Regular market approval granted for Covishield, Covaxin for use in adult population

The approval has been granted under the New Drugs and Clinical Trials Rules, 2019

Regular market approval granted for Covishield, Covaxin for use in adult population

Photo for representation purposes

Tribune News Service

Aditi Tandon

New Delhi, January 27

Eight days after subject experts of the Drug Controller General of India recommended regular market authorization for India made Covaxin and locally manufactured Covishield in adults, the national drug regulator on Thursday granted full market approval to the shots, subject to certain conditions, including submission of data of ongoing clinical trials.

Bharat Biotech made Covaxin, and Serum Institute of India’s Covishield are the first Indian vaccines to get regular approval.

So far, these vaccines were allowed for emergency use in the event of the ongoing pandemic.

On January 19, the Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO) on Covid-19, which reviewed Serum Institute of India and Bharat Biotech's applications seeking regular market authorization, had recommended regular market approval to Covishield and Covaxin subject to certain conditions.

This was the second review of the applications by the two firms.

Of all the doses of Covid 19 administered in India, the majority are Covishield and the rest are Covaxin.

SII said they had administered nearly 100 crore shots to Indians and others worldwide is a testimony to population based efficacy and safety of the Covid vaccine.

Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current Covid-19 pandemic.

Under an EUA, national regulators can allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives.

Over the past many months, accelerated vaccine development to prevent or reduce the severity of coronavirus disease 2019 (Covid-19) has resulted in rapid global emergency regulatory approvals, including by DCGI and US Food and Drug Administration (FDA).

On August 23, 2021, US FDA gave the world’s first full regulatory approval for a COVID-19 vaccine to Pfizer-BioNTech COVID-19 vaccine (Comirnaty) for individuals 16 years and older.

Full approval to Covishield and Covaxin will help address concerns of people who were hesitant to get vaccinated due to only emergency use approvals to the shots.

As India expands vaccination, the full approvals will aid the effort by allaying the fears of skeptics through full DCGI confidence in the safety of the two shots and their capacity to prevent severe Covid, hospitalisations and deaths.

 A government analysis of the Omicron induced third wave has shown significant lower mortality this year as compared to the second wave in 2021 on account of over 70 per cent people being covered with two shots as against just 2 per cent in 2021.

 

 

#Covaxin #Covid19vaccine #Covishield

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