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Phase I human trial of indigenous COVID-19 vaccine completed in India: ICMR

As announced earlier, India's first vaccine candidate against the coronavirus disease (COVID-19), Covaxin, has now been applied to volunteers in the first phase of the human clinical trials. The Indian Council of Medical Research (ICMR) on Tuesday said that Bharat Biotech's COVAXIN and Ahmedabad based Zydus Cadila's vaccine has already started Phase II clinical trial.

Phase I human trial of indigenous COVI-19 vaccine complete in India: ICMR
Phase I human trial of indigenous COVI-19 vaccine complete in India: ICMR

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Published : Aug 4, 2020, 10:53 PM IST

New Delhi: India's expectations for an early indigenous vaccine on Tuesday went a step ahead when the Indian Council of Medical Research (ICMR) stating that Bharata Biotech's COVAXIN and Ahmedabad-based Zydus Cadila's vaccine have already started Phase II clinical trial.

Both of them have completed Phase I trial in 11 clinical sites, said Dr Balram Bhargava, director general ICMR.

He further said that the Serum Institute of India (SII) will start phase III clinical trials of Oxford vaccine candidate ChAdOxi by this week in 17 clinical sites. "Covid19 pandemic is progressing rapidly. At the same time we have to find an authentic vaccine following scientific research," said Dr Bhargava while addressing a press conference.

He said that Government has already initiated steps for prioritisation and distribution, logistics and cold chain, stockpiling and training of people for proper distribution of vaccine and approved.

Referring to the virus strain of Covid19, Dr Bhargava said some mutation is going on but it's not such major.

"Virus mutation was looked by National Institute of Virology (NIV) with returnees from Iran, Brazil and other places. Research and studies show it takes 10-50 years as mutation times...but in India, there is no major mutation," said Dr Bhargava.

Referring to testing by RT-PCR testing kits, Dr Bhargava said that 30 indigenous RT-PCR testing kits have been approved.

"There has been a lot of data regarding RT-PCR tests. They have good sensitivity rate almost to 85 to 90 per cent," said Dr Bhargava. As far as Rapid Antigen Test is concerned, 3 domestic companies have been approved with the high specificity of tests.

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He informed that ICMR will publish the findings of sero survey from containment zones very soon. It was in June, ICMR has initiated a nationwide serosurvey to ascertain the prevalence of Covid19 infection amongst the population. The newly appointed Union Health Secretary Rajesh Bhusan said that COVID 19 is spreading in new areas. However, 10 states bear the 82 per cent caseload of Covid19 whereas 50 districts across India carry the 66 per cent of the COVID cases load. Referring to the under-reporting of deaths, Bhushan said that initially there were certain deaths from a few states which were not reported properly.

However, most of the deaths have come from specific urban areas of states "which register hike in death cases even in normal time." He said that Delhi register 93 per cent deaths in normal times, and more than 100 per cent death is being reported from Mumbai and Tamil Nadu in normal cases. "We have to get clarity on medically certified deaths due to Covid19. In Delhi such death rate is 69 per cent, Tamil Nadu 85 per cent and Maharastra 67 per cent," said Bhushan.

Bhushan said that there are 28 states and UTs across India including Rajasthan, Punjab, Uttar Pradesh, Andhra Pradesh, West Bengal etc which register Covid19 positivity rate of less than 10 per cent.

"Last week's positivity of India was 11 per cent, which means a few states are showing the rise in Covid19 cases," said Bhushan.

He said that all states have also been asked to increase the testing capacity to 10 lakh per day. He said that India's case fatality rate is 2.10 per cent at present which is one of the lowest in the world and lowest since the first lockdown.

"On June 17, the case positivity rate was 3.36 per cent, but at present, it has drastically reduced to 2.10 per cent," said Dr Bhargava.

Referring to the gender and age-wise mortality, Dr Bhargava said that 50 per cent of death took place between the age group of 60 and above. 37 per cent deaths took place for the people in the age of 45 to 60 and 11 per cent deaths took place for the people who fall in the age group of 26 to 44.

There was 1 per cent death for the people below the age group of 17 and below and 1 per cent for the people between 18 to 25 years of age.

"About 68 per cent of Covid19 reported among male patients and 32 per cent among female patients in India," said Bhushan. Recovered cases are above double of the active cases.

"There are 5,86,298 active COVID 19 cases at present against a recovered number of 12,30,509," said Bhushan.

He said that 28 states and UTs in India are performing more than 140 tests per day per million population. As many as 24 states and UTs have better tests per million than the national average of 15119.

Also read:Indian medical experts welcome Oxford trial results for COVID vaccine

He said that India is conducting 479 tests per day per million population for the detection of Covid19. "With 6.6 lakh tests done in last 24 hours, India's total testing figure now stands at more than 2 crores," said Bhushan," said the health secretary.

Bhushan during the day also briefed a Parliamentary Committee on Health and Family Welfare on the status of Outbreak of pandemic Covid19 and related contingent and mitigation plan. Sources said that Bhushan, during his presentation briefed the 30 members committee on the containment strategy being undertaken to control Covid19 in India.

Committee chairperson and Samajwadi Party MP Ramgopal Yadav was, however, absent from the meeting. Meanwhile, 18 states across India have registered 175 deaths of doctors due to Covid19 with Tamil Nadu registering maximum death of 43 doctors, said an Indian Medical Association (IMA) data. end.

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