CDSCO panel seeks local clinical trial data from Serum Institute of India for approval of Covishield as booster dose

An expert panel of India’s central drug authority which reviewed Serum Institute’s application for approval of Covishield as booster dose against COVID-19 on Friday recommended that the firm submit local clinical trial data and proposal along with justification for the booster dose approval, official sources said.

On December 1, Prakash Kumar Singh, director, Government and Regulatory affairs at Serum Institute of India (SII), had sought approval from the Drugs Controller General of India (DCGI) for Covishield as booster dose, citing adequate stock of the vaccine in the country and a demand for a booster shot due to the emergence of new coronavirus variants.

Singh had referred to the UK’s Medicines and Healthcare products Regulatory Agency giving a go-ahead to the booster doses of AstraZeneca ChAdOx1 nCoV-19 vaccine in the application.

“The subject expert committee (SEC) on COVID-19 at CDSCO reviewed SII’s application and following detailed deliberation recommended that the Pune-based firm should submit local clinical trial data and proposal along with the justification for booster dose approval,” a source said.

Singh is learnt to have said in the application that as the world continued to face the pandemic situation, many countries had started administering booster dose of COVID-19 vaccines.

“You are aware that now there is no shortage of Covishield in our country and the demand for a booster dose is increasing day by day from the people who have already taken two doses in view of the ongoing COVID-19 pandemic and emergence of new strains,” he had said in the application.

The Union government informed parliament that the National Technical Advisory Group on Immunisation and the National Expert Group on Vaccine Administration for COVID-19 are deliberating and considering scientific evidence for the need and justification for a booster dose against Covid.

According to the information available on http://www.ourworldindata.org, more than 60 countries across the world are providing booster doses of COVID-19 vaccine, Minister of State for Health Bharati Pravin Pawar said in a written reply on Friday.

Recently, states like Kerala, Rajasthan, Karnataka and Chhattisgarh urged the Centre to decide on allowing booster doses of COVID-19 vaccine amid concerns raised by ‘Omicron’, the new variant of SARS-CoV-2.

The Delhi High Court had on November 25 directed the Centre to clarify its stand on administering booster doses to those who are fully vaccinated against coronavirus, saying it does not want a second-wave-like situation on account of being conservative.