Moderna expects to start late-stage COVID-19 vaccine trial on July 27

NEW YORK (Reuters) – Moderna Inc said on Tuesday it plans to start a late stage clinical trial for its COVID-19 vaccine candidate on or around July 27, according to its listing for the phase 3 study at clinicaltrials.gov.

Moderna said it will conduct the trial at 87 study locations, all in the United States.

The experimental vaccine will be tested in 30 states and Washington, D.C. Around half of the study locations are in hard-hit states like Texas, California, Florida, Georgia, Arizona and North and South Carolina.

The United States has reported record numbers of new coronavirus cases in recent days, with much of the surge coming from those states.

The federal government is supporting Moderna’s vaccine project with nearly half a billion dollars and has chosen it as one of the first to enter large-scale human trials.

Tensions between the company and government scientists contributed to a delay of the trial launch, Reuters reported earlier this month.

Shares of Moderna rose about 2.5% on Nasdaq at midday.

(Reporting by Michael Erman, Editing by Franklin Paul and Richard Chang)

U.S. tops 3 million known infections as coronavirus surges

By Callaghan O’Hare and Lisa Shumaker

HOUSTON (Reuters) – The U.S. coronavirus outbreak crossed a grim milestone of over 3 million confirmed cases on Tuesday as more states reported record numbers of new infections, and Florida faced an impending shortage of intensive care unit hospital beds.

Authorities have reported alarming upswings of daily caseloads in roughly two dozen states over the past two weeks, a sign that efforts to control transmission of the novel coronavirus have failed in large swaths of the country.

California, Hawaii, Idaho, Missouri, Montana, Oklahoma and Texas on Tuesday shattered their previous daily record highs for new cases. The biggest jumps occurred in Texas and California, the two largest U.S. states, with more than 10,000 each. About 24 states have reported disturbingly high infection rates as a percentage of diagnostic tests conducted over the past week.

In Texas alone, the number of hospitalized patients more than doubled in just two weeks.

The trend has driven many more Americans to seek out COVID-19 screenings. The U.S. Department of Health and Human Services said on Tuesday it was adding short-term “surge” testing sites in three metropolitan areas in Florida, Louisiana and Texas.

In Houston, a line of more than 200 cars snaked around the United Memorial Medical Center as people waited hours in sweltering heat to get tested. Some had arrived the night before to secure a place in line at the drive-through site.

“I got tested because my younger brother got positive,” said Fred Robles, 32, who spent the night in his car. “There’s so many people that need to get tested, there’s nothing you can do about it.”

Dean Davis, 32, who lost his job due to the pandemic, said he arrived at the testing site at 3 a.m. Tuesday after he waited for hours on Monday but failed to make the cutoff.

“I was like, let me get here at 3, maybe nobody will be here,” Davis said. “I got here, there was a line already.”

In Florida, more than four dozen hospitals across 25 of 67 counties reported their intensive care units had reached full capacity, according to the state’s Agency for Health Care Administration. Only 17% of the total 6,010 adult ICU beds statewide were available on Tuesday, down from 20% three days earlier.

Additional hospitalizations could strain healthcare systems in many areas, leading to an uptick in lives lost from the respiratory illness that has killed more than 131,000 Americans to date. At least 923 of those deaths were reported Tuesday, the biggest single-day toll since June 10 but still far fewer than the record 2,806 tallied back in April.

A widely cited mortality model from the University of Washington’s Institute for Health Metrics and Evaluation (IHME) projected on Tuesday that U.S. deaths would reach 208,000 by Nov. 1, with the outbreak expected to gain new momentum heading into the fall.

A hoped-for summertime decline in transmission of the virus never materialized, the IHME said.

“The U.S. didn’t experience a true end of the first wave of the pandemic,” the IHME’s director, Dr. Christopher Murray, said in a statement. “This will not spare us from a second surge in the fall, which will hit particularly hard in states currently seeing high levels of infections.”

‘PRESSURE ON GOVERNORS’

President Donald Trump, who has pushed for restarting the U.S. economy and urged Americans to return to their normal routines, said on Tuesday he would lean on state governors to open schools in the fall.

Speaking at the White House, Trump said some people wanted to keep schools closed for political reasons. “No way, so we’re very much going to put pressure on governors and everybody else to open the schools.”

New COVID-19 infections are rising in 42 states, based on a Reuters analysis of the past two weeks. By Tuesday afternoon, the number of confirmed U.S. cases had surpassed 3 million, affecting nearly one of every 100 Americans and a population roughly equal to Nevada’s.

