Johnson & Johnson (J&J) and the US Department of Health and Human Services have expanded an agreement to support the next phase of COVID-19 vaccine candidate research and development, the company said on Saturday.
Under the agreement, the company will commit approximately $604 million and the HHS Department's Biomedical Advanced Research and Development Authority will commit about $454 million to support the Phase 3 ENSEMBLE trial evaluating Janssen's investigational COVID-19 vaccine candidate as a single dose in up to 60,000 volunteers worldwide, the company said in a statement.Also Read: Johnson & Johnson says first batches of COVID-19 vaccine may be available as soon as January
J&J started testing the vaccine in adults in a 60,000-volunteer Phase III study in late September. It had to pause the trial in early October because of a serious medical event in one participant.
The US-based company had said that unexplained illness was being reviewed by an independent data and safety monitoring board as well as its own clinical and safety team. The data board is then required to submit its findings to the US Food and Drug administration before the study can be restarted.
However, the study resumed in October-end. In a statement, J&J didn't disclose the nature of the volunteer's illness but said a thorough evaluation "found no evidence that the vaccine candidate caused the event."