Takeda group begins manufacturing COVID-19 plasma treatment ahead of approval

By Michael Erman

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)

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Over 50 Salt Lake City officers under quarantine ahead of vice presidential debate

The city has seen a rise in new cases over the last month.

Salt Lake City’s latest rise in novel coronavirus cases has affected dozens of the city’s police officers, with at least 9% under quarantine ahead of Wednesday night’s vice presidential debate.

As of Tuesday evening, 17 officers tested positive for COVID-19, and 52 were in quarantine, Detective Michael Ruff told ABC News. On Monday, the department said 15 officers tested positive and 25 others were under quarantine.

A 2019 report by the Salt Lake City police department said the force had 542 uniformed officers, and Ruff could not say how much that number has changed over the year.

Ruff the department’s duties during the debate at the University of Utah shouldn’t be hindered because other agencies, including the university police, state police and federal authorities will be assisting.

“There are a lot of people who are working on this,” he said.

PHOTO: Salt Lake City police officers wear face masks to protect against the spread of the new coronavirus as they patrol in Salt Lake City, Utah, April 21, 2020.

Salt Lake City police officers wear face masks to protect against the spread of the new coronavirus as they patrol in Salt Lake City, Utah, April 21, 2020.

Salt Lake City police officers wear face masks to protect against the spread of the new coronavirus as they patrol in Salt Lake City, Utah, April 21, 2020.

As for the city’s day-to day police matters, Ruff said that the department has been shifting schedules and personnel to fill the gaps. The spokesman added that some of those quarantined officers were still working but only taking cases by phone for which in-person police work may not be required.

“You may have an incident where someone calls about fraud and doesn’t have a suspect ID. They’d be taking the call,” Ruff added.

The coronavirus situation that’s ensnared police is part of a larger trend of rising COVID-19 cases in Salt Lake City, according to data from the county’s Health Department. As of Tuesday evening, there were 34,087 total cases and 16 total deaths, with 136 people hospitalized due to the virus and 254 hospitalized since the pandemic began.

PHOTO: A car pulls into one of the first drive through testing facilities for Coronavirus (COVID-19) virus in a parking lot outside the University of Utah's Sugar House Health Clinic in Salt Lake City, Utah, March 16,  2020.

A car pulls into one of the first drive through testing facilities for Coronavirus (COVID-19) virus in a parking lot outside the University of Utah’s Sugar House Health Clinic in Salt Lake City, Utah, March 16, 2020.

A car pulls into one of the first drive through testing facilities for Coronavirus (COVID-19) virus in a parking lot outside the University of Utah’s Sugar House Health Clinic in Salt Lake City, Utah, March 16, 2020.

Since Sept. 8, 8,904 people contracted the virus, more than a quarter of the city’s total cases, according to health department data. The seven-day average of new daily cases went from 142 on Sept. 8 to 424 on Oct. 4.

Nicholas Rupp, a spokesman for the Salt Lake County Health Department, told ABC News in a statement that the greatest increase in numbers come from “younger people, high school and

Florida forges ahead in lifting curbs amid virus concerns

MIAMI — As the summer coronavirus spike in Sunbelt states subsides, Florida has gone the furthest in lifting restrictions, especially on restaurants where the burden of ensuring safety has shifted to business owners and residents — raising concerns of a resurgence.

In his drive to return the state to normalcy, Republican Gov. Ron DeSantis lifted limits on indoor seating at restaurants, saying they can operate at 100% in cities and counties with no restrictions and that other local governments with some restrictions can’t limit indoor seating by more than 50%.

In some of Florida’s touristy neighborhoods, patrons have since been flocking to bars and restaurants, filling terraces, defying mask orders — drawing mixed reactions from business owners and other customers.

“We’re generally concerned that we’re going to find ourselves on the other side of an inverted curve and erasing all the progress we’ve made,” said Albert Garcia, chairman of the Wynwood Business improvement district, which represents 50 blocks of restaurants and bars in Miami’s trendy arts district.

