Revital Healthcare EPZ Ltd. Achieves WHO Prequalification for Early-Activation Auto-Disable Syringe: A Milestone for African Manufacturing and Immunization Programming

Mombasa, Kenya – [26th September 2023] – Revital Healthcare EPZ Ltd., a leader in African medical device manufacturing, announces a historic milestone in African manufacturing excellence. The company is the first to be granted Pre-Qualification (PQ) status by the World Health Organization (WHO) on July 11, 2023 for their early activation auto-disable (AD) syringe in Africa. This marks Revital’s more than ten-year commitment to injection safety in immunization programming across Africa.

The early-activation feature is the gold standard for safety in Immunization programs as preferred by UNICEF, and renders the syringe disabled at the start of administering and injection. Historically, the introduction of these devices have resulted in substantial reductions in rates of blood-borne infections such as HIV in immunization programs across Africa.

There are currently eight manufacturers who have WHO PQ status for this product, however Revital’s is the first and only to be produced in Africa. This is expected to decrease average syringe transport times by up to 80-90% for Africa, critical for rapid outbreak response and timely immunization campaigns.

Roneek Vora, Director of Marketing and Sales for Revital Healthcare EPZ Ltd., comments, “Revital’s historic WHO pre-qualification for the early-activation AD syringe exemplifies the transformative power of African innovation and manufacturing excellence. Our commitment to the well-being of our fellow people, especially children receiving life-saving immunization, is our motivation to continue to progress.”

Revital will be able to produce upwards of 300 million AD syringes per year.

This work was made possible through a grant from the Bill & Melinda Gates Foundation. In addition to supporting the development of this product to increase supply security for Africa, this helped create more than 200 new local jobs in Kilifi County, 80% of which are staffed by women in support of a joint commitment to gender equality.

“As the first African manufacturer to be approved by WHO to produce early activation auto-disable syringes, Revital is paving the way to expand local production of syringes,” said Violaine Mitchell, Director of Immunization at the Bill & Melinda Gates Foundation.

“We are proud to support Revital’s efforts to sustainably expand the supply of these syringes in Africa and ensure vaccines are delivered safely and quickly across the continent.”

The WHO PQ listing for the 0.5ml early-activation AD syringe can be accessed through the WHO Vaccine Quality Catalogue.

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“Our successful WHO Prequalification for the early activation auto-disable syringe marks a significant milestone in our commitment to healthcare excellence. This recognition validates our syringe’s rigorous adherence to stringent international standards, ensuring its efficacy, safety, and reliability in diverse healthcare settings globally.”

“I am thrilled by our achievement of WHO Prequalification for the early activation auto-disable syringe. This accomplishment reflects our dedication to manufacturing precision and the highest quality standards, further solidifying our position as a global healthcare leader, and setting new benchmarks for innovation in medical device manufacturing. 

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