COVID-2019 in America, effect on politics and economy

[JRT]

Seth Lederman says that after the population receives effective vaccinations, Sars-Cov-2 / COVID-19 will transition from pandemic to endemic disease, and is not going to go away.

Covid-19 Is Not Going to Go Away: Tonix Pharmaceuticals CEO

05 December 2020

(New Bedford, Massachusetts) Seth Lederman, chairman and chief executive officer of Tonix Pharmaceuticals, talks about the coronavirus outbreak and the rollout of vaccines. Tonix has two Covid-19 vaccine in the pipeline. Lederman speaks on "Bloomberg Daybreak: Australia."

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[JRT]

Dr. Fauci says January could be 'Real Dark Time' for us

07 December 2020

(Albany, New York) Anthony Fauci, the U.S. government’s top infectious-disease expert, warned that the Christmas season could be worse than Thanksgiving for fueling the spread of Covid-19 over the subsequent weeks. “The middle of January could be a real dark time for us,” Fauci said Monday at a news briefing held by New York Governor Andrew Cuomo.

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[JRT]

As virus spreads, Kansas hospital runs out of staff

by Heather Hollingsworth
08 December 2020

The radiology technician slept in an RV in the parking lot of his rural Kansas hospital for more than a week because his co-workers were out sick with COVID-19 and no one else was available to take X-rays.

A doctor and physician assistant tested positive on the same day in November, briefly leaving the hospital without anyone who could write prescriptions or oversee patient care. The hospital is full, but diverting patients isn’t an option because surrounding medical centers are overwhelmed.

The situation at Rush County Memorial Hospital in La Crosse illustrates the depths of the COVID-19 crisis in rural America at a time when the virus is killing more than 2,000 people a day and inundating hospitals.

The virus is sidelining nurses, doctors and medical staff nationwide, but the problem is particularly dire in rural communities like La Crosse because they don’t have much of a bullpen - or many places to send patients with regional hospitals full.

The staff shortages have forced people like Eric Lewallen, a Gulf War veteran and alfalfa farmer who moonlights as a radiology technician, to mount a last line of defense. To keep the hospital open, he had no choice but to start living in his RV in the parking lot because he needed to be on site as the only remaining healthy staffer to perform X-rays.

“I’m it,” Lewallen said shortly after begging the hospital laundry staff to start washing his scrubs because he had run out of clean ones.

“To keep a critical access hospital open, you have to have X-ray and lab functioning,” he said. “If one of those go down, you go on diversion and you lose your ER at that point. We don’t want that to happen, especially for the community.”

La Crosse, a town of 1,300 people that dubs itself as the “Barbed Wire Capital of the World” and is home to a barbed wire museum, is like many small towns struggling with the virus. Case numbers have soared, there’s an outbreak at the nursing home, and its county has opted out of Democratic Gov. Laura Kelly’s latest mask mandate.

And there are few larger medical centers to send its sickest patients with the rest of the region also overrun by the virus.

The larger Hays Medical Center, which is just 25 miles (40.23 kilometers) away from La Crosse, was always willing to take patients that needed more advanced care in the past. But it turned away 103 transfers in November alone. In the 14 years prior, it had rejected transfers just twice, said Dr. Heather Harris, the medical director there.

Physician assistant Kai Englert was able to fill in for six days at La Crosse, overseeing several COVID-19 patients, one of whom died after no larger hospital would take the patient. The La Crosse hospital doesn’t have a ventilator and the oxygen it provided wasn’t sufficient with the patient’s “chest full of COVID.” But Englert doubts more advanced would have made much difference because the patient was so sick.

He said the message from large hospitals is: “We are not going to waste a bed on someone who is going to die anyway. They can die in a small town and that is the sad reality of the situation.”

In November, the hospital had to close its attached clinic and turn to a temporary staffing agency to keep the emergency room open after the doctor and physician assistant tested positive for the virus on the same day. The nurse practitioner was also out on medical leave. Currently, a certified nursing assistant is quarantining, and at least two other nurses tested positive previously.

The doctor and physician assistant returned Thursday after finishing their quarantine and were swamped with a backlog of patients.

Michael Cooper, the hospital’s CEO, said it was a stroke of luck that he could find anyone to fill in while they were gone given the level of strain on the state’s hospitals. According to the Kansas Hospital Association, 42% of them are reporting staffing shortages.

