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March 7, 2022

SII receives EUA grant recommendation from SEC for Covid-19 vaccine

The DCGI approved the vaccine for restricted use in an emergency situation for adults in December last year.

Serum Institute of India (SII) has received an emergency use authorisation (EUA) grant recommendation from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) for its Covid-19 vaccine, Covovax, for people aged 12 to 17 years.

The recommendation comes after the panel held a meeting for Covid-19 associated proposals, ANI reported

The vaccine is produced by the transfer of technology from Novavax. 

In December last year, the DCGI had granted approval to the vaccine for restricted use in an emergency situation for adults.

However, the final approval for emergency use authorisation from DCGI is still awaited.

If DCGI grants the EUA, Covovax will become the fourth vaccine indicated for usage in individuals aged 12 to 17 years.

The news agency noted that the vaccine is currently not included in the inoculation drive being carried out in the country to date.

Covovax has also obtained an emergency use listing from the World Health Organization (WHO) and conditional marketing approval from the European Medicines Agency (EMA). 

The company also submitted the results from the Phase III trials on the analysis of the booster dose of the vaccine.

Furthermore, SII obtained permission from the SEC to carry out a Phase III clinical trial of a booster shot of the vaccine in adult subjects, PTI reported quoting official sources.

In February, the company had submitted an application seeking the DCGI approval to carry out the observer-blind, randomised, controlled Phase III trial.

This trial will assess the safety and immunogenicity of the booster vaccine in adults who already received Covid-19 vaccines, Covishield or Covaxin, a minimum of three months ago.

In January, Novavax and SII submitted an application seeking EUA from the South African Health Products Regulatory Agency (SAHPRA) for the former’s Covid-19 vaccine candidate, NVX-CoV2373.

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