Author Archives: Reuters News Agency

Moderna would seek limited emergency use of COVID-19 vaccine based on early data

By Julie Steenhuysen

CHICAGO (Reuters) – If Moderna Inc’s COVID-19 vaccine proves to be at least 70 percent effective, the company plans to seek emergency authorization for its use in high-risk groups, the company’s chief executive told Reuters.

Moderna’s vaccine candidate – mRNA-1273 – is nearing the finish line in its push to enroll 30,000 individuals in a late-stage trial of a novel coronavirus vaccine. But the company may be able to declare victory early if it is able to show that people who got the vaccine fared much better in its trial that people who didn’t.

Vaccines must demonstrate they are at least 50% more effective than a placebo to be considered for approval. To prove that, government officials have said, at least 150 COVID-19 infections must be recorded among trial participants with at least twice as many occurring among the placebo group.

If a vaccine is especially effective, companies could have their answer sooner.

An independent safety board will take a first look at Moderna’s data as soon as a total of 53 people in the trial become infected with COVID-19. Moderna is projecting the interim analysis will occur in November, but it could come as early as October.

If most of the people who got sick got the placebo shot, that would indicate the vaccine was protecting those inoculated and could be enough evidence to seek U.S. regulatory approval for Emergency Use Authorization (EUA).

“If the interim readout is deemed by the independent safety committee as positive with 70 or 80 or 90% efficacy, we will indeed consider approval,” Stephane Bancel, Moderna’s chief executive officer, said in a telephone interview.

“At such a level of efficacy, if we get there, we can protect a lot of lives in the people at the highest risk, and so, we will consider filing for an EUA for a very limited population,” Bancel said.

He said the FDA will determine whether the benefit of the vaccine to a small group of high-risk individuals outweighs the risk of not having a full readout of safety data from all 30,000 study participants.

The two groups of high-risk individuals who might be covered in such an EUA would be healthcare workers and the elderly, Bancel said.

Bancel said the company wants to gather more data on the safety of the vaccine in the study population over a period of several months before seeking full FDA approval.

Moderna released its study protocol on Thursday, making public details on how its vaccine will be evaluated. If the vaccine does not reach the efficacy mark after 53 cases, the data safety and monitoring board will take another interim look at the data after 106 cases, and a final look after 151 people in the trial become infected with the virus.

Public health officials have said that approving a vaccine for widespread use based on a small number of cases would not offer enough safety information to show how the vaccine would perform.

Moderna, which has never brought a vaccine to market, has received nearly $1 billion from the U.S. government under its Operation Warp Speed program. It has also struck a $1.5 billion supply agreement with the United States.

In a presentation to investors on Tuesday, Pfizer Inc said the company has enrolled more than 29,000 people in its 44,000-volunteer trial to test an experimental COVID-19 vaccine the company is developing with German partner BioNTech.

Pfizer expects to have enough data to show whether the vaccine works by the end of October.

(Reporting by Julie Steenhuysen; editing by Peter Henderson and Cynthia Osterman)

NIH launches trial of Rigel drug for severe COVID-19

By Deena Beasley

(Reuters) – The U.S. National Institutes of Health on Thursday launched a clinical trial of fostamatinib, currently used to treat a blood platelet-destroying autoimmune disorder, in patients hospitalized with severe COVID-19, the disease caused by the novel coronavirus.

The tablets, sold under the brand name Tavalisse by Rigel Pharmaceuticals Inc, have shown in lab and animal studies the ability to block production of sticky, web-like substances that the immune system produces to trap foreign invaders.

For reasons that are still not clearly understood, the immune systems of some COVID-19 patients can overreact, creating an inflammatory cascade that can be toxic to organs, cause blood clots and worsen pneumonia.

Fostamatinib is designed to block activity of an enzyme that regulates parts of the body’s immune response, including “neutrophil extracellular traps,” or NETs, that white blood cells release to ensnare and kill pathogens.

“I am most excited about this drug because I know that as a targeted therapy it inhibits NETs, which we think is a big contributor to mortality,” said Dr. Richard Childs, clinical director of the National Heart, Lung, and Blood Institute.

The randomized, placebo-controlled Phase 2 trial will enroll 60 patients at the NIH Clinical Center in Bethesda, Maryland, Inova Health System’s Northern Virginia hospital and possibly other Inova locations.

