Category: Corona Virus Vaccine

Hahn has instructed staff: no more mistakes, said an official. The next few announcements have to be flawless.

Polls show that nearly a fifth of adults would refuse a coronavirus vaccine if one were available, in some cases over fears that any approval would be motivated by politics rather than science. Just 14 percent of voters would be more likely to take a vaccine recommended by Trump, according to a recent POLITICO/Morning Consult poll.

The FDA has been heavily scrutinized as regulators speed coronavirus therapies and potential vaccines, including its March decision to grant emergency authorization for a Trump-favored drug called hydroxychloroquine despite scant data that it worked to fight the virus. FDA subsequently withdrew the authorization after evidence the treatment didnt work, prompting public objections from the president.

Watchdogs and researchers again criticized the agency last week for its news release on the plasma authorization titled, Another Achievement in Administrations Fight Against Pandemic which many people within the FDA considered a breach of the agencys historic focus on science and for overstating the treatments effectiveness.

Hahn took to Twitter last Monday night to apologize for exaggerating the benefits of plasma, angering Azar, Caputo and other senior Trump administration officials. HHS officials the next day began the process of severing Hahns contract with Wayne Pines, a longtime APCO Worldwide executive and the communications consultant who advised him to make the apology.

HHS chief of staff Brian Harrison told POLITICO that the cancellation of Pines contract was routine, because it violated department protocols, and the department has been reviewing thousands of contracts, many of which are in the process of being canceled.

The timing was 100 percent coincidence and the cancellation was made by HHS at the recommendation of the HHS general counsel, Harrison said, adding that Azar was completely unaware of any contract with Wayne Pines.

Three senior officials also said FDA had not previously informed HHS leadership, including Caputo, about the contract with Pines.

Bringing someone on doesnt mean as a contractor, said a senior HHS official. If ever mentioned, the secretary wouldve assumed it was as an employee and that the operating division wouldve followed the appropriate hiring process.

However, three current and two former officials said that it was well-known by HHS leadership that Pines had been advising Hahn for months. Three people with knowledge of the situation said Azars own relationship with Pines dated back several years.

"Wayne Pines was an instrumental leader in Secretary Azar's confirmation hearing process," said a senior HHS official, who said that Azar consulted with Pines and worked out of his conference room at APCO Worldwide while preparing to become HHS secretary in 2017 and 2018.

Hahn asked for permission to bring Pines on board under contract in a meeting with Azar in late April, the senior official added, noting that FDA at the time was without a full-time media chief and Pines was a published author on FDA and crisis communications. This was the right guy at the right time.

The process of removing Pines last week was not coincidental, the senior official insisted. "Wayne was scapegoated by certain FDA officials for Hahn's apology tour." Pines was formally notified on Wednesday that his services would no longer be necessary, the senior official added.

Hahn subsequently ousted Emily Miller, the White House-installed spokesperson for FDA, who had no prior public health experience and had clashed with multiple officials, including Caputo, in her 11-day tenure. Two people close to the situation also said Miller played a key role in titling last weeks plasma announcement as a Trump administration achievement. While Miller will remain at the agency, her future position is still under consideration, but will likely be senior adviser to the commissioner, said four people familiar with the discussions.

Meanwhile, John Wolf Wagner who was removed as FDAs external affairs chief on Wednesday after just two months in that role is a close ally of Caputo, who officials say had served as Wagners effective boss.

Wolf is a very nice manzero FDA experience, said one senior health official. He has made it very clear that he does not take direction from Hahn.

Officials said both Wagner and Miller, a former reporter at the right-wing One America News Network, had frequently butted heads with the career civil servants in the FDA press office.

For instance, Wagner instructed the press shop that every response to reporters coronavirus-related or otherwise had to be brief, top-line statements, said one current FDA official.

Wagner and Miller also were against press officers speaking directly with reporters and often questioned staff when they worked on announcements that were unrelated to the pandemic, the official added, creating an additional logjam for staff who had to explain why other food and drug policy announcements were newsworthy. Its been very chaotic and confusing, the official said.

The latest news in health care politics and policy.

Current and former officials say the Trump administration has hampered its own message by installing political appointees with limited public health expertise during a pandemic.

Longtime communications hands have called on the health department to rely on experts in medical and scientific communications given the crisis.

They can be the best damn practitioners of communications, but if they've never done science or medicine, thats a problem, said Bill Pierce, who served as HHS top spokesperson during the George W. Bush administration and who now works at APCO. Science and medical communications is an art you have to know and understand the terrain. Its not just pronouncing funny words.

At stake: convincing Americans they can trust treatments devised by the Trump administration, even as messaging blunders consume disparate parts of the health department and questions swirl about their independence.

Youve got a public relations disaster at FDA, youve got a public relations disaster at CDC, and no one seems to be controlling the message, said a senior official. HHS is losing the PR narrative here.

Meanwhile, two career civil servants with years of FDA expertise have temporarily replaced Wagner and Miller in FDAs top communications roles, a move that drew bipartisan applause.

This is a huge relief, tweeted Rob Califf, a former FDA commissioner during the Obama administration a message swiftly seconded by Scott Gottlieb, Trumps former commissioner. Hahn himself praised the shift.

Thanks for your support of our career communicators, the FDA commissioner tweeted. They are top-notch professionals who understand our science-based mission.

Nonetheless, the White House is considering political appointees to potentially replace Wagner and Miller, said two individuals with knowledge of personnel plans.

