Friday, May 7, 2021

Pfizer seeks vaccine approval within days; Home test ok’d

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Pfizer and BioNTech plan to submit a request “within days” to the Food and Drug Administration for emergency-use approval of a vaccine they say has shown to be 95% effective in mass testing.

The companies hope to provide 50 million doses by year’s end and 1.3 billion doses in 2021.

“Our objective from the very beginning was to design and develop a vaccine that would generate rapid and potent protection against COVID-19 with a benign tolerability profile across all ages,” said Ugur Sahin, M.D., CEO of BioNTech. “We believe we have achieved this.”

The vaccine effort is one of many racing the clock amid a surge in cases, hospitalizations and deaths. The Midwest continues to take a beating – more than 900 staffers at the Minnesota-based Mayo Clinic alone have contracted COVID-19 in the past two weeks, the Pioneer Press reports.

“It shows you how easy it is to get COVID-19 in the Midwest,” Dr. Amy Williams. “We need everyone in the communities we serve to do their part to limit the spread of COVID-19.”

📈 Today’s numbers: The U.S. has reported more than 11.3 million cases and more than 248,500 deaths, according to Johns Hopkins University data. The global totals: 55.5 million cases and 1.33 million deaths

This file will be updated throughout the day. For updates in your inbox, subscribe to The Daily Briefing newsletter.

COVID means more millennials taking care of kids and parents.

Millennials, age 24 to 39, took on hundreds of billions of dollars in student debt only to graduate from college just as the Great Recession of 2007-09 was upending the economy. And now, as a result of the COVID-19 pandemic, they’re suddenly becoming the largest contingent of the “sandwich generation,” the cohort of adults providing financial and other support to both children and elderly parents. The pandemic has tipped more millennials into a juggling act of caregiving.

“We think generally the situation with COVID has accelerated the trend,” says Jeff Beligotti, vice president and head of long-term care solutions for New York Life. ” It has continued to financially squeeze the millennial generation.”

Paul Davidson

More than 900 Mayo Clinic staffers infected in last two weeks

Almost 1,000 staffers at the Mayo Clinic have contracted COVID-19 in the past two weeks, the system’s dean of clinical practice says. Dr. Amy Williams said 93% of the infections took place away from work, and that most of the infections that took place at work involved eating in a break room with a mask off, according to the Pioneer Press. Williams also said the clinic is seeing more patients transferring in, an indication that hospitals elsewhere in Minnesota and surrounding states are overwhelmed because of this surge.

“Everybody is getting very tired of wearing a mask and hearing about social distance, being told to wash their hands, but we’re doing this because we care about our communities,” Williams said. “We don’t want families to lose loved ones.

Pfizer to seek FDA approval for vaccine within days

Pfizer and BioNTech plan to submit a request “within days” to the FDA for emergency-use approval of their vaccine. The companies said their ongoing Phase 3 testing has found the vaccine to be 95% effective, up from a preliminary finding of 90%. The data also will be submitted to other regulatory agencies around the world, the companies said in a statement. The companies said they expect to produce up to 50 million vaccine doses globally by year’s end and up to 1.3 billion doses by the end of 2021. Experts say frontline healthcare workers are expected to be first in line for inoculation.

The Phase 3 clinical trial began on July 27 and has enrolled 43,661 participants to date, the companies said.

Pfizer, based in New York, appears to be just a step ahead of Moderna, a Cambridge, Massachusetts-based biotechnology company. Moderna announced Monday that its candidate vaccine appears to be 94.5% effective against the disease. It was not immediately clear when Moderna would seek FDA approval.

Six lawmakers test positive as Congress struggles with virus

In less than a week, six members of Congress announced they had tested positive for COVID-19. Sen. Chuck Grassley, the 87-year-old Iowa Republican who is third in line to the presidency, spent much of Monday casting votes and attending a meeting with Senate Republican leadership that included Senate Majority Leader Mitch McConnell. Grassley announced his diagnosis the following day. Rep. Don Young, R-Alaska, 87, who is frequently seen without a mask, was hospitalized for three days.

“I’ve been shot, I’ve been rolled over, I’ve been hit in the head a hundred times, but I’ve never felt as bad as I did” with the virus, Young told The Washington Post. “This is not good.”

Christal Hayes

South Dakota: High death rate, high denial rate

South Dakota’s high rates of COVID-19 and low virus regulation have sparked criticism even as some dying of the virus there don’t believe it poses a real threat. That’s according to Jodi Doering, a South Dakota nurse who has gained national attention for her account of working on the front lines in a state where leaders have long minimized the impact of the virus and refused to implement rules like mask mandates. South Dakota and neighboring North Dakota have the highest per capita rates of COVID-19 infection and death in the nation.

“I have a night off from the hospital. As I’m on my couch with my dog I can’t help but think of the Covid patients the last few days,” Doering wrote in a recent tweet. “The ones that stick out are those who still don’t believe the virus is real.” Read more here.

Joel Shannon

Pfizer vaccine prompts run on dry ice, medical freezers

Minus 112 is so cold it shatters rubber, stresses metals – and can protect what’s expected to be the first COVID-19 vaccine. Pfizer and collaborator BioNTech have a vaccine they say is 95% effective and could be approved within a month, so the reality of moving and storing the life-saving vials is coming into sharp focus. Dry ice orders are spiking and the backlog to buy $15,000 medical-grade ultracold freezers is up to six weeks.

“In the science world, it’s not that cold,” said Tonya Kuhl, chair of the chemical engineering department at the University of California, Davis. “But in the regular world, it certainly is. That temperature is really important in storage to keep things stable.”

