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The Latest: US health officials warn of false positives

Iowa Governor Kim Reynolds gets the Johnson & Johnson COVID-19 vaccine during a news conference at Iowa PBS in Johnston, Iowa Wednesday, March 3, 2021. (Zach Boyden-Holmes/The Des Moines Register via AP)
Original Publication Date March 11, 2021 - 10:56 PM

WASHINGTON — U.S. health officials are warning health professionals about the risk of false positive results with a widely used laboratory test for COVID-19 and flu.

The Food and Drug Administration issued the alert to Friday for health facilities using Roche’s cobas test for coronavirus and seasonal flu. The agency warned that problems with the test’s processing tubes could result in false diagnosis in people who are not actually infected.

Roche’s testing system is widely used to screen large batches of patient samples in hospitals and laboratories.

The FDA recommends health workers test samples multiple times to help assure accuracy. If the test delivers conflicting results it may indicate a problem and use should be discontinued, the agency says.

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THE VIRUS OUTBREAK:

— WHO grants emergency use of J&J vaccine

— White House says it will direct states to allow shots for May 1

— AP-NORC Poll: People of colour bear burnt of virus economic toll

— The pandemic has taken a huge toll on children's mental health.

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Follow AP’s pandemic coverage at https://apnews.com/hub/coronavirus-pandemic, https://apnews.com/hub/coronavirus-vaccine and https://apnews.com/UnderstandingtheOutbreak

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HERE’S WHAT ELSE IS HAPPENING:

LAS VEGAS -- Nevada’s top coronavirus official didn’t guarantee the state can meet President Joe Biden’s goal of offering a vaccination to every adult who wants a shot by May 1, but he said it gives everyone something to work toward.

COVID-19 Task Force chief Caleb Cage says everything depends on vaccine allocations. Seventeen new COVID-19 deaths were reported statewide Friday, bringing the pandemic total in Nevada to almost 5,100.

The number of cases statewide is nearing 300,000, while Nevada also passed the 575,000 mark in vaccines initiated.

State officials say almost 324,000 Nevadans, or more than 10% of the state population, are now fully vaccinated.

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DES MOINES, Iowa — More than 1 million doses of coronavirus vaccine have been administered in Iowa, even as residents who qualify struggle to make appointments for a shot.

The Iowa Department of Public Health said Friday that Iowa has administered 1.03 million doses.

The milestone reflects significant increases in vaccine supplies but it’s unclear how the state will handle surging demand as more adults become eligible in the coming months. Iowa has no centralized system for people to secure a vaccine appointment.

Gov. Kim Reynolds dismissed an early plan to pay Microsoft to set up a statewide registration and appointment scheduling program. Instead, the state set up a website that offers information about where to get vaccines but leaves scheduling to individuals.

President Joe Biden said Thursday evening that he expects the nation to have sufficient vaccine supply by May 1 so anyone who wants a vaccine will be able to schedule an appointment. Reynolds said Iowa could beat that deadline if vaccine supply increases and remains stable.

It’s unclear whether Iowa is prepared to handle such a volume of people when there already appears to be a bottleneck setting up appointments.

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WASHINGTON — Former White House coronavirus co-ordinator Dr. Deborah Birx is joining the George W. Bush Institute as a senior fellow.

Birx, who was tapped by former Vice-President Mike Pence to manage the Trump administration’s response to the pandemic, clashed with President Donald Trump and other officials who moved to set aside science and promote “reopening” the country. Birx, who initially was interested in a job in the Biden administration, faced criticism for not speaking out more forcefully against the former president’s guidance.

The former U.S. Global AIDS Coordinator, Birx had previously overseen the President’s Emergency Plan for AIDS Relief and led the government’s engagement with international partners on addressing other communicable diseases.

Birx will work on the institute’s public health work, as well as policy efforts to study “how to better position our country to tackle health disparities in the future based off the lessons learned from the COVID-19 pandemic.”

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SAN FRANCISCO -- California on Friday announced it has administered 2 million vaccine doses to people in vulnerable, low-income ZIP codes.

This will allow counties to more quickly reopen activities such as indoor dining and indoor gyms at reduced capacity.

Gov. Gavin Newsom announced last week that he would set aside 40% of vaccine for residents of some 400 ZIP codes the state deems most vulnerable. The point is to tie reopening standards to ensure that the people most impacted by the pandemic are protected against the virus.

By hitting the 2 million mark, the state will reassess counties and allow them to move to the red tier within 48 hours instead of waiting until Tuesday.

