Serum Institute of India Gets CDSCO Panel Nod for Phase III CT of Inactivated Salk Polio Vaccine
New Delhi: Based on the interim report of the Phase II clinical trial of the Inactivated Salk Polio Vaccine (Adsorbed) presented by vaccine maker Serum Institute of India, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has granted approval to Serum Inst. of India for further conduct of Phase III clinical trial as per the approved protocol.
This came after the firm presented the interim report of the Phase II clinical trial of the approved Phase II/III clinical trial of Inactivated Salk Polio Vaccine (Adsorbed).
Polio vaccines are vaccines used to prevent poliomyelitis (polio). Polio, or poliomyelitis, is a disabling and life-threatening disease caused by the poliovirus. The virus spreads from person to person and can infect a person's spinal cord, causing paralysis. Two types are used: an inactivated poliovirus given by injection (IPV) and a weakened poliovirus given by mouth (OPV).
Inactivated polio vaccine (IPV) was developed in 1955 by Dr Jonas Salk. Also called the Salk vaccine IPV consists of inactivated (killed) poliovirus strains of all three poliovirus types. IPV is given by intramuscular or intradermal injection and needs to be administered by a trained health worker. IVP produces antibodies in the blood to all three types of poliovirus. In the event of infection, these antibodies prevent the spread of the virus to the central nervous system and protect against paralysis.
At the recent SEC meeting for Vaccines held on the 27th of June 2023, the expert panel reviewed the interim report of the Phase II clinical trial of the Inactivated Salk Polio Vaccine (Adsorbed) presented by vaccine maker Serum Institute of India.
After detailed deliberation, the committee noted the interim report of the Phase II clinical trial and recommended further conducting the Phase III clinical trial as per the approved protocol.
