The Latest: US regulators allow remdesivir for hospitalized
FOSTER CITY, California — U.S. regulators are now allowing use of experimental antiviral drug remdesivir for all patients hospitalized with COVID-19, drugmaker Gilead Sciences said Friday.
It said the Food and Drug Administration has expanded its emergency use authorization, which lets doctors administer the IV drug during the pandemic. Until now, that was limited to patients with severe COVID-19.
Foster City, California-based Gilead applied to the FDA on Aug. 10 for formal approval of remdesivir, to be sold under the brand name Veklury.
Gilead said in a statement that the expanded emergency use was based on results of a recent federal study of hospitalized patients with different levels of severity, plus a Gilead study published a week ago. Gilead’s study found that among hospitalized patients with moderate COVID-19, those getting remdesivir were 65% more likely to improve after a five-day treatment course than those just getting standard care.
Remdesivir previously was shown to shorten treatment by about four days for hospitalized patients with severe disease, compared with those getting standard supportive care.
HERE’S WHAT YOU NEED TO KNOW ABOUT THE VIRUS OUTBREAK
— Thousands of U.S. Health departments tell CDC: Reverse testing guidance
— Four people at RNC event in Charlotte test positive for coronavirus
— TikTok celebrities charged with misdemeanors for large parties in LA
— Credibility of FDA and CDC damaged after controversial decisions that outside experts say imply political pressure from the Trump administration.
— Some college towns are dealing with too much partying and too many COVID-19 infections among students.
— Joe Biden and Kamala Harris prepare to travel more as campaign heats up. They’ve worn masks in public and Biden has called on governors to order mask-wearing in their states.
— Follow AP’s pandemic coverage at http://apnews.com/VirusOutbreak and https://apnews.com/UnderstandingtheOutbreak
HERE’S WHAT ELSE IS HAPPENING:
NEW ORLEANS — New Orleans’s youngest public school students will begin returning to classrooms as early as Sept. 14, the city’s school superintendent said Friday as he announced a phased re-opening plan tied to the control of COVID-19.
Henderson Lewis said the plan is for students from prekindergarten through 4th grade to begin returning to schools in phases beginning Sept. 14. Older students will begin returning in October.
“We know that our youngest students have the most to gain from in person learning,” Lewis said.
All of the plans are contingent on current trends indicating the spread of the virus has been successfully limited in the city, Lewis and Dr. Jennifer Avegno, the city’s health officer, said.
The benchmarks include a continued new-case rate of less than 50 per day in the city.
Statewide, the health department reported more than 600 new confirmed cases Friday, bringing the total to at least 146,243, with nearly 128,000 presumed recovered. Thirty newly reported deaths brought the virus-related death toll to at least 4,741.
TOPEKA, Kansas — Fueled in part by college students returning to classes, Kansas has set another pandemic record for the seven-day increase in coronavirus cases, with the surge prompting a school district to put the brakes on some fall sports and another to extend its mask ordinance.
Statewide, the number of new reported cases rose by 1,111 from Wednesday to Friday, bringing the total to 41,048. The state Department of Health and Environment also reported an additional six COVID-19-related deaths, to put the pandemic total at 443.
The average for the seven days ending Friday was 599, 3.6% more than the previous record of 578 for the seven days ending Wednesday. The state also reported 16 clusters in colleges and universities with 189 cases.
Gov. Laura Kelly called the most recent spike in coronavirus cases “horrendous” and said her administration is looking into why it has occurred. But she said outbreaks on college campuses and fraternities and sororities are a factor.
SANTA FE, N.M. — Political party delegates from New Mexico who traveled to the Republican National Convention or President Donald Trump’s speech at the White House are obligated to self-quarantine for 14 days as they return home under a state public health order.
A spokeswoman for Democratic Gov. Michelle Lujan Grisham said Friday that the delegates fall under a self-quarantine provision for most travelers as they enter or return to New Mexico.
Delegate and GOP national committee member Tina Dziuk says she will abide by the state health order and self-quarantine after attending the White House speech, where many people ignored federal guidelines about keeping distance, avoiding crowds and wearing masks to fight the spread of the coronavirus.
Dziuk says she wore a mask to the White House and that New Mexico delegates took responsible steps at the convention to manage potential virus exposure by wearing masks, undergoing COVID-19 test and carrying contract-tracing devices.
The self-quarantine mandate did not apply to New Mexico Democrats, including the governor, because they attended their party’s national convention remotely by video feed without leaving the state.
