Biological E. Limited (BE), a Hyderabad-based vaccine and pharmaceutical firm, announced on Tuesday that the World Health Organization (WHO) has granted Pre-qualification (PQ) status to its Novel Oral Polio Vaccine type 2 (nOPV2). This achievement marks BE’s 10th pre-qualified vaccine.
The nOPV2 vaccine, a next-generation oral polio vaccine, plays a crucial role in combating circulating vaccine-derived poliovirus type 2 (cVDPV2) outbreaks. It is specifically designed to address the persistent threat of cVDPV2 by offering improved genetic stability. Compared to its predecessor, the Sabin poliovirus type 2 (mOPV2), nOPV2 significantly lowers the risk of seeding new outbreaks in environments with low immunity.
Extensive clinical trials have confirmed the safety and efficacy of nOPV2, with promising results featured in The Lancet from 2019 to 2024. The vaccine’s real-world use in outbreak regions has demonstrated its effectiveness in reducing cVDPV2 cases and protecting communities from polio.
BE has played a pivotal role in nOPV2 production, supported by a grant from the Bill and Melinda Gates Foundation (BMGF) to meet global demand. In collaboration with Indonesia’s PT BioFarma, the first manufacturer to receive WHO Pre-Qualification for nOPV2 in January 2024, BE has set up large-scale manufacturing facilities capable of producing over 500 million doses annually. Indian regulatory authorities have approved BE for exporting the vaccine.
Mahima Datla, Managing Director of Biological E. Limited, expressed pride in contributing to the global fight against polio. She emphasized that nOPV2’s WHO pre-qualification represents a major milestone in eradicating polio. Datla also highlighted the vaccine’s design to mitigate concerns about Vaccine-Associated Paralytic Polio (VAPP) associated with traditional OPV. She acknowledged the importance of BE’s collaboration with PT BioFarma and support from the Gates Foundation, noting that the administration of over 1 billion doses of nOPV2 is vital for achieving a polio-free world.
