Category: Corona Virus Vaccine

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CRH COVID-19 hospitalizations nearly triple over past two weeks – The Republic

November 17, 2020

COLUMBUS, Ind. COVID-19 hospitalizations at Columbus Regional Hospital continued to surge to unprecedented levels over the weekend and have more than tripled over the past two weeks.

On Sunday, there were 43 people hospitalized with COVID-19 at CRH the highest number since the pandemic swept through Indiana and up from 12 on Nov. 1, according to the COVID-19 Community Task Force.

It was the fifth time that coronavirus hospitalizations set a new record over the past week.

The surge in hospitalizations at CRH comes as hospitalizations continue to skyrocket across the state, according to the Indiana State Department of Health.

There were 2,768 people hospitalized in Indiana with confirmed or suspected COVID-19 infections, an all-time record and up from 731 on Sept. 12, according to state figures.

Many hospitals across the state, including CRH, have announced plans to prioritize surgical procedures in an effort to help maintain adequate numbers of beds and ensure capacity for those who need urgent inpatient care.

CRH has announced it will begin prioritizing surgical procedures and is evaluating procedures that require an overnight or inpatient stay.

Prioritization of surgical procedures will be based on a variety of factors including the individual patients medical condition and risk for disease progression, as well as availability of inpatient capacity level and vital resources such as critical equipment and supplies, available staff, and beds.

Currently, CRH outpatient care is continuing as usual.

For more on this story, see Tuesdays Republic.

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CRH COVID-19 hospitalizations nearly triple over past two weeks - The Republic

Nursing home and assisted living workers face Covid-19 surge as they cope with grief – CNN

November 17, 2020

Months of caring for older adults in a Rhode Island nursing home ravaged by Covid-19 have taken a steep toll on Silvestri, 37, a registered nurse.

She can't sleep, as she replays memories of residents who became ill and died. She has gained 45 pounds. "I have anxiety. Some days I don't want to get out of bed," she said.

Many of these workers struggle with grief over the suffering they've witnessed, both at work and in their communities. Some, like Silvestri, have been infected with Covid-19 and recovered physically -- but not emotionally.

At least 1,000 of those deaths represent certified certified nursing assistants, nurses and other people who work in institutions that care for older adults, according to a recent analysis of government data by Harold Pollack, a professor at the School of Social Service Administration at the University of Chicago. This is almost certainly an undercount, he said, because of incomplete data reporting.

How are long-term care workers affected by the losses they're experiencing, including the deaths of colleagues and residents they've cared for, often for many years?

Edwina Gobewoe, a certified nurse assistant who has worked at Charlesgate Nursing Center in Providence, Rhode Island, for nearly 20 years, acknowledged, "It's been overwhelming for me, personally."

Every morning, Gobewoe would pray with a close friend at work. "We asked the Lord to give us strength so we could take care of these people who needed us so much." When Kallon was struck by Covid-19, Gobewoe prayed for her recovery and was glad when she returned to work several weeks later.

But sorrow followed in early September: Gobewoe's friend collapsed and died at home while complaining of unusual chest pain. Gobewoe was told that her death was caused by blood clots, which can be a dangerous complication of Covid-19.

She would "do anything for any resident," Gobewoe remembered, sobbing. "It's too much, something you can't even talk about," describing her grief.

I first spoke to Kim Sangrey, 52, of Lancaster, Pennsylvania, in July. She was distraught over the deaths of 36 residents in March and April at the nursing home where she has worked for several decades -- most of them due to Covid-19 and related complications. Sangrey, a recreational therapist, asked me not to name the home, where she continues to be employed.

"You know residents like family -- their likes and dislikes, the food they prefer, their families, their grandchildren," she explained. "They depend on us for everything."

When Covid-19 hit, "it was horrible," she said. "You'd go into residents' rooms and they couldn't breathe. Their families wanted to see them, and we'd set up Zoom wearing full gear, head to toe. Tears are flowing under your mask as you watch this person that you loved dying -- and the family mourning their death through a tablet."

"It was completely devastating. It runs through your memory -- you think about it all the time."

Mostly, Sangrey said, she felt empty and exhausted. "You feel like this is never going to end -- you feel defeated. But you have to continue moving forward," she told me.

Three months later, when we spoke again, Covid-19 cases were rising in Pennsylvania but Sangrey sounded resolute. She'd had six sessions with a grief counselor and said it had become clear that "my purpose at this point is to take every ounce of strength I have and move through this second wave of Covid."

"As human beings, it is our duty to be there for each other," she continued. "You say to yourself, OK, I got through this last time, I can get through it again."

That doesn't mean that fear is absent. "All of us know Covid-19 is coming. Every day, we say, 'Is today the day it will come back? Is today the day I'll find out I have it?' It never leaves you."

To this day, Silvestri feels horrified when she thinks about the end of March and early April at Greenville Center in Rhode Island, where up to 79 residents became ill with Covid-19 and at least 20 have died.

The coronavirus moved through the facility like wildfire. "You're putting one patient on oxygen and the patient in the next room is on the floor but you can't go to them yet," Silvestri remembered. "And the patient down the hall has a fever of 103 and they're screaming, 'Help me, help me.' But you can't go to him either."

"I left work every day crying. It was heartbreaking -- and I felt I couldn't do enough to save them."

Then, there were the body bags. "You put this person who feels like family in a plastic body bag and wheel them out on a frame with wheels through the facility, by other residents' rooms," said Silvestri, who can't smell certain kinds of plastic without reliving these memories. "Thinking back on it makes me feel physically ill."

Silvestri, who has three children, developed a relatively mild case of Covid-19 in late April and returned to work several weeks later. Her husband, Michael, also became ill and lost his job as a truck driver. After several months of being unemployed, he's now working at a construction site.

Since July 1, the family has gone without health insurance, "so I'm not able to get counseling to deal with the emotional side of what's happened," Silvestri said.

Although her nursing home put up a hotline number that employees could call, that doesn't appeal to her. "Being on the phone with someone you don't know, that doesn't do it for me," she said. "We definitely need more emotional support for health care workers."

What does help is family. "I've leaned on my husband a lot and he's been there for me," Silvestri said. "And the children are OK. I'm grateful for what I have -- but I'm really worried about what lies ahead at the same time."

KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation) that is not affiliated with Kaiser Permanente.

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Nursing home and assisted living workers face Covid-19 surge as they cope with grief - CNN

COVID-19: Russia’s approach to vaccine ‘rat race’ has echoes of its spirit in the Cold War – Sky News

November 16, 2020

Russia was the first country to approve a coronavirus vaccine - and it also claims its vaccine is the best.

Last week, two days after US drugs giant Pfizer announced that the vaccine it has developed alongside Germany's BioNTech was 90% effective in protecting people against the virus, the Russian Direct Investment Fund (RDIF) which champions Russia's Sputnik V vaccine, issued a statement suggesting that its vaccine had a 92% efficacy rate.

This first Russian vaccine produced by Moscow's Gamalaya Institute is named after Sputnik, the first satellite into space, launched by the Soviets in 1957.

The website says the name is a nod to the reinvigoration of space research after that first "Sputnik moment", but Sputnik's launch also marked the start of the Cold War space race.

The Soviet spirit then was archly competitive rather than collaborative and that does not appear to have changed.

Of course it's a "rat race", says Svetlana Zavidova, executive director at Russia's association of clinical trials organisations.

She said: "When our president announced the registration on 1 August, his first words were about trying this vaccine on his daughter. Before he never mentioned his daughters."

The Russian president rarely speaks publicly about his family.

The Gamalaya Institute says it drew its analysis on the basis of 20 confirmed cases of COVID-19 among trial participants, divided between those given one or both shots of the vaccine and those given a placebo.

In phase 3 trials of 40,000 participants, 16,000 had received both shots.

The Pfizer interim analysis was based on 94 confirmed cases among its participants. The company said it had decided together with the US Food and Drug Administration (FDA) to drop a first planned analysis based on just 32 cases.

"It's really strange to do the analysis on just 20 cases," Ms Zavidova said.

"How can we draw conclusions about 92% of efficacy, based on that? Maybe they looked at Pfizer's results and just added 2%."

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Her scepticism is reflected in the Russian public more broadly.

Recent surveys from the independent Levada poll suggest a growing hesitancy around the Russian vaccines, with distrust and doubt being the predominant reaction to reports about the appearance of the Russian-made vaccine in a late August survey.

Russia has also vaccinated 10,000 medics and other high-risk groups with Sputnik V.

On the day RDIF published its interim analysis, three medics who had received the first dose of the vaccine were reported as having contracted the virus in Siberia.

The Sputnik V vaccine has two components. Patients are given two injections, the second 21 days after the first. They are considered vaccinated three weeks after the second injection, the Russian Ministry of Health has said.

If Sputnik V's high efficacy is borne out through the rest of the phase 3 trial period, then it has considerable advantages over the Pfizer/BioNTech vaccine in terms of logistics.

The Pfizer vaccine requires storage at minus 70 degrees, whereas Sputnik V can be maintained at minus 18 degrees, making it easier to store and distribute.

Even the president though has admitted that scaling up production for millions of doses of vaccine remains a problem in Russia due to equipment shortages.

As a result, Russia has had to delay the roll-out of mass vaccination.