“You go through your contingency plans and in the back of your mind you are thinking, ‘I am going to have to go on diversion and find a bed for these patients in a time where there are no beds to be found anywhere in the state,’” he said. “That is the crisis that I was really concerned about. If I can’t find a provider that can check on these patients then I am going to have to get rid of these patients. And there is no where to send them.”

Cooper said he would like to have more nurses, too, because of the volume of patients the hospital is treating, but staffing agencies are charging $140 to $240 an hour. “That is more than I pay my doctor.” Instead he is encouraging overtime, which is up about 20 or 25%.

Some of the nurses have taken him up on the offer, working a week straight as the virus surges in the county of 3,300 residents.

“We just kind of piece it together,” said Jolene Morgan, a registered nurse who suspects she contracted the illness in September. She quarantined for 14 days, although she was never tested.

Lewallen, the radiology technician, acknowledges it might get worse but said everyone is working hard from the kitchen and laundry staff to the nurses. The veteran is trying to keep the proper perspective after his experience in the military.

“It’s not like anyone shooting at us or anything, so I am confident we will get through it alright. It will just be a tough spell for awhile,” he said.


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[JRT]

Need a COVID-19 Nurse? That’ll Be $8,000 a Week

by Markian Hawryluk and Rae Ellen Bichell
25 November 2020

(Denver) In March, Claire Tripeny was watching her dream job fall apart. She’d been working as an intensive care nurse at St. Anthony Hospital in Lakewood, Colorado, and loved it, despite the mediocre pay typical for the region. But when COVID-19 hit, that calculation changed.

She remembers her employers telling her and her colleagues to “suck it up” as they struggled to care for six patients each and patched their protective gear with tape until it fully fell apart. The $800 or so a week she took home no longer felt worth it.

“I was not sleeping and having the most anxiety in my life,” said Tripeny. “I’m like, ‘I’m gonna go where my skills are needed and I can be guaranteed that I have the protection I need.’”

In April, she packed her bags for a two-month contract in then-COVID hot spot New Jersey, as part of what she called a “mass exodus” of nurses leaving the suburban Denver hospital to become traveling nurses. Her new pay? About $5,200 a week, and with a contract that required adequate protective gear.

Months later, the offerings — and the stakes — are even higher for nurses willing to move. In Sioux Falls, South Dakota, nurses can make more than $6,200 a week. A recent posting for a job in Fargo, North Dakota, offered more than $8,000 a week. Some can get as much as $10,000.

Early in the pandemic, hospitals were competing for ventilators, COVID tests and personal protective equipment. Now, sites across the country are competing for nurses. The fall surge in COVID cases has turned hospital staffing into a sort of national bidding war, with hospitals willing to pay exorbitant wages to secure the nurses they need. That threatens to shift the supply of nurses toward more affluent areas, leaving rural and urban public hospitals short-staffed as the pandemic worsens, and some hospitals unable to care for critically ill patients.

“That is a huge threat,” said Angelina Salazar, CEO of the Western Healthcare Alliance, a consortium of 29 small hospitals in rural Colorado and Utah. “There’s no way rural hospitals can afford to pay that kind of salary.”

Surge Capacity

Hospitals have long relied on traveling nurses to fill gaps in staffing without committing to long-term hiring. Early in the pandemic, doctors and nurses traveled from unaffected areas to hot spots like California, Washington state and New York to help with regional surges. But now, with virtually every part of the country experiencing a surge — infecting medical professionals in the process — the competition for the finite number of available nurses is becoming more intense.

“We all thought, ‘Well, when it’s Colorado’s turn, we’ll draw on the same resources; we’ll call our surrounding states and they’ll send help,’” said Julie Lonborg, a spokesperson for the Colorado Hospital Association. “Now it’s a national outbreak. It’s not just one or two spots, as it was in the spring. It’s really significant across the country, which means everybody is looking for those resources.”

In North Dakota, Tessa Johnson said she’s getting multiple messages a day on LinkedIn from headhunters. Johnson, president of the North Dakota Nurses Association, said the pandemic appears to be hastening a brain drain of nurses there. She suspects more nurses may choose to leave or retire early after North Dakota Gov. Doug Burgum told health care workers they could stay on the job even if they’ve tested positive for COVID-19.

All four of Utah’s major health care systems have seen nurses leave for traveling nurse positions, said Jordan Sorenson, a project manager for the Utah Hospital Association.

“Nurses quit, join traveling nursing companies and go work for a different hospital down the street, making two to three times the rate,” he said. “So, it’s really a kind of a rob-Peter-to-pay-Paul staffing situation.”

