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NIMS begins subject registration for Covid 19 Vaccine clinical trial

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Covid 19 Vaccine

Hyderabad, July 7 : The subject enrolment for Phase-I clinical trial of India’s first indigenous vaccine for COVID-19 began at Nizam’s Institute of Medical Science (NIMS) here on Tuesday.

On the direction of the Indian Council of Medical Research (ICMR), authorities at NIMS began the process to register 30-60 subjects for the trial.

Blood and swab samples of the subjects will be collected and if found fit they will be administered the first dose of the vaccine after a week.

NIMS Director Dr K. Manohar told reporters that healthy subjects will be screened and their blood and swab samples sent to ICMR-designated lab in New Delhi. After receiving the test reports, the Department of Medicine will analyse the same and issue the fitness certificates to the subjects.

The subjects would be administered two doses of the vaccine. There will be two vaccine dosage of three micrograms and six micrograms, and a placebo.

Each subject would be given the second dose of the same vaccine after 14 days.

For two days after administering the vaccine, the subjects would be monitored for two days in the ICCU at NIMS by a team of doctors, after which they would be sent home and monitored through videoconference or phone.

The phase-I clinical trial would go on for 28 days, after which the ICMR and the Drug Controller General of India (DGCI) would accord permission for Phase-II trial with more subjects.

Phase-1 would have around 375 subjects across the country and Phase-II 875.

NIMS is one of the hospitals selected by the ICMR to undertake clinical trials of Covaxin, which it is developing in partnership with Hyderabad-based Bharat Biotech International Limited (BBIL).

Meanwhile, the Ethics Committee at King George Hospital (KGH) in Visakhapatnam will hold a crucial meeting on Tuesday to finalise the preparations for the clinical trials. KGH is also one of the hospitals selected by ICMR for the trials.

In a letter to the heads of the selected institutions last week, ICMR Director General Balram Bhargava asked them to fast-track all approvals related to initiation of the clinical trials and ensure that the subject enrollment is initiated no later than July 7.

“It is envisaged to launch the vaccine for public health use latest by August 15, 2020 after completion of all clinical trials. BBIL is working expeditiously to meet the target; however, the final outcome will depend on the cooperation of all clinical trial sites involved in this project,” reads the letter dated July 2.

He noted that this is the first indigenous vaccine being developed by India and is one of the top priority projects that is being monitored at the topmost level of the government.

“The vaccine is being derived from a strain of SARS-CoV-2 isolated by ICMR-National Institute of Virology, Pune. ICMR and BBIL are jointly working for the preclinical as well as clinical development of this vaccine,” he wrote.

While experts raised doubts on the August 15 target, the ICMR defended it, saying its process is in accordance with the globally accepted norms to fast-track vaccine development for diseases of pandemic potential.

The research body said the Director’s letter was intended to cut red tape, without bypassing any necessary process, and speed up recruitment of participants for human trials so that these phases can be completed at the earliest.

BBIL refused to comment on ICMR’s August 15 deadline.

The company had announced on June 29 that it had successfully developed Covaxin, India’s first vaccine candidate for COVID-19, in collaboration with the ICMR and NIV.

The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech. The indigenous, inactivated vaccine has been developed and manufactured in Bharat Biotech’s BSL-3(Bio-Safety Level 3) High Containment Facility located in Genome Valley, Hyderabad, the company said.

The Drug Controller General of India – Central Drugs Standard Control Organization (CDSCO), Ministry of Health & Family Welfare granted permission to initiate Phase I and II human clinical trials after the company submitted results generated from preclinical studies, demonstrating safety and immune response.

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52000 new Covid cases, 803 deaths in India in 24 hours

India has one of the lowest Case Fatality Rate (CFR) at 2.09 per cent as compared to the global average.

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New Delhi: With 52,050 new coronavirus (Covid-19) cases and 803 deaths in the last 24 hours, India’s overall caseload stood at 18,55,745 while the total fatalities increased to 38,938, data from the Ministry of Health and Family Welfare revealed on Tuesday.

