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The Subject Expert Committee (SEC) which was reviewing the application of the Serum Institute of India (SII) for the booster dose has said COVID-19 that booster doses cannot be recommended without clinical trials in a meeting that took place on Friday.
The SEC which comes under Central Drugs Standard Control Organization (CDSCO) has sought additional data from the SII and would be doing another meeting, according to news agency ANI quoting sources.
The development comes amid the rising case of the new COVID variant Omicron in the country.
The Serum Institute of India 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.
A new variant of COVID-19 was first reported to the World Health Organisation (WHO) from South Africa on November 25. As per the WHO, the first known confirmed B.1.1.529 infection was from a specimen collected on November 9 this year.
