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HIGHLIGHTS: Will resume Covid-19 vaccine trials after DCGI nod, says Serum Institute

As many as 1,201 deaths reported in India during last 24 hours period pushed the death toll to 77,472. At present, the country has 9,58,316 active cases and 36,24,197 people who have been treated and discharged.

By: Express Web Desk | New Delhi | Updated: September 13, 2020 9:18:00 am
The late-stage trials of the vaccine were suspended this week following an adverse reaction in a volunteer in UK. (Photo: REUTERS)

The Serum Institute of India (SII) Saturday said that phase 2 and 3 clinical trials of the Oxford-AstraZeneca COVID-19 vaccine candidate will resume after receiving a green signal from the Drugs Controller General of India (DCGI). Earlier in the day, AstraZeneca said it had resumed the clinical trials of the vaccine following confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so, the firm said on Saturday.

The late-stage trials of the vaccine were suspended this week following an adverse reaction in a volunteer in UK. Following this, Serum Institute of India (SII) too had paused the ongoing clinical trials of the vaccine candidate in India.

Cautioning people against lowering their guard till an effective anti-coronavirus medicine is developed, Prime Minister Narendra Modi on Saturday came up with a slogan in Hindi to drive home his point. He said, ‘Jab tak dawai nahi, tab tak dhilai nahi’ (No carelessness till a medicine is found).

India reported nearly 1 lakh (97,570) coronavirus cases in the last 24 hours ending 8 am on Saturday. With this, the total tally went past the 46 lakh-mark to reach 46,59,985. Also, as many as 1,201 deaths reported during the same period pushed the death toll to 77,472. At present, the country has 9,58,316 active cases and 36,24,197 people who have been treated and discharged.

Globally, over 28 million have been affected while 915,356 have succumbed to the virus so far and as many as 19,215,800 have recovered. The United States continued to remain the worst-affected, followed by India and Brazil.

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Delhi Metro resumes full services from today, nearly 47 lakh cases in India. Read highlights

22:15 (IST)12 Sep 2020
Will resume Covid-19 vaccine trials after DCGI nod, says Serum Institute

The Serum Institute of India (SII) Saturday said that phase 2 and 3 clinical trials of the Oxford-AstraZeneca COVID-19 vaccine candidate will resume after receiving a green signal from the Drugs Controller General of India (DCGI). Earlier in the day, AstraZeneca said it had resumed the clinical trials of the vaccine following confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so, the firm said on Saturday.

21:41 (IST)12 Sep 2020
Modi govt’s ‘well planned fight’ against Covid has put India in ‘abyss of historic GDP reduction’: Rahul Gandhi

Taking a swipe at the Centre, Congress leader Rahul Gandhi Saturday said its “well planned fight” against the contagious virus has put India in an “abyss” of GDP reduction of 24 per cent, 12 crore job losses, 15.5 lakh crore additional stressed loans and world’s highest daily Covid cases and deaths.

Taking to Twitter, Gandhi wrote: “Modi Govt’s ‘well-planned fight’ against Covid has put India in an abyss of: 1. Historic GDP reduction of 24% 2. 12 crore jobs lost 3. 15.5 lac crores additional stressed loans 4. Globally highest daily Covid cases & deaths. But for the government of India and the media “sab changa si (all is well).” Read more here

20:07 (IST)12 Sep 2020
Oxford’s Covid vaccine trials resume after UK panel deems them safe

British clinical trials for the AstraZeneca-Oxford University Covid-19 vaccine have resumed following confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so, the firm said on Saturday. The late-stage trials of the vaccine were suspended this week following an adverse reaction in a volunteer in UK. Following this, Serum Institute of India (SII) too had paused the ongoing clinical trials of the vaccine candidate in India.

19:25 (IST)12 Sep 2020
COVID-19: IIM Calcutta teachers concerned over institute allowing students to stay on campus

A section of the teachers at IIM Calcutta has expressed concerns over the institute's decision to allow 62 students of its MBA executive programme to stay on the campus amid the pandemic, PTI reported. Despite staying on the campus, the students will, however, continue attending classes online. The institute authorities have taken the decision in view of the students, whose course had begun in April, and were facing problems to stay in rented accomodations outside the campus. A section of the teachers has recently wrote a letter to the IIM Calcutta board, warning that allowing the students inside the campus may lead to a situation similar to that in IIT Kharagpur, which had to impose lock its campus down after several students and faculty members were infected by the disease.