More:

Hahn, HHS in tit for tat feud over Covid-19 messaging - POLITICO

CLARKSVILLE, Tenn. (CLARKSVILLENOW) Montgomery County saw a drastic drop in the calculated number of active COVID-19 cases on Thursday, Sept. 3, after the Tennessee Department of Health implemented a new formula and corrected a zip code error.

On Wednesday, Sept. 2, there were 1,038 active cases reported in Montgomery County, a number that has stayed above 1,000 since early August.

A day later, on Thursday, Sept. 3, that reported number plummeted to only 195 active cases.

Joey Smith, director at the Montgomery County Health Department, said they have been waiting in anticipation for these corrected active cases numbers.

Early in the COVID-19 outbreak, public health staff members conducted ongoing individual follow-up with cases to accurately answer the question, Has this case recovered?' Smith said. As case volume increased and long-term individual follow-up was not feasible, TDH began applying a 21-day automatic cutoff for this question.

The number of active cases was calculated by subtracting the number of recoveries and deaths from the total number of cases.

Previously, the Tennessee Department of Health considered a case recovered after 21 days.

But TDH announced on Sept. 3 they will begin to show that inactive/recovered cases will include people who are 14 days or more beyond their illness onset date (or, for asymptomatic cases, their specimen collection date).

This will more closely align with what is now understood about the infectious period of COVID-19, as recent data from the Centers for Disease Control and Prevention show most patients with COVID-19 are no longer infectious after 10 days, TDH said in a news release.

There are about 1,700 cases for whom the county of residence needed to be corrected. For these individuals, the county does not correspond correctly to their street addresses, Smith said.

Positive case tests come from all over the world, pediatrician offices, clinics, etc., so zip codes that border a county may go incorrectly to another county, Smith said. This discrepancy can occur when a laboratory report contains incorrect county information. Some laboratory systems automatically assign county information based on an individuals ZIP code. Because some ZIP codes straddle county lines, the assigned county may be incorrect.

Smith said the corrected active cases and zip code corrections data will help not just their agency, but several others such as the school system to make decisions based on updated COVID-19 numbers.

Here are the updated Montgomery County numbers as of 2 p.m. Thursday, Sept. 3:

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Active COVID-19 cases revised from 1038 to only 195 in Montgomery County - Clarksville Now

TheWest Virginia Department of Health and Human Resources (DHHR) reportsas of 10:00 a.m., on September 1, 2020, there have been 438,255 total confirmatory laboratory results receivedfor COVID-19, with 10,507 total cases and 222 deaths.

DHHRhas confirmed the deaths of a 72-year old female fromMonroe County, a 65-year old female from Kanawha County, an 84-year old malefrom Kanawha County, a 65-year old female from Logan County, a 62-year oldfemale from Logan County, an 82-year old male from Logan County, a 41-year oldfemale from Mingo County, and a 91-year female from Kanawha County. Thisis another difficult day for West Virginia as the death toll continues to rise,said Bill J. Crouch, DHHR Cabinet Secretary. Our heart goes out to these WestVirginians and their families. Please continue taking every precaution we canto slow the spread of this disease.

CASESPER COUNTY: Barbour (33), Berkeley (804), Boone(143), Braxton (9), Brooke (94), Cabell (544), Calhoun (10), Clay (27),Doddridge (6), Fayette (360), Gilmer (19), Grant (141), Greenbrier (104),Hampshire (92), Hancock (121), Hardy (75), Harrison (269), Jackson (205),Jefferson (360), Kanawha (1,491), Lewis (32), Lincoln (119), Logan (493),Marion (219), Marshall (133), Mason (105), McDowell (70), Mercer (311), Mineral(147), Mingo (249), Monongalia (1,170), Monroe (124), Morgan (37), Nicholas(52), Ohio (291), Pendleton (45), Pleasants (15), Pocahontas (45), Preston(140), Putnam (286), Raleigh (366), Randolph (226), Ritchie (5), Roane (33),Summers (20), Taylor (106), Tucker (11), Tyler (15), Upshur (43), Wayne (253),Webster (7), Wetzel (46), Wirt (8), Wood (310), Wyoming (68).

Pleasenote that delays may be experienced with the reporting of information from thelocal health department to DHHR. As case surveillance continues at the localhealth department level, it may reveal that those tested in a certain countymay not be a resident of that county, or even the state as an individual inquestion may have crossed the state border to be tested.Such is the case of Greenbrier,Hancock, and Wirt counties in this report.

Pleasevisit the dashboard located at http://www.coronavirus.wv.gov for more information.

Here is the original post:

COVID-19 Daily Update 9-1-2020 - West Virginia Department of Health and Human Resources

In April, more than three months before any coronavirus vaccine would enter large clinical trials, the mayor of a picturesque island town in the Pacific Northwest invited a microbiologist friend to vaccinate him.

The exchange occurred on the mayors Facebook page, to the horror of several Friday Harbor residents following it.

Should I pop up and get your vaccine started?????, wrote Johnny Stine, who runs North Coast Biologics, a Seattle biotech company with a focus on antibodies. Dont worry Im immune I have boosted myself five times with my vaccine.

Sounds good, Farhad Ghatan, the mayor, wrote after a few follow-up questions.

Several residents interjected skepticism in the exchange. They were swatted down by the mayor, who defended his friend of 25 years as a pharmaceutical scientist on the forefront. When residents raised additional concerns about Mr. Stines credentials and the unfairness of encouraging him to visit San Juan Island despite travel restrictions Mr. Stine lobbed back vulgar insults. (The geekiest and least R-rated: I hope your lung epithelial cells over express ACE2 so you die more expeditiously from nCoV19.)

