Big pharma yet to apply to SA for vaccine registration
‘We expect applicants will submit once there is a likelihood of use. None will submit before as each application is a lot of work,’ Sahpra chair Helen Rees says
06 January 2021 - 14:06
None of the pharmaceutical companies involved in the manufacture of Covid-19 vaccines has applied to SA’s medicines regulator for registration, an essential first step to their use.
Helen Rees, chair of the SA Health Products Regulatory Authority (Sahpra), said in an interview on Tuesday that only Johnson & Johnson (J&J) had taken the first steps to registration by submitting a “rolling application”, in which data was provided as it became available. However, J&J has not yet got its final results from phase 3 trials, which are expected later in January...
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