Hospitals not only pay the higher salaries offered to traveling nurses but also pay a commission to the traveling nurse agency, Sorenson said. Utah hospitals are trying to avoid hiring away nurses from other hospitals within the state. Hiring from a neighboring state like Colorado, though, could mean Colorado hospitals would poach from Utah.

“In the wake of the current spike in COVID hospitalizations, calling the labor market for registered nurses ‘cutthroat’ is an understatement,” said Adam Seth Litwin, an associate professor of industrial and labor relations at Cornell University. “Even if the health care sector can somehow find more beds, it cannot just go out and buy more front-line caregivers.”

Litwin said he’s glad to see the labor market rewarding essential workers — disproportionately women and people of color — with higher wages. Under normal circumstances, allowing markets to determine where people will work and for what pay is ideal.

“On the other hand, we are not operating under normal circumstances,” he said. “In the midst of a severe public health crisis, I worry that the individual incentives facing hospitals on the one side and individual RNs on the other conflict sharply with the needs of society as whole.”

Some hospitals are exploring ways to overcome staffing challenges without blowing the budget. That could include changing nurse-to-patient ratios, although that would likely affect patient care. In Utah, the hospital association has talked with the state nursing board about allowing nursing students in their final year of training to be certified early.

Growth Industry

Meanwhile business is booming for companies centered on health care staffing such as Wanderly and Krucial Staffing.

“When COVID first started and New York was an epicenter, we at Wanderly kind of looked at it and said, ‘OK, this is our time to shine,’” said David Deane, senior vice president of Wanderly, a website that allows health care professionals to compare offers from various agencies. “‘This is our time to help nurses get to these destinations as fast as possible. And help recruiters get those nurses.’”

Deane said the company has doubled its staff since the pandemic started. Demand is surging — with Rocky Mountain states appearing in up to 20 times as many job postings on the site as in January. And more people are meeting that demand.

In 2018, according to data from a national survey, about 31,000 traveling nurses worked nationwide. Now, Deane estimated, there are at least 50,000 travel nurses. Deane, who calls travel nurses “superheroes,” suspects a lot of them are postoperative nurses who were laid off when their hospitals stopped doing elective surgeries during the first lockdowns.

Competition for nurses, especially those with ICU experience, is stiff. After all, a hospital in South Dakota isn’t competing just with facilities in other states.

“We’ve sent nurses to Aruba, the Bahamas and Curacao because they’ve needed help with COVID,” said Deane. “You’re going down there, you’re making $5,000 a week and all your expenses are paid, right? Who’s not gonna say yes?”

Krucial Staffing specializes in sending health care workers to disaster locations, using military-style logistics. It filled hotels and rented dozens of buses to get nurses to hot spots in New York and Texas. CEO Brian Cleary said that, since the pandemic started, the company has grown its administrative staff from 12 to more than 200.

“Right now we’re at our highest volume we’ve been,” said Cleary, who added that over Halloween weekend alone about 1,000 nurses joined the roster of “reservists.”

With a base rate of $95 an hour, he said, some nurses working overtime end up coming away with $10,000 a week, though there are downsides, like the fact that the gig doesn’t come with health insurance and it’s an unstable, boom-and-bust market.

Hidden Costs

Amber Hazard, who lives in Texas, started as a traveling ICU nurse before the pandemic and said eye-catching sums like that come with a hidden fee, paid in sanity.

“How your soul is affected by this is nothing you can put a price on,” she said.

At a high-paying job caring for COVID patients during New York’s first wave, she remembers walking into the break room in a hospital in the Bronx and seeing a sign on the wall about how the usual staff nurses were on strike.

“It said, you know, ‘We’re not doing this. This is not safe,’” said Hazard. “And it wasn’t safe. But somebody had to do it.”

The highlight of her stint there was placing a wedding ring back on the finger of a recovered patient. But Hazard said she secured far more body bags than rings on patients.

Tripeny, the traveling nurse who left Colorado, is now working in Kentucky with heart surgery patients. When that contract wraps up, she said, she might dive back into COVID care.

Earlier, in New Jersey, she was scarred by the times she couldn’t give people the care they needed, not to mention the times she would take a deceased patient off a ventilator, staring down the damage the virus can do as she removed tubes filled with blackened blood from the lungs.

