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J&J Pauses Coronavirus Vaccine Trials Due to Unexplained Illness | Top News

(Reuters) – Johnson & Johnson

has paused clinical trials of its coronavirus vaccine candidate due to an unexplained illness in a study participant, delaying one of the highest profile efforts to contain the global pandemic.

The move comes around a month after AstraZeneca

also suspended trials of its experimental coronavirus vaccine – which uses a similar technology – due to a participant falling ill.

J&J said on Monday the illness was being reviewed by an independent data and safety monitoring board as well as the U.S. group’s clinical and safety physicians.

The company, which reports quarterly financial results on Tuesday morning, said such pauses are normal in big trials, which can include tens of thousands of people.

It added the voluntary “study pause” in giving doses of the vaccine candidate was different from a “regulatory hold” imposed by health authorities.

AstraZeneca last month paused late-stage trials of its experimental coronavirus vaccine developed with the University of Oxford due to an unexplained illness in a British study participant.

While AstraZeneca’s trials in Britain, Brazil, South Africa and India have since resumed, its U.S. trial is still on hold, pending a regulatory review.

The J&J and AstraZeneca vaccines are both based on a so-called adenovirus, a harmless modified virus that instructs human cells to produce vaccine proteins.

They are both also part of the U.S. government’s Operation Warp Speed programme to support vaccine development.

“This could be a second case of adenoviral vaccine to spur safety concerns,” said Bryan Garnier analyst Olga Smolentseva.

AstraZeneca and medical experts say trial suspensions to look into the cause of a participant’s illness are not uncommon. Underwriters of clinical trial insurance have said premiums for coronavirus vaccines studies are only marginally higher than for pre-pandemic vaccines.

J&J on Sept. 22 became the fourth Warp-Speed participant to enter the final stage of testing on humans, with the aim of enrolling 60,000 volunteers in the United States and abroad.”Everybody is on the alert because of what happened with AstraZeneca,” Dr. William Schaffner, a professor of infectious diseases at the Vanderbilt University School of Medicine, said by email, adding it could take a week to gather information.

“This is likely to be a neurological event,” he said. Last month, J&J said its vaccine candidate produced a strong immune response in an early-to-mid stage clinical trial. This prompted the company to start the large scale trial, with results expected by the end of this year or early 2021.

J&J declined to elaborate on the illness due to privacy concerns. It did say some participants in studies get placebos, and it was not always clear whether a person suffering a serious adverse event in a trial received a placebo or the treatment.

Stat News reported https://www.statnews.com/2020/10/12/johnson-johnson-covid-19-vaccine-study-paused-due-to-unexplained-illness-in-participant/?utm_content=buffer37312&utm_medium=social&utm_source=twitter&utm_campaign=twitter_organic the pause earlier, citing a document sent to outside researchers, which stated that a “pausing rule” had been met, the online system used to enroll patients in the study had been closed and the data and safety monitoring board would be convened.

(Reporting by Ayanti

Takeda Group Begins Manufacturing COVID-19 Plasma Treatment Ahead of Approval | Top News

NEW YORK (Reuters) – The Takeda Pharmaceutical Co-led group that is developing a blood plasma treatment for COVID-19 has started manufacturing while the late-stage trial to determine whether it works is ongoing, Takeda Chief Executive Christophe Weber said on Monday.

The group, known as the CoVIg Plasma Alliance, enrolled its first patient in the Phase III trial on Friday after months of delays. It aims to enroll 500 adult patients from the United States, Mexico and 16 other countries and hope to have results by the end of the year.

“The likelihood it works is very high,” Weber said in an interview. “And that’s why we have launched a campaign in order to accelerate the donation of convalescent plasma to manufacture and produce this product.”

The alliance, which includes CSL Behring, Germany’s Biotest AG and other companies, is testing a hyperimmune globulin therapy, which is derived from blood plasma of people who have recovered from COVID-19. Hyperimmune globulin therapy offers a standardized dose of antibodies and does not need to be limited to patients with matching blood types.

That makes it more advanced and convenient than treatment with convalescent plasma drawn from recovered patients.

The manufacturing process is expensive.

