Category: Corona Virus Vaccine

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FDA ramps up effort to persuade public that coronavirus vaccine decisions will be based on science, not politi – The Philadelphia Inquirer

August 9, 2020

In an article published Friday in JAMA,FDA Commissioner Stephen Hahn, Marks and Anand Shah, FDA's deputy commissioner for medical and scientific affairs, pledged "unequivocally" to review vaccines "according to the established legal and regulatory standards for medical products." In an opinion article in The Washington Post on Wednesday, Hahn said, "I have repeatedly said that all FDA decisions have been, and will continue to be, based solely on good science and data." He also said he has been repeatedly asked whether there has been any inappropriate pressure on the FDA, but he didn't answer that question in the article. In June, in testimony to a House committee, he said he hadn't felt political pressure to make any specific decision.

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FDA ramps up effort to persuade public that coronavirus vaccine decisions will be based on science, not politi - The Philadelphia Inquirer

Europe’s biggest countries are seeing Covid surges — but not this one – CNN

August 9, 2020

Now, just four months later, life in Italy, the country Vice President Mike Pence once said "no one wanted to be like," is nearly back to normal, despite occasional spikes in cases that have been attributed to migrants arriving in the country or living in close quarters.

The death toll has leveled off at just over 35,000, with the number of new reported deaths now less than a dozen most days. The total number of cases now at 250,103 with daily increments in the low hundreds at most.

Nightclubs and schools aren't yet reopened, face masks are mandatory and social distancing is enforced, but summer is in full swing in this country. People are going out for dinner at restaurants, enjoying the summer tradition of an aperitivo on an open square, going on vacation and generally moving forward. It's nothing short of a miracle, especially compared to nations like Brazil and the United States, where the pandemic is still very much out of control.

Before that terrible day in March when nearly 1,000 people died, stories about how Italians were skirting the lockdown were common. Tales of clandestine dinner parties and entire apartment blocks walking the same dog just to get outside seemed to expose the Italian national pastime of bending the rules. The lockdown by then had meant that everyone but the most essential of workers were confined to within just 300 meters of their homes.

People lost jobs, businesses suffered and children lost valuable time as the country's ill-funded education system struggled to adapt to online teaching. But as hard as it was, the images of the dead, of the overcrowded hospitals, of the people -- cherished grandmothers and grandfathers -- dying alone sparked an unimaginable national grief and scared the entire country, says Gianni Rezza, director of the National Health Institute.

"The population reacted quite positively in the first phase, however fear probably played a role," he told CNN. "Images of the coffins carried on military trucks in Bergamo were harsh, and evidently they made it clear how leaving the uncontrolled circulation of the virus would lead to serious problems."

'Out of the storm'

Slowly, things only got better from that horrible day, with daily cases, finally hitting a plateau and falling to a negligible number of daily infections. People took the lockdown seriously, wore masks dutifully, as they continue to do today, and the country gradually healed.

Police strictly enforced the lockdown and civil protection cars patrolled the streets telling people to stay inside over loudspeakers. Then in early May, the country gradually started to open up, first for takeout food, then table service. With each new taste of freedom, the health authorities checked the contagion rate, never allowing more establishments to open if there was a spike, and warning they would lock back down if things turned.

Gyms opened cautiously and stores still cannot be crowded. Trains can only run at 50% capacity and public transportation is limited. Mask compliance is strong because it's the law, and hand sanitizer is a feature at nearly every business entrance.

The worst, at least for now, was finally over. Now spikes in cases can generally be attributed to clusters in migrant camps or in closed communities that are kept under control through aggressive testing.

On July 23, Italy's minister of health Roberto Speranza confirmed that the hard work paid off. "I believe Italy has made it out of the storm," he told Italy's Coldiretti agricultural group. "I'm not thinking of the government but of the country as a whole."

Speranza warned though that it was not yet time to let the guard down completely. "We were the first to be hit in the world after China, we didn't have an instruction manual. We had to learn about the virus," he said. "I think we need to be honest with each other: these have been the most difficult months in the history of the country since the Second World War."

But while Italy celebrated -- at a safe distance -- he was quick to warn that the worst may not yet be over for everyone. "The international situation worries me a lot," he said, noting that on a global scale we were at "the worst moment of the epidemic."

So what makes a country like Italy, long known for its skepticism for anything that even looks like a rule, win this battle that no one else can seem to come close? Second waves have hit Spain, France and Germany and the first wave isn't nearly over in the US or the UK.

Journalist and author Beppe Severgnini told CNN that it is the very Italianness of the Italian people that made it happen. "We coped because we found other resources that were always there: Realism, inventiveness, extended families, solidarity and memories," he told CNN. "In Italy, rules are not obeyed, or disobeyed, as they are elsewhere. We think it's an insult to our intelligence to comply with a regulation without questioning it first."

So when the government instituted a draconian lockdown on March 10, Severgnini says that Italians believed in rule. "With Covid-19, we decided the lockdown made sense, so there was no need to enforce it," he said.

Political will

Many credit Italy's unelected Prime Minister Giuseppe Conte, who has no political affiliation or party behind him, for not playing politics. Each time he instituted a stronger measure, he said the blame was "on me" and not on the government he led.

