New Lockdowns From China To Europe As Virus Trials Stumble

As Europe imposed new restrictions to try to stall a surging second wave of the novel coronavirus, hopes for vaccines to rapidly provide relief suffered a blow Tuesday with the suspension of two clinical trials in the United States.

China meanwhile rushed to test an entire city of nine million within days after a minor coronavirus outbreak in the sprawling country, and Europe struggled to tackle a new surge of infections.

The virus is still spreading rapidly worldwide, with over one million deaths and 37 million infections. Many nations that suppressed their first outbreaks now face a second wave.

More than four million samples had been collected as of Tuesday in the Chinese city of Qingdao More than four million samples had been collected as of Tuesday in the Chinese city of Qingdao Photo: AFP / STR

Hopes for a rapid vaccine rollout suffered a setback as US pharmaceutical firm Eli Lilly said it had suspended the Phase 3 trial of its antibody treatment over an unspecified incident, the second in less than 24 hours after Johnson & Johnson ran into a similar problem.

In Europe, the Netherlands imposed a “partial lockdown” to curb one of the region’s worst coronavirus surges, with all bars, cafes and restaurants to close, and non-medical face coverings mandatory in all indoor spaces for people aged over 13.

In Britain, Labour opposition leader Keir Starmer called for a 2-3 week “circuit break” lockdown to slow the rates, saying the government had “lost control” of the outbreak having ignored stringent measures suggested by scientific experts on September 21.

Britain's Prime Minister Boris Johnson has ordered pubs to close early to help stem the virus spread Britain’s Prime Minister Boris Johnson has ordered pubs to close early to help stem the virus spread Photo: AFP / JUSTIN TALLIS

French President Emmanuel Macron is expected to announce tighter restrictions and faster testing in a prime-time TV interview late Wednesday, with some media speculating Paris and other cities could face evening curfews.

Meanwhile China — where Covid-19 first emerged late last year — launched a drive to test all residents of Qingdao after a handful of cases were detected on Sunday.

More than four million samples had been collected and 1.9 million results returned as of Tuesday afternoon, Qingdao authorities said, adding that no new cases had been found beyond already confirmed infections.

Map with number of Covid-19 deaths by country as of October 13 at 1100 GMT Map with number of Covid-19 deaths by country as of October 13 at 1100 GMT Photo: AFP / Simon MALFATTO

Chinese officials intend to test the entire city — around 9.4 million people — by Thursday.

In scenes contrasting with the fumbled testing efforts elsewhere, health workers in protective clothing swiftly set up tents and residents queued up to provide samples.

As the rest of Europe struggled to contain the disease, Russia also reported its highest-ever number of daily virus deaths, at 244, and a record number of new cases at almost 14,000.

With the pandemic already claiming more than one million lives worldwide, scientists in different nations are rushing to develop vaccines and effective treatments With the pandemic already claiming more than one million lives worldwide, scientists in different nations are rushing to develop vaccines and effective treatments Photo: AFP / Yasin AKGUL

Italy imposed new, tougher rules to control a resurgence, including an end to parties, amateur football matches and snacking

Pauses of coronavirus antibody and vaccine trials are routine, doctor says

Two setbacks have been reported in 24 hours in the fight against the coronavirus. On Tuesday, drugmaker Eli Lilly halted human testing of a COVID-19 treatment citing a potential safety concern. A person familiar with the trial told CBS News the pause will last approximately two weeks.

The treatment, which uses COVID-19 antibodies, is similar to a therapeutic given to President Donald Trump that he touted as a cure. “It was like unbelievable,” Mr. Trump said. “I felt good immediately.”

This comes as Johnson & Johnson said its vaccine trial, the largest to date, is also stopping temporarily while it investigates if an unexplained illness was caused by its vaccine.

CBS News medical contributor Dr. David Agus said these pauses are routine and reassuring.

“So this is not unusual,” Agus said. “I hope that Americans see news like this and have comfort that we are investigating every single issue with these drugs and with these vaccines to make sure they are safe for the American people.”

Thirty-seven states are seeing a rise in average new cases; only one state — South Carolina — is down. A key driver is gatherings. A recent CDC report found that a 13-year-old girl infected 11 people staying at the same house during a family vacation, without masks or social distancing.

With many Americans resisting guidelines, the death toll continues to grow. Leanna Richardson lost her mother — a third-grade teacher from North Carolina — in just 10 days.

“And if anything else, let her death be a reminder that COVID-19 doesn’t care,” Richardson said. “COVID-19 is serious. This is a pandemic. This is not a joke.”

School officials at her mother’s school said they do not believe she contracted the virus at work where she was teaching students in person. 

© 2020 CBS Interactive Inc. All Rights Reserved.

