WHO Prequalifies Biological E’s Novel Oral Polio Vaccine Type 2

In a landmark achievement for global health, the World Health Organization (WHO) has granted pre-qualification status to Biological E’s novel oral polio vaccine type 2 (NOPV2). This development marks a significant milestone in the ongoing battle against polio, particularly in regions afflicted by circulating vaccine-derived poliovirus type 2 (cVDPV2) outbreaks. Biological E, a Hyderabad-based biopharmaceutical company, has developed this next-generation live, attenuated oral vaccine with the specific aim of mitigating the risks associated with cVDPV2. The pre-qualification by WHO is a testament to the vaccine’s efficacy and safety, as it meets stringent international standards required for global distribution.

The NOPV2 vaccine is a result of a collaborative effort between Biological E and PT Bio Farma, an Indonesian pharmaceutical company that was the first to receive WHO pre-qualification for NOPV2 in January 2024. The technology transfer from PT Bio Farma to Biological E has enabled large-scale manufacturing capabilities, with facilities capable of producing over 500 million doses annually. This capacity is crucial for addressing the urgent need for immunization in countries grappling with cVDPV2 outbreaks. The Bill and Melinda Gates Foundation has also played a pivotal role in this initiative by providing financial support to ensure the vaccine meets global demand.

One of the most compelling aspects of the NOPV2 vaccine is its improved genetic stability compared to its predecessor, the Sabin poliovirus type 2 (mOPV2) vaccine. Traditional oral polio vaccines have been associated with vaccine-associated paralytic polio (VAPP), a rare but serious condition occurring in approximately 2 to 4 cases per million births. VAPP results when the weakened virus in the vaccine mutates and regains virulence, causing paralysis. The NOPV2 vaccine addresses this concern by significantly reducing the risk of such mutations, thereby offering a safer alternative for immunization campaigns.

The real-world deployment of the NOPV2 vaccine has already shown promising results in reducing the incidence of cVDPV2 outbreaks. Countries that have adopted this vaccine have reported a noticeable decrease in new cases, underscoring its effectiveness in controlling the spread of the virus. This success is particularly vital in areas with low immunity levels, where traditional vaccines might inadvertently seed new outbreaks. The improved genetic stability of NOPV2 makes it a more reliable option for these vulnerable populations.

Indian regulatory authorities have also approved Biological E to manufacture the NOPV2 vaccine for export purposes, further enhancing its accessibility on a global scale. This approval is a significant step towards ensuring that countries in need can procure the vaccine promptly, thereby accelerating efforts to achieve a polio-free world. The ability to produce and export such a large volume of doses underscores Biological E’s commitment to global health and its capacity to meet international demands.

Biological E’s Managing Director, Mahima Datla, has expressed profound gratitude for the WHO’s pre-qualification and the support from the Bill and Melinda Gates Foundation. She emphasized that this achievement is not just a milestone for the company but a critical advancement in the global fight against polio. Datla reiterated the company’s dedication to eradicating polio and ensuring that no child suffers from this preventable disease. The collaboration with PT Bio Farma and the financial backing from the Gates Foundation have been instrumental in reaching this stage.

The pre-qualification of NOPV2 by WHO is the 10th such recognition for Biological E, highlighting the company’s robust portfolio of vaccines that meet international standards. This accomplishment reflects Biological E’s expertise and leadership in vaccine development and manufacturing. The company’s extensive experience and infrastructure position it as a key player in global health initiatives, particularly in combating infectious diseases like polio.

The introduction of NOPV2 is particularly timely given the rising incidence of cVDPV2 outbreaks, which have been attributed to low immunization rates in certain regions. These outbreaks pose a significant challenge to polio eradication efforts, as they can lead to new cases of paralysis and further spread of the virus. By offering a more stable and effective vaccine, NOPV2 provides a crucial tool for public health authorities to contain and eventually eliminate these outbreaks.

In addition to its role in combating cVDPV2, the NOPV2 vaccine is also expected to contribute to broader immunization strategies. By integrating this vaccine into routine immunization programs, countries can enhance their overall polio control measures and protect future generations from the debilitating effects of the disease. The ability to administer over 1 billion doses in outbreak regions is a testament to the vaccine’s scalability and potential impact on global health.

Biological E’s achievement with NOPV2 is part of a larger narrative of innovation and collaboration in the field of vaccine development. The partnership with PT Bio Farma and the support from the Bill and Melinda Gates Foundation exemplify how cross-border cooperation and philanthropic investment can drive significant advancements in public health. These collaborations are essential for addressing complex global health challenges and ensuring equitable access to life-saving interventions.

The journey towards a polio-free world is fraught with challenges, but the pre-qualification of NOPV2 represents a beacon of hope. It demonstrates that through scientific innovation, strategic partnerships, and unwavering commitment, it is possible to make substantial progress against even the most formidable health threats. Biological E’s NOPV2 vaccine is poised to play a pivotal role in this endeavor, offering a safer and more effective solution for polio immunization.

As the global community continues to strive towards polio eradication, the importance of sustained efforts and vigilance cannot be overstated. The success of NOPV2 underscores the need for continued investment in vaccine research and development, as well as robust immunization campaigns. By leveraging the strengths of organizations like Biological E, PT Bio Farma, and the Bill and Melinda Gates Foundation, the world can move closer to realizing the dream of a polio-free future. The WHO’s pre-qualification of NOPV2 is a significant step in this direction, heralding a new era in the fight against polio.