Eli Lilly says other COVID-19 antibody drug trials ongoing after study halted for safety concern

By Carl O’Donnell and Michael Erman



a large building: FILE PHOTO: Eli Lilly logo is shown on one of their offices in San Diego


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FILE PHOTO: Eli Lilly logo is shown on one of their offices in San Diego

(Reuters) – Eli Lilly & Co on Wednesday said other trials of its experimental coronavirus antibody therapy remain on track after a government-run study testing the treatment in hospitalized COVID-19 patients was paused due to safety concerns.

Lilly said on Tuesday that an independent safety monitoring board requested a pause in the trial, called ACTIV-3, due to a potential safety issue.

The National Institutes of Health (NIH), which is collaborating with Lilly on the trial, said the advisory board paused the trial after seeing a “difference in clinical status” between patients on Lilly’s drug on those who received a placebo, without providing further detail.

Lilly on Wednesday said the paused trial is distinct from others it is conducting because it focuses on hospitalized patients who are more severely ill and being treated with other drugs as well, including Gilead Sciences Inc’s antiviral remdesivir.

The company had already asked U.S. regulators for an emergency use authorization (EUA) for the antibody drug, called bamlanivimab or LY-CoV555, to treat mild to moderate COVID-19 patients, based on interim data from a different study in those less severe illness. It is also testing the drug in nursing homes to see if it can prevent staff and residents from getting infected.

The U.S. Food and Drug Administration did not immediately respond to a request for comment on the status of the EUA application.

LY-CoV555 is similar to the experimental dual-antibody therapy from Regeneron Pharmaceuticals Inc that was used to treat U.S. President Donald Trump. That treatment is also awaiting clearance by U.S. regulators.

Trump touted both drugs as being tantamount to cures in a video he posted last week after being released from the hospital.

Lilly said in a statement that these type of treatments may prove to be less beneficial for hospitalized patients than for those with more mild cases of the disease. A Lilly spokeswoman declined to comment further on why the trial was halted.

The paused trial is being conducted in partnership with the U.S. National Institute of Allergy and Infectious Diseases, a division of the NIH that is working with several drugmakers on COVID-19 treatments and vaccines.

It was halted at the request of an independent oversight panel, called a Data Safety and Monitoring Board (DSMB). It is not uncommon to pause drug trials to investigate safety concerns, and such actions do not necessarily indicate a serious problem.

“Lilly trusts the judgment of the independent DSMB and supports its decisions to exercise caution in ensuring the safety of the patients participating in this study,” the company said in a statement.

(Reporting by Carl O’Donnell; Editing by Chizu Nomiyama and Bill Berkrot)

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A Canadian spin studio followed public health guidelines. But 61 people still caught the covid-19.

Now, despite appearing to have complied with public health regulations, at least 61 people linked to the studio have tested positive for the novel coronavirus.

“They had done all sorts of things to remove the potential for spread,” Richardson told reporters. “Unfortunately, gyms are a higher-risk place because of the fact that generally people are taking off their masks, they’re breathing at a higher rate.”

Although Hamilton requires masks to be worn in most public settings, the law includes an exemption for anyone “actively engaged in an athletic or fitness activity.” In keeping with that policy, the studio, SPINCO, allowed riders to remove their masks once clipped into their bikes, and told them to cover up again before dismounting.

In a recent Instagram post, SPINCO’s owners said that they had been “hesitant” to reopen after getting the green light in July, and would not resume classes “until it is safe to do so.” Health officials have said that the studio is temporarily closed and cooperating fully with the investigation.

“We took all the measures public health offered, even added a few, and still the pandemic struck us again!’” the owners wrote. SPINCO has more than a dozen locations across Canada.

As of Tuesday, 44 cases linked to specific classes were detected, Richardson said. An additional 17 instances of “secondary cases” were found among other contacts.

The city will reexamine gym protocols, Richardson added Tuesday, but in the meantime, “what seems to be the case is that you need to wear that mask” even though government guidelines do not strictly require it.

