Biological E’s novel polio vaccine receives WHO’s pre-qualification status

Biological E announced that the World Health Organisation (WHO) has granted Pre-qualification (PQ) status to their Novel Oral Polio Vaccine type 2(nOPV2). 

This next-generation live, attenuated oral vaccine significantly reduces the risk of circulating vaccine-derived Poliovirus type 2 (cVDPV2) outbreaks and it is aimed at immunisation in countries that are affected by cVDPV2 outbreaks, which is a crucial moment in the fight against polio.

The persistent threat of circulating vaccine-derived Poliovirus type 2 (cVDPV2) outbreaks can be tackled using nOPV2 as the vaccine of choice. nOPV2 has a significantly decreased chance of seeding new outbreaks in low-immunity environments compared to its predecessor, the Sabin poliovirus type 2 (mOPV2) vaccine.

Extensive clinical trials have 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.

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 Bio Farma (PTB) in Indonesia, the first manufacturer of the nOPV2 vaccine to receive WHO Pre-Qualification in January 2024, BE received the 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.

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