COVID-19 Vaccine Development: Key Developments in India

COVID-19 Vaccine Development: Key Developments in India

The Covid-19 emergency has propelled a race for preventive vaccines and treatment, with numerous efforts by companies, commercial consortia, and scientific organizations worldwide.

India is a hub for vaccine production and produces 60 percent of the world's vaccines. Indian companies have played a pivotal role in producing and distributing vaccines worldwide through organizations like UNICEF, Gavi, and WHO.

CDSCO to Fast Track COVID-19 Vaccines

Central Drugs Standard Control Organisation (CDSCO), the national regulatory body for Indian pharmaceuticals and medical devices, has announced to fast-track the regulatory approval process for vaccines, diagnostics, prophylactics, and therapeutics designed to prevent or treat COVID-19.

As part of an effort to provide quick access to vaccines and drugs to manage COVID-19, the CDSCO is creating a dedicated coronavirus unit to address inquiries on the development of these products. As per the CDSCO notification:

  • Any firm or research institute with a protocol for repurposing existing drugs/vaccines for the treatment of COVID-19 will be given priority for review and approval.

  • Applications for clinical trial permission and application to import or manufacture drugs or vaccines for sales and distribution would be processed on priority through expedited review and accelerated approval.

  • CDSCO will also be expediting reviews and approvals for drugs and vaccines already approved in other countries. As per this measure, any firm having a drug or vaccine already approved for COVID-19 in any other country can directly approach the Drugs Controller General of India (DCGI) for expedited review and accelerated approval. This step will help reduce the time for crucial drugs and vaccines to reach the market.

  • On a case-by-case basis, CDSCO may agree to abbreviate, defer, or waive the need for developers of drugs and vaccines to generate animal toxicity, clinical, stability, and other types of data related to COVID-19.

  • CDSCO also plans to process applications to manufacture or import COVID – 19 drugs or vaccines for test, analysis, or clinical trial within seven days.

Indian Companies - Key Players in the Global Vaccine Industry

The leading companies working towards developing a COVID-19 vaccine are Serum Institute of India, Bharat Biotech, and Zydus Cadila.

Serum Institute of India, a pioneer in vaccine development, has collaborated with Codagenix, an American biotech company, to develop a "live attenuated" vaccine. The vaccine candidate, developed using synthetic lab-made coronavirus using Codagenix's deoptimization technology, is in the preclinical stage. The vaccine is expected to enter human clinical trials in the coming months and be market-ready by early 2022.

Bharat Biotech has partnered with the University of Wisconsin Madison and US-based firm FluGen to develop a unique vaccine against COVID-19 called CoroFlu. CoroFlu will be developed on the backbone of FluGen's flu vaccine candidate known as M2SR.

Zydus Cadila is working on two vaccine approaches - the first approach includes the development of a DNA vaccine against the viral membrane protein of the virus, while a live attenuated recombinant measles virus (rMV) vectored vaccine will be developed in the second approach.

Premas Biotech, a company that specializes in creating recombinant protein for vaccine development, has out-licensed its vaccine candidate to Akers Biosciences Inc, USA. As per Premas Biotech, these recombinant proteins target the three proteins on the SARS-CoV-2 virus: the spike protein, envelope protein, and membrane protein. The ability to target all three offers a strong case for the vaccine.

Other Indian companies in the COVID-19 vaccine landscape include Biological E, Indian Immunologicals, Mynvax, Auro Vaccines, and Gennova Biopharmaceuticals.

Way Forward – High Hopes Pinned on India

As countries across the world look forward to the development of both preventive vaccines and treatment for Covid-19, the challenges of access and scaling up of manufacturing capacities for delivering therapies to millions of people cannot be overlooked. With the world collaborating to find a viable vaccine for Covid-19, high hopes set on India - the powerhouse of vaccine manufacturing.

Enabling large scale manufacturing, advancing rapid regulatory reforms and collective action can help deliver the appropriate vaccine at the right time to the right person. References

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.

FORM MD-24 is an application for grant of permission to conduct, clinical performance evaluation of new in vitro diagnostic medical device.

Yes. Clinical trial at each site shall be initiated after the approval of the clinical trial protocol and other related documents by the Ethics Committee for that site, registered with the CLA.

An audio-video recording of the informed consent process in case of vulnerable subjects in clinical trials of New Chemical Entity or New Molecular Entity including procedure of providing information to the subject and his understanding on such consent, shall be maintained by the investigator for record.

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.

The clinical performance evaluation shall be initiated within a period of one year from the date of grant of permission.

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