NIMS to begin human trials of Covid-19 vaccine soon

NIMS to begin human trials of Covid-19 vaccine soon

Sribala.Vadlapatla@timesgroup.com

Hyderabad:  04.06.2020

The Nizam’s Institute of Medical Sciences (NIMS) in Hyderabad is among 12 other centres across the country to begin human trials for a coronavirus vaccine soon.

The vaccine trial proposal was placed before the ethics committee on Friday at NIMS after the Indian Council of Medical Research (ICMR) added the hospital cum-research-facility to the list of centres.

“Any such trial needs permission from the hospital's ethics committee, and as a first step, we did that and expecting the nod in a day or two, before we start the trials,” a top official from the health department told TOI.

The vaccine to be developed by Bharat Biotech will be applied intravenously to volunteers. The vaccine trial will continue for six months and only healthy people in the age group between 22-50 years will be selected for human trials, irrespective of gender.

Institutes with clinical pharmacology wings and experience of handling similar human trials, have been selected for the human trials.

NIMS in the last 12 years has the experience of conducting about a dozen human trials, including that of the successful meningococcal vaccine.

“There are only six or seven very experienced institutes in the entire country having done phase 1 clinical trials,” said a doctor at Nizam’s Institute of Medical Sciences.

Nizam’s Institute of Medical Sciences is among 12 other centres from across the country to begin human trials for a coronavirus vaccine soon

Govt bungles, doctor gets tsunami of calls

Govt bungles, doctor gets tsunami of calls

Manuja.Veerappa@timesgroup.com

04.06.2020

Bengaluru: At 7.30am on Thursday, Dr Ashwin S answered a call on his cellphone. It was the beginning of a nightmare for the non-invasive cardiologist as his phone kept buzzing, virtually non-stop, through the day.

About 50 calls were from relatives of Covid-19 patients, pleading for a bed in the ‘hospital’ in which he ‘works’. The callers believed he worked at Shekhar Hospital on Bull Temple Road, Bengaluru, but Ashwin was helpless since he isn’t an employee there. The barrage of calls was a courtesy of the state government’s bungling.

The genesis of Ashwin’s woes lay in a public notice issued by the department of health and family welfare, listing 73 private hospitals in the city where 50% of beds were reserved for Covid patients. Besides names and addresses of the hospitals, the notice also listed a contact person and his/her phone number for each hospital, besides nodal officials from Bescom and BBMP. The contact for Shekhar Hospital was listed as one Dr Ashwini S, but the number was Ashwin’s. Neither Ashwin nor Shekhar Hospital knows how the number made it to the list.

“I’ve been getting calls for the past couple of days,” the doctor said. “When asked where they got my number from, all callers have a common answer: A WhatsApp forward. I haven’t had much sleep because people are calling at odd hours. These are distress calls so you have to answer them. But it is taking a toll on me mentally. We are frontline workers in very trying circumstances so it’s not easy to deal with a situation like this.”

It only got worse the health department’s list was published in several dailies on Friday. “I can’t switch off my phone because I have to attend to the needs of my patients. I think it is a prank which is in very bad taste because it is a question of life and death. I have been texting the number of Shekhar Hospital to callers,” said Ashwin. Shekhar Hospital said it was unaware a wrong contact number was published until Ashwin brought it to their notice.

“Dr Ashwin worked with us in the past, but we don’t know how his number has been listed as our hospital contact,” said Dr Kaushik Aithal from Shekhar Hospital. “We were not asked for any contact number. We have written to the district health office (DHO), Bengaluru Urban, demanding the number be changed.”

The hospital, in the letter to DHO, has listed the contact number as: 9482676525.

The contact for Shekhar Hospital was listed as one Dr Ashwini S, but the number was Ashwin’s. Neither Ashwin nor Shekhar Hospital is aware how the number made it to the government list.

