In pre-clinical data recently published in Nature, Johnson & Johnson’s lead vaccine candidate for SARS-CoV-2, the virus that causes COVID-19, provoked strong antibody responses in non-human primates, subsequently blocking infection of their lungs.
“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,” Dr. Paul Stoffels, vice chairman of the Executive Committee and Chief Scientific Officer of Johnson & Johnson, said. “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.”
During the preliminary studies, conducted by researchers from Beth Israel Deaconess Medical Center and J&J subsidiary Janssen Pharmaceutical Companies, researchers brought a range of seven vaccine prototypes to bear. Among them, ad26.COV2.S provoked the highest levels of neutralizing antibodies, bringing the most protection. Those six primates issued that candidate showed no detectable virus in their lower respiratory tract after exposure to SARS-CoV-2. Only one showed any at all in a nasal swab.
The results were strong enough to prompt a phase 1/2a clinical trial in the U.S. and Belgium, with a phase 3 clinical trial expected to follow in September. A phase 2a study in the Netherlands, Spain and Germany is being planned, as well as an additional phase 1 study in Japan. During the phase 1/2a trial, the candidate will be evaluated for its safety, side effects and immunogenicity in over 1,000 adults between 18 to 55 years old and those aged 65 years and older.
A major focus of the phase 3 study will be effects on populations disproportionately hit by the pandemic, meaning that minority participants such as Black and Hispanic Americans would be emphasized.
“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,” Dr. Mathai Mammen, global head of Janssen Research & Development, said. “We know that, if successful, this vaccine can be rapidly developed, produced on a large scale and delivered around the world.”
If the vaccine proves safe and effective, Johnson & Johnson hopes to supply more than one billion doses globally throughout 2021.