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USAID on expanding digital health globally – part one

Adele Waugaman, senior digital health coordinator of the COVID-19 response at the United States Agency for International Development
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Adele Waugaman, senior digital health coordinator of the COVID-19 response at the United States Agency for International Development (USAID), tells us what the agency focuses on to strengthen digital health infrastructure globally and improve and expand healthcare access.

USAID learned a great deal from the Ebola outbreak in West Africa concerning effective digital health distribution and strategies for digital health implementation that were then applied to its COVID-19 response globally – although COVID-19 itself has enhanced its understanding even more.

“COVID has shone a bright light on digital connectivity, both where it exists and the potential digital technologies have to further the delivery of public services, especially in the health sector and where digital connectivity does not exist,” Waugaman states.

USAID is an influential leader in the COVID-19 digital health response, and Waugaman had a significant part in developing the agency’s first two digital health policies adopted by countries globally.

Digital Strategy and Digital Health Vision

Waugaman joined USAID, in part, to help with a multi-year study looking at the global response to the Ebola outbreak and what the agency could learn from the use of data, digital systems, and information covering the global health and the humanitarian aspects components of that response.

In 2020, USAID launched two policy documents to guide how the agency invests in digital infrastructure as part of its development and humanitarian assistance programmes: Digital Strategy and Vision for Action in Digital Health (aka Digital Health Vision).

Waugaman helped write USAID’s Digital Strategy and led the creation of the Digital Health Vision.

Both documents called on the agency to strategically consider how it funded, designed, managed, and integrated digital technologies into the full breadth of its programming.

“There were some clear lessons learned from [the Ebola outbreak], both in terms of what was working well and where opportunities exist to deepen and strengthen the way global health funders writ large, including USAID, could sharpen their investment approach as it relates to data and digital systems,” Waugaman says.

“We were able to incorporate those learnings directly into the USAID Digital Health Vision, to take those lessons from the margins into the mainstream and institutionalise them in the way that the agency does its work.”

When the pandemic hit, USAID leveraged the policy documents (the Digital Health Vision for the health sector in particular) to inform how it invested in digital technologies to support the COVID-19 response through its work globally.

The Digital Strategy and the Digital Health Vision stress the importance of taking a more holistic and comprehensive approach that carefully accounts for the broader ecosystem in which digital solutions are used.

Waugaman says sponsors need to think about capacity needs within the government, within the workforce, the quality of reach of digital connectivity itself and where digital infrastructure investments may be needed.

From a health sector perspective, donors also need to consider supporting countries in creating dedicated national digital health strategies that enable various systems to join together, allowing for interoperability so data can be easily exchanged.

“We hope that because USAID has taken this systems-strengthening approach to many of our digital investments, these will be more likely to improve service delivery and strengthen core health systems over time,” Waugaman states.

Approaching new investments

COVID-19 has underscored the importance of taking a systems-level approach to investments to protect against the accidental misuse of technologies and ensure they perform in the way they’re designed.

Misinformation and disinformation have factored into the global response to COVID-19, especially including issues around vaccines.

However, just as these platforms can facilitate the spread of misinformation, they can also allow organisations to rapidly gather, code and analyse misinformation by theme.

One can then combine this data with community intelligence and work with country partners to develop effective response strategies.

“The Digital Health Vision and the Digital Strategy underscore the importance of the enabling environment, which includes country policy and regulatory environments and institutional and workforce capacity,” Waugaman states.

“When you have those puzzle pieces in place, you have strong protections and highly skilled individuals interfacing with these systems, which can certainly help promote the intended use of these digital tools.”

Having the noted policies established can also counteract the direct and second-order impacts of COVID that could roll back progress in global health and development.

COVID’s effects extend beyond the immediate health impact at the individual, community, or population levels.

“Economists in 2021 estimated the pandemic cost the world over $11 trillion. So, significant rippling impacts throughout national and global economies and significant impacts within the health sector,” Waugaman states.