ICMR’s Aug 15 deadline to vaccine maker stirs a row

ICMR’s Aug 15 deadline to vaccine maker stirs a row

Council: Only Meant To Speed Up Process

Sushmi.Dey@timesgroup.com

New Delhi:  04.06.2020

An Indian Council of Medical Research letter which sought fast-tracking of approvals relating to clinical trials and spoke of the launch of a vaccine by August 15 stirred the medical and scientific community on Friday, with questions being asked on how such deadlines could be adhered to given the complexity and time required for trials on humans.

A vaccine candidate by Bharat Biotech received approval to enter initial phases of human clinical trials only earlier this week. In a letter to Bharat Biotech and chosen hospitals for trials, ICMR director general Balram Bhargava advised “to fast-track all approvals related to initiation of the clinical trial and ensure that the subject enrolment is initiated no later than July 7” in view of the public health emergency and “urgency to launch the vaccine”.

Belagavi hospital set for ‘mission Aug’

Jeevan Rekha Hospital in Belagavi is among 12 institutions selected by ICMR to fasttrack clinical trial approvals for indigenous Covid-19 vaccine candidate — Covaxin — reports Shreyas HS.

Hospital director Amith S Bhate said he was informed two days ago. “We are ready to complete the mission by August,” he said, adding that confirmation from the state government is awaited. P 2

‘Vaccine timeline unrealistic’

ICMR has partnered with Bharat Biotech to develop a vaccine called Covaxin.

Official sources said the health ministry had asked ICMR about the letter and was informed that the objective was to speed up the processes relating to vaccine development rather than set any hard deadlines.

"We need the vaccine at the earliest and that was what ICMR wanted to convey," a source said. ICMR officials also told TOI that no deadlines were being set.

However, the tone of the letter, suggesting that noncompliance will be treated seriously, generated concern over whether processes were being rushed. "It is envisaged to launch the vaccine for public health use latest by August 15 after completion of all clinical trials. BBIL is working expeditiously to meet the target, however final outcome will depend on the cooperation of all clinical trial sites involved in this project," Bhargava said in the letter dated July 2.

The content of the letter mainly suggested a timeline and the accent was to stick to it, but some experts called it "unrealistic" and even "unethical". Health experts also raised concerns about ICMR’s role as a co-creator of the vaccine and also attributing timelines resulting in a "conflict of interest".

Zydus vaccine gets DCGI nod for trials

Ahmedabad: Pharmaceutical and healthcare major Zydus Cadila has received approval from the Drug Controller General of India (DCGI) and Central Drugs Standard Control Organisation (CDSCO) to start Phase I and II human clinical trials in India of its vaccine candidate for Covid-19. Called ZyCoV-D, it is a plasmid DNA vaccine candidate for Covid-19. Zydus Cadila is the second company, after Bharat Biotech, to have received regulatory permission to conduct human clinical trials for a potential Covid-19 vaccine. TNN

Nearly 66% of Indians are of working age

Nearly 66% of Indians are of working age

TIMES NEWS NETWORK  04.06.2020

India’s much-discussed “demographic dividend” continues to swell, with the share of working-age population in the country’s total population increasing, data from the recently released Sample Registration System’s 2018 report shows. This is true not just nationally but across all major states.

The SRS report, an annual publication from the office of the census commissioner and registrar general, estimates that in 2018, nearly two-thirds of the population, or 66%, was between the ages of 15 and 59. This proportion has inched up each year, an analysis of reports from 2013 onwards shows.

Those of working age constituted over two-thirds of the population in 12 of the 22 major states in 2018 while five years earlier, this was true in only four of the current states. Two states — Andhra Pradesh and Telangana — had over 70% of their populations in the working age bracket and Bihar remained the lone state in which those aged 15 to 59 were less than 60% of the total.

In general, states widely considered less developed had a lower proportion of their population in the working-age groups. This is because most of these states have also had relatively high fertility rates and hence a relatively larger base of the really young.

Among the states with high development indicators, Kerala stands out as an exception with its working-age population being of a similar proportion as in states like Assam and Odisha. The difference however is that in Kerala’s case, this is due to a relatively larger proportion of the elderly thanks to decades of low fertility and high life expectancy.

