Biological E announced in July 2024 that WHO has granted prequalification status to the company’s Novel Oral Polio Vaccine type 2 (nOPV2). Biological E describes this as a “monumental stride” towards global polio eradication, celebrating the 10th Biological E vaccine to receive this status. nOPV2 is a next-generation live, attenuated oral vaccine that “significantly reduces” the risk of circulating vaccine-derived poliovirus type 2 (cVDPV2) outbreaks and is intended for use in countries affected by these outbreaks in a “crucial moment in the fight against polio”.
A strong candidate
Biological E states that nOPV2 can tackle the “persistent threat” of circulating cVDPV2; the vaccine boasts “improved genetic stability” with a “significantly” lower risk of “seeding new outbreaks” in low-immunity environments, compared to the Sabin poliovirus type 2 (mOPV2) vaccine. Through “extensive” clinical trials the safety and immunogenicity of nOPV2 have been “rigorously” evaluated. Furthermore, use in outbreak regions has shown that nOPV2 can “significantly” decrease the incidence of cVDPV2 outbreaks.
Mahima Datla, Managing Director of Biological E, is “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.”
Ms Datla also recognised the role of key collaborator PT Bio Farma (PTB) in Indonesia and supporter, the Bill and Melinda Gates Foundation. The Gates Foundation provided a grant to support efforts to meet the global demand. She described the PTB collaboration as a “privilege” and extended “heartfelt gratitude” to the Gates Foundation for “entrusting us with the responsibility of manufacturing nOPV2”.
“Together we are committed to advancing the cause of global health equity and guaranteeing that no child is affected by the devastating effects of polio. The significance of this milestone extends beyond scientific achievement; it represents a beacon a hope for millions of children and families around the globe.”
Ms Datla states that administering more than 1 billion doses of nOPV2 in outbreak regions is “crucial to realising the dream of a polio-free world”.
We look forward to welcoming Dr Ajoy Chakrabarti, Portfolio and Platform Lead, Polio, Global Health Programme, Gates Foundation to the Congress in Barcelona this October; get your tickets to join us here and don’t forget to subscribe to our weekly newsletters here.
