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Trump Considers Fast-Tracking AstraZeneca Covid Vaccine Ahead Of Elections

Trump Considers Fast-Tracking AstraZeneca Covid Vaccine Ahead Of Elections

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Trump Considers Fast-Tracking AstraZeneca Covid Vaccine Ahead Of Elections Tyler Durden Sun, 08/23/2020 - 14:26

With Trump expected to make a "major therapeutic announcement" at 530pm "sharp", and tweeting that the "important White House news conference" will be "very good news"...

... speculation is rampant what Trump will announce.

One clue comes from the Financial Times which moments ago reported that the Trump administration is "considering the bypassing normal US regulatory standards to fast-track an experimental coronavirus vaccine from the UK for use in America ahead of the presidential election."

The FT is referring to a covid vaccine trial being conducted by AstraZeneca, and whose fast-tracking "would involve the US Food and Drug Administration awarding 'emergency use authorisation' (EUA) in October to a vaccine being developed in a partnership between AstraZeneca and Oxford university, based on the results from a relatively small UK study if it is successful, the people said."

One problem is that accelerating the AZN study would prompt concerns that it does not comply with US regulations, and that its safety would not have tested on a sufficient large group of people:

The AstraZeneca study has enrolled 10,000 volunteers, whereas the US government’s scientific agencies have said that a vaccine would need to be studied in 30,000 people to pass the threshold for authorisation. AstraZeneca is also conducting a larger study with 30,000 volunteers, although the results from that will come after the smaller trial.

Trump is said to be eager to rush out a vaccine before the elections to allow him "to claim he has turned the tide" on the virus, especially as Democratic criticism of his handling of the pandemic has emerged as one of the main presidential election criticisms of his administration. In his convention speech on Thursday night, Joe Biden said that the US response to the virus was the "worst performance of any nation."

According to the FT, Mark Meadows, Trump's chief of staff, and Steven Mnuchin, Treasury secretary, have told top Democrats that the administration was considering fast-tracking a vaccine, according to one person briefed on a July 30 meeting the pair held with Nancy Pelosi. Meadows said in the meeting that "there could be emergency authorization, possibly for the AstraZeneca vaccine, in September. Mr Mnuchin added that the administration expected an EUA for a vaccine before full approval, said the person, who added that Ms Pelosi warned that there should be “no cutting corners” in the vaccine approval process."

That said, a spokesperson for the Treasury secretary was quick to deny this, saying "Secretary Mnuchin did not make any comments regarding AstraZeneca, nor is he familiar with the specifics of the AstraZeneca vaccine candidate. He is also not aware of any plans the FDA may have regarding any emergency use authorisation for any potential vaccine, beyond what he has heard publicly stated. The secretary believes, and has always believed, that any decision on vaccine candidates and any possible EUA is up to the FDA."

Also casting doubt on speculation that Trump will announce the fast-tracking of a vaccine is Michael Caputo, a spokesperson for the US health and human services department (which contains the FDA) who said any claim that the administration would issue an EUA before the election was "absolutely false." Echoing Bank of America's latest timeline, Caputo said the administration was hopeful that a vaccine would be developed by the first quarter of 2021

“We have always been working towards that goal. I’ve never been told at any point in time that that goal has changed,” he said. “Talk of an October surprise is a lurid resistance fantasy. Irresponsible talk of an unsafe or ineffective vaccine being approved for public use is designed to undermine the president’s coronavirus response.”

A spokesperson for AstraZeneca told the FT that it had "not discussed emergency use authorisation with the US government” and that it "would be premature to speculate on that possibility."

Of course, it wouldn't be the first time that Trump has "surprised" his own staffers. In this case, however, an unexpected fast-tracking of a potential covid vaccine will likely lead to another round of resignations (especially since there appears to be a lot of political backroom dealing seeking to promote Gilead's Remdesivir as the vaccine of choice although doubts have been case after it emerged that Remdesivir may only provide modest benefit against 'moderate' COVID-19). As the FT notes, if the FDA, which is led by commissioner Stephen Hahn, were to grant emergency approval to the AstraZeneca vaccine based on the Oxford study, "it could provoke a string of resignations from the agency."

