The Africa Centers for Disease Prevention and Control (Africa CDC) has commended Revital Healthcare EPZ Ltd, a Kenyan biotechnology company, for achieving a significant milestone in African manufacturing excellence, as it becomes the first African company to be granted Pre-Qualification (PQ) status by the World Health Organization (WHO), for its early activation auto-disable (AD) syringe.
In a statement released by the Africa CDC on its website, while eight manufacturers worldwide have WHO PQ status for this product, Revital Healthcare EPZ Ltd. stands as the first and only African producer.
According to the statement, this milestone is expected to revolutionize the healthcare landscape in Africa, by reducing average syringe transport times by up to 80-90%, crucial for rapid outbreak responses and timely immunization campaigns.
Revital will produce over 300 million AD syringes annually, strengthening Africa’s healthcare infrastructure and securing the supply of essential medical equipment on the continent.
The statement explains further: “In line with its vision for a New Public Health Order, Africa CDC is committed to strengthening local manufacturing capabilities on the continent. We recognise that achieving WHO PQ status for the company’s early activation auto-disable syringe is a significant step towards self-reliance in healthcare product production.
“This achievement aligns with Africa CDC’s goals of promoting local manufacturing excellence to enhance healthcare delivery and ensure the availability of critical medical supplies on the continent and high-quality regulatory approval of African products(…).
“The Revital Healthcare approval serves to highlight why Africa CDC continues to call for focused and supportive regulatory processes, for African manufacturers. We call on WHO, investors and other partners, to strengthen their efforts to and work in support of African manufacturing, including regulatory facilitation and support and to do so in collaboration and coordination with Africa.
“Revital Healthcare EPZ Ltd.’s accomplishment exemplifies the potential of African innovation and manufacturing prowess. It underscores our collective commitment to building a resilient and self-sufficient healthcare ecosystem in Africa. As Africa CDC, we look forward to working closely with Revital Healthcare, to support the necessary pooled procurement and market access.”
Established in 2008, Revital Healthcare (EPZ) Ltd. is based in Mombasa, Kenya and became the first East and Central African company to manufacture medical devices such as Auto-Disable syringes, thereby preventing the reuse of.syringes and reducing the transfer of infectious diseases.
With the estäblishment of its second manufacturing plant in 2017, the company has grown to become one of the largest manufacturers of medical devices on the African continent, with a continuous expansion in manufacturing capacities and the introduction of new medical devices in its portfolio.
Re-use of injection equipment is responsible for most of the infections that result from immunization. Fortunately, several new types of syringes have been designed to prevent reuse: auto-disable (AD) syringes automatically become disabled after one use. WHO and UNICEF now recommend that auto-disable syringes be used for administering vaccines— particularly in mass immunization programs.
The early-activation feature is the gold standard for safety in Immunization programs as preferred by UNICEF, rendering the syringe disabled at the start of administering and injection.
A few years back, Revital Healthcare had received funding from the Africa Health Fund, the Asia Africa Investment and Consulting Pte Ltd and Ohara Pharmaceutical Co.Ltd., the Gates Foundation and private Japanese investors, among others