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India's First COVID-19 Vaccine, COVAXIN, Enters Clinical Trials with Accelerated Timeline

  • Bharat BioTech's COVAXIN, developed with the National Institute of Virology, initiates Phase 1 clinical trials involving 375 participants to assess safety and efficacy.
  • The accelerated timeline for COVAXIN's clinical trials, aiming for completion by August 15, has faced criticism from experts citing potential health risks.
  • Zydus Pharma and BioNTech have also announced their own vaccine candidates, increasing the number of companies developing potential coronavirus vaccines in India.
  • India now ranks third globally in COVID-19 cases, surpassing Russia, with over 11.6 million infections and 537,000 deaths reported.
Bharat BioTech, a Hyderabad-based company, is commencing clinical trials for COVAXIN, India's first COVID-19 vaccine. The initial phase will involve 375 participants, with plans to expand to over 1,100 individuals in Phase 1 and 2 trials. This vaccine was developed in collaboration with the National Institute of Virology in Pune, utilizing an isolated strain of the SARS-CoV-2 virus.
The ICMR Director, Dr. Balram Bhargava, had previously communicated to 12 trial sites the urgency to complete all clinical trials by August 15. However, this aggressive timeline has been met with skepticism from experts, who caution that fast-tracking vaccine trials within four weeks could introduce significant health risks. The Indian Academy of Sciences, a Bengaluru-based scientific body, expressed concerns that the announced timeline is "infeasible" and "unrealistic."

Other Vaccine Candidates

In addition to COVAXIN, Zydus Pharma and BioNTech (in collaboration with Pfizer) have also announced their own vaccine candidates, which have received approval from the Drugs Controller General of India (DCGI). This brings the total number of companies in India working on potential coronavirus vaccines to six.

COVID-19 Situation in India

India has surpassed Russia in the number of COVID-19 cases, ranking third globally with over 11.6 million infections and a death toll exceeding 537,000.
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Reference News

[1]
Clinical trials of India's first COVID-19 vaccine to start with 375 people - The Commune
thecommunemag.com · Oct 5, 2024

Bharat BioTech plans to conduct COVID-19 vaccine COVAXIN trials on 375 people, aiming for an August 15 launch, despite e...

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