AstraZeneca coronavirus vaccine up to 90% effective and easily transportable, company says #SootinClaimon.Com

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AstraZeneca coronavirus vaccine up to 90% effective and easily transportable, company says (nationthailand.com)

AstraZeneca coronavirus vaccine up to 90% effective and easily transportable, company says

Health & BeautyNov 24. 2020Suzanne Sunday participates in the AstraZeneca vaccine trial at NYU Langone Health in New York. MUST CREDIT: Photo by Sarah Blesener for The Washington Post.Suzanne Sunday participates in the AstraZeneca vaccine trial at NYU Langone Health in New York. MUST CREDIT: Photo by Sarah Blesener for The Washington Post. 

By The Washington Post · William Booth, Carolyn Y. Johnson · NATIONAL, WORLD, HEALTH, HEALTH-NEWS

LONDON – AstraZeneca on Monday became the third pharmaceutical company to announce positive results from late-stage trials of a coronavirus vaccine, saying that its candidate, developed by Oxford University, is up to 90% effective.

The company is expected to fine-tune its vaccine trial in the United States in the coming weeks. MUST CREDIT: Photo by Sarah Blesener for The Washington Post.

The company is expected to fine-tune its vaccine trial in the United States in the coming weeks. MUST CREDIT: Photo by Sarah Blesener for The Washington Post.

Scientists and politicians alike hailed the third straight week of buoyant scientific news as a sign that, even as coronavirus cases surge to devastating levels in many countries, an end to the pandemic is in sight.

Pfizer and its German partner BioNTech and Moderna have each reported vaccines that were 95% effective in clinical trials. The AstraZeneca trial was 70% effective overall, with up to 90% efficacy in a smaller group that got a lower dosage. Different trial designs make direct comparison complicated, but even with somewhat lower protection, the AstraZeneca vaccine may be a more realistic option for much of the world, as it is likely to be less expensive and does not need to be stored at subzero temperatures.

Peter Piot, director of the London School of Hygiene & Tropical Medicine, who was instrumental in the battle against AIDS, said the positive results from three vaccine candidates cannot be overestimated.

He said that “2020 will be remembered for the many lives lost from covid-19, lockdowns and the U.S. election. Science should now be added to this list.” He added that “the only way to stop covid-19 in its tracks is having multiple effective and safe vaccines that can be deployed all around the world and in vast quantities.”

“I’m totally delighted,” said Hildegund C.J. Ertl, a vaccine expert at the Wistar Institute in Philadelphia. “What it tells me is this virus can be beaten quite easily: 90 to 95% efficacy is something we’d dream about for influenza virus, and we’d never get it.”

In years when the flu vaccine is a good match for the strain in circulation, it ranges between 40 and 60% effective.

The Oxford-AstraZeneca team said in a video conference with journalists that its candidate offered 90% protection against the coronavirus when a subject received half a dose, followed with a full dose one month later. Efficacy was lower – 62% – when subjects received two full doses a month apart.

Andrew Pollard, chief investigator of the Oxford trial, said the findings showed that the vaccine would save many lives.

“Excitingly, we’ve found that one of our dosing regimens may be around 90% effective, and if this dosing regimen is used, more people could be vaccinated with planned vaccine supply,” he said.

Britain has preordered 100 million doses – which at a dose and a half per person would cover most of its population. The United States has ordered 300 million, though both countries have hedged their bets and signed multiple vaccine deals.

The AstraZeneca results have yet to be peer-reviewed or published, and outside scientists said that much depended on seeing those in detail. Many questions remain, including why the lower-dose regimen was more effective. It is also unclear whether the vaccine can reduce transmission of the coronavirus by people who have no symptoms, which would have repercussions for how soon people could stop wearing masks. No one yet knows how long immunity from the vaccine will last.

Sarah Gilbert, a lead Oxford researcher, cautioned that the dose-and-a-half regimen would have to be studied more closely to be fully understood. But she said that the first half-dose might be priming a person’s immune system just enough, and that the booster would then encourage the body to produce a robust defense against infection.

AstraZeneca and Oxford have been conducting Phase 3 clinical trials worldwide, with the most recent data coming from an interim analysis based on 131 coronavirus infections in Britain and Brazil among nearly 23,000 volunteers, with half receiving the vaccine and half getting a placebo.

The company said it will present the results to Britain’s health-care products regulators immediately and will discuss its latest data with U.S. regulators as soon as possible. It is still only midway through its U.S. clinical trial, though, and now wants to adjust the format to further assess the half-dose shot plus booster.

But Michael Kinch, director of the Center for Research Innovation in Business at Washington University in St. Louis, said there needs to be more transparency about the findings. He said the reliance on foreign data, the lack of clarity about which dose should be considered by regulators, and the fact the trial found the stronger 90% efficacy in a small subset of people – fewer than 3,000 people received the dose-and-a-half regimen – raised concern.

“Under normal circumstances, I would say this would not be looked at favorably,” Kinch said.

World markets have rallied on optimistic vaccine news, although shares in AstraZeneca were down Monday on the London Stock Exchange.

Because the vaccine is in production, if approved, the first 4 million doses could be ready in December, and 40 million could be delivered in the first quarter of 2021, company executives said. By the spring, the company and its global partners in Brazil, India, Russia and the United States could be producing 100 million to 200 million doses a month.

At a news conference Monday evening, British Prime Minister Boris Johnson said, “With a favourable wind we should be able to inoculate the vast majority of the people who need the most protection by Easter.”

Johnson – who had the virus last spring and spent several days in an intensive care unit – told Parliament on Monday that vaccines are “edging ever closer to liberating us from the virus, demonstrating emphatically that this is not a pandemic without end.”

No participants who received the vaccine developed severe cases of the coronavirus or required hospitalization, AstraZeneca said Monday. The drugmaker also said that no “serious safety events” were reported in connection with the vaccine, which was typically “well tolerated” by participants regardless of their dosing levels or ages.

The vaccine uses a harmless cold virus that typically infects chimpanzees to deliver to the body’s cells the genetic code of the spike protein that dots the outside of the coronavirus. That teaches the body’s immune system to block the real virus.

Although the reason the regimen with an initial half-dose worked better remains unclear, Ertl said that it could be related to the fact that the body’s immune system can develop a defense mechanism to block the harmless virus that’s used to deliver the spike protein’s code. Giving a smaller initial dose may lessen those defenses, and make the vaccine more effective.

Several other vaccines in late-stage development use a similar technology, harnessing a harmless virus to deliver a payload that will teach the immune system how to fight off the real thing – including a Johnson & Johnson vaccine, a Russian vaccine being developed by the Gamaleya Research Institute and a vaccine made by CanSino Biologics in China.

The Pfizer and Moderna vaccines both use messenger RNA, a new vaccine platform never approved in a medical product for people.

Although the AstraZeneca results indicate somewhat lower efficacy, the vaccine can be stored and transported at normal refrigerated temperatures for up to six months. That could make it significantly easier to distribute around the world than Pfizer’s vaccine, which must be stored at minus-70 degrees Celsius, or Moderna’s, which is stable in refrigerated conditions for only 30 days and must be frozen at minus-20 degrees Celsius after that.

Gilbert and her team began developing the AstraZeneca vaccine in a small laboratory at Oxford on a shoestring budget. The university kicked in $1.3 million and then chose AstraZeneca as a manufacturing partner.

“We wanted to ensure there wouldn’t be any profiteering off the pandemic,” said Louise Richardson, the university’s vice chancellor, so that their vaccine would be widely distributed “and wouldn’t just be for the wealthy and the first world.”

The scientists said that although it appeared to be a race, or a competition, among the front-running vaccine developers, no one company could produce the millions of doses needed to end the pandemic.

“We don’t have enough supply for the whole planet,” Pollard said, adding that the important message is that there are at least three highly effective, safe vaccines that also appear to work well among the elderly, and that they are produced using different technologies, ensuring the quickest route to manufacture the billions of doses that will be needed.

Pollard said that it is “unclear why” the different vaccines were producing different results, and that he and the scientific community are awaiting full data from all the clinical trials. He said different studies were also using different end points to describe efficacy.

“At this moment, we can’t fully explain the differences,” Pollard said. “It’s critical to understand what everyone is measuring.”

Getting a coronavirus vaccine from loading dock to upper arm may be the hardest part #SootinClaimon.Com

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Getting a coronavirus vaccine from loading dock to upper arm may be the hardest part (nationthailand.com)

Getting a coronavirus vaccine from loading dock to upper arm may be the hardest part

Health & BeautyNov 24. 2020Ahmed El Kority, pharmacy director at Riverside Shore Memorial Hospital in Virginia, inspects a new ultracold freezer that will be used to store coronavirus vaccine that must be kept as cold as minus-70 Celsius. MUST CREDIT: Photo for The Washington Post by Parker Michels-BoyceAhmed El Kority, pharmacy director at Riverside Shore Memorial Hospital in Virginia, inspects a new ultracold freezer that will be used to store coronavirus vaccine that must be kept as cold as minus-70 Celsius. MUST CREDIT: Photo for The Washington Post by Parker Michels-Boyce 

By The Washington Post · Lena H. Sun, Frances Stead Sellers · NATIONAL, HEALTH, HEALTH-NEWS

Riverside Health System in Virginia has ordered a specialized freezer for each of its five hospitals to keep precious vials of coronavirus vaccine as cold as a deep Antarctic freeze.

Public health officials in Nashville and Baltimore are revamping routine flu clinics to test delivery methods for coronavirus vaccinations.

And in Maine, top health official Nirav Shah spends sleepless nights devising drive-through immunization facilities where vaccinators won’t have to wear winter parkas in addition to their personal protective gear.

Shah’s solution? Fire stations and carwashes.

Those venues are heated “so you have shelter from the snow and cold,” he said. “We haven’t inked any of those agreements yet, but that’s where our head is at.”

Buoyed by promising results from major clinical trials of three coronavirus vaccines, public health officials are preparing for the daunting task ahead of delivering those shots to tens of millions of Americans. On Monday, a third pharmaceutical company announced positive results from late-stage trials of a coronavirus vaccine, saying that its candidate is up to 90 percent effective.

The vaccines need to be distributed across 50 states, plus U.S. territories, that have different demographics and shifting needs. The leading products must be stored at different temperatures and have different minimum orders, with each requiring two shots but at different intervals.

Complicating matters: A final decision on who is eligible to get the early doses must wait for a federal advisory group’s recommendations. That can’t happen until regulators authorize the new vaccines. And once set in motion, the distribution – from loading dock to upper arm – has to be accomplished equitably and with as few handoffs as possible because it’s all being done amid a pandemic.

The stakes are enormous. The massive undertaking to immunize most of the population requires extraordinary communication, planning and coordination. Federal, state and local officials are working with hospitals and pharmacies, suppliers of dry ice, gloves and vials, and carriers such as UPS and FedEx. A successful operation could transform the health and economic well-being of society, in the United States and overseas.

“There are a million moving parts,” said Bruce Gellin, president of global immunization at the Sabin Vaccine Institute. “The system is complex to start with, [and] it is being modified to mount an immunization campaign of historic proportions,” he said, warning that while “expectations are sky high,” there are pitfalls at every step.

Officials are wrestling with how to ensure vulnerable populations receive the vaccine. Almost certainly at the front of the line: about 21 million front-line health-care workers. Next up are likely to be other essential workers, many of whom come from Black, Latino and Asian communities hard hit because of socioeconomic factors. Many can’t work from home, don’t have transportation and live in crowded housing.

