{"id":72239,"date":"2020-12-09T19:00:12","date_gmt":"2020-12-09T13:30:12","guid":{"rendered":"https:\/\/blog.forumias.com\/?p=72239"},"modified":"2021-03-05T12:49:09","modified_gmt":"2021-03-05T07:19:09","slug":"process-and-issues-linked-to-emergency-use-authorisation-eua-of-covid-vaccines-in-india","status":"publish","type":"post","link":"https:\/\/forumias.com\/blog\/process-and-issues-linked-to-emergency-use-authorisation-eua-of-covid-vaccines-in-india\/","title":{"rendered":"Process and Issues linked to Emergency Use Authorisation (EUA) of COVID Vaccines in India"},"content":{"rendered":"

Emergency Use Authorisation (EUA)<\/strong><\/span><\/p>\n

This article explains the process of Emergency Use authorization<\/strong><\/span>, <\/strong><\/span>based on The Indian Express Article “Three Covid-19 vaccine developers seek emergency use approval in India”\u00a0<\/strong><\/em><\/span><\/p>\n

Central Drug Standard Control Organisation (CDSCO) has received applications from 3 vaccine developers seeking Emergency Use Authorisation\/Approval (EUA) for their candidate Covid-19 vaccines which are still under trial. These Vaccines are COVISHIELD, COVAXIN, and BNT162b2. <\/strong><\/span><\/p>\n

None of the Vaccine developers has yet generated data about the effectiveness of their vaccine from phase-III trials conducted in India.<\/strong><\/span><\/p>\n

What is the normal process of Vaccine Development? <\/strong><\/span><\/p>\n

In normal circumstances, a Vaccines has to go through several phases, with each phase taking many months to get completed, but in the case of COVID, it is expected that vaccines would be in the market within a year from its start, after seeking Emergency Use Approval (EUA) from their respective governments.<\/span><\/p>\n

After Pre-clinical testing of Vaccines, it is tested on the human under clinical trials before its mass production.<\/span><\/p>\n

Clinical trials<\/span><\/strong>: It involves testing on humans<\/strong>. There are 3 phases of clinical trials;<\/span><\/p>\n

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  1. Phase I<\/strong><\/span> of a clinical trial is conducted on a small group of healthy individuals<\/strong>. It only indicates what is the ideal dose required to administer in the next stage, it provides evidence of the vaccine\u2019s ability to generate an immune response and its safety.<\/span>\n
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    1. The vaccine is not considered safe if it develops any major complication, however little headache and fevers are expected.<\/span><\/li>\n<\/ol>\n<\/li>\n
    2. In phase II<\/strong><\/span>, the range of participants is expanded to a few hundred healthy participants<\/strong> to check the immune response system in the body and it also assesses the time period for which antibodies last to provide immunity against the virus.<\/span><\/li>\n
    3. Phase-III<\/strong><\/span> involves a very large group of people (Thousands of individuals)<\/strong> to investigate its efficiency among large population groups. Half of the population is administered the actual Vaccine and the other half are administered dummy vaccines.<\/span>\n
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      1. Individuals administered Vaccines are checked on fixed intervals which can be months in normal conditions to see whether their immune system is responding to the virus or not.<\/span><\/li>\n<\/ol>\n<\/li>\n<\/ol>\n

        After the Vaccine is successfully tested, it would require regulatory approval<\/strong> before it can be produced in bulk quantity.<\/span><\/p>\n

        Emergency Use Authorisation (EUA)<\/strong><\/span><\/p>\n

        The term \u201cEmergency Use Authorisation (EUA)\u201d has been used mainly by the regulatory agencies like FDA in the US<\/strong> and some other countries with the following guidelines;<\/span><\/p>\n

        FDA has specified that it would consider an application for EUA only if phase 3 data showed <\/strong><\/span><\/span><\/p>\n