Still, campaigners in the north of the country, where the virus swirled unchecked from the first reported case on February 21 to when the country locked down March 10, insist that he didn't take it seriously enough at first. He was interrogated by prosecutors in June to determine if the draconian lockdown should have started sooner.

Rezza believes that not only fear played a role, but also the government is to be congratulated, citing Conte's adherence to science over popularity. "There was for once, I would say, a clarity and a certain courage on the part of politicians because they listened to the scientists, in particular the minister of health," he said, referring to Speranza.

"Politicians also made courageous decisions because the lockdown meant that a part of the population can be unhappy and have economic repercussions. The decision to lockdown on a national level was certainly brave."

In the US, lockdowns have been erratic, and in the UK, the reopening has been complex and hard for the population to understand. There are loopholes and exceptions to almost every rule. Even in Spain where the virus hit hard and the lockdown was rigid, the virus has managed to find a new footing, in part because authorities reopened too fully, too fast. You can go dancing in Spain, but not yet in Italy.

France, too, has seen a resurgence of the virus, but authorities there only instituted a mandatory face mask indoor rule on July 20. Italy has continued the requirement since the beginning and Speranza says they will likely stay for some time to come.

Despite the success story in beating back the virus, Italy has suffered tremendous economic losses. GDP is expected to contract by around 10% this year and many businesses tied to the tourism sector may never open again. But the lack of a second wave -- so far -- means that there will likely not be another lockdown and businesses can continue to build back up without fear of having to lose even more money.

Severgnini, who has lived in the US, draws the contrast between Italy's startling success so far with America's obvious struggle to flatten the national curve. "The United States was born out of a rebellion, and you can still feel it," he said. "But to rebel, sometimes, is absurd -- during a pandemic, for instance."

He also believes that fear played a role. "Fear can be a form of wisdom," he said. "Boldness, a show of carelessness," he said. "Ah, and we don't have Donald Trump, which helps."

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Europe's biggest countries are seeing Covid surges -- but not this one - CNN

Hope in defeating COVID-19: More therapeutic and vaccine advances – Medical News Today

August 9, 2020

In this installment of our Hope Behind the Headlines series, we look at the latest scientific advances that offer hope in the fight against SARS-CoV-2, the new coronavirus, including promising therapeutic finds and the most recent steps toward vaccine development.

Even as the world remains uncertain about how the coronavirus pandemic will evolve, scientists have been working tirelessly to stop the spread of SARS-CoV-2.

In our previous Hope Behind the Headlines feature, we highlighted some of the most promising advances in coronavirus vaccine developments.

Researchers around the world continue to test new approaches to SARS-CoV-2 immunization and promising therapeutic options for COVID-19, the disease that the novel coronavirus causes.

In this feature, we present the most recent efforts to tackle the virus behind the ongoing pandemic.

Stay informed with live updates on the current COVID-19 outbreak and visit our coronavirus hub for more advice on prevention and treatment.

One of the key necessities in controlling the spread of the new coronavirus is efficient testing.

To this end, a team of researchers at the University of Colorado Boulder have developed a test that, they claim, can give a result in as little as 45 minutes.

The researchers say that sample collection for this test is simple and does not require the delicate and potentially unpleasant process of swabbing that is typical of currently available tests.

Instead, all a person has to do is spit into a tube, add a special solution to this sputum sample, and return the sealed tube to the laboratory for analysis. The laboratory testing requires only readily available materials, according to the tests developers. This helps save a lot of time in processing the results.

The main question concerns accuracy: Will the test give a significant number of false-negative or false-positive results?

No, according to the researchers. The test predicted with 100% accuracy all of the negative samples, and 29 of [the] 30 positive samples were predicted accurately, says lead author Nicholas Meyerson, Ph.D.

However, the research has yet to be peer reviewed and validated through the replication of the findings, though the team has coopted a second set of investigators to verify their initial, promising, results.

Such fast-turnaround tests could help detect asymptomatic carriers of SARS-CoV-2, who may contribute to the spread of the virus without realizing it.

Prof. Roy Parker, the director of the universitys BioFrontiers Institute and senior author of the study paper, has commented that:

Our modeling showed that whether a test is sensitive or supersensitive is not that important. What is important is frequent testing, with the test results returned as fast as possible, which identifies more infected people faster and can limit new infections.

Nitric oxide is a gas that doctors sometimes use to treat people with very low blood oxygen levels.

Though researchers have noted that this approach does not appear to improve mortality rates among these patients, nitric oxide has demonstrated a surprising ability that has caught the eye of investigators at The George Washington University School of Medicine and Health Sciences.

Previous experiments in cell cultures have shown that nitric oxide is able to stop the replication of SARS-CoV, the coronavirus that causes SARS.

Given the genetic similarity of SARS-CoV and SARS-CoV-2 the nucleotide sequences of which have approximately 79% similarity the researchers suggest that nitric oxide may also be able to inhibit the new coronavirus.

In a review of the available evidence published in the journal Nitric Oxide, the investigators argue that the gas might help relieve some potentially fatal symptoms of COVID-19, the disease that SARS-CoV-2 causes.

Thus, they encourage other scientists to look into the therapeutic potential of nitric oxide in the context of the current pandemic.