“It’s like treating an individual patient while rebuilding the entire health-care system,” said Alfred Sommer, former dean of the Johns Hopkins Bloomberg School of Public Health, who was part of the team that vanquished smallpox four decades ago. Challenges will crop up, he said, such as immunizing disadvantaged communities. “Even with special outreach programs, it will not be easy with the vaccines ready for approval.”

Further complicating the logistics: the continued intrusion of politics. The Trump administration has not given information about vaccine distribution to the Biden transition team, President-elect Joe Biden’s chief of staff, Ron Klain, said in an interview Sunday on ABC’s “This Week,” adding to the potential for disruption.

“I have faith that the incoming administration will not completely upend the thousands of man and woman hours of work we’ve put in,” said Cindy Williams, vice president of the Riverside Health System and a member of Virginia’s coronavirus advisory committee. “Creating additional chaos as we’re managing this is really a bad idea.”

Once the vaccines are authorized by the Food and Drug Administration, doses will be allocated to each state according to population, with some held in reserve in case of loss or theft. Within 24 hours of FDA action, doses will be “prepositioned” at key sites designated by each state where vaccines will be administered to the first priority groups.

U.S. government officials anticipate having 40 million doses of vaccines from pharmaceutical giant Pfizer and biotech firm Moderna by the end of the year, enough to vaccinate 20 million people, a small fraction of the U.S. population of 330 million. (The United States will receive about half of Pfizer’s 50 million doses globally.) Government officials say it will be April before most people could get vaccinated.

The good news from AstraZeneca, manufacturer of the third vaccine, which is easier to store and transport, means the company will also apply for regulatory approval in the United States.

Americans will receive coronavirus vaccines free. The federal government is paying for much of the delivery and vaccine administration costs. But state officials are asking Congress for at least $8 billion for vaccination efforts; to date, $200 million in federal funds has been sent to state, territorial and local jurisdictions.

The vials will be sent first to large hospitals and other sites where mass immunization clinics can take place. But even that first step presents daunting travel, storage and handling requirements.

The Pfizer vaccine will be shipped to sites selected by states in GPS-tracked, suitcase-sized “shippers” with 50 pounds of dry ice pellets, and must be kept at minus-70 Celsius. Upon arrival, the dry ice must be refreshed, or the vials of vaccine must be transferred to ultralow-temperature freezers. The specifications are exacting if the vials stay in the shippers: The container cannot be opened more than twice a day, the dry ice must be replenished every five days, and the contents must be used within 15 days. The vials can stay at refrigerator temperature for five days before their contents degrade.

The Moderna vaccine is less demanding, with a storage temperature of minus-20 Celsius, which is the same for many medications.

The shipments need to be coordinated with kits of syringes, needles, face masks and other ancillary supplies.

From there, every state, territory and each of six major metropolitan areas is responsible for its own deployments. States are in varying stages of preparation. Many have designated large hospital systems to be the first places to receive vaccine. Maine, for example, has chosen five hospitals with ultracold freezers to receive its first doses, and each has a plan to reach into the community. But just in case, the state bought an ultracold freezer for its public health emergency warehouse that can store more than 200,000 doses.

Maine has held meetings with transportation officials and the National Guard to work through worst-case scenarios, Shah said. If there’s a flood or loss of power, a backup generator for the freezer would kick in. If shots are transported during a blizzard, the vaccine convoy could follow 30 minutes behind a salt truck.

The Centers for Disease Control and Prevention has told states they don’t need to buy specialized freezers because immunizations in the earliest phases will focus on sites that can vaccinate as many people as possible and will be able to handle the cold chain requirements, even without freezers.

But at the Henry Ford Health System in Detroit, Northwell Health in New York and Riverside in Virginia, officials bought them anyway, executives said on a conference call Thursday about vaccine distribution organized by Premier, the group purchasing organization and supply consultancy for 4,100 hospitals. The executives’ assumption was that early public vaccination clinics will be most efficiently done on the campuses of hospitals with ultracold freezers.

Among them is Riverside Shore Memorial Hospital on Virginia’s Eastern Shore, a medically underserved and rural community that includes poultry and agricultural workers who did not have health insurance until the state recently expanded Medicaid, said Williams, of Riverside Health. It is one of three major health-care providers for the community, and the only one with an ultracold freezer.

Clinicians will need to be trained to administer the vaccines, which have different protocols. The Pfizer version must be diluted before the shot is given – inverting the vial 10 times “gently,” according to the Pfizer instructions. In contrast, the Moderna vaccine does not require on-site mixing and should not be shaken.

To start with, vaccination efforts may favor urban areas. That’s because the vaccines will arrive in big batches: For Pfizer, the minimum order is 975 doses. Moderna’s smallest batch is 100 doses.

In Alaska, “you’re not going to have 900 people within 1,000 square miles,” said Danny Staley, a senior vice president at the Association of State and Territorial Health Officials. “You’re wanting to do that at a mass vaccination clinic, where we know people can use it so we don’t waste it,” he said.

“The most disadvantaging issue is the minimum order,” said Ann Lewandowski, program manager for the Southern Wisconsin Immunization Consortium, a group of 42 rural hospitals in Wisconsin. None has the resources to purchase a special freezer, which can cost $12,000 to $15,000 and might be needed for only a year until vaccines are developed that don’t require such frigid temperatures.

Identifying enough health-care workers to be immunized is also challenging for rural hospitals that may have only 20 nurses and 20 doctors. “You would need to reach out to pharmacists, reach out to dentists and all these other professionals, but 975 is really an impossible goal,” Lewandowski said.

On a recent call, a Pfizer representative told Lewandowski the company hopes to send out smaller batches of 125 doses by April. But even that creates logistical challenges because the vials need to be coordinated with the ancillary kits, which are equipped for 100 doses.

Health-care personnel from rural hospitals may have to drive to get their shots at larger hubs in Madison, Milwaukee or Eau Claire, Lewandowski said. That could pose a barrier for staffers already stretched thin caring for patients with covid-19, the illness caused by the coronavirus.

“These are health-care workers who are taking risks to serve the state in our time of need, and it’s not fair to discriminate against them simply because they live in a geographically challenged place,” Lewandowski said.

A Pfizer spokeswoman said the company is working on a smaller pack size that will be ready the first three months of 2021.

Final recommendations on who gets the first shots will come from an independent committee on immunizations that advises the CDC. There is broad agreement that health-care workers will be first, and will include clinicians, custodial staff, home health aides, pharmacists, paramedics and staff in long-term care facilities, according to meetings of the Advisory Committee on Immunization Practices. That first group may also include about three million long-term care residents.

Jose Romero, a pediatric infectious-diseases specialist who chairs the immunization panel, said “essential workers” are likely to be high on the list. That might include people who stock supermarket shelves or pick vegetables, many of whom belong to communities of color devastated by covid-19.

“That is part of the equity question we are trying to solve,” Romero said.

That assumes priority groups are willing to take the first shots. Health officials say they are increasingly worried about staffers who say they won’t take the vaccine, according to internal surveys and conversations with clinicians.

“When it comes to this vaccine, what I’m hearing from colleagues . . . is that their confidence is lacking,” Pamela G. Rockwell, a physician representing the American Academy of Family Physicians, said during last month’s meeting of the federal immunization advisory committee.

“I’m already won over,” she said. “We need to win over a lot of primary care physicians . . . We need to do this right and get our patients convinced that this is safe so we can save our country.”

Federal health officials are also concerned.

“I am worried that people are going to equate the complicated storage and handling as somehow more reason to be hesitant about the vaccine, when in fact, it has nothing to do with how well the vaccines work,” said a senior federal health official involved in distribution with the Defense Department and private industry. The official spoke on the condition of anonymity because they were not authorized to speak publicly on the record.

At Riverside, a survey last month of about 1,000 employees, most in nursing and administrative positions, found about a third said they would take the vaccine, another third said they would not, and the remainder wanted more data on safety and efficacy. A separate poll of physicians found nearly half would not take the vaccine. The surveys were conducted before reports about the vaccines’ effectiveness, and acceptance is likely to increase, said Riverside’s Williams.

Patients will be more likely to be vaccinated if they ask their doctors if they’re willing to be vaccinated and the physician says yes, she said.

Saad B. Omer, an epidemiologist and infectious-diseases expert who directs the Yale Institute for Global Health, has done extensive studies about the political and social factors influencing trust in vaccines. What he sees now is not “your run-of-the-mill vaccine hesitancy.” President Donald Trump’s actions fueled mistrust in science, he said.

But health-care personnel can be persuaded. Strong endorsements from a trusted person, such as Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, can make a huge difference, according to a study Omer conducted recently.

Experts who study vaccine hesitancy say promotional campaigns that use social media and increase community engagement with trusted leaders will be key to encouraging use of a new vaccine.

Adam Abadir, director of communications at the Baltimore City Health Department, said the city’s health officials had been using routine flu clinics to hone strategies such as tailored social media campaigns and outreach through pastors and other trusted community members.

“We now have partners in place who can deliver the messages,” Abadir said, even though he doesn’t yet know what those messages will say.

In Nashville, the annual “Flulapalooza” mass vaccination event at Vanderbilt University Medical Center – last year, they managed 15,000 shots on site in one day – was modified as Flula-2-uza to test strategies for the coronavirus, which may involve reversing their strategy and venturing out to remote workers.

The new vaccines are likely to produce more unpleasant side-effects than a flu shot, potentially leading recipients to need a day or two off work.

“Any group of individuals that work together, we can’t vaccinate them all at the same time,” said Thomas Talbot, chief hospital epidemiologist at Vanderbilt, which will likely be among the first sites to receive the Pfizer vaccine and is looking at how to stagger immunizations to minimize the impact on departments.

In Baltimore, a mobile flu clinic in a predominantly Latino community drew more than 150 people on a recent stormy morning to a school parking lot, where a team of Spanish-speaking officials were working with next year in mind.

Drive-through vaccination isn’t viable for people in the city who lack transportation, said Rebecca Dineen, assistant commissioner for the city’s Bureau of Maternal and Child Health. So the health department is pushing hard to foster links in public housing and with neighborhood leaders who will be key to coronavirus distribution.

“You don’t need a fancy innovative approach,” Dineen said. “A lot of it is really knowing your people.”

Shah, in Maine, is hoping that beyond cultivating relationships with pharmacies and physicians offices, fire stations and carwashes will be all the innovation he needs.

“We think the fire departments are a pretty good source for sites because there are so many, many small towns in Maine,” he said.

EMS clinicians can be vaccinators there or at carwashes.

“People trust them,” he said. “And trust matters a lot.”

Smallest health providers face biggest problem finding protective gear #SootinClaimon.Com

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Smallest health providers face biggest problem finding protective gear (nationthailand.com)

Smallest health providers face biggest problem finding protective gear

Health & BeautyNov 23. 2020Denadlhy Belleus Pierre puts on her equipment before helping patients with covid-19 antibody tests in Washington in June 2020. MUST CREDIT: Photo for The Washington Post by Amanda VoisardDenadlhy Belleus Pierre puts on her equipment before helping patients with covid-19 antibody tests in Washington in June 2020. MUST CREDIT: Photo for The Washington Post by Amanda Voisard 

By The Washington Post · Amy Goldstein · NATIONAL, HEALTH, HEALTH-NEWS

WASHINGTON – As the coronavirus rages across the country, community health centers and small doctors’ offices, AIDS clinics and homeless shelters are struggling with a scarcity of protective gear to buffer workers from harm, their budgets and buying power unable to compete with large medical institutions.

https://www.washingtonpost.com/video/c/embed/e4d1635c-6ae6-4d59-91ae-42853b31da7a?ptvads=block&playthrough=false

Most U.S. hospitals and health systems have, over the pandemic’s nine months, stitched together systems and improvisations to acquire masks, gowns, gloves and other personal protective equipment (PPE). Yet many small health-care and social-service settings continue to suffer from shortages they expect to grow worse.

