The Supreme Court of Appeal has dismissed an application for leave to appeal by Solidarity and Afriforum over a 2021 court case where they challenged a condition by South African Health Products Regulatory Authority (SAHPRA) that the Johnson & Johnson vaccine be restricted to the government. SAHPRA said that this was not a condition that they had imposed.
On 26 July 2023, the Supreme Court of Appeal (SCA) dismissed an application for leave to appeal filed by Solidarity and Afriforum (the Applicants) on the grounds that there is no reasonable prospect of success.
The Pretoria High Court struck Solidarity and AfriForum’s application from the court roll on the grounds of an alleged lack of urgency, and the court also ordered them to pay SAHPRA’s legal costs which was filed in June 2021 by the Applicants, wherein they alleged that when SAHPRA approved and registered the J&J vaccine, SAHPRA imposed a condition that the sale of the J&J vaccine is restricted to the National Government. The applicants argued that SAHPRA was not mandated to stipulate the condition that only the government may purchase the J&J vaccine and questioned the legality of such a condition.
SAHPRA refuted this claim because this is not a condition that SAHPRA had imposed. Subsequently, the applicants proceeded to lodge an application for leave to appeal with the SCA . SAHPRA CEO, Dr Boitumelo Semete-Makokotlela said, “This court ruling indicates that SAHPRA is judicious in adhering to its mandate responsibly. We welcome the outcome of this judgement.”
The South African Health Products Regulatory Authority (SAHPRA) has authorised an injection containing the antiretroviral cabotegravir for use to prevent HIV infection, according to drugmaker ViiV Healthcare.
“We are very pleased that this week, SAHPRA granted regulatory approval of Apretude or cabotegravir long-acting injectable,” ViiV Healthcare spokesperson Catherine Hartley told Spotlight. “It brings a much-needed innovative HIV prevention option to the communities that need it most, including women and adolescent girls where challenges with adherence, limited efficacy, and stigma have hindered the impact of current PrEP options.”
At the time of publication, SAHPRA had not yet confirmed the registration, although Spotlight understands a media statement on the issue is imminent. The regulator received ViiV Healthcare’s initial application for approval in November 2021.
ViiV Healthcare has not disclosed at what price it will offer the shot in South Africa or other African countries. The company has, through a deal with the Geneva-based Medicines Patent Pool, agreed to grant voluntary licenses to at least three generic producers that could potentially supply the injection to South Africa. It is however expected to take three to five years before any of the generics will be ready.
Executive Director of the HIV prevention organisation AVAC confirmed news of the authorisation late Wednesday in a social media post, calling it a critical step in making the injection available to millions that could benefit from the shot.
The bi-monthly shot likely outperformed the pill, the World Health Organization explains in new guidelines, mainly because it was easier for people to get an injection every two months than to take the pills every day.
Previously, Spotlight reported that pilot projects are slated to begin providing access to the HIV prevention shot early next year. Demonstration projects run in partnership with the national health department and research organisations the Wits Reproductive Health and HIV Institute and Ezintsha are expected to offer patients a choice of the HIV prevention shot, pill, or monthly vaginal ring.
The pilot projects, sometimes called “demonstration” projects, will be looking to help answer major questions about an eventual national rollout, including how to create national awareness campaigns about the HIV prevention injection and how to provide it outside of hospitals and clinics and closer to communities.
SAHPRA authorisation marks the first step toward an eventual national rollout, according to national health department HIV prevention technical advisor Hasina Subedar. Subedar spoke to Spotlight in July at the International AIDS Conference. In particular, the finer details of the registration – which are still not public – will guide who can and can’t receive the shot, for instance.
Ivermectin, which has some reports of high effectiveness in limited studies, has received approval from the SA government to be used under strict control for compassionate use.
Dr Boitumelo Semete-Makokotlela, head of the South African Health Products Regulatory Authority (SAHPRA), said that practitioners applying to use the drug will be considered case-by-case.
Ivermectin has a long history of use as an antiparasitic treatment in animals, while in humans it’s used as an anthelmintic drug that is usually indicated for filarialand resistant scabies infections. While the World Health Organization has suggested the drug has encouraging effects on coronavirus, although it hasn’t been properly evaluated yet.
“We absolutely share everyone’s desperation at this point,” said Helen Rees, SAHPRA chairwoman. “So the question about ivermectin and self-medication goes back to what everyone in the scientific community is saying. And that is, we don’t know if it works and we don’t know if it doesn’t work. That’s why we need to get data.”
Physicians in Zimbabwe are reportedly treating COVID with ivermectin in combination with silver nanoparticles – normally used as an algaecide – to great success.
Rees, however, warned South Africans that people self-medicating “need to be very careful because we don’t have any information about the quality of what you’re taking.”
Dr Semete-Makokotlela said that clear guidelines for the rollout would be given tomorrow. She added that SAHPRA granted the health department permission to distribute the Oxford/AstraZeneca COVID vaccine, the first one for SA. It is also currently reviewing applications from Johnson & Johnson and Pfizer, but has yet to receive an application from Moderna, she said.