She has to pay for mental health therapy out-of-pocket now, unlike when she was on staff at a hospital. But as a so-called traveler, she knows each gig will be over in a matter of weeks.

At the end of each week in New Jersey, she said, “I would just look at my paycheck and be like, ‘OK. This is OK. I can do this.’”

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[Albany Rifles]

“I’m it,” Lewallen said shortly after begging the hospital laundry staff to start washing his scrubs because he had run out of clean ones.

This is just jaw dropping. My wife recently retired as the CNO at a 300 bed hospital. I asked her if this was an unusual ask.

She said absolutely not...it is baked into the hospital SOP for disaster coverage to provide services like this for staff to keep going.

[TopHatter]

‘I literally don’t know’: Operation Warp Speed scientist can’t explain Trump’s vaccine order
It remains unclear how the president’s directive would be enforced.

The chief scientist of the Trump administration’s Operation Warp Speed was unable to explain President Donald Trump’s latest executive order Tuesday, which aims to prioritize shipment of the coronavirus vaccine to Americans over other countries.

Moncef Slaoui, who Trump tapped in May to head up the administration’s efforts to hasten vaccine development, appeared puzzled when asked to clarify the president’s order during an interview on ABC’s “Good Morning America.”

“Frankly, I don’t know, and frankly, I’m staying out of this. I can’t comment,” Slaoui said. “I literally don’t know.”

“You don’t know?” asked anchor George Stephanopoulos.

“Yes,” Slaoui said.

“But you’re the chief science adviser for Operation Warp Speed,” Stephanopoulos pressed.

“Our work is, you know, rolling,” Slaoui replied. “We have plans. We feel that we can deliver the vaccines as needed. So I don’t know exactly what this order is about.”

Indeed, it remains unclear how Trump’s executive order would be enforced, as drugmakers are already making agreements to deliver supplies for other countries.

Slaoui was similarly dismissive when asked about the executive order in another interview Tuesday, telling Fox News that “what the White House is doing is what the White House is doing.”

Scott Gottlieb, Trump’s former commissioner of the Food and Drug Administration, speculated Tuesday on CNBC that there may be “authorities that the administration could invoke” to compel vaccine makers to break distribution agreements with other countries.

But Gottlieb also cautioned that “the countries that the vaccine was sold to are our close allies,” and said the U.S. will rely on those nations as part of the “global supply chain” of vaccine materials in the coming weeks and months.

The White House is hosting a vaccine summit Tuesday, at which Trump is expected to congratulate Operation Warp Speed officials and others involved in the U.S. vaccine distribution effort.

However, representatives from vaccine developers Pfizer and Moderna, which have already filed for emergency authorization of their shots from the FDA, will not be in attendance.

Slaoui’s remarks also come amid fallout from a New York Times story published Monday, which reports that administration officials turned down an offer from Pfizer to purchase additional vaccines in July.

Now, Pfizer may be unable to supply the U.S. with sufficient vaccines before next June because of subsequent deals with other countries, the Times reported.

White House press secretary Kayleigh McEnany denied the Times report Tuesday, telling Fox News that “it’s just simply not the case that we were offered more [vaccines] and rejected them.”

And despite concerns over purchasing availability, McEnany said the U.S. “will get the next batch in short order,” adding that “those negotiations are ongoing.”
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Donald Trump is so breathtakingly stupid...and the people around him are even worse. I wonder how much more they can f--k things up before January 20th

[kato]

“I’m it,” Lewallen said shortly after begging the hospital laundry staff to start washing his scrubs because he had run out of clean ones.

This is just jaw dropping. My wife recently retired as the CNO at a 300 bed hospital. I asked her if this was an unusual ask.

She said absolutely not...it is baked into the hospital SOP for disaster coverage to provide services like this for staff to keep going.

Huh. Over here work clothes in hospitals (i.e. scrubs and such) are generally considered to be contaminated and have to be deposited with the hospital laundry before leaving the building.

There are stations where people sign in electronically to retrieve a new set when starting their shift. The laundry service of the local hospital (with over 100 staff for that function) washes about 90 tons of clothing and bedding per week, including 12,000 clothing articles per day :

[Albany Rifles]

Huh. Over here work clothes in hospitals (i.e. scrubs and such) are generally considered to be contaminated and have to be deposited with the hospital laundry before leaving the building.

There are stations where people sign in electronically to retrieve a new set when starting their shift. The laundry service of the local hospital (with over 100 staff for that function) washes about 90 tons of clothing and bedding per week, including 12,000 clothing articles per day :

Kato,

That is the way that surgical scrubs, etc., are treated here. But most medical personnel buy their own scrubs and wear them to work. Different units often color coordinate.