A New Orleans mission for the homeless and addicted finally gave up searching for masks after an offer from a local sports team fizzled, so its staff members rely on disinfecting throughout the day. To conserve gowns, a Boston health center requires nurses to stand without them on the opposite side of plexiglass barriers from most patients who come for coronavirus tests, instructing people how to swab their own noses. And a pediatrician near Fredericksburg, Va., was thrilled when her husband spotted N95 masks at a nearby Lowe’s, because her office manager was unable to get more than a list of where to look for supplies from the state.

The scrounging and adapting to scarcity attest to a two-tier reality that has emerged in health workers’ ability to obtain the equipment that provides a physical barrier against the virus that has sickened more than 12 million people in the United States and killed at least 255,000.

“No one is talking about this huge inequity of availability,” said Megan Ranney, a Providence, R.I., emergency room doctor and Brown University researcher who in March co-founded with several other worried physicians Get Us PPE, a group that collects and distributes donated supplies.

Since it started, Get Us PPE has fulfilled 12% of the requests it has received – a percentage dropping lately as the pandemic intensifies and the eagerness for protective equipment increasingly outstrips donations. Yet requests from hospitals have declined from the thousands in April to fewer than 100 per month more recently, the group’s information shows.

This disparity – with small facilities facing PPE shortages to a greater extent than larger ones – has not been recognized in federal officials’ recent statements about masks, gloves, goggles and gowns to protect workers especially vulnerable to infection.

In a statement on the pandemic this month, President-elect Joe Biden said the government must provide “frontline health-care workers” with resources “including personal protective equipment that is again in short supply.” Nor did Senate Minority Leader Chuck Schumer, D-N.Y., and two other Senate Democrats draw the distinction among facilities last week when they announced a bill that would devote $10 billion to the federal Strategic National Stockpile to increase purchases of N95 masks and other protective supplies.

And in a briefing Thursday by the White House’s coronavirus task force, David Sanford, on loan from the Defense Department to the Federal Emergency Management Agency to oversee supplies, said: “Since the late summer, we have grown our personal protective equipment capability 10 times to 15 times” in the stockpile and at FEMA over levels before the pandemic, with four months’ worth of N95 masks likely to be needed in the current surge of cases. Sanford did not mention that some places still have trouble getting them.

According to hospital CEOs, state officials, procurement specialists and nonprofits such as Get Us PPE, shortages linger in some small hospitals, especially those in rural areas and the most intense virus hot spots.

Exam gloves are in a global shortage now, and some distributors of other supplies are rationing orders as the pandemic worsens and hospitalizations rise, according to David Gillan, senior vice president for sourcing at Vizient, a company that works with 60% of the nation’s hospitals on group purchasing and other performance improvements.

And many hospitals are getting by, using new government-approved protocols for cleaning and reusing N95 masks that were meant to be worn once and discarded.

At York General Hospital, with 25 beds in a small Nebraska town of that name, the hospital board voted to spend nearly $80,000 from its strained budget to buy a robot that disinfects with ultraviolet light to allow N95 masks to be used five times. The cleaning process meets guidelines issued this year by the Centers for Disease Control and Prevention. But Jennifer Uffelman, York General’s environmental health safety and security coordinator, said the hospital would “absolutely not” be reusing masks if it had an adequate supply.

“It just makes people feel better when they know they can go to the cupboard and get a new one,” Uffelman said. “It just makes people feel better to know we have the stock, we are not worried about shortages. But they know we are doing everything we can. . . . The science has said this is safe.”

Still, unlike in the pandemic’s early days, York now has a “burn rate calculator” the state handed out to track the use of PPE. And Doug Carlson, Nebraska’s chief procurement officer, said that, in late April, he and others created a model in which hospitals and other facilities fill out a form to submit to the state’s regional health districts and, once a week, supplies are distributed from a central warehouse.

Such systems were not common at the pandemic’s outset, and many hospitals – especially small ones – began relying on folkways they developed.

The Texas Organization of Rural and Community Hospitals had never bought members any type of supplies until its president, John Henderson, started getting frantic daily calls about PPE from many of the state’s 157 rural hospitals. “We were at the end of the supply chain, and the supply chain was broken,” he said.

TORCH, as the group is known, began developing relationships with vendors and buying and collecting donations of masks, hand sanitizer and other gear. It crammed boxes into its Austin offices and created chains of volunteers to drive, relay-style, across Texas’s expanse for deliveries.

Now, as the pandemic surges in West Texas, stressors are reemerging, and gloves are a particular trouble spot, Henderson said. But most of the state’s rural hospitals are far closer to having what they need, according to Henderson and several hospital chief executives.

In some corners of the nation, the scrounging has been even more homespun. At Mat-Su Regional Medical Center in Palmer, Alaska, nearly 40 miles north of Anchorage, Thomas Quimby, the emergency department’s medical director, became the leader of the hospital’s coronavirus task force in March.

“We were short on everything,” Quimby recalled. “We went around and bought up all the industrial respirators” the hospital could find and turned to a local distillery to start making hand sanitizer. But it could not find disposable gowns, so the task force came up with the idea of asking a local sewing club to make cloth versions.

One April day, Quimby reached for a gown among several hanging from an IV pole in the emergency department’s hallway – and realized that the cream-colored fabric printed with cowboys had been his favorite sheets as a boy. He had known that his mother, Sandy Quimby, a half-hour away in Eagle River, was a pack rat. He had not known that she was part of the Mat-Su Valley Makers, the sewing club.

Over several months, the hospital has phased out community-made gowns because it found a commercial supplier.

“I feel much better about PPE than when the first wave hit,” said Anne Zink, Alaska’s chief medical officer. Even though Alaska’s small population and great distance are hindrances to purchasing, she said, the state has been able to stockpile most of the equipment it needs for the hospitals it supplies.

Gillan, of Vizient, said hospitals in general have become less reliant on federal and state supplies because they have found ways to buy their own.

Despite the current glove shortage, Gillan said, “it’s remarkable to see how all of these hospitals are working with the manufacturers and the distributors.” And as a backup, he said, Vizient has built up its disaster response so that, when its client hospitals run low on certain PPE, “we address them when we’re made aware of those, one hospital at a time.”

Such buying power and reserve sources are far different than in the world that Steven Chies inhabits as president of North Cities Health Care, a family-owned company outside Minneapolis that runs two nursing homes and an assisted-living facility.

Large nursing facilities are faring better. But the most recent figures the American Health Care Association, a trade group, submitted to federal health officials on behalf of about 14,000 nursing homes, show that more than 600 were out of N95 masks and that an additional 900 or so had less than a one-week supply. Few are completely without gloves or gowns, the data indicates.

Yet as a small company without much buying clout, Chies said, “it’s week-to-week. It’s more of a gut punch when you don’t get what you ordered, and you’re concerned our staff won’t have the right equipment. It’s just scary at that point.” This month, all of the suppliers he relies on have cut back on what they are willing to send, and Chies fears scarcity will grow as coronavirus cases keep setting records.

At the moment, his workers have enough gloves and surgical masks, but supplies of disposable gowns are low, and N95 masks are so scarce that workers use them only when entering the rooms of patients with nebulizers for asthma or other equipment that increases the spread of aerosols.

That sense of relative scarcity is familiar to Genevieve Daftary, director of pediatric medicine at Codman Square Health Center in Boston, in the shadow of the city’s large, well-heeled academic medical centers. Protective equipment “is not a budget item for an organization always operating on the margin,” she said. “What we’ve realized is there is no cavalry coming,” despite an intense effort by the development staff to raise money for such supplies and find donations.

“We’ve learned to triage, not just the patients, but triage the PPE,” Daftary said.

Of 2,900 face shields on hand, fewer than one-third have padding at the forehead and comfortable elastic at the back. The rest, less expensive, “are the ones giving you a headache” by the end of the day, she said.

Over the months, the health center has altered protocols so that fewer workers need to wear the scarce gowns and masks. Patients arriving for a test with the worst symptoms typical of covid-19, the illness caused by the novel coronavirus, are ushered into an exam room in the clinic’s urgent-care section. Just outside the room, a nurse practitioner, physician assistant or doctor – not suited up in protective gear – calls the patient, who picks up a phone on the room’s desk, and the medical worker takes the patient history. Only after getting filled in does another staff member wearing protective gear duck inside to see the patient, limiting exposure, while wearing the same gown all day.

People without symptoms, or with mild ones, are directed for tests to an auditorium down the street, where they are seated before tables with laminated instructions, tissues, a swab and a vial. A three-sided plexiglass wall separates them from a clinic staff member, stationed at least six feet away – using a face shield but no mask – to talk them through the test.

In Spotsylvania, Va., Suzanne Richman, a pediatrician in solo practice, began trying to order gowns last winter from McKesson, a major health-care supplier. It was August before a box of 50 arrived, she said.

At one point in the spring, Richman asked her office manager to check with the regional arm of the Virginia Department of Emergency Management, which helps provide PPE. What arrived at Richman’s office was a list of companies to check with about supplies – including McKesson, which wasn’t sending her any.

But, she said, “we were lucky.” One spring day, her husband happened to be at a Lowe’s home improvement center and called to say the store had a couple of boxes of N95 masks. “Buy them all,” she told him.

The New Orleans Mission has stopped looking for masks. It has three sites and provides shelter. It offers addiction treatment and job training to about 300 people at a time.

“We can’t get it, and we can’t afford it,” David Bottner, the mission’s chief executive, said of PPE. New Orleans was an early pandemic hot spot, and Bottner’s staff searched hard for protective gear, looking for donors or help from city government. Finally, as the season’s first hurricane threatened, the city sent a box of masks. It contained 50, enough to last the staff less than two days.

Now, the mission gives out a mask only when people ask. But cleaning five times a day, with a strict rule about temperature checks before anyone enters, has held coronavirus cases over the months to 17 among clients and two among workers.

In September, a representative of a sports team called, Bottner said. “They had a coach that was setting up a fund to buy PPE to help facilities like ours,” Bottner said he was told.

“We said, ‘Oh my God, yes, we could use it.’ “

He never heard back, he said.

CDC recommends preflight testing for those planning to fly internationally #SootinClaimon.Com

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CDC recommends preflight testing for those planning to fly internationally (nationthailand.com)

CDC recommends preflight testing for those planning to fly internationally

Health & BeautyNov 23. 2020

By The Washington Post · Lori Aratani · NATIONAL, WORLD, HEALTH, SCIENCE-ENVIRONMENT, TRANSPORTATION, TRAVEL, HEALTH-NEWS

WASHINGTON – The Centers for Disease Control and Prevention is recommending that those planning to travel internationally this season get tested for the novel coronavirus before and then again after their flights.

The new advice, released Saturday evening, comes just days after officials at the agency “strongly recommended” that people avoid traveling during the upcoming Thanksgiving holiday. The United States is grappling with a dramatic spike in infections, and health officials fear that holiday travel could dramatically worsen the current situation. Total coronavirus infections in the United States have topped 12 million, and cases are approaching 200,000 in a day.

