Covaxin, Covishield get conditional market nod for inoculating adults

Tribune News Service

New Delhi, January 27

The Drug Controller General of India today granted conditional regular market approval for India-made Covaxin and locally manufactured Covishield for use in adult population.

Graph plateauing

Omicron-induced third wave is plateauing in some states like Maharashtra, UP, Delhi, Odisha, Haryana and WB, says the Health Ministry

Health Minister Mansukh Mandaviya said on Thursday the government’s vaccination drive would continue as it is to provide first and second doses for all and a precautionary dose for senior citizens with co-morbidities as well as for frontline workers. Market authorisation means that private hospitals can now directly procure the shots from the manufacturers. The vaccines will, however, not be sold off the shelf and will continue to be administered at registered vaccination centres through the CoWIN platform.

The conditions of the approval say the firms will have to submit data of overseas ongoing clinical trials with due analysis once every six months instead of once every 15 days. The vaccine will be supplied for programmatic setting and all vaccinations done in India will be recorded on CoWIN platform. Adverse event post-immunisation and adverse event of special interest will continue to be monitored with safety data to be submitted once in six months (instead of 15 days).

Bharat Biotech-made Covaxin, and Serum Institute of India’s Covishield are the first Covid shots to get conditional regular approval in India. So far these were allowed for emergency use.

On January 19, the Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO) on Covid-19 had recommended regular market approval to Covishield and Covaxin subject to certain conditions.

The emergency use authorisation (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. The Health Ministry today said the approval indicates the promptness and timeliness with which the public response strategy and decision-making apparatus of the country has responded to the emerging needs during the pandemic. Of all regulatory authorities worldwide, only the United States Food and Drug Administration (USFDA) and the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK have so far granted “conditional market authorisation” to Pfizer and AstraZeneca Covid vaccines, respectively.

The “conditional market authorization” is a new category of market authorisation that has emerged during the current pandemic.

Under this, approval pathways are fast-tracked conditionally to enhance access to certain pharmaceuticals for meeting the emerging needs of drugs or vaccines.

Today’s approvals will allay the fears of skeptics who are vaccine-hesitant due to emergency approval of the shots. The conditional market authorisation also means the vaccine safety has been firmly established.

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 74 per cent adults fully covered with both doses in 2022 as against just 2 per cent in May 2021.

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