The Latest: FDA chief: Sorry for overstating plasma benefits
WASHINGTON –- Food and Drug Administration Commissioner Stephen Hahn on Tuesday apologized for overstating the life-saving benefits of treating COVID-19 patients with convalescent plasma.
Scientists and medical experts have been pushing back against the claims about the treatment since President Donald Trump’s announcement on Sunday that the FDA had decided to issue emergency authorization for convalescent plasma, taken from patients who have recovered from the coronavirus and rich in antibodies.
Trump hailed the decision as a historic breakthrough even though the value of the treatment has not been established. Hahn had echoed Trump in saying that 35 more people out of 100 would survive the coronavirus if they were treated with the plasma. That claim vastly overstated preliminary findings of Mayo Clinic observation.
Convalescent plasma is a century-old approach to treating the flu, measles and other viruses. But the evidence so far has not been conclusive about whether the plasma works for coronavirus, when to administer it and what dose is needed. It also would require a randomized study of some people given the plasma and some not.
HERE’S WHAT YOU NEED TO KNOW ABOUT THE VIRUS OUTBREAK
— British PM Johnson to consider masks at schools
— Spanish Prime Minister offers military for contact tracing
— WHO says reports of Hong Kong man infected twice by coronavirus
— The World Health Organization is cautioning that using blood plasma from COVID-19 survivors to treat other patients is still considered an experimental therapy.
— A Florida judge temporarily blocked Gov. Ron DeSantis from forcing public schools to reopen classrooms, saying the state’s order “disregards safety.”
— Revved by Sturgis Rally, the city is conducting mass coronavirus testing for its 7,000 residents. Health departments in at least six states are trying to track outbreaks from the 10-day rally.
— Follow AP’s pandemic coverage at http://apnews.com/VirusOutbreak and https://apnews.com/UnderstandingtheOutbreak
HERE’S WHAT ELSE IS HAPPENING:
KINGSTON, Jamaica — Jamaica’s Minister of Health says legendary sprinter Usain Bolt has tested positive for the coronavirus.
Minister Christopher Tufton says Bolt was aware of the results and his recent contacts were being traced.
“It is now public knowledge that Mr. Bolt has tested positive. He has been formally notified, I’m told by the authorities,″ Tufton said.
Bolt said on social media Monday that he was awaiting the result of a coronavirus test and was quarantining himself as a precaution.
The 34-year-old retired sprinter, who won Olympic gold in the 100 and 200 meters at the last three games, posted a video on social media. He says there was a surprise birthday party for him and he’s showing no symptoms.
COLUMBIA, Mo. — An associate professor at the University of Missouri has been fired after an online class exchange in which he responded to a student who said he was from Wuhan, China, “Let me get my mask on.”
The Columbia Missourian reported that Joel Poor was relieved of his teaching duties on Monday after the comment was posted on Twitter. Poor was leading an online marketing class. In the video, he asks if any students are from outside the U.S. A student says he is from China.
Poor apologized in an email and said the reference was meant as a joke. But many students replied to the tweet that they found the comment racist and xenophobic.
A university spokesman said the comment was reported to the Office of Civil Rights and Title IX.
LONDON — British Prime Minister Boris Johnson says his government is ready to advise high school students in England to wear face masks “in some contexts” if the medical evidence deems it necessary in containing the spread of the coronavirus.
His government, which oversees schools in England, has come under increasing pressure to change its advice on masks in certain school settings following the decision by the Scottish government to require students over 12 to wear masks.
Johnson says, “if we need to change the advice, then of course we will.”
Schools in England are due to reopen in the upcoming weeks.
STOCKHOLM — The Swedish health agency says at least 3,700 people have mistakenly been given a positive coronavirus result after using a deficient self-administered test kit.
Karin Tegmark Wisell of Sweden’s Public Health Agency says two Swedish laboratories tested the swabs that gave the wrong answer. She says, “Follow-up tests have identified the shortcoming.”
Tegmark Wisell says the flaw “sends a signal that one must constantly work with quality.”
She says those who self-administered the tests had “mild symptoms” or were “asymptomatic” people who haven’t developed symptoms, and those given the wrong answer would be contacted.
The PCR test, one of the two tests used to diagnose coronavirus, swabs the throat and nose to detect the strain of coronavirus.
Sweden on Tuesday reported two more deaths, bringing the confirmed total to 5,814.
THE HAGUE, Netherlands —The Dutch public health institute says coronavirus infections in the Netherlands declined by 425 to 3,588 in the past week.
The percentage of positive tests also fell from 3.5% to 2.5%.
The declines in the institute’s weekly report Tuesday came after stern warnings from Prime Minister Mark Rutte that the country faced a possible second lockdown if people didn’t stick to social distancing, hygiene and other measures aimed at reining in the spread of the virus.
While infections trended downward, the number of hospital admissions and deaths in the past week rose compared to a week earlier.