The primary objective is evaluation of safety.

The trial is likely to take two or three months, and Rigel is considering how a larger study might be conducted, said Raul Rodriguez, the company’s chief executive officer.

Other immune system-modulating drugs are being used in COVID-19 patients, including the decades-old steroid dexamethasone, which is so far the only medication shown to improve their chance of survival.

“The problem is the steroid is a non-targeted therapy. It will also hit parts of the immune system that are very important for fighting off the virus or other infections,” Childs said. “Some patients that get COVID will get a bacterial infection … we see that all the time with influenza.”

Researchers at Imperial College London are also running an open-label study of fostamatinib in patients with COVID-19 pneumonia.

The drug is approved in the United States and Europe for treating adult chronic immune thrombocytopenia, a rare autoimmune disorder in which the body’s immune system destroys healthy platelets, leading to easy or excessive bruising and bleeding.

(Reporting by Deena Beasley; Editing by Timothy Gardner)

U.S. CDC reports 195,053 deaths from coronavirus

(Reuters) – The U.S. Centers for Disease Control and Prevention (CDC) on Wednesday reported 6,571,867 cases of the new coronavirus, an increase of 34,240 cases from its previous count, and said the number of deaths had risen by 961 to 195,053.

The CDC’s tally of cases of the respiratory illness known as COVID-19, caused by a new coronavirus, was of 4 p.m. ET on Sept. 15 versus its previous report a day earlier.

The CDC figures do not necessarily reflect cases reported by individual states.

(Reporting by Dania Nadeem in Bengaluru; Editing by Krishna Chandra Eluri)

Lilly says antibody drug cuts COVID-19 hospitalization, may seek emergency use nod

By Deena Beasley

(Reuters) – Eli Lilly and Co on Wednesday said a single infusion of its experimental antibody treatment reduced the need for hospitalization and emergency room visits for clinical trial patients with moderate COVID-19.

The company said it will discuss the interim results, which have not yet been reviewed by outside experts, with global regulators. The New York Times reported that Lilly Chief Scientific Officer Daniel Skovronsky said the company would talk with the U.S. Food and Drug Administration about the possibility of an emergency use authorization.

The mid-stage study tested three different doses of LY-CoV555, a manufactured copy of a an antibody produced by a patient who recovered from COVID-19. Antibody treatments work by recognizing and locking onto foreign invaders to prevent infection of healthy cells.

Of the total 302 patients treated with the Lilly drug, five or 1.7%, had to be hospitalized or required an emergency room visit. That compared with 6% in the placebo group, Lilly said.

“These data are not a home run but … are among the most encouraging COVID treatment data we’ve seen, particularly given this is in mild-to-moderate outpatients where there has simply been no treatment progress until now,” Raymond James analyst Steven Seedhouse said in a research note.

Oddly, only the middle 2,800-milligram dose achieved the trial’s main goal of reducing the amount of virus detected in patients compared with a placebo 11 days after treatment. Lilly said most trial participants, including those given a placebo, had completely cleared the virus by day 11. Some analysts suggested that future studies may want to use an earlier time point than 11 days.

Most hospitalizations occurred in patients with underlying risk factors such as obesity or advanced age. Lilly said future study would focus on people in these higher-risk groups.

No drug-related serious adverse events or trial deaths were reported.

Lilly said the trial will enroll 800 patients with mild-to-moderate COVID-19, with the next segment testing LY-CoV555 in combination with a second Lilly antibody, LY-CoV016, which binds to a different area of the coronavirus.

The antibodies, given by intravenous infusion, are also being tested for preventing COVID-19 in nursing home residents and staff and for treating patients already hospitalized with COVID-19.

Several companies including Regeneron Pharmaceuticals Inc and Vir Biotechnology are also testing antibody treatments for COVID-19.

Lilly’s shares were up 1.3% to $152.

(Reporting by Deena Beasley in Los Angeles and Manas Mishra in Bengaluru; Editing by Shinjini Ganguli and Bill Berkrot)

Trump urges Republicans to go for ‘higher numbers’ on coronavirus relief

By Susan Cornwell and David Morgan

WASHINGTON (Reuters) – President Trump urged his fellow Republicans Wednesday to go for “much higher numbers” in a coronavirus aid bill, as a stalemate continued in Washington over whether to approve more economic relief from the crisis ahead of Nov. 3 elections.