In Arizona, another hot spot, the rate of coronavirus tests coming back positive rose to 26% for the week ended July 5, leading two dozen states with positivity rates exceeding 5%. The World Heath Organization considers a rate over 5% to be troubling.

The surge has forced authorities to backpedal on moves to reopen businesses, such as restaurants and bars, after mandatory lockdowns in March and April reduced economic activity to a virtual standstill and put millions of Americans out of work.

The Texas state fair, which had been scheduled to open on Sept. 25, has been canceled for the first time since World War Two, organizers announced on Tuesday.

In Ohio, Governor Mike DeWine said the state was ordering people in seven counties to wear face coverings in public starting Wednesday evening.

(Reporting by Callaghan O’Hare in Houston and Lisa Shumaker in Chicago; Additional reporting by Maria Caspani, Gabriella Borter, Caroline Humer and Peter Szekely in New York and Susan Heavey and Jeff Mason in Washington Writing by Paul Simao and Steve Gorman; Editing by Bill Berkrot, Cynthia Osterman, Tom Brown and Leslie Adler)

HHS to open ‘surge’ COVID-19 testing in Florida, Texas, Louisiana

(Reuters) – The U.S. government is creating short-term “surge” testing sites for the novel coronavirus in three metropolitan areas in Florida, Louisiana and Texas to meet demand from rising COVID-19 cases and hospitalizations, the U.S. Department of Health and Human Services (HHS) said on Tuesday.

The program adds testing for 5,000 people per day for a five- to 12-day period and will help identify new cases, particularly among asymptomatic people, and potentially limit the spread of the disease, Assistant Secretary for Health Admiral Brett Giroir said during a call with reporters.

The sites are opening on Tuesday in several locations in the Baton Rouge, Louisiana, area and on Wednesday at multiple sites in the Jacksonville, Florida, area and at one location in Edinburg, Texas.

Florida and Texas are among many U.S. states with high infection rates as a percentage of diagnostic tests conducted over the past week and long testing lines.

After assessing the impact of the testing on the rate of new cases in these areas, the government could deploy such surge testing sites in other locations around the country, Giroir said. He said no decisions have been made yet about other possible sites.

“We need to do this and see what the effect is,” he said.

The U.S. government has largely left testing for COVID-19 to the states after closing down most of the federal testing sites opened in March and April. The surge sites would supplement each state’s own testing plans.

HHS has tapped eTrueNorth, a U.S.-based company that has done community health center testing, for the sites. The tests are free and lab results are available in three to five days.

(Reporting by Caroline Humer in New York and Manojna Maddipatla in Bengaluru; Editing by Shounak Dasgupta and Jonathan Oatis)

Florida shatters records with over 10,000 new COVID-19 cases in single day

By Lisa Shumaker

(Reuters) – Florida shattered records on Thursday when it reported over 10,000 new coronavirus cases, the biggest one-day increase in the state since the pandemic started, according to a Reuters tally.

Outbreaks in Texas, California, Florida and Arizona have helped the United States break records and send cases rising at rates not seen since April.

In June, Florida infections rose by 168% or over 95,000 new cases. The percent of tests coming back positive has skyrocketed to 15% from 4% at the end of May.

Florida, with 21 million residents, has reported more new daily coronavirus cases than any European country had at the height of their outbreaks.

To contain the outbreak, Florida has closed bars and some beaches but the governor has resisted requiring masks statewide in public or reimposing a lock-down.

Only one other state has reported more than 10,000 new cases in a single day. New York recorded 12,847 new infections on April 10, three weeks after the state implemented a strict lock-down that closed most businesses. While the state has relaxed many measures, it requires masks in public and mandates anyone arriving from 16 other U.S. states with high infections self-quarantine for two weeks.

Once the epicenter of the U.S. epidemic, New York saw cases rise by about 6% in June – the lowest rate in the entire country.

(Writing by Lisa Shumaker)

U.S. coronavirus cases rise by 47,000, biggest one-day spike of pandemic

By Paul Simao and Carl O’Donnell

WASHINGTON (Reuters) – New U.S. COVID-19 cases rose by more than 47,000 on Tuesday according to a Reuters tally, the biggest one-day spike since the start of the pandemic, as the government’s top infectious disease expert warned that number could soon double.

California, Texas and Arizona have emerged as new U.S. epicenters of the pandemic, reporting record increases in COVID-19 cases.

