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WASHINGTON — A group of medical experts advising the National Institutes of Health says there is not enough evidence to recommend for or against the use of plasma therapy for patients hospitalized with COVID-19.
The non-endorsement by government advisers comes a week after the Food and Drug Administration granted emergency authorization to the treatment. That decision followed threats from President Donald Trump about the slow pace of FDA’s review, raising concerns that the agency felt pressure to greenlight the therapy.
So-called convalescent plasma is taken from patients who have recovered from the coronavirus and is rich in disease-fighting antibodies. But its use against COVID-19 has not been studied in rigorous patient trials.
The NIH panel says the plasma shouldn’t be considered “standard of care” treatment, due to the lack of data confirming its safety and effectiveness.
The FDA granted its emergency use based on preliminary results gathered from tens of thousands of patients tracked by the Mayo Clinic. The decision merely means that the treatment’s potential benefits outweigh its risks.
But the Mayo study doesn’t have the type of controls needed to draw conclusions about clinical benefits, including overall survival. FDA Commissioner Stephen Hahn was forced to backtrack last week after he overstated the potential life-saving effect suggested by the data.
NIH’s experts urged doctors and patients to enroll in proper studies of the plasma.
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HERE’S WHAT YOU NEED TO KNOW ABOUT THE VIRUS OUTBREAK
— US federal officials to ship rapid coronavirus tests for schools
— NYC delays start of school for more prep time for virus safety measures
— Virus or not, it’s time for class again across Europe
— Apple and Google want more U.S. states to adopt their phone-based approach for tracing and curbing the spread of the coronavirus, building more of the necessary technology directly into phones.
— The Big Ten Conference, already in court and under pressure from players and parents over its decision to cancel fall football, and its new commissioner are now hearing from President Donald Trump.
— Hungry and bored at home? A San Francisco nightclub will bring the food, booze and a drag show to you during the coronavirus pandemic.
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Follow AP’s pandemic coverage at http://apnews.com/VirusOutbreak and https://apnews.com/UnderstandingtheOutbreak
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HERE’S WHAT ELSE IS HAPPENING:
NEW YORK — A handful of the dozens of experimental coronavirus vaccines in human testing have reached the last and biggest hurdle — looking for the needed proof they really work.
A U.S. advisory panel suggested Tuesday a way to ration the first limited doses once a vaccine wins approval. AstraZeneca announced Monday its vaccine candidate has entered the final testing stage in the U.S. The Cambridge, England-based company said the study will involve up to 30,000 adults from various racial, ethnic and geographic groups.
Two other vaccine candidates began final testing this summer in tens of thousands of people in the U.S. One was created by the National Institutes of Health and manufactured by Moderna Inc., and the other developed by Pfizer Inc. and Germany’s BioNTech.
NIH Director Francis Collins tweeted his agency “is supporting several vaccine trials since more than one may be needed.”
There’s no guarantee that any of the leading candidates will pan out — and the bar is higher than for COVID-19 treatments, because these vaccines will be given to healthy people. Final testing, experts stress, must be in large numbers of people to know if they’re safe enough for mass vaccinations.
“The first vaccines that come out are probably not going to be the best vaccines,” Dr. Nicole Lurie, who helped lead pandemic planning under the Obama administration, said at a University of Minnesota vaccine symposium.
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WASHINGTON — A new member of the White House coronavirus task force says claims that he’s pushing herd immunity as a response to the pandemic are an “overt lie.”
Dr. Scott Atlas says in an interview on SiriusXM’s “The Michael Smerconish Program” that he has never advocated a herd immunity strategy to President Donald Trump or anyone in the administration or task force.
The Washington Post reported Monday that Atlas — who recently was added to the task force — has been urging Trump’s top medical advisers to adopt herd immunity as a strategy for fighting the virus.
Herd immunity would involve allowing most Americans to become infected with the virus that causes COVID-19 so people can build up their immunity to it.
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TALLAHASSEE, Fla. — Florida Gov. Ron DeSantis says he’ll lift the state ban on visiting nursing homes that’s prevented seniors from seeing family since mid-March because of the coronavirus.
DeSantis says he’s following recommendations from a nursing home task force that’s met in recent weeks.
The task force recommends the nursing homes allow family members to visit no more than two at a time and wear protective gear that includes masks. Facilities would need to go 14 days without any new cases of coronavirus among staff or residents to allow the visits.
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LONDON — Scotland’s leader has announced new lockdown restrictions for the country’s most populous city, Glasgow, following a spike in coronavirus infections.
First Minister Nicola Sturgeon says people in Glasgow, and the nearby local authorities of West Dunbartonshire and East Renfrewshire, shouldn’t host people from other households for two weeks.