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RDIF recently announced a deal with South Korea to manufacture 150 million doses of the vaccine for global distribution.

Russia has so far registered two vaccines with a third due soon.

"The president has assessed very positively both the Sputnik and Vector product," said Kremlin spokesman Dmitry Peskov on Friday.

"He also has big expectations for the third vaccine. He will make an announcement when he gets vaccinated himself."

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COVID-19: Russia's approach to vaccine 'rat race' has echoes of its spirit in the Cold War - Sky News

Doctors Call for More Restrictions and Caution as Virus Surges – The New York Times

November 16, 2020

Heres what you need to know:A nurse in Bismarck, N.D.Credit...Bing Guan/Reuters

Health care workers in some hard-hit states have taken to social media to issue urgent pleas for new restrictions to slow the spread of the virus and for the public to take precautions more seriously.

In Nebraska, Dr. Dan Johnson, a critical care anesthesiologist with Nebraska Medicine, a major health network in the region, posted on Facebook about the crisis last week, saying that current measures were not enough to stop the high rate of transmission.

The state has seen new virus cases reach an average of 2,033 cases per day, an increase of 99 percent from two weeks earlier. In the state, masks are required at indoor businesses where close contact is maintained, and indoor gathering limits are set at 25 percent of capacity. Retail stores, restaurants and bars are still open, as are houses of worship.

This means that individual citizens and families must take matters into our own hands. Strict adherence to social distancing is essential, Dr. Johnson wrote. If things get completely out of control, every family in Nebraska will be affected either by a death or by serious illness.

On Twitter, Dr. Angela Hewlett, an epidemiologist at the University of Nebraska Medical Center, specifically called on the governor to increase directed health measures, noting that the number of hospitalizations in the state was skyrocketing.

Our community and our hospitals are suffering, she said. We are not an unlimited resource.

In another appeal on Facebook, Dr. John McCarley, a doctor in Chattanooga, Tenn., noted that local hospitals were filling up. He posted: Im not saying we need a lockdown but I am asking everyone to get back to a May 2020 mind-set and routinely wear the mask when indoors around others besides your household.

On the ABC program This Week, Adm. Brett Giroir, the assistant secretary of health and human services, called masks critically important. Theyre highly protective against you spreading it to someone else and we also know that it provides you protection from getting it from someone else, he said.

Chief executives of six hospital systems in northeastern Ohio jointly ran a full-page advertisement in The Cleveland Plain Dealer on Sunday, pleading with the public to remain on guard with virus precautions during the holiday season. We must make sacrifices today by limiting indoor gatherings in the hope of better tomorrows, the hospital executives wrote.

In Amarillo, Texas, an internal medicine doctor said that hospitals in the city were trying to find ways to add additional I.C.U. space, and pleaded with the public to wear a mask and socially distance. An ounce of prevention is better than a pound of cure, Dr. Whit Walker wrote on Facebook. I see some people inside in a public store without a mask. If you give this virus to me I might give the virus to 5 or 20 other people. One or five of those might die from the virus. Even though you feel well, you can carry this virus. Even if you had the infection in the past, you might get this same virus again. This is real. This is deadly.

In North Dakota, a state with critically understaffed hospitals and the nations highest rates of new cases and deaths per person, doctors have for weeks been asking the government to implement stricter restrictions in particular a mask mandate.

On Friday, Gov. Doug Burgum finally obliged by announcing several measures, including a mask mandate, a limit on indoor dining of 50 percent capacity, or 150 people, and a suspension of high school winter sports and extracurricular activities. The state reported 2,270 new infections on Saturday, 19 deaths and 425 hospitalizations.

And in Missouri which announced 7,164 new cases on Saturday, the states third single-day record in a row, along with 11 deaths and more than 2,400 hospitalizations health care workers asked government officials to enact more restrictions in response to their dire words of caution with a statement released Thursday by the Missouri Hospital Association.

We urge Gov. Mike Parson to continue to promote the message that Missourians help and compliance is necessary to help prevent catastrophic increases in hospital admissions, the statement said.

Giulia McDonnell Nieto del Rio

Governors and public health officials across the United States are pleading with Americans to change their behavior and prepare for a long winter as the country shatters record after record for coronavirus cases and hospitalizations.

Both records were broken yet again Friday, as more than 181,100 new cases were reported nationwide, and on Saturday more than 159,000 new cases were recorded, the third-highest total of the pandemic. The seven-day average of new daily cases is more than 145,000, with upward trends in 48 states. Twenty-nine states added more cases in the last week than in any other seven-day period.

With more than 1,017,000 cases added since Nov. 7 the first time that more than a million cases were reported in a seven-day period that means that roughly one in every 323 people in the United States were reported to have tested positive in the last week.

The virus has also killed more than 1,000 Americans a day in the past week, a toll that would shock the nation were it not for the fact that twice as many people were dying daily during a stretch in April, when doctors knew less about how to treat Covid-19, the disease caused by the virus.

More than 1,210 new deaths were reported on Saturday, pushing the seven-day average to more than 1,120 a day, a 38 percent increase from the average two weeks ago. Four states set death records on Saturday: Wyoming (17), Oklahoma (23), Montana (36) and South Dakota (53).

On Saturday, New Jersey, West Virginia, Maryland, Minnesota, Missouri, Indiana, Utah, Montana and Alaska all set single-day records for new cases.

North Dakota also hit a single-day record on Saturday, announcing 2,270 new cases. In a reversal, the states governor, Doug Burgum, announced several measures late Friday, including a mask mandate; a limit on indoor dining of 50 percent capacity, or 150 people; and a suspension of high school winter sports and extracurricular activities until Dec. 14. The state has critically understaffed hospitals and the highest rates of new cases and deaths per person in the nation.

In the spring, North Dakota was one of a handful of states that never entered a lockdown, and Mr. Burgum had for weeks resisted any new orders, emphasizing personal responsibility instead of requirements such as a mask mandate.

But the states situation has rapidly deteriorated: Over the past week, it has averaged 1,381 cases per day, an increase of 37 percent from the average two weeks earlier, and deaths are climbing fast. Hospitals are so overwhelmed that on Monday, Mr. Burgum angered the state nurses union by announcing that medical workers who test positive could stay on the job to treat Covid-19 patients as long as the workers show no symptoms.

In New Mexico on Friday, Gov. Michelle Lujan Grisham announced the nations most sweeping statewide measure of the fall season, issuing a two-week stay at home order to begin Monday. She asked people to shelter in place except for essential trips and said nonessential businesses and nonprofits must cease in-person activities.

Gov. Kate Brown of Oregon issued orders Friday to place the state in a partial lockdown for two weeks, shuttering gyms, halting restaurant dining and mandating that social gatherings have no more than six people. Ms. Brown, along with the governors of California and Washington, also urged residents to avoid all nonessential interstate travel in the days ahead.

Dr. Anthony S. Fauci, the nations top infectious disease expert, appeared on CBS This Morning on Friday to repeat his pleas to Americans to take the virus seriously.

If we do the things that are simple public health measures, that soaring will level and start to come down, he said. You add that to the help of a vaccine, we can turn this around. It is not futile.

A Texas appeals court ruled late Friday that El Paso County did not have the authority to impose a sweeping stay-at-home order, dealing a blow to local officials who had restricted business activity in an effort to stop the out-of-control spread of the coronavirus.

The ruling means that restaurants in the border city of 680,000, which now has more people hospitalized with Covid-19 than most states 1,091 as of Saturday may serve food indoors and outdoors, and gyms, barbershops and nail salons, which have been closed, may reopen.

The decision was the latest to bring efforts to tamp down the resurging virus into the legal sphere. As governors, mayors and other local officials have begun instituting new restrictions, a new wave of legal fights is also anticipated.

In El Paso, it was the owners of local restaurants, joined by Ken Paxton, the Texas attorney general and a Republican, who sued after the top county executive, Ricardo A. Samaniego, a Democrat, imposed the restrictions in late October.

Hospitals were already filling at the time, and Mr. Samaniego said that the order needed to be extended past Thanksgiving to prevent the viruss further spread in the hard-hit community.

A lower court upheld the limits, but the Eighth District Court of Appeals ruled that Mr. Samaniego had overstepped his bounds. The appeals court found that the lockdown conflicted with less restrictive statewide orders by Gov. Greg Abbott, a Republican.

Just as a servant cannot have two masters, the public cannot have two sets of rules to live by, particularly in a pandemic, wrote Chief Justice Jeff Alley.

The county is not pursuing an appeal, a lawyer involved in the case said.

The mayor of El Paso, Dee Margo, a Republican who had questioned the order from the start, said in a statement that the city and its police force would immediately stop enforcement, and called on El Paso residents to do their own part to limit the spread of the virus. We must balance the lives and the livelihoods of our community, and this requires all of us to change our social behavior, he said in a statement.

A state-owned long-term nursing care facility for veterans near Lexington, Ky., is in the grip of a lethal outbreak of the coronavirus.

Eighty-six veterans have tested positive for the virus at the Thomson-Hood Veterans Center since October, and 24 have died, according to Gov. Andy Beshear. Forty-eight of the veterans have recovered, five are in the hospital, and nine are being treated at the center.

