Serum Institute seeks DCGI's approval for Covishield as booster dose

Serum Institute of India has sought from India's drug regulator approval for Covishield as a 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, official sources said.

In an application to the Drugs Controller General of India (DCGI), Prakash Kumar Singh, the Director, Government and Regulatory Affairs at Serum Institute of India (SII) cited that the UK's Medicines and Healthcare products Regulatory Agency has already approved the booster dose of AstraZeneca ChAdOx1 nCoV-19 vaccine, they said.

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

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"People of our country as well as citizens of other countries who have already been fully vaccinated with two doses of Covishield are also continuously requesting our firm for booster dose," an official source quoted Singh as having said in the application on Tuesday.

"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."

It is the need of the hour and a matter of right to health of every individual that they should not be deprived of third dose/booster dose to protect themselves in this pandemic situation, Singh stated.

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

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

The Delhi High Court 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.