Category Archives: Health Disease

Beware of Biden’s New Virus Task Force

Posted on by

As the news breaks from Operation Warp Speed (Trump Administration) on the news of Pfizer’s vaccine. As announced by StatNews:

Pfizer and partner BioNTech said Monday that their vaccine against Covid-19 was strongly effective, exceeding expectations with results that are likely to be met with cautious excitement — and relief — in the face of the global pandemic.

The vaccine is the first to be tested in the United States to generate late-stage data. The companies said an early analysis of the results showed that individuals who received two injections of the vaccine three weeks apart experienced more than 90% fewer cases of symptomatic Covid-19 than those who received a placebo. For months, researchers have cautioned that a vaccine that might only be 60% or 70% effective.

The Phase 3 study is ongoing and additional data could affect results.

In keeping with guidance from the Food and Drug Administration, the companies will not file for an emergency use authorization to distribute the vaccine until they reach another milestone: when half of the patients in their study have been observed for any safety issues for at least two months following their second dose. Pfizer expects to cross that threshold in the third week of November. More here.

Exactly what is presumptive president elect Biden’s plan and will he take full credit for the remarkable work of the Trump White House?

 

Well, let’s look at that shall we?

Source in part with additional context: The experts include Rick Bright, the former director of the Biomedical Advanced Research and Development Authority (BARDA) who said he was forced out his position earlier this year after opposing promoting unproven treatments.(Bright was fired from HHS and became a whistle-blower for fully disagreeing with hydroxychloroquine.

Dr. Zeke Emanuel on concerns surrounding politicization of ...

Bioethicist and oncologist Zeke Emanuel, who served as former adviser to the Obama administration on the Affordable Care Act and is brother of former White House chief of staff Rahm Emanuel, and Atul Gawande, a surgeon who served as advisor to the Clinton and Obama administrations, will also serve on the panel. (Emanuel was the cat that believes people — particularly the aged — who aren’t contributing materially to society should get out of the way for the benefit of the strong. And, Emanuel was a prime architect of the Affordable Care Act, or Obamacare, and remains one of the law’s most enthusiastic apologists. Readers may also recall his infamous 2014 article in The Atlantic, where he wrote that he wants to die at age 75 — implying that we should too — because people after that age become “feeble, ineffectual, even pathetic.”

Dr. Ezekiel J. Emanuel is the vice provost for global initiatives and a professor at the University of Pennsylvania.

He’s also a special adviser to the director-general of the World Health Organization (WHO) as well as a senior fellow at the Center for American Progress. If asked to put a chip on the betting calendar as to when we return to at least a “new normal,” where are you willing to place yours?

I’ve been saying this for months and I’ll continue to say it: November 2021. Even if we get a vaccine and have to play out getting it out there, it’s November 2021. I’m sticking with it. Source

Other experts who will serve as co-chairs include Vivek Murthy, a former surgeon general who served under the Obama administration; David Kessler, former commissioner of the Food and Drug Administration; and Marcella Nunez-Smith, an associate professor of internal medicine, public health and management and the founding director of the Equity Research and Innovation Center. (Marcella Nunez-Smith is at the core of blaming discrimination of healthcare and the pandemic on race.

The three also served as advisers on Biden’s campaign.

“Dealing with the coronavirus pandemic is one of the most important battles our administration will face, and I will be informed by science and by experts,” the president-elect said in a statement.

Biden had announced plans shorty after being projected winner of the presidential election on Saturday to name “a group of leading scientists and experts as transition advisers to help take the Biden-Harris COVID plan and convert it into an action blueprint” that will start in January, when he is inaugurated.

“That plan will be built on bedrock science,” he said.

Meanwhile….the Biden operation is also drafting nominees for cabinet posts:

The Biden transition team, which has been working behind-the-scenes since Labor Day, also has preferred candidates in mind for major Cabinet posts that require Senate confirmation and positions inside the West Wing that do not. The Cabinet announcements are not expected for a few weeks, aides said, and some are likely to be delayed even longer until it’s known who will control the Senate following the January run-offs in Georgia.
Ron Klain, a longtime adviser to Biden and his chief of staff during the early years of the Obama administration, is a leading contender to be White House chief of staff, people close to the process tell CNN.
The Biden transition is a robust effort with two Biden advisers, Jeff Zients and Ted Kaufman, taking the primary lead in overseeing these ongoing efforts. Anita Dunn, a senior adviser to the Biden campaign and former White House communications director, is another one of the co-chairs, along with New Mexico Gov. Michelle Lujan Grisham, and Louisiana Rep. Cedric Richmond.

