Submit safety data of Rotavirus vaccine in 1 to 2 years age group: CDSCO panel Tells Bharat Biotech on Oral Rotavirus Vaccine
Written By : Dr. Divya Colin
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-06-22 12:30 GMT | Update On 2024-06-22 12:30 GMT
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New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined the vaccine major Bharat Biotech International Limited, Hyderabad to submit the safety data of the Rotavirus vaccine in the age group of 1 to 2 years including a published literature report.
This came after the vaccine major Bharat Biotech presented prescribing information on the Rotavirus vaccine for updation based on the WHO position paper, July 2021.
Rotavirus Vaccine (Live Attenuated, Oral) is a monovalent vaccine containing suspension of live rotavirus 116E prepared in Vero cells. Rotaviruses are double-stranded RNA virus of the genus Reoviridae. Rotaviruses are classified in a dual classification system based on two proteins on the surface of the virus into G and P types. Based on this nomenclature, Rotavirus 116E is classified as G9P. A single human dose of ROTAVAC is 0.5 mL containing not less than [NLT] 10 FFU [Focus Forming Unit] of live rotavirus 116E.
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