Nitric oxide plays key roles in maintaining normal vascular function and regulating inflammatory cascades that contribute to acute lung injury and acute respiratory distress syndrome, explains review co-author Dr. Adam Friedman.

And, he adds, Interventions that are protective against acute lung injury and acute respiratory distress syndrome can play a critical role for patients and health systems during the pandemic.

In the conclusion to their paper, Dr. Friedman and his colleagues state emphatically that:

Nitric oxide has demonstrated promise in similar respiratory disease models in modulating the prominent inflammation, and the early reported proofs of concept urgently call for randomized control trials in treating COVID-19. [] If its efficacy is illustrated as therapeutics firms seek its indication for COVID-19, nitric oxide treatment can be pivotal in the worlds fight against this immediate threat to public health.

Many research teams are looking to develop targeted therapies for COVID-19, but creating a new drug from scratch can take a very long time indeed.

And since time is of the essence in putting a stop to the current coronavirus pandemic, some investigators have decided to take a different approach, by reevaluating the potential of existing drugs.

The main benefit of testing readily available medications is that these drugs have already passed human safety trials all that is left is to demonstrate their effectiveness in tackling the new coronavirus and COVID-19.

With this in mind, researchers from Yale University set out to comb through approximately 12,000 drugs that had already received Food and Drug Administration (FDA) approval or were at the clinical stage of testing. Their aim was to find whether any might be successfully repurposed to treat COVID-19.

They pared that enormous initial list down to 100 potentially promising drugs, then to 21, and finally to the 13 drugs most likely to show activity against SARS-CoV-2.

Of the top 13 drugs, the researchers hold out the most hope for LAM-002A, or apilimod, which treats follicular lymphoma, a type of blood cancer, and various autoimmune diseases.

They have reported the process of arriving at this promising candidate in a study paper featured in the journal Nature.

The team has now started a collaboration with the biopharmaceutical company AI Therapeutics to start a phase II clinical trial of LAM-002As potential against SARS-CoV-2.

LAM-002A holds promise to be a powerful new therapy for COVID-19 patients to prevent progression of the disease, hopefully avoiding the need for hospitalization, comments Prof. Murat Gunel, chief scientific adviser at AI Therapeutics.

Research into vaccines also continues at full speed. Two weeks ago, researchers from The University of Texas at Austin reported in a Science paper that they had developed a modified version of SARS-CoV-2s spike protein, which could ultimately help speed up vaccine production.

Spike proteins allow viruses to attach to and infect healthy cells, but scientists use them in vaccines to teach the immune system to detect the viruses associated with the spike proteins.

The research team had previously described the structure of SARS-CoV-2s spike protein. With their recent efforts, they aimed to create a more stable spike protein that would be more resistant to heat stress and easier to transport.

After looking at 100 modified versions of the SARS-CoV-2 spike protein, the scientists were able to pinpoint the 26 most stable ones.

Finally, they combined four of the top 26 modifications to obtain the final protein version, which they have dubbed HexaPro.

HexaPro, the team says, could eventually help bring coronavirus vaccines to more people, faster.

Depending on the type of vaccine, this improved version of the protein could reduce the size of each dose or speed up vaccine production. Either way, it could mean more patients have access to vaccines faster.

Senior author Prof. Jason McLellan

The researchers have now granted a nonexclusive license to manufacture and resell HexaPro to the biotechnology company Sino Biological, and they have also filed a United States patent application for the product.

Other researchers are looking at different experimental vaccines and their potential to keep SARS-CoV-2 at bay.

Last week, investigators from the Beth Israel Deaconess Medical Center, in Boston, MA, working in collaboration with the Johnson & Johnson corporation, reported some preliminary successes with their vaccine candidate.

In a study paper published in Nature, they explain that their vaccine candidate is based on an adenovirus a common cold virus carrying the SARS-CoV-2 spike protein.

The team worked with 52 rhesus macaque monkeys. They immunized 32 of the macaques with single shots of various versions of their experimental vaccine, and they injected the rest with a placebo.

Only six of the macaques received a shot of the vaccine version that the researchers believed to be optimal. After 6 weeks, the scientists exposed all of the monkeys to SARS-CoV-2, to see whether the vaccines had any effect.

Of the six that had received a shot of the vaccine believed to be optimal, none presented SARS-CoV-2 in their lungs, and only one had traces of the virus in its nose, suggesting that the vaccine had repelled the virus.

A single-shot immunization has practical and logistical advantages over a two-shot regimen for global deployment and pandemic control, but a two-shot vaccine will likely be more immunogenic, and thus, both regimens are being evaluated in clinical trials, notes study co-author Dr. Dan Barouch.

At present, the researchers have started clinical trials in humans to further test their vaccine.

We look forward to the results of the clinical trials that will determine the safety and immunogenicity and, ultimately, the efficacy of the [experimental] vaccine in humans, adds Dr. Barouch.

For live updates on the latest developments regarding the novel coronavirus and COVID-19, click here.

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Hope in defeating COVID-19: More therapeutic and vaccine advances - Medical News Today

COVID-19 Only Adding to the Challenges Health Centers Face – MD Magazine

August 9, 2020

Community health centers provide much more for their clientele then just medical advice and health care.

Because of the low income demographic often served at these facilities, health centers also serve as a place people can go to connect them to a world of different opportunities, from literacy and education programs to employment possibilities.