19:09 (IST)12 Sep 2020
International passengers can opt for COVID-19 test, waiting lounge at Delhi airport for Rs 5,000

Delhi airport on Saturday started its on-arrival COVID-19 testing facility wherein an international passenger can pay Rs 5,000 to avail a RT-PCR test and also use the waiting lounge, said senior officials of its operator DIAL. The Civil Aviation Ministry had on September 2 said that international passengers, who have to take connecting domestic flights after landing in India, will have the option of getting themselves tested for COVID-19 at the entry airports. (PTI)

17:47 (IST)12 Sep 2020
BJP Nalbari MLA Ashok Sarma tests positive for COVID-19

BJP MLA Ashok Sarma and his wife have tested positive for coronavirus, taking the total number of legislators in Assam to have infected by the virus to 26, officials said Saturday. A Health Department official said the BJP legislator from Nalbari constituency and his wife will be admitted to Swahid Mukunda Kakati Civil hospital. (PTI)

17:46 (IST)12 Sep 2020
Baghel asks Centre for over Rs 700 cr for COVID-19 hospitals

In view of the surge in coronavirus cases in Chhattisgarh, Chief Minister Bhupesh Baghel has urged the Centre to sanction funds to the tune of Rs 736.74 crore for Covid-19 hospitals and care centres in the state, PTI reported said Saturday. In a letter to Union Health minister Dr Harsh Vardhan, Baghel also sought to increase the capacity of ICU beds at All India Institute of Medical Sciences (AIIMS) in Raipur, the official from the public relations department. "Chhattisgarh has 29 dedicated COVID-19 hospitals and 221 care centres, which have the capacity of 29,111 beds, of which 406 are ICU and 370 are high dependency units (HDU) beds," PTI quoted the chief minister as saying in the letter. 

15:14 (IST)12 Sep 2020
Two more COVID-19 patients die in Ladakh, toll now 38

Two more coronavirus positive elderly persons succumbed to the infection in Ladakh, bringing the number of deaths linked to the disease to 38 in the Union Territory, officials said on Saturday. Both the deaths were reported from Leh district on Friday, the officials said. The deceased, aged 98 and 82, had tested positive for COVID-19 a few days back, they said. The officials said the two were also suffering from other ailments and age-related issues. (PTI)

14:37 (IST)12 Sep 2020
Delhi HC reduces number of benches holding physical hearings as COVID-19 cases rise in Delhi

The Delhi High Court on Saturday said it has reduced the number of benches that would be holding physical hearings due to the "alarming" rise in COVID-19 cases in the national capital and majority of lawyers preferring virtual hearings. According to a note issued by the office of Registrar General Manoj Jain, a full court of the judges of the Delhi High Court deliberated on continuing with physical hearings, which were started from September 1, and decided not to discontinue them completely.

The full court decided that physical hearings would be conducted each day, from September 15 onwards, by one division bench and two single judge benches on rotation. Till now, two division benches and three single judge benches were holding physical courts on rotational basis.

13:57 (IST)12 Sep 2020
Recoveries surge to 36,24,196, 60 per cent of total recoveries concentrated in 5 states

With a record 81,533 people recuperating from COVID-19 in a day, India's total recoveries on Saturday surged to 36,24,196 of which 60 per cent of the cases are from five states, including Maharashtra, Andhra Pradesh and Karnataka. India's COVID-19 case fatality rate has further dropped to 1.66 per cent while the recovery rate has risen to 77.77 per cent, according to the Union Health Ministry.

Sixty per cent of the total recovered cases are being reported from five states - Maharashtra, Tamil Nadu, Andhra Pradesh, Karnataka and Uttar Pradesh, the ministry said on Saturday.

Maharashtra has alone contributed more than 14,000 and Karnataka has contributed over 12,000 to the new single-day recoveries, it highlighted. Also, 60 per cent of the total cases are reported from only five states - Maharashtra, Tamil Nadu, Andhra Pradesh, Karnataka and Uttar Pradesh.

13:55 (IST)12 Sep 2020
We need to strengthen poor to end poverty: PM Modi

Prime Minister Narendra Modi on Saturday called for strengthening the poor in order to remove poverty. He said the Pradhan Mantri Awas Yojana (PMAY) is aimed at empowering the poor.

Modi was speaking at the virtual housewarming ceremony of 1.75 houses built in rural parts of Madhya Pradesh under the PMAY. "To remove poverty, we have to strengthen the poor and this scheme is aimed at empowering them only," he said. Modi also interacted with some of the beneficiaries of the project.