OTTAWA — Canada is extending restrictions on travelers arriving in the country for another month to help combat the spread of COVID-19, Public Safety Minister Bill Blair said on Twitter Friday.
New arrivals in Canada are required to quarantine for 14 days if they don’t show COVID-19 symptoms or isolate for 14 days if they do.
“Our government is extending the existing restrictions on international travel to Canada by one month — until September 30, 2020 — to limit the introduction and spread of COVID-19 in our communities,” Blair in a Tweet.
“Canadian citizens and permanent residents returning to Canada will continue to be subject to strict quarantine measures.”
Canadian citizens and permanent residents who are returning home to Canada will continue to be subjected to strict quarantine measures.
Canada has taken steps to stem the flow of foreign nationals into the country by restricting discretionary travel, including for tourism, recreation and entertainment.
LANSING, Mich. — Michigan has crossed the threshold of 100,000 cases of the coronavirus confirmed since March.
Deaths related to COVID-19 reached 6,446 after six more were recorded, the state health department said Friday.
Most people recover from the virus. It can cause mild or moderate symptoms, such as fever and cough, that clear up in two to three weeks. But for some, especially older adults and people with existing health problems, it can cause pneumonia and lead to death.
Dr. Dennis Cunningham at McLaren Health Care said the number of people who were infected is likely higher than the confirmed cases of 100,699. He noted that enough tests weren’t available in the early weeks of the outbreak.
“We just haven’t had enough testing supplies to test every asymptomatic person, either,” Cunningham told MLive.com.
RENO, Nev. — Nevada officials are reporting what may be the first documented case of coronavirus reinfection in the United States, following similar reports earlier this week from Hong Kong and Europe.
A 25-year-old Reno man with mild COVID-19 symptoms initially was found to have the virus in April, recovered and tested negative twice, and then tested positive again in June. He was much sicker the second time, with pneumonia that required hospitalization and oxygen treatment.
Genetic tests from each episode showed that viruses were similar in major ways but differed in at least 12 spots that would be highly unlikely from natural evolution of the bug if the man had it continuously rather than being infected a second time, said Mark Pandori, director of the Nevada State Public Health Laboratory.
A parent the man lives with also tested positive in June, so it’s possible he acquired a new infection that way.
The findings have not yet been published or reviewed by other scientists, but were posted on a research site.
The case “should cement in our minds that there’s no such thing … as invulnerability” to the virus, even if you’ve already had it, Pandori said. “One can get sick again and that illness can be quite severe.”
LITTLE ROCK, Ark.— Arkansas’ top health official on Friday said the state is beginning to see coronavirus outbreaks at its college campuses as the number of confirmed cases statewide rose by 838. The Department of Health said at least 59,583 people have tested positive for the virus. The department said 5,496 of those are active cases that don’t include people who have died or recovered. The number of people who have died from COVID-19, the illness caused by the virus, rose by 17 to 756. The number of people hospitalized dropped by 26 to 407.
Dr. Jose Romero, the state’s health secretary, said testing events are planned at universities where officials are seeing outbreaks. In one instance, Romero said, one-third of 75 people tested recently at the University of Arkansas at Fayetteville tested positive. “That is an alarming amount,” he said.
Gov. Asa Hutchinson said 181 of the new cases reported Friday came from correctional facilities, most from the state’s Varner Unit.
ITASCA, Ill. — The American Academy of Pediatrics has joined critics calling for the federal Centers for Disease Control and Prevention to reverse its updated position on COVID-19 testing.
“In the battle against the COVID-19 pandemic, we must be led by the science, in a fully transparent process that engages the public’s trust and confidence,” the academy said in a statement. “The inexplicable decision by the U.S. Centers for Disease Control and Prevention to advise against testing individuals who have been exposed to the virus but who are asymptomatic is a dangerous step backward in our efforts to control this deadly virus.”
The academy noted that children often show few or no symptoms, but they are not immune to the virus. “Testing exposed individuals who may not yet show symptoms of COVID-19 is crucial to contact tracing, which helps identify and support other people who are at risk of infection,” the academy said.
SACRAMENTO, Calif. — California Gov. Gavin Newsom is announcing a new process for reopening businesses that is slower and more gradual than what the state tried earlier this summer.
The new rules announced Friday create a four-tier, color-coded system that counties will move through based on their number of cases and percentage of positive tests. It will rely on two metrics to determine which tier a county is in: case rates and the percentage of positive tests.
California has the most confirmed virus cases in the nation, with nearly 700,000 and third-most deaths at 12,550.