Los Angeles County, the nation’s most populous with 10 million residents, said the earliest it would allow museums, gyms, movie theatres and restaurants to open indoors at limited capacity is Monday.

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BATON ROUGE, La. — Louisiana is telling its coronavirus vaccine providers that they must get shots in arms within a week of receiving the doses or risk getting blocked from receiving future shipments of the vaccine.

The state health department sent a notice Thursday to the hospitals, pharmacies, clinics and other community providers of the coronavirus vaccine detailing the state’s expectations. Gov. John Bel Edwards’ office provided a copy of the notification Friday to The Associated Press.

State health department data shows nearly 18% of the state’s total population has received at least the first dose of vaccines that often require two shots. But Louisiana lags many other states in distributing doses.

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PARIS — France’s public health watchdog is recommending the coronavirus vaccine made by Johnson & Johnson to be injected into all people over 18, including the elderly.

In guidance issued Friday, France’s High Authority for Health said the one-dose shot should be preferentially administrated in areas where the virus is spreading fast.

The vaccine, which has been approved Thursday by the European Medicines Agency, is not expected to be delivered in the country before mid-April.

France is already using vaccines made by Pfizer-BioNTech, Moderna and AstraZeneca. The country has injected at least one shot to 9,2 % of its population over 18.

Prime Minister Jean Castex expressed concerns Friday over the “very serious situation” the Paris region, where virus patients occupy 95% of intensive care units. Some patients are about to be transferred to hospitals in other parts of France, he said, adding that the government is ready to impose new restrictions if needed.

The country is under a national 6 p.m. curfew and authorities have ordered an additional weekend lockdown in parts of the French Riviera and in northern France. France has been among countries with the highest death tolls, with at least 90,146 lives lost.

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SAO PAULO — Brazil’s federal government says it has reached a deal to purchase 10 million doses of the Russian-made Sputnik V vaccine against COVID-19, though the shot is yet to be approved by the South American nation’s health agency.

The Brazilian Health Ministry said on Twitter Friday that the jabs will be imported by União Química, a company that has lobbied the government to purchase the vaccines, though its own experience is based on other medical products.

Brazil’s government expects to receive 400,000 shots in April, 2 million in May and another 7.6 million by June.

The ministry said it would also evaluate possible production of thge Sputnik V vaccine by União Química plants in Brazil.

Brazil has already secured contracts for 200 million vaccine doses, half made by AstraZeneca and half by Chinese pharmaceutical company Sinovac.

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BIRMINGHAM, Ala. — Alabama is expanding eligibility for COVID-19 vaccinations to more frontline workers, residents with certain chronic health conditions, and people 55 and older later this month, state officials announced Friday.

“We have been concerned that many people at high risk and others engaged in close-contact work have not been eligible to receive the vaccine yet, but with the additional vaccine supply we are better able to meet the needs of Alabama residents,” Gov. Kay Ivey said in a statement.

The expansion, starting March 22, will add over 2 million people to the groups who can receive a COVID-19 vaccination in Alabama, roughly doubling the number of people now eligible.

The dramatic increase in the number of people eligible comes at a time when demand continues to exceed supply and will increase the competition to find shots.

State Health Officer Scott Harris said Alabama expanded eligibility because of the expectations of the public — particularly as they see people in other states getting shots — and health officials’ expectation that the supply will jump over the coming weeks.

The new eligible groups include more frontline workers; people 55 and older; those with intellectual and developmental disabilities; and residents age 16 to 64 with certain high-risk medical conditions. The qualifying medical conditions include cancer, chronic kidney disease, diabetes, smoking, obesity, sickle cell disease and heart conditions.

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LANSING, Mich. — Michigan announced Friday that all residents age 16 and up will become eligible for the COVID-19 vaccine on April 5, nearly a month before the May 1 date pledged by President Joe Biden.

People age 16 to 49 with certain medical conditions or disabilities will qualify starting March 22, when 50- to 64-year-olds can begin getting shots under a previous announcement. Two days later, March 24, a federally selected regional mass vaccination site will open at Detroit’s Ford Field to administer an additional 6,000 doses a day for two months.

The U.S. is expecting to have enough doses for adults by the end of May, but Biden has warned the process of actually administering those doses will take time. As of Wednesday, about 22% of Michigan’s 16-plus population had been fully or partially vaccinated.

The state health department said it may take “several weeks” beyond April 5 for everyone who wants the vaccine to get an appointment.

