Johnson & Johnson's COVID-19 vaccine candidate generated immune response in nearly all clinical trial volunteers after a single dose, according to interim data analysis published Jan. 13 in The New England Journal of Medicine.
The data shows either one or two doses of the vaccine generated antibody and T-cell responses in nearly all participants in Johnson & Johnson's phase 1/2a trial. The participants were ages 18 to 55 and their immune response lasted for at least 71 days, the duration of the time measured in the study.
The phase 1/2a trial focused on safety and whether the vaccine generates immune response. It was not designed to show whether the vaccine protects recipients against COVID-19 infection or symptomatic manifestation; Johnson & Johnson is conducting phase 3 trials focusing on that determination.
The drugmaker said it is aiming to share data on more advanced trials in late January or early February. Then, an advisory board will review the data to determine its safety and efficacy in preventing COVID-19.
Johnson & Johnson plans to apply for FDA emergency use approval shortly thereafter the advisory board reviews its advanced trial data. The FDA is already examining Johnson & Johnson's manufacturing data weeks ahead of the expected application.
The drugmaker expects to earn approval for its vaccine by March, according to a Jan. 13 Bloomberg report.
Under the terms of its August contract with Operation Warp Speed, Johnson & Johnson promised to manufacture 12 million doses of its vaccine candidate by the end of February and complete production of 100 million doses by the end of June.
However, Operation Warp Speed chief Moncef Slaoui, PhD, said the number of doses the drugmaker will produce by the end of February will be in the "single-digit" millions during a Jan. 12 news conference. He said Johnson & Johnson was working to rapidly increase the number of doses it's manufacturing, aiming for "a larger number in March and a much larger number in April."
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