She says the Scottish government could go farther if people don’t abide by the new limitations. The number of people affected is estimated at 250,000.
Sturgeon says in the three targeted areas, the infections have largely increased from household gatherings. She adds the new measures were “proportionate” with the impact on schools, jobs and the economy.
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WASHINGTON — Federal officials will begin shipping tens of millions of rapid coronavirus tests to state governors this month for use in reopening schools.
The Trump administration’s top testing official, Admiral Brett Giroir, laid out plans Tuesday to distribute some of the 150 million tests ordered from test maker Abbott Laboratories. The federal purchase was first announced last week.
Abbott’s rapid test, the size of a credit card, is the first that doesn’t require specialty computer equipment to develop. The test delivers results in about 15 minutes and is priced at $5, significantly lower than similar older tests.
Giroir says the “great majority” would go to U.S. governors for use in screening children at K-12 schools. The tests could be used to test first responders and other high-risk populations.
Tests will be shipped to 20,000 assisted living facilities. Unlike nursing homes, assisted living facilities are not overseen by Medicare. Because assisted living facilities also house a vulnerable population, they face some of the same risks as nursing homes.
Since the start of the pandemic, the U.S. testing has mainly relied on nasal swab tests sent to labs for processing. But supply shortages led to testing backlogs, delaying results and hindering efforts to track cases.
Health experts view rapid tests run outside the laboratory as key to expanding the number of tests ahead of the flu season. However, Abbott’s new test still requires a nasal swab by a health worker. In general, rapid tests like Abbott’s are less accurate than lab-developed tests. The FDA has said in some cases, negative results with Abbott’s test may need to be confirmed with a lab test.
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LAWRENCE, Kan. — The University of Kansas is requiring no fans at athletic events and Kansas State University is battling four new coronavirus outbreaks.
Kansas Department of Health and Environment is reporting 19 clusters tied to colleges and five tied to schools with younger students.
At the University of Kansas, entrance testing uncovered 474 positive cases. Infections were particularly prevalent among sorority and fraternity members, with 270 positives among 2,698 members tested, for a rate of 10%.
In the Manhattan, Kansas, health officials say the four newest outbreaks include 10 positive cases among the Kansas State football team. There are several cases tied to a fraternity and sorority.
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ROME — Italy registered fewer than 1,000 new coronavirus cases, even as the number of swab tests soared.
The Health Ministry says 978 coronavirus cases were confirmed in the last 24 hours, when some 81,000 tests were conducted. That is 22,500 more tests than the previous day when nearly the same number of cases were detected.
Health experts are encouraging Italy to boost testing and tracing of contacts of the newly infected ahead of schools opening on Sept. 14.
Italy has 270,189 confirmed cases, adding eight deaths to increase the known toll to nearly 35,500.
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NEW YORK — New York City is delaying the start of its school year until Sept. 16 to give teachers more time to prepare for the return of students amid the coronavirus pandemic.
Mayor Bill de Blasio announced the deal struck with unions representing teachers, staff and administrators. Instruction was supposed to begin on Sept. 10. All students will spend the first few days learning from home online before in-person instruction begins for some students on Sept. 21.
The city’s plan to restart schools includes mask-wearing, staggered schedules to reduce the number of students in rooms, supplying every school building with a nurse and asking all staffers to get tested shortly before school starts. A medical monitoring program will includes random virus testing for a sampling of students and staff each month.
The city used ventilation experts to check air flow in classrooms, and officials say they’ll would work to make parks and streets available as teaching space, if needed.
United Federation of Teachers President Michael Mulgrew says the union’s independent medical experts signed off on the reopening plan. Delegates of the UFT were poised to vote on whether to authorize a strike.
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BERLIN — The head of an association representing German medical laboratories has criticized proposals to use veterinary and industrial labs to process coronavirus tests.
Andreas Bobrowksi, chairman of the medical laboratories association BDL, says the capacity to conduct more tests is limited by the shortage of materials required to process them, which he says has been “covered up by rationing.”
Germany has conducted more than 11.2 million tests for the coronavirus since the start of the outbreak. About 244,600 tests have been positive.
Bobrowski says the available test capacity also would be needed to screen for influenza in the coming months. He called for other measures such as preventive quarantine and travel restrictions rather than expanding the number of people who are tested.
Germany has nearly 245,000 coronavirus cases and 9,300 confirmed dead.
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ATHENS, Greece — Greek authorities say the country’s schools will require masks and open fulltime on Sept. 14, a week later than planned.
Officials say the delay will allow people returning from summer holidays to determine whether they have contracted coronavirus on vacation and take precautions against spreading the disease.