“Clearly we are not in total control right now,” Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, told a U.S. Senate committee. “I am very concerned because it could get very bad.”

Fauci said the daily increase in new cases could reach 100,000 unless a nationwide push was made to tamp down the resurgent virus.

“We can’t just focus on those areas that are having the surge. It puts the entire country at risk,” he said.

Fauci said there was no guarantee of a vaccine, although early data had been promising: “Hopefully there will be doses available by the beginning of next year,” he said.

COVID-19 cases more than doubled in June in at least 10 states, including Texas and Florida, a Reuters tally showed. In parts of Texas and Arizona, hospital intensive care beds for COVID-19 patients are in short supply.

More than 126,000 Americans have died from COVID-19 and millions have lost their jobs as states and major cities ordered residents to stay home and businesses closed. The economy contracted sharply in the first quarter and is expected to crater in the second.

‘TRUMP FAILED US’

The European Union has excluded Americans from its “safe list” of countries from which the block will allow non-essential travel beginning on Wednesday.

The fresh rise in cases and hospitalizations has dimmed hopes that the worst of the human and economic pain had passed, prompting renewed criticism of U.S. President Donald Trump as he seeks re-election on Nov. 3.

His rival, Democrat Joe Biden, on Tuesday said that Trump’s “historic mismanagement” of the pandemic cost lives and inflicted more damage than necessary to the U.S. economy.

“It didn’t have to be this way. Donald Trump failed us,” the 77-year-old former vice president said in a speech in Delaware, where he unveiled an updated plan to tackle the pandemic calling for more testing and the hiring of 100,000 contract tracers.

In the past week California, Texas and Florida have moved to close recently reopened bars, which public health officials believe are likely one of the larger contributors to the recent spikes.

On Tuesday, New York, New Jersey and Connecticut added travelers from California and seven other states to those who must self-quarantine for 14 days upon arrival. Texas and Florida were named last week.

South Carolina also has also emerged as a hot spot, reporting a record single-day increase of 1,755 cases on Tuesday.

In Texas, where the number of new cases jumped to a one-day record of 6,975 on Tuesday, Houston hospitals said beds were quickly filling up with COVID-19 patients.

Dr. Marc Boom, chief executive of Houston Methodist Hospital, told CNN on Tuesday that his hospital beds have seen a “very significant” increase in COVID-19 patients, although the death rate has lowered.

Boom said he was worried about Independence Day celebrations this weekend, when Americans traditionally flock to beaches and campgrounds to watch fireworks displays.

“Frankly it scares me,” he said.

 

(Reporting by Carl O’Donnell, Trevor Hunnicutt, Simon Lewis, Saumya Joseph, Brad Brooks, Susan Heavey, Maria Caspani and Paul Simao; Writing by Nathan Layne and Dan Whitcomb; Editing by Bill Berkrot and Richard Pullin)

California, Texas see record COVID-19 surges, Arizona clamps down

By Dan Whitcomb and Maria Caspani

LOS ANGELES (Reuters) – California and Texas both marked record spikes in new COVID-19 infections on Monday, a Reuters tally showed, as Los Angeles reported an “alarming” one-day surge in America’s second-largest city that put it over 100,000 cases.

Los Angeles has become a new epicenter in the pandemic as coronavirus cases and hospitalizations surge there despite California Governor Gavin Newsom’s strict orders requiring bars to close and residents to wear masks in nearly all public spaces.

“The alarming increases in cases, positivity rates and hospitalizations signals that we, as a community, need to take immediate action to slow the spread of COVID-19,” Barbara Ferrer, director of public health for Los Angeles County, said in a statement announcing the sharp rise.

“Otherwise, we are quickly moving toward overwhelming our healthcare system and seeing even more devastating illness and death,” Ferrer said.

Los Angeles Mayor Eric Garcetti announced a “hard pause” on when movie theaters, theme parks and other entertainment venues can reopen. Los Angeles County is the biggest movie theater market in the United States.

Los Angeles County said its beaches will be closed for the Independence Day weekend and fireworks displays will be banned.

Statewide positive tests for COVID-19, the respiratory illness caused by the virus, rose by at least 7,418 in California Monday to nearly 223,000, the biggest one-day increase since tracking began. Los Angeles County, with a population of 10 million, has recorded 100,000 cases.