“It’s still a good idea to do it, in terms of keeping others safe,” she said.

People should also avoid “classes where you’ve got that kind of yelling or coaching over music.”

She declined to use the term “superspreader” to describe the event but said it is a “very large outbreak.”

“It is concerning that it is extended beyond the initial cases who were related to the classes but gone into of course their household contacts and other contacts,” she said. “We continue to look at what does it mean, what do we need to understand about exercise classes?”

The outbreak offers further evidence of the dangers of people gathering indoors without masks, as health experts warn that cases could spike further in the coming months as winter weather sets in and outdoor gatherings and exercise classes will be harder to maintain.

In August, South Korea confirmed dozens of cases linked to a single Starbucks in the city of Paju where many customers did not wear masks. The store employees, who wore masks, were not infected. The outbreak prompted Starbucks to limit its indoor seating in the country and encourage masks among patrons.

In other instances, mask usage has been credited with preventing potential outbreaks. In May, after the reopening of a hair salon in Missouri that required masks, two stylists — who had worked with more than 100 clients — tested positive for the virus. But masks were

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Public health warns of COVID-19 exposure at Trenton dentist’s office

Hastings Prince Edward Public Health is warning residents of the possibility of exposure to COVID-19 at a Trenton dentist’s office after a second person linked to the business has tested positive for COVID-19.

According to the health unit, two cases of the disease were linked to You Make Me Smile Dental Centre on Division Street last week. Despite these cases, the public health unit says there is low risk of exposure at the dentist’s office.

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As the second case has been identified, public health is asking anyone who visited the dental centre between Sept. 28 and Oct. 6 to self-monitor and to get tested if symptoms develop. If you do have symptoms and get tested, you must self-isolate for 14 days from the last visit to the dental centre, regardless of the results, the health unit said. You do not have to self-isolate unless you are showing symptoms.

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Public health said it will follow up with those considered to be at a higher risk of exposure.

“While HPEPH does not typically disclose the location of COVID-19 cases in order to protect individuals’ privacy, this information is disclosed when needed in order to meet public health objectives such as reducing the risk of further transmission,” the public health unit said in a press release Wednesday.

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The office closed voluntarily on Oct. 7 and will remain closed until Oct. 21.

There are currently six active cases of COVID-19 in the Hastings and Prince Edward regions, with 61 total cases since the pandemic began, of which 50 people have recovered and five have died.




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Here’s what’s happening Wednesday with COVID-19 in the Chicago area

Chicago on Tuesday added neighboring Indiana to its emergency travel order that requires travelers returning to the city from there to stay inside for two weeks because of high COVID-19 case counts. The Hoosier state’s inclusion on Chicago’s self-quarantine list was expected.



a man standing in front of a pool: Shelley Gavin, 55, gets a free COVID-19 test provided by Community Organized Relief Effort at I Grow Chicago in West Englewood on Aug. 31, 2020.


© Zbigniew Bzdak / Chicago Tribune/Chicago Tribune/TNS
Shelley Gavin, 55, gets a free COVID-19 test provided by Community Organized Relief Effort at I Grow Chicago in West Englewood on Aug. 31, 2020.

Starting Friday, people traveling into Chicago from Indiana, including Chicagoans who have traveled to Illinois’ eastern neighbor, to will be expected to quarantine themselves for 14 days. Violators can face a fine, though the city has taken few steps to enforce the rules and there are exceptions for essential workers.



a close up of a toy: A worker packages a COVID-19 test swab from a client at Prism Heath Lab, 2322 W. Peterson Ave., in Chicago, on Aug. 6, 2020.


© Jose M. Osorio / Chicago Tribune/Chicago Tribune/TNS
A worker packages a COVID-19 test swab from a client at Prism Heath Lab, 2322 W. Peterson Ave., in Chicago, on Aug. 6, 2020.