However, in an acknowledgment that some might still travel, the CDC says those who plan to fly internationally should consider getting tested one to three days before their flights and again three to five days after travel. In addition to getting tested after they’ve completed their travels, the CDC said, people should stay home for seven days – even if they test negative.

The agency however, did not address whether testing is recommended for those who are flying domestically.

While the CDC has previously encouraged people planning to fly to take steps to protect themselves and others, including washing their hands frequently, wearing masks and practicing social distancing, this is the first time the CDC has encouraged them to get tested.

“Testing before and after travel can reduce the risk of spreading COVID-19,” the agency said in the new recommendation. Travelers should take a viral test and not travel until they’ve received their results. If they test positive, they should immediately isolate, the agency said.

“Testing does not eliminate all risk, but when paired with a period of staying at home and everyday precautions like wearing masks and social distancing, it can make travel safer by reducing spread on planes, in airports, and at destinations,” the recommendation said.

The use of preflight testing is growing. More than 100 countries currently require proof of a negative coronavirus test for entry.

The International Civil Aviation Organization, the United Nations body that oversees aviation, issued new recommendations earlier this month that acknowledged the potential of preflight testing programs.

In the United States, a growing number of states, including Hawaii, Alaska and Connecticut, are allowing travelers to skip quarantine requirements with proof of a negative test. As a result, more airlines and airports are now offering travelers the option of taking a test before they board the flight. Even so, there is no common standard, so it has been left to airlines and airports to design their own testing programs and for travelers to sort out requirements for their particular destination.

Even for those who take precautions, the CDC warns that air travel during the current pandemic does pose risks.

“Air travel requires spending time in security lines and airport terminals, which can bring you in close contact with other people and frequently touched surfaces,” the agency said. “Social distancing is difficult in busy airports and on crowded flights, and sitting within 6 feet of others, sometimes for hours, may increase your risk of getting COVID-19. How you get to and from the airport, such as with public transportation and ridesharing, can also increase your chances of being exposed to the virus.”

While surveys show that fewer people are planning to travel during the Thanksgiving holiday, many are still on the move. The Transportation Security Administration said that on Friday more than a million people passed through airport security checkpoints. It’s only the second time since the pandemic began that the number has been more than 1 million.

Said Erin Sauber-Schatz, head of the CDC’s Community Intervention and Critical Population Task Force during a briefing held Thursday: “The safest way to celebrate Thanksgiving this year is at home with the people in your household.”

Worst may be ahead as D.C. region’s infections spike #SootinClaimon.Com

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Worst may be ahead as D.C. region’s infections spike (nationthailand.com)

Worst may be ahead as D.C. region’s infections spike

Health & BeautyNov 22. 2020A line for coronavirus tests at the Angarai Testing Center in Silver Spring, Md., on Nov. 18. Experts say the winter is expected to bring a spike in virus cases much higher than seen the beginning of the pandemic. MUST CREDIT: Washington Post photo by Toni L. SandysA line for coronavirus tests at the Angarai Testing Center in Silver Spring, Md., on Nov. 18. Experts say the winter is expected to bring a spike in virus cases much higher than seen the beginning of the pandemic. MUST CREDIT: Washington Post photo by Toni L. Sandys 

By The Washington Post · Erin Cox, Julie Zauzmer · NATIONAL, HEALTH, HEALTH-NEWS
A spike in coronavirus cases has brought the Washington, D.C., region to the brink of the toughest season of the pandemic so far, experts say, with the coming winter poised to eclipse the virus’s impact in the spring.

“This is probably the worst” of the pandemic, Joshua Sharfstein, a former top FDA official and Johns Hopkins University public health professor, said of the next three months. “We’re staring at the big battle with covid right now.”

Already, the past two weeks brought record caseloads and a test positivity rate that climbed well past 5 percent and into territory that experts consider widespread community transmission of the virus.

Public health experts and hospital administrators say the abrupt rise in new cases is unlikely to abate in the next few weeks and couldforeshadow a more difficult December, followed by an even rougher January and a darker February. 

“We’re starting to see the spike that the rest of the country saw a week or two weeks ago. That steep climb is what’s really worrying,” said Neil Sehgal, an assistant professor of public health at the University of Maryland.

“At this point, there are not a lot of people in public health who think we’re not going to spike dramatically,” Sehgal said of the region. “We think everyone needs to hunker down and brace for what’s going to be a precipitous increase.”

Hospitals in some parts of the region already are nearing capacity, while others are beginning to execute contingency plans to care for the sick: setting up tents in parking lots, scrounging for staffers and reallocating resources. 

The daily case rates in Maryland, D.C. and Virginia are better than the rates in at least 36 other states in the country, according to Friday’s numbers, but public health experts say the region’s recent rapid ascent in cases could put it on course to join some of the nation’s hardest-hit areas.

Part of the surge was expected, as colder weather pushed people indoors into environments more hospitable to spreading the virus. But small social gatherings – places where people may feel lax about distancing or mask-wearing – have become a primary source of transmission, according to contact tracing data. Governors, county executives, and city leaders either have implemented new restrictions to curb the spread or have warned that they may do so. 

The record numbers the region posted over the past few weeks suggest a large amount of the virus is coursing through the area undetected, experts said. 

“Even if everybody immediately – today – complied with everything the governor said … we’d still see several weeks of increases,” said Clifford Mitchell, the director of Maryland’s Environmental Health Bureau. 

“Obviously, holidays have some impact, but honestly, much more of it has to do with everyday activity that people are doing,” Mitchell said. “That’s the thing that day after day is driving transmission.” 

Local leaders fear that residents are insufficiently cautious in the face of the high but not-yet-astronomical infection rates. Virginia Gov. Ralph Northam, a Democrat, emotionally pleaded with residents to take precautions this week and Maryland Gov. Larry Hogan, a Republican, earlier this month implored people to “just wear the damn mask.” 

Alexandria, Va., health officials urged residents who insist on gathering for the holidays to stay 10 feet apart from others, more than the Centers for Disease Control and Prevention’s recommended six feet.

“You’re going to have your mask off when you’re eating,” said Stephen Haering, the city’s health director. “We also know that the holidays are a time when people are raising their voices. They are laughing. And that joviality is more likely to express the aerosolization of the virus.”

Health officials say a desensitized public could become the virus’s ally.

“There’s a great deal of fatigue. People are worn out. There’s now a degree of complacency,” said Theodore Delbridge, the executive director of the Maryland Institute for Emergency Medical Services System. His organization helps distribute patients and resources so that hospitals do not run out of space, and, he said, all the scenarios seem bleak.

“The models seem to agree that we’re at the beginning of a wave that’s going to affect us for a couple of months,” he said. “Hospitals are near capacity this time of year anyway with seasonal illnesses.”

In the District of Columbia, hospitals that once were more than one-third empty have steadily filled up in recent weeks; in the second week of November, more than 90 percent of the city’s hospital beds were full, the first time during the entire pandemic that the city had reached this marker. The city Department of Health labeled that threshold an indicator that residents’ activities may need to be restricted. D.C. Mayor Muriel Bowser, a Democrat, has said she will add restrictions in the weeks to come.

The doctors who run the city’s hospitals and public health system are thinking ahead to the next step – what they will do if they run out of beds.

Health director LaQuandra Nesbitt said last week that personnel from the U.S. Army Corps of Engineers have walked through each hospital top-to-bottom, looking for spaces such as cafeterias and auditoriums that could be quickly transformed into covid units if the need were to arise.

If those surge spaces were to be filled, too, the city would start housing patients in the emergency beds in the Walter E. Washington Convention Center, which were set up months ago but have not been used.

In Maryland, the Baltimore Convention Center and two other outpatient hospitals had been converted to house coronavirus patients in the spring. They largely went unused then, but they have been kept intact as field hospitals in anticipation of the winter surge.

The coronavirus pandemic has caused such upheaval in the region’s hospital network that 30-year-olds now are being admitted to the region’s preeminent children’s hospital to help lighten the load.

When other hospitals’ intensive care units became overwhelmed in late spring, Children’s National Hospital – which typically treats patients up to about age 21 – started accepting ambulances carrying extremely ill coronavirus patients up to age 30 to reduce the burden on neighboring hospitals. The children’s hospital developed a list of its pediatricians who also have training in adult medicine and kept them on call to care for 20-somethings with covid-19. 

Joelle Simpson, the hospital’s chief of emergency medicine and its medical director for emergency preparedness, said that though she hopes that mask-wearing and hand-washing by the public will blunt the surges in winter illnesses such as the flu that normally fill beds at her hospital, the virus also has taken a significant toll on children’s mental health. Psychiatric admissions have been rising, and Simpson fears they could spike this winter, too.

After scrambling for supplies in the spring, medical leaders in the region say they are well-stocked with all of the personal protective equipment, ventilators and other equipment they might need. But a new shortage has emerged: Staffing has become the most pressing concern at hospitals. 

Already, doctors and pharmacy workers at Children’s National have been asked to take on some of the tasks typically performed by nurses, who are in short supply across the nation. The Johns Hopkins health system tried to hire more than 100 nurses to help the hospital through the coming months, said Jennifer Abele, the chief medical officer at Sibley Memorial Hospital, which belongs to the Johns Hopkins system. But competition has been fierce as almost every hospital in the country recognizes that it needs more medical professionals to handle the virus. Many nurses have chosen to travel to regions that offer higher pay for their work.

“There’s not a large excess number of nurses in the area that we can pull from,” Abele said.

To prevent a nightmare scenario in which hospitals are overflowing, she said Sibley is considering voluntarily canceling elective and semi-elective procedures at the hospital, a measure the health department had ordered for all hospitals at the start of the pandemic to free up staff. 

“Everyone is looking at their contingency plans. We need those staff members to take care of covid patients,” Abele said.

At MedStar Washington Hospital Center, head of infectious diseases Glenn William Wortmann said nurses who typically work three to four shifts a week may be asked to work five or six shifts if the trajectory of the pandemic continues. 

“A very important message that we’re trying to pound out there is that the people in the community can influence this. I cannot influence the numbers here in the hospital, but people in the community can control this,” Wortmann said. 

Howard University Hospital chief executive Anita Jenkins said the hospital can now test patients for coronavirus on-site and get results within hours instead of a week and has an abundant supply of the drug remdesivir, which seems to help some covid-19 patients.

With more knowledge of the virus, treatments have improved and the proportion of covid-19 patients requiring intensive care has dropped, and their stays in the hospital are shorter, she said. A student group donated iPads so that every coronavirus patient has a device to conduct FaceTime calls with family members without risking exposure.

Meanwhile, Jenkins said she hopes the end is in sight – Howard just ordered a new subzero freezer to hold upward of 1,000 vials of an eventual coronavirus vaccine.

Doctors and nurses want more data before championing vaccines to end the pandemic #SootinClaimon.Com

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Doctors and nurses want more data before championing vaccines to end the pandemic (nationthailand.com)

Doctors and nurses want more data before championing vaccines to end the pandemic

Health & BeautyNov 22. 2020Jeffrey A. Hirschfield, a pediatrician in St. Petersburg, Fla., has shared his reservations about a coronavirus vaccine on Twitter. Jeffrey A. Hirschfield, a pediatrician in St. Petersburg, Fla., has shared his reservations about a coronavirus vaccine on Twitter. “It typically takes five to 10 years to successfully develop and vet vaccine candidates, especially those relying on new technologies,” he said. MUST CREDIT: photo for The Washington Post by Octavio Jones. 