In the story above the X Ray tech was undoubtedly talking about his personally owned scrubs...and that is what my wife and I were talking about.

2 different systems.

[kato]

That is the way that surgical scrubs, etc., are treated here. But most medical personnel buy their own scrubs and wear them to work. Different units often color coordinate.

Yeah, got that from context. Hospital scrubs are considered personal protective equipment here legally and therefore have to be provided by the employer at their cost, including repair and cleaning (same as e.g. helmet and protective boots on a construction site for example, or BDUs for a soldier).

[Albany Rifles]

Yeah, got that from context. Hospital scrubs are considered personal protective equipment here legally and therefore have to be provided by the employer at their cost, including repair and cleaning (same as e.g. helmet and protective boots on a construction site for example, or BDUs for a soldier).

I wish!!!

The upside is the purchase and upkeep are tax deductible.

[JRT]

Some hospitals exceeding capacity amid record high number of COVID patients

08 December 2020

At the biggest hospital in Montana, the ICU is at 200% capacity, one doctor has died from the virus, and an ICU nurse is on life support.

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[TopHatter]

CDC’s Redfield told staff to delete email, official tells House watchdog
The instruction was revealed during an investigation into the Trump administration’s political interference at the public health agency.

Centers for Disease Control and Prevention Director Robert Redfield instructed staff to delete an email from a Trump political appointee seeking control over the agency’s scientific reports on the pandemic, a senior CDC official told congressional investigators this week.

Redfield’s apparent instruction was revealed in a Monday closed-door interview with the House subcommittee probing the White House's coronavirus response, which includes the Trump administration’s interference at the federal public health agency. It came following an Aug. 8 email sent by Paul Alexander, who was then the scientific adviser to Health and Human Services spokesperson Michael Caputo, aiming to water down the CDC’s famed Morbidity and Mortality Weekly Reports to match President Donald Trump’s efforts to downplay the virus.

"I was instructed to delete the email," MMWR editor Charlotte Kent told investigators. Kent, who was on vacation when Alexander sent the email, said that she was informed of the request by a colleague who filled in for her, and that she understood the request to be from Redfield. Kent said that she never saw the email herself. "I went to look for it after I had been told to delete it, and it was already gone," she told investigators on Monday.

Rep. Jim Clyburn, who chairs the House Subcommittee on the Coronavirus Crisis, on Thursday warned Redfield and HHS Secretary Alex Azar that instructing staff to delete documents is unethical and possibly a violation of federal record-keeping requirements, according to a letter shared with POLITICO.

"Federal employees have affirmative obligations to preserve documents, and destruction of federal records is potentially illegal," Clyburn warned in a letter to Redfield and Azar. "Federal law also provides for up to three years of imprisonment for willful destruction of federal records."

CDC Director Robert Redfield instructed staff to delete an email from a Trump political appointee seeking control over the agency’s scientific reports on the pandemic.

POLITICO first reported on Sept. 11 that Alexander had demanded — and received — the right to review the CDC's reports, with the approval of top HHS officials. The agency’s MMWR reports, authored by career scientists, are typically free of political interference, and revelations that Trump officials had sought to alter their findings alarmed public health experts who depend on them. Democrats later announced a probe into the Trump administration’s interactions with the federal science agencies.

An HHS spokesperson, while ignoring questions about whether Redfield had asked staff to delete the email, said the House subcommittee had wrongly characterized Kent's remarks.

"We urge the Subcommittee to release the transcript in full which will show that during her testimony Dr. Kent repeatedly said there was no political interference in the MMWR process," the spokesperson said.

CDC did not immediately respond to requests for comment. Kent did not respond to a request for comment.

Alexander has since left the department, and Captuo has been on leave. In Alexander's Aug. 8 email, which was previously obtained by POLITICO, he insisted on an "immediate stop on all CDC MMWR reports due to the incompleteness of reporting."

"Nothing to go out unless I read and agree with the findings how the CDC wrote it and I tweak it to ensure it is fair and balanced and 'complete,'" Alexander added, in a breach of the scientific firewall that CDC has maintained for decades.

In the lengthy email, which switches between red and black font and yellow and blue highlighted text, Alexander laid out demands for retroactive changes to the CDC's reports and insisted that the agency's career scientists were trying to subvert Trump's reelection bid.