The country had crossed the 18-lakh mark on Monday. Currently, 5,86,298 cases are active and 12,30,509 people have recovered from the disease.

India has one of the lowest Case Fatality Rate (CFR) at 2.09 per cent as compared to the global average.

With a recovery rate of 66.3 per cent, a total of 44,306 people were discharged in the last 24 hours, the Ministry said. In the last 24 hours, 6,61,892 samples have been tested.

Maharashtra remained the worst-hit state with 4,41,228 cases and 15,576 deaths, of which 260 occurred in the last 24 hours.

Tamil Nadu comes in second with 257,613 cases and 4,132 deaths. The state registered 98 fatalities in the last 24 hours.

Delhi, Haryana and Himachal Pradesh saw a decline in the number of active cases.

Mizoram, Tripura and Uttarakhand too witnessed active cases plummeting.

While on the global front, India remains the third worst-hit nation. As of Tuesday morning, the overall number of global coronavirus cases has topped 18.1 million mark, while the deaths have increased to over 691,000, according to the Johns Hopkins University.

As of Tuesday morning, the total number of cases stood at 18,193,291 and the fatalities rose to 6,91,642, the University’s Center for Systems Science and Engineering (CSSE) revealed in its latest update.

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COVID-19 pandemic “once in a century”, but still “in our hands”: WHO

“I’m not saying there is no solution now. Whatever happens in the next few months or years, I also believe that it’s in our hands,” he said.

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Tedros Adhanom Ghebreyesus WHO

Geneva, Aug 4 : The chief of the World Health Organization (WHO) said that the COVID-19 pandemic is “a once-in-a-century health crisis,” but it is still “in our hands.”

WHO Director-General Tedros Adhanom Ghebreyesus said at a virtual press conference on Monday that the world has never seen anything like this pandemic for decades, and its effects might last for decades more, Xinhua news agency reported.

“Since we started probably recording, this is the first ever coronavirus-caused pandemic which has two dangerous combinations: it moves fast, and at the same time it’s a killer,” the WHO chief explained.

However, he noted, although the crisis is very severe, there are still solutions and hopes.

“I’m not saying there is no solution now. Whatever happens in the next few months or years, I also believe that it’s in our hands,” he said.

“Since the outbreak started, many countries have shown that it can be controlled, or serious transmission can be suppressed,” Tedros said, adding that he has mentioned many such countries in the past, including Spain, Italy, China and South Korea.

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One person is dying of COVID-19 every seven minutes in Iran: state TV

The report said that Iran’s official coronavirus figures were based only on the number of deaths in hospitals and those who had already tested positive for the coronavirus.

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Iran Covid Case

DUBAI : One person is dying from COVID-19 every seven minutes in Iran, state television said on Monday, as the Health Ministry reported 215 new deaths from the disease and state media warned of a lack of proper social distancing.

Health Ministry spokesman Sima Sadat Lari was quoted by the state TV as saying the 215 deaths in the past 24 hours took the combined death toll to 17,405 in Iran, and the number of confirmed cases rose by 2,598 to 312,035.

State television showed several Iranians in a busy Tehran street without wearing face masks or social distancing.

Some experts have doubted the accuracy of Iran’s official coronavirus tolls. A report by the Iranian parliament’s research centre in April suggested that the coronavirus tolls might be almost twice as many as those announced by the health ministry.

The report said that Iran’s official coronavirus figures were based only on the number of deaths in hospitals and those who had already tested positive for the coronavirus.

British broadcaster BBC reported on Monday that, based on data from an anonymous source, the number of deaths in Iran might be three times higher than officially reported. Iranian health authorities denied the report and said there had been no covebakingr-up.

With COVID-19 deaths surging since restrictions were eased in mid-April, Iranian authorities have said measures to curb the spread of COVID-19 will be reimposed if health regulations are not observed. Since last month, wearing face masks in public places and covered spaces has been mandatory.

Iran’s National Coronavirus Combat Taskforce was expected to announce later on Monday whether nationwide university entrance examinations, with over 1 million participants, will take place in August. Many Iranians have called on social media for the examinations to be postponed.

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