SII gets CDSCO nod for Clinical Trial of reduced inactivated salk Polio vaccine

The firm presented its proposal for conduct of phase II/III clinical trial of reduced inactivated salk polio vaccine (Adsorbed).

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CDSCO FDA

Last Updated on July 16, 2021 by The Health Master

Serum Institute of India (SII) has received approval from the Subject Expert Committee (SEC) at Central Drugs Standard Control Organisation (CDSCO) to conduct phase II/III clinical trial of reduced inactivated salk polio vaccine (Adsorbed).

The firm presented its proposal for conduct of phase II/III clinical trial of reduced inactivated salk polio vaccine (Adsorbed).

After detailed deliberations, the committee recommended for grant of permission to conduct clinical trial subject to the condition that the clinical trial sites for both IPV vaccines studies should be separate and the interim results of phase II should be presented before proceeding to phase III study.

Poliomyelitis vaccine (Inactivated) is indicated for active immunization of infants, children and adults for the prevention of poliomyelitis caused by poliovirus type 1, 2 and 3.

Polio vaccines are vaccines used to prevent poliomyelitis (polio). Two types are used an inactivated poliovirus given by injection (IPV) and a weakened poliovirus given by mouth (OPV). The inactivated polio vaccines are very safe.

Laboratory
Picture: Pixabay

When the IPV (injection) is used, 90% or more of individuals develop protective antibodies to all three serotypes of polio virus after two doses of inactivated polio vaccine (IPV), and at least 99% are immune to polio virus following three doses.

Serum Institute of India Pvt. Ltd. is the world’s largest vaccine manufacturer by number of doses produced and sold globally (more than 1.5 billion doses), supplying the world’s cheapest and WHO accredited vaccines to as many as 170 countries. The institute’s objective has been proliferated by bringing down the prices of newer vaccines such as such as diphtheria, tetanus, pertussis, Hib, BCG, r-hepatitis B, measles, Mumps and Rubella vaccines.

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