The World Health Organisation has granted pre-qualification status to the novel oral polio vaccine type 2 (nOPV2) of Hyderabad-based vaccine maker, Biological E.
A next-generation live, attenuated oral vaccine promising to significantly reduce the risk of circulating vaccine-derived Poliovirus type 2 outbreaks, nOPV2 is intended for use in countries affected by cVDPV2. This is the 10th pre-qualified vaccine of BE, the company said, announcing the WHO decision in a release on Tuesday, July 31, 2024.
BE has received technology for the vaccine from PT BioFarma (PTB) of Indonesia and qualified large-scale manufacturing facilities that produce more than 500 million doses of nOPV2 vaccine annually. Indian regulatory authorities have approved BE to manufacture the vaccine for export purposes.
Gates Foundation grant
The company said it has emerged as an important player in the production of the nOPV2 vaccine and selected for a grant from the Bill and Melinda Gates Foundation to assist in meeting the growing global demand. PTB became the first manufacturer of nOPV2 to receive WHO pre-qualification in January 2024.
“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,” Biological E. Managing Director Mahima Datla said.
The persistent threat of cVDPV2 outbreaks can be tackled with 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, BE said.
Extensive clinical trials have evaluated the safety and immunogenicity of nOPV2, leading to promising results published in The Lancet (2019-2024). 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, the company said.
“Collaborating with PTB is a privilege and we extend our heartfelt gratitude to the Gates Foundation for entrusting us with the responsibility of manufacturing nOPV2. Administering over 1 billion doses of nOPV2 in outbreak regions is crucial to realising the dream of a polio-free world,” Ms. Datla said.
