There is light in the foot-and-mouth disease (FMD) vaccine manufacturing tunnel in South Africa. Minister of agriculture, Willie Aucamp, has announced that qualifying private companies will henceforth be able to make use of the Agricultural Research Council’s (ARC) intellectual property (IP) relating to FMD vaccines. This means approved establishments can manufacture the ARC’s FMD vaccine at scale, provided they meet certain criteria. The ARC and its board unanimously agreed to this on 21 September.
The minister said in a statement that the ARC vaccine is a highly effective defence against domestic FMD strains and requires only a single annual dose. However, due to manufacturing constraints, the ARC currently cannot manufacture its FMD vaccine at scale. Allowing local and/or international companies to manufacture the ARC vaccine under conditional IP licensing agreements with the ARC will therefore help the ARC overcome its current manufacturing constraints.
“Although the implementation of this decision will not happen overnight, it is a huge step forward in combating this FMD outbreak, and I am proud to confirm that all parties involved have committed to do whatever they can to ensure that this decision is implemented without delay.”
The ARC will also submit representative FMD field-circulating virus isolates from South Africa to the Pirbright Institute in the United Kingdom in October for a second round of vaccine-matching assessments. This exercise will provide an additional scientific assessment of the suitability of available local and imported vaccines against FMD viruses currently circulating in South Africa.
FMD vaccine not the only crucial one
Well-known livestock veterinarian and director of Veterinarian Network, Dr Danie Odendaal, says he welcomes the announcement but is disappointed it was not embraced earlier, as it could have saved the industry from the current disaster. He said a state institution without sufficient manufacturing capacity should never accept a shortage and should use appropriately qualified private-sector manufacturing capacity under controlled contractual, licensing, and regulatory arrangements. He noted, however, that this does not mean that the state is transferring its responsibility to the private sector.
“The state remains responsible for ensuring that the country has the necessary disease-control capability. Private companies can provide the manufacturing capacity, technology, investment and production flexibility required to fulfil that responsibility.”
He noted that this principle should extend beyond FMD. “Onderstepoort Biological Products (OBP), as a state-owned veterinary vaccine manufacturer, has an important role in South Africa’s animal-health system. But if OBP cannot produce sufficient quantities of an essential vaccine – for example, bluetongue vaccine –when national demand exceeds its available production capacity, then the answer should be to ensure that an appropriately qualified private manufacturer can produce the vaccine on contract and under the required regulatory and quality-control standards.”
Dr Odendaal stressed that vaccine security is part of national disease security and that South Africa needs to change the way it thinks about veterinary vaccines. “We cannot wait for a major disease crisis before asking whether we have enough vaccine, enough manufacturing capacity, enough production facilities, enough raw materials and enough distribution capacity. For strategically important livestock diseases like Rift Valley fever, South Africa needs a national veterinary vaccine security strategy.”
Putting FMD lessons to work
Such a strategy should identify vaccines that are strategically important to the livestock industry, as well as the annual and emergency quantities required. It should critically assess current production capacity and the gap between available capacity and national requirements. A plan should be in place for alternative licensed manufacturers capable of producing the vaccines, mechanisms for rapid technology transfer, and contractual arrangements for emergency production. A very important aspect, he says, is regulatory capacity to evaluate and release products efficiently, along with systems to ensure that vaccines can be rapidly distributed and administered when disease threats emerge.
“The lessons we learned from the current FMD outbreak must not be lost. The minister’s announcement demonstrates that the government now recognises that one manufacturing institution cannot necessarily carry the entire burden of national vaccine supply. However, the lesson should be applied systematically, not only to the current FMD crisis.
“It should, in fact, become normal national animal-health policy rather than an emergency response to a crisis. Minister Aucamp’s decision is therefore more than a decision about the ARC’s FMD vaccine. It could establish a new model for veterinary vaccine security in South Africa. The critical next step is now to implement it rapidly, transparently and at the scale required by the livestock industry.” – Lynette Louw, Plaas Media