Operation Warp Speed Status Report Courtesy of the Military

Posted on by

Below is a compilation of initiatives, actions and accomplishments across Operation Warp Speed (OWS)’s primary efforts in the past week. To learn more about OWS, visit the Department of Health and Human Services (HHS) website and Department of Defense (DOD) website.

Pfizer, Merck, and Moderna among finalists for Operation ...

VACCINE DEVELOPMENT:

The U.S. Food and Drug Administration today authorized the restart of AstraZeneca’s Phase 3 clinical trial in the U.S. As part of the standard review process for adverse events in clinical trials, a voluntary pause was triggered to allow for the examination of safety data by independent monitoring committees. This pause while the adverse event was fully investigated means the science-based, data-driven process continues to work as it should.

Moderna announced it completed enrollment on its Phase 3 clinical trial, noting 37 percent of the 30,000 participants are part of minority populations. To date, more than 25,650 participants of Moderna’s participants have received their second vaccination. According to Moderna’s announcement, the company’s decision to submit a dossier to FDA requesting Emergency Use Authorization will be based on an assessment of whether the potential benefit of the vaccine outweighs the potential risks. The science and data behind this assessment is accruing.

The FDA’s Vaccines and Related Biological Products Advisory Committee met Thursday to discuss the ongoing development of a COVID-19 vaccine. In the interest of transparency over the process, the FDA streamed the entire committee meeting on both its own website and on YouTube. The all-day meeting explored the potential of granting Emergency Use Authorization and the standards and criteria that will be applied to vaccine candidates.

The Centers for Disease Control and Prevention launched a new page on their website dedicated to education on the COVID-19 vaccine planning efforts: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/index.html.

In its commitment to transparency, Operation Warp Speed has posted four redacted contracts here: https://www.hhs.gov/foia/electronic-reading-room/index.html

THERAPEUTICS DEVELOPMENT:

The U.S. Food and Drug Administration approved the antiviral drug Veklury (remdesivir) Oct. 22 for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization.

MANUFACTURING, DISTRIBUTION AND ADMINISTRATION:

Operation Warp Speed is working with the U.S. Marshals Service as part of a “whole of government” approach to ensure the security of the vaccine supply chain, including delivery to administration points. Marshals Service liaisons are embedded with the OWS team to ensure there is consistent communication and information flow in the security sector.

Synchronizing and integrating data across distribution and administration operations is a critical effort of Operation Warp Speed. To that end, OWS is using a specially designed platform to collect, correlate and visualize data across the entire operation. The “Tiberius” platform integrates the related manufacturing, supply chain, allocation, state and territory planning, delivery and administration of both vaccine products and ancillary kits. The 2020 technology provides visibility across all U.S. jurisdictions to provide decision support and ease the burden of public health officials throughout the nation. Additionally this week, HHS in support of Operation Warp Speed began signing Memorandums of Understandings with jurisdictions to provide access to information technology (IT) support to assist them with vaccine response planning and distribution at no cost.
An OpEd by HHS Secretary Alex Azar titled “Why Operation Warp Speed is a Made-in-America story,” highlighted the scaling up of manufacturing facilities across the country. He discussed DOD’s success in applying a military supply chain and logistics mentality to develop and deliver a COVID-19 vaccine to the American people.

KEY ENGAGEMENTS:

HHS Secretary Alex Azar visited Emory University Hospital in Atlanta and saw their work on clinical trials for Regeneron’s antibody cocktail and Moderna’s candidate vaccine.

Operation Warp Speed Chief Science Advisor Dr. Moncef Slaoui visited a Moderna clinical trial site at George Washington University Wednesday and spoke with ABC’s Bob Woodruff.