Several residents reported all of this to a variety of law enforcement and regulatory agencies. In June, the Washington attorney general filed a lawsuit against Mr. Stine not only for pitching the mayor with unsupported claims, but also for administering his unproven vaccine to about 30 people, charging each $400. In May, the Food and Drug Administration sent a letter warning Mr. Stine to stop misleadingly representing his product.

Although his promotional tactics were unusual, Mr. Stine was far from the only scientist creating experimental coronavirus vaccines for themselves, family, friends and other interested parties. Dozens of scientists around the world have done it, with wildly varying methods, affiliations and claims.

The most impressively credentialed effort is the Rapid Deployment Vaccine Collaborative, or RaDVaC, which boasts the famous Harvard geneticist George Church among its 23 listed collaborators. (The research, however, is not happening on Harvards campus: While professor Churchs lab works on a number of Covid-19 research projects, he has assured Harvard Medical School that work related to the RaDVaC vaccine is not being done in his lab, a spokeswoman for Harvard Medical School said.)

Among the most tight-lipped projects is CoroNope, which refuses to name anyone involved because, according to the person responding to messages sent to the groups anonymous email account, the less than half a dozen biologists dont want to risk getting in trouble with the F.D.A. or with their employers.

Each D.I.Y. effort is motivated, at least in part, by the same idea: Exceptional times demand exceptional actions. If scientists have the skills and gumption to assemble a vaccine on their own, the logic goes, they should do it. Defenders say that as long as they are measured about their claims and transparent about their process, we could all benefit from what they learn.

But critics say that no matter how well-intentioned, these scientists arent likely to learn anything useful because their vaccines are not being put to the true test of randomized and placebo-controlled studies. Whats more, taking these vaccines could cause harm whether from serious immune reactions and other side effects, or offering a false sense of protection.

Take it yourself and there is not much anyone can or should do, said Jeffrey Kahn, the director of the Johns Hopkins Berman Institute of Bioethics. But once a person starts encouraging other people to try an unproven vaccine, youre headed right back to the days of patent medicine and quackery, he said, referring to a time when remedies were widely sold with colorful but misleading promises.

The RaDVac vaccine effort, first reported on by MIT Technology Review, is different from Mr. Stines project in two important ways. No one involved plans to charge for the vaccine. And unlike Mr. Stines expletive-laden Facebook rants, RaDVaC has a 59-page scientific document to explain how it works and to guide others who might want to mix up the vaccine formulation on their own.

The white paper is quite impressive, said Avery August, an immunologist at Cornell University in Ithaca, N.Y., who is not involved with RaDVaC.

But the impetus of both projects is similar. In March, as Preston Estep, a genome scientist who lives in the Boston area, was reading about people dying amid the pandemic, he vowed not to sit complacently on the sidelines. He emailed some chemists, biologists, professors and doctors he knew to see whether any were interested in creating their own vaccine. Soon they had devised a formula for a peptide vaccine that could be administered through a spritz in the nose.

Its very simple, Dr. Estep said. It consists of five ingredients you could mix together in a physicians office.

The key ingredient: tiny bits of viral proteins, or peptides, which the scientists ordered online. If all went well, the peptides would train the immune system to defend against the coronavirus, even with no actual virus present.

In late April, Dr. Estep joined several collaborators in a lab as they stirred the concoction and sprayed it in their nostrils. Dr. Church, a longtime mentor to Dr. Estep, said he took it alone in his bathroom to maintain social-distancing precautions.

Dr. Estep soon gave the vaccine to his 23-year-old son, and other collaborators also shared it with their family members. So far, no one has reported anything worse than a stuffy nose and a mild headache, Dr. Estep said. He has also refined the recipe, removing and adding peptides as new coronavirus research has emerged. So far, he has sprayed eight versions into his nose.

A traditional drug development workflow begins with mouse or other animal studies. For RaDVaC, Dr. Estep said, we are the animals.

But without rigorous clinical trials, Dr. August said, theres no reliable way to know if it is safe or effective. He said he feared that the scientists prestigious credentials might imply otherwise.

Dr. Church said that he respected the traditional evaluation process but that there should also be room for pre-research, and that most of what he had been involved with throughout his career including editing genes in human cells was considered fringe at first.

As of last week, Dr. Estep said, about 30 people in the United States, Sweden, Germany, China and Britain had taken the vaccine. He said a university professor in Brazil had told him he was considering making it in his lab and distributing it for free.

There is a long history of scientists openly testing vaccines on themselves and their children, but in recent decades it has become less common, according to Susan E. Lederer, a medical historian at the University of Wisconsin-Madison. Whats ethically and legally acceptable for testing and distributing your own medical product varies by institution and by country.

Updated September 1, 2020

In August, the Scientific Research Institute for Biological Safety Problems, a government institution in Kazakhstan, announced that seven employees had become the first people to try the Covid-19 vaccine they were developing. Russian and Chinese scientists affiliated with government and academic institutions have made similar pronouncements amid the pandemic.

The problem with Mr. Stines product, according to Attorney General Bob Ferguson of Washington, is not that he took it. Its that he sold this so-called vaccine to people in Washington who are frightened and more apt to look for a miracle cure in the midst of a worldwide pandemic, Mr. Ferguson said in a statement. The lawsuit also cites Mr. Stines unsupported safety and effectiveness claims.

In March, a few months after he said he vaccinated himself and his two teenage sons, he posted an ad on the Facebook page for North Coast Biologics. After decades of working with antibodies, Mr. Stine said in an interview, he knew that making a vaccine should be pretty goddamn easy.

He described a job that sounded a bit like writing Hollywood screenplays that never become movies. He makes antibodies that could be used against various pathogens and sells them to companies that could use them to develop drugs, but they probably wont. According to the Washington attorney generals suit, Mr. Stines company was administratively dissolved in 2012.

