Bharat Biotech Gets CDSCO Panel Nod To Manufacture Rotavirus Vaccine Live Attenuated, Oral

This came after Bharat Biotech presented its proposal for a grant of manufacturing permission for the Rotavirus Vaccine (Live Attenuated, Oral) (antibiotic-free).

Rotavirus commonly causes severe, watery diarrhea and vomiting in infants and young children. Children may become dehydrated and need to be hospitalized and can even die. There are nine species of rotavirus, referred to as A, B, C, D, F, G, H, I, and J. Humans are primarily infected by the species Rotavirus A.

Rotavirus primarily infects enterocytes and induces diarrhea through the destruction of absorptive enterocytes (leading to malabsorption), intestinal secretion stimulated by rotavirus non-structural protein, and activation of the enteric nervous system.

Rotavirus vaccine is administered by putting drops in the child's mouth. Babies should get 2 or 3 doses of rotavirus vaccine, depending on the brand of vaccine used. The first dose must be administered before 15 weeks of age. The last dose must be administered by 8 months of age.

At the recent SEC meeting for vaccines held on the 14th and 15th of December 2023, the expert panel reviewed the proposal presented by the vaccine maker Bharat Biotech for the grant of manufacturing the Rotavirus Vaccine (Live Attenuated, Oral) (antibiotic-free).

After detailed deliberation, the committee recommended granting manufacturing permission for the Rotavirus Vaccine (Live Attenuated, Oral) (antibiotic-free).

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