However, even in good times these centers can struggle financially. Factor in the ongoing coronavirus disease 2019 (COVID-19) pandemic might be creating an exceptionally difficult time for health centers across the country.

Larry McReynolds, Executive Director, Family Health Centers at NYU Langone, explained in an interview with HCPLive, how health centers were able to weather the initial storm and switch to telemedicine to help maintain services.

Well, it's certainly been very challenging, but I am very encouraged that health centers for the most part, were able to move from an in person face to face model to a virtual model very, very quickly, he said.

The Nature of Health Centers

Health centers generate $12.6 billion in economic benefits for low-income, rural and inner city communities and create 143,000 jobs, while serving over 24 million patients in 6000 of in Americas most economically challenged neighborhoods.

The overall goal of health centers across the country is to increase access to care and reduce health disparities. This could mean serving patients who either do not have insurance or have insurance that other institutions do not want to take.

Health centers generally serve a high proportion of Medicaid recipient, as well as a large number of uninsured individuals. McReynolds said these patients can come with multiple social economic issues, including unstable housing, low literacy levels, low education levels, low income levels, and food insecurities.

They need to be able to go to a place that doesn't ask the first question of what's your insurance in order to get in the door to see a doctor, he said. So, health centers have a sliding fee scale, so that even the poorest of individuals can have access to care to see a doctor for very little or no money.

The Impact of COVID-19

Those factors in normal times make it very difficult for health centers to even break even. However, the COVID-19 pandemic has made the situation even more untenable and difficult for health centers across the country.

McReynolds said one of the unfortunate byproducts of the situation is the NYU Langone Health Center was forced to lay off some workers, which more than 85% of health centers across the country were forced to do.

However, as case numbers began to improve, McReynolds said, Langone was able to rehire some of the laid off workers.

Like traditional doctors offices and hospitals, McReynolds said one of the tools health centers have successfully utilized during the ongoing pandemic has been telemedicine services. The popularity of these telehealth programs can be seen in Langones behavioral health programs, where McReynolds estimated a 130% increase in productivity from where they were before the pandemic.

The Future

Another service offered at the health center is a school-based program, with programs in more than 63 schools across New York City. However, the mass school closings forced the health center to temporarily halt their own programs.

And so, it really just kind of compounded this disparity problem that COVID adversely affects Hispanics and blacks in infection rates and mortality, McReynolds said. And now the services that are designed to help those folks had to lay people off. So that's a very big challenge for fragile organizations that serve fragile populations.

McReynolds also expects, should a vaccine gain FDA approval, that health centers will have a role in administering it to the public.

McReynolds said there have been a number of new pilot programs tried in an effort to reduce the burden on emergency room visits in favor of community health centers.

The most successful pilot that I think will stay in place is that there will be community health workers or case workers and emergency rooms that will help those people that showed up to the emergency room when it wasnt a real emergency and connect them with the primary caregiver in the community.

Since the pandemic began, there have been an increase in the type of patients needing care, including cardiovascular issues, psychiatric conditions, sleep problems, and substance abuse.

While there are certainly financial worries, to compound what might be an increase in people needing medical assistance, Reynolds said there will always be a role for community health centers.

I think that the biggest challenge is to, to reach out to patients to let them know that we're here for you regardless, he said. Regardless of if you just lost your job and now you don't have insurance anymore because there's 40 million newly unemployed people.

We're here for you, regardless of whatever your health condition is, he added. It's really building on that trust factor of getting the patient to trust us and they have always trusted us because we don't judge them based on income or citizenship or language or anything.

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COVID-19 Only Adding to the Challenges Health Centers Face - MD Magazine

As US reaches 5 million COVID-19 infections, Europe alarmed with failure to contain spread: Dont they care a – Chicago Tribune

August 9, 2020

Had the medical professionals been allowed to operate in the States, you would have belatedly gotten to a point of getting to grips with this back in March, said Scott Lucas, professor of international studies at the University of Birmingham, England. But of course, the medical and public health professionals were not allowed to proceed unchecked, he said, referring to President Donald Trumps frequent undercutting of his own experts.

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As US reaches 5 million COVID-19 infections, Europe alarmed with failure to contain spread: Dont they care a - Chicago Tribune

Johnson & Johnson reaches deal with U.S. for 100 million doses of coronavirus vaccine at more than $1 billion – CNBC

August 9, 2020

Johnson & Johnsonannounced Wednesday that it will develop and deliver 100 million doses of its coronavirus vaccine for the U.S. in a deal totaling more than $1 billion.

The company's experimental vaccine is currently in early stage human trials and is expected to begin late-stage human trials in September, executives have previously said. The deal gives the U.S. the option to order an additional 200 million doses, according to the announcement.

"We are scaling up production in the U.S. and worldwide to deliver a SARS-CoV-2 vaccine for emergency use," said Dr. Paul Stoffels, chief science officer at Johnson & Johnson, in a statement.

The U.S.earlier this year awarded J&J $456 million to develop its vaccine. The company said its goal is to supply more than 1 billion doses globallythrough 2021.

The doses will be provided to Americans at no cost if they're used in a Covid-19 vaccination campaign, the U.S. Department of Health and Human services said in a separate press release. However, health-care professionals could charge for the cost of administering the vaccine, HHS said.