To make his vaccine, he used a genetic sequence for the spike protein on the outside of the coronavirus to make a synthetic version. He put it in a saline solution, injected himself just under the surface of the skin of his upper arm and then took a so-called titer test to look for antibodies in his bloodstream. It took me 12 days from downloading the sequence to being titer positive, he said.

In his Facebook ad, he claimed that this left him immune to the virus and offered interested parties the opportunity to pay $400/person.

As part of an agreement that Mr. Stine eventually struck with prosecutors, he must refund all 30 people who had taken his vaccine.

Mr. Stine seemed amused by this, insisting that few people are likely to apply for a refund. His fee, he said, barely covered travel costs, and often he didnt charge.

A man in his 60s in Montana, who asked to remain anonymous for privacy concerns, said he flew Mr. Stine out to inoculate him and his family. Now, he said, they have been able to return to normal behavior, such as having lunch with friends whose jobs put them at high risk for exposure. The man even joined Mr. Stine to visit a police officer friend in Washington State who had been diagnosed with Covid-19 and was on deaths door. According to all three who were present, no one wore a mask. And Mr. Stine sat close to the sick officer in an enclosed space as he gave him a treatment.

Mr. Stine says his vaccine is similar to a recombinant vaccine being developed by the University of Pittsburgh in Pennsylvania. He also claims that a shot will not only protect people against the virus, but also treat those who have it. Dr. Louis Falo, a lead researcher on University of Pittsburghs effort, said he was skeptical that Mr. Stines vaccine could be safe or effective based on how it was assembled. Even if it was, he said, its unlikely it would help sick people.

In the 1990s, Mr. Stine worked for Patrick Gray, a molecular biologist who contributed to the discovery of a hepatitis B vaccine and is now the chief executive of a biotech company.

Dr. Gray said in an interview that the science Mr. Stine published at Icos, the biotech company where they worked together, was sound but that the young scientist had a penchant for making too much of too little. Johnny was in a hurry to publish his work and advance his career, he said. We often insisted on more confirmation and more controls.

Regarding his current scientific efforts, I dont believe Johnny is a scam artist, but he has ignored F.D.A. regulations necessary for drug development, he wrote in an email. Its just not possible for an individual like Johnny to create a viable vaccine.

The mayor of Friday Harbor said he regretted responding to Mr. Stines message on his Facebook wall, instead of privately. But he does not see why he should apologize for accepting his friends formulation for free. Id rather have the chance of having some protection than no protection at all and waiting and waiting, Mr. Ghatan said.

The controversy, however, has derailed their plans to meet, he said. But if another opportunity arises to get the jab, he said, I would.

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These Scientists Are Giving Themselves D.I.Y. Coronavirus Vaccines - The New York Times

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The Illinois Department of Public Health reported 1,492 new confirmed cases of COVID-19 and 39 additional deaths Tuesday. That is the highest number of COVID-19 related deaths announced in a single day since June 26.

The state received the results of 22,961 COVID-19 tests in the 24 hours leading up to Tuesday afternoon. That is the fewest amount of tests reported by the state since July 6. The seven-day rolling average of Illinois positivity rate increased to 4.3%.

"We reached the maximum capacity of our system and currently are in the process of expanding this," IDPH spokesperson Melaney Arnold wrote in response to a question about why the day's test number was so low. "That work is underway now."

"Reporting test results is working, but it is currently slow and backlogged due to the large volume of testing data that we have processed since the beginning of the pandemic," Arnold said. "We are working on [eliminating] the testing data backlog."

In a response to a follow-up question on if this would affect when someone gets a test result, Arnold said "This does not delay a person getting their test results."

Illinois now has seen 236,515 total cases of the virus and 8,064 people have died. The state has conducted 4,087,122 tests since the start of the pandemic.

As of late Monday, Illinois had 1,513 COVID-19 patients in the hospital. Of those, 362 were in intensive care units, and 146 were on ventilators.

Regional update: According to aJuly 15 updateto the governor's COVID-19 response plan, the state will be tracking public health metrics in a slightly different way to monitor any potential resurgences of COVID-19. Additional restrictions can be placed on any of the state's 11 health regions if the region sustains an increase in its average positivity rate for seven days out of a ten day period.

A region may also become more restrictive if there is a seven-day increase in hospital admissions for COVID-19-related illness or a reduction in hospital medical/surgical beds or ICU capacity below 20%. If a region reports three consecutive days with greater than an 8% average positivity rate, additional infection mitigation will be considered through atiered system of restriction guidelinesoffered by the IDPH.

The North Suburban region (McHenry and Lake counties) has seen four days of positivity increases and two days of hospital admission increases. The region's positivity rate decreased to 6.1%. Currently, 42% of medical/surgical beds are available and 48% of ICU beds.

The West Suburban region (DuPage and Kane counties) has seen five days of positivity increases and two days of hospital admission increases. The region's positivity rate increased to 5.9%. Currently, 38% of medical/surgical beds are available and 49% of ICU beds.

The South Suburban region (Will and Kankakee counties) has seen five days of positivity increases and four days of hospital admission increases. The region's positivity rate remained flat at 8.8%. Additional mitigation measures from the IDPH have been placed on the region and it has less than two weeks to get down below 8%, or it will face additional mitigations. To return to the standard Phase 4 restrictions, the region will need to maintain an average positivity rate of less than or equal to 6.5% over a 14-day period. Currently, 30% of the region's medical/surgical beds are available and 29% of ICU beds.