By The Washington Post · Christopher Rowland · NATIONAL, HEALTH, HEALTH-NEWS
Doctors and nurses, coping with the daily risk of coronavirus exposure, are expected to get top priority to receive vaccines that could become available as soon as next month. But it’s an open question how many will seize their place at the front of the line.

Large health systems, medical societies and the federal government are launching an effort to persuade front-line health care providers to take novel vaccines that were developed, and are likely to be granted emergency approval, in record time.

In Boston, major teaching hospitals are rolling out educational videos aimed at assuring medical staff the process of developing coronavirus vaccines will result in safe and effective shots. At New York’s Mount Sinai Health System, a leading infectious disease doctor said he likely will distribute photos of himself getting a shot in a bid to build confidence in front-line staff.

Hospitals in urban areas are taking additional measures to make sure ethnic and racial minority members, who form a large percentage of their front line nursing and support staffs, receive rapid information about the safety and effectiveness of the new vaccines.

Winning buy-in from doctors and nurses is crucial to gaining broader public support for the vaccines, based on the high degree of trust placed in them by patients. The hesitancy of some health care workers is attracting attention as the first two vaccines, from Pfizer and Moderna, near deployment. Pfizer and its partner, BioNTech, filed their Food and Drug Administration application for emergency use on Friday.

Polling last month showed that 58% of U.S. adults were willing to get vaccinated against the coronavirus. A Pew Research Center poll in September found 51% of Americans said they would definitely or probably get a coronavirus vaccine.

Medical experts said attitudes among doctors, nurses and the public could shift quickly as new data are revealed. But government, academic, and health-care officials say that significant numbers of providers want more data about the vaccine before it is deployed. Some of the information is expected to be released next month by the FDA.

A report released Thursday by University of California Los Angeles researchers said that 66% of Los Angeles health care workers who responded to an online questionnaire (not a randomized sample) said they would delay taking a vaccine. The American Nurses Association, a national union, said one-third of its members do not intend to take the vaccine and another third are undecided.

New Jersey said last week that its data showed that 66% of the state’s doctors planned to receive the vaccine. Among professionals contacted by the state, “some did not want to be in the first round, so they could wait and see if there are potential side effects,” New Jersey Health Commissioner Judith M. Persichilli said at a Nov. 9 news briefing.

“Of those who said they would not take the vaccine, many said they would be more than willing to get the vaccine at a later date when more data is available.”

The hesitancy among doctors and nurses is not the same as the anti-vaccine movement, which medical experts consider a fringe trend fueled by misinformation and conspiracy theories on social media. Health professionals tend to be advocates of vaccines, including seasonal flu shots, shingles vaccines, and childhood inoculations for measles, mumps and rubella.

But in the case of coronavirus shots, health care leaders say President Donald Trump’s frequent promises about vaccines have raised doubts about the objectivity of agency reviews, as have the speed of the manufacturers’ clinical trials, and unfamiliarity with the novel techniques used by the Pfizer and Moderna vaccines to trigger natural antibodies.

“We are vaccines’ greatest champions, but this is the first time that a new vaccine has been developed at a rapid pace in the middle of a pandemic, as opposed to a much longer timeline,” Susan Bailey, a physician in Forth Worth and president of the American Medical Association, said in an interview.

“What I hear from physicians is some of the same concerns that are expressed by everyone. They worry the process has been politicized. They are concerned because they haven’t see any published data yet. And they don’t feel comfortable making the decision one way or another until they see the evidence,” Bailey said.

Medical professionals are “the most trusted source for health information,” the Centers for Disease Control and Prevention said late last month during a meeting to discuss national distribution plans. “Concerns among health-care providers is a risk for overall vaccine confidence.” The CDC did not respond to a request for comment.

After the fastest development ever, the Food and Drug Administration could grant emergency authorization for the two vaccines as soon as December. That would begin an immediate push to vaccinate 20 million people before the end of the year and hundreds of millions in 2021.

Health professionals must quickly learn the science behind a pair of mRNA vaccines that work differently from traditional vaccines and will need to help convince the public that the vaccines are safe and effective, said Howard Koh, a professor at the Harvard T.H. Chan School of Public Health and a U.S. assistant secretary of health during the Obama administration.

“A doctor who can’t commit to a vaccine personally may find it difficult, if not impossible, to advise their patients to do so,” he said.

“Operation Warp Speed – just that name connotes urgency and timeliness, but could bring to mind for many a fear of the process being rushed,” Koh said. “And we have seen the administration contradicting their own top public health officials and trying to accelerate a process that we know has to be done with all deliberate speed.”

Pfizer and Moderna have provided data from their large-scale Phase 3 trials only via news releases, which contained the highly promising news that both vaccines were 90% effective or more and have not presented any serious safety concerns.

Bailey, Koh and other leaders said it is crucial for the companies to publish full trial results as soon as possible to win approval from physicians.

In coming weeks, the FDA and the companies will be analyzing data from the trials in more detail. The agency has said it will require two months of follow-up safety analysis in trial participants before it will consider issuing emergency-use authorizations – still much faster than the typical minimum follow-up of six months. An FDA committee of independent advisors also will review available efficacy and safety evidence in a public hearing before the EUA is issued. Pfizer did not respond to requests for comment. Moderna said it plans to release more data that should satisfy concerns.

“We believe that transparency with respect to mRNA-1273 scientific results (especially as increasing amounts of data become available) will be the strongest antidote over time to individual uncertainties or anxieties,” Ray Jordan, Moderna’s chief corporate affairs officer, said in an email. “We expect to publish results in peer-reviewed journals as data sufficiently mature over time, just as we have with the multiple evaluated outcomes from our Phase I trial.”

Bailey, the AMA president, said that as an allergist and immunologist, she frequently receives questions about the new vaccines.

“When my patients ask me, I say once I’ve seen the studies and feel confident that no corners have been cut, and no steps have been skipped, and we have a safe and effective vaccine, I’ll be the first in line,” she said.

In an AMA video released on Nov. 2, Bailey said the number of physicians expressing hesitancy was “unprecedented” and said it posed “real risk” to public confidence in vaccines. Since the video was released, President Trump was defeated in his bid for a second term, and Pfizer and Moderna reported that their vaccines worked in more than 90% of people who received them.

Once full data sets are available, if they show a sound safety profile, doctors will come around, Bailey said in an interview. “Most of us are not sitting around reading journals right now. We’re literally trying to save lives,” she said, “but when that data is available, I think the uptake will be quite rapid.”

At the Association of American Medical Colleges, Chief Scientific Officer Ross McKinney said many questions remain about the effectiveness of the vaccines, and how long immunity will last. But the promising Pfizer and Moderna results, plus the outcome of the presidential election, will rapidly shift the landscape, he predicted.

“We’re past November 3, and the perception that the vaccine was being force-fed for an election win is no longer an issue,” McKinney said. “I suspect you are going to see very different numbers on hesitancy. I think you are going to see a huge change in the perceived reluctance to get vaccinated.”

The CDC said 98% of doctors and 92% of nurses were vaccinated for influenza during last winter’s flu season. Many hospital systems mandate staff receive flu shots, but similar directives are not expected for coronavirus vaccines — at least not immediately — because they will still be considered experimental.

Introducing new vaccines is not easy during a global health emergency and a national political debate stoked by a president known to frequently distort, discredit and make false claims about science. The national pandemic response has been marked by emotional and confusing political battles.

In New York, Democratic Gov. Andrew Cuomo formed his own panel of experts to review vaccines that are authorized by the FDA, saying in September, “I’m not going to trust the federal government’s opinion, and I wouldn’t recommend to New Yorkers based on the federal government’s opinion.” Trump responded by saying that the federal government will not send a coronavirus vaccine to New York when it becomes available.

The president repeatedly promised during his reelection campaign that a vaccine would be approved for the United States before the Nov. 3 election. That did not happen. Now, convincing Americans and the medical community that the first vaccines are safe and effective will fall to Trump’s lame-duck administration and then to President-elect Joe Biden.

“These mRNA vaccinations have never been approved before, so there is no reliable track record of safety. We should expect to set the bar higher for safety,” said Jeffrey A. Hirschfield, a pediatrician in St. Petersburg, Fla., who has discussed his reservations on Twitter. “It typically takes five to 10 years to successfully develop and vet vaccine candidates, especially those relying on new technologies.”

Marie Ritacco, a longtime nurse at St. Vincent Hospital in Worcester, Mass., and vice president of a state nurses union, said many nurses will continue to rely on personal protective equipment and strict anti-infection procedures rather than be in the first wave of health-care workers receiving coronavirus vaccines.

“I’m not an anti-vaxxer. I believe in vaccinations. But I’ve never seen a process this fast,” she said. “I don’t think we have enough data to show that it is safe, will not cause harm and will be highly effective. We drive all these decisions on data, and the data is just not there yet.”

Vaccines that use mRNA, or messenger RNA, work by carrying a genetic message into the body that signals cells to produce the coronavirus’s distinctive spike protein, triggering an immune response that creates specific antibodies. Traditional vaccines depend on inactivated virus to accomplish that mission, or some use a viral vector such as a harmless cold virus engineered to contain the genetic instructions for the spike protein.

Health systems nationwide are preparing to distribute the vaccine, and some are beginning to prepare their workforces.

Marci Drees, the infection prevention officer and hospital epidemiologist at ChristianaCare, a hospital system based in Wilmington, Del., said rank-and-file workers will need to be reassured about the safety and efficacy of vaccine from within their own systems. Guidance from the CDC and the FDA will be helpful, but faith in government reviews has been shaken and cannot be the sole source of information, she said.

“A lot of it will be on the ground level, because there has been so much distrust in general,” Drees said. “Being very transparent about what we know, and what we don’t know, is really important.”

She said she receives frequent questions from ChristianaCare medical staff about the two-month safety follow-up window that FDA is relying on to assess the risk of adverse events.

“We are not going to have long-term safety data on these vaccines, but we do know that most side effects occur within the first few weeks after vaccination,” so the FDA’s two-month threshold should give people confidence, Drees said.

In Boston, the large Mass General Brigham health system, which encompasses large academic medical centers including Massachusetts General Hospital and Brigham and Women’s Hospital, as well as community hospitals, has produced videos for its 80,000 employees.

The videos feature assurances from some of the system’s physicians that a vaccine will not be released unless it is known to be safe after thorough reviews by FDA scientists, as well as those outside the government who serve on independent advisory committees.

“We know there are concerns about whether politics played a role in vaccine approval, and we wanted to clearly communicate that there are independent groups that participate in the process that we trust and respect,” said Paul Biddinger, a Mass General physician and the director of emergency preparedness for the broader Mass General Brigham system.

Academic medical centers are expected to be the earliest sites for distribution of mRNA vaccines because they have enough of the ultracold freezers required for their storage, as well as research scientists who can help interpret clinical trial data for their communities.

It is vital that physicians and nurses at these institutions show that they are willing to take the vaccines first, not just to reduce the spread of the coronavirus in a high-risk environment, but also to demonstrate to the community that they stand behind the vaccines, Biddinger said.

That is especially true for vulnerable groups that have been hit hardest by the coronavirus, including African Americans, he said, who may mistrust the U.S. health-care system, given historical examples of unethical medical experiments that targeted Black people and caused harm.

Initial scarcity of supply will result in a gradual escalation of experience with the vaccines. By the time hundreds of millions of doses are available for everyone in the nation, Biddinger said, health systems should be ready to strongly recommend they be used more broadly.

“We think it will snowball with increasing availability of product,” he said, “and people can look back, and we can say we have vaccinated hundreds of thousands, millions of people, and we have not seen adverse events, and therefore we should do this because we want to save lives and get us out of the pandemic.”