“The Global Fund, for example, did a modelling study that shows that COVID has set back progress toward ending other diseases, such as HIV, malaria, and tuberculosis, by a number of years. This loss will likely reverberate for at least another decade.”

On the flip side, people have had to take a step back and look at their work differently due to this crisis.

COVID-19 has helped highlight how the global health community can work together differently by increasing the coordination of health programmes and health service delivery.

This coordination theme resonates with USAID’s digital health work and the principles of the Digital Health Vision, which note the importance of aligning various funding streams toward one unified country plan for the digital transformation of health systems.

USAID is considering these coordination and integration opportunities as part of how it responds not just to COVID-19 but more broadly to meet current needs and ensure countries are made more resilient and strengthened for future health shocks.

“That’s part of the lesson of learning from Ebola and applying those lessons to COVID. We’re working hard as an agency to be iterative and mindful of what we’re learning. We’re making investments and incorporating those learnings directly into the way we work so we work better and smarter as we go,” Waugaman states.

Supporting durable strategic software with national digital health strategies and plans is particularly important for more broadly supporting primary healthcare systems.

“This is important not just for meeting the urgent needs that COVID-19 has surfaced, but also for meeting the longer-term health needs of the populations we serve,” Waugaman states.

In part two of our series next week, we’ll cover how donors are crucial to ensuring all countries have access to digital health solutions, the value of these partnerships in improving effectiveness in healthcare and how pharma can help donors expand digital health infrastructure globally.

About the interviewee

Adele Waugaman is senior digital health advisor at USAID’s Bureau for Global Health, seated in the Center for Innovation and Impact (CII). Currently she advises the agency’s COVID-19 response informed by the priorities of the USAID Vision for Action in Digital Health, the Agency’s first dedicated policy guidance related to investments in digital technologies and data systems that support country-based health programs. She has authored and edited reports on trends at the intersection of digital technologies and international development, including Fighting Ebola with Information: Learning from the Use of Data, Information, and Digital Technologies in the West African Ebola Outbreak Response, and Disaster Relief 2.0: The Future of Information-Sharing in Humanitarian Emergencies.

About the author

Jessica Hagen is a freelance life sciences and health writer and project manager who has worked with medical XR companies, fiction/nonfiction authors, nonprofit and for-profit organisations and government entities.

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40,000 National Guard Troops Face Unemployment As Vaccine Deadline Imminent

40,000 National Guard Troops Face Unemployment As Vaccine Deadline Imminent

Up to 40,000 Army National Guard troops – around 13% of the force…

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40,000 National Guard Troops Face Unemployment As Vaccine Deadline Imminent

Up to 40,000 Army National Guard troops - around 13% of the force - could be fired for not getting the mandated COVID-19 vaccine (which has limited efficacy against Omicron, doesn't stop transmission, has been linked to elevated heart problems, and has been mandated for a healthy demographic that rarely dies of the disease).

Michigan Army National Guard Sgt. Mark Abbott administers a COVID-19 vaccine

Guard soldiers have until Thursday to get the jab, according to the Associated Press, which notes that between 20% and 30% of Guard soldiers in six states remain unvaccinated.

"We’re going to give every soldier every opportunity to get vaccinated and continue their military career. Every soldier that is pending an exemption, we will continue to support them through their process," Lt. Gen. Jon Jensen, director of the Army National Guard, told AP. "We’re not giving up on anybody until the separation paperwork is signed and completed. There’s still time."

Last year, Defense Secretary Lloyd Austin ordered all service members to get the vaccine, with different branches maintaining different deadlines for the jab. The Army National Guard was given the maximum amount of time, largely because its roughly 330,000 soldiers are scattered throughout the country, including remote locations.

The Army Guard’s vaccine percentage is the lowest among the U.S. military — with all the active-duty Army, Navy, Air Force and Marine Corps at 97% or greater and the Air Guard at about 94%. The Army reported Friday that 90% of Army Reserve forces were partially or completely vaccinated.