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Johnson & Johnson Pauses COVID-19 Vaccine Clinical Trials over Participant’s ‘Unexplained Illness’

Johnson & Johnson has paused its late stage clinical trials for a COVID-19 vaccine because of an “unexplained” illness in one of the participants, the company said Monday. 

It said in a news release that the trial was paused while the study’s independent Data Safety Monitoring Board conducted a review and evaluation of the participant’s condition.

“Adverse events — illnesses, accidents, etc. — even those that are serious, are an expected part of any clinical study, especially large studies.”

The company noted the “significant distinction” between a study pause and a regulatory hold, explaining that a pause is not unexpected in vaccine trials. 

“A study pause, in which recruitment or dosing is paused by the study sponsor, is a standard component of a clinical trial protocol,” the statement said.

Johnson & Johnson’s coronavirus vaccine became the fourth to begin Phase 3 trials in the United States last month and becomes the second to be paused in the U.S. after AstraZeneca’s vaccine trial was put on hold last month after a volunteer in Britain developed a neurological complication.

AstraZeneca’s trial has resumed in Britain, but is still paused in the United States as the U.S. Food and Drug Administration carries out an investigation.

Johnson & Johnson did not reveal the specifics of the unexplained illness but will be conducting a review to see if it is related to the vaccine. 

“We must respect this participant’s privacy. We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information,” the company said.

“Serious adverse events are not uncommon in clinical trials, and the number of serious adverse events can reasonably be expected to increase in trials involving large numbers of participants. Further, as many trials are placebo-controlled, it is not always immediately apparent whether a participant received a study treatment or a placebo.”

When the trial’s move to Phase 3 was announced last month, the National Institutes of Health said it would involve up to 60,000 participants. 

The company’s vaccine is one of six being tested in the U.S. in the race to find an effective vaccine to ease the pandemic that has killed more than 215,000 Americans.

Johnson & Johnson’s vaccine requires only one dose of vaccine, so federal officials have expressed hope that testing can be carried out faster than studies of other vaccines which will require two doses, such as those made by Moderna and Pfizer, CNN reported. 

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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

Gossamer Bio Announces Topline Results for Phase 2 Trials of Oral GB001 in Asthma and Chronic Rhinosinusitis

– Primary endpoint of asthma worsening not met in LEDA Study, however consistent numeric reductions ranging from 32-35% observed across all three GB001 groups –

– Statistically significant improvements in key secondary endpoint of time to first asthma worsening of 28% and 30% observed for 20 mg and 60 mg doses of GB001, respectively; 23% improvement observed in 40 mg group –

– TITAN Study in chronic rhinosinusitis did not meet primary or secondary endpoints –

– Gossamer to hold webcast to discuss trial results at 8:00 am EDT –

Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, today announced topline results from its Phase 2b LEDA trial in patients with moderate-to-severe eosinophilic asthma and its Phase 2 TITAN trial in patients with chronic rhinosinusitis.

“While we did not achieve statistical significance on the primary endpoint in the LEDA Study, we are encouraged by the consistent results observed for all three doses of once-daily, oral GB001 therapy across the primary and secondary endpoints,” said Sheila Gujrathi, M.D., Co-Founder and Chief Executive Officer of Gossamer. “We believe these data provide important information for designing a well-powered Phase 3 program for GB001 in severe asthma. We plan to engage in global regulatory discussions in order to inform our thinking around potential partnerships or strategic alternatives for this program.”

“The results of the robust LEDA Study are meaningful and help us to further understand the DP2 pathway in asthma,” said Bruce Levy, M.D., Chief, Division of Pulmonary and Critical Care Medicine at Brigham and Women’s Hospital and Professor of Medicine at Harvard Medical School. “I believe GB001 as an oral treatment has the potential to serve the high unmet need of patients with uncontrolled severe asthma.”

LEDA Phase 2b Trial Design

The LEDA trial enrolled 480 patients with uncontrolled, moderate-to-severe eosinophilic asthma and assessed the effect of oral GB001 add-on therapy to standard of care over 24 weeks, comparing three dose groups of once-daily, oral GB001 (20 mg, n=120; 40 mg, n=118; and 60 mg, n=122) to placebo (n=120).

The primary endpoint, asthma worsening, included five components and was chosen for its sensitivity in detecting deterioration in clinical outcome measures known to be correlated with exacerbations. A patient was considered to have experienced asthma worsening if they met any of the five components by Week 24. This endpoint has previously been used in the context of steroid withdrawal studies, including a prior Phase 2 trial of GB001.