Among the staff, 63 have tested positive. Fifty-two of them have recovered, and 11 cases are still active, Mr. Beshear said in a news conference on Friday. He said that the outbreak, the centers first, was the result of community spread and that it began when three veterans and seven staff members tested positive last month. The U.S. Department of Veterans Affairs provided medical staff to assist at the center.

The governor pleaded with Kentuckians to do what they could to limit the viruss spread. This is the toughest spot weve been in thus far, Mr. Beshear said. You must do your part and folks, this is now to the point where you need to be wearing your mask simply to protect yourself. It will also help others around you, but if you are not wearing a mask, you are putting yourself at personal risk of this virus.

Over the past week, the state has logged an average of 2,405 cases per day, an increase of 43 percent from the average two weeks earlier. Since the start of the pandemic, Kentucky has had 138,854 coronavirus cases and 1,739 deaths, according to a New York Times database.

The spread of the virus within Thomson-Hood, in Wilmore, Ky., is the latest example of the vulnerabilities at veterans homes around the country. Eighty-one have died of the virus at a veterans center in Paramus, N.J., and two former leaders at the Holyoke Soldiers Home in Holyoke, Mass., were indicted on charges of criminal neglect in connection to a coronavirus outbreak that contributed to the deaths of at least 76 residents.

We are still battling, a post from Monday on Thomson-Hoods Facebook page said. Keep praying for our incredible, warrior staff and our precious veterans.

More than 1,000 Americans are dying of the coronavirus every day on average, a 50 percent increase in the last month. Iowa, Minnesota, New Mexico, Tennessee and Wisconsin have recorded more deaths over the last seven days than in any other week of the pandemic. Twice this past week, the country has suffered more than 1,400 deaths reported in a single day.

Its getting bad and its potentially going to get a lot worse, said Jennifer Nuzzo, an epidemiologist and senior scholar at the Johns Hopkins Center for Health Security. The months ahead are looking quite horrifying.

More than 244,000 people have died from the coronavirus in the United States, more than any other country, and experts say the pace of new deaths is likely to accelerate in the coming weeks.

In towns and cities in Wisconsin and New Mexico, medical examiners are stocking extra body bags, parking mobile morgue units the size of trucks outside their doors and ensuring that refrigerated morgue trucks are cooled and ready to be used if needed. And hospitals are filling with patients, threatening the limits of medical systems in some regions.

Deaths lag several weeks behind infections, so the toll being recorded now reflects transmission that happened several weeks ago, before the country began logging more than 140,000 new cases per day and hospitalizations reached their highest levels of the pandemic. On Friday, public health officials reported more than 181,000 new cases across the country, more than ever before.

The rising case numbers and the threat of mounting deaths have led some experts to call for a coordinated national shutdown for four to six weeks, but with no announcements from the White House for new measures to respond to the soaring outbreak, most of the country is open for business, even as a few governors began calling for new restrictions on Friday.

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[chanting] U-S-A! [cheering] [chanting] We love Trump! [chanting] Four more years! [drumming] [chanting] Stop the steal!

President Trump and his motorcade drove by hundreds of supporters who showed up in Washington on Saturday for demonstrations protesting the outcome of the 2020 election, which Mr. Trump has refused to concede.

The president was on his way to his private golf club in Sterling, Va., and was greeted, according to a pool report, by applause and cheers from a crowd in which many were unmasked. People who watched him go by carried signs reading Best prez ever and Stop the steal. Some people climbed building structures by Freedom Plaza as the motorcade passed to get a better view.

Election results in the last two states were announced on Friday, with President-elect Joseph R. Biden Jr. winning Georgia to finish with a total of 306 electoral votes the same number that Mr. Trump won in 2016 and called a landslide and Mr. Trump winning North Carolina, for a total of 232 electoral votes.

Demonstrations of the Trump faithful planned for Saturday in Washington include a Million MAGA March, a Stop the Steal rally and a Women for Trump event, and at least several thousand people turned out.

A 53-year-old truck driver who declined to give his name because he feared losing his job for attending drove from Pennsylvania for the occasion.

Though many in the crowd were not wearing masks, he put one on as the crowd sang The Star-Spangled Banner, acknowledging concerns that he might expose himself to the coronavirus and infect his 81-year-old mother.

Im hoping maybe I dont catch it, but you cant stop everything, he said.

At a White House briefing on Friday in his first public remarks since the election was called the president came close to acknowledging Mr. Bidens win before catching himself.

This administration will not be going to a lockdown, Mr. Trump said in the Rose Garden, adding that hopefully the whatever happens in the future, who knows which administration it will be. I guess time will tell. But I can tell you this administration will not go to a lockdown. There wont be a necessity.

On Friday, Mr. Biden urged the distracted president to turn his attention to the rapidly worsening pandemic and take stronger action. In a blistering statement, Mr. Biden said that the recent surge, which is killing more than 1,000 Americans every day and is currently hospitalizing about 70,000, required a robust and immediate federal response.

I am the president-elect, but I will not be president until next year, Mr. Biden said. The crisis does not respect dates on the calendar, it is accelerating right now.

New Yorks mayor, Bill de Blasio, announced on Saturday morning that the citys seven-day positivity rate for coronavirus tests remained below 3 percent, the threshold that would trigger the closure of all in-person classes as the city confronts a surge in coronavirus cases. About 300,000 children of the 1.1 million in New York Citys public school system have returned to classrooms so far.

The positivity rate remained at 2.47 percent Saturday, lower than days earlier, Mr. de Blasio said on Twitter, but he warned that the decision to shut down the school system, the nations largest, was not off the table yet. That could change, he tweeted. We MUST fight back a second wave to keep our schools open. It is still possible that the city could reach the 3 percent threshold within the next few days.

Officials had warned that the positivity rate could surpass 3 percent this week, and many had anticipated that school closures could happen as soon as Monday.

Signs that the pandemic is making a feared resurgence in what was once the epicenter of a global pandemic have become evident. New Yorkers have been standing in long lines for hours for tests, some seeking to determine if they could return to work, and some fearing they may have gotten infected during the election or during the street celebrations after Joseph R. Biden Jr. was declared the winner of the presidential race. Others were hoping for a negative test so they could visit out-of-state relatives over the Thanksgiving holiday.

Mr. de Blasio reported 926 new cases for the preceding 24 hours and added that 97 people had been admitted to area hospitals.

New York City may choose to close its classrooms, where transmission of the virus has been strikingly low, before the halt of indoor dining, which falls under Gov. Andrew M. Cuomo, not the mayor.

During a conference call with reporters on Saturday, Mr. Cuomo said that Mr. de Blasio should focus on the positivity rate of individual schools instead of making that determination based on citywide rates. He suggested that an individual school should close its doors only after 3 percent of its staff and student body had tested positive for the virus to avoid a citywide disruption of in-person classes. He added that thousands of students rely on schools for free breakfast and lunch, and that the economy depends on keeping them open.

If you close the schools, you make it more difficult for parents to go to work, because now they have to worry about whos going to take care of their children, Mr. Cuomo said.

Global Roundup

Chancellor Sebastian Kurz of Austria said on Saturday that the country would go into a full lockdown after an existing partial shutdown failed to stem rising infections.

If we do not react massively, there is a great risk that the numbers will continue to rise or remain at a high level and overstretch the health system, Mr. Kurz said during a news conference announcing the measures.

Starting on Tuesday and going until at least Dec. 6, schools and most stores will close and people will be required to work from home unless their physical presence at a job site is critical. People will be able to leave their homes only for essential reasons, such as grocery shopping.

My urgent request: Do not meet anybody, Mr. Kurz said. Every social contact is one too many.

The new measures represent the kind of emergency lockdown Mr. Kurz had hoped to avoid. Similar restrictions in the spring led to a drop in new infections, but they also significantly damaged the national economy.

The recent, lighter shutdown, which went into effect on Nov. 3, allowed stores, schools and other services to stay open, but closed cultural sites, bars and restaurants.

On Friday, Austria recorded 9,586 cases in a single day, a record, and about nine times more than during the countrys peak in March, according to health ministry figures.

In other news from around the world:

The authorities in Greece announced on Saturday the closure of all schools as the country faces a spike in coronavirus infections and deaths. Health officials announced 3,038 new infections on Friday. A nationwide public curfew is now also in effect from 9 p.m. until 5 a.m., with exceptions made for people who need to go out for work, to visit a doctor or to walk a pet. Greeces total caseload since the start of the pandemic is 69,675.

The five-day average of coronavirus cases in Ireland rose nearly 10 percent this week, despite strict lockdown measures that had led to a sharp decrease in cases since mid-October, the health department said on Saturday. We have seen higher numbers in recent days than we expected based on the encouraging trends of the last three weeks, Chief Medical Officer Tony Holohan said in a statement. Ireland has had 67,526 cases and 1,978 deaths in total.

Tuscany and Campania are the latest Italian regions to lock down. Starting on Sunday, residents will be allowed to leave their homes only for essentials and travel outside their own municipalities only for work and health reasons. On Saturday, Italy registered 37,255 new cases and 544 deaths.

Driving will be banned on Sundays throughout Lebanon after the country went into a two-week lockdown that forced nonessential business to close. Vehicles can be driven for three days each week based on even- and odd-numbered license plates, and a sunset to sunrise curfew was extended.

A party in the suburbs of Paris with 300 attendees was dispersed, the police said on Saturday. The gathering was in violation of virus restrictions, and the police said bottles were thrown at them.