Weber said the treatment could be slightly more costly to make than monoclonal antibody treatments like the ones Regeneron Pharmaceuticals Inc and Eli Lilly and Co have developed. The alliance does not intend to profit from the treatment, Weber said.

The Takeda CEO said he does not know how many doses of the treatment the group will be able to produce by the end of the year. That will depend on donations as well as the dosage size they decide to test in the clinical trial.

The trial will test the hyperimmune globulin therapy in combination with Gilead Sciences Inc’s antiviral drug remdesivir compared with patients who get remdesivir alone, he said.

(Reporting by Michael Erman; Editing by Bill Berkrot)

Copyright 2020 Thomson Reuters.

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Aiming to hit top fitness levels post Covid recovery, says Surender Kumar

(MENAFN – IANS)

New Delhi, Oct 12 (IANS) Defender Surender Kumar, who was one of the six players of the Indian men’s hockey team too have tested positive for Covid-19 in August, has revealed that the entire period was mentally very challenging for him.

“I would often tell myself that so many people around the globe have battled this virus including top sports people and have come out of it. It was a difficult phase but I am really grateful for the kind of support system we had from Hockey India and SAI who made every effort to get us the best treatment,” Kumar said.

Unlike his other compatriots who had tested positive and recovered, Kumar had developed venous thrombosis, a condition in which there are blood clots. It is one of the many complications related to Covid-19 recovery phase.

“Again, I am grateful to Hockey India and SAI for ensuring my recovery is closely monitored. I get my routine check-ups done regularly. We also have a doctor on campus who I can consult in case of any discomfort. I feel we are just fortunate to have this kind of support. My focus now is on hockey,” he said.

“The team coaching staff ensured we were in a good space mentally for that entire period of two-three weeks where we were in the hospital followed by mandatory isolation,” added the defender from Karnal Haryana who was part of the Indian Team for Rio Olympics in 2016.

Having returned to the pitch in mid-September and join the rest of the team, his main aim is to gain full-fitness.

“I am happy to be back to regular schedule with the rest of the core group. Initially, chief coach would emphasis on taking it slow and not exerting too much even though we would feel no discomfort in pushing ourselves. It’s now been over three weeks since I have returned to training. I am feeling good and aiming to hit top fitness levels,” he said.

–IANS

aak/

MENAFN1210202002310000ID1100941496


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Abbott Wins U.S. Emergency Use Authorization for New COVID-19 Antibody Test | Top News

(Reuters) – Abbott Laboratories said on Monday the U.S. Food and Drug Administration has issued an emergency use authorization for its lab-based COVID-19 antibody blood test.

The test, AdviseDx, can be used to identify a type of antibody called Immunoglobulin M (IgM) in blood samples to determine if someone has been exposure to the novel coronavirus, potentially indicating a recent or prior infection.

Abbott has already received emergency use authorization for seven tests, including molecular tests, a rapid antigen test and another test which can detect a type of antibody called IgG.

The FDA’s emergency use authorization allows the use of unapproved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases with no adequate or approved alternatives.

IgG is longer lasting in the body after an infection, but IgM is more useful for determining a recent exposure to the coronavirus as these antibodies become undetectable weeks to months following an infection, Abbott said http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20201012:nPn8KFxtXa.

Unlike molecular tests, which can detect whether someone has the coronavirus, antibody tests determine if someone has had a previous infection by detecting disease-fighting proteins called antibodies.

However, antibody tests are not recommended as the sole basis of diagnosis of COVID-19 as these antibodies may not be detected in the early days of the infection.

Shares of Abbott were up 0.5% at $110.21 in early trading.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Amy Caren Daniel)

Copyright 2020 Thomson Reuters.

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Aiming to Hit Top Fitness Levels Post Covid-19 Recovery, Says Surender Kumar

Defender Surender Kumar, who was one of the six players of the Indian men’s hockey team too have tested positive for Covid-19 in August, has revealed that the entire period was mentally very challenging for him.

“I would often tell myself that so many people around the globe have battled this virus including top sports people and have come out of it. It was a difficult phase but I am really grateful for the kind of support system we had from Hockey India and SAI who made every effort to get us the best treatment,” Kumar said.