The Pentagon has said that after June 30, Guard members won’t be paid by the federal government when they are activated on federal status, which includes their monthly drill weekends and their two-week annual training period. Guard troops mobilized on federal status and assigned to the southern border or on COVID-19 missions in various states also would have to be vaccinated or they would not be allowed to participate or be paid. -AP

Complicating matters is a rule that Guard soldiers deployed on state active duty may not require a vaccination, depending on state-level mandates. 

According to the report, at least seven governors have asked Austin to reconsider, or drop, the vaccine mandate for National Guard members - with some having filed or joined lawsuits to that end.

Austin, apparently following his own special brand of science, told them to pound sand, saying that Covid-19 "takes our service members out of the fight, temporarily or permanently, and jeopardizes our ability to meet mission requirements," adding that troops will either need to get vaccinated or lose their Guard status.

"When you’re looking at, 40,000 soldiers that potentially are in that unvaccinated category, absolutely there’s readiness implications on that and concerns associated with that," said Jenson, adding "That's a significant chunk." 

AP reports that around 85% of Army Guard soldiers are fully vaccinated, while 87% are at least partially vaccinated.

Tyler Durden Sun, 06/26/2022 - 18:00

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Government

CDC Confirmed Post-Vaxx Death From Blood-Clotting Two Weeks Before Alerting Public: Emails

CDC Confirmed Post-Vaxx Death From Blood-Clotting Two Weeks Before Alerting Public: Emails

Authored by Zachary Stieber via The Epoch Times…

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CDC Confirmed Post-Vaxx Death From Blood-Clotting Two Weeks Before Alerting Public: Emails

Authored by Zachary Stieber via The Epoch Times (emphasis ours),

The Centers for Disease Control and Prevention (CDC) confirmed in late 2021 that a person died from blood clotting after receiving a COVID-19 vaccine that had been linked with an increased risk of blood clotting, but did not alert the public for two weeks, newly obtained emails show.

A general view of the Centers for Disease Control headquarters in Atlanta, Ga., on April 23, 2020. (Tami Chappell/AFP via Getty Images)

Dr. Tom Shimabukuro, a CDC official, told colleagues at the CDC and the Food and Drug Administration (FDA) on Dec. 2, 2021, “We have confirmed a 9th TTS death following Janssen vaccination,” according to emails obtained by The Epoch Times through a Freedom of Information Act request.

TTS refers to thrombosis with thrombocytopenia syndrome, a condition that features low platelet levels combined with blood clots.

Officials had recommended a nationwide pause on the administration of the vaccine, produced by Johnson & Johnson (J&J) subsidiary Janssen, in April 2021 after six women experienced TTS after J&J vaccination and three died. But they lifted the pause after determining the vaccine remained safe and effective.

The condition was not discussed much in the ensuing months, despite the CDC later reporting that five additional deaths occurred before Aug. 31, 2021. Shimabukuro gave a single update, in mid-October 2021, saying five total deaths had been reported.

That was until December 2021. Twelve days after Shimabukuro alerted colleagues of the ninth death, the FDA urged healthcare workers not to administer the vaccine to people with certain conditions because of the TTS risk. Two days after that, Dr. Isaac See, another CDC official, informed the public during a meeting that nine deaths had occurred post-vaccination.

It’s unclear when the CDC learned of the sixth, seventh, and eighth deaths.

The CDC takes reports made to the Vaccine Adverse Event Reporting System and attempts to confirm the reports, including post-vaccination deaths. A higher number of post-vaccination TTS deaths have been reported to the system than the number the CDC has verified.

One day after Shimabukuro confirmed the ninth death, his message was forwarded by Dr. Amanda Cohn, another CDC official, to CDC Director Dr. Rochelle Walensky.

“See below, information on a 9th completely tragic death from TTS,” Cohn wrote.