The Senate’s number two Republican, John Thune, reacted cautiously to Trump’s appeal on Twitter.

The standoff dates to mid-May, when the Democratic-majority House of Representatives approved $3.4 trillion in new aid, including unemployment benefits, money for schools, the U.S. Postal Service, and testing.

The Senate’s Republican leaders countered with a $1 trillion plan, but some of their own members balked at that. Last week they put a $300 billion bill up for a vote that Democrats blocked as insufficient.

“Go for the much higher numbers, Republicans, it all comes back to the USA anyway (one way or another!)” Trump wrote on Twitter Wednesday.

Congress and the White House approved more than $3 trillion worth of coronavirus relief measures earlier this year.

Thune, speaking after Trump’s tweet, said proposals had to stay in a “realistic” range. Noting the original $1 trillion Senate Republican plan, he said: “As you go upwards from there you start … losing Republican support pretty quickly.”

A $1.5 trillion compromise floated Tuesday by the House Problem Solvers Caucus, a bipartisan group of dozens of centrist lawmakers, was attacked by members of both parties, including leading House Democrats. White House Chief of Staff Mark Meadows, however, said it deserved consideration.

Thune said there was some Republican interest in the $1.5 trillion package, but that the $500 trillion it included in aid for state and local governments would be hard for Republican senators to swallow. Meadows told reporters Wednesday that the state and local issue was probably the biggest obstacle to a deal.

Another Republican senator said Wednesday he thought a deal of around $1.5 trillion or $1.7 trillion was possible.

House Speaker Nancy Pelosi has offered to drop her aid demand to about $2.2 trillion. She faces growing pressure from moderate Democrats to take another vote on COVID-19 relief, but told MSNBC Wednesday that the way forward depends on the willingness of the White House to accept a bill large enough to address the severity of the coronavirus pandemic.

“What we want is to put something on the floor that will become law. And so that requires a negotiation,” she said. “We think they (the White House) should come to the table.”

(Reporting by Susan Cornwell and David Morgan; additional reporting by Alexandra Alper; editing by Jonathan Oatis)

U.S. charges seven in wide-ranging Chinese hacking effort

WASHINGTON (Reuters) – The U.S. Justice Department said on Wednesday it has charged five Chinese residents and two Malaysian businessmen in a wide-ranging hacking effort that encompassed targets from video games to pro-democracy activists.

Federal prosecutors said the Chinese nationals had been charged with hacking more than 100 companies in the United States and abroad, including software development companies, computer manufacturers, telecommunications providers, social media companies, gaming firms, nonprofits, universities, think-tanks as well as foreign governments and politicians and civil society figures in Hong Kong.

U.S. officials stopped short of alleging the hackers were working on behalf of Beijing, but in a statement Deputy Attorney General Jeffrey Rosen expressed exasperation with Chinese authorities, saying they were – at the very least – turning a blind eye to cyber-espionage.

“We know the Chinese authorities to be at least as able as the law enforcement authorities here and in like minded states to enforce laws against computer intrusions,” Rosen said. “But they choose not to.”

He further alleged that one of the Chinese defendants had boasted to a colleague that he was “very close” to China’s Ministry of State Security and would be protected “unless something very big happens.”

“No responsible government knowingly shelters cyber criminals that target victims worldwide in acts of rank theft,” Rosen said.

The Chinese Embassy in Washington did not immediately return an email seeking comment. Beijing has repeatedly denied responsibility for hacking in the face of a mounting pile of indictments from U.S. authorities.

Along with the alleged hackers, U.S. prosecutors also indicted two Malaysian businessmen, Wong Ong Hua, 46, and Ling Yang Ching, 32, who were charged with conspiring with two of the digital spies to profit from computer intrusions targeting video game companies in the United States, France, Japan, Singapore and South Korea.

The Justice Department said the pair operated through a Malaysian firm called SEA Gamer Mall. Messages left with the company were not immediately returned. Messages sent to email addresses allegedly maintained by the hackers also received no immediate response.

