South Africa’s medicines regulator has confirmed that one of the conditions attached to its approval of Johnson & Johnson’s (J&J) COVID-19 vaccine restricts its sale to the national government, reports BusinessLIVE. This means that neither provincial governments nor private-sector entities, such as large employers or pharmacies, can buy directly from the vaccine manufacturer, even if it were willing to sell directly to them. J&J and several other vaccine manufacturers have previously indicated they will only sell to the national, but private-sector players have been hopeful that this position will shift at some point.
BusinessLIVE reports that in a written response to questions, SA Health Products Regulatory Authority (SAHPRA) spokesperson Yuven Gounden confirmed J&J could not market its vaccine to the private sector. This restriction is in line with the government’s vaccine strategy, which makes clear it will source, distribute and oversee the rollout of the vaccine, he said.
The registration conditions have been imposed in terms of section 15 (6)(a) of the Medicines and Related Substances Act, which states that “any registration under this section may be made subject to such conditions as may be determined by the authority”.
BusinessLIVE reports that Health Justice Initiative (HJI) founder Fatima Hassan welcomed the restriction on the sale to the government, saying it would ensure fair allocation of the vaccine. “It is not a restriction on rights, but a response to the global reality of a situation of vaccine nationalism and limited supplies. There needs to be a central plan, with central allocation, with the private sector involved in distributing and administering it,” she said.