The police in Germany used a water cannon on Saturday to break up a group of about 600 protesters that had gathered in Frankfurt to criticize lockdown measures. In Lisbon, hundreds of bar and restaurant workers protested a partial weekend and nighttime lockdown across most of Portugal.

At least 10 people died in Piatra Neamt, a town in northeastern Romania, on Saturday after a fire broke out in an intensive care unit being used for 16 Covid-19 patients, all of them on ventilators, according to The Associated Press. The fire spread rapidly, most likely fed by the oxygen being used to treat the intubated patients, local media reports said. The national health minister, Nelu Tataru, told the local news media that the fire had probably been caused by an electrical short circuit. Ten other people were injured in the incident, seven of them critically, including the doctor on duty, who had rushed to help the patients.

President-elect Joseph R. Biden Jr.s first economic test is coming months before Inauguration Day, as a slowing recovery and accelerating coronavirus infections give new urgency to talks on government aid to struggling households and businesses.

With a short window for action in the lame-duck congressional session, Mr. Biden must decide whether to push Democratic leaders to cut a quick deal on a package much smaller than they say is needed or to hold out hope for a larger one after he takes office.

A continued standoff over aid could set the stage for sluggish growth that persists long into Mr. Bidens presidency. Republican and Democratic leaders remain far apart on the size and contents of a rescue package, though both sides say lawmakers should act quickly.

The shifting dynamics of both the pandemic and the recovery are complicating the debate. Even as it has slowed, the economy has proved more resilient than many experts had expected, leading Republicans, in particular, to resist a big new dose of federal aid. But the recent surge in hospitalizations and deaths has increased the risk that the economy could slow further.

Last spring, economists were nearly unanimous in urging Congress to provide as much money as possible, as quickly as it could. Now, many conservative economists say a much smaller follow-up package would suffice. Even as progressives argue for trillions of dollars in aid, a growing number of liberal economists are urging Democrats to compromise and accept a smaller package to get money flowing quickly.

But others with ties to Mr. Bidens team see the economic and political trade-offs differently. William E. Spriggs, a Labor Department official under former President Barack Obama, agreed that it was vital for Congress to act quickly. But he urged Democrats not to accept too small a deal.

You will get people saying it didnt work, so we dont need to do it again, said Mr. Spriggs, whom prominent Democrats have pushed for a role in the Biden administration. You make it harder to go to the well again.

Just two small hospitals serve mostly rural Elkhart County in northern Indiana, and earlier this week one of them instructed the local ambulance services not to bring any more patients.

With coronavirus cases hitting daily records, Elkhart General Hospital had run out of room.

The hospitals capacity is 144 beds and more than 200 patients had been admitted, said Dr. Michelle Bache, the hospitals vice president for medical affairs. On Tuesday, more than 90 were Covid-19 patients, and there were over 20 people with various medical issues in the emergency room needing beds.

The patients were building up in the waiting room and causing an unsafe situation, said Dr. Bache, adding that it was only the second time in her 22 years at the hospital that ambulances had been diverted.

Continue reading here:

Doctors Call for More Restrictions and Caution as Virus Surges - The New York Times

Doctors try to keep up with flood of COVID-19 research – Press Herald

November 16, 2020

Scientists from around the world are studying COVID-19, fueled by a torrent of research funding as governments make solving the virus a top priority. For doctors, the rapid pace of research generates a staggering volume of new information that must be absorbed and analyzed.

Dr. John Alexander, chief medical officer at Central Maine Healthcare in Lewiston, said the hospital has a clinical team that keeps up on the latest research for multiple diseases. Lately, they have been dealing with a flood of novel coronavirus research. The team often meets daily, sometimes more than once a day.

The research is evolving quickly, but they live, breathe and sleep clinical research, Alexander said. This is a disease we only began learning about 9-10 months ago.

As an example of the rapid pace, so much money is flowing into vaccine research that vaccine development, which normally takes three to five years or longer, is taking place much more quickly without any scientific shortcuts. A vaccine could be approved as soon as later this month, with the first shots given by the end of the year. That would be less than a year after the pandemic started in the United States, a previously unheard-of timeline.

On the treatment side, in addition to scholarly medical journals, social media groups discuss the latest research, and the internet offers many corners where scientists summarize and delve into the latest research.

At Brief19, a Twitter account on COVID-19 research run by a group of doctors and scientists, daily updates plumb the intricacies of research papers. In the latest posting, scientists looked at research in the Journal of the American Medical Association discussing Fluvoxamine vs Placebo and Clinical Deterioration in Outpatients With Symptomatic COVID-19. The upshot is that in this small pilot study, SARS-CoV-2 outpatients with mild illness who took fluvoxamine a selective serotonin reuptake inhibitor approved for obsessive compulsive disorder and also used as an anti-depressant had a lower likelihood of clinical deterioration 15 days later.

In other words, some light bedtime reading.

Scientific knowledge advances so quickly that one of the podcasts published by Brief19 this spring carried a warning that said, If you are listening to these more than a few days in the future, please beware that information may have changed and check subsequent episodes.

Dr. David Seder, chief of critical care at Maine Medical Center, said a team of hospital doctors are frequently reading the latest information and sharing the studies with one another.

Youre constantly reading to make sure youre up to date, because research is constantly evolving, Seder said. COVID-19 is an extreme example of this.

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Doctors try to keep up with flood of COVID-19 research - Press Herald

How Pfizer Will Distribute Its Covid-19 Vaccine – The New York Times

November 13, 2020

Even in normal times, mass-vaccination campaigns involve many moving parts within a vast network of suppliers, transporters and middlemen.

The particulars of Pfizers vaccine will make this effort even more complex. The vaccine, developed with the German company BioNTech, has to be stored at around minus 70 degrees Celsius (minus 94 Fahrenheit) until shortly before it is injected. That is about the temperature of the South Pole on a winter day and colder than any of the other leading vaccines in development.

Pending results from other front-runners in the vaccine race could change the stakes. Moderna Therapeutics said on Wednesday that it had seen enough Covid-19 cases in its late-stage study to do an early analysis of its vaccine, which uses the same messenger RNA technology that Pfizers does. The technology has never produced an approved vaccine.

Nine other candidates are also in the final stage of testing. If any of those win approval from the F.D.A., that will reduce the importance of Pfizers vaccine but also introduce new questions, such as which hospitals and people get the different vaccines.

For now, though, Pfizer is in the spotlight.

If an analysis planned for next week confirms the vaccines safety, the company is likely to ask the F.D.A. this month for emergency authorization to distribute its vaccine. In that case, limited doses will most likely be shipped to large hospitals and pharmacies to be provided to health care workers and other vulnerable groups.

But the specifics of how that will work are hazy at best.

Pfizer does not yet know where the government wants the vaccine sent or who will be first in line to receive it, said Ms. Alcorn, the supply-chain executive.

Were working very closely, in the U.S., in particular, with Operation Warp Speed to identify those distribution points, Ms. Alcorn said, referring to the federal initiative to produce and distribute Covid-19 vaccines. We dont have them today.

See the article here:

How Pfizer Will Distribute Its Covid-19 Vaccine - The New York Times

Vaccine Design Will Likely Determine the Success of Each COVID-19 Vaccine – JD Supra

November 13, 2020

This article provides a basic overview of the immune system and how its successful engagement is necessary to produce a commercial vaccine, with a specific focus on the SARS-CoV-2 virus that causes the COVID-19 disease and the current pandemic. It also generally describes the different types of vaccines that could or are being used to make a commercial SARS-CoV-2 vaccine and identifies their current clinical status.

More than 200 years ago, the disfiguring and deadly smallpox virus was a major health issue until one scientist fully appreciated the significance of the phrase, as smooth as a milk maids skin. But how does that vain expression relate to vaccines? It connects the highly contagious causing smallpox virus with the much milder and related cowpox virus. In 1796, Englands Edward Jenner hypothesized why milkmaids, who routinely became infected with the cowpox virus, seemed to be immune to the smallpox virus and its disfiguring scars. He tested his hypothesis by inoculating a young boy with material harvested from a cowpox pustule, after which, the boy recovered from a mild cowpox illness. Two months later, Jenner inoculated the same boy with material from a smallpox pustule. Fortunately for the boy, he did not develop smallpox and he remained unscarred. (Reidel 2005.)

The scientific name for the cowpox virus is Variolae Vaccinae; its name partially derives from the Latin word for cow vacca. Thus, Jenner called this procedure vaccination and the material used in this process was called a vaccine. He devoted his life to promote vaccination and its use spread throughout England and Europe during his lifetime. In 1977, almost two centuries later, smallpox was eradicated as a result of vaccinations for that disease, which is a testament to Jenners lifes work. (Reidel 2005.)

The cowpox example demonstrates the basic principle of vaccination against a pathogen, typically a bacteria or virus that causes a disease. Any component in a vaccine that causes immunity against the pathogen is known as an antigen. An antigen is a molecule or a portion of a molecule recognized by the immune system as foreign that stimulates an immune response, which sometimes provides protective immunity from future infections. The cowpox virus vaccine induced protective immunity against the smallpox virus because the cowpox and smallpox viruses have structurally related antigens. In the case of the boy in Jenners experiment, his primed and prepared immune system was able to recognize and neutralize the incoming smallpox virus before it could cause disease. Thus, Jenner demonstrated that vaccination can protect an individual from disease.

