Prognosis
J&J Plans to Submit South African Vaccine Trial Data
- U.S. drugmaker among several testing vaccines in South Africa
- Doses will be made in the country if approval is granted
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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 authorization in February, and “other health regulatory applications around the world will be made in parallel,” according to the company.