Bharat Biotech, Serum to get permission for Covaxin, Covishield

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Bharat Biotech, Serum to get permission for Covaxin, Covishield

Bharat Biotech and Serum Institute of India will have to submit data from overseas ongoing clinical trials of their COVID 19 vaccines Covaxin and Covishield with due analysis on a six month basis or as and when available, the government said on Thursday.

The drug authorization status of both vaccines has been given by the Drugs Controller General of India DGCI Despite the fact that over 160 crore doses of both vaccines have been administered in India, the manufacturers will have to be under a strict screening of the government for safety profiles and efficacy of their vaccines.

Conditional Market Authorization is a new category of market authorization that has emerged during the current global epidemic of COVID - 19.

The Union Health Ministry said in a statement that the approval pathways through this route are fast tracked with certain conditions to enhance access to certain pharmaceuticals for meeting the emerging needs of drugs or vaccines.

Only the United States Food and Drug Administration USFDA Medicines and Healthcare Products Regulatory Agency MHRA of the UK has granted conditional market authorization to Pfizer and AstraZeneca for their COVID 19 vaccines. India followed suit. The National Drug Regulator, DCGI, has given approval for market authorization of two COVID 19 vaccines, Covaxin and Covishield, which are administered under the national COVID 19 vaccine program subject to certain conditions on Thursday.

The Subject Expert Committee on the Central Drugs Standard Control Organization CDSCO recommended an upgrade of status for the vaccines from restricted use in emergency situations to grant new drug permission with conditions in the adult population on January 19th, 2022.

The vaccines will be supplied for programmatic setting and all vaccinations done within the country to be recorded on CoWIN platform and Adverse Event Following Immunization AEFI Adverse Event of Special Interest AESI will continue to be monitored. The safety data including AEFI and AESI will be submitted to the firm on a six month basis or as and when available, whichever is earlier as per New Drugs and Clinical Trials Rules NDCT Rules, 2019, the government said.

Covishield, an adenovirus vector vaccine developed by Oxford University and AstraZeneca, is being produced under license by the Serum Institute of India. Covaxin is a whole virion vaccine or the inactivated virus vaccine developed by Bharat Biotech in association with Indian Council of Medical Research ICMR India's nationwide COVID 19 vaccination program was launched on 16 January, 2021. More than 160 crore doses have been administered as of today.