The immune system is composed of an elaborate mixture of different cell types and cell signals that collaborate to provide a regulated and timely response to pathogens. The immune system can be sub-divided into two systems: (1) the innate immune system and (2) the adaptive immune system. The innate immune system is the bodys first line of defense that acts immediately or within hours of a pathogens appearance in the body. This system is a generic defense system in that it is not tailored to any specific pathogen. Conversely, the adaptive immune response develops over time to produce a tailored response that specifically targets the pathogen and includes antibody molecules and cells trained to recognize pathogens and pathogen-infected cells.

The innate immune system has multiple layers, but begins with physical barriers, such as the skin and mucus. The skin creates an unfavorable environment for pathogens, for example, because it is relatively dry, contains beneficial microbes as well as naturally occurring antimicrobial compounds against pathogenic microbes. Moreover, the skins outer layer is continuously sloughed off. Beneficial microorganisms on the skin play a symbiotic role by outcompeting pathogenic microbes. These microbes are present all over the skin as well as throughout the digestive tract. Mucus is another physical barrier that contains antimicrobial components, but it is also able to physically trap infectious agents, and in the respiratory tract, pathogens entrapped by mucus can be expelled by a productive cough. (Murphy et al. 2012.)

White blood cells, which are important facilitators of inflammation, are another part of the innate immune system. Inflammation is a primary signal of, and is one of the first responses to, an infection. During inflammation, chemical signals called cytokines are released by damaged or infected cells. The cytokines are a diverse group of chemical compounds that convey instructions to cells surrounding the damaged/infected cells and are responsible for many of the physiological responses to an infection, such as dilation of blood vessels, heat and soreness. Cytokines signal the recruitment of other immune related white blood cells and stimulate defense mechanisms against intruders. For example, some white blood cells are equipped to detect the presence of unique viral RNA sequences and upon detection they release cytokines such as interferon, which activates a defense system that can capture the nascent virus. (Sparrer and Gack 2015; McNatt 2013 (discussing Tetherin protein capture of viruses).)

White blood cells are composed of a multitude of different cell types, are localized throughout the body, and are on constant surveillance for pathogens. Examples are:

One kind of phagocytic cell, known as a dendritic cell, present pieces of the digested pathogen as antigens on its cell surface, which is then available to activate other immune cells. As explained below, these presented antigens help activate the adaptive immune system by teaching the cells involved in the adaptive immune system how to recognize and react to the pathogen. (Murphy et al. 2012.) This interplay between the two immune systems is discussed more in Section II. B. below.

The complement system forms another part of the innate immune system. The complement system completes or complements the adaptive immune response because it comprises a set of specialized proteins in the blood that interact with antibodies (proteins produced by the adaptive immune system) and phagocytic cells to help clear foreign and damaged material. In a process called opsonization, antibodies and/or complement proteins coat a pathogen to facilitate its engulfment by phagocytic cells. In particular, complement proteins can bind with unique cell surface markers on the pathogen or with antibodies that have attached to the surface of a pathogen. These pathogen-bound complement proteins then interact with components on the cell surface of a phagocytic cell, which then engulfs and kills the pathogen. In addition, some complement components bind uniquely foreign pathogenic surface molecules, such as carbohydrates (made of sugars), and then destroy the pathogen by making holes in it. Finally, once the complement system has been activated, it causes interacting cells to release cytokines (i.e., chemical signals) that promote inflammation and recruit phagocytic cells. (Murphy et al. 2012.)

The adaptive immune system develops over-time, potentially taking many days or weeks to develop. That is time well spent because it provides a tailored and specific response to the pathogen that can last months, years, or even a life-time. Its capacity to remember past pathogens prepares the immune system to immediately pre-empt a new infection from the same or a related pathogen. This quick and effective response was demonstrated by the cowpox/smallpox example discussed in Section I and is fundamental to successful vaccination.

Cells that make up the adaptive immune system can be divided into two classes: B-cells and T-cells, each of which supply specialized soldiers to fight the pathogen. Each of these cell types originate from the bone marrow, but they mature in different places: B-cells remain in the bone marrow, whereas T-cells migrate to the thymus. Thus, their names signal the organ where they matured (B for bone marrow and T for thymus). During maturation, billions of B-cells and T-cells, each of which tailors its own unique cell-surface receptor, are selected or trained so that none of their receptors recognize self components in the body so as to eliminate any chance of autoimmunity (i.e., friendly fire.) The cell-surface receptor is like a lock that will recognize a specific key, which for present purposes is a pathogen-associated antigen. After maturation training, these newly formed nave B-cells and nave T-cells or nave trained soldiers march via the bloodstream and lymphatic system and take residence in their barracks, known as the peripheral lymphoid organs, such as the spleen and lymph nodes. The nave trained soldiers are considered nave because they have not yet received their orders to be activated and unleashed against the enemy pathogen. (Murphy et al. 2012.)

During an infection, information from the innate immune system gained from engaging with the pathogen is used to activate the adaptive immune system to mount a specialized and tailored attack on the enemy pathogen. Dendritic cells from the innate immune system perform reconnaissance and they follow the cytokine flare signals sent out by cells near the pathogen, which is where the battle is taking place. They are the immune systems super scouts. They are super because they directly engage the pathogenic enemy and also pass on enemy information to the specialized soldiers (nave B-cells and T-cells) of the adaptive immune system awaiting in their barracks. At the battle site, the dendritic super scout cells engage the enemy by digesting them and then displaying antigenic pieces of the enemy on their cell surface as keys. These cells are now super scouts that march to the barracks (e.g., the lymph nodes) with their antigenic keys proudly presented to the resident nave B-cells and T-cells. T-cells lose their navet if their locks fit the antigenic keys presented by the dendritic cells, transforming them into super trained soldiers, able to identify enemy invaders to fend off the pathogenic enemy. (Murphy et al. 2012.)

The dendritic cell super scouts, and super trained soldier T-cells collaborate to present the pathogenic key to those nave soldier B-cells that have the corresponding key hole in their lock, thereby converting those cells into super trained B-cells. Both classes of super trained soldier B-cells and T-cells, use the lock and key training method as a learned visual of the enemy in order to seek and destroy the pathogen. Thus, this training and selection by the adaptive immune system creates a tailored and specific immune response.

Of the billions of potential soldiers, only a tiny fraction of them the few and the proud may have been activated with the learned visual antigens. Those few recruits, however, do not provide enough troop strength to defeat the enemy pathogen, which typically reproduce quickly, and so the number of recruits must be vastly increased. Consequently, both B-cell and T-cell super trained soldiers receive additional signals to clone themselves. By expanding the number of cells, the barracks begin to swell during an infection and that is why after infection the lymph nodes become swollen and tender to the touch. (Murphy et al. 2012.) (Note: do not touch them. Rather, let the soldiers expand and prepare for battle.)

The newly cloned troops are also strengthened by receiving special fire-power capabilities, such as antibodies for tagging and bagging the enemy for destruction. Some of the super trained T-cells are transformed into one of three different kinds of specialized T-cell. The first kind become like special forces that gain the ability to recognize and kill infected cells. The second kind become like drill sergeants that help train and activate the immune system, such as the B-cells, as described above, to facilitate antibody production. The third kind become like officers who manage/regulate the battles/immune responses.

The activated and clonally expanded B-cells also have their weapon capabilities upgraded. Instead of just expressing the receptor lock on their cell surface, they are equipped to produce and release large amounts of free-floating clonal copies of the locks called antibodies. These free-floating antibodies are specialized and tailored weapons, like missiles, that home-in on the antigen keys on the enemy pathogen and with help from the complement system, tag them for death by immune cells (as discussed above in Section II.A.3). The antibodies can also independently neutralize the enemy. For example, in the case of a virus, after antibodies have covered all of the viral keys, the virus will be unable to use its keys to access the cellular locks to gain entry into the hosts cells, thereby blocking any further viral infection.

After the battle has been won, these specialized super trained soldiers cells and associated antibodies slowly wane. Yet, while some battles are forgotten as time passes, others are always remembered. Thus, often a sub-population of the trained and converted B-cell and T-cell super trained soldiers become memory cells after they retire from battle. These cells retain the memory of their specific enemy, but they will be re-activated as soon as their former pathogenic enemy (or a close resemblance) appears. Upon re-activation, these already primed and prepared cells rapidly arrive for battle to fight in the first response of any reinfection. This time around, they quickly expand their clonal troops and produce their specialized weapons, antibodies and special forces, to quash the enemy. Sometimes there is extra support already roaming the body some antibodies from the last battle may still be present that can bind and neutralize the pathogen. This fast action alters the course of an infection to prevent disease. This is the principal purpose and role of vaccination victory without war. (Murphy et al. 2012.)

After it is administered, the ideal vaccine safely replicates the same immunological outcome from a natural infection (i.e., protective immunity), without causing disease or any substantial adverse effects. The adaptive immune response is the key to a successful vaccine. After vaccination, both memory B-cells and memory T-cells will be convinced that there had been a previous infection by the target pathogen that is now remembered, even though there was no prior battle. In essence, they will be on guard, surveying for what are considered to be past foes. T-cells derived from the memory T-cells will now be on hand so that they are ready to kill the pathogen and any newly infected cells harboring the pathogen. The memory B-cells will now be ready to replicate and produce massive amounts of neutralizing antibodies. Therefore, a successful vaccination will provide protective immunity and the affected individual may never realize there had been any contact with the pathogen. (Murphy et al. 2012.)

