The World Health Organization (WHO) on Tuesday granted the pre-qualification (PQ) status to Biological E’s novel oral polio vaccine type 2 (nOPV2), the company said. The nOPV2 is a next-generation oral vaccine developed to combat vaccine-derived Poliovirus type 2 (cVDPV2) outbreaks. Hyderabad-based vaccine and pharmaceutical company 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, Biological E, said the WHO pre-qualification 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 pre-qualification. 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. This next-generation live, attenuated oral vaccine significantly reduces the risk of circulating cVDPV2 outbreaks and it is aimed at immunisation in countries that are affected by cVDPV2 outbreaks, a crucial moment in the fight against polio.
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.