The North region (Boone, Carroll, DeKalb, Jo Daviess, Lee, Ogle, Stephenson, Whiteside and Winnebago counties) has seen five days of positivity increases and two days of hospital admission increases. The region's positivity rate increased to 5.5%. Currently, 46% of medical/surgical beds are available and 47% of ICU beds.

The North-Central region (Bureau, Fulton, Grundy, Henderson, Henry, Kendall, Knox, La Salle, Livingston, Marshall, McDonough, McLean, Mercer, Peoria, Putnam, Rock Island, Stark, Tazewell, Warren and Woodford counties) has seen four days of positivity increases and four days of hospital admission increases. The region's positivity rate remained flat at 6.8%. Currently, 46% of medical/surgical beds are available and 45% of ICU beds.

Chicago has seen four days of positivity increases and three days of hospital admission increases. The region's positivity rate remained flat at 5.6%. Currently, 29% of medical/surgical beds are available and 41% of ICU beds.

Suburban Cook County has seen four days of positivity increases and five days of hospital admission increases. The region's positivity rate decreased slightly to 6.7%. Currently, 29% of medical/surgical beds are available and 41% of ICU beds.

Region 4, near St. Louis, has the state's worst positivity rate at 9.6%, but the rate did decrease 0.8 percentage points in one day. Region 6, which includes Champaign, has the state's best positivity rate at 2.0%, an increase of 0.3 percentage points in one day.

To see how other regions across the state are doing, see the full IDPH dashboard here.

Newly reported deaths include:

Adams County: 1 male 80s

Bureau County: 1 male 70s, 1 male 80s

Christian County: 1 female 80s

Coles County: 1 male 70s

Cook County: 1 female 30s, 2 females 70s, 4 males 70s, 1 female 80s

DeKalb County: 1 female 90s

DuPage County: 1 female 80s

Jackson County: 1 male 60s

Kane County: 1 male 80s

Lake County: 1 female 80s

La Salle County: 1 female 80s, 1 male 80s, 1 female 90s

Macon County: 1 male 70s

Macoupin County: 1 female 70s

Madison County: 1 male 80s, 1 female 90s

Mercer County: 1 male 90s

Morgan County: 1 female 80s, 1 female 90s

Moultrie County: 1 male 80s

Rock Island County: 1 female 60s, 1 male 70s, 1 male 80s

Sangamon County: 1 female 80s, 1 male 90s

Tazewell County: 1 female 70s

Vermilion County: 1 male 60s

Will County: 1 male 60s

Williamson County: 1 female 70s

Winnebago County: 1 female 80s

Continue reading here:

Illinois announces 39 new COVID-19 deaths, highest in one day since June 26 - Northwest Herald

Several months ago, the inhabitants of one half of the planet braced for a potentially devastating addendum to COVID-19 as another flu season approached. And then, nothing.

In much of the Southern Hemisphere, a meaningful flu season mostly failed to materialize as usual in April around the time autumn is poised to become winter. Now, in what is often the peak period for reported cases, they continue to lag well behind the norm.

For many experts, the notion of dealing with a heavy flu season and a pandemic at the same time is daunting. The combination could overwhelm health systems, and complicate the ability to make accurate diagnoses. Yet, the lack of flu season in the Southern Hemisphere was not entirely welcome.

Thats because the rest of the world north of the equator, including places that have struggled to contain COVID-19 during summer, now lacks a detailed blueprint for dealing with a combined flu season and pandemic as the weather begins to turn.

Researchers hoping to study the interaction between seasonal flu and the coronavirus came up empty in the Southern Hemisphere in recent months. In South Africa, government laboratories that would normally record more than 1,000 cases of flu between April and August instead recorded a single case. Meanwhile Australia reported 193 notifications of laboratory-confirmed influenza for July compared with 70,071 in the same month last year.

Australia did not see a spike in cases during what is normally flu season.

Image: World Economic Forum

Reasons for the diminished influenza spread in the Southern Hemisphere include social distancing and other measures implemented to combat COVID-19. Influenza and the coronavirus spread in similar ways, including via droplets emitted through coughing and talking. They also both put the elderly and people with chronic medical conditions at greater risk.

Now, countries in the Northern Hemisphere, including the US where flu season normally begins around October, must rely on flu shots and whatever preventive measures that have been put in place to fight COVID-19 and are being adhered to in order to likewise keep influenza in check.

The WHO has so far estimated that the crude mortality ratio for COVID-19 is between 3% and 4%, while mortality is usually well below 0.1% for seasonal influenza. Still, influenza-pneumonia is among the leading causes of death in the US. During the 2018-2019 flu season, it resulted in nearly 500,000 hospitalizations there and an estimated 34,157 fatalities.

Influenza is regularly a leading cause of death in the US.

Image: World Economic Forum

Experts seem to have mixed views on whether the Northern Hemisphere will now be better off thanks to the lack of influenza spread in the other half of the globe. In any case, they suggest getting a flu shot to better protect against a perfect storm of influenza and coronavirus as we await a COVID-19 vaccination.

On the Strategic Intelligence platform, you can find feeds of expert analysis related to Vaccination, COVID-19 and hundreds of additional topics. Youll need to register to view.

Image: World Economic Forum

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This is how flu season might affect the COVID-19 curve - World Economic Forum

Imagine for a moment a headline from the perhaps not-too-distant future: The United States announced an approved vaccine targeting the SARS-CoV-2 virus, that spike-protein-studded bastard that causes COVID-19.

Great news, right?

