Despite two manufacturers having applied to the South African Health Products Regulatory Authority (SAHPRA) to have their vaccines registered in the country, health department spokesperson Popo Maja says only one manufacturer has confirmed that it will deliver Covid-19 vaccines to the country.
“So far, there is only one manufacturer, which is the Oxford-AstraZeneca Covid vaccine. However, negotiations are ongoing with other manufacturers, because we don’t want to put all our eggs in one basket,” Maja said.
The timeframe for getting the vaccines approved was dependent on the quality and integrity of the data that was submitted by the applicants, according to the health products regulator.
In this case, the regulator is aligned with the European Medicines Agency, the Medicines and Healthcare products Regulatory Agency, and the World Health Organisation National Control Laboratory Network to register the vaccines.
The health department and SAHPRA say that ongoing monitoring and surveillance will be conducted to ensure vaccine recipients’ safety and manage any complications resulting from vaccination.
“Pharmacovigilance involves ongoing monitoring of quality, safety, and efficacy of any medicinal product used and is a mandatory regulatory requirement,” says SAHPRA spokesperson Yuven Gounden.
“In many cases of the vaccine, there are studies still ongoing to establish any further side effects, which may not have been experienced before, and a record is made thereof and acted on accordingly.
“Thus, it is important to request consent to use and collect information from those persons who are accepting vaccinations, and that these are informed about this and provide their consent.”
He added that it is a regulatory requirement from all medicine regulatory authorities worldwide that the manufacturers of any medicinal product provide ongoing monitoring of their products’ safety. These reports are handed to the regulator to investigate and make appropriate decisions on a specific product’s ongoing safety and efficacy.
According to Maja, the department is involved in talks with other manufacturers to secure more than one kind of vaccine.
“The government is also exploring all options to ensure that the process of rolling out vaccines is safe and cost-effective, by engaging with vaccine producers,” he says.
“It is also envisaged that it might be necessary to obtain more than one kind of vaccine to cover the needs and requirements of different groupings. The department will announce the names of the producers once there is a breakthrough to avoid jeopardising the negotiations.”
Health Minister Dr Zweli Mkhize during a broadcast on Morning Live said the Serum Institute — an Indian-based pharmaceutical manufacturer, which makes the Oxford-AstraZeneca vaccine — is charging South Africa about $5 a dose. The Johnson & Johnson vaccine is pegged at about $10 a dose, as is Pfizer’s.
The government will be the sole purchaser of the vaccines and then re-sell them to private schemes to “ensure equity”.
Maja says that the treasury will soon “issue an official communication on vaccine-funding models.”