Covishield booster dose cannot be recommended without clinical trials: CDSCO panel
Amid the emergence of the new Covid variant Omicron, the SII had sought approval to administer the booster dose of its Covishield vaccine on the basis of adequate stock of the jab and rising demand for the booster shots.
New Delhi: The Subject Expert Committee (SEC) under Central Drugs Standard Control Organization (CDSCO) has said that Covid-19 booster doses cannot be recommended without clinical trials.
The SEC was reviewing the application of the Serum Institute of India (SII) for the booster dose in a meeting that took place on Friday.
The panel has sought additional data from the SII before another meeting.
Amid the emergence of the new Covid-19 variant Omicron, the SII had sought approval to administer the booster dose of its Covishield vaccine on the basis of adequate stock of the jab and rising demand for the booster shots.
Prakash Kumar Singh, director, government and regulatory affairs at SII, had at the time cited that the UK's Medicines and Healthcare Products Regulatory Agency has already approved the booster dose of AstraZeneca ChAdOx1 nCoV-19 vaccine. "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," Singh had stated in an application submitted before the Drugs Controller General of India (DGCI).
Many experts have also recommended a booster dose in India especially after the emergence of the new Covid-19 variant Omicron. But the government has not taken any decision so far.
However, the National Technical Advisory Group on Immunization (NTAGI) also conducted a virtual meeting regarding the additional doses of Covid-19 vaccines in India, but the meeting resulted in no consensus over the issue.
A clarification statement released by the Indian SARS-CoV-2 Genomics Consortium (INSACOG) has also said that they have never recommended a booster dose.