"Today's investment represents the next step in supporting Janssen's vaccine candidate all the way through manufacturing, with the potential to bring hundreds of millions of safe and effective doses to the American people,"HHS Secretary Alex Azar said in the statement. Janssen Pharmaceutical, which is owned by J&J, is developing the vaccine.

J&J is one of a handful of companies that have reached a deal with the U.S. to supply their potential coronavirus vaccine upon federal approval.The U.S. announced Friday it will pay drugmakerSanofiandGlaxoSmithKlineup to $2.1 billion to develop and deliver 100 million doses of their potential vaccine.

The U.S. also said it will payPfizerand biotech firmBioNTech$1.95 billion to produce and deliver 100 million doses of their Covid-19 vaccine if it proves safe and effective, thecompanies announcedin late July.

J&J's vaccine candidate,Ad26.COV2.S,is using the same technology it used to make its experimental Ebola vaccine, which was provided to people in the Democratic Republic of Congo in late 2019.

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Johnson & Johnson reaches deal with U.S. for 100 million doses of coronavirus vaccine at more than $1 billion - CNBC

1,011 new confirmed cases and 7 new probable cases of COVID-19; 18 additional confirmed deaths and 7 new probable deaths – WLTX.com

August 9, 2020

This brings the total number of confirmed cases to 99,713, probable cases to 722, confirmed deaths to 1,949, and 82 probable deaths.

COLUMBIA, S.C. The South Carolina Department of Health and Environmental Control (DHEC) today announced 1,011 new confirmed cases and 7 new probable cases of the novel coronavirus COVID-19, 18 additional confirmed deaths and 7 new probable deaths.

This brings the total number of confirmed cases to 99,713, probable cases to 722, confirmed deaths to 1,949, and 82 probable deaths.

Confirmed and probable cases: please click here.Confirmed and probable deaths: please click here.

Richland County reported 82 confirmed cases, no probable cases; Lexington County reported 42 confirmed cases, no probable cases.

Testing in South CarolinaAs of yesterday, a total of 843,241 tests have been conducted in the state. See a detailed breakdown of tests in South Carolina on the Data and Projections webpage. DHECs Public Health Laboratory is operating extended hours and is testing specimens seven days a week, and the Public Health Laboratorys current timeframe for providing results to health care providers is 24-48 hours

Percent PositiveThe total number of individual test results reported to DHEC yesterday statewide was 7,853 (not including antibody tests) and the percent positive was 12.9%.

More Than 125 Mobile Testing Clinics Scheduled StatewideAs part of our ongoing efforts to increase testing in underserved and rural communities across the state, DHEC is working with community partners to set up mobile testing clinics that bring testing to these communities. Currently, there are 126 mobile testing events scheduled through September 29 with new testing events added regularly. Find a mobile testing clinic event near you at scdhec.gov/covid19mobileclinics.

Residents can visit scdhec.gov/covid19testing for information about getting tested at one of 223 permanent COVID-19 testing facilities across the state.

Hospital Bed OccupancyAs of this morning, 2,269 inpatient beds are available and 8,157 are in use, which is a 78.24% statewide inpatient bed utilization rate. Of the 8,157 inpatient beds currently used, 1,378 are occupied by patients who have either tested positive or are under investigation for COVID-19. Of the 1,585 ventilators, 547 are in use and 219 of those are COVID-19 patients.

For the latest information related to COVID-19 visit scdhec.gov/COVID-19. Visit scdmh.net for stress, anxiety and mental health resources from the S.C. Department of Mental Health.

*As new information is provided to the department, some changes in cases may occur. Cases are reported based on the persons county of residence, as it is provided to the department. DHECs COVID-19 map will adjust to reflect any reclassified cases.

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1,011 new confirmed cases and 7 new probable cases of COVID-19; 18 additional confirmed deaths and 7 new probable deaths - WLTX.com

9 more local residents die of COVID-19 as virus slams 2 long-term care facilities – Villages-News

August 9, 2020

Nine more local residents have succumbed to COVID-19 as the virus continues to sweep through local long-term care facilities, The Villages and surrounding communities.

Six of the latest fatalities were from Lake County and the other two lived in Marion County. They were identified Saturday by the Florida Department of Health as:

Seventeen new COVID-19 cases were reported Sunday at two Villages-area long-term care facilities that clearly have been struggling with the virus. Those include:

Fifty-three new cases also were reported in The Villages and surrounding communities, bringing the total in the local area to 2,266. Those include:

Overall, the tri-county area is reporting 12,617 cases an increase of 197 from Friday to Saturday among 5,453 men, 6,984 women, 51 non-residents and 129 people listed as unknown. There have been 197 deaths and 933 people hospitalized.

Sumter County is now reporting 1,284 cases an increase of 47 in a 24-hour period among 653 men, 619 women, eight non-residents and four people listed as unknown. There have been 41 deaths and 176 people have been treated in area hospitals.

Bushnell has 231 cases 129 of which are at the Sumter Correctional Institution among 103 inmates and 26 staff members. Others have been identified in Coleman (69), Lake Panasoffkee (66), Webster (63), Center Hill (36), Lady Lake portion of the county (27) and Sumterville (27). The federal prison in Coleman also is reporting 360 cases among 270 inmates and 90 staff members.