Many thanks for letting us know … any tragic case,” Walensky responded.

The emails were partially redacted; one was fully redacted.

Read more here...

Tyler Durden Sun, 06/26/2022 - 15:30

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Innovation Pharmaceuticals Inc (OTCMKTS: IPIX) Breaking Out as Biotech Reports Brilacidin Inhibits Omicron, Delta, Gamma and Alpha SARS-CoV-2 Variants Based on In Vitro Testing

Innovation Pharmaceuticals Inc (OTCMKTS: IPIX) is moving steadily northbound with power after the Company reported Brilacidin, its defensin-mimetic drug…

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Innovation Pharmaceuticals Inc (OTCMKTS: IPIX) is moving steadily northbound with power after the Company reported Brilacidin, its defensin-mimetic drug candidate exhibiting broad-spectrum antiviral activity, inhibited the Omicron and Delta variants of SARS-CoV-2 based on in vitro testing conducted in collaboration with (NIH) and (NIAID) scientists. Researchers at Rutgers University have also shown Brilacidin inhibited in vitro the Gamma and Alpha variants of SARS-CoV-2. Brilacidin has now been tested in vitro in seven SARS-CoV-2 strains (Omicron, Delta, Gamma, Alpha, Italian, Washington, Wuhan) and three human coronavirus (H-CoV) strains (OC43, 229E, and NL63), in addition to MERS-CoV and SARS-CoV-1. Brilacidin has consistently inhibited all coronaviruses tested, independent of cell type, at generally attainable systemic concentrations (based on established human pharmacokinetics of IV-administered Brilacidin).  

Emerging SARS-CoV-2 variants, and increasingly their sub-variants, contain immunity-evading mutations. These mutations alter key parts of the SARS-CoV-2 spike protein that attach to human cells, making the virus more transmissible and potentially more virulent. Unlike other antivirals, such as monoclonal antibodies, and most vaccines, Brilacidin has been shown not to target the Spike S1 and Spike RBD regions of SARS-CoV-2, acting instead through dual-acting neutralizing and blocking antiviral properties, able to target virus and host. These antiviral traits support Brilacidin’s ability to maintain its anti-coronavirus activity and suggest Brilacidin would be less subject to resistance. Taken together, the results from NIH/NIAID testing of Brilacidin are supportive of previously completed research and give the Company confidence in the compound’s antiviral potential. The Company remains active in pursuing additional government-based funding opportunities, as well as licensing partnerships, to advance Brilacidin in the highly attractive area of developing novel broad-spectrum medicines for treating viral diseases. Microcapdaily has been reporting on IPIX for a long time and we were there when the stock (then trading as CTIX) made a legendary run skyrocketing to $4.93 per share. 

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Innovation Pharmaceuticals Inc (OTCMKTS: IPIX) is a clinical stage pharmaceutical company developing innovative therapies with anti-infective, oncology, anti-inflammatory and dermatology applications. The Company owns the rights to Brilacidin, its lead drug in a new class of compounds called defensin-mimetics, and Kevetrin (thioureidobutyronitrile), its anti-cancer compound. Brilacidin is being studied by the Company, as well as other independent researchers, as a potential broad-spectrum antiviral therapeutic for the treatment of viruses including the novel coronavirus (SARS-CoV-2), which is responsible for COVID-19. 

Brilacidin is Innovation Pharma’s lead drug candidate in its Host Defense Protein (HDP)-mimetic franchise. Brilacidin has been granted Fast Track designation by the FDA and currently is being evaluated in a randomized, placebo-controlled Phase 2 clinical trial in hospitalized COVID-19 patients (see NCT04784897). Two independent Machine Learning (AI) studies also identified Brilacidin as one of the most promising inhibitors of SARS-CoV-2, the virus responsible for COVID-19, based on Brilacidin’s molecular properties. Modeled after HDPs, the “front-line” of defense in the body’s innate immune system, it is a synthetic, non-peptidic small molecule that kills pathogens swiftly, significantly reducing the likelihood of drug resistance developing. Just as importantly, Brilacidin functions in a robust immunomodulatory capacity, lessening inflammation and promoting healing. 