Authorities confirmed 32 virus deaths last week, bringing the Dutch death toll to 6,207.
MADRID — Spanish Prime Minister Pedro Sánchez has offered officials running the country’s 17 regions help from the military to conduct coronavirus contact tracing.
He has pledged to declare regional emergency orders if the expansion of the pandemic continues, facilitating regional officials’ ability to issue lockdowns and restrict mobility.
Sánchez says the infection rate is “preoccupying” but called it “far from the situation in mid-March,” when the government imposed a state of emergency.
Spain is grappling to control transmission of the virus, with a new wave hitting the country only days before the opening of the school year. Sánchez encouraged Spaniards to download a contact-tracing mobile app that the government is rolling out.
More than 400,000 people have been infected since the onset of the epidemic and at least 28,872 have died from the coronavirus. However, the figure doesn’t capture many who died without being tested.
MILWAUKEE — Milwaukee Public Schools officials have suspended the start of regular-season fall sports indefinitely due to the coronavirus.
Administrators say the decision was made for the safety of athletes, staff and fans.
MPS athletics director Bobbie Kelsey says district officials understand “the disappointment and frustration” with the delay in the start of sports, but say the district “must always make responsible decisions when it comes to the health of our athletes and fans.”
Milwaukee Public Schools officials say the district will consider how low- to high-contact sports affect athletes but says it will not operate sports until it can be done safely.
HONG KONG — Hong Kong will ease some social distancing measures later this week, allowing beauty salons and cinemas to reopen and relaxing an evening dine-in ban, as daily coronavirus infections in the city dwindled.
Restaurants now banned from providing dine-in services after 6 p.m. will be allowed to serve customers until 9 p.m. starting Friday. Businesses such as cinemas, beauty salons and some outdoor sports venues will be allowed to reopen, and residents will no longer be required to wear masks when exercising outdoors or while in country parks.
“Under the new normal, it is not possible for us to wait until there are no more local cases before relaxing the social distancing measures,” Sophia Chan, Hong Kong’s health minister said in a news conference on Tuesday.
The semi-autonomous southern Chinese city had seen a surge in coronavirus infections in July, leading the government to implement its toughest social-distancing measures yet, which included limiting public gatherings to two people.
Since then infections have gradually dwindled, with the city reporting just nine infections as of Monday, the first time in more than a month that cases have fallen to single-digits. Hong Kong has recorded 4,692 infections, with 77 deaths.
Hong Kong will implement voluntary, universal community testing for up to two weeks from Sept. 1 to detect asymptomatic patients.
BERLIN — The World Health Organization says reports that a Hong Kong man became infected twice with the coronavirus provide important information for scientists studying immunity and developing a vaccine.
A spokeswoman for the U.N. health agency said Tuesday that the unpublished study from Hong Kong offers the first “clear documentation” that reinfection with the virus that causes COVID-19 is possible, but cautioned that the number of such cases is likely very small.
Margaret Harris noted that the case in Hong Kong was just one in 23 million lab-confirmed coronavirus infections worldwide so far.
“We will probably see other documented cases, but it seems to be not a regular event,” she told reporters. “We would have seen many more cases.”
Harris said the case would help researchers understand how the human body builds up immunity to the virus.
“It is not the same as the immune protection that a vaccine provides,” she added, noting that part of the development of vaccines involves ensuring that they confer immunity.
“With the vaccine, you ideally want stronger immunity,” Harris said. “That’s one of the things you’re looking for when you’re studying what sort of immunity your candidate vaccine stimulates.”
LONDON — High school students in Scotland will have to wear face coverings in corridors and other communal areas from Monday, a move that is likely to pile pressure on the other constituents of the United Kingdom, including England, to follow suit.
The country’s education secretary, John Swinney, said the Scottish government is giving “obligatory guidance” to students aged 12 and above to wear face coverings when moving around schools.
He also told the BBC that individual exemptions could be granted for health reasons and that masks should be worn on school buses.
Within the U.K., Scottish schools reopened first, followed by those in Northern Ireland. Schools in England are Wales are due to reopen in September.
The British government, which runs schools in England, has said there are no plans to review the guidance on face coverings in school, arguing that it would ”obstruct communication between teachers and pupils.”
Scotland has often led the way during the pandemic on the wider use of face coverings. It, for example, mandated their use in shops after they reopened weeks before England.
LONDON — AstraZeneca says it has begun testing a new antibody-based drug for the treatment and prevention of COVID-19.
The company said Tuesday that the trial would assess the safety and tolerability of a drug known as AZD7442, which combines two monoclonal antibodies, or immune system proteins that are created in the laboratory and seek to mimic natural antibodies. AZD7442 was developed by Vanderbilt University Medical Center in Nashville, Tennessee.
The trial, which involves 48 adults in the U.K., is the first time AZD7442 has been tested on humans. If it proves safe, the drug will move on to further trials to determine whether it is effective in prevention and treatment of COVID-19.
