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Covishield Booster Dose: Expert Panel Seeks Local Trial Data for Approval

SII has submitted an application to the DCGI, requesting approval of Covishield as a booster dose for COVID-19.

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Covishield Booster Dose: Expert Panel Seeks Local Trial Data for Approval
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An expert panel of India's central drug authority on Friday, 10 December, asked for more data as it considers Serum Institute's application for the approval of Covishield as a booster vaccine for COVID-19.

Adar Poonawalla-headed Serum Institute of India (SII), which has manufactured the vaccine in collaboration with Oxford University and AstraZeneca, has been asked to submit local clinical trial data, official sources told news agency PTI.

Director of Government and Regulatory Affairs at SII Prakash Kumar Singh, in an application to the Drugs Controller General of India (DCGI) on 30 November, had observed that the UK's Medicines and Healthcare products Regulatory Agency has already approved the booster dose of AstraZeneca ChAdOx1 nCoV-19 vaccine.

The application had sought approval from India's drug regulator for Covishield as a booster dose, stating that there is no shortage of the vaccine in the country.

On 25 November, the Delhi High Court had directed the Centre to clarify its stand on booster doses, adding that it does not want a second-wave-like situation on account of being conservative.

"The National Technical Advisory Group on Immunization (NTAGI) and National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) are deliberating and considering scientific evidences related to dose schedule of COVID-19 vaccines and the need for justification for booster dose," the Health Ministry had informed the Parliament on Friday, 10 December.

(With inputs from PTI)

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