Kevetrin is a small molecule that has demonstrated the potential of becoming a breakthrough cancer treatment by inducing activation of p53, a protein frequently referred to as the “Guardian of the Genome” due to its critical role in controlling cell mutations. In most cancers, regardless of origin, type, and location, the p53 pathway becomes inactivated (dysfunctional), thus preventing the body from performing its natural anti-tumor functions. The TP53 gene is the most studied gene of all time. Conducted at the Dana-Farber Cancer Institute and at Beth Israel Deaconess Medical Center, a Phase 1 clinical trial evaluating Kevetrin in treating Advanced Solid Tumors has been successfully completed, with patients showing good toleration and encouraging signs of potential therapeutic response. The Company has concluded its open-label, dose-escalation Phase 2a trial of Kevetrin in Platinum-Resistant/Refractory Ovarian Cancer. Highly encouraging preliminary data from the first patients treated in the trial showed modulation of the p53 protein in response to administration of Kevetrin. With a promising bioavailability profile, and to leverage its short half-life (the drug exits the body in approximately 8 to 10 hours), efforts are underway to develop Kevetrin as an oral anti-cancer agent (tablet or capsule) that can be administered daily, potentially even multiple times per day. The FDA has awarded Kevetrin Orphan Drug status for Ovarian Cancer, Pancreatic Cancer, and Retinoblastoma, qualifying it for developmental incentives and an extra 7 years of market exclusivity upon drug approval. The FDA also has granted Kevetrin Rare Pediatric Disease designation for childhood Retinoblastoma. 

Microcapdaily has been covering IPIX for years starting with CTIX back in 2015 reporting on the stocks legendary run to $4.93 per share. We stated on CTIX back in the day: “As anyone in the industry knows, regulating the p53 pathway has long been the holy grail of cancer research and big pharma has spent hundreds of millions of dollars researching ways to achieve this with no success thus far. It seems Kevetrin(TM) has accomplished this; extensive preclinical research on Kevetrin shows the re-activation of p53 across a wide spectrum of cancer lines including colon, lung, breast and pancreatic cancers. The market potential for Kevetrin in treating drug-resistant cancers is worth $5 billion a year. Other cancers could easily represent an additional $5 billion annually, he adds.”

IPIX has established a valuable intellectual property portfolio: 

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On June 23 IPIX reported Brilacidin, the Company’s defensin-mimetic drug candidate exhibiting broad-spectrum antiviral activity, inhibited the Omicron (B.1.1.529) and Delta (B.1.617.2) variants of SARS-CoV-2 based on in vitro testing conducted in collaboration with National Institutes of Health (NIH) National Institute of Allergy and Infectious Diseases (NIAID) scientists. Researchers at Rutgers University have also shown Brilacidin inhibited in vitro the Gamma (P.1) and Alpha (B.1.1.7) variants of SARS-CoV-2. Brilacidin has now been tested in vitro in seven SARS-CoV-2 strains (Omicron, Delta, Gamma, Alpha, Italian, Washington, Wuhan) and three human coronavirus (H-CoV) strains (OC43, 229E, and NL63), in addition to MERS-CoV and SARS-CoV-1. Brilacidin has consistently inhibited all coronaviruses tested, independent of cell type, at generally attainable systemic concentrations (based on established human pharmacokinetics of IV-administered Brilacidin). Identifying COVID-19 countermeasures with novel mechanisms of action is vital. SARS-CoV-2 continues to evolve at an accelerated pace, raising questions as to what the dominant variant (or sub-variant) may be this fall and winter, when infections often spike — and if today’s COVID-19 vaccines and therapeutics can maintain their effectiveness. 

