The Novel Oral Polio Vaccine type 2 (nOPV2) of Biological E has been granted the Pre-qualification (PQ) status by the World Health Organisation (WHO).
“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,’‘ Mahima Datla, Managing Director, Biological E, said in a release.
The vaccine has been specifically designed to address concerns about Vaccine-Associated Paralytic Polio (VAPP), which has occurred in approximately two-four cases per million births with the traditional OPV due to the vaccine virus reverting to a virulent form, she added.
Polio-free world
“Collaborating with PT BioFarma (PTB) is a privilege and we extend our heartfelt gratitude to the Gates Foundation for entrusting us with the responsibility of manufacturing nOPV2,’‘ Datla said, adding that the achievement of administering over one billion doses of nOPV2 in outbreak regions is crucial to realising the dream of a polio-free world.
The nOPV2 is the 10th pre-qualified vaccine of the Hyderabad-based vaccine maker. According to BE, the next-generation live, attenuated oral vaccine “significantly reduces the risk’‘ of circulating vaccine-derived Poliovirus type 2 (cVDPV2) outbreaks and is aimed at immunisation in countries that are affected by cVDPV2 outbreaks which is crucial in the fight against polio.
Clinical trials 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.
Gates Foundation grant
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 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.