U.S. Assistant Attorney General for National Security John Demers said on Wednesday that the Malaysian defendants were in custody but were likely to fight extradition.

The Justice Department said it has obtained search warrants this month resulting in the seizure of hundreds of accounts, servers, domain names and “dead drop” Web pages used by the alleged hackers to help siphon data from their victims.

The Department said Microsoft Corp. had developed measures to block the hackers and that the company’s actions “were a significant part” of the overall U.S. effort to neutralize them. Microsoft did not immediately return a message seeking comment.

(Reporting by David Shepardson, Susan Heavey, Raphael Satter and Mark Hosenball in Washington; Editing by Chizu Nomiyama and Matthew Lewis)

U.S. could have capacity of 3 million COVID-19 tests per day, HHS official says

(Reuters) – The United States could have a capacity of 3 million coronavirus tests per day this month, and scale up to a high of as much as 135 million tests a month by October, a top health official told a U.S. Congress panel on Wednesday.

Half of the three million tests would be rapid point-of-care tests, said Admiral Brett Giroir, assistant secretary for health at the U.S. Department of Health and Human Services.

The average turnaround time for lab-based tests was now about 1.5 days on average, Giroir told the U.S. Senate panel.

Officials also stressed that coronavirus vaccines would not be immediately available to the broader public after regulatory clearance.

It would take around 6 to 9 months for enough people to be vaccinated for effective immunization, Centers for Disease Control and Prevention Director Robert Redfield said.

(Reporting by Manas Mishra in Bengaluru and Carl O’ Donnell in New York; Editing by Shinjini Ganguli and Shounak Dasgupta)

Girl power in the deep blue sea: World’s largest fish are female

By Will Dunham

WASHINGTON (Reuters) – Male and female whale sharks – filter-feeding marine behemoths – grow at different rates, with females doing so more slowly but getting much larger than the guys, according to research that offers deeper insight into the biology of Earth’s largest fish.

Researchers said on Wednesday they had tracked the growth of 54 whale sharks over a 10-year period in the vast Ningaloo Reef off Australia’s west coast, where hundreds of these slow-swimming endangered fish migrate annually.

Whale sharks of both sexes were found to have their fastest growth as juveniles, about 8-12 inches (20-30 cm) annually.

Overall, males were found to grow slightly more quickly than females, plateauing at around 26 feet (8 meters) long after reaching sexual maturity at about 30 years old. Females plateaued at around 14 meters (46 feet) when they reached sexual maturity at about age 50.

It is believed whale sharks may live 100-150 years. The longest-known whale shark reached about 60 feet (18 meters).

“Whale sharks are remarkable in that females have massive litters of pups, up to 300 at one time. Being very large is almost certainly a prerequisite for carrying this many young inside a female’s body,” said Australian Institute of Marine Science marine biologist Mark Meekan, who led the research published the journal Frontiers in Marine Science.

These sharks have a brownish-grayish color on the back and sides with white spots, with a white underside.

“Our study provides the first evidence that male and female whale sharks grow at different rates,” Meekan said. “Previously, researchers had to rely on estimates of growth and age extracted from the vertebrae of dead sharks that had either stranded on shore or been killed by a fishery. Samples were very limited and didn’t cover a very wide size range of animals, confounding attempts to produce reliable estimates of growth patterns.”

They are filter feeders, swimming great distances through the world’s tropical oceans to find enough plankton to sustain themselves.

“Our study has important implications for conservation,” Meekan said. “If it takes many years, 30 or more, for these animals to become mature, there are lots of threats such as hunting and ship-strike that they may succumb to before they get a chance to breed, making conservation strategies for these animals an urgent task.”

(Reporting by Will Dunham; Editing by Sandra Maler)

Virtual schooling dents retail sales, Trump economic message

By Ann Saphir

(Reuters) – Slower-than-expected sales at retailers in August suggest a speed bump is emerging in the U.S. economic recovery from coronavirus lockdowns, less than two months before the Nov. 3 presidential election.

Overall, retail sales have returned to their pre-crisis levels and then some, gaining 0.6% in August, the Commerce Department said on Wednesday. The rebound plays into U.S. President Donald Trump’s narrative of resurgent growth after a sharp pandemic downturn. Incumbent presidents are generally helped at the polls by a strong economy, and hurt by a weak one.