Redfield has publicly dismissed reports of political interference in the agency's work.

"I just want to assure you and the other senators and the American public, that the scientific integrity of the MMWR has not been compromised," Redfield told a Senate committee on Sept. 16. "It will not be compromised on my watch."

Kent also told investigators that the CDC, in an earlier incident, delayed the publication of a July report on coronavirus spread at a Georgia summer camp following a "requested delay by Dr. Redfield and HHS." The report was held for two days and instead released about 15 minutes after Redfield concluded testimony to Clyburn's panel.

Clyburn said that HHS and CDC have been slow to respond to his inquiry. In his letter, he also threatened to subpoena HHS and CDC if they didn’t comply with his subcommittee’s ongoing probe. The subcommittee is still waiting for documents that it requested on Sept. 14, Clyburn said in his letter.

Following Kent's interview with investigators on Monday, HHS canceled four interviews that had been scheduled with top CDC staff, including CDC Principal Deputy Director Anne Schuchat, Acting Chief of Staff Nina Witkofsky, Acting Deputy Chief of Staff Trey Moeller and communications official Kate Galatas. According to the oversight committee, HHS complained that the panel overstepped the bounds of its investigation during Kent’s interview.

The HHS spokesperson, who requested anonymity, said the subcommittee was "not operating in good faith," and that it was attempting "to violate basic common practices of attorney-client privilege that protect the interests of the Department but more importantly the witness."
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The damage done to this country and its citizens by Donald Trump and his Administration is simply incalculable.

[JRT]

US experts convene to decide whether to OK Pfizer vaccine

by Lauran Neergaard and Matthew Perrone
10 December 2020

(Washington, D.C.) — A U.S. government advisory panel convened on Thursday to decide whether to endorse mass use of Pfizer’s COVID-19 vaccine to help conquer the outbreak that has killed close to 300,000 Americans.

The meeting of outside advisers to the Food and Drug Administration represented the next-to-last hurdle before the expected start of the biggest vaccination campaign in U.S. history. Depending on how fast the FDA signs off on the panel’s recommendation, shots could begin within days.

The FDA panel functions like a science court. During the scheduled daylong session, it was expected to debate and pick apart the data — in public — on whether the vaccine is safe and effective enough to be cleared for emergency use. With unprecedented interest in the normally obscure panel, the FDA broadcast the meeting via Youtube, and thousands logged on.

“The American public demands and deserves a rigorous, comprehensive and independent review of the data,” said FDA’s Dr. Doran Fink, who described agency scientists working nights, weekends and over Thanksgiving to get that done.

The FDA is not required to follow the committee’s advice but is widely expected to do so. Once that happens, the U.S. will begin shipping millions of doses of the shot.

Later this month, the FDA is expected to pass judgment on another vaccine, developed by Moderna and the National Institutes of Health, that has proved about as protective as Pfizer’s. Vaccine candidates by Johnson & Johnson and AstraZeneca are also in the pipeline.

The initial supplies from Pfizer and Moderna will be limited and reserved primarily for health care workers and nursing home patients, with other vulnerable groups next in line until the shots become widely available on demand, something that will probably not happen until the spring.

The meeting of experts on vaccine development, infectious diseases and medical statistics came as the coronavirus continues surging across much of the world, claiming more than 1.5 million lives, including about 290,000 in the U.S.

Hanging over the meeting was a warning from British officials that people with a history of serious allergic reactions shouldn’t get the vaccine. Government authorities there are investigating two reports of reactions that occurred on Tuesday when Britain became the first country in the West to begin mass vaccinations against the scourge.

Still, a positive recommendation and speedy U.S. approval appeared nearly certain after FDA scientists issued an overwhelmingly positive initial review of the vaccine earlier this week.

FDA said results from Pfizer’s large, ongoing study showed that the shot, which was developed with Germany’s BioNTech, was more than 90% effective across people of different ages, races and underlying health conditions, including diabetes and obesity. No major safety problems were uncovered. Common side effects included fever, fatigue and pain at the injection site.

“The data presented in the briefing report were consistent with what we heard before and are really exciting,” said Dr. William Moss, head of Johns Hopkins University’s International Vaccine Access Center. “Nothing that I see would delay an emergency use authorization.”

The meeting also represented an opportunity for regulators to try to boost public confidence in the breakneck development process that has produced the Pfizer vaccine and a string of other upcoming shots with remarkable speed — less than a year after the virus was identified.