Unlike his other compatriots who had tested positive and recovered, Kumar had developed venous thrombosis, a condition in which there are blood clots. It is one of the many complications related to Covid-19 recovery phase.

“Again, I am grateful to Hockey India and SAI for ensuring my recovery is closely monitored. I get my routine check-ups done regularly. We also have a doctor on campus who I can consult in case of any discomfort. I feel we are just fortunate to have this kind of support. My focus now is on hockey,” he said.

“The team coaching staff ensured we were in a good space mentally for that entire period of two-three weeks where we were in the hospital followed by mandatory isolation,” added the defender from Karnal Haryana who was part of the Indian Team for Rio Olympics in 2016.

Having returned to the pitch in mid-September and join the rest of the team, his main aim is to gain full-fitness.

“I am happy to be back to regular schedule with the rest of the core group. Initially, chief coach would emphasis on taking it slow and not exerting too much even though we would feel no discomfort in pushing ourselves. It’s now been over three weeks since I have returned to training. I am feeling good and aiming to hit top fitness levels,” he said.

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As Globe Gallops Into Vaccine Trials, Insurers Remain Unfazed | Top News

By Noor Zainab Hussain, Carolyn Cohn and Ludwig Burger

LONDON/FRANKFURT (Reuters) – The world is racing towards a vaccine in record time, stirring public concerns about safety to the extent that nine leading developers have felt compelled to issue a pledge to uphold scientific standards and testing rigour.

Yet, while more than 40 experimental COVID-19 vaccines are being tested on humans, the insurance companies with decades of experience in assessing the risks of clinical trials don’t see anything to be unduly concerned about.

Executives at insurer Allianz and brokers Gallagher and Marsh, among the leading players in clinical trials insurance, told Reuters that premiums had only marginally increased so far in the current pandemic.

They argued there was little structural difference to trials carried out in the past, despite drugmakers around the world competing to shatter the fastest time in history for developing a vaccine, which stands at around four years.

“Rates have been relatively stable. Even this year we have so far seen only moderate price increases on average, with higher price jumps for particularly exposed COVID-19 trials,” said Mark Piazzi, senior underwriter liability at Allianz Global Corporate & Specialty (AGCS).

This was echoed by David Briggs, managing director, life sciences practice at Gallagher, who said every trial was rated on its methods and the kinds of patients involved.

Gallagher said premiums in Britain, for example, started at about 5,000 pounds ($6,500) per trial.

Total claims limits in policies were typically set at roughly $6-12 million, depending on the country’s rules, according to several insurance companies interviewed by Reuters.

In Britain, for instance, claim limits were usually set at no lower than 5 million pounds, while in Germany the figure was around 10 million euros ($11.8 million).

‘LOSS EXPERIENCE NOT DRAMATIC’

However part of the reason why premiums have not risen as sharply as some people might have expected is that claims from trial are generally uncommon, according to executives. This is because patients have often signed so-called informed consent agreements, they said.

Jim Walters, managing director of Life Sciences & Chemical Group at broker Aon, said such agreements outlined the risks that patients were taking by participating in the trial.

“So, you know, everything from you could have a sore spot on your arm. To you could potentially die. And you know, they would literally go that far in some of these protocols,” he added.

“Those generally tend to hold up in courts and in legal systems around the world. That means that the loss experience coming out of clinical trials is not very dramatic.”

Claims are often limited to circumstances linked to the improper conduct of trials or any wrongdoing, rather than side-effects of the treatment, executives said.

Such have been the worries about the vaccine race among some members of the public, who fear safety standards could slip, that nine developers issued a joint pledge last month to “uphold the integrity of the scientific process”.

ASTRAZENECA TRIAL SUSPENSION

AstraZeneca and Oxford University’s suspension of global Phase

UK Study Tests if BCG Vaccine Protects Against COVID | Top News

LONDON (Reuters) – The widely used BCG tuberculosis vaccine will be tested on frontline care workers in Britain for its effectiveness against COVID-19, researchers running the UK arm of a global trial said.

Bacillus Calmette-Guérin (BCG) vaccine, used to protect against tuberculosis, induces a broad innate immune-system response and has been shown to protect against infection or severe illness with other respiratory pathogens.

