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A government expert panel has recommended regular market approval for Serum Institute of India's (SII) Covishield and Bharat Biotech's Covaxin, news agency PTI reported on Wednesday quoting official sources.
"The Subject Expert Committee (SEC) on Covid-19 of the Central Drugs Standard Control Organisation (CDSCO) which reviewed SII and Bharat Biotech's application for the second time on Wednesday has recommended granting regular market approval to Covishield and Covaxin subject to certain conditions," the agency source said.
SII and Bharat Biotech had earlier submitted applications to the Drugs Controller General of India (DCGI) seeking regular market authorisation for their respective Covid-19 vaccines Covishield and Covaxin.
However, during last week's meeting, the panel had sought more data and documents from Serum and Bharat Biotech following which the companies recently had submitted a response along with more data and information.
Over 100 crore Covishield doses have been given in India and abroad which is a testimony of its safety and efficacy, Serum is said to have informed the DCGI and expert panel which had sought more data for granting full marketing approval to the Covid vaccine.
Covaxin and Covishield were granted Emergency Use Authorisation (EUA) in January 2021.
The move also comes after the Hyderabad-based vaccine manufacturer Bharat Biotech recently announced that its indigenously developed Covid-19 vaccine Covaxin is now a universal vaccine for adults and children.
Earlier, Bharat Biotech had claimed that Covaxin can neutralise both Delta and Omicron variants of coronavirus.
India’s Covid-19 vaccination coverage has crossed 159.54 crore today, according to union health ministry data, with most of the shots administered were of Covaxin or Covishield.
Amid rising concerns over the highly transmissible Omicron variant of coronavirus, the government has also approved vaccination drive for the age group of 15-18 years from 3 January.
Notably, only Bharat Biotech's indigenously-made shot 'Covaxin' will be used for vaccinating this age group.
According to a note sent by the Union health ministry to all states and Union territories, additional doses of Covaxin will be sent to the states for administering the vaccine to this population category.
As many as 3,70,32,672 doses have been administered in the 15-18 age group so far in the country.
(With inputs from PTI)
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