WHO pre-qualifies Biological E.’s innovative Oral Polio Vaccine Type 2: Report

New Delhi: Polio continues to remain a major health burden across the world. Polio is a virus that can affect the brain and spinal cord and can cause paralysis or even death, so far there is no cure for the disease but it can be prevented through vaccination. Recently, Biological E Limited (BE), a Hyderabad-based vaccine and pharmaceutical company announced that the World Health Organization (WH0) has granted a pre-qualification (PQ) status to their novel oral polio vaccine type 2 (nOPV2).

According to the firm, this is a next-generation live attenuated oral vaccine that significantly minimises the dangers of circulating vaccine-derived poliovirus type 2 (cVDPV2) outbreaks. The vaccine focuses on providing immunity to countries that are affected by cVDPV2 spreads. The vaccine was manufactured in collaboration with PT BioFarma (PTB) in Indonesia, and the first producer of the n0PV2 vaccine received the WHO pre-qualification in January 2024. Moreover, BE has also received technology from PTB and qualified for large-scale manufacturing facilities that could produce over 500 million doses of the nOPV2 vaccine every year.

Biological E Limited in a report noted that the vaccine the new vaccine has been particularly designed to address the concerns about the Vaccine-Associated Paralytic Polio (VAPP) that occurred in around 2 to 4 cases per million births with the traditional OPV due to the vaccine pathogen reverting to a virluent form.

The continuous clinical trials have evaluated the safety and immunogenicity of nOPV2, leading to positive results that are published in The Lancet (2019-2024). Moreover, the vaccine’s real-world deployment in outbreak regions has revealed that the vaccine can drastically reduce the incidence of cVDPV2 outbreaks and may provide protection to the communities from the dangers of polio. The vaccine has been supplied to over 130 countries and its therapeutic products are sold in India, the USA and Europe. Currently, it consists of 10 WHO-approved vaccines and 10 USFDA-approved Generic Injectables.