At Mount Sinai in New York, Bernard Camins, an infectious disease doctor who is Mount Sinai’s director of prevention and is helping coordinate the hospital system’s vaccine distribution, said the coronavirus vaccination for medical workers will be modeled on efforts to push the annual influenza vaccine.

“I’m surprised considering how bad this pandemic has been that (vaccine hestiancy) is equivalent to 50%” among Mount Sinai health care staff, Camins said during a webiner Thursday sponsored by national healthcare provider EHE Health, calling that a “pessimistic” estimate based on his anecdotal conversations. “Unfortunately, it’s the mixed messages they have gotten.”

Experimental drug given to Trump to treat covid-19 wins FDA clearance #SootinClaimon.Com

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Experimental drug given to Trump to treat covid-19 wins FDA clearance (nationthailand.com)

Experimental drug given to Trump to treat covid-19 wins FDA clearance

Health & BeautyNov 22. 2020

By The Washington Post · Laurie McGinley, Carolyn Y. Johnson · NATIONAL, HEALTH, POLITICS, SCIENCE-ENVIRONMENT, HEALTH-NEWS ·
WASHINGTON – The Food and Drug Administration on Saturday granted emergency authorization to the experimental antibody treatment given to President Donald Trump last month when he developed covid-19, the disease caused by the coronavirus.

The drug, made by Regeneron Pharmaceuticals, is designed to prevent infected people from developing severe illness. Instead of waiting for the body to develop its own protective immune response, the drug imitates the body’s natural defenses. It is the second drug of this type – called a monoclonal antibody – to be cleared for covid-19. The FDA authorized Eli Lilly & Co.’s drug on Nov. 9.

Regeneron’s drug is a cocktail of two monoclonal antibodies, called casirivimab and imdevimab. The FDA said in authorizing the cocktail that it may be effective treating mild to moderate covid-19 in adults and children aged 12 or older, and is indicated for those at high risk of developing severe illness. Doctors hope the drugs will keep those patients from being hospitalized.

But as with the Lilly treatment, the Regeneron drug is a biological product that is complicated and time-consuming to make; initially, it will be in short supply. The shortages, coupled with the complexities of administering the intravenous medication, have raised concerns about whether people with the greatest need will be able to get it.

Regeneron executives said on the company’s earnings call in early November that they project having enough doses for 80,000 patients by the end of November, and 300,000 total doses by the end of January.

Trump received an infusion of Regeneron’s investigational drug – a cocktail of two antibodies – on Oct. 2 after he was diagnosed with covid-19 and began showing symptoms. He received the drug through a compassionate use program that allows people to get unapproved drugs. Housing and Urban Development Secretary Ben Carson disclosed on Facebook Friday that he had also been cleared to receive the Regeneron drug for covid-19, through Trump’s intervention, “which I am convinced saved my life.”Chris Christie, the former Republican governor of New Jersey who also had covid-19, received access to the Lilly drug.

In tweets and videos after Trump was released from the hospital, the president inaccurately described the Regeneron drug as a cure and pressed the FDA to quickly clear the medication. It was several weeks, however, before the agency took action.

Monoclonal antibodies, which are concocted in laboratories, are proteins that mimic the immune system’s ability to attack the virus. Regeneron’s covid-19 drug is manufactured in cells from genetically engineered hamsters cells.

In a clinical trial, the Regeneron drug reduced hospitalizations or emergency room visits when given to people at high risk of developing severe disease. It was also shown to reduce the amount of virus in people’s bodies. The safety and effectiveness of the drug will continue to be studied. It is not authorized for use in hospitalized patients.

In a study published on Oct. 28 in the New England Journal of Medicine, researchers said the Lilly cocktail lowered the risk of follow-up medical visits and reduced levels of virus in people with mild to moderate symptoms for covid-19.

The progress on monoclonal antibodies comes as pharmaceutical and biotech companies are racing to produce coronavirus vaccines. Pfizer and Moderna might get emergency clearance for their vaccines by year’s end; Pfizer applied for FDA authorization on Friday. But it will take months to vaccinate the population of the United States, much less the world, and the shots may not work for everyone. The antibody treatments can play an important role in making the disease less dangerous.

Still, if the pandemic keeps raging, the treatments will be in short supply. Unlike conventional pills, these drugs are synthesized by living organisms in specialized reactors, at a biological pace that can’t be rushed. A worldwide scramble to find capacity to make the drugs is underway, with companies striking deals with competitors to increase their manufacturing capabilities.

Through Operation Warp Speed, the Trump administration effort to speed up treatments and vaccines, the government has bought 300,000 doses each from Lilly and Regeneron at a cost of about $1,250 and $1,500 per dose, respectively, with an option to buy hundreds of thousands more. But that comes as the nation is approaching 200,000 new coronavirus cases each day.

In a sign of how quickly the supply could be used up as the pandemic surges across the country, 40 percent of the doses of Lilly’s bamlanivimab has already been allocated to states. 

Because of the limited supply, the number of doses each state receives will be determined by the number of confirmed cases and hospitalizations in a given week, federal officials said.

In a recent briefing, Health and Human Services Secretary Alex Azar said the antibody treatments have “the potential to save thousands of lives and significantly reduce the disease’s burden on the health-care system.”

Where the antibody drugs will be administered is not clear, particularly because covid-19 patients are contagious and can’t be given the drug at established infusion clinics alongside those with compromised immune systems.

“You can’t send them to places where cancer patients are being treated,” said Mark McClellan, director of the Duke-Margolis Center for Health Policy and a former FDA commissioner. He said that many hospital systems have extra space they could dedicate to the antibody treatments, or could set up pop-up centers. Home-infusion providers such as CVS could administer the drug in nursing homes and people’s residences, he said.

Because of the expected shortages, doctors have expressed concerns that the medicines won’t find their way to patients who need them the most, especially in disadvantaged communities.

Trump administration officials, at the recent briefing, promised to fairly and swiftly distribute the treatment, basing distribution on a strategy similar to what is used for remdesivir, an antiviral drug for hospitalized patients. The administration’s rollout of remdesivir was plagued by problems in its early phases, but officials said they had learned from those mistakes. 

National Harbor curfew issued for minors as D.C. region sets coronavirus record for 17th day #SootinClaimon.Com

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National Harbor curfew issued for minors as D.C. region sets coronavirus record for 17th day (nationthailand.com)

National Harbor curfew issued for minors as D.C. region sets coronavirus record for 17th day

Health & BeautyNov 21. 2020People have their temperature taken as they wait to be checked in to receive a coronavirus test Wednesday in Silver Spring, Md. MUST CREDIT: Washington Post photo by Toni L. SandysPeople have their temperature taken as they wait to be checked in to receive a coronavirus test Wednesday in Silver Spring, Md. MUST CREDIT: Washington Post photo by Toni L. Sandys 

By The Washington Post · Rachel Chason, Dana Hedgpeth, Fenit Nirappil · NATIONAL, HEALTH, HEALTH-NEWS

The rate of coronavirus spread across the greater Washington, D.C., region has doubled since the start of November, pushing the number of average daily cases to a record Friday for a 17th consecutive day.

The continued surge prompted Prince George’s County, Md., to issue a curfew for unaccompanied minors that begins this weekend in its waterfront entertainment and dining district. It follows several new restrictions added across the region’s jurisdictions this month as coronavirus cases have exploded.

Virginia, Maryland and D.C. recorded 5,027 new daily infections Friday, lifting the rolling seven-day average of cases to 4,361 – a number that has risen each day since Nov. 3.

Prince George’s County cited the rise in cases in deciding to impose a weekend curfew at National Harbor beginning at 5 p.m. Friday for unaccompanied minors. County Executive Angela Alsobrooks, a Democrat, has said large groups of young people are gathering in the area, including at hotels where parents have rented rooms for their children to host parties.

She previously warned that those events have upset business owners and posed a threat to public safety.

“We are required to take this necessary action to limit the spread of the virus,” she said in a statement late Thursday announcing the curfew.

The curfew will be in effect starting at 5 p.m. on Fridays, Saturdays and Sundays – continuing until 6 a.m. the next morning – for those 17 and under who are without an adult. Minors accompanied by adults are still allowed to shop and dine in the area.

County Health Officer Ernest Carter said contact tracing shows most people in Prince George’s who are contracting the virus recently have attended a large party or gathering.

“We know covid-19 is spreading due to people engaging in these high-risk activities, and it needs to stop or more Prince Georgians will get sick and die,” he said.

Those who violate the curfew, including their parents or guardians, could face a $1,000 fine or a misdemeanor, officials said, noting that it is parents’ responsibility to ensure their children do not violate the curfew.

Prince George’s, like the rest of the region, is seeing a marked uptick in coronavirus cases. The county last week reported 2,087 new cases – a 50 percent increase from the week before. The county’s test positivity rate has increased to 8.5 percent, doubling in the past month.

Across the state, Maryland reported 2,353 new cases Friday, lifting its seven-day average of daily cases to 2,188 – its 17th consecutive daily record. Maryland also reported 26 additional deaths, which ties for the most in a single day since June 16.

A new order from Gov. Larry Hogan, a Republican, went into effect Friday that clamps down on the hours restaurants and bars can operate and the number of people allowed in retail stores and at religious facilities.

The order, which Hogan announced Tuesday, requires bars and restaurants in Maryland to close at 10 p.m. for indoor service and reduces capacity allowed in retail stores, religious facilities, fitness centers, personal service facilities and bowling alleys to 50 percent. It also rescinded an earlier order that allowed fans at racetracks and at college and professional football stadiums.

The statewide order only minimally changed conditions in Montgomery and Prince George’s counties, which generally have opted to reopen at a slower pace than state guidelines allow.

In Virginia, state health officials reported 2,544 new cases Friday, sending the seven-day average number of new infections above 2,000 for the first time since the start of the pandemic. The state also recorded 16 new fatalities.

D.C.’s 130 new infections Friday puts its seven-day average at 163 daily cases – double the average of early November. The city also reported two new fatalities.

New D.C. cases in recent weeks have disproportionately originated from Wards 4, 5 and 6, in some of the city’s most gentrifying neighborhoods.

Areas near Union Station, as well as Adams Morgan and U Street, are in the middle of the pack among D.C. neighborhoods for their number of cases since the start of the pandemic, but among the biggest drivers of new cases in the city, according to an analysis of city data by The Washington Post.

Foggy Botton, Capitol Hill and the Southwest Waterfront – which haven’t traditionally been among the city’s hardest-hit areas – have seen the highest rates of increase since late September.

D.C. Mayor Muriel Bowser, a Democrat, hasn’t added new restrictions amid the latest jump in cases but said this week she would do so “soon.” Virginia and Maryland – as well as several of Maryland’s most populous jurisdictions – have reimposed several pandemic-related restrictions in recent days.

The number of fatalities connected to the coronavirus has risen along with case counts in recent weeks. The greater Washington region is averaging 38 virus-related deaths each day, the most since Sept. 22.

