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Friday, May 7th, 2021

BARDA, Janssen expand Phase 2a trial of COVID-19 vaccine to include adolescents

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An ongoing Phase 2a trial of a Janssen Pharmaceutical Companies-developed COVID-19 vaccine candidate has been expanded to include adolescents between the ages of 12 and 17.

While there are still no approved COVID-19 vaccines for children, cases of COVID-19 in children have generally been less severe. The trial for Ad26.COV2.S, the Janssen vaccine, is being pursued with help from the Biomedical Advanced Research and Development Authority (BARDA).

Janssen is the pharmaceutical arm of Johnson & Johnson. In the United States, the companies currently have an approved, single-dose vaccine for adults, which has proven approximately 66.3 percent effective at preventing cases of COVID-19. It was approved under Food and Drug Administration Emergency Use Authorization for adults in February 2021.

The newly expanded trial will allow adolescents to participate with parental consent. Safety and efficacy will be the focus of evaluation. Currently, such efforts are ongoing in the UK and Spain, although preparations for the trial in the U.S. and other nations are underway.