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Emergency approval for Zydus Cadila to take few more days, say sources

According to sources, India's drug regulator Drugs Controller General of India (DCGI) will consider giving emergency use authorisation (EUA) to Zydus Cadila for its COVID-19 vaccine ZyCoV-D in a few more days.

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Published : Jul 12, 2021, 2:21 PM IST

New Delhi: India's drug regulator Drugs Controller General of India (DCGI) will consider giving emergency use authorisation (EUA) to Zydus Cadila for its COVID-19 vaccine ZyCoV-D in a few more days, sources told the media.

"Subject Expert Committee (SEC) is expected to meet this week and will review the data. However, final approval for EUA will be given only after a few meetings," sources said. Sources further informed that the DCGI's SEC will examine data submitted by Zydus Cadila for children above 12 years. But if data found to be satisfied then final approval from DCGI may be granted in few days.

ZyCoV-D is a DNA Covid vaccine, which carries the genetic code for that part of a virus that triggers the immune system of the body. According to sources, the continuous and rolling review of data is ongoing and even if SEC meeting takes place this week then final approval will take few more days.

Read: Zydus Cadila seeks emergency use authorisation for ZyCoV-D COVID-19 vaccine for 12 years, above

Earlier, on Friday, Dr VK Paul, Member (Health) of the NITI Aayog told ANI that a decision on the approval of Zydus Cadila's COVID-19 vaccine is expected soon, adding that the data and evaluation would determine the outcome.

ZyCoV-D is a three-dose COVID shot, the world's first Plasmid DNA vaccine.

ANI

New Delhi: India's drug regulator Drugs Controller General of India (DCGI) will consider giving emergency use authorisation (EUA) to Zydus Cadila for its COVID-19 vaccine ZyCoV-D in a few more days, sources told the media.

"Subject Expert Committee (SEC) is expected to meet this week and will review the data. However, final approval for EUA will be given only after a few meetings," sources said. Sources further informed that the DCGI's SEC will examine data submitted by Zydus Cadila for children above 12 years. But if data found to be satisfied then final approval from DCGI may be granted in few days.

ZyCoV-D is a DNA Covid vaccine, which carries the genetic code for that part of a virus that triggers the immune system of the body. According to sources, the continuous and rolling review of data is ongoing and even if SEC meeting takes place this week then final approval will take few more days.

Read: Zydus Cadila seeks emergency use authorisation for ZyCoV-D COVID-19 vaccine for 12 years, above

Earlier, on Friday, Dr VK Paul, Member (Health) of the NITI Aayog told ANI that a decision on the approval of Zydus Cadila's COVID-19 vaccine is expected soon, adding that the data and evaluation would determine the outcome.

ZyCoV-D is a three-dose COVID shot, the world's first Plasmid DNA vaccine.

ANI

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