LEDA Primary and Secondary Endpoint Results

The primary endpoint of the trial was not met, though consistent and meaningful numeric reductions in the odds of asthma worsening as compared to placebo were observed across all GB001 groups: 33% (p=0.1425), 32% (p=0.1482), and 35% (p=0.1086), for the GB001 20 mg, 40 mg, and 60 mg groups, respectively. In addition, statistically significant improvements in the key secondary endpoint of time to first asthma worsening as compared to placebo

J&J pauses coronavirus vaccine trials due to unexplained illness

(Reuters) – Johnson & Johnson JNJ.N 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 AZN.L 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 here 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

J&J pauses COVID-19 vaccine trials due to illness [Video]

Johnson & Johnson announced Monday (October 12) it’s temporarily paused trials for a COVID-19 vaccine after a participant in the study fell ill for unknown reasons.

The news delays one of the highest profile efforts to contain the global pandemic.

And also another major setback in the race for a COVID-19 vaccine, after AstraZeneca paused late-stage trials of its vaccine candidate last month, also due to unexplained illness in a trial participant.

Johnson and Johnson said in a statement that their participant’s illness is being reviewed and evaluated by an independent monitoring board as well as the company’s clinical and safety physicians.

The company said that the current “study pause” in giving doses of the vaccine was different from a “regulatory hold” required by health authorities.

It added that such pauses are normal in big trials, which can include tens of thousands of people.

J&J had kicked off its final 60,000-person trial just last month, the results of which were expected by the end of this year or early 2021.

Johnson & Johnson declined to elaborate on the participant’s illness due to privacy concerns.

But the company says that some participants in studies get placebos, and it can be unclear whether a person suffering a serious illness in a clinical trial received a placebo or the treatment.

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Johnson & Johnson pauses clinical trials for a COVID vaccine over patient illness

Johnson & Johnson has paused its clinical trials for a COVID-19 vaccine following a patient illness, just weeks after it announced it was in its final stage.

A pause is not entirely unexpected in vaccine trials. When another vaccine trial was temporarily stopped last month, experts hailed the move, pointing to it as an example of the scientific rigor that is being maintained despite the understandably intense public interest for a COVID-19 vaccine.

The Johnson & Johnson trial was paused after an “unexplained” illness in one of its participants and in compliance with regulatory standards, the company said in a news release Monday night. The pharmaceutical company said the patient’s condition was being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board.

“We must respect this participant’s privacy,” the company’s statement said. “We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information.”

It’s unclear whether the patient received the experimental vaccine or were in the placebo-control group.

AstraZeneca also started its Phase 3 vaccine trial last month but was placed on pause in the U.S. after a participant in the United Kingdom was reported to have developed a spinal cord injury. The company resumed its trial with Oxford University in the U.K. but was awaiting Food and Drug Administration approval to continue in the U.S.

Dr. Francis Collins, director of the National Institutes of Health, told NBC News last month that the pause should reassure those with concerns about possible vaccine safety issues.

“If anybody thinks we’re just glossing over these kinds of issues in the big rush to approve a vaccine, this ought to be reassuring,” Collins said during a “Doc to Doc” interview with NBC News medical correspondent Dr. John Torres, which was streamed on Facebook.

Pfizer and Moderna also have vaccine trials that went into Phase 3 in July, both of which require two doses about a month apart. The Johnson & Johnson vaccine is instead administered in one dose, avoiding the complicated coordination to require that people return in time for the second dose.

Johnson & Johnson announced last week that European Commission approved an advance purchase agreement from its parent company, Janssen Pharmaceutical Companies, for 200 million doses of the vaccine to E.U. member states following approval. The company also said it was looking to allocate up to 500 million vaccine doses toward international efforts for low-income nations.

This story originally appeared on NBCNews.com.

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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

South Korea’s Celltrion gets approval for Phase 3 trials of COVID-19 antibody drug

By Sangmi Cha

SEOUL (Reuters) – South Korean drugmaker Celltrion Inc <068270.KS> said on Monday it has received regulatory approval for Phase 3 clinical trials of an experimental COVID-19 treatment.

The approval comes as the company plans to seek conditional approval for its antibody drug, CT-P59, for emergency use by the end of this year.

The treatment, the most advanced antibody drug in terms of research in South Korea, is directed against the surface of the virus and designed to block it from locking on to human cells.

The third stage trials will be conducted on some 1,000 asymptomatic coronavirus patients and those who have come into close contact with COVID-19 patients in Korea, Celltrion said in a statement.

The Ministry of Food and Drug Safety recently approved a Phase 2/3 study on patients with mild and moderate cases of COVID-19, Lee Sang-joon, Celltrion’s senior executive vice president, told Reuters.

Celltrion began commercial production of the drug in September – likely to amount to around 1 million doses – in anticipation of demand in both domestic and overseas markets.

In July, Celltrion separately launched overseas human trials of its treatment in Britain.

(Reporting by Sangmi Cha; Editing by Kenneth Maxwell)

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