The latest from the coronavirus outbreak in Colorado:

>> FULL COVERAGE

Now, imagine the headline the next day: For the foreseeable future, there wont be enough doses of the vaccine for everyone to get it. Some will be vaccinated right away. Some will have to wait months, maybe even longer, as the pandemic slowly churns on.

So, who should be first in line?

As experts across the country focus their attention on the question, Colorado has ramped up its own effort to create an ethical and logistical framework to distribute the vaccine. The goal is for the process to be rational, fair, transparent and equitable. But, with so many unknowns surrounding the virus, research and vaccine politics still in play, thats a lot harder than it sounds.

It is super-complex to think about how to do this, said Dr. Anuj Mehta, a pulmonologist and critical care specialist at National Jewish Health and Denver Health who is helping to lead some of the discussions. Doing all our due diligence now makes us far more likely to implement a plan when a vaccine becomes available with little delay.

Mehta is part of a working group at the Governors Expert Emergency Epidemic Response Committee, a collection of mostly outside medical and health experts who give advice to Gov. Jared Polis on how to respond to the pandemic. The Colorado Department of Public Health and Environment also has teams of employees working in parallel on vaccine roll-out plans.

And all of this exists underneath the discussion currently taking place within the federal Centers for Disease Control and Prevention and the National Academy of Medicine on what a national vaccine distribution and prioritization system should look like.

Its a lot of moving parts, and thats before you get to the unknowns and what-ifs about the vaccine itself. Will it require one dose or two? Will it need to be shipped and stored at super-cold temperatures? Will it be equally safe for all age groups? Will people actually want to receive it?

These questions are why Colorados plans, when finished in the coming weeks, will likely look pretty unfinished. They need to be more outlines than dictates, and they need to be flexible.

You cant even plan for all these things in advance because your allocation protocol might change based on all the circumstances, said Dr. Matthew Wynia, a bioethicist who leads the Center for Bioethics and Humanities at the University of Colorado Anschutz Medical Campus.

One of the few things that does seem certain now is that the federal government will control the early distribution of the vaccine.

A letter sent to states from the U.S. Department of Health and Human Services earlier this month told states to expect that limited COVID-19 vaccine doses will be available in fall 2020 and that COVID-19 vaccine distribution will be managed centrally. This is similar to the way the federal government has handled the distribution of the drug remdesivir, which actually creates even more uncertainty for state planners.

Remdesivirs distribution has been criticized as opaque and haphazard. States and hospitals have struggled to understand how much they would receive and when, making it difficult to plan for how to allocate it.

If the same thing plays out with a vaccine, it would put intense pressure on state prioritization plans. The fewer doses there are available or that can be planned on to be available the more scrutiny there will be on who is at the head of the line.

In general thats going to be the most contentious thing you see, said May Chu, a clinical professor in epidemiology at the Colorado School of Public Health. And thats more politics than a scientific decision, though I think that science should drive.

Mehta said much of the discussion in his working group has involved thinking about priority tiers based on someones job, risk of exposure and risk of getting really sick if they do catch the virus.

Much like with emerging federal guidance, Mehta said health care workers and first responders would likely be near the top though, again, this is all still under discussion. They are most likely to encounter the virus in the wild as a result of their work, he said. And protecting them has a multiplier effect in that it allows them to continue helping others fight the virus.

Other essential workers people who work in grocery stores and schools, for instance would also be near the top. And people most vulnerable to the virus, such as those in nursing homes or people with underlying health conditions, could also be in line for greater priority.

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But these are all still pretty broad categories. And if Colorado receives only a trickle of doses, they wont be specific enough to create an orderly process. So Mehta said the working group has been talking about subtiers and subtiers of subtiers.

Health care workers at inpatient hospitals and facilities might be prioritized over those working in outpatient facilities. Inpatient doctors and nurses whose work exposes them to the coronavirus, like emergency room staff or respiratory therapists, would be in line ahead of staff whose jobs bring less risk. Older health care workers in those higher-risk jobs might go in front of younger ones. On and on these discussions go, focusing more and more narrowly on who faces the greatest risk and would benefit most from a vaccine.

Its the thing that keeps me up at night sometimes, Mehta said. Are we being too specific or are we not being specific enough?

In some broad ways, these debates resemble the ethical discussions around creating crisis standards of care guidelines for how hospitals should triage patients if there are just too many to save everyone. But there are also important logistical and strategic wrinkles, too.

Say you decide the firefighters should be among the first to receive a vaccine. How do you get it to them? Do you hold pop-up vaccination clinics at fire stations? Do you make them all drive to a central location? Does this change if the vaccine thats approved requires special storage or multiple doses? Can you reach rural and urban areas equally as effectively or do you even need to if the virus is more active in one region than another?

Mehta said the forthcoming federal guidance likely wont be detailed enough to answer these questions, which is why Colorado needs to come up with its own plan. But he said Colorado will also need better data to execute on its plan if you want to prioritize health care workers who are 65 or older, for instance, it helps to know how many of those there, he said.

Thats led us to start thinking about what data needs to be collected over the next four months, he said.

So far, what Mehta and his group are discussing tracks mostly with the national conversation about vaccine prioritization its an ethics-heavy dialogue about who most needs and deserves to be protected. Its a conversation that thinks of a vaccine like a shield, guarding against malicious assault.

But Wynia said there are other ways to look at the issue. What if we thought of a vaccine as a sword, allowing us to take the fight to the virus and attack it not where we fear it will end up but where it is right now?

There is a strategy that has been successfully used to combat smallpox called ring vaccination. Whenever a case pops up in a community, the strategy floods the community with vaccine. Contacts of the infected person get vaccinated. Contacts of contacts get vaccinated, as do contacts of contacts of contacts. The goal is to paint rings of immunization around the infection, keeping it confined.