For safety reasons, many vaccines developed today are not living organisms or infectious viruses like the cowpox example that is they do not cause a disease. Jenners cowpox pustule vaccine caused a mild disease and contained a cross-reactive pox antigen to the smallpox virus, but there were probably other components in that pustule that helped to activate a robust and lasting immune response. (Riedel 2005.) However, infection with a related, mild virus, is rarely an option as a vaccine for a disease. Rather, modern vaccines typically have a selected subset of antigenic fragments from the pathogen, sometimes just a single fragment. Because of this, many modern vaccines need help because the reduced number of antigenic components from the pathogen on their own may fail to elicit a robust adaptive immune response. Such a vaccine design needs helping agents to activate a robust immune response. These helping agents are called adjuvants, because they help produce a fuller immune response. No adjuvant was required for the Jenner cowpox vaccine because it contained live cowpox virus that presented multiple antigens and persisted long enough to stimulate a robust immune response. (Murphy et al. 2012.)

Adjuvants are compounds that can stimulate phagocytic dendritic cells, which, as discussed above, are super scouts that digest the pathogens into small antigenic pieces and then present them as keys to other immune cells to achieve a full adaptive immune response. Adjuvants include a diverse group of chemicals, believed to act by different mechanisms, including aluminum salts, oil-in-water emulsions, and modified toxins from other pathogens, such as the pertussis toxin. (Murphy et al. 2012.)

Today, development of new adjuvants is a very active area of research because a limited number of adjuvants have been approved for use in humans and because modern vaccines, due to their reduced number of antigens, have failed when using the traditional adjuvants. (Shi 2019.) Often, each adjuvant must be tested with each potentially new vaccine. Some new adjuvants currently under investigation are based on molecules that are naturally found at a site of infection. These new adjuvants include structures that are unique to pathogens, for example: (1) flagellin, a protein that helps bacteria move, and (2) double stranded viral RNA, a hallmark of RNA viruses, such as SARS-CoV-2, discussed below. In addition, cytokines involved in host immunological signaling are being investigated as new adjuvants. (Murphy et al. 2012; Shi 2019.) For example, in the development of vaccines against the virus that causes COVID-19, the pharmaceutical company GlaxoSmithKline (GSK) has decided to share its proprietary vaccine adjuvant named AS03. GSK has been collaborating with four vaccine developers, including Sanofi. (Walker 2020.) The AS03 vaccine adjuvant is an oil-in-water emulsion made from squalene (a small molecule that animals use to make cholesterol), vitamin-E (e.g., DL--tocopherol) and polyoxyethylene sorbitan monooleate (e.g., the detergents, polysorbate 80 or tween 80 that are added to some foods). (Walker 2020; US Patent 9,700,605; Wu 2019.)

Viruses can be considered as tiny packets of genetic information. The amount of genetic information in a virus is minuscule compared to a human cell, consisting of as few as only thousands of nucleotides. In contrast, a human cell nucleus contains around 3 billion nucleotides. Viruses cannot replicate on their own, but rather they rely on a hosts cellular machinery in order to reproduce. In general, viruses encode just enough genetic information: (1) to produce the equipment necessary to hi-jack the host cells machinery for itself, (2) to avoid the hosts immune defenses, and (3) to produce unique viral components, such as viral coat proteins.

There are two classes of viruses: (1) enveloped viruses, which are encased in a lipid (i.e., fatty) membrane that contains viral proteins and (2) non-enveloped viruses, which have a more robust and durable outer layer (i.e., capsid shell) made of proteins. Both classes of virus contain spike proteins on their surface that act as keys to gain entry into a host cell. The spike protein key will only fit the right lock, which is a receptor on the hosts cell surface that the virus uses to locate a susceptible cell for infection. After the key-lock connection has been made, the virus gains control of the host cell and the infection begins. As described above, if antibodies block the viral keys, the virus cannot bind to the host cell and it is neutralized. A major role of vaccination is to have these protective neutralizing antibodies already present to stop an infection.

It is important to appreciate the distinction between a virus and the disease that it causes. The scientific name of the virus that has caused the present pandemic is Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2) or the 2019 Novel Coronavirus (2019-nCoV). Only a sub-set of infected individuals develop the disease named Coronavirus Disease 2019 (COVID-19) when infected by SARS CoV-2. This is conceptually like HIV-1 and AIDS, where the Human Immunodeficiency Virus 1 (HIV-1) is the virus that causes the disease called Acquired Immune Deficiency Syndrome (AIDS). Not everyone who is infected with HIV-1 has or will develop AIDS, as is the case for SARS CoV-2 and COVID-19.

A vaccine should protect the site of primary infection. The SARS CoV-2 virus infects the epithelial (outer layer) cells in lungs and nasal passages and can spread to infect other less accessible blood vessel endothelial cells that line the interior surface of its lumen. (Hou 2020.) The SARS CoV-2 virus is an enveloped virus and its spike protein key recognizes the host human cell receptor lock protein, which is known as Angiotensin-converting Enzyme 2 (ACE-2). (Callaway 2020.) The human ACE-2 protein is found on various cell types, including: (1) those lining the nasal passage, (2) those lining the lung alveolar cells (these facilitate exchange of oxygen and carbon dioxide gases), (3) endothelial blood vessel cells found throughout the body, (4) arterial smooth muscle cells, and (5) enterocytes (cells of the intestinal lining). (Hamming 2004; Hou 2020.) Because they are exposed to air, alveolar and nasal cells are the most susceptible cells for infection from the SARS CoV-2 virus, which is spread through airborne microdroplets. (Hou 2020.) After entry into and replication in alveoli, the viruses can exit towards the blood vessels. Thus, after infection of the lung alveoli, it is possible the adjacent endothelial cells in the blood vessels become a secondary site of infection, which may be one way the infection spreads and becomes systemic. (Garca 2020; Nova 2019.) An ideal vaccine should provide protection to the alveolar and nasal epithelial cells of the respiratory tract to stop any potential secondary infections of the blood vessels.

The mutation rate of SARS CoV-2 is low, which bodes well for vaccine development. For more rapidly mutating viruses such as flu or HIV-1, successful vaccines have been either elusive, as for HIV-1 or have to be redeveloped each season, as for flu. (Callaway 2020.) The lack of success for HIV-1 and flu vaccines may be because the rapidly mutating viruses stay steps ahead of the immune system soldiers. So far, the mutations that have accumulated in the SARS-CoV-2 virus have not changed the capability of antibodies to neutralize the virus or provided an advantage for the virus. (Callaway 2020.) This may mean that additional development of vaccines will be unnecessary beyond the first round of successful vaccines currently being developed against SARS-CoV-2. See Table 1, below. However, how long an individuals immunity lasts against that virus (see discussion above re: memory cells at Section II. B. 5) has yet to be determined, meaning that re-vaccination may be necessary.

Various types of modern vaccines are generally described in this section, along with the pros and cons of each type. The various universities, institutes and pharmaceutical companies developing vaccines against SARS-CoV-2 are identified and classified according to the type of vaccine and its clinical stage in development in Table 1, below.

An obvious benefit of having multiple different vaccines in development is the increased chance of finding at least one successful vaccine. There are other benefits. Different vaccines may be useful because the virus could mutate to escape any one vaccine, making the escaped vaccine of little use. Additionally, different vaccines may provide protection against other related pathogenic viruses if those viruses are cross-reactive to one of the vaccines, as in the cowpox/smallpox example. In-fact, the spike protein from the related SARS-CoV from 2003 is 75% identical to the SARS CoV-2 spike protein and neutralizing antibodies from the SARS-CoV can also neutralize SARS-CoV-2. (Hou 2020.) Yet another reason for having different vaccines is that some may not work in certain human populations because not all individuals are able to present the same vaccine derived antigen for training the B-cells and T-cells. Finally, different vaccines can benefit vaccine production capacity if different manufacturing methods are used to make the different vaccines, as that can reduce competition for limited resources.

Live attenuated virus vaccination requires an infectious virus that has been mutated to become substantially weakened (i.e., attenuated) so that it causes no more than mild symptoms. Also essential is that the attenuated virus have the required antigen(s). The cowpox vaccine is a good example of an attenuated virus vaccine, which caused a much milder disease but resulted in protective immunity from the harsher smallpox virus. Modern genetic engineering enables precise and controlled mutagenesis of many viruses to reduce their pathogenicity. Historically, testing on attenuated virus vaccines for safety and efficacy has occurred over a relatively long period before they have been approved. This has been the case for the live-attenuated virus vaccines that are currently used to vaccinate against polio, measles, mumps, rubella, and varicella. (Murphy 2012). Because the SARS-CoV-2 virus has only recently been discovered and because the need for a vaccine is urgent, there presently is no effort to develop a live-attenuated vaccine for SARS-CoV-2.