HHS Deputy Secretary Hargan visited the University of Kansas Medical Center for a meeting with their leadership and physicians about the Phase 3 clinical trials they have been overseeing for the AstraZeneca Vaccine. Deputy Secretary Hargan will also join Nebraska Governor Pete Ricketts on Saturday, October 24 for a tour of the University of Nebraska Medical Center where they are conducting clinical trials for COVAXX vaccine and therapeutic candidates.

Dr. Anthony Fauci joined a Univision Town Hall entitled “COVID-19 Vaccines: Myths and Facts” to discuss the importance of Hispanics being represented in clinical trials.

The Washington Post: “Unprecedented vaccine trials on track to begin delivering results.”

Operation Warp Speed Chief Operating Officer Gen. Gus Perna and Vaccine Development Lead Dr. Matt Hepburn will participate in a discussion with The Heritage Foundation on “The Fight to get a COVID-19 Vaccine” Oct. 27 at 3 p.m. The virtual event is free and open for registration.

SENIOR LEADER QUOTES:

“Clinical trial volunteers are the real heroes of this pandemic. Many people are looking for a way to make an impact and serve. Volunteering is a tremendous opportunity to be helpful.” ~Dr. Matt Hepburn, OWS Vaccine Development Lead

“Advances in science are the foundation for the unprecedented progress we are seeing under Operation Warp Speed. But the broader set of requirements for ultimate success—unwavering leadership, ingenuity, determination, the commitment of enormous resources, exceptional logistical infrastructure, and public-private collaboration—can be assembled only in America.” ~HHS Secretary Alex Azar

“It’s not a certainty, but the plan – and I feel pretty confident – should make it such that by June, everybody could have been immunized in the U.S.” ~Dr. Moncef Slaoui, OWS Chief Advisor

“Trust in the science. We have executed vaccine development with rigor. The leading scientists in the world and the quality of the nation’s pharmaceutical base, with oversight of the FDA’s gold standard, lend credibility to this unprecedented effort.” ~Paul Ostrowski, OWS Director for Supply, Production and Distribution

Operation Warp Speed is a partnership among components of the Department of Health and Human Services and the Department of Defense, engaging with private firms and other federal agencies, and coordinating among existing HHS-wide efforts to accelerate the development, manufacturing and distribution of COVID-19 vaccines, therapeutics and diagnostic

Mouthwash, Baby Shampoo May Deactivate Coronaviruses

Posted on by

In part from Medical News Today to collaborate the story:

A new research review suggests that publicly available mouthwashes could, in theory, inhibit SARS-CoV-2. The team behind the review call for further research to be done to confirm their speculative findings.

If clinical trials prove effective, the findings, published in the journal Function, may provide another way to reduce the spread of the disease until scientists can produce an effective, publicly available vaccine.

Since the sudden emergence and rapid spread of the SARS-CoV-2 virus, scientists and researchers have focussed on the development of a vaccine that could help protect people vulnerable to COVID-19.

However, scientists have estimated that an effective, publicly available vaccine could take at least 12–18 months to develop.

In the meantime, some scientists are focusing on ways to reduce the rate of infection to controllable levels that will not overwhelm hospital intensive care units.

*** THIS IS NOT A CURE, IT IS A SUGGESTED OPTION TO SLOW THE SPREAD***

How Much Mouthwash Should Someone Use

HERSHEY, Pa. — As the world waits for a vaccine to COVID-19, a new study finds there may be a way to slow the spread sitting in your medicine cabinet. Researchers from Penn State College of Medicine say nasal and oral rinses like mouthwash can deactivate human coronaviruses. Their study concludes these common, over-the-counter products should have the same effect on SARS-CoV-2, the virus causing COVID-19.

The group tested various products including one-percent baby shampoo, a neti pot, peroxide sore-mouth cleansers, and mouthwash, seeing how each would lower the viral load of coronavirus strains in a patient’s mouth. Their findings reveal most of these products effectively shut down virus particles in less than two minutes. Researchers hope they may also lower the chances of COVID infection among people carrying the virus.

