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J&J CSO Claims Single Dose COVID-19 Vaccine on Track for March Rollout

J& J is on track to roll out a single-shot coronavirus vaccine in March, and plans to have clear data on how effective it is by the end of January or early February

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This article was originally published by PharmaLive.

J&J COVID-19 vaccine on track for March rollout, still aims for 1 billion doses this year: executive

CHICAGO (Reuters) – Johnson & Johnson is on track to roll out its single-shot coronavirus vaccine in March, and plans to have clear data on how effective it is by the end of this month or early February, the U.S. healthcare company’s chief science officer said.

Dr. Paul Stoffels in an interview on Tuesday also said J&J expects to meet its stated target of delivering 1 billion doses of its vaccine by the end of this year as the company ramps up production.

The New York Times reported earlier on Wednesday that J&J was experiencing manufacturing delays that would reduce the number of doses initially available. Stoffels declined to say how many doses would be ready to go into people’s arms in March, presuming it receives emergency authorization from the U.S. Food and Drug Administration.

“We are aiming for 1 billion doses in 2021. If it is a single dose, that means 1 billion people. But it will be in a ramp-up throughout the year,” Stoffels said.

Initial launch capacity depends in part on validation of manufacturing plants, he added. The company is scaling up efforts to both produce the active vaccine and the means to package and ship it in large quantities.

Johnson & Johnson’s vaccine is being produced in the United States, Europe, South Africa and India with the help of contract manufacturers in order to build capacity.

FILE PHOTO: Paul Stoffels, Chief Scientific Officer of Johnson & Johnson attends the annual meeting of the World Economic Forum (WEF) in Davos, Switzerland January 22, 2016. REUTERS/Ruben Sprich

“It’s a few weeks too early to be giving final numbers on what we can launch in the first couple months,” he said.

Although J&J’s clinical trial protocols allowed for an early look at the data after 20 people became infected by the novel coronavirus, the company intends to deliver data on at least 154 confirmed cases – the target needed to fully assess the vaccine’s efficacy – when it releases results. That should come in the last week of January or the first week of February, Stoffels said.

The U.S. Food and Drug Administration requires at least two months of safety data on half of the study participants to ensure no unexpected side effects crop up, as well as data on specific populations such as the elderly. The company crossed that two-month threshold earlier this month.

“That point came so close to the final analysis that we decided not to do an interim analysis,” Stoffels said.

A surge in COVID-19 cases in the fall that exceeded J&J’s initial projections allowed the company to reduce the number of study volunteers to 40,000 from the initially planned 60,000 participants. Data can be collected faster when community transmission is widespread during testing.

J&J plans to seek emergency use authorization from the FDA based on the study of the vaccine as a single shot, Stoffels said. If results of ongoing studies suggest people would fare better with a second booster shot, Stoffels said J&J would file separately for a booster dose authorization.

The company is closely monitoring changes or mutations in the virus that might affect the vaccine’s effectiveness.

Scientists are particularly concerned about a highly transmissible variant of the virus first discovered in South Africa that could affect how well vaccines protect against it.

Because part of J&J’s clinical trial is being conducted in South Africa, Stoffels said the company should have data on how its vaccine fares against this new variant.

Reporting by Julie Steenhuysen; Editing by Bill Berkrot
Reuters source: https://www.reuters.com/article/us-health-coronavirus-johnson-johnson/jj-covid-19-vaccine-on-track-for-march-rollout-still-aims-for-1-billion-doses-this-year-executive-idUSKBN29I2GS

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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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IPIX

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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