Elizabeth Weise

COVID immunity could last for years, study says

COVID-19 infections could result in immunity that could last for years, a new study indicates. The study, published online but not yet been peer reviewed, found that most participants in the study who had been infected with COVID-19 retained enough immune cells to fend off infection eight months later. That could indicate immunity may remain for years, the authors of immune memory study said.

“That amount of memory would likely prevent the vast majority of people from getting hospitalized disease, severe disease, for many years,” Shane Crotty, a virologist at the La Jolla Institute of Immunology who co-led the new study, told The New York Times.

Bedsores a growing concern as COVID hospitalizations rise

Hospitals are putting extra focus on preventing pressure injuries, known as bedsores or pressure ulcers, as coronavirus cases continue to rise across the country and ICU beds fill with critically ill patients. The National Pressure Injury Advisory Panel (NPIAP) estimates pressure injuries affect more than 2.5 million patients each year and claim over 60,000 lives. Dr. William Padula, president-elect of NPIAP and professor at University of Southern California, worries that pressure injuries may increase this year amid estimates there could be up to 19,000 new COVID-19 hospitalizations per day by Dec. 7. Padula said pressure injuries can occur within hours of being in the ICU immobilized and on a ventilator.

“The skin is the largest organ system,” said Dr. Martine Sanone, associate professor of geriatrics and palliative medicine at Icahn School of Medicine at Mount Sinai. “However, when we think of critical illness, we forget about that first barrier.”

Adrianna Rodriguez

Nursing home cases surpass 10K in a week, an all-time high

New coronavirus cases have surged to an all-time high at nursing homes across the country despite federal efforts to shield residents through aggressive testing and visitor restrictions, a new report shows. Federal data shows 10,279 COVID-19 cases during the week of Nov. 1, the most recent data available. The figures surpassed the previous high of 9,903 cases in late July, according to a report by the American Health Care Association and National Center for Assisted Living.

The surge in cases among the nation’s most vulnerable residents comes as cases, hospitalizations and deaths surge nationwide.

“We have been begging people the last eight months to wear a mask, socially distance and to be careful,” said Mark Parkinson, president and CEO of AHCA/NCAL. “Unfortunately, the public has not listened or complied.”

– Ken Alltucker

Chicago schools to resume in-person classes in January

Chicago Public Schools plans to welcome some students back into classrooms in January, officials announced Tuesday. Parents can decide whether they want to send their children to classrooms or continue remote learning. Students enrolled in moderate and intensive classrooms and pre-kindergarten are scheduled to return Jan. 11, 2021. Students in kindergarten through 8th grade will be back on Feb. 1. Officials have not announced a return date for high school students yet.

The Chicago Teachers Union strongly opposed the news, calling it “arbitrary.” But school officials believe children can safely return to classrooms, pointing to other states and some European countries that are keeping schools open despite a surge in COVID-19 cases.

“It’s our moral imperative to do everything in our power to safely open schools beginning with our youngest and highest-needs learners,” said Chicago schools CEO Janice Jackson.

FDA allows 1st rapid test that gives results at home

U.S. regulators on Tuesday allowed emergency use of the first rapid coronavirus test that can be performed and developed entirely at home. The FDA granted emergency authorization to the 30-minute test kit from Lucira Health, a California manufacturer. The company’s test allows users to swab themselves to collect a nasal sample. The sample is then swirled in a vial that plugs into a portable device, that interprets the results and displays whether the person tested positive or negative for coronavirus.

Study: Museums losing millions due to COVID-19

A new American Alliance of Museums study released Tuesday showed that recent COVID-19 surges are doing a number on already-hurting museums. According to an October AAM survey of 850 respondents from across the USA about the continued impact of coronavirus on museums, millions of dollars are being lost – with around a third of institutions facing permanent closure – and job loss is mounting as nearly 30% of American museums remain closed since the March lockdown.

“The financial state of U.S. museums is moving from bad to worse,” Laura Lott, AAM’s president and CEO, said in a statement. “Those that have reopened are operating on an average of 35% of their regular attendance — a reduction that is unsustainable long-term. Those that did safely serve their communities this summer do not have enough revenue to offset higher costs, especially during a potential winter lockdown. Without financial help, we could see thousands of museums shutter forever.”

Montana Gov. Steve Bullock issues stricter rules, curfew

Montana Gov. Steve Bullock announced a new round of directives Tuesday, which will limit crowd size and close bars, restaurants and casinos at 10 p.m., in an effort to slow the spread of the coronavirus. The new directives go into effect 5 a.m. Friday.

“The situation is serious in Montana, and it is serious across the nation,” Bullock said. “We need to turn things around over the next few months while we wait on a widely distributed vaccine or else we risk hospitals that turn patients away and risk any further ability to control the spread.”

Montana is among the 36 states with a mask mandate. What are the rules in your state? Check the list.

– Phil Drake, Great Falls Tribune

Los Angeles plans new restrictions, including curfew

Los Angeles County imposed new restrictions on businesses Tuesday and is readying plans for a mandatory curfew for all but essential workers if coronavirus cases keep spiking. The county of 10 million residents — the nation’s most populous — has seen daily confirmed cases more than double in the last two weeks to nearly 2,900. Hospitalizations have topped 1,100, a rise of 30% in that period.

The county, which for most of the pandemic has had a disproportionately large share of California’s cases, issued new restrictions ordering nonessential retail businesses to limit indoor capacity to 25% and restaurants to 50% capacity outdoors. Restaurants already are not allowed to serve customers indoors. All those businesses must close at 10 p.m. The changes take effect Friday.

COVID-19 resources from USA TODAY

Contributing: The Associated Press

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