning also is underway for a Phase 2a study in the Netherlands, Spain and Germany and a Phase 1 study in Japan. For more information about these studies, please visit www.clinicaltrials.gov.

As the Company plans its COVID-19 Phase 3 clinical development program, discussions are underway with partners with the objective to start a pivotal Phase 3 clinical trial of the single vaccine dose versus placebo in September, pending the interim data of Phase 1 and 2 trials and approval of regulators. Simultaneously, the Company also is planning to start a parallel Phase 3 clinical trial of a two-dose regimen versus placebo.

The Company also will emphasize the representation of populations that have been disproportionately impacted by the pandemic as it designs and implements its COVID-19 Phase 3 trial program. In the United States, this would include significant representation of Blacks, Hispanic/Latinx and participants over 65 years of age.

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.

Dan Barouch, M.D., Ph.D., Director of the Center for Virology and Vaccine Research at BIDMC and the Ragon Institute, stated, "The pre-clinical data, generated in collaboration with the Johnson & Johnson team, highlights the potential of this SARS-CoV-2 vaccine candidate. Moreover, the data suggest that antibody levels may serve as a biomarker for vaccine-mediated protection."

In the studies, researchers first immunized the NHPs with a panel of vaccine prototypes and then challenged them with SARS-CoV-2 infection. The scientists found that of seven vaccine prototypes tested in the study, Ad26.COV2.S (referred to in the Nature article as Ad26-S.PP), elicited the highest levels of neutralizing antibodies to SARS-CoV-2. The level of antibodies correlated with the level of protection, confirming previous observations and suggesting they could be a potential biomarker for vaccine-mediated protection. The six NHPs that received a single immunization with Ad26.COV2.S showed no detectable virus in the lower respiratory tract after exposure to SARS-CoV-2, and only one of six showed very low levels of the virus in a nasal swab at two-time points.

"As we collectively battle this pandemic, we remain deeply committed to our goal of providing a safe and effective vaccine to the world. Our pre-clinical results give us reason to be optimistic as we initiate our first-in-human clinical trial, and we are excited to enter the next stage in our research and development toward a COVID-19 vaccine. We know that, if successful, this vaccine can be rapidly developed, produced on a large scale and delivered around the world," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, LLC, Johnson & Johnson.

The Company's fundamental responsibility is to provide patients, consumers and healthcare providers with products that are as safe and effective as possible. Johnson & Johnson takes evidence- and science-based, ethics- and values-driven approach to medical safety, putting patient and consumer wellbeing first and foremost in its decision making and actions, with an emphasis on transparency.

As Johnson & Johnson progress the clinical development of SARS-CoV-2, the Company continues to increase manufacturing capacity and is in active discussions with global strategic partners to support worldwide access. Johnson & Johnson aims to meet its goal to supply more than one billion doses globally through the course of 2021, provided the vaccine is safe and effective