Drug Controller Gives Conditional Market Approval To Covishield, Covaxin

The Drug Controller General of India and the Central Drugs Standard Control Organisation have given market approval to Covishield and Covaxin, both the COVID-19 vaccines in the country under the New Drugs and Clinical Trials Rules, 2019.

This conditional market authorisation is subject to the vaccine manufacturers continue to record all vaccinations through the CoWin platform along with monitoring adverse events following immunisation (AEFI) and adverse events of special interest (AESI). They have to present clinical data and adverse event data every six months to the drug regulator. This conditional market approval is only for adults above 18 and has not been extended to the 15-18 population that is being vaccinated with Covaxin.

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Both the vaccines received restricted emergency use authorisation on January 3, 2021 and were launched for use on January 16, 2021. Subsequently, in the months following immunisation, Serum Institute of India which manufactures Covishield and Bharat Biotech which manufactures Covaxin approached the CDSCO to receive complete approval.

The difference between market approval and emergency use authorisation lies in the final data both the manufacturers sent to the drug regulator in the past few months. When the vaccines were given emergency use authorisation, they were still new, unapproved products that needed several rounds of clinical trials to assess their safety and efficacy. In the past year, the manufacturers were expected to send clinical and adverse event data to the CDSCO every fortnight.

According to the CDSCO, the submitted clinical data showed that the vaccines were effective in the long run and with over 160 crore doses administered to the population of the country, they provided conditional market approval to the vaccines. So far, only the Pfizer vaccine in US and the AstraZeneca vaccine in UK have received market approval by the US Food and Drug Administration and the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) across the world.

Emergency use authorisations are normally given to unapproved products which are seen to act as countermeasures during public health emergencies. These unapproved products are used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions.

India has currently given one dose of vaccine to 95 per cent of its eligible population and double vaccinated close to 74 per cent of its adult population, the Health Ministry stated in the press conference on January 27. It has also given close to 97 lakh precautionary doses to health workers and those who are older than 60 years of age. The government launched vaccination for children between the ages of 15-18 on January 3 and has so far vaccinated 59 per cent of that population.