A Milestone in Polio Eradication
Biological E Limited (BE), a prominent vaccine and pharmaceutical company based in Hyderabad, has achieved a significant milestone in the global fight against polio. On Tuesday, the World Health Organization (WHO) granted pre-qualification (PQ) status to BE’s novel oral polio vaccine type 2 (nOPV2). This development marks a major advancement in the battle against circulating vaccine-derived Poliovirus type 2 (cVDPV2) outbreaks.
The Significance of nOPV2
nOPV2 represents a groundbreaking advancement over its predecessor, the Sabin poliovirus type 2 (mOPV2) vaccine. According to BE, nOPV2’s improved genetic stability significantly reduces the risk of seeding new outbreaks in low-immunity environments. This is crucial in regions where the traditional vaccine has been linked to circulating vaccine-derived Poliovirus type 2 (cVDPV2) outbreaks.
The vaccine’s improved stability makes it a vital tool in the fight against polio, especially in countries struggling with cVDPV2 outbreaks. The pre-qualification by WHO indicates that nOPV2 meets rigorous international standards for quality, safety, and efficacy.
Extensive Clinical Trials and Real-World Impact
The development of nOPV2 has been supported by extensive clinical trials, which have evaluated its safety and immunogenicity. Promising results from these trials were published in The Lancet between 2019 and 2024. These trials demonstrated that nOPV2 is not only effective but also significantly safer compared to previous vaccines, particularly in reducing the incidence of vaccine-associated paralytic polio (VAPP).
In addition to clinical trials, the real-world deployment of nOPV2 in outbreak regions has shown its effectiveness in decreasing the incidence of cVDPV2 outbreaks. This practical success underscores the vaccine’s potential to safeguard communities from the devastating effects of polio.
Collaboration and Manufacturing
The achievement of WHO pre-qualification is a testament to BE’s commitment to global health. BE has been an important player in the production of nOPV2, working closely with PT Bio Farma (PTB) in Indonesia. PTB was the first manufacturer to receive WHO pre-qualification for nOPV2 in January 2024. BE received technology transfer from PTB and has established large-scale manufacturing facilities capable of producing over 500 million doses of nOPV2 annually.
The collaboration with PTB and the support from the Bill and Melinda Gates Foundation (BMGF) have been instrumental in meeting the growing global demand for this vaccine. The Gates Foundation’s grant has provided critical support in scaling up production and ensuring the availability of nOPV2 for outbreak response.
Statements from BE’s Leadership
Mahima Datla, Managing Director of Biological E Limited, expressed her enthusiasm about the WHO pre-qualification. She stated, “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.”
Image Source BE LTD
Datla also highlighted the importance of the collaboration with PTB and the support 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.”
Global Impact and Future Prospects
The achievement of WHO pre-qualification for nOPV2 is more than a scientific breakthrough; it represents a beacon of hope for millions of children and families worldwide. The goal of administering over 1 billion doses of nOPV2 in outbreak regions is crucial to realizing the dream of a polio-free world. This milestone reinforces the global commitment to eradicating polio and demonstrates the effectiveness of collaborative efforts in addressing global health challenges.
In conclusion, Biological E Limited’s achievement in securing WHO pre-qualification for nOPV2 marks a significant step forward in the global fight against polio. With its improved safety profile and effectiveness, nOPV2 has the potential to play a pivotal role in preventing polio outbreaks and moving closer to the eradication of this debilitating disease.
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