Nethra Sailesh, Pune
The World Health Organization has given a pre-qualification status to new oral polio vaccine type 2 (nOPV2) manufactured by Biological E Limited, a private Hyderabad company. The nOPV2 is the 10th pre-qualified vaccine by the manufacturer.
Oral Polio Vaccine (OPV) is the most common kind of vaccine given to children via mouth drops. According to the Global Polio Eradication Initiative (GPEI), OPV is manufactured with a live and weakened version of the poliovirus that in rare cases can mutate into vaccine, associated paralytic polio (VAPP) or vaccine derived polio virus (VDPV) or circulating vaccine derived poliovirus (cVDPV). This happens in approximately 1 in 2.7 million doses of OPV that is administered.
WHO’s pre-qualification status denotes that the vaccine is safe, efficient and meets the quality-standards. The status is granted only after a rigorous process of assessment and Inspection.
GEPI reported that cVDPV, a rare form of polio has seen a recent spike in areas of low immunization. Currently, for cVDPV immunization, the monovalent oral polio vaccine mOPV2 is administered.
The novel oral polio vaccine type 2 (nOPV2) is more genetically stable, which reduces the likelihood of the virus mutating. According to a statement by Biological E, the vaccine will help decrease the risk of cVDPV outbreaks in low immunization areas. Ms Mahima Datla, the managing director at BE said that the vaccine was specifically designed to challenge vaccine associated paralytic polio (VAPP).
Biological Limited was selected to receive a grant from the Bill and Melinda Gates Foundation. Additionally, they have collaborated with PT Bio Farm, an Indonesian manufacturer to mass produce the vaccine annually. With the help of PTB’s technology, they produce more than 500 doses of the vaccine. BE has also been approved by Indian regulatory bodies to manufacture the vaccine for exportation.
The company mainly exports its products, while some are sold across India, USA, and Europe. Earlier this year, in the BioAsia 2024 conference in Hyderabad, Biological E announced its collaboration with Takeda, a Japanese Pharmaceutical company. The deal includes manufacturing and distributing dengue vaccines on an international scale. BE is set to churn out 50 million doses of QDENGA per year.