“BCG has been shown to boost immunity in a generalised way, which may offer some protection against COVID-19,” Professor John Campbell, of the University of Exeter Medical School, said.

“We are seeking to establish whether the BCG vaccine could help protect people who are at risk of COVID-19. If it does, we could save lives by administering or topping up this readily available and cost-effective vaccination.”

The UK study is part of an existing Australian-led trial, which launched in April and also has arms in the Netherlands, Spain and Brazil. The BCG vaccine is also being tested as a protection against COVID-19 in South Africa.

The British trial is recruiting volunteers ahead of winter months that officials have warned may be tough as the country grapples with a second wave of infections.

UK Prime Minister Boris Johnson has indicated that restrictions to curb the pandemic could be in place until spring.

The trial’s UK arm, which is being run from Exeter, southwest England, is seeking to recruit 1,000 people who work in care homes and community healthcare nearby.

Globally, more than 10,000 healthcare staff will be recruited.

(Reporting by Alistair Smout; Editing by Christina Fincher)

Copyright 2020 Thomson Reuters.

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U.S. COVID-19 cases top 50,000 for 3rd straight day

Oct. 10 (UPI) — For the third-straight day, the number of positive cases of COVID-19 in the United States topped 50,000, a level not seen since August, U.S. officials said Saturday.

Data the Johns Hopkins University global tracker showed there were 57,420 new cases and 990 deaths Friday in the United States. Since the beginning of the pandemic, the country has had 7.7 million confirmed cases and at least 214,000 deaths.

An updated model released Friday by the Institute for Health Metrics and Evaluation at the University of Washington School of Medicine, projects 394,693 deaths in the United States by Feb. 1. The model predicts that U.S. daily deaths will peak at 2,300 in mid-January with 116,000 hospital beds needed by Jan. 22. Daily U.S. deaths are around 1,000 this month.

Expanding the use of masks from the United States’ current rate of 69% to about 95% — the rate in Singapore — would save 79,000 lives between now and Feb. 1, the study predicted.

The virus is increasing in 24 states listed in the “red zone,” according to White House Coronavirus Task Force documents published Sunday and obtained by the Center for Public Integrity. North Dakota, South Dakota, Wisconsin, Montana and Utah top the list of outbreaks.

In North Dakota, the state health department reported 4,169 active positive cases Saturday with a 14-day rolling positivity rate of 7.24%. The state health department reported that 11.3 % of staffed hospital beds were available for future patients.

In South Dakota, where Gov. Kristi Noem has resisted ordering statewide lockdowns and mask mandates, the state health department reported there were 732 new cases Friday, with the state’s positivity rate at 12.1% and an average of five deaths per day. The number of average daily positive cases in South Dakota has increased by almost 50% over the past week, The New York Times reported Saturday.

In Wisconsin, the state said 2,354 positive tests were reported Friday, with a positive testing rate of 17.6%. Eighteen deaths were recorded Friday from COVID-19.

Gov. Tony Evers issued an emergency order Tuesday mandating that public indoor gatherings not exceed occupancy rates of 25%.

“Wisconsin is now a COVID-19 hotspot,” Evers said in a statement. “Wisconsin must use all its tools, including keeping people physically apart and wearing face coverings, to slow this dangerous spike. The consequences of failing to act could be devastating and deadly.”

Scenes from the White House as coronavirus hot spot

White House Deputy Press Secretary Brian Morgenstern speaks to members of the White House press corps about the status of President Donald Trump’s health as he recovers from coronavirus outside of the West Wing of the White House on Wednesday. Photo by Sarah Silbiger/UPI | License Photo

U.S. COVID-19 deaths top 50,000 for 3rd straight day

Oct. 10 (UPI) — For the third-straight day, the number of positive cases of COVID-19 in the United States topped 50,000, a level not seen since August, U.S. officials said Saturday.

Data the Johns Hopkins University global tracker showed there were 57,420 new cases and 990 deaths Friday in the United States. Since the beginning of the pandemic, the country has had 7.7 million confirmed cases and at least 214,000 deaths.

An updated model released Friday by the Institute for Health Metrics and Evaluation at the University of Washington School of Medicine, projects 394,693 deaths in the United States by Feb. 1. The model predicts that U.S. daily deaths will peak at 2,300 in mid-January with 116,000 hospital beds needed by Jan. 22. Daily U.S. deaths are around 1,000 this month.