“This combination of antibodies, coupled to our proprietary half-life extension technology, has the potential to improve both the effectiveness and durability of use in addition to reducing the likelihood of viral resistance,” said Mene Pangalos, executive vice president of biopharmaceutical research at AstraZeneca.
The treatment is based on antibodies from people who recovered from COVID-19.
BERLIN — Germany is warning against travel to the Paris region and part of southeastern France as coronavirus infections rebound.
The warning against nonessential travel issued by the foreign ministry on Monday evening came as Germany’s national disease control center added the Ile-de-France and Provence-Alpes-Cote d’Azur regions to a growing list of “risk areas.”
The list currently includes most of the world outside the European Union. Inside the EU, it now includes all of Spain apart from the Canary Islands, parts of Croatia, Bulgaria, Romania and Belgium, and the two French regions. Luxembourg was recently dropped from the list.
People arriving in Germany from “risk areas” are required to undergo virus tests and self-quarantine until the results arrive.
NEW DELHI — India has reported more than 60,000 new infections in the last 24 hours, taking the country’s total to 3.17 million.
The Health Ministry on Tuesday also reported 848 deaths in the past 24 hours, taking total fatalities up to 58,390.
Meanwhile, India’s recovery rate has reached nearly 76% as more than 2.4 million people affected by the virus have been discharged from hospitals. The Health Ministry said that 66,550 patients — the highest in a day — recovered from the virus in the last 24 hours.
The Health Ministry said the country’s COVID-19 tests per million has risen sharply to 26,016 as cumulative tests surged to nearly 36 million.
In June, India began using cheaper, faster but less accurate tests to scale up testing. Authorities have rationed the use of the more precise molecular tests that detect the genetic code of the virus. Nearly a third of the tests India is using now are the less accurate ones that screen for antigens, or viral proteins. They require frequent retesting, which isn’t always happening.
UNITED NATIONS — The United Nations chief says the tourist industry has been devastated by the COVID-19 pandemic, with $320 billion lost in exports in the first five months of the year and over 120 million jobs at risk.
Secretary-General Antonio Guterres said in a policy briefing and video address released Tuesday that tourism is the third-largest export sector, behind fuels and chemicals, and accounted for 7% of trade last year.
“It employs one in every 10 people on Earth and provides livelihoods to hundreds of millions more,” he said. “It boosts economies. … It allows people to experience some of the world’s cultural and natural riches and brings people closer to each other, highlighting our common humanity.”
But the U.N. chief said that in the first five months of 2020, because of the coronavirus pandemic, international tourist arrivals decreased by more than half.
Guterres said the tourism impact of COVID-19 has been a “major shock” for richer developed nations “but for developing countries, it is an emergency, particularly for many small island developing states and African countries.”
Tourism for some of those countries represents over 20% of their GDP, he said.
SEOUL, South Korea — South Korea is closing schools and switching back to remote learning in the greater capital area as the country counted its 12th straight day of triple-digit daily increases in coronavirus cases.
Education Minister Yoo Eun-hae said Tuesday that at least 193 students and teachers were found infected over the past two weeks in the Seoul metropolitan region, where a viral surge has threatened to erase the country’s hard-won epidemiological gains.
South Korea’s Centers for Disease Control and Prevention reported 280 new cases of COVID-19, pushing the 12-day total to 3,175. The country’s caseload is now at 17,945, including 310 deaths.
Yoo said most children at kindergartens, elementary, middle and high schools will receive online classes at least until Sept. 11. High-school seniors will continue to go to school so their studies are not disrupted ahead of the crucial national college exams.
The country delayed the start of the school year for weeks because of an outbreak in the southeast in spring before proceeding with phased reopenings beginning in May.
BEIJING — Beijing universities are preparing to administer virus tests to students returning to the city’s campuses.
The cost of testing all 600,000 students will be born by the universities themselves, according to the Beijing Municipal Education Commission.
University classes are scheduled to begin Sept. 9. Roughly 75 percent of Chinese students in lower grades returned to class as of last month, many on staggered schedules. The rest are expected to return by this week or on Sept. 1.
China’s National Health Commission on Tuesday reported no new local infections for a ninth straight day and said 14 new cases were found in travelers arriving from abroad. The northwestern city of Urumqi, the center of China’s most recent major outbreak, was relaxing restrictions on some residential compounds after several days of no new local infections.
MELBOURNE, Australia — Australian hot spot Victoria state has recorded an increase in new coronavirus cases, although health authorities are confident infections are continuing to trend down.
Victoria’s Health Department on Tuesday reported 148 new COVID-19 infections in the latest 24-hour period and eight deaths. Victoria reported 116 new cases and 15 deaths on Tuesday. That was the lowest daily tally of new cases since 87 were reported on July 5. The daily count has been as high as 725 news cases in early August.
State capital Melbourne is around half way through a six-week lockdown.