Earlier this week, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research — which is responsible for assessing the vaccines — told Reuters that he would resign if the agency were to approve a jab before definitive data showing it was safe and effective.

“I could not stand by and see something that was unsafe or ineffective that was being put through,” Dr Marks said. “You have to decide where your red line is, and that’s my red line.”

He went on: “I would feel obligated [to resign] because in doing so, I would indicate to the American public that there’s something wrong.”

An FT source siad that if Dr Marks were to quit, other scientists in his division of FDA would follow suit.

But while a round of FDA departures may not bother Trump, the lack of uptake of the vaccine by a skeptical public will surely be a major concern.

For one thing, as the FT notes, the relatively small UK trial was not designed to produce sufficient data of the kind that would be required for emergency authorisation in the US. US drugmakers Moderna and Pfizer, which are also trialling vaccines, both plan to enrol 30,000 participants in Phase III studies they started in July. Moderna said it would complete enrollment by the end of September, while Pfizer has said it has already enrolled 11,000.

An FT source briefed on the plan said: "I don’t see a way forward for [AstraZeneca],” based on the 10,000-person trial. “They’re not going to get there. They won’t have the clinical end points."

Paul Offit, a vaccine expert at the Children’s Hospital of Philadelphia, echoed the skepticism saying it would be "very disappointing” if the Trump administration were preparing such a plan before it had even seen the data because it risked "politicising the science", although that particular horse has long ago left the barn. He added that even if the study were successful, a 10,000-person trial would not be large enough to rule out rarer side effects. "The job of the FDA is to protect the American public if they see these data as inadequate."

The FDA's Hahn already faced criticism earlier this year after the FDA granted emergency approval for hydroxychloroquine - an unproven drug repeatedly touted by Mr Trump - before reversing its decision when multiple studies showed the drug was not an effective treatment for coronavirus.

Others have also chimed in on the importance of following proper procedure:

In June, Francis Collins, director of the National Institutes of Health, told CNN: “Each vaccine needs to be tested on about 30,000 volunteers. We don’t believe that we have enough power in the analysis, to be able to document the vaccine works unless you get to roughly that number.”

Robert Redfield, head of the Centers for Disease Control and Infection, told the FT on Friday: “Although we have talked about doing this at ‘warp speed’, it is not through any cuts in our efforts for vaccine safety or scientific integrity. I am confident there will be all the rigour we have always had for developing vaccines for human requirements.”

The decision over whether to fast-track a so-far unproven vaccine also involves none other than Anthony Fauci, with the FT concluding that the administration’s exploration of ways to circumvent normal procedures "had prompted infighting among the government’s top scientists. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, and Dr Collins are stressing the importance of scientific rigour whereas Moncef Slaoui, the White House’s vaccine tsar, wants to forge ahead, the person said."

Judging by the tone of Trump's tweet, those pushing for "forging ahead" have gotten the upper hand.

But even if Trump decides to pursue a fast-tracking, he will face other challenges, not the lest of which is widespread skepticism within the US - and especially among his own core base - toward a vaccine, any vaccine.

As we reported earlier quoting from Bank of America, "even in the best of times, many people refuse to get a flu shot. Americans seem particularly skeptical about public health policy. If masks are unacceptable, what about shots of a brand new drug? A RIWI survey in June and July found big differences across countries (Chart 1). Certainly we would expect the initial take-up to be slow. After all, there have been a lot of confusing public health messages.  Such caution is to some degree warranted, with the vaccines being rushed to market without knowledge of the long-term side effects."

One final point, also from Bank of America: "It is also important to note that rolling out a vaccine will not immediately end all social distancing behavior. Some people will respond quickly as pent-up demand is released, taking that long-delayed vacation, for example. However, we assume the majority of people will re-engage slowly as they become more comfortable that the health risk is indeed gone. Some activities could take very long to fully recover."

