Biopharma company Biological E Limited (BE) has achieved World Health Organization (WHO) Pre-qualification (PQ) for its Novel Oral Polio Vaccine type 2 (nOPV2). This milestone marks the 10th vaccine from the Hyderabad-based firm to receive WHO prequalification.
Biological E
The nOPV2 is a next-generation live, attenuated oral vaccine designed to combat poliovirus type 2. BE highlighted that the vaccine has demonstrated significant efficacy in reducing the risk of circulating vaccine-derived poliovirus type 2 (cVDPV2) outbreaks. The results from extensive clinical trials, which were published in The Lancet between 2019 and 2024, confirm the vaccine’s safety and immunogenicity.
With its improved genetic stability, nOPV2 reduces the risk of new outbreaks in environments with low immunity compared to its predecessor, the Sabin poliovirus type 2 (mOPV2) vaccine. BE noted that real-world use in outbreak regions has shown a substantial decrease in cVDPV2 incidence.
The WHO PQ for nOPV2 is seen as a significant achievement by BE, with Managing Director Mahima Datla emphasizing that the vaccine addresses concerns related to Vaccine-Associated Paralytic Polio (VAPP), which occurs in about two to four cases per million births with the traditional oral polio vaccine due to the vaccine virus reverting to a virulent form.
In support of global polio eradication efforts, BE has been selected for a grant from the Bill and Melinda Gates Foundation (BMGF) to help meet the increasing demand for the nOPV2 vaccine. The company has received technology transfer from PT BioFarma of Indonesia—the first manufacturer to achieve WHO prequalification for nOPV2 in January 2024—and has the capacity to produce over 500 million doses annually.
Additionally, BE has obtained approval from Indian regulatory authorities to manufacture the vaccine for export.
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