Argentine vaccine manufacturer Biogénesis Bagó has withdrawn its authorisation to South African company Design Biologix to submit and hold a Section 21 application for the import of Bioaftogen, its foot-and-mouth disease (FMD) vaccine, into South Africa, with immediate effect.

By Jasper Raats, senior journalist at African Farming and Landbouweekblad

This is evident from an official letter issued by Biogénesis Bagó on 2 February and signed by Santiago Cornejo of the Argentine company. According to the letter, the authorisation granted to Design Biologix on 15 January this year has been revoked in its entirety, including any exclusive representation rights. Design Biologix may no longer act in any way on behalf of Biogénesis Bagó in this regard.

Karen Nel of Design Biologix confirmed that the authorisation has been revoked. “It’s true. We can’t do anything about it. We just hope the vaccine enters the country soon and that it will be in time to help the agricultural community,” she said. She declined to elaborate further on the matter.

A source close to the ministerial advisory committee on FMD has meanwhile confirmed to African Farming that, among others, John Steenhuisen, Minister of Agriculture, Mooketsa Ramasodi, Director-General of the Department of Agriculture, and Dr Emily Mogajane, chairperson of the ministerial FMD advisory committee, had earlier met with representatives of the Argentine Embassy in South Africa and Biogénesis Bagó.

Also read: FMD | Argentine vaccine could be in SA soon

However, the minister’s spokesperson confirmed on Friday, 30 January, that the department “stands 100% behind Design Biologix’s application” and would do nothing to delay or derail it.

African Farming could not confirm rumours that Onderstepoort Biological Products (OBP) submitted a Section 21 application to the South African Health Products Regulatory Authority (SAHPRA) on the same day as Design Biologix for the import of the Biogénesis vaccine.

However, it appears from information within animal health circles that the state now plans to import and distribute the vaccine via OBP itself.

Dr Jacob Modumo, acting CEO of OBP, did not return African Farming’s phone call. It is therefore unclear how OBP would handle the import, storage and distribution of the vaccine.

There are already questions in the industry about OBP’s ability to manufacture and handle vaccines, as the institution still does not meet international standards for good manufacturing practices (GMP) after 13 years.