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.
“We have a rolling application from J&J and we have had extensive discussions with the Serum Institute of India and AstraZeneca on registration for emergency use. We have had an earlier discussion with Pfizer,” she said.
To apply for registration, manufacturers must submit a dossier containing the data from clinical trials to enable regulators to assess efficacy and safety.
“We expect applicants will submit once there is a likelihood of use. None of them will submit before as each application is a lot of work,” Rees said.
SA has not yet secured any direct orders from pharmaceutical companies but has paid a deposit to the Covax global vaccine initiative, which includes a wide range of vaccine manufacturers, the biggest of which is the Serum Institute of India. Health minister Zweli Mkhize has said that the country aims to vaccinate 40-million people by the end of 2021.
Rees said Sahpra had plans in place to ensure quick registration once applications were made. These include an expert committee that was available to look at applications as soon as they came in and “reliance agreements” with the World Health Organisation (WHO) and other national regulatory authorities, including the Food and Drug Administration (FDA) in the US and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, to share information.
“The reliance agreements, the expert committee and dialogue with companies means that regulatory approval will not be a barrier,” she said.
At this stage, SA’s only options for an early vaccine before the arrival of Covax in the second quarter are the Oxford University-AstraZeneca vaccine and the Pfizer vaccine. Moderna has indicated it will not enter the SA market
J&J has a technology transfer agreement with SA company Aspen Pharmacare to fill and package 225-million doses. While these are for global use by J&J and will be distributed by the company, Aspen is lobbying for some to remain in SA.
Rees said Sahpra would also consider the Russian and Chinese vaccines, should it be approached by the manufacturers with the necessary data.
“In the earlier days both Russia and China were producing for domestic use. They have now changed their position and want to make their vaccines available globally, but the data still needs to be reviewed. The first thing that would need to be done would be for them to approach the department of health, and if that went well, we would then step in,” she said.
Would you like to comment on this article?
Sign up (it's quick and free) or sign in now.
Please read our Comment Policy before commenting.