Marion County continues to lead the tri-county area with 6,260 cases an increase of 276 in 24 hours. Those are comprised of 2,420 men, 3,794 women, 13 non-residents and 33 people listed as unknown. There have been 89 deaths and 484 people hospitalized.

Ocala continues to pace Marion County with 4,941 cases an increase of 178 overnight and 79 percent of all the cases reported in the county. Others have been identified in Dunnellon (187), Citra (132), Reddick (75), Silver Springs (74), Ocklawaha (64), Weirsdale (34), Anthony (34), Fort McCoy (17), Orange Lake (8), Lowell (5), Sparr (5), Candler (3), East Lake (3), Morriston (2), Fairfield (2), Salt Springs (1), Williston (1) and McIntosh (1). A total of 1,217 cases have been reported among inmates (1,158) and staff members (59) at Lowell Correctional Institution and Marion Correctional Institution.

Lake County has 5,023 cases an increase of 115 in 24 hours among 2,380 men, 2,571 women, 30 non-residents and 92 people listed as unknown. There have been 67 deaths and 273 people requiring some form of hospital care.

Clermont continues to lead Lake Couty with 1,322 cases an overnight increase of 50. Others have been identified in Tavares (607), Eustis (424), Groveland (366), Mount Dora (336), Mascotte (175), Minneola (143), Sorrento (131), Umatilla (94), Montverde (80), Grand Island (50), Howey-in-the-Hills (34), Astatula (34), Yalaha (25), Astor (23), Altoona (20), Paisley (17), Okahumpka (12), Ferndale (5) and Mount Plymouth (3).

All told, Florida is reporting 526,577 COVID-19 cases an increase of 8,502 from Friday to Saturday. Of those, 520,086 are residents. There have been 8,238 deaths and 30,251 people have been hospitalized across the Sunshine State. Those numbers show 187 more deaths since Friday and an additional 521 people requiring hospital care.

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9 more local residents die of COVID-19 as virus slams 2 long-term care facilities - Villages-News

There are 5 easy steps to tame COVID-19, says Fauci – Harvard Gazette

August 9, 2020

Our society is, in so many ways, at a tipping point. Theres so much that we need to do right now, and theres one thing we need most of all, and thats voices of conviction, voices of reason to help guide us through these difficult times, Bacow said.

Williams said the field of public health has had a profound and positive effect on the lives of Americans over the past century but wondered whether the evidence suggests that in this case, it somehow failed.

Our goals are enormous, and our struggles at times are heavy, yet when public health works, our impact extends far and wide and becomes deeply embedded in our culture and our history, Williams said. Has public health failed or have those in education, government, and policy failed public health? Believe me, there are no simple answers, but we do know this: We are in the middle of one of the worst public health crises this country has ever seen, and many factors that got us to this point must change.

In his comments, Fauci avoided responses and phrasing that blamed any single individual or small group of individuals for missteps, but he was firm in his contention that basic public health measures are enough, if universally observed and applied, to send the coronavirus into retreat.

The NIAID director was asked how the U.S., the most powerful nation in the world, ended up faring so poorly in its battle with the pandemic, racking up the highest numbers of cases and deaths. Fauci said that the critical point came after the initial springtime peak. Nations in Europe kept their lockdown measures in place until infections fell to very low levels, allowing them to shift resources to detecting and tracing cases that inevitably accompanied reopening. In the U.S., he said, new daily cases were still at about 20,000 a week when states began reopening, and relatively soon thereafter the numbers began rising again, recently hitting a peak over 70,000.

If you wanted to get control over it, it would be nice if everybody was singing the same tune.

Anthony Fauci

In addition, he said, state reopening plans proceeded at different paces. Some states reopened slowly, similar to the pace of European nations, while others went much faster. Another variable, he said, was the extent to which residents of different states adhered to reopening guidelines, with some following recommendations while others ignored the restrictions, sometimes in notably large groups.

If you wanted to get control over it, it would be nice if everybody was singing the same tune, Fauci said. But what has happened is we have a situation where we say, Open up in a measured, prudent way, and you get some that do it fine, and then you see the pictures of people at bars with no masks and not social distancing.

Many of those flouting precautions, Fauci said, wrongly believe that their behavior endangers only themselves. He said they dont understand that not only can they get sick, but they can also transmit the virus to people who are more vulnerable.

And, while it is true that the virus does seem to hit the young less hard than older adults, going into bars is still a gamble, he said. Despite overall trends, many younger people have gotten sick and even died of the virus.

As long as you have any member of society, any demographic group, who is not seriously trying to get to the endgame of suppressing this, it will continue to smolder and smolder and smolder, Fauci said. And that will be the reason why weve plateaued at an unacceptable level.

Fauci said his abiding faith in the American spirit makes him cautiously hopeful that people who have resisted complying will ultimately do whats needed to avoid more drastic measures that would worsen the economic harm being felt nationwide.

The more we give a consistent message, the more people will realize what we should do, Fauci said.

During the hourlong event, Fauci addressed a number of other topics, including his optimism about vaccine prospects by the end of the year, the importance of ensuring equitable treatment and vaccination in communities of color, as well as his concern about the distrust of science and the anger directed at experts. Fauci said he has continued to receive harassment and death threats against himself and his family and has had to hire security guards.