Wynia said that would probably only work for coronavirus if we could first suppress viral transmission to very low levels. As it is right now in the United States, theres just too much spread to be able to isolate cases like that.

But the strategy points to another that could be deployed against the virus depending on local circumstances: Forget about who is most deserving of vaccination; focus instead on who is most likely to spread the virus. In other words, vaccinate irresponsible young people first.

The right allocation protocol might actually change from place to place, Wynia said.

Mehta said he has been in conversations where he has heard Wynia talk about pandemic ethics the idea that you may have to shed certain pre-existing beliefs and think about what works best against the virus. The two are friends, but theyve only ever met in Zoom videoconferences.

Mehta said he thinks the sword approach is the wrong one, even though he said hes seen research that suggests it could be effective. First, he said, its a logistical nightmare, which Wynia agrees with. How would you really identify who between the ages of 18 and 40 is most likely to be spreading the virus, many asymptomatically?

But theres another issue. The public might revolt.

I question how people would view that, even if it mathematically made sense, Mehta said.

To Mehta, the work to create an allocation system also serves an important function beyond public health. In this time of historic stress, a fair and equitable system can help maintain social cohesion. And a system that treats best those who are behaving the worst could damage that sense of unity.

Wynia agrees there, too. Vaccinating the population is important. Keeping the population united is more so.

We tend to go with guidelines in the U.S., Wynia said. Were reluctant to force people to do anything. But that does come with a cost that there will be a pretty high risk that there will be haves and have nots.

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Months before its arrival, Colorado tries to answer the question: Who should get the coronavirus vaccine first? - The Colorado Sun

Governor Ralph Northam walks through the Foodbank of Southeastern Virginia and the Eastern Shore in Norfolk Friday morning July 31, 2020. Sentara Healthcare, Truist and the Federation of Virginia Food Banks started a initiative to provide free meals to families during the pandemic. The "We Care" COVID-19 Virginia Emergency Food Support Plan features a five day food supply and will be distributed through Virginias seven regional food banks and their associated partners. (Jonathon Gruenke/Daily Press)

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In hopes of preventing holiday COVID-19 surge, Northam says hell keep restrictions on Hampton Roads through L - Virginian-Pilot

Existing infrastructures will help get the COVID-19 vaccine to the public.

HOUSTON We fantasize a lot about how life will be better when a COVID-19 vaccine is available. KHOU 11 has learned health officials are now working to build on existing immunization infrastructure, including expanding it, to make it work for COVID-19 vaccine distribution.

In Houston, the Department of Health said it was in the beginning stages of planning, working with the Centers for Disease Control and Prevention, as well as DSHS on what the coronavirus inoculation process will look like.

There is a lot to consider, KHOU 11 learned, including who will administer the vaccine and how they will order and receive it, where the inoculation will take place, who will pay for it and how many individuals in every age group, at high risk or not will need doses.

Vaccines will also have to be properly stored and accounted for, part of the training that will be needed for some providers.

Once the vaccine is available, we're gonna need all hands on deck, the chief of the immunization program for the Houston Health Department Omar Salgado told KHOU 11. It's going to be available to private providers, pubic providers, it's going to be available to hospitals, pharmacies and federally qualified health centers.

In a Zoom interview, Salgado told KHOU 11, the department has to first do a survey of the health care providers that already work with them to administer the Texas Vaccines for Children program, an effort to provide low-cost vaccines to eligible kids from birth to 18 years of age, and the providers who are a part of the Adult Safety Net Program, created by DSHS to increase vaccine access for uninsured adults.

Salgado said the survey will count the existing clients wholl need the COVID-19 vaccine. Health officials will also have to figure out how many total vaccines are needed to inoculate the entire population of Houston and Harris county, including those who dont see a doctor regularly.

Salgado said the list of the providers already in the system, familiar with the vaccine ordering process that first goes through the state and then the CDC system, will have to be expanded. Providers will have to be trained, Salgado said, to make sure as many Texans as possible have access to the coronavirus vaccine.

There are different manufacturers, some of the manufacturers will have a vaccine that is going to take one dose to get immunity. Others are going to need two doses, which means they'll come in for the first dose and come back probably four weeks later to get that booster to build that immunity, Salgado said.

Salgado told KHOU 11 people can expect drive-through vaccination clinics, similar to COVID testing sites.

What we're doing right now, we are creating maps, maps of our community to determine which areas are high in COVID cases, so we can start to target those areas, he said. When the COVID vaccine comes out, we're gonna have to prioritize. It's going to first target first responders and those are the elderly population.

When the vaccine does come out, the Houston Health Department is up to the task.

Well definitely be ready, Salgado said.

In an emailed statement, the Texas Department of State Health Services said its currently working with the CDC, planning for COVID-19 vaccine distribution.

Final plans will depend on the formulation of the vaccine and the distribution schedule once one or more vaccines are approved, wrote Chris Van Deusen, Director of Media Relations. Health care providers interested in administering the COVID-19 immunization should register with ImmTrac2, the Texas immunization registry."

Texas is one of the few states that has an existing adult vaccine program, according to Claire Hannan, Executive Director of the Association of Immunization Managers. Both the adult vaccine and childrens vaccine programs are established immunization framework health officials could lean on to distribute the COVID-19 vaccine.

The Association is a Maryland-based non-profit that includes vaccine experts and leaders from all 50 states, plus large cities, including Houston, and U.S. territories, working to control vaccine-preventable diseases.

