Emergency use authorisation for Oxford Covid vaccine: What does it mean

NEW DELHI: The government-appointed expert panel on Friday granted emergency use approval for the Oxford University-AstraZeneca vaccine made and distributed by the Serum Institute of India.
After Drugs Controller General of India (DCGI) gives its approval, India too will likely begin the mass immunisation programme with a dosing regimen that had shown an efficacy rate of 62%. AstraZeneca had said its vaccine had shown 90% efficacy in a small subset of volunteers — none older than 55 — administered with a half dose followed by a full dose a month apart.
What is Emergency Use Authorisation?
Regulatory authorities need to approve vaccines, medicines, diagnostic tests and medical devices before these can be used on the general public or used by medical professionals.
The US Food and Drug Administration (FDA) defines emergency use authorisation as a “mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current Covid-19 pandemic.”
What is the process in India?
In India, the Central Drugs Standard Control Organisation (CDSCO) has the power to grant EUA. Unlike US FDA or UK regulator, there are no provisions for EUA under India’s drug regulations and the process for receiving one is not clearly defined.

What India follows is the ‘accelerated approval process’.
Under this process, the approval of the new drug may be based on data generated in clinical trial. Accelerated approval may also be granted to a new drug if it is intended for the treatment of a serious or life-threatening condition or disease.
If the remarkable efficacy is observed with a defined dose in the Phase II clinical trial of the new drug, it may be considered for grant of marketing approval by the Central Licencing Authority based on Phase II clinical trial data.
Complete approval vs authorisation?
According to the US FDA, the people have to made aware that the vaccine has only been granted an emergency use authorisation and not complete approval. Final approval is granted only after completion of the trials and analysis of full data; until then, EUA allows the medicine or the vaccine to be used by the public and health officials.
No country has made vaccination compulsory for its people.
Dry run of Covid vaccination
A dry run for Covid-19 vaccination will be conducted by all state and union territory administrations on January 2 to test the linkages between planning and implementation and to identify the challenges, the Centre said on Thursday. The activity is proposed to be conducted in all state capitals in at least 3 session sites.

Some states will also include districts that are situated in difficult terrain/have poor logistical support, while Maharashtra and Kerala are likely to schedule the dry run in major cities other than their capital. The central government has also asked all states and UTs to ensure effective preparedness for the Covid-19 vaccine roll-out.
India will be vaccinating a priority group of 300 million people first — 10 million healthcare providers, 20 million frontline workers, and 270 million people over the age of 50 and under 50 but with co-morbidities.
(With agency inputs)