Looking ahead, Fauci said the one certainty is that this pandemic will be followed by another, and we should prepare for it. Since this is the third coronavirus pandemic after SARS and MERS it would behoove us not only to continue to invest in public health infrastructure after COVID-19 fades, but also to begin searching for a universal coronavirus vaccine.

Shame on us if were not prepared for the next coronavirus pandemic, Fauci said.

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There are 5 easy steps to tame COVID-19, says Fauci - Harvard Gazette

COVID-19 in Africa: Dampening the storm? – Science

August 7, 2020

Coronavirus disease 2019 (COVID-19) has spread rapidly and extensively to most countries in the world, resulting in considerable mortality in Europe and the United States, as well as in numerous upper-middle-income countries in South America and Asia. Experts predicted millions of COVID-19 deaths in Africa because many countries in the continent rank poorly on the United Nations Development Programme's Human Development Index. However, more than 4 months after the first cases in Africa were detected, prevalence and mortality are still low. It remains unclear if Africa is really spared from substantial cases and deaths. However, differences between Africa and the most affected countries in reliable reporting and death registration, lockdown stringency, demography, sociocultural aspects, environmental exposures, genetics, and the immune system could help to explain the experience of COVID-19 in Africa.

Africa faces major health and socioeconomic challenges that should have allowed rapid transmission of COVID-19. These include a weak health system (per capita health expenditure of <$50 in most West African countries compared with >$2500 in Europe and the United States), population crowding, poverty, and unhygienic conditions (1). Population densities are very high in most African capital cities such as Dakar (12,617 persons/km2), Abidjan (11,155 persons/km2), or Lagos (13,909 persons/km2), whereas New York City has 7101 persons/km2. However, although community transmission was reported in many major African cities months ago, the predicted number of cases and deaths has not yet been observed (see the figure). Low case numbers are often attributed to insufficient testing. However, many African countries implemented testing early on, and, based on the Our World in Data database (2), more tests per the number of cases were carried out than in other countries at similar phases of the epidemic (see the figure). Regarding the number of deaths, few functional civil registration services and thus statistics exist on the continent, raising questions about the reliability of mortality data. Potential underreporting of COVID-19associated deaths would not be specific to Africa, but the margin of error could be wider. To date, African countries have not indicated acute health emergencies; however, reliable age-stratified data are needed to fully grasp the COVID-19 situation in Africa to allow appropriate measures to be taken.

Measures such as travel restrictions, curfews, and school closures were implemented early in Africa compared with other continents, often before an African country had detected a case (fig. S1). These early responses might have resulted in fewer imported cases and reduced intracountry transmission, allowing sufficient time to prepare the constrained health systems for diagnosis and to prepare strategies for quarantine, contact tracing, and social distancing on a continent that already has experience in such practices to control epidemics such as Lassa fever and Ebola. Although it is likely that the early lockdown in Africa contributed to the slow spread, containment measures are not fully respected in many countries. Most people work in the informal business sector, such as in traditional markets, making strict lockdown measures impossible to implement. Recently, some African governments have been pressured to relax lockdown measures, for example, to carry out congregational prayers in mosques in Senegal. It remains unknown whether relaxation of containment measures will result in increased cases or if other factors are at play.

The majority of COVID-19associated deaths occur in older people. Africa has a comparatively young population, with a median population age of 19.7 years for the continent versus 38.6 years for the United States. Africa's youthful population is reflected in the structure of age-stratified cases (fig. S2). Based on global age-specific case fatality rates for COVID-19 and the age demographics of Africa, COVID-19 deaths would be expected to be only four times (3), rather than the observed 40 times, lower than in Europe or the United States. However, no aggregated data on age-specific case or death rates are available for the continent. There is substantial intergenerational mixing in Africa, and, with more cases of subclinical infections in the young, it could be a matter of time before expansive numbers of cases and deaths are recorded. Alternatively, a more rapid development of herd immunity among the youthful population might lead to fewer severe cases. Data from antibody tests (serosurveys) should clarify if transmission was more widespread with a high rate of asymptomatic and mild cases in African countries than in other countries.

The genetic characteristics of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and human genetics may be among the reasons for low incidence of severe COVID-19 in Africa. Although the relative contribution from Africa to the SARS-CoV-2 GISAID (Global Initiative on Sharing All Influenza Data) sequence database is small, the isolates found in Africa are representative of the different clades of SARS-CoV-2 found on other continents (fig. S3). Thus, it is unlikely that strains of SARS-CoV-2 in Africa have reduced virulence. Moreover, African-Americans constitute a disproportionate burden of deaths in the United States, so it seems unlikely that the lower mortality from COVID-19 in Africa is due to genetic factors. Nonetheless, the COVID Human Genetic Effort consortium aims to elucidate whether genetics can play a role in the patterns of disease worldwide.

SARS-CoV-2 infection leads to a heterogeneous outcome. About 80% of symptomatic cases are mild to moderate, whereas 20% can develop severe respiratory disease and display high rates of mortality (4). The development of an effective adaptive immune response can limit viral infection, whereas uncontrolled activation of innate immune cells leads to a cytokine storm and hyperinflammation in the lungs, ultimately leading to acute respiratory distress syndrome (ARDS) and multiorgan failure (4, 5). Being able to suppress viral infection early or to temper excessive inflammatory responses are likely complementary mechanisms to prevent severe disease.

