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  • Submit safety data of...

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 2024-06-22T18:00:12+05:30  |  Updated On 22 Jun 2024 6:00 PM IST
Submit safety data of Rotavirus vaccine in 1 to 2 years age group: CDSCO panel Tells Bharat Biotech on Oral Rotavirus Vaccine
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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.
Rotavirus is most often spread through a fecal-oral route. It can also be caused by eating or drinking contaminated food or water. The virus may live on surfaces such as doorknobs, toys, and other hard objects for a long time.
ROTAVAC is indicated for active immunization of infants from the age of 6 weeks for the prevention of gastroenteritis due to rotavirus infection when administered as a 3-dose series
The rotavirus vaccine protects against rotavirus infections, which are the leading cause of severe diarrhea among young children. The vaccines prevent 15–34% of severe diarrhea in the developing world and 37–96% of the risk of death among young children due to severe diarrhea.
At the recent SEC meeting for Vaccine held on 31st May 2024, the expert panel reviewed the prescribing information on the Rotavirus vaccine for updating based on the WHO position paper, July 2021.
After detailed deliberation, the committee recommended submitting safety data of the Rotavirus vaccine in the age group of 1 to 2 years including a published literature report for further review.
Also Read:CDSCO Panel advises Dr Reddy's Laboratories to Revise Phase III CT Protocol for Live Attenuated Varicella Vaccine study
Rotavaccdscobharat-biotechrotavirus vaccinerotavirusrotavirus oral vaccine
Dr. Divya Colin
Dr. Divya Colin

    Doctor of Pharmacy

    Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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