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Contex
- India’s vaccine manufacturer Biological E. Ltd has received full Phase II Pre-Qualification (PQ) approval from the World Health Organization (WHO) for its Novel Oral Polio Vaccine type 2 (nOPV2).
More about the News
- Upgrade from Phase I to Phase II: Earlier in June 2024, Biological E. had received Phase I approval, which allowed it to manufacture only the final vaccine product using externally supplied ingredients. With Phase II PQ, the company can now manufacture both the drug substance and the final vaccine entirely at its own facilities.
- WHO Pre-Qualification Significance: It means the vaccine meets global standards of safety, efficacy, and quality. It allows procurement by UN agencies like UNICEF and GAVI for international immunisation campaigns.
About nOPV2
- Purpose of nOPV2: nOPV2 is designed to control outbreaks of circulating vaccine-derived poliovirus type 2 (cVDPV2). It is specifically used in emergency response campaigns.
- Improved Genetic Stability: Unlike older oral polio vaccines, nOPV2 has enhanced genetic stability. This reduces the risk of the weakened virus mutating and causing vaccine-derived outbreaks.
- Rapid Outbreak Control Tool: When polio outbreaks occur, quick vaccination is crucial. nOPV2 enables faster containment due to easier oral administration and mass campaign suitability.
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About Polio and Polio Vaccines |
| ● Polio is a highly infectious viral disease that primarily affects children under five. It can cause irreversible paralysis and, in severe cases, death.
Types of Poliovirus ● There are three types of poliovirus (Type 1, 2, and 3). Wild poliovirus type 2 and 3 have been eradicated globally, but vaccine-derived type 2 outbreaks remain a concern. Types of Polio Vaccines ● Oral Polio Vaccine (OPV): Given orally, widely used in mass campaigns. ● Inactivated Polio Vaccine (IPV): Given via injection, contains killed virus and prevents paralysis but is less effective in stopping transmission. India’s Achievement ● India was declared polio-free in 2014 after sustained immunisation efforts under the Global Polio Eradication Initiative (GPEI). However, global eradication remains incomplete.
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