Each state has received supplemental funding from CDC to raise flu vaccination rates and will be receiving flu vaccine doses as well, Hannan said. Texas is using these funds to reach out and enroll additional sites to their Adult Safety Net program, including pharmacies, nursing homes, long-term care facilities, etc. And they will be providing the flu doses form CDC to adults through these newly enrolled and existing sites, and then building relationships with these sites in preparation for COVID-19 vaccination.

Hannan said the Texas Adult Safety Net program has 570 clinics enrolled, including 300 Federally Qualified Health Centers and Rural Health Clinics that inoculate uninsured adults.

We have about 40,000 providers across the country enrolled in this childrens program, Hannan said. We probably need to triple or quadruple that with providers that serve adults. We need to get them enrolled. We need to get them trained. We need to make sure they understand how to store the vaccine. We need to get them to agree to give it to the right people to manage their inventory, report the doses administered into immunization registries. So, you know, that system we have in place for children, we just need to expand that for adults.

Hannan said the system in place to administer the flu vaccine is a good one to build on, as well as the experience the country had in 2009 with the H1N1 pandemic.

I guess I'd say we're probably almost halfway there, Hannan said. We just need to put those all those pieces together to make it work.

This is an unprecedented time, she added. Getting all of America vaccinated with a brand-new vaccine, we've never done anything like that before. In this case, it's a massively larger campaign. We're looking at getting more Americans vaccinated and potentially with two doses. So, it's a little bit bigger than the flu.

Hannan said she anticipated the COVID-19 vaccine to be free of charge. How this will work is clearer if you have a private provider.

We think that enrolling private providers will allow the providers to have an incentive to give the vaccine because they will be able to charge insurers for an admin fee, Hannan said. So, the vaccine will be free. The insurance will cover the admin fee. You know, this is what we anticipate happening. This is the way that it happened in 2009. And this is the way it also works with the Vaccines for Children program.

The details of how this will work for the uninsured are being worked out, she said.

[What] we're really working through now is working with pharmacies, community health centers and figuring out how we're going to make that work, Hannan said. It's unknown exactly who's going to pay for the admin fee. We want to make sure the vaccine is accessible and is available and is affordable, as widespread as possible in as many communities as we can get.

Hannan said the Federal Governments COVID-19 vaccine effort, dubbed Operation Warp Speed, is taking a deep dive at certain areas in the United States to see what challenges the nation-wide coronavirus vaccine distribution could encounter, and how to solve those before the vaccine is available.

According to the Department of Health and Human Services (HHS) website, Operation Warp Speed is supposed to produce and deliver 300 million doses of safe and effective vaccine, with the initial doses available in January of 2021.

Operation Warp Speed is a partnership between HHS, the CDC, the FDA, the National Institutes of Health, the Department of Defense and the Biomedical Advanced Research and Development Authority.

They're going to North Dakota, California, Philadelphia, Florida and Minnesota, Hannan said. And they're going to be focusing on different challenges in those areas

and working through a number of the issues and then putting out some guidance and a model plan following these visits.

Hannan is hopeful the COVID testing issues that have been widely reported across the country wont be repeated with vaccine distribution.

With the time period we have to prepare, we can really work out some of these kinks and work out a way to get the vaccine seamlessly out to the public, she said.

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Work being done now to distribute COVID-19 vaccine when it's ready - KENS5.com

In yet another hitfor IL-6 inhibitors inCOVID-19, Sanofi and Regeneron's Kevzara failed a study in hundreds of severe and critical patientsand the partners are now giving up on the rheumatoid arthritis med as a coronavirus treatment.

In a Tuesday update, Sanofi said that its study of Kevzara in 420 patients inArgentina, Brazil, Canada, Chile, France, Germany, Israel, Italy, Japan, Russia and Spain didn't meet its endpoints. Patients who received the medicine did experience slightly shorter hospital stays and speedier improvements in their condition versus placebo, but the results werent statistically significant.

The Kevzara study, like othersfor Roche's IL-6 inhibitor Actemra, came from a theory that inhibiting IL-6 may help stave off the potentially deadly cytokine storm associated with some COVID-19 infections. Even though thetrial failed,Sanofi isproud of its work advancing knowledge of the disease, R&D chief John Reed said in a statement.

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In times like these, commitment to properly designed, controlled clinical trials, provides the information and understanding the scientific community needs for fact-based decision making, he added.

RELATED:Sanofi, Regeneron shut downKevzaratrial in COVID-19 after finding no benefit for ventilated patients

The latest results follow last month's failure of a U.S. study of Kevzara in coronavirus patients. Regeneron, which led that trial, reportedsome minor positive trends," but again the meds benefit didnt reach statistical significance.

While Sanofi and Regeneron aren't planning any further studies on Kevzara, Roche said in late July it's committed to researching Actemra in COVID-19, including in combo with Gilead's remdesivir.

Looking forward for Sanofi, the companyis advancing two COVID-19 vaccine candidatesone in partnership with GlaxoSmithKline and other with Translate Biowhile Regeneron has a promising antibody treatment. In a note this week, analysts with Morningstar said a Regeneron cocktailtherapy could score $6 billion in revenue next year if approved.

RELATED:Sanofi chose a proven platform over speed in its COVID-19 vaccine hunt, CEO says

Thecoronavirusvaccine field, meanwhile, will be worth around $18billion next year, Bernstein analyst Ronny Gal wroteon Monday. His team predicts the Sanofi/GSK partnership will earnaround $2 billion in COVID-19 vaccine revenues during 2021 and 2022, with the number graduallydecliningin later years.

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After another Kevzara fail in COVID-19, Sanofi and Regeneron shift their attention elsewhere - FiercePharma