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EUR/AUD bearish breakdown supported by additional China fiscal stimulus and AU inflation

Weak PMI readings from the Eurozone, an increase in China’s budget deficit ratio, and renewed inflationary pressures in Australia may trigger a persistent…

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October 24, 2023

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  • Weak PMI readings from the Eurozone, an increase in China’s budget deficit ratio, and renewed inflationary pressures in Australia may trigger a persistent bearish sentiment loop in EUR/AUD.
  • Watch the key short-term resistance at 1.6700 for EUR/AUD.
  • A break below 1.6250 key medium-term support on the EUR/AUD may trigger a multi-week bearish impulsive down move.

The Euro (EUR) tumbled overnight throughout the US session as it erased its prior gains against the US dollar recorded on Monday, 23 October; the EUR/USD shed -104 pips from yesterday’s intraday high of 1.0695 to close the US session at 1.0591, its weakest performance in the past seven sessions.

Yesterday’s resurgence of the USD dollar strength has been attributed to a robust set of October flash manufacturing and services PMI data from the US in contrast with weak readings seen in the UK and Eurozone that represented stagflation risks.

Interestingly, the Aussie dollar (AUD) has outperformed the US dollar where the AUD/USD managed to squeeze out a minor daily gain of 21 pips by the close of yesterday’s US session. The resilient movement of the AUD/USD has been impacted by positive news flow out from China, Australia’s key trading partner.

China’s national legislature has just approved a budgetary plan to raise the fiscal deficit ratio for 2023 to around 3.8% of its GDP which was above the initial 3% set in March and set to issue additional sovereign debt worth 1 trillion yuan in Q4. This latest round of additional fiscal stimulus suggests that China’s top policymakers are expanding their initial targeted measures to address the ongoing severe liquidity crunch in the domestic property market as well as to reverse the persistent weak sentiment inherent in the stock market.

In addition, the latest set of Australia’s inflation data surpassed expectations has also reinforced another layer of positive feedback loop in the Aussie dollar which in turn may put Australia’s central bank, RBA on a “hawkish guard” against cutting its policy cash rate too soon.

The less lagging monthly CPI Indicator has risen to an annualized rate of 5.6% in September, above consensus estimates of 5.4%, and surpassed August’s reading of 5.2% which has translated into a second consecutive month of uptick in inflationary growth.

In the lens of technical analysis, a potential bearish configuration setup has emerged in the EUR/AUD cross pair from a short to medium-term perspective.

Major uptrend phase of EUR/AUD is weakening

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Fig 1: EUR/AUD medium-term trend as of 25 Oct 2023 (Source: TradingView, click to enlarge chart)

Even though the price actions of the EUR/AUD have been oscillating within a major ascending channel since its 25 August 2023 low of 1.4285 and traded above the key 200-day moving average so far, the momentum of this up movement is showing signs of bullish exhaustion.

Yesterday (24 October) price action ended with a daily bearish reversal “Marubozu” candlestick coupled with the daily RSI momentum indicator that retreated right at a significant parallel resistance in place since March 2023 at the 65 level which suggests a revival of medium-term bearish momentum.

EUR/AUD bears are now attacking the minor ascending support

Fig 2: EUR/AUD minor short-term trend as of 25 Oct 2023 (Source: TradingView, click to enlarge chart)

The EUR/AUD has now staged a bearish price action follow-through via the breakdown of its minor ascending support from its 29 September 2023 low after a momentum bearish breakdown that was flashed earlier yesterday (24 October) during the European session as seen from the 4-hour RSI momentum indicator.

Watch the 1.6700 key short-term pivotal resistance (also the 50-day moving average) for a further potential slide toward the intermediate supports of 1.6460 and 1.6320 in the first step.

On the other hand, a clearance above 1.6700 invalidates the bearish tone to see the next intermediate resistance coming in at 1.6890.

