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  • Covishield booster...

Covishield booster dose cannot be recommended without clinical trials: CDSCO panel

Medical Dialogues TeamBy Medical Dialogues TeamPublished On 2021-12-16T18:16:11+05:30  |  Updated On 16 Dec 2021 12:46 PM GMT
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...

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.

Also Read: Omicron spreading at unprecedented rate, not seen with any previous variant: WHO

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.

Also Read Pfizer vaccine Booster reduces Covid 19 infection and severity across all Age Groups: NEJ
Serum Institute of India Omicron Variant covid19 sec committee cdsco 
Source : ANI
Medical Dialogues Team
Medical Dialogues Team

    Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers. Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in.

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