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Clinical Trial Results

Rotavirus Vaccine Developed In India Shows Efficacy In Phase III Trial

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us
rttnewslogo20mar2024

Rotavirus is the leading cause of severe diarrhea among children worldwide. Children are immunized against rotavirus by either GlaxoSmithKline plc's (GSK) Rotarix or Merck & Co. Inc.'s (MRK) RotaTeq, both of which are oral vaccines.

Rotavac, a new rotavirus vaccine developed in India, has demonstrated its efficacy in preventing severe rotavirus diarrhea in a phase III clinical trial that enrolled 6,799 infants.

The vaccine developed by the Government of India's Department of Biotechnology and Bharat Biotech significantly reduced severe rotavirus diarrhea by 56 percent during the first year of life, with protection continuing into the second year of life, according to the trial results. The vaccine also showed impact against severe diarrhea of any cause.

Bharat Biotech intends to file for registration of Rotavac in India. The vaccine, which is likely to be priced at $1.00, may be a more affordable alternative to the rotavirus vaccines already on the market, says the company.

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