Advantages for live-attenuated virus vaccines include (Murphy 2012):

Disadvantages for live-attenuated virus vaccines are due to decreased safety. For example, these vaccines (Murphy 2012, Riedel 2005):

Inactivated and killed virus vaccines are typically made by growing and harvesting virus-like particles or viruses, respectively, in a controlled environment, after which they are treated by chemical, heat, or radiation treatment. To increase safety, an inactivated virus vaccine uses virus-like particles that are genetically inactivated. These virus-like particles are bioengineered to alter key genes and proteins of the virus to render it non-infectious. For example, it is common to remove most of the genetic material from the virus, which makes virus-like particles that are gutted shells of their former native versions. (Mohsen 2017.) Examples of inactivated vaccines include hepatitis B, human papillomavirus, and malaria. (Mohsen 2017.) Examples of killed virus vaccines include polio, rabies, hepatitis A, cholera, plague and most influenza vaccines. (Murphy 2012.)

Advantages for inactivated/killed virus vaccines include:

Disadvantages for inactivated/killed virus vaccines include:

DNA vaccines are composed of DNA fragments that encode viral proteins or protein fragments (i.e., peptides). The DNA encodes either surface or internal proteins of the virus. Internal viral proteins are chosen if they are predicted to be strongly antigenic and would be expected to be presented at the cell surface of infected cells, which would then be targeted by the immune system for killing. Surface viral proteins are often based on the spike protein that the virus uses to infect a host cell so that the vaccine induces antibodies that can neutralize the pathogen, as discussed in Section IV.

The DNA is then introduced to the host via an injection, usually in the deltoid muscle, and some small percentage of the DNA finds its way into host cells. (Liu 2019.) But to increase cellular entry of the DNA, there are generally two methods of delivering the DNA. The first method packages the DNA into nano-particles that facilitate entry into the cells. (Dalirfardouei 2020.) The second method does not package the DNA but rather relies on electroporation. Briefly, at the site of the injection, mild electric-pulses produce nano-holes in the cell surface. The nano-holes and electricity then facilitate the DNA to enter the cell. This electroporation method is used by Inovio Pharmaceuticals to deliver a potential DNA vaccine against COVID-19. See Table 1 below. (US Patent 7,328,064; US Published Patent Application No. 2019/0284263.)

The modified host cells use their machinery to make the mRNA corresponding to the vaccine DNA sequence, which directs the production of the viral protein/peptide. To the extent that the protein/peptide is made available to the immune system and is a good antigen, it will be recognized as foreign and elicit an immune response. As of 2018, there were no approved DNA vaccines for human use, although at that time there were more than 500 clinical trials on DNA vaccination. There is, however, one approved DNA vaccine for horses against the West Nile Virus. (Hobernik and Bros 2018.)

Advantages of a DNA vaccine are its safety and production benefits (Hobernik and Bros 2018):

Disadvantages of DNA vaccines relate to vaccine composition (Murphy 2012; Hobernik and Bros 2018.):

Conceptually, mRNA vaccines are very similar to DNA vaccines except: (1) the mRNA is directly encoded into protein/peptide and (2) the mRNA is typically packaged into lipid nano-particles, which protects the mRNA and facilitates delivery to the host cells, with or without electroporation.

Advantages to an mRNA vaccine are similar to DNA vaccines, but there are also added benefits:

Disadvantages to mRNA vaccines are similar to DNA vaccines except that:

Protein vaccines are composed of antigenic proteins or peptides derived from the pathogen. These vaccines are typically made using bioengineering techniques where DNA that encodes the pathogenic protein or peptide is introduced into a bacteria, yeast, or a mammalian cell line that allows for growth in large scale bioreactors. The purified antigenic protein or peptide is then formulated into a vaccine and injected into the individual. This method has been successfully used to vaccinate against the hepatitis B virus. (Murphy 2012.)

Advantages for protein/peptide vaccines are:

Disadvantages for protein/peptide vaccines are:

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Hamming, I, W Timens, MLC Bulthuis, AT Lely, GJ Navis, and H van Goor. Tissue Distribution of ACE2 Protein, the Functional Receptor for SARS Coronavirus. A First Step in Understanding SARS Pathogenesis. J Pathol 203, no. 2 (June 2004): 63137.

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Vaccine Design Will Likely Determine the Success of Each COVID-19 Vaccine - JD Supra

Dont Get Too Excited About the Coronavirus Vaccine – The New York Times

November 13, 2020

The announcement that a coronavirus vaccine developed by Pfizer with the German drugmaker BioNTech is more than 90 percent effective at preventing Covid-19 cases much better than many anticipated is cause for celebration. With a vaccine of this efficacy, suppression of the disease is entirely realistic.

Unfortunately, this development doesnt mean we can all relax and start doing more things. It means we need to tighten up even further until the vaccine becomes available.

The goal is now no longer to learn to live indefinitely with the virus. Its to get as many people through the winter as possible without getting sick. Keeping the infection rate low is important, because thats what will allow us to push the virus into the ground as quickly as possible once we have the vaccine in hand.

A death avoided this winter is a life saved. We are no longer delaying the inevitable.

Its always been hard to convince people to make good choices when considering sacrifices. Uncertainty around when wed get an effective vaccine made it even harder. Cutting off in-person interactions for an uncertain stretch of time was excruciating. But it may be more palatable to hunker down if its only for a defined period.

To make the situation concrete, lets consider the upcoming Thanksgiving holiday. With cases growing rapidly around the country, especially in the northern Midwest, indoor social gatherings are more dangerous than at any point since the spring. Thanksgiving dinners are ideal settings for superspreader events: They crowd people from all over around a table to talk, laugh and drink, often in poorly ventilated rooms. Many families stuff themselves into houses for an entire long weekend.

Many of us havent seen our extended relatives for months. If we believe this pandemic will be raging for another year or more its tempting to think that the benefits of reconnecting over Thanksgiving might outweigh the risk of infection. We cant wait forever; maybe its worth rolling the dice.

The calculus is very different, however, if a vaccine is around the corner. While Pfizers still needs to be approved, manufactured and distributed, the company estimates that 50 million doses could be distributed before the end of the year. Another 1.3 billion would come in 2021. If other vaccines also show success, relief could come as soon as the spring.

Assuming this timeline holds, the case for skipping Thanksgiving becomes much stronger. People no longer have to pick between the risk of spreading Covid-19 and the risk of forgoing seeing family for the foreseeable future. They have only to sacrifice seeing them this fall in order to see them much more safely a number of months later. Why not wait?

The point generalizes. Without question, the sacrifices required to keep us safe from Covid-19 are costly. And the costs are not just financial; mental health is at risk as well as physical health as people forgo care, including self-care, to remain free from infection. All of that becomes easier to swallow if its for a shorter period of time.

The changed risk picture also has significant policy implications. As we speak, a nervous Europe has mostly locked itself down again, hoping to stave off the worst effects of a huge surge in infections. Germany, France and England have closed bars, restaurants, gyms and more.

For the most part, we havent done the same here in the United States, even in states that have been hit hard. Part of that is because our nations response to the pandemic has become politicized. But part of it, too, reflects the belief that indefinite business closings are just too costly. Countless small businesses would fail and unemployment would skyrocket. Many argue that we have to live with increased disease because we cant lock down for years.

But mask mandates, gathering restrictions and business closings are more tolerable and the impositions they require more justifiable if we have more confidence that theyll be temporary.

By the same token, Pfizers announcement strengthens the case for federal financial support. Covid-19 is still going to hurt some businesses disproportionately, either because theyll be forced to close again or because people have stopped going out as much. But Congress no longer needs to write a blank check to support them. It just needs to provide a lifeline for a number of months, a much more palatable prospect.

Providing these resources will have the added benefit of making it politically easier for states to adopt assertive measures to get a handle on case counts that are spiraling out of control. Its a bad idea for restaurants and bars to be open for indoor dining this winter. Temporarily closing them down would be easier to stomach if these establishments are given the wherewithal to reopen next year.

The same is true for aid to individuals who find themselves out of work as the virus-induced economic troubles deepen. Another round of topped-up unemployment insurance doesnt present the same financial risk to the United States as a never-ending financial obligation to the jobless.

The Pfizer announcement is unmitigated good news. But it would be a tragic mistake to relax our vigilance. Instead, continue to mask up, stay home and consider canceling or limiting your Thanksgiving plans. This is still a marathon, but the end is much closer than before.

Nicholas Bagley (@nicholas_bagley) is a law professor at the University of Michigan.

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Dont Get Too Excited About the Coronavirus Vaccine - The New York Times

Infected again or endless COVID? How the ‘reinfection phenomenon’ could impact vaccines, herd immunity and human behavior. – USA TODAY

November 13, 2020

A 25-year-old Nevada man was the first American confirmed to have caught COVID-19 twice, and his second infection was worse than the first. USA TODAY

By medical standards,Nicole Worthley is considered extraordinarily rare. She was diagnosed with COVID-19 on March 31 and again in September.

She was walloped both times, with a fever for six weeks and side effects all summer before round two kicked in.

But she can't prove she had COVID-19 twice. That requires genetic testing of both infections, which has only happened a few dozen times in the world, and never in South Dakota where she lives.

Many states are keeping track of claims of reinfection South Dakota, for example, is studying at least 28, while Washington state is investigating 120 but they are still considered extremely unusual, according to health experts, including the World Health Organization.

In Colorado, 241 people have had a second positive PCR test more than 90 days after the first one. "All are investigated as cases, including isolation instruction for the case and quarantine instruction for their close contacts," according to a Colorado Department of Health and Environment spokesperson.

