The results from the nonhuman primate study, published in Nature, demonstrated that the adenovirus serotype 26 (Ad26) vector-based vaccine elicited a strong immune response and successfully produced neutralizing antibodies against SARS-CoV-2. Moreover, the vaccine prevented subsequent infection after a single vaccine dose and there was no detectable virus in the lower respiratory tract after exposure to SARS-CoV-2.
A phase I/IIA clinical trial of the vaccine candidate, Ad26.COV2.S, is underway in the U.S. and Belgium and will enroll over 1,000 healthy adults to evaluate safety and immunogenicity. Planning is underway for a phase IIA study in the Netherlands, Spain, and Germany, and a phase I study in Japan.
The company intends to move into a phase III trial in September. This study will evaluate a single vaccine dose versus a placebo. Simultaneously, a phase III trial of a two-dose regimen will also be conducted.
Johnson & Johnson continues to increase manufacturing capacity and is in discussion with global partners to support worldwide access. If the vaccine is approved, the company aims to supply more than 1 billion doses globally by the end of 2021.
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