SANTA FE, N.M. — Political party delegates from New Mexico who traveled to the Republican National Convention and President Donald Trump’s speech at the White House are obligated to self-quarantine as they return home to a state that requires face masks and limits public gatherings. A spokeswoman for Democratic Gov. Michelle Lujan Grisham on Friday said the delegates are subject to the state’s current 14-day self-quarantine provision that applies to most travelers as they enter or return to New Mexico. The precaution is based on the incubation period of the coronavirus. New Mexico is relaxing its stay-at-home order gradually as the spread of COVID-19 slows across much of the state.
LOS ANGELES — TikTok celebrities Bryce Hall and Blake Gray were charged after hosting two parties in the Hollywood Hills despite a ban on large gatherings during the coronavirus pandemic.
The Los Angeles city attorney’s office says prosecutors filed misdemeanor charges against Hall and Gray. They are accused of violating the city’s pandemic health order and a party house ordinance. Penalties include a year in jail and up to $2,000 in fines.
The internet celebrities share the home and have millions of followers on TikTok. Los Angeles police responded to both parties, which featured several hundred guests, and issued citations.
Mayor Eric Garcetti says with bars closed in town, large house parties can become “super spreaders.” City Attorney Mike Feuer says he isn’t aware of any coronavirus cases linked to their parties. However, he says with a public health crisis and so many followers, they shouldn’t be “violating the law and posting videos about it.”
Los Angeles County has recorded nearly 237,000 coronavirus cases and more than 5,700 confirmed deaths, making it the hardest-hit county in the state.
DETROIT — The Detroit school district reached a deal to start the academic year, a week after members of the Detroit Federation of Teachers authorized a strike over coronavirus safety.
The deal includes capping classroom size at 20 students, offering extra pay to teachers and checking daily temperatures of students and staff, officials say. Classes start Sept. 8.
Superintendent Nikolai Vitti says the “agreement signals we will work together to provide equitable education opportunities for our children and families.”
The Detroit Public Schools Community District is the largest in Michigan with nearly 50,000 students. Despite the agreement with the union, some teachers don’t want to return to in-class instruction, citing the virus risk. The district say teachers will have the option of teaching online, though nearly all schools with have some in-person instruction.
The district say teachers could earn an extra $3,000 for the year for working in classrooms.
Michigan has nearly 100,000 coronavirus cases and 6,440 confirmed deaths.
THE HAGUE, Netherlands — The Dutch government is extending financial support into next year for businesses and workers hit by the deep recession caused by the coronavirus pandemic.
Prime Minister Mark Rutte says the latest support package, his government’s third virus bailout, amounts to more than 10 billion euros ($12 billion) to protect companies and safeguard jobs threatened by the economic downturn.
He says the new aid package also aims to help those whose business or job didn’t survive.
He says, “in that case, it’s very important that people are helped from one job to another.”
The coalition government’s current coronavirus aid package is due to end in October.
ROME — Italy had the highest one-day increase in coronavirus cases since May, with 1,462 confirmed cases in the previous 24 hours.
The Health Ministry says Lombardy, the region hardest hit in Italy in the pandemic, had the most cases at 316 on Friday.
Early in the outbreak, the average age of infected people in Italy was close to 70. Last week, the average age was 29, with most of the cases in travelers returning from vacations.
Italy has 265,409 total confirmed cases in the pandemic. With nine more deaths, the known toll in Italy rose to nearly 35,500.
MANAGUA, Nicaragua — More than 60,000 of the Nicaraguan refugees and asylum seekers in Costa Rica are going hungry during the coronavirus pandemic, the U.N. Refugee Agency said Friday.
Before the COVID-19 pandemic struck, 93% of the Nicaraguan refugees in Costa Rica reported steady work-related income. By the end of July, that figure had dropped to 59% as the pandemic froze much of the country’s economic activity, the U.N. agency said.
“This leaves many also at risk of eviction and homelessness,” the statement said. One fifth of the refugees surveyed say they didn’t know where they would live in the next month.
BUDAPEST, Hungary — The Hungarian government says it will close its borders to foreigners from Sept. 1.
Hungarians returning from abroad will need to quarantine for two weeks unless they twice test negative for the coronavirus. Gergely Gulyas, Prime Minister Viktor Orban’s chief of staff, says some exceptions would be made for foreigners, but he didn’t provide details.
Hungary has reported 5,511 coronavirus cases and 614 confirmed deaths. It registered 132 new cases on Friday, the second-highest figure since the start of the pandemic.