×

UPSC Courses

DNA banner

DAILY NEWS ANALYSIS

GS-III :
  • 04 July, 2020

  • 3 Min Read

Covaxin 

Covaxin

Part of: GS-III- S&T (PT-MAINS-PERSONALITY TEST)

The Central Drugs Standard Control Organisation (CDSCO) has granted approval to Bharat Biotech to conduct human clinical trials for ‘Covaxin’, making it the first indigenous Covid-19 vaccine candidate to receive this approval.

  • Covaxin has been developed by the company Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR). It is an inactivated vaccine manufactured in the company’s Bio-Safety Level 3 (BSL-3) High Containment facility located in Hyderabad (Telangana).
  • The permission was granted after the company submitted results from pre-clinical studies of the vaccine that demonstrated its safety and immune response. Phase I and II clinical trials will start across India in July 2020.

ImpPoints

  • Clinical trials in humans are classified into three phases: phase I, phase II and phase III and in certain countries formal regulatory approval is required to undertake any of these studies.
  • The phase I clinical studies carry out initial testing of a vaccine in small numbers (e.g. 20) of healthy adults, to test the properties of a vaccine, its tolerability, and, if appropriate, clinical laboratory and pharmacological parameters. Phase I studies are primarily concerned with safety.
  • Phase II studies involve larger numbers of subjects and are intended to provide preliminary information about a vaccine’s ability to produce its desired effect (usually immunogenicity) in the target population and its general safety.
  • Extensive phase III trials are required to fully assess the protective efficacy and safety of a vaccine. The phase III clinical trial is the pivotal study on which the decision on whether to grant the licence is based and sufficient data have to be obtained to demonstrate that a new product is safe and effective for the purpose intended.
  • An application for market authorization may be submitted to the National Regulatory Authority (NRA) on the basis of the data from phase III testing and if approved, the vaccine then becomes commercially available in that particular country.
    • The Central Drugs Standard Control Organisation (CDSCO) under Directorate General of Health Services, Ministry of Health & Family Welfare is the National Regulatory Authority (NRA) of India.
  • According to the World Health Organisation (WHO), out of 200 Covid-19 vaccine candidates, 15 have entered clinical trials.
    • AstraZeneca is the world’s leading Covid-19 vaccine candidate and has reached the final stage in terms of development. It is being developed by researchers at the University Of Oxford (UK).
    • US Firm Moderna’s vaccine (MRNA-1273) will go into phase III clinical trials in July.

Source: TH


Coal: Dominant energy source in India

 Coal: Dominant energy source in India Despite efforts to transition to renewable energy, coal will continue to be India's dominant energy source. What is the country's current energy capacity? According to Climate Action Tracker projections, fossil fuel accounts for more than half of the country's installed energy capa

Norms to Prevent False Online Reviews

Norms to Prevent False Online Reviews The Department of Consumer Affairs recently announced new regulations to protect consumers from "false and misleading reviews." It is part of the Bureau of Indian Standards norms, which will go into effect on November 25. Important Guidelines: E-commerce platforms will be required t

Development of Great Nicobar

Development of Great Nicobar The Ministry of Environment, Forests, and Climate Change recently approved an ambitious Rs 72,000 crore development project on the strategically important Great Nicobar Island. Over the next 30 years, the project will be implemented in three phases. About the proposal A greenfield city with an Interna

The Country's First Suicide Prevention Policy

The Country's First Suicide Prevention Policy Ministry of Health and Family Welfare recently announced the "National Suicide Prevention Strategy." It is the country's first of its kind, with time-bound action plans and cross-sector collaborations aimed at reducing suicide mortality by 10% by 2030. The strategy is consist

Non-performing assets

Non-performing assets According to RBI data, the mega write-off exercise has enabled banks to reduce their non-performing assets (NPAs) or defaulted loans by Rs 10,09,510 crore ($123.86 billion) over the last five years. However, banks have only been able to recover 13% of it so far. Concerning the news This massive write-off wou

Toppers

Search By Date

Newsletter Subscription
SMS Alerts