SII’s Covovax vaccine recommended for Phase 3 trial as booster dose in adults

The Subject Expert Committee of India`s apex drugs authority Drugs Controller General of India (DCGI) has recommended permission for vaccine manufacturer Serum Institute of India to conducting Phase 3 trial of Covovax as booster dose in adults, said a source familiar with the development.

The Pune-based SII had sought the permission from the DCGI to conduct Phase 3 study to evaluate the safety and immunogenicity of Covovax as booster dose on those who have received primary vaccination either with Covishield or Covaxin at least three months back.

Earlier, the Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO) on Friday recommended granting the Emergency Use Authorisation for SII`s Covid-19 vaccine Covovax among 12-17 years age bracket.

The apex drug regulatory body had already approved Covovax for restricted use on December 28. However, this vaccine has not been included in national vaccination programme yet.

India on Sunday reported further decline in fresh Covid cases at 5,476 in the last 24 hours. The active Covid cases have also further reduced to 59,442 which constitute 0.14 per cent of the country`s total positive cases, as per the ministry report on Sunday.

With the administration of over 26.19 lakhs covid vaccine doses in the last 24 hours, India`s Covid inoculation coverage has reached 178.83 crore as of Sunday morning.