COVID vaccines approved for use in emergency situations, says Minister

New Delhi India January 27 ANI Union Health Minister Dr Mansukh Mandaviya said on Thursday that the Central Drugs Standard Control Organisation CDSCO has now upgraded the permission for Covaxin and Covishield from restricted use in emergency situations to normal new drug permission in the adult population with certain conditions.

The Union Minister wrote on Twitter that CDSCO has now upgraded permission for COVAXIN and Covishield from restricted use in emergency situations to normal new drug permission in the adult population with certain conditions. Mandaviya tweeted that the conditions include provision for programmatic settings, including registration on the CoWin platform and the ability to submit safety data on a six-monthly basis.

The union minister said that the government's drive for free COVID 19 vaccination will continue.

According to CDSCO, the proposals for regular market approval were reviewed by the Subject Expert Committee SEC for COVID-19 in consultation with the CDSCO. After detailed deliberation, the committee recommended updating the status of approval of COVID vaccines from Restricted use in an emergency situation to New Drug permission as per rules in the adult population with conditions.

The vaccines are for sale or distribution under the New Drugs and Clinical Trials NDCT Rules, 2019 in adult population with the condition that the Firm must submit data of overseas ongoing clinical trials of the product on a six month basis or as and when available, whichever is earlier.

The vaccine will be supplied for the programmatic setting and all vaccinations done within the country will be recorded on the CoWIN platform and AEFI. AESI will continue to be monitored. The firm will submit the safety data, including Adverse Events Following Immunization AEFI and Adverse Events of Special Interest AESI, with due analysis on a six monthly basis or as and when available, as per NDCT Rules.