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Coronavirus LIVE Updates: AstraZeneca Pauses Vaccine Trial after Volunteer Develops Illness

News18.com | September 9, 2020, 6:10 PM IST
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Coronavirus LIVE Updates: In disappointing news on the vaccine front, pharmaceutical company AstraZeneca said it had "voluntarily paused" a randomised clinical trial of its coronavirus vaccine in what it called a routine action after a volunteer developed an unexplained illness. The company, which is developing the drug alongside the University of Oxford, is a frontrunner in the global race for a Covid-19 vaccine. "As part of the ongoing randomized, controlled global trials of the Oxford coronavirus vaccine, our standard review process was triggered and we voluntarily paused vaccination to allow review of safety data by an independent committee," a spokesperson said. "This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials."

It added that in large trials, illnesses will sometimes happen by chance but must be reviewed independently. "We are working to expedite the review of the single event to minimise any potential impact on the trial timeline," the spokesperson added. It was not immediately clear where the patient was, or the nature and severity of their illness. Holds during clinical trials are not uncommon, but this is thought to be the first time it has happened for a Covid-19 vaccine trial. AstraZeneca is one of nine companies currently in late-stage Phase 3 trials for their vaccine candidates. In the US, the company began enrolling 30,000 volunteers across dozens of sites on August 31. The vaccine, called AZD1222, uses a weakened version of a common cold causing adenovirus that has been engineered to code for the spike protein that the novel coronavirus uses to invade cells. After vaccination, this protein is produced inside the human body, which primes the immune system to attack the coronavirus if the person is later infected.
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Sep 9, 2020 6:10 pm (IST)

Experts Welcome Order Permitting Tests Without Prescription | Hospitals and private labs welcomed the Delhi High Court's order that doctor's prescription will not be mandatory for COVID-19 testing, saying the new system will make the tests "accessible and affordable" to more people in the city. Until now, it was mandatory for a person to get a doctor's prescription or symptoms to get tested for the virus. 

Sep 9, 2020 5:54 pm (IST)

Financial Situation in Pondy 'Very Critical': CM | Puducherry Chief Minister V Narayanasamy said the fiscal situation of the territorial government was 'very critical' as the flow of revenue had fallen considerably during the ongoing COVID-19 period. He flayed the Centre for being 'irresponsive' to the repeated pleas of his government to sanction funds. Addressing a virtual press conference, he said, "We cannot raise the taxes although we are managing the expenditure from out of the state government's funds and also by utilising the Covid-19 Fund and Disaster Management Fund." The Chief Minister pointed out that Rs 700 crores was due from the Centre for last five months under compensation for implementing the GST here.

Sep 9, 2020 5:39 pm (IST)

The COVID-19 tally in Bihar rises to 1,52,192, including 775 deaths and 1,35,791 recoveries. Active cases stand at 15,625.

Sep 9, 2020 5:30 pm (IST)

6 Members of Great Andamanese Tribe Recover | Tribal Affairs Minister Arjun Munda expressed happiness after six members of the dwindling Great Andamanese tribe, who tested positive for coronavirus, recovered and returned to their island in the Andaman and Nicobar archipelago. "It is indeed my pleasure to inform you that six members of a vulnerable tribal group from Andaman and Nicobar Islands who tested positive and were undergoing treatment, have recovered and returned to their Island. God bless them with many more years of healthy life," he posted on Twitter.

Sep 9, 2020 5:09 pm (IST)

Bangalore Metro Services Commence on 'Green Line' | As part of gradually restoring Metro rail operations, the Bangalore Metro Rail commenced services on another sector--the Green line-- two days after resuming it on another one. However, the services are yet to attract large number of passengers as most have apparently kept away due to Covid-19 apprehensions, according to officials.

Sep 9, 2020 5:03 pm (IST)

Tripura Reports 582 New Cases, 9 Fatalities | As many as 582 more people tested positive for COVID-19 in Tripura today, pushing the state's tally to 16,739. Tripura's coronavirus death toll rose to 161 as nine more people succumbed to the infection.

Sep 9, 2020 4:50 pm (IST)

Prescription Not Needed for Testing: Delhi Govt | "It has been decided that there'll be no requirement of a prescription from a qualified medical practitioner for COVID-19 testing in Delhi. However, tests will be conducted in accordance with advisory issued by ICMR and as per orders issued by Delhi government from time to time," says Delhi government.

