The Union Government has given approval to the Covid-19 vaccine developed by Hyderabad based Bharat Biotech which has created a huge commotion with medical experts questioning the government's decision.

“Covaxin” which is a whole Virion Inactivated Coronavirus Vaccine, has been developed by Bharat Biotech in collaboration with the Indian Council for Medical Research (ICMR) and the National Institute of Virology (NIV), Pune.

The Union Health Ministry has approved the indigenously developed coronavirus vaccine for restricted and conditional use, which means that those who will receive “Covaxin” dosage will be monitored the same way as volunteers were in clinical trials.

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How A Vaccine Gets Approval In India?

Different countries have different procedures for authorizing and regulating vaccines, even though the process of development is universal.

In India, clinical trials and approval of new drugs including vaccines are governed by the New Drugs and Clinical Trial Rules that were notified in March 2019.

Here are the following steps for the approval of the vaccine in India, under normal conditions:

  • At first, the viral strain is identified, and a vaccine is then developed that is potentially safe and immunogenic.

  • Complete characterization of the vaccine strain by in-vitro experiments.

  • In order to determine safety and dosage, pre-clinical studies on small animals such as mice, rabbits, guinea pigs, etc. are conducted.

  • After small animals, preclinical studies are conducted on large animals to determine safety, protective efficacy, and potential dose and formulation.

  • With less than 100 volunteers, phase-I human trials are conducted to establish the safety of the vaccine.

  • Phase-II human clinical trials on usually less than 1,000 individuals to determine the immunogenicity or immune protection.

  • Finally, Phase-III human trials are taken to determine the efficacy of the vaccine, the number of volunteers counts around several thousand and after successful completion of the phase-III studies, approval is granted.


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What Is Emergency Use Authorization?

According to the vaccine approval rules of India, Emergency Use Authorization is not granted in the country, the term became popular after its usage in the United States.

However, in India, there is a chance of "accelerated approval" in "special situations", the current Covid-19 situation can be termed as one “special situation”.

The 2019 rules say, "Accelerated approval may also be granted to a new drug [read vaccine] if it is intended for the treatment of a serious, or life-threatening condition, or disease of special relevance to the country, and addresses unmet medical needs."

There is another special provision for accelerated approval for a vaccine if the phase-II results show "remarkable efficacy".

"If the remarkable efficacy is observed with a defined dose in the phase-II clinical trials of the investigational new drug for the unmet medical needs of serious and life-threatening disease in the country, it may be considered for grant of marketing approval by the central licensing authority based on phase-II clinical trial data,” the 2019 vaccine rules say.

Who takes that decision?

The Central Drugs Standard Control Organisation (CDSCO), grants approval to any newly developed vaccine, headed by the Drug Controller General of India (DCGI). The CDSCO works under the Union health and family welfare ministry.