Phase 2-3 Clinical Trials for Covaxin To Commence On Children Aged 2-18 Years Soon

Phase 2-3 Clinical Trials for Covaxin To Commence On Children Aged 2-18 Years Soon

On the 13th of May, 2021, as per one of the country's top health officials, India's very first trial of a domestically manufactured Covid-19 vaccine is all set to commence on children in the next 10-12 days. At the forefront of global concerns lies the fear that the next wave of the pandemic may strike the country hard if the citizens are not given preliminary safety measures such as the vaccine.

Bharat Biotech, the maker of Covaxin, had proposed to conduct Phase II and Phase III clinical trials of their COVID-19 vaccine for children belonging to the age group of 2 to 18 years. This trial is going to be administered to 525 healthy volunteers. However, the news was met with high levels of apprehension and resistance by the public.

On Tuesday, the Government of India said that trials pertaining to Covaxin's efficacy against the SARS-COV-2 virus and its variants on children of ages 2-18 years aim to have all citizens vaccinated by the end of 2021, making over 200 Crore doses available from August to December. Addressing a Health Ministry briefing, Niti Aayog member VK Paul provided his statement on the matter by saying, "Covaxin has been approved by the Drugs Controller General of India (DCGI) for phase II and III clinical trials in the age group of 2 to 18 years."

India's drug regulator DCGI accepted the recommendation of the Subject Expert Committee (SEC) and approved the Hyderabad-based Bharat Biotech to commence their Phase II/III clinical trials on the 13th of May. Covaxin by Bharat Biotech is backed by the Indian Council of Medical Research (ICMR) and is effective so far against the majority of the new variants of the virus that have unleashed immeasurable damage in India during the second wave.

The clinical trials phase II and III for Covaxin consist of two Covid-19 vaccine shots injected to the volunteers on days 0 and 28, respectively. The data of the efficacy and any side effects shall be recorded by the company and ICMR to arrive at a conclusive report. These trials will be hosted at various sites, such as AIIMS Delhi, AIIMS Patna and Meditrina Institute of Medical Sciences, Nagpur.

The announcement for the approval of trials on children came as a shock amidst reports of new COVID-19 strains affecting an alarmingly growing number of children. Earlier this week, the Chief Minister of Delhi, Mr Arvind Kejriwal, made an appeal to the Central Government for the immediate cancellation of all airway services embarking from and to Singapore, claiming the new strain of Coronavirus detected there is "highly dangerous" to children. This new variant could capsize India in the third wave, he said on his social media account.

Among others who have raised their concerns for the safety of the children undergoing trials, a bench of Chief Justice DN Patel and Justice Jyoti Singh issued notice on a Public Interest Litigation (PIL) filed by Sanjeev Kumar. This notice seeks direction to stay the order passed on the 13th of May, which gave Bharat Biotech the consent for conducting clinical trials on children between the ages of 2-18 years. The Ministry of Women and Child Development, too, was delegated as a party to these proceedings.

In a subsequent hearing, the Delhi High Court on Wednesday, the 19th of May, denied an interim stay order on the clinical trials of Covaxin on the children volunteering. However, the court has also sent out notices to the Drugs Controller General of India (DCGI) and other parties involved with a plea challenging the DCGI's approval to Bharat Biotech for conducting these trials. Further developments are awaited in the matter, given the citizens' nervousness to subject children to the Coronavirus vaccine clinical trial in India, especially with several noted side-effects found in adults.

Besides Covaxin, the vaccine producer Serum Institute's Covishield is also being utilized to vaccinate citizens in India. In the meantime, Russia's Sputnik V is also being made available for beneficiaries who are 45 years or older at Apollo Hospital at Hyderabad's Jubilee Hills. Small to medium level hospitals in Mumbai, too, could begin administering Sputnik V vaccines from the month of June.

Frequently Asked Questions

What is an “orphan drug” as per the New Drugs and Clinical Trial Rules, 2019?

“Orphan drug” means a drug intended to treat a condition which affects not more than five lakh persons in India.

The extrapolation of the safety and efficacy data of a particular clinical indication (for which clinical studies has been done) of a similar biologic to other clinical indications may be possible if following conditions are met: Similarity with respect to quality has been proven to reference biologic Similarity with respect to preclinical assessment has been proven to reference biologic Clinical safety and efficacy is proven in one indication Mechanism of action is same for other clinical indications Involved receptor(s) are same for other clinical indications New indication not mentioned by innovator will be covered by a separate application.

The permission to initiate clinical trial granted in Form CT-06 or automatic approval in Form CT 4A shall remain valid for a period of 2 years from the date of its issue, unless extended by the CLA.

Yes. Before enrolment of first participant in any clinical trial, registration in CTRI is mandatory

The three tier mechanism comprises the following authorities: 1. Institutional Biosafety Committee (IBSC) at the Institute/ company – To ensure biosafety on-site 2. Review Committee on Genetic Manipulation (RCGM) in the Department of Biotechnology - Managed genetically engineered cell banks 3. Genetic Engineering Appraisal Committee (GEAC) in the Ministry of Environment & Forests (MoE&F)- for genetically modified organisms/ living modified organisms

Any person or institution or organisation having permanent establishment in India who intends to conduct clinical trial of a biological product can submit application for clinical trial.

After obtaining permission in CT-11 or CT-14 or CT-15 as the case may be, the person, who intends to manufacture the biological product for CT, shall make an application for grant of license to manufacture the biological product by the respective State Licensing Authority (SLA) in accordance with the provisions of the Act and the Drugs and Cosmetics Rules, 1945.

No. For biological product and substances discovered or developed in countries other than India, Phase I data should be submitted along with the application. After submission of Phase I data generated outside India to the Central Licensing Authority, permission may be granted to repeat Phase I trials or to conduct Phase II trials and subsequently Phase III trial concurrently with other global trials for that biological product.

“New drug” means, (i) a drug, including active pharmaceutical ingredient or phytopharmaceutical drug, which has not been used in the country to any significant extent, except in accordance with the provisions of the Act and the rules made thereunder, as per conditions specified in the labelling thereof and has not been approved as safe and efficacious by the Central Licencing Authority with respect to its claims; or (ii) a drug approved by the Central Licencing Authority for certain claims and proposed to be marketed with modified or new claims including indication, route of administration, dosage and dosage form; or (iii) a fixed dose combination of two or more drugs, approved separately for certain claims and proposed to be combined for the first time in a fixed ratio, or where the ratio of ingredients in an approved combination is proposed to be changed with certain claims including indication, route of administration, dosage and dosage form; or (iv) a modified or sustained release form of a drug or novel drug delivery system of any drug approved by the Central Licencing Authority; or (v) a vaccine, recombinant Deoxyribonucleic Acid (r-DNA) derived product, living modified organism, monoclonal anti-body, stem cell derived product, gene therapeutic product or xenografts, intended to be used as drug; Explanation: The drugs, other than drugs referred to in sub-clauses (iv) and (v), shall continue to be new drugs for a period of four years from the date of their permission granted by the Central Licencing Authority and the drugs referred to in sub-clauses (iv) and (v) shall always be deemed to be new drugs;

In India, genetically modified organisms (GMOs) and the products thereof are regulated under the “Rules for the manufacture, use, import, export & storage of hazardous microorganisms, genetically engineered organisms or cells, 1989” (referred to as Rules, 1989) notified under the Environment (Protection) Act, 1986.

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