Expanding the use of masks from the United States’ current rate of 69% to about 95% — the rate in Singapore — would save 79,000 lives between now and Feb. 1, the study predicted.

The virus is increasing in 24 states listed in the “red zone,” according to White House Coronavirus Task Force documents published Sunday and obtained by the Center for Public Integrity. North Dakota, South Dakota, Wisconsin, Montana and Utah top the list of outbreaks.

In North Dakota, the state health department reported 4,169 active positive cases Saturday with a 14-day rolling positivity rate of 7.24%. The state health department reported that 11.3 % of staffed hospital beds were available for future patients.

In South Dakota, where Gov. Kristi Noem has resisted ordering statewide lockdowns and mask mandates, the state health department reported there were 732 new cases Friday, with the state’s positivity rate at 12.1% and an average of five deaths per day. The number of average daily positive cases in South Dakota has increased by almost 50% over the past week, The New York Times reported Saturday.

In Wisconsin, the state said 2,354 positive tests were reported Friday, with a positive testing rate of 17.6%. Eighteen deaths were recorded Friday from COVID-19.

Gov. Tony Evers issued an emergency order Tuesday mandating that public indoor gatherings not exceed occupancy rates of 25%.

“Wisconsin is now a COVID-19 hotspot,” Evers said in a statement. “Wisconsin must use all its tools, including keeping people physically apart and wearing face coverings, to slow this dangerous spike. The consequences of failing to act could be devastating and deadly.”

Scenes from the White House as coronavirus hot spot

White House Deputy Press Secretary Brian Morgenstern speaks to members of the White House press corps about the status of President Donald Trump’s health as he recovers from coronavirus outside of the West Wing of the White House on Wednesday. Photo by Sarah Silbiger/UPI | License Photo

U.S. COVID-19 Cases Hit Two-Month High, 10 States Report Record Increases | Top News

(Reuters) – New cases of COVID-19 in the United States hit a two-month high on Friday with over 58,000 infections of the new coronavirus reported and hospitalizations in the Midwest at record levels for a fifth day in a row, according to a Reuters analysis.

Ten of the 50 states reported record one-day rises in cases on Friday, including the Midwestern states of Indiana, Minnesota, Missouri and Ohio. Wisconsin and Illinois recorded over 3,000 new cases for a second day in a row – a two-day trend not seen even during the height of the previous outbreak in the spring, according to Reuters data.

The Western states of Montana, New Mexico and Wyoming also reported their biggest one-day jumps in cases, as did Oklahoma and West Virginia.

Nineteen states have seen record increases in new cases so far in October. (Graphic: https://tmsnrt.rs/2SFLb7o)

Amid the resurgence in cases across the nation, President Donald Trump, who recently contracted COVID-19, is set to resume his re-election campaign on Saturday by addressing supporters from the balcony of the White House.

He is then scheduled to travel on Monday to central Florida to hold his first campaign rally since leaving the hospital.

Trump and his administration have faced criticism for their handling of the pandemic that has claimed over 213,000 lives in the country, as well as for a lax approach to mask-wearing and social distancing in the White House.

There is no federal mandate to wear a mask, and 17 states do not require them, according to a Reuters analysis.

In addition to rising cases, hospitals in several states are straining to handle an influx of patients.

Seven states on Friday reported record numbers of hospitalized COVID-19 patients: Arkansas, Kansas, Missouri, Montana, North Dakota, Oklahoma and Wisconsin.

In the Midwest, hospitalizations rose to nearly 9,000, continuing a streak of records that began on Monday. (Graphic: https://tmsnrt.rs/3lwVO9f)

There are now over 34,000 hospitalized nationally, up 18% in the past two weeks.

While deaths nationally continue to trend downward, the United States is losing on average 700 lives a day. Three states reported a record one-day increase in fatalities on Friday: Arkansas, Missouri and Montana. Health experts caution that deaths are a lagging indicator and usually rise weeks after cases climb.

(Reporting by Lisa Shumaker; Editing by William Mallard)

Copyright 2020 Thomson Reuters.

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