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nOPV2 vaccine for Polio becomes the 1st Ever Vaccine to be listed under WHO’s EUL

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The World Health Organization (WHO) listed nOPV2 (novel Oral Polio Taccine type 2) Polio vaccine produced by Indonesia’s Bio Farma PT for Emergency Use Listing (EUL), this is the first approval by WHO of its kind amidst several outbreaks in several parts of the world. 

i.The nOPV2 vaccine is aimed at containing outbreaks of circulating Vaccine-Derived Polio Virus (cVDPVs)  in African Countries, Meditarranean countries as well as Western Pacific and Southeast Asian Region. 

ii.VDPVs are caused by the virus strains used in the polio vaccines regaining their ability to cause polio.

Emergency Use Listing (EUL):

i.EUL Procedure assesses the suitability of yet-to-be licensed health products during public health emergencies.

ii.The main objective behind EUL is to make the medicines, vaccines and diagnostics available faster to address the emergency (Public Health Emergency of International Concern).

Background:

i.The EUL procedure was introduced during the West Africa Ebola outbreak of 2014-16, Ebola diagnostics received emergency use listing.

ii.Numerous COVID-19 diagnostics have also been listed under the procedure, however nOPV2 is the first such listing for a vaccine.

iii.The Recent listing would pave the way for similar measures to be adopted for a COVID-19 product.

EUL Procedure:

i.It is carried out in three phases: Preparedness Phase, Emergency Phase & Post-Listing Phase.

ii.Under EUL procedure, phase II and phase III clinical trial data is assessed along with data on safety, efficacy and manufacturing quality.

iii.The data is then reviewed by independent experts who consider the body of evidence on the vaccine under consideration, the plans for monitoring its use, and for further studies.

Recent Related News:

i.On September 9-10, 2020, the 73rd session of WHO (World Health Organization) South East Asia Region (SEAR) was hosted virtually by Thailand from Bangkok under the Chairmanship of Mr. Anutin Charnvirakul, Deputy Prime Minister and Minister of Health, Thailand

About World Health Organization (WHO):

Director General – Dr Tedros Adhanom Ghebreyesus

Headquarters – Geneva, Switzerland