Pharmaceutical giant Johnson & Johnson's experimental COVID-19 vaccine has produced a strong immune response against the novel coronavirus in an early-to-mid stage clinical trial, as per the data published on September 25.
"The data demonstrate that a single dose of COVID-19 vaccine, Ad26.COV2.S, induced a strong neutralising antibody response in nearly all participants aged 18 years and older and was generally well-tolerated," J&J said, adding that the immune responses were similar across the age groups studied, including older adults.
Unlike the three vaccines developed by Moderna, Pfizer and BioNTech, and AstraZeneca and the University of Oxford, that require a re-visit and second shot three to four weeks after the first one to trigger a protective immune response, J&J will be initially testing a single dose.
A single shot, versus a rival two-dose approach being tested by Moderna Inc and Pfizer Inc, could simplify the distribution of the vaccine. The trial in close to 1,000 healthy adults, which is backed by the US government, began after the J&J vaccine was found in July to offer strong protection in a single dose to monkeys.
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Based on the current results, J&J on September 23 kicked off a final 60,000-person trial, which could pave the way for an application for regulatory approval. The company said it expects results of the Phase 3 trial by the end of the year or early next year.
"The trial will include those both with and without comorbidities associated with an increased risk for progression to severe COVID-19, and will aim to enrol participants in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa and the United States," Johnson & Johnson said in a statement.
The results, released on the medical website medRxiv, have not been peer-reviewed. Researchers, including those from J&J's unit Janssen Pharmaceuticals, said 98 percent of participants with data available for the interim analysis had neutralizing antibodies, which defend cells from pathogens, 29 days after vaccination.
However, immune response results were available from only a small number of people - 15 participants - over 65 years old, limiting the interpretation.
In participants older than 65, the rate of adverse reactions such as fatigue and muscle aches was 36 percent, much lower than the 64 percent seen in younger participants, the results showed, suggesting the immune response in older people may not be as strong.
The researchers said more details on safety and effectiveness will follow when the study is completed.
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