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Hyderabad, India – In a significant stride towards global polio eradication, Biological E. Limited (BE), a leading vaccine and pharmaceutical company based in Hyderabad, announced on Tuesday that their Novel Oral Polio Vaccine type 2 (nOPV2) has been granted Pre-qualification (PQ) status by the World Health Organisation (WHO).
The nOPV2, which is BE’s 10th pre-qualified vaccine, represents a groundbreaking advancement in the fight against circulating vaccine-derived poliovirus type 2 (cVDPV2) outbreaks. This next-generation live, attenuated oral vaccine is designed to significantly mitigate the risk of cVDPV2 outbreaks, particularly in regions where such outbreaks are prevalent.
BE’s nOPV2 addresses the persistent threat of cVDPV2 with its enhanced genetic stability, which markedly decreases the likelihood of seeding new outbreaks in low-immunity environments. This feature distinguishes it from its predecessor, the Sabin poliovirus type 2 (mOPV2) vaccine, which has been associated with a higher risk of reverting to a virulent form.
The safety and immunogenicity of nOPV2 have been rigorously evaluated through extensive clinical trials, with promising results published in The Lancet between 2019 and 2024. Moreover, the vaccine’s deployment in outbreak regions has demonstrated a substantial reduction in cVDPV2 incidence, thereby protecting communities from the devastating impacts of polio.
Biological E. Limited has emerged as a key player in the production of the nOPV2 vaccine. The company was awarded a grant from the Bill and Melinda Gates Foundation (BMGF) to help meet the growing global demand for this crucial vaccine. In collaboration with PT BioFarma (PTB) in Indonesia, the first manufacturer to receive WHO Pre-Qualification for nOPV2 in January 2024, BE has successfully acquired technology from PTB and established large-scale manufacturing facilities capable of producing over 500 million doses of nOPV2 annually. These efforts have been sanctioned by Indian regulatory authorities for export purposes.
Mahima Datla, Managing Director of Biological E. Limited, expressed her pride in the company’s contribution to the global polio eradication effort. “Our collective quest to eradicate polio marks a significant milestone with the WHO pre-qualification 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,” she stated.
Datla also expressed gratitude for the collaboration with PT BioFarma and the support from the Gates Foundation. She emphasized the broader significance of this achievement, stating, “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 realising the dream of a polio-free world.”
The WHO pre-qualification of BE’s nOPV2 marks a pivotal advancement in global health, bringing the world one step closer to the eradication of polio.