Another broad trend that emerges from the data is that states that already have higher proportions of workingage populations have seen that share grow faster than the others. Thus, those that started off with a better "demographic dividend" five years ago now have even more of it.

Experts have pointed out that this dividend, which comes from the number of dependants on each working person being low, will not last for ever with the population steadily aging. It has also been argued that if those of working age are not provided skills and jobs, the dividend could prove to be a curse rather than a blessing.

Zydus’ vaccine gets DCGI nod for human trials

DNA PLATFORM

Zydus’ vaccine gets DCGI nod for human trials

Pharma Major To Ramp Up Production

TIMES NEWS NETWORK

Ahmedabad:  04.06.2020

Pharmaceuticals and healthcare major Zydus Cadila has received regulatory nod to start phase I and II human clinical trials in India of its vaccine candidate for Covid-19. Called ZyCoV-D, it is a plasmid DNA vaccine in trial stage. The approval has been issued by Drug Controller General of India (DCGI) - Central Drugs Standard Control Organisation (CDSCO.

Zydus Cadila has become the second company after Bharat Biotech to have received the approval to conduct human clinical trials for the potential Covid-19 vaccine.

“The company’s vaccine has successfully completed preclinical phase and has now received the permission to initiate phase I/II human clinical trials in India,” Zydus Cadila said in a statement on Friday.

The company’s vaccine candidate has been indigenously developed at its Vaccine Technology Centre in Ahmedabad.

Pankaj Patel-promoted Zydus Cadila has already manufactured clinical GMP batches of the vaccine candidate and plans to initiate the clinical trials in July 2020 across multiple sites in India in over 1,000 subjects.

“In animal studies, the vaccine was found to elicit a strong immune response in species like mice, rats, guinea pigs and rabbits. No safety concerns were observed for the vaccine candidate in repeat dose toxicology studies by both intramuscular and intradermal routes of administration,” added the company.

With ZyCoV-D, Zydus has successfully established the DNA vaccine platform, which can also be rapidly used to modify the vaccine in couple of weeks in case the virus mutates to ensure that the vaccine still elicits protection.

Int’l flights suspended till July 31

Int’l flights suspended till July 31

New Delhi:  04.06.2020

Schedule international passenger flights will now remain suspended till the month-end, except for those allowed by the government on a caseto-case basis.

These flights were suspended on March 22 this year and the DGCA had recently said they would remain suspended till July 15. On Friday, the DGCA issued a circular extending the suspension till 11.59 pm on July 31.

“…Scheduled international commercial passenger services to/from India (shall remain suspended) till 11.59 pm of July 31. This restriction shall not apply to international all-cargo operations and flights specifically approved by DGCA. However, international scheduled flights may be allowed on selected routes on a case to case basis,” says a DGCA circular issued Friday. TNN

Sonia pushes for OBC quota in med colleges

Sonia pushes for OBC quota in med colleges

TIMES NEWS NETWORK

New Delhi:  04.06.2020

Congress party President Sonia Gandhi has asked the Centre to extend reservation for OBCs under All India Quota (AIQ) of medical and dental seats in colleges run by states and UTs, saying its denial does injustice to the Mandal classes.

In aletter to PM Modi, Sonia Gandhi wrote, “Reservation for OBC candidates under AIQ is restricted to central Institutions. As per the data compiled by the All India Federation of Other Backward Classes, since 2017, OBC candidates lost over 11,000 seats, in AIQ, due to non-implementation of OBC reservations in State/UT medical education institutions.”

By seeking the extension of AIQ in NEET to state institutions, Sonia Gandhi has waded into an ongoing controversy which is playing out on different turfs. While a petition is pending in the Supreme Court, the National Commission for Backward Classes too has taken cognisance of the issue.

“In the interest of equity and social justice, I strongly urge the Government to extend reservation for OBC candidates in AIQ of medical and dental seats, even in the State/ UT Medical education institutions,” she urged.

Full report on www.toi.in