An expert panel of the Central Drugs Authority of India on Friday reviewed the Serum Institute’s application for approval of Covishield as a booster dose against COVID-19, official sources said, recommending that the firm recommend that the local clinical Submit proposal with trial data and justification for booster dose approval.
On December 1, Prakash Kumar Singh, director of government and regulatory affairs at Serum Institute of India (SII), sought approval from the Drugs Controller General of India (DCGI) as a booster dose for Kovidshield, citing adequate stock of the vaccine. Was. The country and demand for booster shots as new coronavirus variants emerge.
Singh had cited the UK’s Medicines and Healthcare products regulatory agency for pushing forward the booster dose of the AstraZeneca ChAdOx1 nCoV-19 vaccine in the application.
A source said, “The Subject Expert Committee (SEC) on COVID-19 at CDSCO has reviewed the application of SII and after detailed deliberations, recommended that the Pune-based firm be allowed to conduct local clinical trials. The data and proposal must be presented with justification for booster dose approval.”
Singh is understood to have said in the application that as the world is facing the pandemic situation, many countries have started giving booster doses of COVID-19 vaccines.
“You are aware that now there is no dearth of Covidshield in our country and the demand for booster doses is increasing day by day from those already in view of the ongoing COVID-19 pandemic and the emergence of new strains. Have taken two doses,” he had said in the application.
The Central Government informed the Parliament that the National Technical Advisory Group on Immunization and the National Expert Group on Vaccine Administration for COVID-19 are considering and considering the scientific evidence for the need and justification of booster doses against Covid-19.
As per information available on www.ourworldindata.org, more than 60 countries across the world are providing booster doses of the COVID-19 vaccine, Minister of State for Health Bharti Praveen Pawar said in a written reply on Friday.
Recently, states like Kerala, Rajasthan, Karnataka and Chhattisgarh urged the Center to take a decision on allowing booster doses of the 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 Center to clarify its stand on giving booster doses to those who have been fully vaccinated against the coronavirus, saying it was being conservative as it looked like a second wave. does not want the situation.
This story has been published without modification in text from a wire agency feed. Only the title has been changed.
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