Sep 9, 2020 4:14 pm (IST)

UP CM Calls for Increased Contact Tracing | Uttar Pradesh Chief Minister Yogi Adityanath called for increasing contact tracing of coronavirus patients in Lucknow, Kanpur and Allahabad. According to the health department, the state reported 6,743 COVID-19 cases on Tuesday, out of which, 887 cases were found in Lucknow, 431 in Kanpur Nagar, 306 cases in Allahabad, among other places.

Sep 9, 2020 3:57 pm (IST)

Directorate of Agriculture (DoA), J&K teams up with Directorate of Health Services to conduct COVID-19 tests for all govt employees. "Govt of J&K has taken the initiative to get every employee tested for #COVID19 to stop spread of virus," says S Andrabi, Director, DoA.

Sep 9, 2020 3:40 pm (IST)

Covid Testing Crosses 5.18cr, Recoveries Over 33.95k | Over 11.54 lakh COVID-19 tests were conducted in a span of 24 hours taking India's cumulative tests to over5.18 crore so far, while during the same period nearly 75,000 people have recuperated from the disease taking the total number of recoveries to33,98,844 in the country,the Centre said today.

Sep 9, 2020 3:32 pm (IST)

Travel, Tourism Sector Likely to Lose Rs 5 Lakh Crore | The coronavirus pandemic has dealt a crippling blow to the Indian travel and tourism industry and the entire value chain linked to the sector is likely to lose around Rs 5 lakh crore or USD 65.57 billion, according to a study by industry chamber CII and hospitality consulting firm Hotelivate. The organised sector alone is likely to lose USD 25 billion. The figures are quite alarming and the industry needs immediate measures for survival, according to the CII-Hotelivate report.

Sep 9, 2020 3:12 pm (IST)

Kejriwal Holds Meet with Officials Over Covid-19 | Delhi Chief minister Aarvind Kejriwal today held a review meeting with Health Minister, Chief Secretary, senior officials and MS of govt hospitals and directed all MS and authorities to take all possible steps to prevent the spread of Corona and assured the hospitals of full support in this regard. 

Sep 9, 2020 3:08 pm (IST)

SII Says No Issues With Indian Vaccine Trials | Commenting on the recent reports on AstraZeneca halting the trials in the UK, Serum Institute of India told CNN News18, “We can't comment much on the UK trials, but they have been paused for further review and they hope to restart soon. As far as Indian trials are concerned, it is continuing and we have faced no issues at all." 

Sep 9, 2020 3:05 pm (IST)

CanSino Phase 3 Vaccine Trial Expected to Begin in Pak Soon | Falling COVID-19 infection numbers in Pakistan will not affect a Phase 3 clinical trial for a potential vaccine being developed by China's CanSino Biologics, which is expected to begin this month, according to officials running the trial. Pakistan’s drug regulator last month gave the go-ahead for the country’s first Phase 3 clinical trial for CanSino's candidate, Ad5-nCoV, which will be led by the government-run National Institute of Health (NIH) along with pharmaceutical company AJM - the local representative of CanSino.

Sep 9, 2020 3:03 pm (IST)

Haryana Edu Minister Tests Positive | Haryana Education Minister Kanwar Pal said today that he has tested positive for coronavirus. He requested all those who might have come in his contact during the past few days to isolate themselves and get their tests done. "After some symptoms, I got my Covid test done and it returned positive. I request all those who might have come in my contact to isolate themselves and get their tests done, the minister tweeted. The minister's aide said that Kanwar Pal's report came positive in the morning and he was currently in Chandigarh.

Sep 9, 2020 2:36 pm (IST)

WHO Says Vaccine Safety Top Priority as AstraZeneca Pauses Study

WHO officials did not immediately respond directly to questions from Reuters over the move by AstraZeneca to pause global trials, including large late-stage trials.

Sep 9, 2020 2:14 pm (IST)

Thailand Tests 600 Exposed to Mystery Covid Case | Thailand said today it had tested nearly 600 people potentially exposed to the country's first domestic coronavirus case in over three months, but has so far found no new infections. The man, 37, had worked as a nightclub DJ at three different venues in the capital Bangkok in the two weeks before he tested positive on arrival in prison, following his recent conviction for a drugs-related offence. Individuals deemed at risk across 12 venues including the court where he appeared, nightclubs and supermarkets were tracked down and 569 tests were administered, the Public Health Ministry said. So far, all tests have come back negative and 32 individuals were awaiting results. 