Most convalescent symptomatic COVID-19 patients develop virus-specific neutralizing antibodies as well as specific CD4+ and CD8+ T cell responses (5). The efficiency and adequacy of these adaptive responses to clear viral infections depends on multiple factors, including past or concurrent infections with other pathogens. For example, antibodies directed to the four human coronaviruses that cause common colds could cross-react and neutralize SARS-CoV-2 in humans (6), and preexisting cross-reactive T cells can be found in individuals that have not been exposed to SARS-CoV-2 (7), suggesting previous exposure to related human coronaviruses could generate immunological cross-reactivity (7).

There are considerable differences in environmental exposures in Africa, compared with Europe or the United States. Noncommunicable diseases (NCDs)such as cardiovascular diseases, obesity, and type 2 diabetesare risk factors for severe COVID-19. These environmentally and behaviorally driven conditions are increasingly recognized in urban centers in Africa, and most COVID-19 deaths in Africa have been in older people with NCDs. However, infectious diseases such as HIV, tuberculosis, malaria, and other respiratory infections or those caused by helminths (parasitic worms) are prevalent in Africa, but there is currently little information on whether, or how, these infections affect COVID-19 disease progression.

The distribution of coronavirus disease 2019 (COVID-19) cases and deaths per 1 million inhabitants per continent reveals surprisingly low rates in Africa (left). This is despite comparable levels of testing per confirmed cases across continents (right). The dotted lines show the number of tests performed per number of detected cases. Data are from European Centre for Disease Prevention and Control COVID-19 situation updates, United Nations World Population Prospects 2019, and Our World in Data (2).

It is increasingly recognized that the immune system is shaped not only by genetics but also by environmental factors, such as exposure to microorganisms and parasites. This educates the immune system to protect against invading pathogens not only specifically but also nonspecifically through, for example, trained immunity, which involves the reprogramming of innate cells that, on secondary encounter with a pathogen, can show a stronger response (8) or virtual memory (9). Virtual memory T cells (TVM cells) expand in response to cytokines such as helminth-induced interleukin-4 (IL-4), rather than through pathogen-specific antigens, leading to enhanced antiviral effector functions (9). Thus, it can be envisaged that TVM cells are more prevalent in people in Africa owing to the higher exposure to such pathogens. This could contribute to the control of SARS-CoV-2. Additionally, as postulated by the hygiene hypothesis, early and chronic exposure to pathogens leading to relentless immune cell activation in harsh environments induces a strong regulatory immune response to counteract excessive inflammation (10).

The ability to prevent excessive inflammation could be a critical parameter that is associated with COVID-19 outcome. Recent data suggest that inflammatory alveolar macrophages (AMs), which can arise from differentiation of recruited monocytes upon infection, are increased in the lungs of patients with severe COVID-19 (11). It is unclear whether these monocyte-derived AMs are an important source of the cytokine-release syndrome observed during SARS-CoV-2 infection or whether they are involved in the pathogenesis of ARDS. However, monocyte and macrophage inflammatory cytokines, such as IL-6, have been repeatedly observed to be a marker of severe COVID-19, and myeloid cells are thus likely to be associated with the hyperinflammation. Monocytes from African individuals with high exposure to pathogens can be less proinflammatory (12). Thus, their recruitment into the lungs might prevent high cytokine production and therefore lead to better outcomes of COVID-19. Moreover, the airway microbiota, as well as more distal gut microbiota, could play important roles in preventing or potentiating respiratory tract infections and modulating virus-induced inflammation, as has been shown for several respiratory viruses (13). The known variations in microbiota across geographical areas could thus also participate in modulating disease severity and should be studied.

Africa should be part of the roadmap for COVID-19 research. Although there are no available data on the immune responses in African COVID-19 patients, studies show clear differences in the activation, proinflammatory, and memory profiles of the immune cells not only in Africans versus Europeans but also among Africans with high and low exposure to microorganisms and parasites (14) (fig. S4). Does the difference in immunological profiles matter for the outcome of COVID-19 in Africa? This needs further investigation, and the pattern of COVID-19 in urban and rural Africa could be informative.

There are differences in opinion about whether the pattern of SARS-CoV-2 spread is different in Africa compared with that in the United States and Europe. So far, despite a paucity of data, it appears that the virus is spreading differently and potentially with an attenuated outcome in Africa. There has been limited testing of asymptomatic cases or of antibody titers. Therefore, it is unknown whether early interventions were successful in preventing transmission or whether there are differences in susceptibility between populations of different regions. Perhaps the COVID-19 pandemic can emphasize the need for widespread implementation of public health tools, such as high-quality data, accurate diagnostics for track and trace, good communication, and an effective vaccine. Early testing of vaccines in different regions of Africa is essential because the high degree of exposure to pathogens can limit some vaccine responses (15). The first COVID-19 vaccine testing is starting in South Africa (Ox1Cov-19 Vaccine VIDA-Trial), and others are planned. Hopefully, this will stimulate the full participation of Africa in research into the critical factors that hold the key to innovative solutions in the fight against the pandemic.

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COVID-19 in Africa: Dampening the storm? - Science

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