But last month’s rise was driven in part by an increase in gasoline prices, not typically a cause for consumer celebration. Meanwhile core retail sales, a closer measure of underlying spending trends, fell 0.1% last month. Both readings fell short of economists’ expectations.

Back-to-school shopping season, or the lack of it, was one cause. Many students actually could not head back to the classroom because of COVID-19 restrictions, and their curbed spending on supplies helped drive down core retail spending, said Regions Financial Corp economist Richard Moody. Meanwhile, a jump in sales at restaurants and bars drove most of the gain in overall retail sales.

The softening comes as nearly 30 million Americans are on some form of unemployment insurance. An extra $600 weekly that out-of-work-adults were getting in government aid expired at the end of July; it was replaced by a program that sent out $300 payments, but stopped taking new applicants on Sept. 10.

Lawmakers have so far failed to agree to any new aid package, and without more fiscal help, economists say the recovery will stall.

“The economy is weak: there are no two sides around that,” says Eric Winograd, senior economist at AllianceBernstein. Part of a voter’s calculus in picking a president may be, “Do you think additional stimulus is necessary, and if so what do you want that to look like?”

(Reporting by Ann Saphir; editing by Heather Timmons and Nick Zieminski)

Crews battle wildfires in U.S. West as smoke travels the world

By Deborah Bloom and Brad Brooks

PORTLAND, Ore. (Reuters) – As fire crews continued to battle deadly wildfires sweeping the western United States, thousands of evacuees in Oregon and other states faced a daily struggle while scientists in Europe tracked the smoke on Wednesday as it spread on an intercontinental scale.

With state resources stretched to their limit, President Donald Trump on Tuesday night approved a request from Oregon’s governor for a federal disaster declaration, bolstering federal assistance for emergency response and relief efforts.

Dozens of fires have burned some 4.5 million acres (1.8 million hectares) of tinder-dry brush, grass and woodlands in Oregon, California and Washington state since August, ravaging several small towns, destroying thousands of homes and killing at least 34 people.

The Federal Emergency Management Agency (FEMA) has obligated more than $1.2 million in mission assignments to bring relief to Oregon and has deployed five urban search and rescue teams to the wildfire-torn region, the agency said in a statement on Wednesday.

Search teams scoured incinerated homes for the missing as firefighters kept up their exhausting battle.

The wildfires, which officials and scientists have described as unprecedented in scope and ferocity, have filled the region’s skies with smoke and soot, compounding a public health crisis already posed by the coronavirus pandemic.

Scientists in Europe tracked the smoke as it bore down on the continent, underscoring the magnitude of the disaster. The European Union’s Copernicus Atmosphere Monitoring Service (CAMS) is monitoring the scale and intensity of the fires and the transport of the resultant smoke across the United States and beyond.

“The fact that these fires are emitting so much pollution into the atmosphere that we can still see thick smoke over 8,000 kilometers (4,970 miles) away reflects just how devastating they have been in their magnitude and duration,” CAMS Senior Scientist Mark Parrington said in a statement.

CAMS said it uses satellite observations of aerosols, carbon monoxide and other constituents of smoke to monitor and forecast its movement through the atmosphere.

Eight deaths have been confirmed during the past week in Oregon, which became the latest and most concentrated hot spot in a larger summer outbreak of fires across the entire western United States. The Pacific Northwest was hardest hit.

The fires roared to life in California in mid-August, and erupted across Oregon and Washington around Labor Day last week, many of them sparked by catastrophic lightning storms and stoked by record-breaking heat waves and bouts of howling winds.

Weather conditions improved early this week, enabling firefighters to begin to make headway in efforts to contain and tamp down the blazes.

The California Department of Forestry and Fire Protection (CalFire) said 16,600 firefighters were still battling 25 major fires on Tuesday, after achieving full containment around the perimeter of other large blazes.

Firefighters in the San Gabriel Mountains just north of Los Angeles waged an all-out campaign to save the famed Mount Wilson Observatory and an adjacent complex of broadcast transmission towers from flames that crept near the site.

(Reporting by Gabriella Borter, Deborah Bloom, Shannon Stapleton and Adrees Latif; Writing by Will Dunham; Editing by Jonathan Oatis)