The FDA has also faced weeks of criticism from President Donald Trump for not rushing out a vaccine before Election Day.

“There have been a lot of questions about why it takes us so long or are we being rigorous enough?” FDA Commissioner Stephen Hahn said in an interview. “I’m hoping that people will see with our transparency that we have taken a very rigorous stance on this.”

Hahn said the agency had already teed up the process to authorize the vaccine by filling out all the legal paperwork in advance, regardless of the ultimate decision.

RARE ADVERSE REACTIONS

The FDA uncovered no major safety problems in its review of Pfizer’s 44,000-person study, including no allergic reactions of the type reported in Britain. But such studies can’t detect rare problems that might only affect a tiny slice of the general population.

FDA reviewers noted four cases of Bell’s palsy that occurred among people getting the vaccine. They concluded the cases were probably unrelated to the vaccine because they occurred at rates that would be expected without any medical intervention. But the agency did say cases of the nerve disorder should be tracked, given that other vaccines can cause the problem.

“I think we have to be upfront, without scaring people, that we don’t know yet about any potential, rare, long-term adverse events,” Moss said.

EFFICACY QUESTIONS

The FDA found the vaccine highly effective across various demographic groups. But it is unclear how well the vaccine works in people with HIV and other immune-system disorders.

The study excluded pregnant women, but experts were expected to tease apart the data for any hints in case women get vaccinated before realizing they’re pregnant.

A study of children as young as 12 is underway.

IMPACT OF EMERGENCY AUTHORIZATION

Answering some of these questions will require keeping Pfizer’s study going for many more months.

When the FDA panel met in October, experts warned against allowing study participants who received dummy shots to switch and get the real vaccine as soon as it receives the FDA’s emergency OK. Doing that could make it impossible to get answers to certain questions, such as ho long the protection lasts.

Pfizer and BioNTech say they want to allow such participants to get the vaccine on request or, at the latest, after six months of follow-up. The FDA hasn’t made clear if it will accept that approach.

“FDA is adamant that they want these trials completed,” said Norman Baylor, former director of FDA’s vaccine office.

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AP writer David Koenig contributed to this story from Dallas.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.


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[surfgun]

My co-workers aunt just passed away from cancer. The co-worker reports that State has listed her cause of death as Covid-19. This appears to be SOP.

[TopHatter]

My co-workers aunt just passed away from cancer. The co-worker reports that State has listed her cause of death as Covid-19.

Your co-worker....are they a member of Cult45 like yourself, by chance? Is your coworker familiar with the medical term "comorbidities" ?

This appears to be SOP.

In the fevered imaginations of Cult45, yes. That's what scientific ignorance and denial does.

In reality, no.

Debunking the False Claim That COVID Death Counts Are Inflated
President Trump and other conspiracy fantasists touted the fake claim that COVID death counts are exaggerated. But three kinds of evidence point to more than 250,000 deaths

A persistent falsehood has been circulating on social media: the number of COVID deaths is much lower than official statistics, and therefore the danger of the disease has been overblown. In August, President Donald Trump retweeted a post claiming that only 6 percent of these reported deaths were actually from COVID-19. (The tweet originated from a follower of the debunked conspiracy fantasy QAnon.) Twitter removed the post for containing false information, but fabrications such as these continue to spread. In September outgoing U.S. Representative Roger Marshall of Kansas—now incoming senator—complained that Facebook had removed a post in which he claimed that 94 percent of COVID-19 deaths reported by the Centers for Disease Control and Prevention “were the result of 2-3 additional serious illnesses and were of advanced age.”

Now some facts: Researchers know beyond a doubt that the number of COVID-19 deaths in the U.S. surpassed a quarter of a million people by November 2020. This number is supported by three lines of evidence, including death certificates. The inaccurate idea that only 6 percent of the deaths were really caused by the coronavirus is “a gross misinterpretation” of how death certificates work, says Robert Anderson, chief mortality statistician at the CDC's National Center for Health Statistics.

The scope of the coronavirus's deadly toll is clear, even if the exact toll varies by a small fraction depending on the reporting system. “We're pretty confident about the scale and order of magnitude of deaths, but we're not clear on the exact number yet,” says Justin Lessler, an infectious disease epidemiologist at the Johns Hopkins Bloomberg School of Public Health. To understand why the figures converge, even if they contain some uncertainty, it is important to know how they are collected and calculated.