The move came as Illinois health officials announced 2,851 newly confirmed cases of COVID-19 and 29 additional deaths, pushing the state’s death toll past 9,000.



a person sitting in a car: Workers conduct drive-thru COVID-19 testing at Swedish Covenant Hospital on Oct. 13, 2020, in the Ravenswood neighborhood of Chicago.


© Erin Hooley / Chicago Tribune/Chicago Tribune/TNS
Workers conduct drive-thru COVID-19 testing at Swedish Covenant Hospital on Oct. 13, 2020, in the Ravenswood neighborhood of Chicago.

It was the seventh day in a row with more than 2,600 cases. That brings the state total to 324,743 confirmed cases and 9,026 deaths. The seven-day statewide positivity rate is 4.5% for the week ending Oct. 12.

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COVID-19 in Illinois by the numbers: Here’s a daily update on key metrics in your area

COVID-19 cases in Illinois by ZIP code: Search for your neighborhood

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Illinois coronavirus graphs: The latest data on deaths, confirmed cases, tests and more

Here’s what’s happening Wednesday with COVID-19 in the Chicago area and Illinois:

6:55 a.m.: Challenges to Pritzker’s COVID-19 restrictions back in court

After months of maneuvering, attorneys will be in court in Sangamon County Wednesday arguing over Gov. JB Pritzker’s powers to impose controls to curtail the spread of the coronavirus.

The hearing involves multiple cases filed by attorney Thomas DeVore on behalf of clients in six counties who contend that the coronavirus pandemic is not a public health emergency under the definition of Illinois law.



a person wearing a costume: Workers prepare for a drive-thru COVID-19 testing participant at Swedish Covenant Hospital on Oct. 13, 2020, in the Ravenswood neighborhood of Chicago.


© Erin Hooley / Chicago Tribune/Chicago Tribune/TNS
Workers prepare for a drive-thru COVID-19 testing participant at Swedish Covenant Hospital on Oct. 13, 2020, in the Ravenswood neighborhood of Chicago.

Because of that, the lawsuits argue that Pritzker doesn’t have the authority impose restrictions like limit on businesses in order to control the spread of COVID-19.

The essentially identical lawsuits were originally filed in Edgar, Bond, Richland, Clinton, and Sangamon counties. In each case, plaintiffs want the court to declare a public health emergency does not exist and that Pritzker be barred from exercising powers under the Emergency Management Act in those counties.



a person sitting in a parking lot: A warning sign alerts passersby as vehicles are lined up at a COVID-19 testing site at Saucedo Scholastic Academy on Oct. 13, 2020, in Chicago.


© John J. Kim / Chicago Tribune/Chicago Tribune/TNS
A warning

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South Africa’s Biovac in talks to manufacture COVID-19 vaccines

By Wendell Roelf and Alexander Winning

CAPE TOWN (Reuters) – A South African company part-owned by the government is in talks with the global COVID-19 vaccine distribution scheme and pharmaceutical companies to produce some of the vaccines the country needs to protect itself against the disease.

The Biovac Institute, a Cape Town-based joint venture between the government and private sector, could produce up to 30 million doses of COVID-19 vaccines per year, depending on the technology involved, Chief Executive Morena Makhoana told Reuters.

Depending on whether the vaccines require a one- or two-dose regimen, that could be enough for a quarter or half of South Africa’s population.

“We need to look at who is likely to get to the finishing line and who has the technological fit,” Makhoana said, when asked which vaccine candidate Biovac might partner with. “Discussions are happening and we are fairly confident that … we will be able to clinch a deal.”

The Coalition for Epidemic Preparedness Innovations (CEPI), the foundation that co-leads the COVAX scheme alongside the World Health Organization and vaccines alliance GAVI, has identified Biovac as a potential drug product manufacturer but has not signed an agreement yet, a CEPI spokesman said.

Drug product manufacturing typically includes steps like vaccine formulation, filling and finishing of vials, labelling and packaging, he said.