Sep 9, 2020 1:54 pm (IST)

Safety For Vaccine Comes First, Says WHO | Safety of a prospective vaccine for COVID-19 comes "first and foremost", the World Health Organization's chief scientist said today, as a trial of a candidate from AstraZeneca <AZN.L> was paused, at least temporarily, due to concerns over side effects. "Just because we talk about speed...it doesn't mean we start compromising or cutting corners on what would normally be assessed," Dr. Soumya Swaminathan said on a social media event. "The process still has to follow through rules of the game. For drugs and vaccines which are given to people, you have to test their safety, first and foremost."

Sep 9, 2020 1:41 pm (IST)

533 More Maha Police Official Test Positive | 533 more Maharashtra police personnel tested Covid-19 positive while 3 died, in the last 24 hours. Total number of positive cases in the police force rise to 17,972 including 3,523 active cases, 14,269 recoveries & 180 deaths till date, said Maharashtra Police. 

Sep 9, 2020 1:30 pm (IST)

Czech Covid Cases Top 1,000 in a Day for First Time | The Czech Republic reported today a record one-day spike in COVID-19 infections, with 1,164 new cases, as it battles a surging spread of the coronavirus. Daily case figures have regularly come in above 500 so far in September, already well above a previous daily peak of 377 in March during the first wave of infections. Czech authorities, which acted quickly to impose a strict lockdown in March to halt the spread of the virus, are keen to avoid taking that costly route again after the economy shrank by 11% in the April-June period on an annual basis.

Sep 9, 2020 1:17 pm (IST)

Russia's Covid Death at 18,135 | 142 people had died from the new coronavirus in the last 24 hours, Russia said today, which raised the official death toll to 18,135. Russia's coronavirus taskforce reported 5,218 new cases, bringing its nationwide tally to 1,041,007, the fourth largest caseload in the world.

Sep 9, 2020 1:14 pm (IST)

45,288 Pleas at Delhi Airport for Quarantine Exemption | Delhi airport's online portal has received approximately 45,288 applications from international passengers since August 8 to avail exemption from seven-day institutional quarantine, said its operator DIAL today. The government had said last month that from August 8, if any arriving international passenger has a negative report from an RT-PCR test done 96 hours prior to the journey, he or she need not undergo institutional quarantine in India. Delhi airport had launched an online portal for this purpose.

Sep 9, 2020 1:08 pm (IST)
Sep 9, 2020 1:02 pm (IST)

In a data update, the Ministry of Health has said five states of Maharashtra, Karnataka, Andhra Pradesh, Uttar Pradesh and Tamil Nadu contribute 61% of the total active cases. The total number of active cases in the country stands at 8,97,394 as on date.

Sep 9, 2020 12:59 pm (IST)

West Bengal Assembly Speaker and MLAs arrive at the State Assembly for Rapid Antigen COVID19 test ahead of Assembly's monsoon session.

Sep 9, 2020 12:56 pm (IST)
 

Apex Court on Religious Places | The Supreme Court has issued notices to Centre and all states regarding re-opening of religious places of all faiths. The court has agreed to examine if religious places can be reopened with precautionary measures. On a PIL seeking reopening of religious places across the country, the apex court has issued notice on the PIL seeking reopening of religious places. CJI Bobde observes that the possibility of the prayer sought will be examined.

Sep 9, 2020 12:40 pm (IST)
Sep 9, 2020 12:28 pm (IST)
Sep 9, 2020 12:24 pm (IST)

India Reports 89,706 Fresh Covid-19 Cases, Death Toll Rises to 73,890 With 1,115 Fatalities

The COVID-19 case fatality rate has further dropped to 1.69 per cent. There are 8,97,394 active cases of COVID-19, which is 20.53 per cent of the total caseload in the country, the data stated.

Sep 9, 2020 12:23 pm (IST)

Union Health Minister Dr Harsh Vardhan attended the 73rd session of WHO Regional Committee for South East Asia, through video conferencing.

