WHO Grants Pre-Qualification to Biological E's Novel Oral Polio Vaccine Type 2

Biological E. Limited announced that the World Health Organisation has granted pre-qualification to its Novel Oral Polio Vaccine type 2. Known as nOPV2, this vaccine significantly reduces the risk of vaccine-derived Poliovirus type 2 (cVDPV2) outbreaks, targeting immunisation in affected countries. The vaccine boasts improved genetic stability, reducing new outbreak risks.

Biological E. Limited (BE) announced on Tuesday that the World Health Organization (WHO) has granted pre-qualification status to its Novel Oral Polio Vaccine type 2 (nOPV2).

The nOPV2, BE's 10th pre-qualified vaccine, is a next-generation live, attenuated oral vaccine that significantly reduces the risk of circulating vaccine-derived Poliovirus type 2 (cVDPV2) outbreaks, according to a press release from BE.

Targeted for immunisation in countries affected by cVDPV2 outbreaks, nOPV2 represents a critical advancement in the global fight against polio.

The vaccine features improved genetic stability, substantially lowering the risk of seeding new outbreaks in low-immunity environments compared to its predecessor, the Sabin poliovirus type 2 (mOPV2) vaccine, as mentioned in the release.

Mahima Datla, managing director of Biological E. Limited, expressed, "We are pleased to be a part of the global effort to eradicate polio. The WHO pre-qualification of nOPV2 marks a significant milestone in our collective quest to eradicate polio."

nOPV2 has been specifically designed to address concerns about Vaccine-Associated Paralytic Polio (VAPP), which occurred in approximately 2 to 4 cases per million births with traditional OPV due to the vaccine virus reverting to a virulent form.

BE, in collaboration with PT BioFarma (PTB) in Indonesia, the first manufacturer to receive WHO Pre-Qualification for nOPV2 in January 2024, has successfully acquired the technology from PTB and established large-scale manufacturing facilities capable of producing over 500 million doses of nOPV2 annually.

The vaccine production has also received approval from Indian regulatory authorities for export purposes, the press release added.

(With inputs from agencies.)