Biological E’s Novel Oral Polio Vaccine type 2 (nOPV2) has received Pre-qualification (PQ) status from the World Health Organization (WHO), marking a significant achievement in the global effort to eradicate polio. This development was announced by Mahima Datla, Managing Director of Biological E, who expressed enthusiasm about contributing to the worldwide quest to eliminate polio.
The nOPV2 vaccine was developed to address the risks associated with Vaccine-Associated Paralytic Polio (VAPP), which is a rare condition that can occur when the traditional Oral Polio Vaccine (OPV) virus reverts to a virulent form. VAPP has been observed in approximately two to four cases per million births with the traditional OPV. The nOPV2 is specifically engineered to mitigate this risk, thus enhancing the safety profile of polio vaccination efforts.
Datla highlighted the importance of the nOPV2 vaccine in combating the circulating Vaccine-Derived Poliovirus type 2 (cVDPV2) outbreaks, which pose significant challenges in some regions. The pre-qualification by WHO underscores the vaccine’s readiness for global deployment and its potential to substantially reduce the incidence of cVDPV2 outbreaks. The nOPV2 vaccine has already achieved a milestone by administering over one billion doses in outbreak regions, a crucial step toward a polio-free world.
In collaboration with PT BioFarma (PTB) in Indonesia, which was the first manufacturer to receive WHO Pre-Qualification for nOPV2 in January 2024, Biological E has leveraged technology transfer and established large-scale manufacturing capabilities. The partnership with PTB and the support from the Bill and Melinda Gates Foundation (BMGF) have been instrumental in scaling up production to meet global demand. Biological E has been granted a BMGF grant to help fulfill this demand and has secured approval from Indian regulatory authorities to manufacture nOPV2 for export purposes.
Clinical trials of the nOPV2 vaccine have demonstrated promising results regarding its safety and immunogenicity, as published in The Lancet. The real-world application of the vaccine in outbreak regions has shown a significant reduction in cVDPV2 incidence, confirming its effectiveness in preventing polio and protecting communities.
The pre-qualification of nOPV2 by WHO is a testament to Biological E’s commitment to improving public health and advancing polio eradication efforts. This achievement represents a critical advancement in vaccine technology and global health initiatives, aiming to eliminate polio and safeguard future generations from the disease.
SOURCE:
ECONOMIC TIMES