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Coronavirus LIVE Updates: AstraZeneca Pauses Vaccine Trial after Volunteer Develops Illness
FILE PHOTO: The company logo for pharmaceutical company AstraZeneca is displayed on a screen on the floor at the New York Stock Exchange, U.S., April 8, 2019. REUTERS/Brendan McDermid/File Photo

Meanwhile, a multi-centric study funded by the Indian Council of Medical Research (ICMR) has found that use of convalescent plasma therapy in coronavirus-infected patients does not help in reducing mortality or progression to severe Covid-19. The 'open-label parallel-arm phase II multicentre randomised controlled trial' (PLACID Trial) was conducted across 39 public and private hospitals across India between April 22 to July 14 to investigate the effectiveness of convalescent plasma (CP) for the treatment of COVID-19, it said. The convalescent plasma (CP) therapy involves taking antibodies from the blood of a person who has recovered from COVID-19 and transfusing those antibodies into an active coronavirus patient to help kickstart the immune system to fight the infection. A total of 464 participants (moderately ill COVID-19 patients admitted to hospitals) were enrolled for the study, which has not yet been peer-reviewed and has appeared on medRxiv, a preprint server.

The National Task Force for COVID-19, a committee formed by the ICMR to respond to the pandemic, has reviewed and approved this study, it said. The Clinical Management Protocols for COVID-19 issued by the Union Health Ministry on June 27 allowed use of convalescent plasma (Off label) for treating coronavirus-infected patients in moderate stage of the illness under "investigational therapies" This authorisation has been paralleled by questionable practices such as calls for donors on social media, and the sale of CP on the black market with exorbitant price tags in India, the study said.

Additionally, although CP is a safe therapeutic modality, plasmapheresis, plasma storage and NAb measurement are all resource-intensive processes, with a limited number of institutes in the country having the capacity to undertake these activities in a quality-assured manner. "The CP was not associated with reduction in mortality or progression to severe COVID-19," the study said, adding this trial has high generalisability and approximates real-life setting of CP therapy in settings with limited laboratory capacity. A prior measurement of neutralising antibody titres in donors and participants may further clarify the role of CP in management of COVID-19, it said.

The study trial included 464 moderately ill coronavirus infected hospitalised patients, of whom 235 were given convalescent plasma along with best of standard care while 229 received only standard care, as per the study. Those in the intervention arm received two doses of 200 ml of CP, transfused 24 hours apart, in addition to the BSC (best standard of care). The two plasma units were collected preferably from different donors depending on the availability and ABO compatibility to increase chances of receiving CP with NAb, it said. "The PLACID trial results indicate that there was no difference in 28-day mortality or progression to severe disease among moderately ill COVID-19 patients treated with CP along with BSC compared to BSC alone," the study said.

The central implementation team at the ICMR was responsible for study design, study coordination, data analysis, data interpretation and writing of the report, the study stated. Patient enrolment, data collection and actual conduct of the study was done at public and private hospitals independently and the investigators in the ICMR had no role in it, it added.

Convalescent plasma (CP) as a passive source of neutralising antibodies and immunomodulators is a century-old therapeutic option used for the management of viral diseases. According to the study, only two randomised controlled trials on CP use in COVID-19 have been published, one from China and the other from the Netherlands.

Both were halted prematurely, the China study due to inadequate patient enrolment and the one from the Netherlands due to a need to redesign the trial based on interim findings. In both studies, no mortality benefit was noted, and the Dutch study raised uncertainties regarding pre-transfusion antibody-status of patients as a potential factor in identifying appropriate candidates for CP therapy.

This uncertainty in the published evidence is reflected in a recent systematic review, which remained undecided on both the safety and effectiveness of CP as a therapeutic option in hospitalized patients of COVID-19. Meanwhile, CP therapy has received regulatory approval for use in patients in different countries. This has resulted in its widespread adoption in real-world clinical practice, where it is being used to treat COVID-19 patients with a wide spectrum of disease severity.

"Given these uncertainties, we undertook the current study to determine the effectiveness of using CP in moderately ill COVID-19 patients admitted to hospitals across India in limiting progression to severe disease and determine the associated short-term adverse effects," the study said. All participants or their family members or legally authorised representatives were provided with information regarding the trial in a language they were comfortable with, and written informed consent was obtained prior to participant recruitment, it said.
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