The Central Drugs Standard Control Organisation (CDSCO), a prominent health authority in India, has given the green light to Bharat Biotech to initiate human clinical trials for its Covid-19 vaccine candidate, Covaxin. This marks the first indigenous Covid-19 vaccine to receive such approval. The vaccine is a product of a collaboration between Bharat Biotech and the Indian Council of Medical Research (ICMR).
Covaxin was developed within the Bharat Biotech’s high-security Bio-Safety Level 3 (BSL-3) containment facility in Hyderabad, Telangana. This approval came after the company submitted promising results from their pre-clinical studies that showcased both the safety and immune response efficacy of the vaccine. Phase I and II clinical trials are set to commence across India in July 2020.
Understanding the Clinical Trials Phases
Clinical trials are an integral part of the vaccine development process. These trials, typically divided into three phases (phase I, phase II and phase III), reinforce the safety and efficacy of vaccines. In some countries, obtaining regulatory approval is a prerequisite before any trial can be initiated.
Phase I trials entail testing a potential vaccine on a small cohort of healthy adults. In this phase, the assessment focuses on the vaccine’s safety, tolerability, and pertinent clinical laboratory and pharmacological parameters. Safety is the central concern in this initial stage.
In phase II trials, the number of subjects is increased. During these trials, preliminary data is collected regarding the vaccine’s ability to produce its desired effect, commonly its immunogenicity, in the target population, along with its general safety.
On reaching phase III, extensive trials are undertaken to fully assess the protective efficacy and safety of the vaccine. This phase offers the primary evidence based on which licensing decisions are made. Sufficient data is collected to ascertain the safety and efficacy of the vaccine for its intended purpose.
Following successful Phase III trials, an application for market authorization may be submitted to the National Regulatory Authority (NRA). If approved, the vaccine can be commercially distributed in the country.
The Role of Central Drugs Standard Control Organisation
The Central Drugs Standard Control Organisation (CDSCO), under the Directorate General of Health Services of India’s Ministry of Health & Family Welfare, functions as India’s National Regulatory Authority (NRA).
Global Progress on Covid-19 Vaccines
According to the World Health Organization (WHO), there are currently 200 Covid-19 vaccine candidates in progress. Out of these, 15 have entered clinical trials. AstraZeneca’s vaccine, developed by researchers at the University of Oxford (UK), leads the global race and is in the final development stage.
US firm Moderna’s vaccine (MRNA-1273) is also showing promise and will enter phase III clinical trials in July.