Hyderabad: Hyderabad-based vaccine and pharmaceutical company, Biological E Limited (BE), on Tuesday announced that the World Health Organisation (WHO) has granted pre-qualification (PQ) status to their novel oral polio vaccine type 2 (nOPV2).
This next-generation live, attenuated oral vaccine significantly reduces the risk of circulating vaccine-derived poliovirus type 2 (cVDPV2) outbreaks, and it aims to immunize countries affected by cVDPV2 outbreaks.
In collaboration with PT BioFarma (PTB) in Indonesia, the first manufacturer of the nOPV2 vaccine to receive WHO pre-qualification in January 2024, BE has successfully received technology from PTB and qualified large-scale manufacturing facilities that produce more than 500 million doses of the nOPV2 vaccine annually.
“We are pleased to be a part of the global effort to eradicate polio. Our collective quest to eradicate polio marks a significant milestone with the WHO prequalification of nOPV2. This vaccine has been specifically designed to address concerns about Vaccine-Associated Paralytic Polio (VAPP), which has occurred in approximately 2 to 4 cases per million births with the traditional OPV due to the vaccine virus reverting to a virulent form,” said Biological E. Limited, Managing Director, Ms Mahima Datla.
BE has become an important player in the production of the nOPV2 vaccine, having been selected for a grant from the Bill and Melinda Gates Foundation (BMGF) to assist in meeting the growing global demand.
She further expressed BE's gratitude for the collaboration with PT BioFarma (PTB) and the support of a grant from the Gates Foundation, “Collaborating with PTB is a privilege and we extend our heartfelt gratitude to the Gates Foundation for entrusting us with the responsibility of manufacturing nOPV2.
Together we are committed to advancing the cause of global health equity and guaranteeing that no child is affected by the devastating effects of polio. The significance of this milestone extends beyond scientific achievement; it represents a beacon of hope for millions of children and families around the globe. The achievement of administering over 1 billion doses of nOPV2 in outbreak regions is crucial to realizing the dream of a polio-free world,’’ she added.
Extensive clinical trials have rigorously evaluated the safety and immunogenicity of nOPV2, leading to promising results published in The Lancet (2019-2024). Furthermore, the vaccine's real-world deployment in outbreak regions has shown that it can significantly decrease the incidence of cVDPV2 outbreaks, safeguarding communities from the ravages of polio, she said.
BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to more than 130 countries and its therapeutic products are sold in India, the USA and Europe. The portfolio of BE currently consists of 10 WHO-approved vaccines and 10 USFDA-approved Generic Injectables. Recently, DCGI has approved BE’s 14-Valent Pneumococcal Conjugate vaccine.