Johnson & Johnson’s preliminary data from the South African arm of a phase 3 Covid-19 vaccine trial will be ready for submission to U.S. regulators by Jan. 21, according to the head of the country’s Medical Research Council.
The timing ties in with the U.S. drug giant’s statement that interim data from the late-stage trial it is conducting in a number of countries is expected by the end of this month. If the data show the one-dose vaccine to be safe and effective, J&J will approach U.S. regulators for an emergency use authorisation in February, and “other health regulatory applications around the world will be made in parallel,” according to the company.
Moncef Slaoui, the chief scientific adviser to the U.S. Operation Warp Speed program, has said the emergency clearance could be granted by U.S. regulators by early February.
J&J is one of four vaccine developers running late-stage trials in South Africa. Business Day, a Johannesburg-based newspaper, reported the planned timing of the data submission earlier. It was confirmed by Glenda Gray, president of the research council and co-chair of the local study.
J&J has signed an agreement under which Aspen Pharmacare Holdings Ltd. will manufacture the vaccine if it is approved by regulators. The shot will be made at a facility in South Africa that has the capacity to produce 300 million doses a year.
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