SII seeks DCGI nod for phase-3 trial of Covovax as booster dose

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Pune-based vaccine manufacturer Serum Institute of India (SII) has sought permission from Drugs Controller General Of India (DCGI) to conduct phase-3 study of Covovax vaccine as booster dose. A source said that the manufacturer has sought approval for its vaccine as booster dose among adults.

The source confirmed that approval has been sought to evaluate the safety and immunogenicity of Covovax as booster dose on those who have received primary vaccination either with Covishield or Covaxin at least three months ago.

The apex drug regulatory body, DCGI had approved Covovax along with other one Covid vaccine and one anti-viral drug for restricted use on December 28. However, this vaccine has not been included in national vaccination program yet.

The World Health Organization had alao approved Covid vaccine Covovax for emergency use listing in December last year. The vaccine Covovax is produced by the Serum Institute of India under licence from Novavax and is part of the COVAX facility portfolio.

Covovax has a two-dose regime and is the third India-related vaccines to be approved by the WHO.

Meanwhile, India on Sunday reported decline in fresh Covid infections at 10,273 cases. The active Covid case has also reduced to 1,11,472 which constitute 0.26 per cent of the country’s total positive cases.

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