Other Sunbelt states that have been COVID-19 hot spots over the summer haven’t gone as far. In Texas, bars have been closed since June under Republican Gov. Greg Abbott’s orders, and restaurants can hold up to 75% of their capacity, while face covers are required throughout the state. And in Arizona, restaurants and bars must run at half-capacity.

Though Florida’s governor generally wears a mask when arriving at public appearances and has allowed municipalities to impose mask rules, he has declined to impose a statewide mandate. And on Sept. 25, as the state entered a Phase 3 reopening, he barred municipalities from collecting fines for mask violations.

DeSantis says contact tracing has not shown restaurants to be substantial sources of spread.

“I am confident that these restaurants want to have safe environments,” he said earlier this week. “And I’m also confident that as a consumer, if you don’t go and you don’t think they’re taking precautions, then obviously you’re going to take your business elsewhere.”

Craig O’Keefe, managing partner for Johnnie Brown’s and Lionfish in Delray Beach, said they’re now accommodating as many people as they did before the pandemic began and he’s hired eight people in the past few days. Demand surged last weekend.

“It was like someone turned the light on,” O’Keefe said. “It was great to see people out smiling, having fun getting to see each other. It’s been a really nice thing to get people back to work.”

Shutdowns and restrictions have battered Florida’s economy, leaving hundreds of thousands unemployed in the tourist-dependent state.

Earlier this week, The Walt Disney Co. announced it would lay off 28,000 workers in its theme parks division even after the Florida parks were allowed to reopen this summer.

Florida has had more than 14,500 deaths from the pandemic, ranking 12th per capita among states. Its outbreak peaked in the summer, seeing as many as 12,000-15,000 cases added per day. New cases, positivity rates, hospitalizations and deaths have been on a downward trend for

After mixed messages from White House, Trump says ‘real test’ ahead in his COVID fight

WASHINGTON (Reuters) – President Donald Trump said from his hospital room on Saturday that he felt “much better” but the next few days will be “the real test” of his treatment for COVID-19, capping a day of contradictory messages from the White House about his condition.

In a four-minute video posted on Twitter, Trump, looking tired and wearing a jacket and open-necked shirt, said he “wasn’t feeling so well” when he first arrived at Walter Reed National Military Medical Center on Friday.

“Over the next period of a few days, I guess that’s the real test, so we’ll be seeing what happens over those next couple of days,” Trump said, seated at a round table in front of an American flag.

The remarks came hours after differing assessments of his health from administration officials left it unclear how ill the president had become since he tested positive for coronavirus on Thursday night, a matter of enormous public concern.

A White House team of doctors said on Saturday morning that Trump’s condition was improving and that he was already talking about returning to the White House. One doctor said Trump told them “‘I feel like I could walk out of here today.’”

Within minutes, White House chief of staff Mark Meadows gave reporters a less rosy assessment, telling them, “The president’s vitals over the last 24 hours were very concerning and the next 48 hours will be critical in terms of his care. We’re still not on a clear path to a full recovery.”

Meadows, whose initial comments were delivered on condition that he not be identified, altered his tone hours later, telling Reuters that Trump was doing “very well” and that “doctors are very pleased with his vital signs.”

Meadows did not clarify the discrepancy in his comments. A Trump adviser who spoke on condition of anonymity said the president was not happy to learn of Meadows’ initial remarks.

Trump was flown from the White House to Walter Reed, near Washington, about 17 hours after he announced his illness. Administration officials, who described the move as precautionary, said he would stay at the hospital for several days.

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Another source who was briefed on Trump’s condition said the president was given supplemental oxygen before he went to the hospital. The decision to hospitalize Trump came after he had experienced difficulty breathing and his oxygen level dropped, according to a source familiar with the situation.

White House doctor Sean P. Conley told reporters outside the hospital on Saturday that Trump had not had trouble breathing, and was not given oxygen at Walter Reed.

“The team and I are extremely happy with the progress the president has made,” Conley said.

He declined to give a timetable for Trump’s possible release from the hospital, and later had to issue a statement saying he misspoke after appearing to suggest Trump had been diagnosed as early as Wednesday.

“Today’s spectacle – doctors saying one thing, White House sources saying another thing,