Pfizer and BioNTech apply for regulatory clearance of their coronavirus vaccine #SootinClaimon.Com

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Pfizer and BioNTech apply for regulatory clearance of their coronavirus vaccine (nationthailand.com)

Pfizer and BioNTech apply for regulatory clearance of their coronavirus vaccine

Health & BeautyNov 21. 2020

By The Washington Post · Carolyn Y. Johnson · NATIONAL, HEALTH, HEALTH-NEWS

Pfizer and its German partner BioNTech applied Friday for emergency authorization of their coronavirus vaccine, a landmark moment and a signal that a powerful tool to help control the pandemic could begin to be available by late December.

https://www.washingtonpost.com/video/c/embed/3658ede2-f4cc-48ba-942e-17de469fe2d8?ptvads=block&playthrough=false

The U.S. race to develop a vaccine has set scientific speed records since it launched in January, and the submission of a first application to regulators cements that. Now, that effort will move to its next, deliberative phase – a weeks-long process in which career scientists at the FDA to scrutinize the data and determine whether the vaccine is safe and effective to be used in a broad population.

“It is with great pride and joy, and even a little relief that I can say our request for emergency use authorization for a covid-19 vaccine is now in the FDA’s hands,” Pfizer chief executive Albert Bourla said in a video message shared by the company. “This is a historic day – a historic day for science and for all of us.”

Only after the FDA has given the green light will a first, limited group of high-risk people be able to access the shots. Government officials anticipate having enough vaccine to inoculate about 20 million people with the two-dose regimen in the United States in December, between Pfizer and BioNTech’s vaccine and a second shot likely to be considered for emergency authorization soon, from biotechnology company Moderna. The United States will receive about half of the 50 million doses Pfizer is aiming to produce by the end of the year.

There will probably be enough vaccine for 25 million to 30 million people a month in early 2021, according to Moncef Slaoui, chief scientific adviser of Operation Warp Speed, the federal government initiative to speed up vaccine development. He did not specify how many doses each company would contribute.

Glimpses of the Pfizer data through news releases have so far exceeded expectations: The two-dose vaccine regimen was 95% effective at preventing disease in clinical trials and had no major safety problems, according to the company. It was 94% effective in people older than 65, a group of critical concern because older people are more likely to develop life-threatening illness after contracting the virus. The companies are also submitting two months of follow-up data on 38,000 people of the 44,000 in the trial. They will present safety data on 100 children between 12 and 15 years old, a group they only recently began to include in their trial.

Those findings will be scrutinized by regulators – including at a full-day advisory committee meeting in which external scientists will meet to make recommendations to the agency on whether it should clear the vaccine for broader use.

The companies have started applications that are updated continuously with other regulators, including regulators for the European Union and the United Kingdom. The drugmakers said they will submit applications in other countries within days. They are poised to distribute the first doses of vaccine within hours of a regulatory decision.

The hope that many scientists and physicians feel about unprecedented scientific success in developing a remarkably effective vaccine has been tempered by a grim reality. No vaccine will arrive in time to alter the current surge of virus, as hospitals are overwhelmed, testing capacity is stretched and intensive care units fill with sick people – right before holidays that may seed even more outbreaks.

“My message to the American people is to hang in there with us. Take the simple steps that the doctors have talked about today because there is a light at the end of the tunnel. This isn’t forever,” Health and Human Services Secretary Alex Azar said in a briefing Thursday.

On Wednesday, Pfizer announced its 44,000-person vaccine trial had hit the necessary endpoints for safety and efficacy and that it could file for emergency authorization within days. The vaccine was 95% effective at preventing disease in the large clinical trial, and Pfizer and BioNTech had gathered sufficient safety data to support an application, with no major safety problems identified.

Half of the participants in Pfizer’s trial received two doses of the study vaccine, and half received two shots of saline. Then, the investigators waited to see which participants fell ill as they were exposed to the virus in their normal lives.

Out of 170 cases of covid-19 so far, 162 were in the placebo group – a strong signal the vaccine protected people. Nine in 10 cases of severe illness were in the placebo group, another strong sign the vaccine protected against mild and serious cases. The most common adverse event rated as “severe” in the trial was fatigue, in 3.7% of participants after the second dose.

An emergency authorization for a vaccine is typically a lower standard than full approval. Still, FDA guidelines sought to set a high standard for a vaccine, even under emergency authorization. That guidance required a vaccine be at least 50% effective, with a minimum of two months of safety data on half the participants.

There are concerns the encouraging news on a vaccine could backfire and make it harder to persuade people to participate in ongoing clinical trials that are needed to test other vaccine candidates, which will be critical in making enough vaccine for the entire population.

William Hartman, an anesthesiologist running a trial of the vaccine being developed by AstraZeneca at UW Health in Madison, Wis., said that about 20 times a day, he and others working on the trial are asked whether a volunteer could receive a different vaccine that receives authorization sooner. Recently, staff have had to scramble to fill slots that have opened because of last-minute cancellations.

Hartman said he fears that convincing people to volunteer for a trial in which they have a 50-50 chance of receiving a placebo could become even harder once any vaccine receives authorization.

“I do worry about the numbers declining, because it’s going to take way more than one vaccine or two vaccines to cover the population of the world,” Hartman said. “We’re going to need several of these candidates to come forward.”

Hartman is also worried that people hearing good news about a vaccine won’t be prepared for what is coming. In Dane County, Wisconsin, where he works, coronavirus cases have exploded, matching in one month the total in the previous eight months. His hospital hasn’t run out of capacity, but it is a constant concern, particularly with Thanksgiving, Christmas and New Year’s likely to seed a new surge of cases.

“Even with this exciting news of these vaccines, it’s still going to be a dark couple of months here,” Hartman said. “There’s a lot of people who are going to be celebrating with their families and other people outside of their immediate bubble, and I think that a vaccine, in no way is going to help with that right now.”

Hogan’s first batch of coronavirus tests from South Korea were flawed, never used #SootinClaimon.Com

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Hogan’s first batch of coronavirus tests from South Korea were flawed, never used (nationthailand.com)

Hogan’s first batch of coronavirus tests from South Korea were flawed, never used

Health & BeautyNov 21. 2020Gov. Larry Hogan, with his wife, Yumi Hogan, right, announces the initial purchase of 500,000 coronavirus tests from South Korea. MUST CREDIT: Washington Post photo by Michael Robinson Chavez.Gov. Larry Hogan, with his wife, Yumi Hogan, right, announces the initial purchase of 500,000 coronavirus tests from South Korea. MUST CREDIT: Washington Post photo by Michael Robinson Chavez. 

By The Washington Post · Steve Thompson · NATIONAL, HEALTH, POLITICS, HEALTH-NEWS

Maryland Republican Gov. Larry Hogan spent $9.46 million in state funding to import 500,000 coronavirus tests from South Korea that turned out to be flawed and weren’t used, emails, documents and interviews show.

https://www.washingtonpost.com/video/c/embed/10f8a901-7e60-49dc-aa4d-632ad863d4ad?ptvads=block&playthrough=false

As it became clear that the much-touted tests could not help detect which Maryland residents had contracted the novel coronavirus, the Hogan administration quietly paid the same South Korean company $2.5 million for 500,000 replacement tests.

The state offered the tests free to two private labs, one of which declined because the tests took much longer to process than U.S. versions, records and interviews show.

https://www.washingtonpost.com/video/c/embed/0886585b-f2e3-4ad3-9c40-41b279a178ee?ptvads=block&playthrough=false 

The University of Maryland, which had spent months equipping its lab in Baltimore to process coronavirus tests, abandoned the replacement South Korean tests this fall after a spate of suspected false positives. But the other private lab continues to use them; a state official said Wednesday that 370,000 of the replacement tests have been used.

https://www.washingtonpost.com/video/c/embed/e908a52e-c525-4110-8780-ef7009edd7c6?ptvads=block&playthrough=false

Hogan heralded the initial purchase as “an exponential, game-changing step forward” and featured it as the climax of his political memoir, published this summer.

“No one knew how many lives those 500,000 tests might save, but it would be a lot,” he wrote of their arrival in April at Baltimore-Washington International Marshall Airport. “The successful mission got tons of attention in the national media.”

Local officials in Maryland hoped that the purchase would make screening in the state more widely available. When the tests were not quickly deployed, they – and state lawmakers – began asking what was going on.

But Hogan and his top health and procurement officials withheld the tests’ flaws from the legislature, state spending authorities and the public, according to a review of public testimony and hundreds of pages of emails and other records.

In response to queries from lawmakers, Hogan’s top officials repeatedly said they did not know how many tests had been used.

Hogan declined requests to discuss the tests for this article. Responding to written questions, spokesman Mike Ricci said the governor and his aides have kept Marylanders “updated often on the progress we are making in our long-term testing strategy.”

Ricci said the original tests “could have been used through a custom lab process, but this would have taken longer than purchasing the upgraded kits.”

Told of The Washington Post’s findings, state lawmakers said they felt misled by the Hogan administration.

“It’s incredibly frustrating that the administration seems to have taken very obvious measures to avoid accountability and oversight of these tests,” said Sen. Clarence Lam, D-Howard, the Senate’s lone physician. “We spent a lot of money on these tests, and to not be able to have forthcoming answers as to how they were used while people were dying is just unconscionable.”

– – –

As the coronavirus made its initial dash across the United States, scientists and health specialists recognized the need to massively expand testing capacity.

The most widely used type of screening – called a polymerase chain reaction (PCR) test – diagnoses infections by looking for specific genes within small bits of genetic material collected from nasal swabs. Those specimens are processed in laboratories, using PCR test kits and chemical compounds called reagents.

By mid-March, U.S. manufacturers were able to ship PCR tests by the millions to domestic labs. But testing remained scarce because of limitations in how many kits labs could process, as well as shortages of swabs and reagents.

Hogan, at the time the chairman of the National Governors Association, urged President Donald Trump to help expand testing. But the federal government left it to the states to lead the effort, and they were forced to scramble for supplies amid the crisis. Meanwhile, South Korea was drawing worldwide attention for its effective handling of the virus through large-scale testing.

Hogan began considering whether his Korean-born wife, Yumi, could help acquire tests from her native country. Emails obtained by The Post through the Maryland Public Information Act show that he directed procurement and health officials to vet various South Korean test makers, focusing on them rather than U.S. suppliers.

On March 28, Hogan asked Yumi to join him on a call with Lee Soo-hyuck, the South Korean ambassador to the United States. The conversation, Hogan said, set in motion negotiations with the South Korean company LabGenomics.

The state soon sent a letter of intent to buy 500,000 LabGenomics PCR tests – branded LabGun – and scheduled the first of several wire transfers that would total $9 million for the tests and $464,389 in shipping costs.

That amounted to almost $19 per test, more expensive than some tests that had become available domestically. At the same time, emails show, some U.S. companies were starting to contact state officials with their own offers.

An executive at Thermo Fisher Scientific, one of the nation’s leading PCR test providers, contacted Hogan’s office the same week that the state sent its letter of intent to South Korea. Noting inefficiencies in other states’ approaches to testing, the company offered to help Maryland, saying it had relationships with private labs across the state and would expedite sending testing supplies to whichever labs state officials chose to process their coronavirus tests.

Matthew Clark, Hogan’s chief of staff at the time, said he would contact some of the labs, but made clear that acquiring test kits was not his first concern.

“The key question will be availability of reagent and swabs,” he said in an email to Thermo Fisher executives on April 5. “Obviously test cartridges/kits are needed but we don’t have the same shortages there.” Clark, who left Hogan’s administration at the end of May, referred questions to current administration officials.

Over the next two weeks, state officials moved forward with importing the South Korean tests – an effort that Hogan repeatedly described as immensely complicated.

“It took dozens and dozens of phone calls, night after night, sometimes it seemed like all night, working through language barriers and the 13-hour time difference,” the governor would write in his book.