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GigXR partners with NUS Medicine to deliver holographic clinical scenarios for gastroenterology training

GigXR, Inc., a global provider of holographic healthcare training, announced today its partnership with the Yong Loo Lin School of Medicine, National University…

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October 24, 2023

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GigXR, Inc., a global provider of holographic healthcare training, announced today its partnership with the Yong Loo Lin School of Medicine, National University of Singapore (NUS Medicine), one of the world’s leading medical schools, to introduce a new gastrointestinal module for the award-winning HoloScenarios application. Created to better prepare medical and nursing students in diagnosing and treating acute gastrointestinal diseases, HoloScenarios: Gastrointestinal delivers evidence-based, robust clinical simulations that present hyperrealistic holographic simulated patients and medical equipment to be used in any physical learning environment, accessed anywhere in the world.

Credit: Yong Loo Lin School of Medicine, National University of Singapore (NUS Medicine), and GigXR

GigXR, Inc., a global provider of holographic healthcare training, announced today its partnership with the Yong Loo Lin School of Medicine, National University of Singapore (NUS Medicine), one of the world’s leading medical schools, to introduce a new gastrointestinal module for the award-winning HoloScenarios application. Created to better prepare medical and nursing students in diagnosing and treating acute gastrointestinal diseases, HoloScenarios: Gastrointestinal delivers evidence-based, robust clinical simulations that present hyperrealistic holographic simulated patients and medical equipment to be used in any physical learning environment, accessed anywhere in the world.

Going beyond linear step-based training traditionally seen with virtual reality (VR), HoloScenarios: Gastrointestinal uses mixed reality (MR) to simulate the entire patient journey, while including branching logic to catalyze variance in learning experiences. From taking basic medical history to performing invasive testing and emergency procedures, the new module empowers learners to master vital medical decision-making and manual skills as they would see them in real-life clinical scenarios and patient care.

HoloScenarios: Gastrointestinal is created in collaboration with renowned medical professionals and educators from NUS Medicine who specialize in the fields of Gastrointestinal (GI) Surgery and holographic medical training. The module is delivered by the Gig Immersive Learning Platform, the enterprise-scale platform enabling the creation, curation, and sharing of immersive training applications and modules made by the world’s preeminent healthcare institutions and MR developers.

“Gastrointestinal pathologies can be complex and challenging to diagnose. This module will allow learners to form a deeper understanding and appreciation of the gastrointestinal tract, especially the three-dimensional understanding of anatomy and body functions,” said Associate Professor Alfred Kow Wei Chieh from the school’s Department of Surgery and Assistant Dean (Education) at NUS Medicine. “We believe mixed reality is the next evolution in healthcare training, and collaborating with immersive platform innovators like GigXR helps us to bring this vital content to more learners globally and, ultimately, improve patient care.”

With international medical and surgical credentials that include MBBS (S’pore), M Med (Surg), FRCSEd (Gen Surg), FAMS, and FACS, Associate Professor Kow has trained thousands of healthcare professionals and advanced surgical fellows. He received the 2023 REAL Advancing in Liver Transplantation Award for his contributions to global liver transplantation education and is a founding member of The Holomedicine® Association.

“GigXR has one of the most advanced and comprehensive platforms in mixed reality, especially in medical training, and enables the exchange of developments, innovation, and expertise with a wider community across Asia and beyond,” added Associate Professor Kow. He is also the Head and Senior Consultant of the Division of Hepatobiliary & Pancreatic Surgery, Department of Surgery, at Singapore’s National University Hospital (NUH), the teaching hospital of NUS Medicine.

The new module also delivers enhanced realism in training learners to more accurately diagnose and treat acute gastrointestinal diseases. Whereas VR has been widely used in gastroenterology training for linear step-based skills, such as in endoscopic procedures, it is limited in its ability to simulate fully realized clinical scenarios. Holographic patient simulation in MR merges hyper-realistic holograms in physical learning spaces that accurately reflect the clinical environment and tools with which learners will care for real patients.

With HoloScenarios: Gastrointestinal, learners can interact with the holographic simulated patients, holographic medical equipment, instructors, and each other. This allows them to master both technical and soft skills, such as patient empathy and team communication, in hyper-realistic, safe-to-fail environments that reduce cognitive load. If the holographic patient displays the need for further care, such as a definitive surgery, learners can discuss a definitive treatment plan.