The first source of death data is called case surveillance. Health-care providers are required to report cases and deaths from certain diseases, including measles, mumps and now COVID-19, to state health departments, which pass this information along to the CDC, Anderson says. The surveillance data are a kind of “quick and dirty” accounting, says Shawna Webster, executive director of the National Association for Public Health Statistics and Information Systems. States gather all the information they can on these diseases, but this is the first pass—no one has time to double-check the information or look for missing laboratory tests, she says. For that, you have to look for the next source of information: vital records.

This second line of evidence comes from the National Vital Statistics System, which records birth and death certificates. When somebody dies, a death certificate is filed in the state where the death occurred. After the records are registered at a state level, they are sent to the National Center for Health Statistics, which tracks deaths at a national level. Death certificates are not filed in the system until outstanding test results are in and the information is as complete as possible. By the time a record gets to the vital records system, “it is as close to perfect as it's going to get,” Webster says.

A physician, medical examiner or coroner fills out the cause of mortality on the death certificate. That specialist is instructed to include only conditions that caused or contributed to death, Anderson says. One field lists the sequence of events leading to the death. “What we're really trying to get at is the condition or disease that started the chain of events leading to the death,” Anderson says. “For COVID-19, that might be something like acute respiratory distress due to pneumonia due to COVID-19.” A second part of the certificate lists other conditions that may have contributed to the death yet were not part of the sequence of events that led up to it, he says. These are called comorbidities, and although they can be contributing factors, they cannot be directly involved in the chain of cause and effect that ended in death. Medical conditions such as diabetes or heart disease are common comorbidities, and they can make a person more vulnerable to the coronavirus, Anderson says, “but the fact is: they're not dying from that preexisting condition.”

“When we ask if COVID killed somebody, it means ‘Did they die sooner than they would have if they didn't have the virus?’” Lessler says. Even a person with a potentially life-shortening condition such as heart disease may have lived another five, 10 or more years, had they not become infected with COVID-19.

The 6 percent number touted by Trump and QAnon comes from a weekly CDC report stating that in 6 percent of the coronavirus mortality cases it counted, COVID-19 was the only condition listed on the death certificate. That observation most likely means that those death certificates were incomplete because the certifiers gave only the underlying cause of death and not the full causal sequence that led to it, Anderson says. Even someone who does not have another health condition and dies from COVID-19 will also have comorbidities in the form of symptoms, such as respiratory failure, caused by the coronavirus. The idea that a death certificate with ailments listed in addition to COVID-19 means that the person did not really die from the virus is simply false, Anderson says.

Medical personnel move a deceased patient to a refrigerated truck serving as a makeshift morgue at Brooklyn Hospital Center in New York City on April 9, 2020. Credit: Angela Weiss Getty Images
The surveillance and vital statistics data provide a pretty good picture of how many deaths are attributable to the coronavirus, but they do not capture all of them, and that is where the final line of evidence come in: excess deaths. They are the number of deaths that occur above and beyond the historical pattern for that time period, says Steven Woolf, a physician and population health researcher at the Virginia Commonwealth University School of Medicine. In a paper published in October 2020 in JAMA, Woolf and his colleagues examined death records in the U.S. from March 1 through August 1 and compared them with the expected mortality numbers. They found that there was a 20 percent increase in deaths during this time period—for a total of 225,530 excess deaths—compared with previous years.

Two thirds of these cases were attributed to COVID-19 on the death certificates, and Woolf says there are two types of explanations for the rest: Some of them were COVID-19 deaths that simply were not documented as such, perhaps because the person died at home and was never tested or because the certificate was miscoded. And some of the extra deaths were probably a consequence of the pandemic yet not necessarily of the virus itself. For instance, he says, imagine a patient with chest pain who is scared to go to the hospital because he or she does not want to get the virus and then dies of a heart attack. Woolf calls this “indirect mortality.” “The deaths aren't literally caused by the virus itself, but the pandemic is claiming lives,” he says.

The numbers in Woolf's study come from provisional death data, the kind that the CDC has not yet checked for miscoding or other issues. What builds his confidence in these results, however, is that they have been replicated numerous times by his group and others. “All serious analyses of these data are showing that the number of deaths we're hearing on the news is an undercount,” he says.

COVID-19 is now the third leading cause of death in the U.S., and the toll continues to rise as cases, hospitalizations and fatalities surge across the country. The complete number may never be known, even after the pandemic ends, but already it is a staggering number of lives cut short.
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