BE receives WHO pre-qualification status for its oral polio vaccine

Hyderabad, Jul 30 (PTI) Biological E. Limited (BE) on Tuesday announced that the World Health Organisation (WHO) has granted pre-qualification status to its Novel Oral Polio Vaccine type 2 (nOPV2).

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

It is aimed at immunisation in countries that are affected by cVDPV2 outbreaks, which is a crucial moment in the fight against polio.

With its improved genetic stability, nOPV2 has a significantly decreased chance of seeding new outbreaks in low-immunity environments as against its predecessor, the Sabin poliovirus type 2 (mOPV2) vaccine, the release said.

Mahima Datla, managing director, Biological E. Limited, said: “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 pre-qualification of nOPV2.”

The 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, she said.

In collaboration with PT BioFarma (PTB) in Indonesia, the first manufacturer of the nOPV2 vaccine to receive WHO Pre-Qualification in January 2024, BE has successfully received technology from PTB and qualified large-scale manufacturing facilities that produce more than 500 million doses of nOPV2 vaccine annually.

BE has been approved by the Indian regulatory authorities to manufacture the vaccine for export purposes, the release added.