Emerging SARS-CoV-2 variants, and increasingly their sub-variants, contain immunity-evading mutations. These mutations alter key parts of the SARS-CoV-2 spike protein that attach to human cells, making the virus more transmissible and potentially more virulent. Unlike other antivirals, such as monoclonal antibodies, and most vaccines, Brilacidin has been shown not to target the Spike S1 and Spike RBD regions of SARS-CoV-2, acting instead through dual-acting neutralizing and blocking antiviral properties, able to target virus and host. These antiviral traits support Brilacidin’s ability to maintain its anti-coronavirus activity and suggest Brilacidin would be less subject to resistance. Related, results from new NIH/NIAID in vitro testing of Brilacidin in over 20 acutely infectious viruses, and from the Brilacidin Phase 2 COVID-19 clinical trial, are being prepared for publication. Findings from the Rutgers’ Brilacidin research can be accessed at the link below1 and build on earlier published Brilacidin research conducted by scientists at George Mason University and at University of Arizona and University of California-San Francisco. 

In 2021, the Company completed a Phase 2 clinical trial of Brilacidin (NCT04784897) for treatment of moderate-to-severe COVID-19 patients. While the trial did not meet its primary endpoint in reducing time to sustained recovery through day 29, certain patient subgroups did show treatment benefits of Brilacidin for that primary endpoint. For example, patients treated early from onset of symptoms achieved sustained recovery more quickly (Brilacidin 5-dose group vs pooled placebo, p=0.03). To date, only a modicum of success has been demonstrated by any company conducting clinical trials in moderate-to-severe hospitalized cases of COVID-19. A possible reason for this may be owing to frequent changes in the standard of care with patients receiving a cocktail of fluctuating concomitant medications, which complicates the interpretation of the clinical trial data and that of the new drug candidate being evaluated. Clinical observations of COVID-19 patients treated with Brilacidin further lead us to believe that higher and more frequent dosing of Brilacidin may be more appropriate to tackle this complex disease in the hospital setting. 

Taken together, the results from NIH/NIAID testing of Brilacidin are supportive of previously completed research and give the Company confidence in the compound’s antiviral potential. The Company remains active in pursuing additional government-based funding opportunities, as well as licensing partnerships, to advance Brilacidin in the highly attractive area of developing novel broad-spectrum medicines for treating viral diseases. 

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Currently trading at an $18 million market valuation IPIX has $8.7 million in the treasury, over $11 million in assets vs. $4.5 million in total liabilities. IPIX is CTIX reincarnated and this stock can move skyrocketing to $4.93 per share back in the day; a run we reported on from the beginning. IPIX is heating up and getting noticed by investors after the Company reported Brilacidin, its defensin-mimetic drug candidate exhibiting broad-spectrum antiviral activity, inhibited the Omicron and Delta variants of SARS-CoV-2 based on in vitro testing conducted in collaboration with (NIH) and (NIAID) scientists. Researchers at Rutgers University have also shown Brilacidin inhibited in vitro the Gamma and Alpha variants of SARS-CoV-2. Brilacidin has now been tested in vitro in seven SARS-CoV-2 strains (Omicron, Delta, Gamma, Alpha, Italian, Washington, Wuhan) and three human coronavirus (H-CoV) strains (OC43, 229E, and NL63), in addition to MERS-CoV and SARS-CoV-1. Brilacidin has consistently inhibited all coronaviruses tested, independent of cell type, at generally attainable systemic concentrations (based on established human pharmacokinetics of IV-administered Brilacidin). We will be updating on IPIX when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with IPIX.

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Disclosure: we hold no position in IPIX either long or short and we have not been compensated for this article.

The post Innovation Pharmaceuticals Inc (OTCMKTS: IPIX) Breaking Out as Biotech Reports Brilacidin Inhibits Omicron, Delta, Gamma and Alpha SARS-CoV-2 Variants Based on In Vitro Testing first appeared on Micro Cap Daily.

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