California is among a number of U.S. states including Florida, Texas and Arizona battling a new wave of infections as the nation emerges from weeks of clamp-downs on residents and businesses. COVID-19 infections in Texas rose by 6,545 on Monday to nearly 160,000, also setting a record for a one-day increase.

Nationally, cases rose by more than 40,000, for the fourth time in the past five days.

ARIZONA HIT HARD

Arizona Governor Doug Ducey on Monday ordered the closure of bars, nightclubs, gyms, movie theaters and water parks for at least 30 days. Ducey also delayed the start of public schools until at least Aug. 17.

“Our expectation is that next week our numbers will be worse,” Ducey said at an afternoon news conference. Vice President Mike Pence will travel to Phoenix on Wednesday to discuss efforts to fight the pandemic’s resurgence.

Texas and Florida ordered the closure of all their recently reopened bars on Friday.

New Jersey Governor Phil Murphy said on Monday indoor dining will not resume on Thursday as planned and would be postponed indefinitely.

In Kansas, Governor Laura Kelly imposed a statewide mandate requiring the wearing of masks in public spaces, which she said was necessary to avoid another shutdown.

Beaches in Florida’s Broward County and Palm Beach County will not open for the July 3-5 holiday weekend, officials said on Sunday, a blow to residents hoping to celebrate Independence Day there. Miami-Dade County has also announced beach closures for the holiday weekend.

AMC, the largest U.S. movie theater chain, on Monday said it was pushing back the reopening of its theaters to July 30 from July 15.

In June, 22 U.S. states reported record increases in new cases, often multiple times, including Alaska, Arkansas, Montana, New Mexico, North Carolina, Oregon and Utah.

The city of Jacksonville, Florida, venue for part of the Republican nominating convention in August, said on Twitter it would be requiring masks in public starting later on Monday.

White House press secretary Kayleigh McEnany said on Monday that Trump “has no problem with masks and to do whatever your local jurisdiction requests.”

The New York Times reported on Monday that 43% of U.S. deaths from COVID-19 were linked to nursing homes and long-term care facilities. The paper cited its own tracking database.

(Reporting by Dan Whitcomb in Los Angeles and Maria Caspani in New York; Additional reporting by Susan Heavey and Doina Chiacu in Washington, Nathan Layne in Wilton, Connecticut, Lisa Shumaker in Chicago and Brad Brooks in Austin; Writing by Grant McCool and Dan Whitcomb; Editing by Howard Goller, Bill Berkrot, Cynthia Osterman, Leslie Adler and Jane Wardell)

Where COVID-19 is spreading fastest as U.S. cases rise 46% in past week

By Chris Canipe and Lisa Shumaker

(Reuters) – The United States saw a 46% increase in new cases of COVID-19 in the week ended June 28 compared to the previous seven days, with 21 states reporting positivity test rates above the level that the World Health Organization has flagged as concerning.

Nationally, 7% of diagnostic tests came back positive last week, up from 5% the prior week, according to a Reuters analysis of data from The COVID Tracking Project, a volunteer-run effort to track the outbreak.

The World Health Organization considers a positivity rate above 5% to be a cause for concern because it suggests there are more cases in the community that have not yet been uncovered.

Arizona’s positivity test rate was 24% last week, Florida’s was 16%, and Nevada, South Carolina and Texas’s were all 15%, according to the analysis.

Thirty-one states, mostly in the U.S. West and South, reported more new cases of COVID-19 last week compared to the previous week, the analysis found. Florida, Louisiana, Idaho and Washington state saw new cases more than double over that period.

In response to the new infections, Louisiana and Washington state have temporarily halted the reopening of their economies. Washington also mandated wearing masks in public.

Florida ordered all bars and some beaches to close. Idaho was not immediately available for comment.

Nationally, new COVID-19 cases have risen every week for four straight weeks. While part of that increase can be attributed to a 9% expansion in testing, health experts have also worried about states relaxing stay-at-home orders that had been credited with curbing the outbreak.

State officials across the country report the same trend in the new cases: People under 35 years old are going to bars, parties and social events without masks, becoming infected, and then spreading the disease to others.

Cases continue to decline in Northeast states, but some Midwest states that had new infections under control are seeing cases once again rise, including Illinois, Michigan and Pennsylvania.

 

(Reporting by Chris Canipe in Kansas City, Missouri, and Lisa Shumaker in Chicago; Editing by Tiffany Wu)

‘A recipe for disaster,’ U.S. health official says of Americans ignoring coronavirus advice

By Susan Heavey and Doina Chiacu

WASHINGTON Reuters) – A spike in U.S. coronavirus infections is fueled in large part by people ignoring public health guidelines to keep their distance and wear masks, the government’s top infectious disease official said.