“While we wait for a vaccine to be developed, methods to reduce transmission are needed,” says Craig Meyers, distinguished professor of microbiology, immunology, obstetrics, and gynecology in a university release. “The products we tested are readily available and often already part of people’s daily routines.”
Both mouthwash and baby shampoo render 99.9% of coronaviruses inactive

Meyers and his team replicated the reaction between virus cells in mouths and noses when they encounter rinses and mouthwashes. Health officials say these are the two major points where coronavirus enters and exits the body, which explains the emphasis on face mask protection.

Researchers introduced their virus solutions to all of the cleansing products for 30 seconds, one minute, and two minutes. Meyers explains that the outer envelope of their viruses and SARS-CoV-2 are so genetically similar that the results should mean COVID-19 would become inactive after exposure to rinses as well.

The results reveal one-percent baby shampoo solution deactivated more than 99.9 percent of human coronaviruses after two minutes of contact. Researchers say doctors, who regularly have contact with infected patients, often use baby shampoo to rinse out their sinuses.

Even better, the results find several mouthwash and gargling products leave 99.9 percent of coronaviruses inactive after just 30 seconds. Some of these rinses stopped 99.99 percent of coronavirus.

“People who test positive for COVID-19 and return home to quarantine may possibly transmit the virus to those they live with,” Meyers adds. “Certain professions including dentists and other health care workers are at a constant risk of exposure. Clinical trials are needed to determine if these products can reduce the amount of virus COVID-positive patients or those with high-risk occupations may spread while talking, coughing or sneezing. Even if the use of these solutions could reduce transmission by 50%, it would have a major impact.”

Researchers will now be looking to expand their study to clinical trials involving COVID-19-positive patients.

The study appears in the Journal of Medical Virology.

NASA Prepares to Launch Contact Tracing Program

Posted on by

As the COVID-19 pandemic continues its spread in the U.S., NASA is tapping commercial software to start an internal contact tracing program.

Why NASA Needs a New Logo | Space

According to an information collection notice posted Tuesday in the Federal Register, the voluntary program “will be used to determine whether NASA personnel have been exposed to the COVID-19 virus and to track and trace their interactions across the NASA community for identifying possible points of exposure.”

Once the program is stood up, NASA plans to designate a health care-focused employee to act as the NASA Contact Tracer to lead the effort.

When a NASA employee or contractor agrees to sign up for the program, the Contact Tracer will start by going through the privacy considerations so the employee understands their rights and how their personal information will be used, after which the employee “will be asked, orally, to confirm if they have symptoms or not,” by replying “yes” or “no.”

That information—along with the employee’s contact information and the names, phone numbers and email addresses of those they have been in close contact with—will be entered into the new tracking app.

“While participation is voluntary, it is strongly encouraged as failure to provide the requested information may result in potential increased exposure of personnel to the virus,” the notice states.

The “newly developed tracking and tracing digital application” was built on NASA’s Salesforce platform. Salesforce’s workforce management platform has been used by a variety of organizations to start internal contact tracing programs, including some 35 state governments, according to company CEO Marc Benioff.

Interested parties have until October 4 to submit comments.

Specifically, under the Federal Register notice, the agency wants feedback on “whether the proposed collection of information is necessary for the proper performance of the functions of NASA, including whether the information collected has practical utility;” “ways to enhance the quality, utility and clarity of the information to be collected;” and “ways to minimize the burden of the collection of information on respondents, including automated collection techniques or the use of other forms of information technology.”

*** The Flawed World of Contact Tracing: Where’s Carol The Tester? source

“While participation is voluntary, it is strongly encouraged as failure to provide the requested information may result in potential increased exposure of personnel to the virus,” NASA wrote in the notice.

The information collected through NASA’s contact tracing program may also be shared with private or government healthcare providers and other entities with access to all NASA systems of records. By keeping the contact tracing records in a digital format, NASA wrote that it hopes to “ensure higher rate of inclusion and assist in the efficiency of the stages of report processing by human subject matter analysts.”

NASA is estimating that the contact tracing program will cost about $1.9 million per year. The agency is accepting comments on its contact tracing program – such as ways to enhance the quality of its data and ways to minimize the burden of information collection on personnel – through October 4.