To gain a deeper evaluation of outward symptoms, co-located learners can safely walk around the patient hologram that is displayed on top of their real-world surroundings. Whereas VR locks learners into a virtual “box,” MR enables clear visibility and awareness of physical surroundings. This allows learners to move freely without fear of physical collisions and safety so they can fully focus on learning key gastrointestinal treatment, diagnostic, and communication skills with peers and instructors.

“In healthcare, educators are not only trying to help learners master and retain vital knowledge, but recall and apply it when a patient’s life may be at risk,” said Dr. Gao Yujia, MBBS (S’Pore), MRCS, FRCSEd, Consultant and Assistant Group Chief Technology Officer at Singapore’s National University Health System, and Vice Chairman of The Holomedicine® Association. “With HoloScenarios: Gastrointestinal, learners will have the ability to not only visualize the presentation of a given disease in 3D but better understand how to apply key learnings in the clinical context and within team environments.” Dr Gao is also the Director of Undergraduate Medical Education for Surgery at NUS Medicine.

With scenarios across gastrointestinal pathologies that include gastrointestinal bleeding, intestinal obstruction, and chronic liver failure, learners can master complex and potentially critical situations. They can learn, for example, how to stabilize patients who are dehydrated, bleeding, or septic, as well as the types of diagnostic procedures that may then be required to get a definitive diagnosis. Using mixed reality headsets or any Android, iOS smartphone or tablet, learners can access HoloScenearios: Gastrointestinal from anywhere for remotely distributed, yet highly immersive simulation.

“Immersive technology has accelerated the sharing of expertise for teaching, training, and simulation. Mixed reality, with its natural propensity to facilitate hyperrealistic, safe, and collaborative learning, continues to accelerate both the quality and scale of training outcomes,” said Jared Mermey, CEO of GigXR. “We are immensely proud to partner with NUS Medicine which has been at the forefront of adopting mixed reality in both clinical and educational use cases. By bringing their esteemed expertise onto our platform with the co-creation of HoloScenarios’ newest module, we believe clinical breakthroughs in diagnosing and treating gastrointestinal diseases will take a giant leap forward.”

Designed specifically for pedagogy, the Gig Immersive Learning Platform is trusted by over 70 enterprise-scale healthcare institutions across four continents to build full immersive curricula utilizing a robust content catalog – all of which is managed from a single dashboard. Third-party content developed by leading 3D medical partners, including DICOM Director, 3D4Medical by Elsevier, and ANIMA RES, seamlessly integrates with the platform to provide complementary, in-depth anatomy applications that empower learners with a broader physical context for the pathologies that they study.

“The Gig Immersive Learning Platform has quickly become the premier educational, social network for sharing healthcare training expertise in the immersive format, spanning global healthcare institutions and the Department of Defense to content developers and enterprises large and small,” said David King Lassman, Founder of GigXR. “HoloScenarios: Gastrointestinal marks the latest milestone in our rapidly expanding catalog, which now boasts a dozen different licensable training modules that span holographic simulated patients, clinical scenarios, anatomy, pathophysiology, and 3D medical imaging.”

NUS joins the University of Cambridge and Cambridge University Hospitals (CUH) NHS Foundation Trust, University of Michigan, and Morlen Health, a subsidiary of Northwest Permanente, P.C., as the world-class institutions partnering with GigXR to co-create holographic healthcare training. These simulations include modules centered around Respiratory diseases, Basic Life Support, Advanced Cardiac Life Support, Neurology scenarios, and now, with NUS, Gastrointestinal diseases.

GigXR and NUS Medicine plan to launch HoloScenarios: Gastro in Spring 2024. For more information on GigXR, visit GigXR.com or email sales@gigxr.com. For more information on NUS, visit nus.edu.sg.