13:55 (IST)12 Sep 2020
Prone position may saves severe COVID-19 patients, but can damage limb nerves, scientists say

While a prone position may ease breathing in severely ill COVID-19 patients on ventilators, scientists say this life-saving, face-down posture can also cause permanent nerve damage in these vulnerable individuals. According to the researchers, including those from Northwestern University Feinberg School of Medicine in the US, the nerve damage is a result of reduced blood flow and inflammation, which other non-COVID-19 patients on ventilators in this position rarely experience. Based on the study, accepted for publication in the British Journal of Anaesthesia, the scientists said this type of injury has been missed because critically ill people are expected to wake up with some generalised weakness when they have been bedridden.

13:54 (IST)12 Sep 2020
Dabbawalas urge Maha govt to permit them local train travel

Mumbai's dabbawalas or lunch-box carriers have urged the Maharashtra government to permit them to travel in local trains, which are currently running in a restricted manner in light of the COVID-19 outbreak, an official said on Saturday. Access to local trains will enable dabbawalas to resume their business with full capacity, said Subhash Talekar, president of Mumbai Dabbawala Association.

At present, only people employed in essential services are allowed to travel in suburban trains. "Dabbawalas are also part of essential services are they deliver food to Mumbaikars. And since most officers are now functioning with reduced capacity, people have been asking us to deliver their meals," Talekar said.

13:52 (IST)12 Sep 2020
Covaxin animal trials generated ‘robust immune response’: Bharat Biotech
Bharat Biotech kicked off the human trials for its Covid-19 vaccine candidate Covaxin in mid-July.

Telangana-based Bharat Biotech India (BBL) Friday said animal trials of Covaxin, its Covid-19 vaccine candidate, were successful. In a press release, the company said Covaxin generated “robust immune responses”.

“The vaccine candidate was found to generate robust immune responses. Thus, preventing infection and disease in the primates upon high amounts of exposure to live SARS-CoV-2 virus,” the company stated, adding that the results “demonstrate the protective efficacy in a live viral challenge model”.

Bharat Biotech had tested its vaccine candidate on four groups of 20 rhesus macaques. The primates were administered a “two-dose vaccination regimen of inactivated SARS-CoV-2 vaccine”.

13:29 (IST)12 Sep 2020
No carelessness till medicine is developed, says PM Modi on COVID-19

Cautioning people against lowering their guard till an effective anti-coronavirus medicine is developed, Prime Minister Narendra Modi on Saturday came up with a slogan in Hindi to drive home his point. He said, 'Jab tak dawai nahi, tab tak dhilai nahi' (No carelessness till a medicine is found).

Modi gave this slogan while addressing the virtual housewarming ceremony of 1.75 lakh houses built in rural parts of Madhya Pradesh under the Pradhan Mantri Awas Yojana (PMAY). "Jab tak dawai nahi, tab tak dhilai nahi. Do gaj ki doori, mask hai jaroori (Face mask and maintainting distance of two yards is necessary)," he said.

12:15 (IST)12 Sep 2020
With almost 25,000 news Covid-19 cases, Maharashtra crosses one million-mark
India’s daily Covid-19 count since mid-August

Meanwhile, the number of confirmed infections in Maharashtra crossed the one million (10-lakh) mark on Friday, with the addition of almost 25,000 new cases. The state has almost the double number of confirmed infections compared to Andhra Pradesh, which has the second highest caseload in the country. Maharashtra also has also recorded the highest number of deaths, more than 29,000, which is close to 40 per cent of all coronavirus-related deaths in the country.

Uttar Pradesh recorded its highest single day rise on Friday, with more than 7,000 new infections getting detected. The confirmed infections are now just a shade below 3 lakh, a figure which most certainly would be crossed on Saturday.

On Friday, more than 97,500 new cases were detected across the country, taking the total number of confirmed infections to 46.59 lakh, of which more than 36.24 lakh, or about 78 per cent have recovered from the disease. The number of active cases is now 9.58 lakh.

12:13 (IST)12 Sep 2020
India coronavirus numbers explained: Kerala is 13th state to cross one lakh mark
Kerala’s Covid-19 graph

Kerala, the first state in the country to have been affected by the novel coronavirus epidemic, now has over one lakh people who have been infectedwith the disease. Close to 3,000 new cases were detected in Kerala on Friday, which took the total confirmed infections past the one lakh mark, the 13th state in the country to have crossed that figure.

At one point, Kerala was seen to have brought the epidemic under control. After recording the first 500 cases by the end of April, the state had been reporting news cases in no more than single digits, on some days not at all. By that time, Maharashtra had started discovering more than 1,000 cases a day. States like Delhi, Tamil Nadu and Gujarat were finding several hundred cases every day. The state was hailed as a model in effective containment.

