BE receives WHO's Pre-qualification status for novel oral polio vaccine

Hyderabad: Biological E. Limited (BE), a Hyderabad-based vaccine and pharmaceutical company, on Tuesday announced that the World Health Organisation (WHO) has granted Pre-qualification (PQ) status to their Novel Oral Polio Vaccine type 2 (nOPV2).

nOPV2 is the 10th pre-qualified vaccine of BE. This next-generation live, attenuated oral vaccine significantly reduces the risk of circulating vaccine-derived poliovirus type 2 (cVDPV2) outbreaks and it is aimed at immunisation in countries that are affected by cVDPV2 outbreaks, the company said.

The persistent threat of cVDPV2 outbreaks can be tackled with the use of nOPV2 as the vaccine of choice. 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 BE said.

Extensive clinical trials have rigorously evaluated the safety and immunogenicity of nOPV2, leading to promising results published in The Lancet (2019-2024). Furthermore, the vaccine's real-world deployment in outbreak regions has shown that it can significantly decrease the incidence of cVDPV2 outbreaks, safeguarding communities from the ravages of polio.

BE has become an important player in the production of the nOPV2 vaccine, having been selected for a grant from the Bill and Melinda Gates Foundation (BMGF) to assist in meeting the growing global demand.

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.

Mahima Datla, Managing Director, Biological E. Limited, said that they 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. 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," she said.

Expressing BE's gratitude for the collaboration with PT BioFarma (PTB) and for the support of a grant from the Gates Foundation, she further said, “The significance of this milestone extends beyond scientific achievement; it represents a beacon of hope for millions of children and families around the globe. The achievement of administering over 1 billion doses of nOPV2 in outbreak regions is crucial to realising the dream of a polio-free world.’’