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PGI-Chandigarh among 17 trial sites for Oxford vaccine Covishield

The permission was granted after the Serum institute satisfied certain requirements sought by the Drug Controller in the design of the proposal.

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Covid 19 Vaccine

Chandigarh, Aug 4 : The PGI Hospital here is among the 17 trial sites in India for conducting the second and third phases of human clinical trials of Covishield, the potential vaccine developed by Oxford University, its director said on Tuesday.

The trials would involve administration of the vaccine to 1,600 healthy adults across 17 sites.

Postgraduate Institute of Medical Education and Research (PGIMER) Director Jagat Ram said, “It’s an honour to be entrusted with this vital responsibility of being one of the sites for phase two and three trials on Covishield vaccine.

“The results of phase one trials in the UK have been encouraging and did not present any serious adverse side effects. Phase two and three trials will be done on a larger human population to see its efficacy and requisite protection against COVID-19 in humans.”

Further detailing, the Director added, “As the results of the trials will have far reaching impact, we will strengthen our capacities, wherever required, to come out with tangible outcomes.

“A core group will be constituted to work out the modalities and comprehensive plan along with timelines to meet the desired expectations of Drugs Controller General of India and contribute towards containing the pandemic to the best of our abilities.”

Earlier, a committee of experts on COVID-19 under Central Drugs Standard Control Organisation (CDSCO) had recommended the Drugs Controller General of India (DCGI) to grant approval to the Serum Institute of India (SII) for conducting the Phase two and three trials.

The permission was granted after the Serum institute satisfied certain requirements sought by the Drug Controller in the design of the proposal.

In addition to PGIMER Chandigarh, the other sites for trials include AIIMS in Delhi, ABJ Medical College in Pune, Rajendra Memorial Research Institute of Medical Sciences (RMRIMS) in Patna, AIIMS in Jodhpur, Nehru Hospital in Gorakhpur, Andhra Medical College in Visakhapatnam and JSS Academy of Higher Education and Research in Mysuru.

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Moderna COVID-19 vaccine appears safe, shows signs of working in older adults – study

Moderna is already testing the higher dose in a large Phase III trial, the final stage before seeking emergency authorization or approval.

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COVID-19 Vaccine

Results from an early safety study of Moderna Inc’s MRNA.O coronavirus vaccine candidate in older adults showed that it produced virus-neutralizing antibodies at levels similar to those seen in younger adults, with side effects roughly on par with high-dose flu shots, researchers said on Tuesday.

The study, published in the New England Journal of Medicine, offers a more complete picture of the vaccine’s safety in older adults, a group at increased risk of severe complications from COVID-19.

The findings are reassuring because immunity tends to weaken with age, Dr. Evan Anderson, one of the study’s lead researchers from Emory University in Atlanta, said in a phone interview.

The study was an extension of Moderna’s Phase I safety trial, first conducted in individuals aged 18-55. It tested two doses of Moderna’s vaccine – 25 micrograms and 100 micrograms – in 40 adults aged 56 to 70 and 71 and older.

Overall, the team found that in older adults who received two injections of the 100 microgram dose 28 days apart, the vaccine produced immune responses roughly in line with those seen in younger adults.

Moderna is already testing the higher dose in a large Phase III trial, the final stage before seeking emergency authorization or approval.

Side effects, which included headache, fatigue, body aches, chills and injection site pain, were deemed mainly mild to moderate.

In at least two cases, however, volunteers had severe reactions.

One developed a grade three fever, which is classified as 102.2 degrees Fahrenheit (39°C) or above, after receiving the lower vaccine dose. Another developed fatigue so severe it temporarily prevented daily activities, Anderson said.

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Venkiah Naidu tests Covid-19 positive, in home quarantine

Vice President Venkaiah Naidu, 71, announced on Tuesday evening that he has been tested positive for coronavirus. He told HT that he is doing fine and the initial tests show no major complications.

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Rajya Sabha VP Naidu

Vice President Venkaiah Naidu, 71, announced on Tuesday evening that he has been tested positive for coronavirus.