11:08 (IST)12 Sep 2020
PM Modi to inaugurate 1.75 lakh homes built under PM Awas Yojana in MP today

Prime Minister Narendra Modi takes part in a programme - ‘Grih Pravesh’ organised under Pradhan Mantri Awaas Yojana (Gramin) in Madhya Pradesh, through video conference. Madhya Pradesh CM Shivraj Singh Chouhan also participates in the event.

11:02 (IST)12 Sep 2020
Covid-19 vaccine, explained: A deep dive into 4 key things you must know
The Oxford University vaccine candidate being administered to a volunteer at Bharati Vidyapeeth's Bharati Hospital and Research Centre, Pune, during the Phase 2 trials. (Express Photo by Arul Horizon)

Safety and efficacy are the two words used to describe the requirements for any new therapy, including vaccines. This article details the specific metrics behind these generic descriptors that a Covid-19 vaccine will have to satisfy.

The other questions tackled are: When will a vaccine be available? Is the vaccine being fast-tracked, and, therefore, unsafe? Can we trust the vaccine when it is approved? As much as we all would like the comfort of certainty, all of these questions have answers with caveats. Some reasons for the ambiguity are articulated here.

10:46 (IST)12 Sep 2020
Oxford vaccine trials paused: Why this may not be a serious blow
A employee is seen at the Reference Center for Special Immunobiologicals (CRIE) of the Federal University of Sao Paulo (Unifesp) where the trials of the Oxford/AstraZeneca coronavirus vaccine were being conducted, in Sao Paulo, Brazil. (Photo: REUTERS/File)

Serum Institute of India (SII) said on Thursday (September 10) that it would pause the ongoing clinical trials in India of the Covid-19 vaccine candidate developed by the University of Oxford. The move follows a show-cause notice issued by the drug regulator to the Pune firm over a single adverse reaction that was detected at one of the global trial sites.

SII is sponsoring mid- and late-stage human clinical trials for the vaccine candidate in India. The firm, the world’s largest vaccine manufacturer, has been contracted by the Swedish-British pharma giant AstraZeneca and the University of Oxford to manufacture the vaccine for low- and middle-income countries. Prabha Raghvan explains why this may not be a serious blow

coronavirus, coronavirus news, coronavirus today news, covid 19 vaccine, coronavirus vaccine, coronavirus india, coronavirus india news, corona cases in india, india news, coronavirus news, covid 19 india, corona news, corona latest news, india coronavirus, coronavirus live news, coronavirus live update, covid 19 tracker, india covid 19 tracker, corona cases in india, corona cases in india A hospital worker pauses next to an ambulance outside of Kingsbrook Jewish Medical Center in Brooklyn, May 11, 2020. (Dave Sanders for The New York Times)

Coronavirus India LIVE updates

Meanwhile, with the reopening of service on the Airport Express Line, the Delhi Metro resumed its full services from Saturday. Now the metro trains will run from 6 am to 11 PM on all lines, the Delhi Metro Rail Corporation (DMRC) said.

A study on the first national sero surveillance to estimate the prevalence of the novel coronavirus, conducted in May, shows that as many as 8.56 lakh cases were present in the 233 districts deemed ‘zero-caseload’ at the time — confirming the under-detection of cases in the country.

While an independent group of experts began investigating the severe illness in a participant that led to a halt on clinical trials of AstraZeneca’s coronavirus vaccine, the World Health Organisation said there was nothing to be discouraged about, since these kinds of incidents routinely happen during trials.

Meanwhile, the India trials of the vaccine, being carried out by Pune-based Serum Institute of India, have also been halted. Serum had, on Wednesday, claimed that the India trials would remain unaffected by AstraZeneca’s decision. However, it was issued a show-cause notice by the officer of the Drug Controller General of India, and on Thursday, Serum said it was putting a hold on India trials. Till now, 100 participants have been given the vaccine in India where combined phase-2 and phase-3 trials were approved last month. About 1,600 participants were planned to be enrolled for the complete trial.

In Geneva, WHO chief scientist Soumya Swaminathan said the AstraZeneca pause was not a setback, and nothing to be discouraged about. She said the incident just demonstrated that the process of vaccine development was not always a “fast and straight road”.

“I think this is good… perhaps a wake-up call or lesson for everyone to recognise that there are ups and downs in research, there are ups and downs in clinical development, and that we have to be prepared for those,” Swaminathan said.

“We need not be discouraged. Such things happen,” she said.

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