Submit safety data of Rotavirus vaccine in 1 to 2 years age group: CDSCO panel Tells Bharat Biotech on Oral Rotavirus Vaccine

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.