The COVAX scheme aims to deliver 2 billion doses of COVID-19 vaccine by the end of 2021. CEPI is reserving capacity with vaccine manufacturers worldwide so that goal can be met.

South Africa has submitted a non-binding confirmation of intent to participate in COVAX.

Makhoana said Biovac could not make “live virus” vaccines at this stage, precluding some vaccines being trailed in South Africa in partnership with Oxford University and Johnson & Johnson. He declined to name the companies Biovac was speaking to.

The Department of Science and Innovation, the ministry that manages the government’s stake in Biovac, supports its ambitions because it wants to stimulate local manufacturing and limit the impact of vaccine procurement on the country’s balance of payments, Director-General Phil Mjwara said.

Currently South Africa’s government buys about 95% of the vaccines supplied annually by Biovac, covering diseases such as tuberculosis, cervical cancer and influenza, with the rest sold to countries in the rest of Africa.

In the past Biovac has partnered with companies like Pfizer and Sanofi.

(Reporting by Wendell Roelf and Alexander Winning; Editing by Tim Cocks and Elaine Hardcastle)

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Covid-19 News: Live Updates – The New York Times

Here’s what you need to know:

Credit…Erin Schaff/The New York Times

More than 38 million people worldwide have been infected with the coronavirus, and as of Monday, fewer than five of those cases have been confirmed by scientists to be reinfections.

Nevertheless, fears of repeat bouts of illness, impotent vaccines and unrelenting lockdowns were raised anew when a case study about a 25-year-old man in Nevada was published on Monday. The man, who was not named, became sicker the second time that he was infected with the virus, a pattern the immune system is supposed to prevent.

And rare as these cases may be, they do indicate that reinfection is possible, said Akiko Iwasaki, an immunologist at Yale University, who wrote a commentary accompanying the Nevada case study, published in The Lancet Infectious Diseases.

The New York Times asked more experts what is known about reinfections with the coronavirus.

It’s impossible to know how widespread the phenomenon is, they told us. To confirm a case, scientists must look for significant differences in the genes of the two coronaviruses causing both illnesses. In the U.S., many people were not tested unless they were sick enough to be hospitalized. Even then, their samples were usually not preserved for genetic analysis, making it impossible to confirm suspected reinfections.

Plus, a resurgence of symptoms doesn’t prove reinfection. More likely, these are people experiencing symptoms connected to the original infection.

But people with a second bout may pass the virus to others. An infection in a patient in Hong Kong was discovered only because of routine screening at the airport, and the man was isolated in a hospital even though he had no symptoms. But his viral load was high enough that he could have passed the virus to others.

Credit…Tom Stromme/The Bismarck Tribune, via Associated Press

Uncontrolled coronavirus outbreaks in the U.S. Midwest and Mountain West have strained hospitals, pushed the country’s case curve to its highest level since August and heightened fears about what the winter might bring.

Sixteen states each added more new cases in the seven-day period ending Monday than they had in any other weeklong stretch of the pandemic. North Dakota and South Dakota are reporting more new cases per person than any state has previously. And in Wisconsin, home to 10 of the country’s 20 metro areas with the highest rates of recent cases, crews are preparing a field hospital at the state fairgrounds.

“While we are hopeful we can flatten the curve enough to never have to use the facility, Wisconsinites across our state are struggling and they are rightfully scared of this virus,” Gov. Tony Evers wrote to legislative leaders this week in a letter seeking support for his mask order and limits on public gatherings.

About 50,000 new cases are being reported each day on average in the United States for the

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Med students on how COVID-19 pushed them to take action, highlighted health care inequities

It was on a Saturday in mid-March when Abby Schiff, then a third-year medical student at Harvard working through surgery clinical rotations, found out she wouldn’t be going back to the hospital.

She had worked the day before, but with the coronavirus threat growing quickly, Schiff, like thousands of other medical students across the country, was sidelined when the Association of American Medical Colleges issued a temporary suspension of clinical rotations in hopes of protecting students and patients, and conserving personal protective equipment (PPE).