In fact, Naidu addressed an annual healthcare virtual conference on ‘Post-COVID Healthcare World’ on Tuesday evening. Within minutes after he finished addressing the Covid programme, Naidu was informed about his Covid test results. According to officials, the vice president promptly undertook additional tests.

“The Vice President of India who underwent a routine Covid-19 test today morning has been tested positive. He is however, asymptomatic and in good health. He has been advised home quarantine. His wife Smt. Usha Naidu has been tested negative and is in self-isolation,” the vice president secretariat tweeted.

The Vice President is the top Indian functionary to be tested positive for covid so far. He had frequently chaired the recently concluded monsoon session of Parliament that ran for ten days before getting adjourned on September 23 amid Covid concerns.

During the session, two union ministers – Nitin Gadkari and Prahlad Patel – and at least 30 MPs tested positive for Covid-19, prompting the authorities to cut short the session.

Naidu’s aides maintained his initial report shows that lung has not been affected and that he has no visible complication.

Addressing the healthcare conference on Tuesday, Naidu had called upon people to adapt to the new normal amid pandemic and take maximum precautions and condemned the instances of stigma and discrimination against frontline warriors and Covid-19 patients.

Calling upon people to adapt to the culture of the new normal and take all the prescribed precautions seriously to fight Covid-19 pandemic, he said that it was highly critical for the people to act responsibly and support the multifarious efforts of the government and health professionals to break the transmission of the dreaded virus.

“We simply cannot allow complacency to set in and lower our guard,” he added.

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Delhi hospital doctors halt OPD services to protest assault

The doctors’ associations are furious that the FIR in the case was lodged in the name of an individual rather than the institution, which allegedly goes against the directions of the Delhi and central governments.

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Safdarjung Hospital Delhi

New Delhi, Sep 29 : Barring emergency cases, the Resident Doctors Association (RDA) of Delhi government’s Maharishi Valmiki Hospital on Tuesday announced all essential and non-essential services provided by its members had been withdrawn to protest against an assault on a doctor.

The RDA said it protested the hospital administration’s action not to lodge an institutional FIR against a patient and her attendant for assaulting an on-duty doctor on Saturday.

The RDA formally informed the hospital Medical Superintendent about the protest through a notice.

The notice read: “Since no confirmation has been made till date, we are left with no alternative but to withdraw resident doctors from essential services from 10 a.m. today, for which intimation was given to you on September 26 and again on September 28.”

“We are disheartened by the way this issue is being handled. The doctor concerned is under severe mental stress, and things may worsen for him if he doesn’t get institutional support on priority,” it said.

“Who will be responsible if something goes wrong with the resident doctor? We don’t want the patients to suffer and want to resume duties at the earliest, but not at the cost of threat to our lives, integrity, and respect towards the profession,” the RDA warned.

Meanwhile, RDAs of various government hospitals also expressed their solidarity with the victim doctor. The RDAs of Safdarjung Hospital, Lady Hardinge Medical College, Baba Sahib Ambedkar Medical College and Hospital, and Guru Teg Bahadur Hospital extended support to the protest by the doctors and also the demand to lodge an institutional FIR in the case of assault.

“We condemn the assault, extend our deepest support and stand unanimously and in solidarity with the protesting Resident Doctors Association of Maharishi Valmiki Hospital and demand immediate appropriate action by the authorities against the accused,” the RDAs said.

The doctors’ associations are furious that the FIR in the case was lodged in the name of an individual rather than the institution, which allegedly goes against the directions of the Delhi and central governments.

On Saturday, Dr Rahul Jain was allegedly assaulted by a patient, identified as Priyanka, and her attendant Naresh when the doctor asked them to come by turn in the operation theatre. He had also asked them to wear masks.

Later, Dr Jain lodged an FIR against both at the Bawana police station under Sections 186, 188, 353, 332, 506 and 34 of the IPC and other relevant laws.

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COVID-19 affects different people in different ways. Most infected people will develop mild to moderate illness and recover without hospitalization.