Project RoomKey for Homeless Destroying SF Hotels

Posted on by

San Francisco has undertaken a major effort to house people experiencing homelessness amid the coronavirus pandemic and has established a number of alternative housing options, including private hotels, congregate sites, trailers and recreational vehicles. As of Thursday, the city has placed more than 700 people living on the streets in housing, and more rooms are being prepared, according to the city’s data tracker. Individuals over age 60 and with underlying health conditions are receiving priority for housing.

Project Roomkey, a program in which the Federal Emergency Management Agency will pay 75% of costs associated with housing some homeless, including people who test positive or may have been exposed to the virus, and older homeless people and those with underlying health conditions.

San Francisco hotels to become housing for homeless ... source

FNC: Thousands of homeless people have been housed in several of San Francisco’s empty hotels in an effort to slow the spread of coronavirus.

However, City Journal contributor Erica Sandberg told “Tucker Carlson Tonight” Wednesday the policy has been an “absolute disaster”

“It’s solving exactly nothing and as a matter of fact, it’s making all the problems worse,” said Sandberg, who described the scene inside the hotels as “about as bad as you can imagine, only exponentially worse.”

SAN FRANCISCO GIVES DRUGS, ALCOHOL TO HOMELESS IN HOTELS DURING CORONAVIRUS

“You are talking drug-fueled parties, overdoses, deaths, people are being assaulted. You have sexual assaults going on, it is pandemonium,” she said. “It is extremely bad and it needs to stop.”

City officials reportedly secured close to 5,000 rooms at several city hotels that signed up to house homeless and other members of at-risk populations who need to quarantine or socially distance themselves.

In coronavirus landscape, moving homeless people into ... source

Controversy ensued after a report alleged that the city was providing alcohol, marijuana, and methadone to homeless addicts residing in the hotels.

“The people who are assigned as disaster workers, these people have been librarians,” Sandberg told host Brian Kilmeade. “They are just paper pushers, administrators who are reassigned to these hotels and what they are telling me is beyond the pale.

 

“They are not just horrified, they are traumatized by what they see. You have mattresses that have feces on them, blood, hospital bands on the floor. What people are seeing is so horrible that they walk out and they say, ‘I don’t want to go back in there.'”

Meanwhile, Sandberg said, city officials are “trying to put this kind of a Band-Aid on it and pretend it’s not happening.

“Oh, it’s happening,” she added, “and it’s worse than people imagine.”

***

Per the Governor’s website in part:

Project Roomkey will target hotels in counties with significant homeless populations that are also experiencing high concentrations of COVID-19 transmission. Local governments to date have secured 6,867 hotel and motel rooms for this purpose.

Every hotel/motel within Project Roomkey will include essential wraparound services, such as custodial, laundry, security and support staff. The Governor also announced a partnership with Chef José Andrés’s World Central Kitchen, which will provide three meals a day to select Project Roomkey hotels through a statewide contract to support local efforts as needed.

To provide safer options during the COVID-19 pandemic, Project Roomkey isolation units serve three critical public health purposes:

  • Prioritize individuals experiencing homelessness who are asymptomatic, but are at high risk, such as people over 65 or who have certain underlying health conditions, and move them into motel or hotel units where they can more safely self-isolate.
  • Provide isolation capacity for individuals experiencing homelessness who have been exposed to COVID-19 (as documented by a state or local public health official, or medical health professional) that do not require hospitalization, but need isolation or quarantine; and
  • Provide isolation capacity for individuals experiencing homelessness who are COVID-19 positive, but who don’t need hospitalization. Without these isolation units, their only choice is to return to a congregate shelter setting or back to an encampment – both of which would lead to further spread of COVID-19.

The local governments are responsible for identifying which shelter clients or encampment residents are selected for these hotel isolation placements and transporting them to the hotels for intake.

The Governor’s ongoing efforts to deploy 1,305 trailers to local governments continues to progress. Trailers, purchased by the state and operated by the local governments, serve the same function as the hotels and complement the efforts of Project Roomkey. The state has purchase orders in place, and executes them and delivers the trailers as local governments provide deployment locations. To date, the state has purchased and deployed 584 trailers. The Governor also announced today the state will receive an additional 28 trailers through philanthropic support in partnership with Homeful, a California-based nonprofit focused on eradicating homelessness.