She didn’t sit around waiting, though. As nurses came out of retirement and medical school professors pressed pause on teaching to answer the call to action on the front lines, Schiff also got to work. Within hours, she and a group of other students started building a crash course on COVID-19 for medical professionals.

“At the time, a lot of Harvard medical students were talking about what was going on, and [it] felt like we suddenly had a lot of time on our hands,” Schiff told ABC News. “There was this crisis going on. How can we best contribute?”

PHOTO: Abby Schiff, a fourth-year medical student at Harvard Medical School, helped to create the school's COVID-19 curriculum and still keeps it updated on a regular basis. (ABC News)
PHOTO: Abby Schiff, a fourth-year medical student at Harvard Medical School, helped to create the school’s COVID-19 curriculum and still keeps it updated on a regular basis. (ABC News)

In less than a week, 70 of Schiff’s colleagues, including students and faculty, had put together a comprehensive, open-source COVID-19 curriculum.

“So we had about 80 pages of content — all referenced, all freely available — including things like thought questions, quiz questions… helpful information about how to put on masks and PPE, run ventilators,” she said. “And then also an explainer about basic epidemiological terms, about sort of the basics of virology and immunology and the clinical manifestations that were known at the time.”

Seven months later, the curriculum is still being updated with the latest science on a regular basis. Today, it includes modules on mental health, global health and communication, all meant to “dispel misinformation and myths,” said Schiff.

PHOTO: Fourth-year Harvard medical student Abby Schiff (second from top left) attends a video meeting with her fellow students to discuss updates to their school's open-source COVID-19 curriculum. (Courtesy Abby Schiff )
PHOTO: Fourth-year Harvard medical student Abby Schiff (second from top left) attends a video meeting with her fellow students to discuss updates to their school’s open-source COVID-19 curriculum. (Courtesy Abby Schiff )

As co-chair for outreach, she said her role is to reach out to students and groups that are using the curriculum to get an idea of their needs and how they can best be met, as well as recruiting students to contribute. The curriculum has already been implemented in 32 medical schools across the country as either an elective or mandatory course, and it has been translated into 27 languages and used in at least 110 countries, Schiff said.

“It’s had a really wide reach, including in areas where there are fewer resources available,” she said. “In the age of the internet, and especially when there’s something like this pandemic that’s affecting people in every single country and really just upending the structures of knowledge, it’s really important to keep information

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Cue Health awarded $481 million to scale up production of COVID-19 test: HHS

(Reuters) – The U.S. government has awarded diagnostic testing company Cue Health Inc $481 million to scale up the production of rapid COVID-19 molecular test, the Department of Health and Human Services said on Tuesday.

The company will raise the domestic production of COVID-19 test kits to 100,000 per day by March 2021 under the deal and deliver 6 million tests and 30,000 instruments to the government to support its response to the pandemic, the health agency said.

The point-of-care test can detect the novel coronavirus in about 20 minutes with nasal swab samples collected using a Sample Wand from the lower part of the nose, the HHS said.

The system also allows results to be sent to a mobile phone via an app.

The company’s test kit was approved by the U.S. Food and Drug Administration (FDA) in June for emergency use in patient care settings under the supervision of qualified medical personnel.

The development of the company’s health platform was supported by funding from the Biomedical Advanced Research and Development Authority (BARDA) for a molecular influenza test, starting in 2018, the department said.

BARDA later expanded the collaboration with the company to include the development of Cue’s COVID-19 test, it added.

(Reporting By Mrinalika Roy and Vishwadha Chander in Bengaluru; Editing by Anil D’Silva)

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World Bank approves $12 bln for Covid-19 vaccines

The World Bank said Tuesday that it approved $12 billion for developing countries to finance the purchase and distribution of Covid-19 vaccines, tests and treatment.

The financing “aims to support vaccination of up to a billion people,” the bank said in a statement.