There may be a COVID-19 vaccine by the end of the year. But 'normality' may not come until the end of 2021

The U.S. Centers for Disease Control and Prevention said in a statement that it is investigating some possible reinfections but has not yet confirmed any. It only considers infections more than 90 days apart to be possible reinfections; otherwise, someone's illness is likely a lingering infection.

Worthley said she's not sure which is worse: Being able to be reinfected, or having a lingering virus that could flare up anytime.

Nicole Worthley believes s he's been infected twice with COVID-19, forcing herself and three kids, ages 6, 8 and 10, to isolate at home for months.(Photo: Courtesy Nicole Worthley)

"Whether or not I personally have a proven reinfection isn't to me as important as it's possible that you can get it again," she said. "Or, if you don't believe that, then it's possible that for six straight months you can have COVID-19, still test positive for COVID-19 and still be actively ill from it because I don't think there's a lot of understanding of that right now."

No one knows how long the immune system can keep someone safe from COVID-19 after infection.

Some diseases like measles are one and done. Once infected or vaccinated and the immune system typically provides protection forever. With other viruses, like the common coldsome of which are closely related to the coronavirus that causes COVID-19protection might not last a year, or even a season.

COVID-19 was discovered less than a year ago, so scientists don't yet know how long the body can fight it off.

The answer has implications for the longevity and effectiveness of vaccines, the possibility of communities developing so-called herd immunitywhere the virus no longer spreads because so many people have already been infected, and how those infected once should feel and behave.

Worthley, 37, could be considered a "long-hauler"someone whose COVID-19 lasted for months after infection.

She was diagnosed the last day of March after suffering sharp chest pains. A few days later, she was so short of breath thatshe could barely walk across her apartment.

A single parent to three kids, ages 6, 8 and 10, Worthley struggled to function. "The room would be spinning and I'd be wheezing and stuff. Sometimes I could feel my teeth tingling," she said.

She ran a fever for four straight weeks, then had a break for a day or sonot enough to meet the 72-hour window to be declared healthy and then spiked again for two more weeks.

She and her kids were stuck in their Sioux Falls apartment from late March until early June.

Cold weather, holiday visitors and pandemic fatigue: Experts warn COVID-19 will get much worse this winter

The children never got more than a few tired days and a yucky cough. But she knows her illness affected them. During his bedtime prayers, her oldest son often said he was thankful she was still alive.

In early June, the family was finally allowed to go out. Worthley was told she didn't need another test; she was no longer considered infectious.

She went back to work at the daycare center where she's an assistant teacher but only part-time because the pandemic had driven away some families.

Still, all summer, Worthley, previously healthy though admittedly overweight, had weird symptoms. Her doctor prescribed a beta blocker for heart palpitations and an anticonvulsant for nerve pain in her legs.

She donated convalescent plasma in September, hoping the antibodies her immune system had developed could help someone else fight off COVID-19.

Nicole Worthley had a fever for six weeks during her first bout with COVID-19, but "only" 17 days with her second.(Photo: Nicole Worthley)

Then, at the end of September, about a month after her kids started in-person school, her 10-year-old came down with strep.

Worthley was feeling lousy, too, so she got tested for strep. Negative.

A few days later, still feeling weak, she called her doctor. Can you smell anything, the doctor asked.

"I got the Vicks out," Worthley said. Nothing.

Four days later, she got a positive COVID-19 test result.

"It was easier this time," she said. "I was only feverish for 17 days."

She had diarrhea, upset stomach, loss of taste and some respiratory issues, but not as bad as the first infection. More than a month later, though, she still can't smell and a half-hour phone call was punctuated with her coughs.

Worthley believes she is among the 28 people that the South Dakota Department of Health has said it's investigating for reinfection, although she's yet to hear from anyone at the state.

So far, only a few dozen people worldwide have been confirmed to have been infected twice with SARS-CoV-2, the virus that causes COVID-19.

One man in Hong Kong didn't know he'd been infected a second time. He only found out when he was routinely tested on his return home from a trip to Italy. Another man, just 25, in Nevada, was sicker the second time.

In both cases, genetic analysis of the infections proved that they were infected twice, with slightly different versions of the virus not just long-suffering. The World Health Organization has received reports of reinfections, but they are relatively rare so far.

"Our current understanding of the immune response is that the majority of people who are infected mount an immune response within a few weeks of infection," a WHO spokesman said via email. "We are still learning about how long the antibodies last. So far, we have data that shows that the immune response lasts for several months."

In a statement, a CDC spokesperson said the agency is actively investigating a number of suspected cases of reinfection, though none has been confirmed.

"CDCs investigation of the reinfection phenomenon is in its early stages," he said.

'Pleasantly surprised': Pfizer's COVID-19 vaccine candidate shown to be 90% effective in early findings

Jeffrey Shaman, a professor at the Columbia University Mailman School of Public Health, who has been investigating reinfections, said scientists still have a lot of open questions.

Among other things, he said, they want to know: How often reinfection can happen, are people contagious with the second infection and for how long, and do people who are reinfected have less severe cases the second time or are they worse off?

To answer those questions, researchers like him have to figure out what's behind these reinfections, Shaman said.

People might fail to generate immune memory with the first infection, and need repeated exposure to build up immunity. If so, a vaccine might have the same problem, and it won't bevery effective.

Or people might get antibodies to the virus and then lose them, Shaman said. In that case, a vaccine's benefit might not last long.

The worst-case scenario would be what happens with dengue.In the case of that mosquito-borne tropical disease,someone can get sicker if infected a second time, or infected after getting a vaccine.Then, a vaccine could actually be harmful though theres no evidence thats the case with COVID-19.

Sometimes diseases that start as outbreaks can become endemic, returning year after year.

The 1918 flu, for instance, was so devastating because it was new and no one had built up resistance, Shaman said. It came back repeatedly but "didn't have the huge pulses of people dying," he said, possibly because their bodies had built up some immunity to it.

If that's the case with COVID-19, then a vaccine, even a partially effective one, could have a big benefit by exposing people to the virus and helping them build up tolerance, he said.

It's not yet clear how long someone is contagious with COVID-19 if their symptoms linger or recur.

A study published Thursday in JAMA Internal Medicinefound that 18% of COVID-19 patients in an Italian hospital tested positive again after recovering from symptoms and having a negative test.

Only 1 of the 32 patients tested showed signs of replicating virus in their bloodstream, suggesting that they were either still infectious or reinfected but that couldn't be confirmed because no genetic testing was done. That patient was still suffering symptoms 39 days after initial diagnosis, though the others who tested positive again were unlikely to be contagious, the study concluded.

Until scientists learn the answers to these questions, people who have been infected once shouldn't assume they're protected indefinitely, and should continue to wear masks, wash hands, maintain distance and avoid crowds, Shaman said.

"The only way we're going to get a sense of it is over time," he said.

Worthley admits she could have been more careful about wearing a mask. When she first caught COVID-19 in March, few people were wearing them, and Worthley didn't know of anyone at church, work, her kids' schools who had COVID.

In the summer and early fall, she wore a mask at work, but not at church. She assumed she'd be protected because she'd been sick for so long.

Now, Worthleysaid she's not confident of being protected against the virus, so she always wears a mask.

"I have a whole bunch of them in my van," she said.

Contact Karen Weintraub at kweintraub@usatoday.com.

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

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Infected again or endless COVID? How the 'reinfection phenomenon' could impact vaccines, herd immunity and human behavior. - USA TODAY

DHEC shares update on preparations for the coronavirus vaccine in SC – WLTX.com

November 13, 2020

The Board of SCDHEC met and spoke about preparations being made for the COVID-19 vaccine.

COLUMBIA, S.C. The South Carolina Department of Environmental Control (SCDHEC) Board met Thursday morning to discuss the COVID-19 response and vaccination plan, among other things.

Stephen White is the Immunization Branch Leader at SCDHEC and provided the board members a look at what that COVID-19 vaccine efforts look like at the department.

Theres a lot of things that we do know, and theres a lot of things that we dont know," White said.

According to White, DHEC created an interim plan on Oct. 16 that was submitted and approved by the CDC HHS.

The plan is still under revision as things continue to change, but the CDC has asked them to prioritize certain populations.

Were doing that in tandem with a vaccine advisory committee. Dr. Bell, Linda Bell, helps to coordinate that. Its a very large group of external stakeholders that meet on a weekly basis and they provide good feedback for DHEC to consider for our allocation purposes once the vaccine is made available to the state.

According to White, in order for a place to be a 'COVID provider' and administer the vaccine, they have to be enrolled per CDC requirements.

So currently DHEC has set up an enrollment team within DHEC. We are currently processing enrollments as we get those and currently to date we have 139 organizations which have registered, if you will or applied to be a COVID provider.

White said this vaccine will be one of the trickier ones they have handled.

Were used to in the past as far as refrigerated or frozen vaccines these are ultracold vaccines that are stored at -80 degrees Celsius which is really cold.

The vaccine is also a two-dose vaccine that requires the same brand for both doses.

Issues like these, along with how to properly store and distribute the vaccine are all logistical issues the team is hoping to solve before they are made available.

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DHEC shares update on preparations for the coronavirus vaccine in SC - WLTX.com

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