The site in Detroit will operate 12 1/2 hours every day for eight weeks, vaccinating at least 168,000 people with two Pfizer shots, potentially more if a one-dose vaccine is used in the final two weeks. Detroit was selected by the Federal Emergency Management Agency, which is prioritizing vulnerable areas.

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GENEVA — The World Health Organization granted an emergency use listing for the coronavirus vaccine made by Johnson & Johnson, meaning the one-dose shot can be used as part of the international COVAX effort to distribute vaccines globally, including to developing countries with no supplies.

In a statement on Friday, the U.N. health agency said “the ample data from large clinical trials” shows the J&J vaccine is effective in adult populations. The emergency use listing comes a day after the European Medicines Agency recommended the shot be given the green light across the 27-country European Union. The U.S. Food and Drug Administration granted the J&J vaccine an emergency authorization last month.

A massive study that spanned three continents found the J&J vaccine was 85% effective in protecting against severe illness, hospitalization and death. That protection remained strong even in countries such as South Africa with variants.

The U.N.-backed COVAX effort previously announced it had an initial agreement with J&J to provide 500 million doses, but it’s not legally binding.

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ATLANTA — U.S. health officials have posted more specific COVID-19 guidance for preschools and other childcare programs.

The Centers for Disease Control and Prevention is recommending very young children and childcare workers are placed in groups that stay together throughout an entire day. It is similar guidance applied to schools with older students.

The guidance is more emphatic about wearing masks, calls on all childcare workers to get vaccinated and issues more information about the importance of ventilation.

The guidance was issued Friday, replacing advisory documents the CDC posted last summer.

It’s meant for programs that care for children before they start kindergarten. That includes preschool programs and home-based family childcare programs.

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GENEVA — The head of the World Health Organization called on countries not to limit the exportation of critical vaccine ingredients, calling it “one of the major challenges we need to solve” amid a finite supply of COVID-19 vaccines.

WHO chief Tedros Adhanom Ghebreyesus says the U.N. health agency met this week with its partners, industry representatives and others to identify potential solutions to the shortages. Tedros says there were shortages in materials including glass vials, plastic filters and other elements.

“The sudden increase in demand for vaccine production has led to a shortage of these and other supplies,” Tedros says.

He says limiting the production of COVID-19 vaccines was restricting the available supply and could possibly jeopardize the production of routine vaccines for childhood diseases.

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ROME — Italy’s new premier has pledged to triple the number of daily vaccinations administered daily throughout the country as coronavirus cases rise.

Mario Draghi inspected a vaccination centre at Rome’s Leonardo da Vinci airport on Friday and noted the pace, now running 170,000 shots daily, had picked up this month.

Italy’s medicines agency blocked use of one batch of AstraZeneca vaccines, after “several grave adverse events” were reported, Draghi says, describing it as a “precautional decision” in line with other European nations.

Meanwhile, Italy is tightening COVID-19 restrictions for Easter weekend as many hospitals warn they’re running out of ICU beds for coronavirus patients.

The government decided at a Cabinet meeting the entire nation will be under strict ‘’red zone’’ rules the Easter weekend of April 3-5. The day after Easter, called ‘’Little Easter,’’ is a national holiday when many Italians travel for vacations or gather in parks or at beaches for picnics with friends and families. Travel between regions is already banned under previous restrictions.

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WASHINGTON — The Biden administration says it has the authority to direct states to open up their vaccine supply to all adult Americans by May 1 using the same mechanism it used to order teachers and childcare workers eligible this month.

States are required to distribute the federally provided vaccines in accordance with guidelines set by the Department of Health and Human Services. The department will issue a directive that states allow all adults to be vaccinated under their eligibility criteria by May 1.

The federal government also controls supply directly through the federal retail pharmacy program, federally-run mass vaccination sites and federally qualified community health centres. It could use those mechanisms as well to expand eligibility

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PRAGUE — The health authorities in the Czech Republic have administered over 1 million coronavirus vaccine shots.

Health Minister Jan Blatny says the vaccination program is picking up speed. So far, almost 288,000 people in the nation of 10.7 million received both shots.

The number of shots surpassed 44,000 in the previous two days, a record. Blatny says the country will receive 1.13 million vaccines of Pfizer, Moderna and AstraZeneca in March. The country expects another 2.1 million in April when the first batch of the newly authorized Johnson & Johnson is scheduled to arrive.

The minister says unlike some other countries, the Czech Republic will continue administering AstraZeneca vaccines.

There were 11,083 new cases reported on Thursday. The country has 22,865 confirmed deaths.

News from © The Associated Press, 2021
The Associated Press

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