The money is part of an overall World Bank Group (WBG) package of up to $160 billion through June 2021 designed to help developing countries battle the novel coronavirus pandemic.

“This financing package helps signal to the research and pharmaceutical industry that citizens in developing countries also need access to safe and effective Covid-19 vaccines,” the statement read. 

“It will also provide financing and technical support so that developing countries can prepare for deploying vaccines at scale, in coordination with international partners.”

Access to safe and effective vaccines “and strengthened delivery systems is key to alter the course of the pandemic and help countries experiencing catastrophic economic and fiscal impacts move toward a resilient recovery,” World Bank Group President David Malpass said in the statement.

The financing “will also support countries to access to Covid-19 tests and treatments, and expand immunization capacity to help health systems deploy the vaccines effectively,” the statement added.

The financing approval was expected as Malpass had announced the project in late September.

While vaccines have yet to appear on the market, Malpass noted in an interview with the French daily Le Figaro that it was necessary to prepare because of the complicated vaccine distribution process.

The Bank’s approach, according to the statement, draws on its “significant expertise in supporting large scale immunization programs for vaccine preventable diseases, as well as public health programs to tackle infectious diseases such as HIV, tuberculosis, malaria and neglected tropical diseases.”

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Eli Lilly pauses trial of antibody drug Trump touted as COVID-19 ‘cure’ over safety concern

By Michael Erman and Carl O’Donnell

(Reuters) – Eli Lilly and Co said on Tuesday that the government-sponsored clinical trial of its COVID-19 antibody treatment similar to one taken by U.S. President Donald Trump has been paused because of a safety concern.

Trump touted the Lilly drug, along with the antibody treatment from Regeneron Pharmaceuticals Inc that he received for his COVID-19, as tantamount to a cure in a video he posted last week.

The announcement comes one day after Johnson & Johnson said it was forced to pause a large high-profile trial of its experimental coronavirus vaccine because a volunteer fell ill. J&J said it does not yet know if that person was given the vaccine or a placebo.

AstraZeneca Plc’s U.S. trial for its experimental COVID-19 vaccine has also been on hold for over a month after a volunteer in its UK study fell ill. Trials of that vaccine resumed in other regions after a brief halt.

Lilly said earlier this month it was applying for emergency use authorization (EUA) for the antibody drug, LY-CoV555, for patients with mild to moderate COVID-19 based on data from another clinical trial.

It is not uncommon to pause drug trials to investigate safety concerns, and such actions do not necessarily indicate a serious problem. Because of the urgent need for drugs and vaccines to tackle a pandemic that has claimed over 1 million lives worldwide – and the speed with which they are being developed – these trials have come under intense scrutiny.

“Out of an abundance of caution, the ACTIV-3 independent data safety monitoring board (DSMB) has recommended a pause in enrollment,” Lilly spokeswoman Molly McCully said in an emailed statement. “Lilly is supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study.”

The Indianapolis-based drugmaker did not comment on the implications for the paused trial, called ACTIV-3, which is testing the treatment on COVID-19 patients who require hospitalization, or on its other ongoing trials. It is also testing the drug in nursing homes to see if it can prevent staff and residents from getting infected.

The U.S. Food and Drug Administration and the National Institutes of Health did not immediately reply to requests for comment.

Lilly began its ACTIV-3 trial in August and is aiming to recruit 10,000 patients primarily in the United States.

The trial compares patients who receive its antibody drug plus Gilead Sciences Inc’s antiviral drug remdesivir with those who receive remdesivir alone.

Lilly sought the EUA from U.S. regulators after publishing data in September showing LY-CoV555 helped cut hospitalization and emergency room visits for COVID-19 patients. The treatment is being developed with Canadian biotech AbCellera.

Lilly shares closed nearly 3%.

(Reporting by Michael Erman and Carl O’Donnell in New York; Additional reporting by Deena Beasley in Los Angeles; Editing by Bill Berkrot)

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