Health
WHO grants prequalification status to Biological E's new oral polio vaccine type 2
Novel oral polio vaccine type 2 (nOPV2)
The World Health Organization has prequalified Hyderabad-based vaccine maker Biological E's new oral polio vaccine type 2 (nOPV2).
The next-generation live-attenuated oral vaccine, nOPV2, is expected to significantly reduce the risk of outbreaks of vaccine-derived poliovirus type 2 and is intended for use in countries affected by cVDPV2. The company said this is BE's 10th prequalified vaccine, announcing the WHO decision in a release on Tuesday.
BE received vaccine technology from Indonesia's PT BioFarma (PTB) and a certified large-scale manufacturing facility to produce more than 500 million doses of nOPV2 vaccine per year. Indian regulators have approved BE to manufacture the vaccine for export purposes.
Gates Foundation Grants
The company said it has emerged as a key player in the production of nOPV2 vaccines and received a grant from the Bill & Melinda Gates Foundation to help meet growing global demand. PTB became the first nOPV2 manufacturer to receive WHO PQ in January 2024.
“Our collective efforts towards polio eradication have reached an important milestone with the pre-qualification of nOPV2 by WHO. This vaccine was specifically designed to address concerns about Vaccine-Associated Paralytic Polio (VAPP), which occurs at approximately 2-4 cases per million births with conventional OPV due to reversion of the vaccine virus to a virulent form,” said Mahima Datla, Managing Director, Biological E.
The persistent threat of cVDPV2 outbreaks can be addressed by using nOPV2 as the vaccine of choice, as nOPV2, with its improved genetic stability, is significantly less likely to cause new outbreaks in low-immunity settings compared to its predecessor, the Sabin poliovirus type 2 (mOPV2) vaccine, BE said.
Extensive clinical trials have evaluated the safety and immunogenicity of nOPV2, with encouraging results published in The Lancet (2019-2024). According to the company, the vaccine has been used in endemic areas and shown to be able to significantly reduce the incidence of cVDPV2 epidemics and protect communities from the onslaught of polio.
“We are honored to collaborate with PTB and we are extremely grateful to the Gates Foundation for entrusting us with the responsibility of manufacturing nOPV2. Administering more than one billion doses of nOPV2 in polio-endemic areas is critical to realizing the dream of a polio-free world,” said Datla.
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