News Desk, AnyTV, New Delhi
Published by: Shiv Sharan Shukla
Updated Sun, 06 Mar 2022 06:21 PM IST
Summary
A committee of experts from the Central Drugs Authority of India has recommended allowing the Phase III clinical trial of Kovovax as a booster dose in adults. It is made by Serum Institute.
A committee of experts from the Central Drugs Authority of India has recommended allowing the Phase III clinical trial of Kovovax, a corona vaccine developed by the Serum Institute, as a booster dose in adults. Official sources gave this information on Sunday.
The Drug Controller General of India (DCGI) on December 28 approved Kovovax for limited use in emergencies for adults. It is yet to be included in the country’s vaccination program.
On February 21, Prakash Kumar Singh, director of government and regulatory affairs at SII, had applied for an EUA for Kovovax for children in the age group of 12 to 17 years to DCGI.
According to sources, the Subject Expert Committee on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) on Friday deliberated on the application of SII and recommended EUA to Kovovax. In the EUA’s application, Singh said data from two studies on nearly 2,700 children aged 12 to 17 years showed that Kovovax is very effective, immunosuppressive and safe.
A source quoted Singh as saying that this approval will be beneficial not only for our country but for the whole world and will fulfill the vision of our Prime Minister to produce in India for the world. In line with the vision of our CEO Adar C Poonawalla, we are confident that Kovovax will play a vital role in protecting the children of our country and the world against COVID-19 and keep our tricolor high in the world.
Expansion
A committee of experts from the Central Drugs Authority of India has recommended allowing the Phase III clinical trial of Kovovax, a corona vaccine developed by the Serum Institute, as a booster dose in adults. Official sources gave this information on Sunday.
The Drug Controller General of India (DCGI) on December 28 approved Kovovax for limited use in emergencies for adults. It is yet to be included in the country’s vaccination program.
On February 21, Prakash Kumar Singh, director of government and regulatory affairs at SII, had applied for an EUA for Kovovax for children in the age group of 12 to 17 years to DCGI.
According to sources, the Subject Expert Committee on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) on Friday deliberated on the application of SII and recommended EUA to Kovovax. In the EUA’s application, Singh said data from two studies on nearly 2,700 children aged 12 to 17 years showed that Kovovax is very effective, immunosuppressive and safe.
A source quoted Singh as saying that this approval will be beneficial not only for our country but for the whole world and will fulfill the vision of our Prime Minister to produce in India for the world. In line with the vision of our CEO Adar C Poonawalla, we are confident that Kovovax will play a vital role in protecting the children of our country and the world against COVID-19 and keep our tricolor high in the world.