J&J vaccine conditions:

SA’s medicines regulator has confirmed that one of the conditions attached to its approval of Johnson & Johnson’s (J&J’s) Covid-19 vaccine restricts its sale to the national government, Business Day has learnt.

This means that neither provincial governments nor private sector entities, such as large employers or pharmacies, can buy directly from the vaccine maker, even if it were willing to sell directly to them.

J&J and several other vaccine makers have indicated they will only sell to the national government, but private sector players have been hopeful that this position will shift at some point.

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 be the entity to source, distribute and oversee the rollout of the vaccine, he said.

“The government, as the sole purchaser of vaccines, will distribute [them] to provincial governments and the private sector,” 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”.

This section of the act is broadly enabling and does not restrict the nature of the conditions imposed by Sahpra.

Health Justice Initiative (HJI) founder Fatima Hassan welcomed the restriction on sales 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.

Gounden declined to indicate what other conditions had been attached to the registration of the vaccine, referring Business Day to the company.

J&J announced on April 1 that its single-dose shot had been registered by Sahpra, with conditions. J&J did not respond to questions asking what these conditions were.

Hassan said the HJI had written to Sahpra urging it to be more transparent about vaccine approvals.

“You need to share information with the public in a timely manner to avoid contributing to greater vaccine hesitancy. If you look at the best practice of other regulators, they make a lot of information available.

“It is important [that Sahpra] discloses all the conditions of all approvals, whether full or section 21 authorisations.

“In the next few months there will be more and more approvals, and we need to make sure there is transparency at all levels,” Hassan said.

IT IS NOT A RESTRICTION ON RIGHTS, BUT A RESPONSE TO THE GLOBAL REALITY OF VACCINE NATIONALISM