A daily surge in confirmed cases has been most pronounced in southern and western states that did not follow health officials’ recommendations to wait for a steady decline in infections for two weeks before reopening their economies.

“That’s a recipe for disaster,” Anthony Fauci, who directs the National Institute of Allergy and Infectious Diseases, told CNN in an interview broadcast on Monday.

“Now we’re seeing the consequences of community spread, which is even more difficult to contain than spread in a well-known physical location like a prison or nursing home or meatpacking place,” Fauci told the cable channel in the interview, which was recorded on Friday.

More than 2.5 million people have tested positive for the coronavirus in the United States and more than 125,000 have died of COVID-19, the respiratory illness it causes, according to a Reuters tally. The U.S. tally is the highest in the world while the global death toll in the pandemic surpassed half a million people on Sunday.

California ordered some bars to close on Sunday, the first major rollback of efforts to reopen the economy in the most populous U.S. state, following Texas and Florida ordering the closure of all their bars on Friday. Arizona and Georgia are among 15 states that had record increases in cases last week.

U.S. Vice President Mike Pence on Sunday pressed Americans to adopt face masks during a trip to Texas and wore one himself, a sharp turnaround for the administration. Republican President Donald Trump has refused to cover his face in public.

Pence and other top health officials were expected to visit Arizona and Florida later this week.

In places where cases are soaring, U.S. health officials are also considering “completely blanketing these communities with tests,” Fauci said, to try to get a better sense of an outbreak.

They would either test groups, or “pools,” of people or have community groups do contact tracing in person rather than by phone. Contact tracing involves identifying people who are infected and monitoring people who may have been exposed and asking them to voluntarily go into quarantine.

Fauci said that he was optimistic that a vaccine could be available by year’s end but that it was unclear how effective it would prove to be, adding that no vaccine would be 100% effective and citing challenges to achieve so-called herd immunity.

The top Republican in the U.S. House of Representatives, Kevin McCarthy, on Monday stressed individual actions to stop the spread of the virus, deflecting criticism from Democrats and some health experts that Trump botched the prevention effort.

“You can’t say the federal government should do everything, and then say the federal government can’t tell the states what to do,” McCarthy told CNBC. “The governors have a big responsibility here but every American has a responsibility. They should wear a mask.”

(Reporting by Susan Heavey and Doina Chiacu in Washington; Writing by Grant McCool; Editing by Howard Goller)

U.S. to ship remdesivir to states including California and Texas with rising COVID-19 cases

NEW YORK (Reuters) – The U.S. government will ship more of Gilead Sciences Inc’s <GILD.O> antiviral treatment remdesivir to states experiencing an increase in COVID-19 cases including California, Texas, Florida and Arizona, according to the Department of Health and Human Services’ website.

The government reallocated remdesivir to states with increasing cases, White House task force coordinator Deborah Birx said during a briefing on Friday.

HHS said on its website that the doses will ship starting Monday and extinguish the full amount of Gilead’s donation of 120,647 treatment courses. It said it would continue to work with Gilead to determine how the company’s anticipated inventory of 2 million doses by year’s end will be allocated.

California will receive 464 cases of 40 vials each, Texas will receive 448 cases of 40 vials, Florida will receive 360 cases of 40 vials and Arizona will receive 356 cases of 40 vials, according to the website.

Gilead donated the courses after the treatment received emergency use authorization from the U.S. Food and Drug Administration last month.

New York, which was one of the hardest hit states initially, was allocated 2,714 cases in total.

(Reporting by Caroline Humer; Editing by Tom Brown)

Texas governor orders bars closed due to coronavirus

(Reuters) – Texas Governor Greg Abbott on Friday ordered the closure of all bars that get 51 percent of their gross receipts from alcohol, except for take-out, and the curbing of other business activity due to surging cases of the novel coronavirus in the state.

“As I said from the start, if the positivity rate rose above 10%, the State of Texas would take further action to mitigate the spread of COVID-19,” Abbott said in a press release, explaining an executive order. “At this time, it is clear that the rise in cases is largely driven by certain types of activities, including Texans congregating in bars.”

(reporting by Jonathan Allen in New York and Nathan Layne in Wilton, Connecticut; Editing by Chizu Nomiyama)