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SEC seeks more data from Serum Institute over COVID vaccine Covovax for 7-12 age group: Sources

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SEC seeks more data from Serum Institute over COVID vaccine Covovax for 7-12 age group: Sources
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New Delhi [India], April 30 (ANI): The Drugs Controller General of India’s (DCGI) subject expert committee on Friday sought more data from Pune based Serum Institute of India (SII) on the Covovax vaccine for the age group of 7-12 years.

“SEC has sought more data for Covovax vaccine for 7-12 years age group after a meeting took place in the evening today,” said sources to ANI.

Earlier in the day, the National Technical Advisory Group on Immunization (NTAGI) approved the Serum Institute of India’s COVID-19 vaccine Covovax for the age group of 12-17 years.

Covovax has already been recommended by the Drugs Controller General of India (DCGI) for children above 12 years of age, but its administration has not been allowed yet.

Earlier this month in an Exclusive Interview with ANI, Serum Institute of India (SII) CEO Adar Poonawalla said, “Covovax will be used for children. It has been recommended by DCGI and we’re waiting for the Government of India to allow us to put it on the CoWIN app to make it available to everyone.”

It may be noted that last month, an expert panel of the country’s central drug authority had recommended granting Emergency Use Authorisation (EUA) to Covovax for the 12-17 age group.

The Drugs Controller General of India (DCGI) approved Covovax for restricted use in an emergency situation for adults on December 28. Earlier on February 21, the Serum Institute of India submitted an application to the DCGI seeking EUA for Covovax for the 12 to 17 years age group.

The Subject Expert Committee on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) then deliberated on SII’s application and recommended granting EUA to Covovax.

Poonawalla had said that Covovax has been approved by DCGI and we’re waiting for the Government of India to allow us to put it on CoWIN app to make it available to everyone. (ANI)

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New Delhi [India], April 30 (ANI): The Drugs Controller General of India's (DCGI) subject expert committee on Friday sought more data from Pune based Serum Institute of India (SII) on the Covovax vaccine for the age group of 7-12 years.

"SEC has sought more data for Covovax vaccine for 7-12 years age group after a meeting took place in the evening today," said sources to ANI.

Earlier in the day, the National Technical Advisory Group on Immunization (NTAGI) approved the Serum Institute of India's COVID-19 vaccine Covovax for the age group of 12-17 years.

Covovax has already been recommended by the Drugs Controller General of India (DCGI) for children above 12 years of age, but its administration has not been allowed yet.

Earlier this month in an Exclusive Interview with ANI, Serum Institute of India (SII) CEO Adar Poonawalla said, "Covovax will be used for children. It has been recommended by DCGI and we're waiting for the Government of India to allow us to put it on the CoWIN app to make it available to everyone."

It may be noted that last month, an expert panel of the country's central drug authority had recommended granting Emergency Use Authorisation (EUA) to Covovax for the 12-17 age group.

The Drugs Controller General of India (DCGI) approved Covovax for restricted use in an emergency situation for adults on December 28. Earlier on February 21, the Serum Institute of India submitted an application to the DCGI seeking EUA for Covovax for the 12 to 17 years age group.

The Subject Expert Committee on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) then deliberated on SII's application and recommended granting EUA to Covovax.

Poonawalla had said that Covovax has been approved by DCGI and we're waiting for the Government of India to allow us to put it on CoWIN app to make it available to everyone. (ANI)

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