hyderabad-pharma-company-gets-who-nod-for-oral-polio-vaccine

In a significant milestone in the fight against polio, a novel oral polio vaccine developed by the Hyderabad-based vaccine and pharmaceutical company, Biological E Limited (BE), has been granted pre-qualification (PQ) status by the World Health Organisation (WHO)

 

The nOPV2 is a next-generation oral vaccine developed to combat vaccine-derived Poliovirus type 2 (cVDPV2) outbreaks. Biological E has received a grant from the Bill and Melinda Gates Foundation to assist in meeting the growing global demand.

 

Mahima Datla, managing director of Biological E, said the WHO prequalification was a significant milestone, and this vaccine has been specifically designed to address concerns about vaccine-associated paralytic polio (VAPP).

 

It 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 added.

 

Biological E has collaborated with PT Bio Farma (PTB) in Indonesia, the first manufacturer of the nOPV2 vaccine to receive the WHO prequalification. The company has received the technology from PTB and qualified large-scale manufacturing facilities that produce more than 500 million doses of the nOPV2 vaccine annually.

 

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. They would need over 1 billion doses of nOPV2 in outbreak regions. BE has received approval from the Indian regulatory authorities to manufacture the vaccine for export purposes.

 

“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 prequalification 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,” said Biological E. Limited, Managing Director, Mahima Datla.