Government spokesman Stelios Petsas urged parents and children back from holiday to limit their social contacts until school starts.
Education Minister Niki Kerameos says schoolchildren and teachers diagnosed with coronavirus or who live with somebody with it, along with people belonging to high-risk groups, will be exempt from attending classes. They can use distance learning.
The government will provide free masks to all teachers and pupils at state and private schools.
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CAIRO — Egypt reopened its ancient sites in Cairo and elsewhere in the country for the first time since they were closed in March to stem the coronavirus.
The reopening came despite a recent upward trend in new infections. Antiquities Minister Khalid el-Anany says museums, temples and other sites are reopened at 50% capacity.
In the southern ancient city of Luxor, tourists from France and Ukraine visited the famed Karnak Temple, arriving from the Red Sea resort of Hurghada, according to the ministry.
Since July, Egypt lifted most of its restrictions in place against the pandemic, reopening cafes, clubs, gyms, theaters and worship houses.
Egypt’s health ministry has reported more than 98,900 confirmed cases and 5,421 deaths.
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BERLIN — Authorities in Berlin say protesters must wear face masks to curb the spread of the coronavirus after a demonstration where thousands ignored social distancing rules last weekend.
German news agency dpa reported Berlin state’s executive agreed to make masks mandatory for protests with more than 100 participants. There will be exceptions for car and bicycle rallies.
Until now, masks weren’t required at open air events unless the minimum distance of 1.5 meters between participants couldn’t be maintained.
Police ordered a large protest dissolved on Saturday because participants didn’t respect the rules. The demonstration was against mask wearing and other pandemic protection measures.
Participants have mostly wore masks at other protests in Berlin, including a large Black Lives Matter demonstration in June and a rally by Hong Kong pro-democracy campaigners on Tuesday.
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LISBON, Portugal — Portugal has launched its first coronavirus contact tracing app, called Stayaway Covid, after weeks of delays over privacy concerns and amid debatable success for similar apps deployed by European governments.
The smartphone app uses Bluetooth technology to help discover whether people have been in proximity to someone infected with the coronavirus. It uses an application programming interface developed recently by Apple and Google.
Health Minister Marta Temido said at the app’s launch Tuesday it is “voluntary, confidential, secure and trustworthy.”
The developers at INESC TEC say the app doesn’t have access to personal data.
But Portugal’s D3 – In Defense of Digital Rights Association, a nonprofit group, says public information about the app’s source code is incomplete. It also asked for the code that shows how Apple and Google use the data to be made public.
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SARAJEVO, Bosnia-Herzegovina — Schools in much of Bosnia reopened amid coronavirus restrictions and despite relatively high number of daily new infections.
The Serb-dominated Republika Srpska half of the country decided to fully open elementary and high schools. In the Bosniak-Croat Federation, which includes the capital Sarajevo, the government opted for a mixed approach, combining online lessons and traditional classes.
Although less hit by coronavirus compared to larger western European nations, Bosnia reported more than 19,000 cases to date and about 600 confirmed deaths.
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COPENHAGEN, Denmark — Finnish health authorities say some 900,000 people have downloaded a coronavirus tracing app a day after it was launched.
The Koronavilkku app is aimed at finding out whether a person has been exposed to the coronavirus, according to the Finnish Institute for Health and Welfare. It says the free application was created to help break infection chains. App users send a randomly generated code via Bluetooth to others when in close contact.
“The Koronavilkku mobile app is part of the government’s test, trace, isolate and treat strategy,” said the health ministry’s permanent secretary, Kirsi Varhila.
The app has been published in Finnish and Swedish, the Nordic country’s two official languages, and an English version is planned for later this year.
Finland has had more than 8,000 cases and reported 335 deaths.
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PRAGUE — The Czech Republic has started the new school year, making it mandatory again to wear face masks on public transport.
The health authorities have argued that measure could help contain the coronavirus pandemic as many of almost 1.4 million students at elementary and high schools use the public transport every weekday.
Masks are also mandatory at Prague’s international airport, government and state offices, clinics and pharmacies starting Tuesday.
Strict hygiene measures are in place at schools, but the authorities reversed their initial order for all to use protective face coverings inside school buildings.
Face masks have only been recommended in schools in Prague, one of the worst-hit regions in the Czech Republic, with almost 45 infected per 100,000 people.
Education Minister Robert Plaga said about 20 of some 12,000 schools have remained closed because teachers and staffers have been quarantined.
The Czech schools were closed on March 11 and only some of them partially reopened at the end of May on a voluntary basis.
The Czech Republic has had 24,618 confirmed cases of COVID-19, including 424 deaths, according to government figures.
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