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Oxford Covid Vaccine Emergency Use Authorization: What does it mean? India News

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NEW DELHI: On Friday, the government-appointed panel of experts granted emergency use approval for the University of Oxford AstraZeneca vaccine manufactured and distributed by the Serum Institute of India.
After the Comptroller General of Drugs of India (DCGI) gives its approval, India will also likely start the mass immunization program with a dosing regimen that has 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, given a half dose followed by a full dose one month apart.
What is the emergency use authorization?
Regulatory authorities must approve vaccines, drugs, diagnostic tests, and medical devices before they can be used by the general public or medical professionals.
The US Food and Drug Administration (FDA) defines emergency use authorization as a “mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current pandemic. of Covid-19 “.
What is the process in India?
In India, the Central Drugs Standard Control Organization (CDSCO) has the power to grant USA. Unlike the US FDA or the UK regulator, there are no provisions for the US under Indian drug regulations and the process for receiving one is not clearly defined.

What India follows is the “accelerated approval process”.
Under this process, approval of the new drug can be based on data generated in a clinical trial. Expedited approval may also be granted for a new drug if it is intended to treat a serious or life-threatening condition or disease.
If remarkable efficacy is observed at a defined dose in the Phase II clinical trial of the new drug, the granting of marketing approval by the Central Licensing Authority based on the data from the Phase II clinical trial may be considered.
Full approval vs authorization?
According to the US FDA, people should know that the vaccine has only been granted an emergency use authorization and not a full approval. Final approval is granted only after completion of testing and complete data analysis; Until then, the US allows the public and health officials to use the drug or vaccine.
No country has made vaccination mandatory for its population.
Proof of vaccination against Covid
All state and territory administrations in the union will conduct a Covid-19 vaccination trial on January 2 to test the links between planning and implementation and to identify challenges, the Center said Thursday. The activity is proposed to take place in all state capitals at at least 3 session sites.

Some states will also include districts that are located in difficult terrain / have poor logistical support, while Maharashtra and Kerala will likely schedule the drill in major cities in addition to their capital. The central government has also asked all states and UT to ensure effective preparation for the launch of the Covid-19 vaccine.
India will first vaccinate a priority group of 300 million people: 10 million healthcare providers, 20 million frontline workers, and 270 million people over 50 and under 50, but with comorbidities.
(With contributions from the agency)

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