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UC Riverside physicist awarded National Medal of Science

RIVERSIDE, Calif. — Physicist Barry C. Barish, a distinguished professor of physics and astronomy at UC Riverside, was awarded the National Medal…

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October 24, 2023

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RIVERSIDE, Calif. — Physicist Barry C. Barish, a distinguished professor of physics and astronomy at UC Riverside, was awarded the National Medal of Science by President Joe Biden at a ceremony held at the White House today. Established in 1959 by the U.S. Congress, the National Medal of Science is the highest recognition the nation can bestow on scientists and engineers.

Credit: Stan Lim, UC Riverside.

RIVERSIDE, Calif. — Physicist Barry C. Barish, a distinguished professor of physics and astronomy at UC Riverside, was awarded the National Medal of Science by President Joe Biden at a ceremony held at the White House today. Established in 1959 by the U.S. Congress, the National Medal of Science is the highest recognition the nation can bestow on scientists and engineers.

The President’s National Medal of Science is given to individuals “deserving of special recognition by reason of their outstanding contributions in biology, computer sciences, education sciences, engineering, geosciences, mathematical and physical sciences, and social, behavioral, and economic sciences, in service to the Nation.” It is administered by National Science Foundation.

Barish was recognized for “exemplary service to science, including groundbreaking research on sub-atomic particles. His leadership of the Laser Interferometer Gravitational-Wave Observatory led to the first detection of gravitational waves from merging black holes, confirming a key part of Einstein’s Theory of Relativity. He has broadened our understanding of the universe and our Nation’s sense of wonder and discovery.”

“UCR congratulates Prof. Barish on receiving the National Medal of Science,” said UCR Chancellor Kim A. Wilcox. “The distinguished names of previous winners make this recognition very exceptional. Prof. Barish is a strong inspiration for our students, researchers, and faculty. UCR continues to benefit from his extraordinary achievements.”

Barish won the 2017 Nobel Prize in physics for the discovery of gravitational waves. He joined the UCR faculty in 2018. He earned his bachelor’s degree in physics in 1957 and his doctorate in experimental particle physics in 1962, both from from UC Berkeley. He joined Caltech as a postdoc in 1963, became a professor in 1966, and was appointed Linde Professor of Physics in 1991. He led the Laser Interferometer Gravitational-wave Observatory, or LIGO, effort from its inception through the final design stages, and in subsequent discoveries. In 1997, he created the LIGO Scientific Collaboration, which enables more than 1,000 collaborators worldwide to participate in LIGO.

Barish has served on many committees, including co-chairing the subpanel of the High Energy Physics Advisory Panel that developed a long-range plan for U.S. high-energy physics in 2001. He chaired the Commission of Particles and Fields and the U.S. Liaison Committee to the International Union of Pure and Applied Physics.

He is the recipient of the Fudan-Zhongzhi Science Award (China), Princess of Asturias Prize for Science and Technology (Spain), Giuseppe and Vanna Cocconi Prize from the European Physical Society, the Enrico Fermi Prize from the Italian Physical Society, and the Klopsteg Award from the American Association of Physics Teachers. He is a member of the National Academy of Sciences, which awarded him the Henry Draper Medal. From 2003 to 2010, he served as a presidential appointee to the National Science Board.

He is an elected member of the American Academy of Arts and Sciences and a fellow of both the American Association for the Advancement of Science and of the American Physical Society, where he also served as president. He has received honorary doctorates from the University of Bologna, University of Florida, University of Glasgow, and Universitat de València in Spain. He has been inducted as honorary academician into the Royal Academy of European Doctors, based in Spain. He was elected a foreign member of the Royal Society in 2019. Last year, he won the Copernicus Prize, bestowed by the government of Poland. Earlier this year, he was elected a corresponding member of the Royal Academy of Sciences and Arts of Barcelona. 

The University of California, Riverside is a doctoral research university, a living laboratory for groundbreaking exploration of issues critical to Inland Southern California, the state and communities around the world. Reflecting California’s diverse culture, UCR’s enrollment is more than 26,000 students. The campus opened a medical school in 2013 and has reached the heart of the Coachella Valley by way of the UCR Palm Desert Center. The campus has an annual impact of more than $2.7 billion on the U.S. economy. To learn more, visit www.ucr.edu.

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