Bharat Biotech and Serum Institute of India (SII) will have to submit data of overseas ongoing clinical trials of their COVID-19 vaccines Covaxin and Covishield with due analysis on six monthly basis or as and when available, whichever is earlier, the government said on Thursday.
The provision is a part of the market authorization status that both the vaccines have received from the Drugs Controller General of India (DGCI). Despite over 160 crore doses of both the 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 pandemic of COVID-19.
“The approval pathways through this route are fast-tracked with certain conditions to enhance the access to certain pharmaceuticals for meeting the emerging needs of drugs or vaccines,” the Union Health Ministry said in a statement.
Of the global Stringent Regulatory Authorities, only the United States Food and Drug Administration (USFDA) Medicines and Healthcare products Regulatory Agency (MHRA) of the UK have granted “conditional market authorization” to Pfizer and AstraZeneca, respectively, for their COVID-19 Vaccines. India has followed the suit. The national drug regulator, DCGI has given nod to market authorization of two COVID-19 vaccines, Covaxin and Covishield being administered under the national COVID-19 vaccination program subject to certain conditions on Thursday.
The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) had recommended for upgradation of status for the vaccines from restricted use in emergency situations to grant of new drug permission with conditions in the adult population on 19th January 2022.
“The vaccines shall 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) shall continue to be monitored. The firm shall submit the safety data including AEFI and AESI with due analysis on six monthly 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 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 16th January, 2021. As of today, more than 160 crore doses have been administered.