Cape Town - After more than two decades, South Africa’s vaccine industry has been reignited with the local production launch of a paediatric vaccine.
Biovac, a Cape Town-based biotech company, announced on Thursday it had commenced production of Hexaxim, a six-in-one paediatric vaccine, in a partnership with French pharmaceutical company Sanofi Pasteur.
The launch was held virtually with representatives from both companies in attendance, as well as keynote speaker and Minister of Science and Innovation Dr Blade Nzimande.
“This capacity is going to put us in good standing in South Africa in terms of future production of vaccines, even possibly down the line, a Covid-19 vaccine,” Nzimande said. “It plays a very important foundation to build our capacity as a country.”
The liquid vaccine prevents six childhood diseases including diphtheria, tetanus, pertussis, polio, haemophilus influenzae B, and hepatitis B. It is made up of nine antigens, and the vaccine is subject to 50 manufacturing steps, 223 analytical methods, and 1 277 individual tests before it is distributed.
Nzimande highlighted the benefits of a combination vaccine, saying it allowed for infants to make multiple trips to medical facilities. “Multiple visits, as we know, has a high risk of default,” he explained. “With defaults, we know this results in children not receiving the required vaccines, but also the risk of the child contracting a vaccine-preventable disease and can spread to other vulnerable groups. This is a huge mitigation factor. We just have one shot that actually deals with six to nine conditions.”
The vaccine was first introduced in 2015 to the Department of Health’s Expanded Programme of Immunisation (EPI). Since then, over 5 million doses have been supplied to South African infants with the supply having been imported and packaged by Biovac.
In addition to South Africa, the vaccine is used in eight other markets globally including Mexico, Chile, Belgium, and Saudi Arabia.
Established in 2003, Biovac was formed in partnership with the national government to re-establish a vaccine manufacturing capability. “As a small country with limited means, we have to find innovative ways of building vaccine manufacturing capability,” said Biovac chief executive Dr Morena Makhoana. “During the first five years we were established, we had to raise capital, understanding that the capital for biotechnology is quite high. We had to reformulate some of our strategies after we had inherited a site that was given to the company by the South African government.”
The production comes eight years after a technology transfer agreement was reached in 2012 between Biovac and Sanofi to bring the technology required to produce vaccines locally . The transfer was completed in 2016 and Biovac received its Good Manufacturing Practice certification two years later. Full-scale production can now commence following approval from the South African Health Products Regulatory Authority.
“We had to recruit quite aggressively and we had to secure tech transfers,” Makhoana explained. “We then got into execution, and that meant to not only get the tech transfers down the line, but also ensure we get the required certification from the regulatory authority.”
Makhoana added: “The country has demonstrated to the world it provides a ripe environment for innovation and entrepreneurship.”
Stephen Alix, Head of Commercial Operations at Sanofi Pasteur said the Covid-19 pandemic illustrated a need to prioritise vaccines such as Hexaxim. “The route to immunisation is even more crucial during a pandemic,” he said. “We need to keep preventable diseases at bay while our resources are redirected to managing and containing the crisis faced by countries.”
Weekend Argus