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Wednesday, Jul 08, 2020 13:00 [IST]

Last Update: Wednesday, Jul 08, 2020 07:17 [IST]

A shot in the arm

Covaxin, India's first possible vaccine against Covid-19, will be tested on over 1,100 people in two phases, according to reports. Bharat Biotech, an unlisted Indian vaccine maker, received regulatory approval to start human clinical trials for its experimental shot. The phase 1 trial of Covaxine is scheduled to start next week. The company has planned to enroll 375 people in the first phase of clinical trials, according to Indian Council for Medical Research (ICMR). The company has set July 13 as the last date of enrolment for the first trial.
The ICMR has selected 12 institutes to conduct these trials, including AIIMS in Delhi and Patna. Depending on the results of the first trial, the company has a plan to enroll 750 people in the second phase of trial.
Zydus Cadila has also got an approval from the Drugs Controller General of India (DCGI) for human clinical trials for ZyCov-D, its indigenously developed vaccine candidates against Sars-Cov-2, which causes Covid-19. Before the two Indian vaccines, Covaxin and ZyCov-D, 18 experimental Covid-19 vaccines are in various phases of human trials across the world. One of the leading candidates is AZD1222, which has been developed by the Jenner Institute of University of Oxford and licensed to AstraZeneca, a British-Swedish multinational pharmaceutical and biopharmaceutical company. Behind AZD1222 is the MRNA-1273 vaccine developed by Kaiser Permanente Washington Health Research Institute and taken up for production by the US-based Moderna pharmaceutical. AstraZeneca and Moderna have already entered into an agreement with Indian manufacturers for production of the Covid-19 vaccines.
However, the ICMR on Sunday clarified that it only “envisages" a vaccine for Covid-19 by 15 August, and this isn’t a deadline for its launch. The clarification came after the state-run body kicked up a furore over what looked like a reckless rush to resolve our corona crisis just in time for Independence Day. Fears had arisen that safety trials would be given the short shrift to clear a fast track for a vaccine. All the clinical trials that are in order shall be done, averred the council.
The ICMR has said that just as red tape was not allowed to become a hindrance in the fast-track approval of new indigenous testing kits or for introducing in the Indian market potential COVID-19 related drugs, the indigenous vaccine development process has also been sought to be insulated from slow file movement.
With the world left reeling by the Covid pandemic, there has been a global scramble for immunity jabs. Oxford University’s vaccine was expected out by late 2020. This was seen as the earliest possible debut, given the intensive and extensive safety tests that must be conducted over a span of months. Hurrying these checks could risk a medical mishap, said experts who raised eyebrows on Friday over a leaked memo written by ICMR’s head asking for its vaccine to be expedited. To put such doubts to rest and earn confidence, the council should open its clinical records to scrutiny.

Sikkim at a Glance

  • Area: 7096 Sq Kms
  • Capital: Gangtok
  • Altitude: 5,840 ft
  • Population: 6.10 Lakhs
  • Topography: Hilly terrain elevation from 600 to over 28,509 ft above sea level
  • Climate:
  • Summer: Min- 13°C - Max 21°C
  • Winter: Min- 0.48°C - Max 13°C
  • Rainfall: 325 cms per annum
  • Language Spoken: Nepali, Bhutia, Lepcha, Tibetan, English, Hindi