Cape Town based, biotech company, Biovac, has begun local manufacturing of global pharmaceutical company, Sanofi Pasteur’s six-in-one paediatric vaccine.
This is the first time since the mid-1990s that any sterile manufacturing of human vaccines has been done on South African soil.
“Biovac is extremely proud to be able to commence local manufacture of one of the most complex combination vaccines, globally. This will further strengthen our contribution to the local bio-economy, by producing vaccines that are relevant for South Africa with a high public health benefit,” Biovac CEO, Dr Morena Makhoana said.
This fully liquid six-in-one vaccine seeks to prevent six childhood diseases, namely diphtheria, tetanus, pertussis, hepatitis b, haemophilus influenza b and poliomyelitis. Combination vaccines reduce the risk of needle stick injuries associated with multiple injections, increase compliance, and reduce the cold chain requirements needed in healthcare facilities.
The hexavalent vaccine does not need to be mixed before injection. This makes it easier to administer in remote and resource-poor health settings. It is a key vaccine in the national immunisation programmes in eight public markets, including Mexico, Saudi Arabia, Belgium, Chile and South Africa.
“Vaccines are a critical public health need and although South Africa is a developing economy, its public vaccine schedule is robust and world class. Production and supply of vaccines are quite sophisticated, especially for the six-in-one combination vaccine, as a single vaccine may take up to 36 months to be manufactured,” Sanofi Pasteur Head of Commercial Operations, Stephen Alix said.
“Long-term commitment and partnering with governments and stakeholders are imperative to ensure sustainability of vaccines. The strategy for South Africa and Africa is to work with our partners and governments to increase vaccine coverage by ensuring that every child is vaccinated against vaccine-preventable diseases,” Alix said. “Globally, South Africa is the leading country in the utilisation of this type of vaccine. With very few partnerships of this nature, Sanofi Pasteur’s technology transfer to Biovac is for the most innovative vaccine globally.”
Biovac has been labelling and packaging the vaccine for the past five years and is now approved by the South African Health Products Regulatory Authority (SAHPRA), to manufacture under sterile conditions. This is the first technology transfer of this vaccine by Sanofi to an external partner.
The commencement of local manufacturing of a hexavalent vaccine positions Biovac as a strong contender to manufacture complex vaccines. “Through local manufacturing we will be able to further strengthen security of supply whilst contributing to the local economy,” says Makhoana.