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SII's Covovax receives DCGI approval market authorization as heterologous booster dose

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eMediNexus    17 January 2023

Official sources disclosed that the Drug Controller General of India (DCGI) has given market authorization to Serum Institute of India’s (SII) COVID-19 vaccine Covovax for adults as a heterologous booster dosage for those who have already had two doses of Covishield or Covaxin. The DCGI approved the vaccine after Wednesdays recommendations from the Central Drugs Standard Control Organization′s Subject Expert Committee.

 

Pakash Kumar Singh, Director of Government and Regulatory Affairs at SII, recently wrote to the DCGI requesting approval of the Covovax heterologous booster dose for those aged 18 and over in light of the worsening COVID-19 pandemic situation in some countries.

 

On March 9, 2022, the DCGI approved Covovax for the 12–17 age range. On June 28, 2022, the DCGI approved Covovax for children between the ages of 7 and 11. On December 28, 2021, the DCGI approved Covovax for restricted use in emergency cases for adults.

 

Covovax is produced using technology that was transferred from Novavax. The European Medicines Agency has granted it conditional marketing authorization. On December 17, 2021, the World Health Organization (WHO) authorized its listing for emergency usage.

 

US-based vaccine manufacturer Novavax announced a license agreement with the SII for manufacturing and commercializing NVXCoV2373, (its COVID-19 vaccine candidate) for use in India and other low- and middle-income nations in August 2020.

 

(Source: https://health.economictimes.indiatimes.com/news/pharma/dcgi-approves-market-authorisation-for-siis-covid-vaccine-covovax-as-heterologous-booster-dose/97042592)

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