– – –

On Saturday, April 18, the first of two chartered Korean Air flights arrived at BWI airport, its belly loaded with 350,000 LabGun tests packed in dry ice. A second shipment of 150,000 tests would arrive a few days later.

At a news conference that Monday, Hogan announced his test purchase to the world, boasting that what “we have just acquired is equal to the total amount of testing that has been completed by four of the top five states in America combined.”

But the tests required labs to process them. From a list supplied by Thermo Fisher, Hogan administration officials selected two: Integrated Cellular and Molecular Diagnostics (ICMD), based in Greenbelt, and CIAN Diagnostics, based in Frederick. The private labs would test specimens from nursing homes and community sites on behalf of the state, records show.

According to a copy of CIAN’s contract and an interview with an ICMD executive, the state agreed to pay the companies $98 per test, regardless of whether the labs used the Korean test kits, which the state would provide free, or purchased Thermo Fisher tests, called TaqPaths.

Asked why Hogan’s administration agreed to pay the labs the same fee when the state also had to provide the test kit, Ricci referred The Post to health officials. Dennis Schrader, the health department’s chief operating officer, told The Post he didn’t know.

ICMD discovered problems with the LabGun kits, just as University of Maryland scientists would. “We couldn’t reproduce what the literature was saying,” said Richard Puritz, a company vice president, referring to documentation that came with the tests.

Fran Phillips, who retired in July as deputy health secretary, said the problems reported by ICMD prompted her to ask Robert Myers, director of the state’s public health lab, to look at the test kits. He realized that materials in the kits didn’t match those the test maker had submitted to the Food and Drug Administration for authorization weeks earlier.

“He said, ‘There’s no point in going through with the validation study. We just don’t have the right stuff here,’ ” Phillips said in an interview Wednesday.

State officials alerted CIAN to the problems. “The state said do not use them, so we didn’t use them,” CIAN principal Sam Mullapudi said.

Emails exchanged later between a scientist at the University of Maryland at Baltimore and the school’s president also detail problems with the LabGuns.

The test kit’s instructions on how to interpret results were, in some ways, the opposite of what LabGenomics had submitted to the FDA, according to a May 19 email from professor Jacques Ravel to the university’s president, Bruce Jarrell. The email, obtained this month through a Public Information Act request, said required steps were given in a different order.

LabGenomics officials did not respond to multiple requests for comment about the test kits.

“Because this is a sensitive issue, we would like to discuss the matter with you first and strategize on how to proceed with bringing this up to the State,” Ravel wrote in an email to Jarrell.

During a phone call with state officials, Jarrell learned they already were arranging to replace all the tests with new shipments of LabGun tests from South Korea. The first shipment arrived May 21, records show. University scientists confirmed the replacement tests matched what the FDA had authorized, according to an email from Ravel to Jarrell.

Still, the LabGun test, by design, took longer than Thermo Fisher’s TaqPath tests to process in large batches.

“The LabGun basically takes twice as long,” said Puritz of ICMD. Rather than continuing to try to use the free LabGuns, the company kept buying TaqPaths, which Puritz said had not been in short supply.

CIAN and the University of Maryland lab, however, began “bridging studies” that FDA regulations required to ensure the LabGun tests could be used with those labs’ instruments.

– – –

The hype around Hogan’s test purchase had raised expectations among nursing homes, county governments and others that their arrival would quickly expand the state’s testing capacity. But as the weeks passed with no sign of them, lawmakers – both Republicans and Democrats – grew impatient.

Sen. Paul Pinsky, D-Prince George’s, who chairs the Education, Health and Environmental Affairs Committee, asked Hogan to send someone from his office to the panel’s meeting on May 27, noting that the test purchase was made “outside of normal procurement channels.”

At that meeting, Pinsky and Lam pressed General Services Secretary Ellington Churchill Jr. about reports that the tests were not being used. They repeatedly asked whether the state had all the supplies it needed and, if not, what was missing.

“For two weeks, we saw on national TV that Santa Claus had landed in Maryland, and you had procured 500,000 tests with the administration to save our lives,” Pinsky said.

Churchill, whom Hogan had thanked when announcing the initial test purchase and whose name appeared on the invoice for the replacement tests, disclosed nothing about the problems with the tests, repeatedly referring lawmakers’ questions to the state health department.

“I’m going to try not to sound like a broken record,” he told the lawmakers.

Asked by The Post about his responses to lawmakers, Churchill said in a statement that he was proud of the state’s procurement officers for their “unprecedented effort to secure large quantities of medical commodities.”

A week later, Phillips and Health Secretary Robert Neall attended a meeting of the Covid-19 Response Legislative Work Group. Again, Lam and other lawmakers pressed for answers.

Lam grew frustrated as Phillips, who gave the presentation, spoke at length but did not respond to inquiries about how many of the tests from South Korea had been used or whether there were any problems.

“It’s a very simple question,” Lam said, interrupting her. “How many of those tests have been used to date?”

Phillips avoided answering, saying the LabGun tests were part of a long-term strategy as the state planned for the fall.

In a briefing memo to the governor, Hogan adviser Keiffer Mitchell Jr. said the health officials “stuck to their talking points and the hearing went well.”

Phillips said Wednesday that she didn’t think the work group session was the right place to detail the state’s testing challenges.

“As I remember, I didn’t feel like it was the situation to get into all of the problems that go into the fact that we couldn’t get to the testing goals that we were aiming toward,” she said. “I thought that the information we did convey was complete, and it was thorough, and it was truthful.”

– – –

Unlike with the initial purchase of tests from South Korea, Hogan and his top officials kept the arrival of the replacement tests quiet.

“There shall be no media, no publicity, and no pictures for this flight,” Ricky Smith, the Hogan-appointed executive director of BWI, told subordinates in an email before the shipment.

The governor first mentioned them publicly nearly two months later, while being interviewed on Washington Post Live about his memoir, “Still Standing.” The pandemic delayed publication of the book, which details Hogan’s tenure as the highly popular Republican leader of a blue state. Hogan added several chapters about his actions in the coronavirus crisis, culminating in his purchase of the first South Korean tests.

“We’re actually getting, you know, upgraded and new and improved testing from South Korea,” the governor told Post interviewer Frances Stead Sellers on July 16.

Asked about the new tests later that day by Jayne Miller, an investigative reporter for WBAL-TV in Baltimore, he again described the purchase as an upgrade.

“They were swapped out, like you trade in your iPhone, for faster, better tests . . . at a couple dollars more per kit,” Hogan said, according to the news report. Miller reported that Hogan said no one had raised concerns about the original batch of tests.

Hogan administration officials also referred to the tests as “upgrades” when submitting information on Aug. 28 to the Board of Public Works, which authorizes state expenditures. Paperwork provided to the board said the new tests cost the state $2,514,265.

Hogan officials did not respond to questions about why the state had to pay to replace the flawed tests.

The state also spent $2.5 million to create a robotic lab at the University of Maryland at Baltimore, which a news release said would become “the backbone of the state’s testing strategy.”

Deborah Kotz, a spokeswoman for the University of Maryland School of Medicine, said university labs began to process LabGun tests on June 10. By late summer, the university was processing a few thousand tests a day, far short of the 20,000 officials had hoped for.

In mid-July, state officials told nursing homes that they would have to begin arranging their own weekly testing for employees, after the state had provided testing for months. Officials said the university lab would provide the tests for $40 per specimen, about half the going rate.

The university entered arrangements with 23 nursing homes on Aug. 14, but turned away dozens more. As capacity expanded in later weeks, Kotz said, the university added 49 more nursing facilities.

At a meeting of the House health committee in late August, lawmakers again grilled Neall and Schrader, who accompanied him. This time, the impatience was evident on both sides of the aisle.

“I hate to belabor this point, but I know I share the frustration with many of the delegates that I talk to on the question of the Korean tests,” said Brian Chisholm, R-Anne Arundel. “Did we really use the original Korean tests that we showed all over the media?”

Schrader said he didn’t know.

Committee Chair Shane Pendergrass, D-Howard, asked for an accounting of how many of the original and replacement South Korean tests had been used.

“I don’t know whether we have that information, Madam Chair. I will inquire,” replied Neall, a former state senator.

“How could you not know what tests you’re giving to the lab?” Pendergrass said. “Don’t you know whether the tests were swapped out or they weren’t swapped out?”

“I do not know,” Neall said.

“Well who would know?” Pendergrass asked.

“Well, I’ll try to get the answer for you,” Neall replied. “The only thing that I’m saying is that those tests came at a time when the world didn’t have any tests, and we were damn glad to get them. And the fact that we got them saved a lot of lives, because we were able to test when other people were not able to test.”

Schrader told The Post on Thursday that he only became involved in testing issues in June, after the replacements had arrived.

Neall, who plans to retire Dec. 1, did not respond to a request for comment about his statements.

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Days after the August meeting, in early September, health officials in Howard County received word of an apparent coronavirus outbreak at Lorien Columbia nursing home, a 205-bed facility that had about 90 cases among patients and staff members during the first months of the pandemic.

About 30 Lorien employees had just tested positive, according to the University of Maryland lab. They were ordered to isolate, meaning they could not go to work.

“That was just mouth-dropping,” recalled Lisa de Hernandez, a spokeswoman for the Howard County Health Department.

But several of the workers soon were tested again, and this time the results were negative, according to county health officials. When the others were retested, those results, too, were negative.

Health officials soon learned that between Sept. 2 and Sept. 8, the university lab had also given dozens of people at several other facilities suspected false positive results.

The lab’s director, Jeffrey Parker, sent an email to nursing homes, saying it was investigating test results. He added that the lab had stopped using the LabGun tests and was moving to a test that could check for both the coronavirus and influenza.

Soon afterward, Jarrell, the university’s president, released a statement saying the lab had been “planning for some time” to make the switch.

Ricci, the governor’s spokesman, declined to say whether those plans were a reversal of assertions by Hogan and Phillips that the LabGun tests were a key part of the state’s strategy for the fall.

The state’s Office of Health Care Quality inspected the university lab in response to the suspected false positives and found shortcomings in how the lab ensured specimens were properly transported and stored. The report did not identify a cause of the suspected false positives, and LabGenomics officials did not return requests for information.

Kotz, the university spokeswoman, said scientists and inspectors found no evidence showing the results were false positives. She declined to say whether the LabGun tests were involved. Although “a few nursing homes” had an increase in positive results, she said in an email, the university reported results during that time to “several other nursing homes where no increase in positivity was observed.”

Kotz said the university has used 129,000 of the LabGun tests. But she declined to say how many results from those tests were reported to patients. She said the figure “includes tests used in our validation and tests used for repeat testing when [the] first test is undetermined.”

CIAN, the private lab located in Frederick, is still using the LabGun tests, Mullapudi said. State records indicate that the lab was using about 1,300 per day in mid-September. On Wednesday, Schrader told the state Board of Public Works that, so far, 370,000 of the LabGun tests had been used, a figure that includes the tests processed at the university lab as well.

The board – which is chaired by Hogan and includes Democrats Comptroller Peter Franchot and Treasurer Nancy Kopp – accepted increasing the state’s testing contract with CIAN to $45 million, which includes tests given at the governor’s mansion and State House complex for state employees.

Hogan said he expects to have used all of the LabGun tests by the end of the year.

Franchot replied that he was glad to hear it, noting that the purchase had prompted some criticism.

“That was a bunch of nonsense,” Hogan said. He described the tests as the “backbone of our testing strategy,” adding that he bought them “at a time where there were no tests available in America.”

Hogan’s first batch of coronavirus tests from South Korea were flawed, never used (nationthailand.com)