Covid-19 vaccines approved for use in India - What you need to know

Covid-19 vaccines approved for use in India - What you need to know


Indian, one of the leaders in the pharmaceutical sector, is set to play a vital role in the global COVID-19 vaccination effort.On 03 January 2021, the Drugs Controller General of India (DCGI) granted emergency approval for two COVID-19 vaccines –Covishield and Covaxin. Both Covishield and Covaxin work by triggering the immune system against the spike protein of the SARS-CoV-2 virus (novel coronavirus). While Covaxin uses an inactivated SARS-CoV-2 virus, Covishield includes a weakened version of adenovirus.

Bharat Biotech's Covaxin

Covaxin is the first COVID-19 vaccine made in India. The vaccine is developed by Bharat Biotech in collaboration with the Indian Council of Medical Research and the National Institute of Virology.

Covaxin is a whole virion inactivated vaccine made up of killed coronaviruses, making it safe to be injected into the body. When the vaccine is administered, the dead virus can trigger the immune system to produce antibodies against the novel virus. As per the National Institute of Virology, antibodies induced by Covaxin can neutralise the UK variant strains as well. Covaxin is given in two doses, four weeks apart.

Covaxin was studied in preclinical studies in mice, rats, rabbits and Syrian hamster. Challenge studies on on-human primate models have also been carried out. Phase I and Phase II clinical trials showed that the vaccine is safe and demonstrates a robust immune response.

The efficacy, safety, and immunogenicity of Covaxinare being studied in a phase III trial in 25,800 subjects aged ≥18 years. The study population also include subjects aged above 60 years of age (2400 subjects) and subjects with comorbidities (more than 4500 subjects).

As per the interim analysis of the phase III trial, Covaxindemonstrated 81% efficacy in preventing COVID-19 in those without prior infection after the second dose. The first interim analysis is based on 43 cases, of which 36 cases of COVID-19 were observed in the placebo group versus seven cases observed in the Covaxin group.

Covishield

Covishield is the Indian version of the Oxford -AstraZeneca COVID-19 vaccine (AZD1222). The Serum Institute of India manufactures Covishield.

Covishield consists of a replication-deficient chimpanzee adenoviral vector, ChAdOx1, containing the SARS-CoV-2 spike protein gene. Covishield is given in two doses, four and 12 weeks apart.

The interim analysis of Covishield, published in Lancet in December 2020, reports that the vaccine has an efficacy rate of 70.4% and possesses an acceptable safety profile. The efficacy results are based on a pre-specified pooled analysis of phase III trials in the UK and Brazil.

Based on the interim safety and immunogenicity data from the overseas clinical studies, the Indian regulators granted approval for the Phase II/III clinical trial of Covishield on an Indian cohort. The study on the Indian population was initiated in November 2020 and has enrolled 1600 people at 15 different centres across the country.

Vaccine candidates in development

Apart from Covaxin and Covishield, several other vaccines are at different stages of clinical development:

COMPANYVACCINECURRENT STATUS
Cadila Healthcare LtdZyCov-D -Plasmid DNA vaccineReceived DCGI approval for conducting phase III trial
Biological E in collaboration with US-based Dynavax and Baylor College of MedicineCOVID-19 subunit vaccine candidate. CpG 1018 used as adjuvantPhase I/II trials ongoing
Genova biopharmaceuticals in collaboration with Seattle-based HDT Biotech CorporationHGCO19 -mRNA vaccineReceived DCGI approval for conducting phase I/II trial
Bharat BioTechBBV154 -Novel adenovirus vectored, intranasal vaccineReceived DCGI permission forPhase Itrials
Dr Reddy's Lab and Gamaleya National Centre in RussiaSputnik VPhase II/III clinical trials ongoing in Indian population. Interim results from the phase III trial in Russia showed an efficacy rate of 91.6%.
Serum Institute of India and American vaccine development company NovavaxCOVOVAX-recombinant protein-based vaccine Applied to initiate the bridging trial in India.Was found to be 89.3% effective in a UK trial.

India's mega immunisation drive

The pandemic can be controlled only if the approval, production, and distribution of the vaccines go smoothly and vaccines are administered to the people, especially those vulnerable.

India's mega immunisation drive started on 16 January 2021. Nearly 30 million people were vaccinated in the first phase; healthcare and frontline workers were given priority. In the second phase, people over 60 and those between 45 and 59 with comorbidities are getting vaccinated. From 01 April 2021, all above 45 can get vaccinated.

India is reported to make 60% of the world's vaccines and plays a major role in the global vaccination drive. India is also providing vaccine to neighbouring countries. As of 25 March 2021, India has shipped 604.49 lakh doses of vaccines to 76 countries.

References

  1. COVAXIN® -India's First Indigenous COVID-19 Vaccine. Available at: https://www.bharatbiotech.com/covaxin.html. Accessed: 25 March 2021.
  2. Press Statement by the Drugs Controller General of India (DCGI) on Restricted Emergency approval of COVID-19 virus vaccine. Available at: https://pib.gov.in/PressReleseDetail.aspx?PRID=1685761Accessed: 25 March 2021.
  3. Voysey M, Clemens SAC, Madhi SA, et al. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK [published correction appears in Lancet. 2021 Jan 9;397(10269):98].Lancet. 2021;397(10269):99-111.
  4. Logunov DY, Dolzhikova IV, Shcheblyakov DV, et al. Safety and efficacy of an rAd26 and rAd5 vector-based heterologousprime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia [published correction appears in Lancet. 2021 Feb 20;397(10275):670].Lancet. 2021;397(10275):671-681. doi:10.1016/S0140-6736(21)00234-8
  5. Harrison EA, Wu JW. Vaccine confidence in the time of COVID-19.Eur J Epidemiol. 2020;35(4):325-330.
  6. Bharat Biotech Announces Phase 3 Results of COVAXIN. Available at: https://www.bharatbiotech.com/images/press/covaxin-phase3-efficacy-results.pdf. Accessed: 25 March 2021.7.Vaccine Supply. Ministry of external affairs. https://www.mea.gov.in/vaccine-supply.htm


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.

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.

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.

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