Biovac and PATH announce partnership to develop novel vaccine against newborn infection

• Kate Davidson | PATH Media Relations | media@path.org
• Tanisha Ramshai | Meropa Communications | tanishar@meropa.co.za | +27834390350
• Luyanda Majija | Meropa Communications | luyandam@meropa.co.za | +27786262296

Durban, South Africa, 2 May 2017—The South Africa–based Biovac Institute (Biovac) and PATH, an international health organization, are pleased to announce the launch of a collaborative partnership to develop a novel vaccine against Group B Streptococcus (GBS), supported by a grant from the Bill & Melinda Gates Foundation. The partnership was announced today at the Innovation Effect Africa symposium held alongside the World Economic Forum event in Durban.

Biovac, a public-private partnership based in Cape Town, will be one of only three companies in the world and the only developing-country vaccine manufacturer to develop a novel conjugate vaccine against GBS.

GBS is a leading cause of severe infection in newborns and young infants in many countries, including South Africa. In fact, the estimated incidence of invasive GBS disease in South Africa is among the highest, with 2.38 cases per 1,000 live births. Whilst people of all ages can contract the GBS bacterial infection, newborns are more susceptible and vulnerable to this potentially deadly infection—particularly as an estimated 1 in 4 pregnant women carries the GBS bacterium, which can be passed to babies during birth. In parts of the developing world, mortality rates can reach as high as 38 percent. Babies who survive the disease are often left with lifelong disabilities such as deafness, blindness, and developmental delays. GBS may also play a role in miscarriage and stillbirth.

Preventative antibiotic treatment given to mothers before birth can successfully prevent early-onset GBS in newborns, but this option is not available in most resource-limited countries—and it doesn't always protect against late-onset GBS, which can occur in the weeks or months following birth without any clear cause.

A vaccine against GBS would be revolutionary in that it would be given to pregnant mothers who would pass on the protective antibodies to their babies, ensuring protection at birth and during the first critical months of life (when late-onset GBS disease is a risk).

No licensed vaccines currently exist to protect against GBS infection. A GBS vaccine designed specifically for low-resource countries could provide a chance for all babies to get a healthy start in life. Inventprise, a Seattle-area biotechnology startup with experience in conjugate vaccine development, will provide initial technical support, ensuring Biovac is well-positioned to manufacture a vaccine that targets sub-Saharan Africa and potentially other low-income regions of the world.

"Biovac has demonstrated the ability to successfully partner with leading multinational companies in vaccine manufacture. This recent collaboration with PATH and the Bill & Melinda Gates Foundation further adds to Biovac being the partner of choice in human vaccines in Africa and fulfills our quest to not only being a manufacturer but a true developer of novel vaccines aimed at African and developing-world diseases," said Dr. Morena Makhoana, CEO of Biovac.

PATH has one of the world's largest vaccine portfolios, with expertise covering the full spectrum of activities needed to reach those most at risk from vaccine-preventable diseases. That includes preclinical work and clinical trials in low-resource settings to build evidence of a vaccine's effectiveness.

For example, PATH, the World Health Organization, and Serum Institute of India Pvt. Ltd. led a global collaboration with scientists and partners that developed and introduced the MenAfriVac® vaccine, the first vaccine tailor-made for countries in Africa's "meningitis belt."

"A vaccine against GBS could provide newborn babies with needed protection against a serious and life-threatening disease for which they are at risk during the first months of life," said Dr. Mark Alderson, director of PATH's GBS, polyvalent meningococcal, and pneumococcal vaccine projects. "Our partnership with Biovac—an up-and-coming vaccine development company based in South Africa—reflects our goal to serve the people most affected by this devastating disease and deliver a vaccine where it is most needed."

"The first few weeks of a baby's life are by far the most critical—newborns are more susceptible to infection because they haven't yet developed immunity and many infections occur too early to be prevented by vaccination of the infant; infections can, however, be prevented if mothers are protected by immunizations and then provide their babies with natural antibodies," said Dr. Keith Klugman, director of the pneumonia team at the Bill & Melinda Gates Foundation. "The Gates Foundation is proud to partner with PATH and Biovac on our first grant to an African company to develop a Group B Streptococcus vaccine specifically designed to protect mothers and babies in sub-Saharan countries where the disease is most prevalent."

"The South African Government, through the Department of Science and Technology, has been continuously positioning South Africa and the continent as a hub of research excellence with world-class facilities through its investments and policies. We have long recognized that innovation is increasingly crucial for health and economic development and are, therefore, pleased with the collaborative partnership announced by Biovac and its partners. The development of a novel vaccine against GBS is a critical milestone in the search for a vaccine to protect newborns from this disease through immunization of their mothers. Despite advances in the prevention and treatment of neonatal disease, sepsis and meningitis caused by GBS still present public health challenges especially in developing countries, and a strategy to prevent GBS infection is of critical importance. In this regard, I would like to express my unwavering support for this partnership and acknowledge PATH and the Bill & Melinda Gates Foundation for the confidence they are bestowing on us as a country and the continent through this partnership with Biovac," said Ms. Naledi Pandor, Minister of Science and Technology in South Africa.

Biovac was established as a private-public partnership and is one of a handful of vaccine manufacturers in Africa. It is located in Cape Town, South Africa and its mission is to re-establish end-to-end vaccine development and manufacture in South Africa. It has established modern vaccine manufacturing infrastructure and is partnering with multinational vaccine companies for the transfer of technology thereby accelerating the building of the aforementioned capacities. In addition, Biovac has established expertise in conjugate vaccine development that it will exploit and build upon in the development of a novel conjugate vaccine against GBS.