Archive for December, 2021

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Link:
The association between sexual function and body image among postmenopausal women: a cross-sectional study - BMC Women's Health - BMC Blogs Network

WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZeneca's EVUSHELD (tixagevimab co-packaged with cilgavimab), a long-acting antibody (LAAB) combination, has received emergency use authorization (EUA) in the US for the pre-exposure prophylaxis (prevention) of COVID-19, with first doses expected to become available very soon.

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The Food and Drug Administration (FDA) granted the EUA for EVUSHELD for pre-exposure prophylaxis of COVID-19 in adults and adolescents (aged 12 and older who weigh 40kg or more) with moderate to severe immune compromise due to a medical condition or immunosuppressive medications and who may not mount an adequate immune response to COVID-19 vaccination, as well as those individuals for whom COVID-19 vaccination is not recommended. Recipients should not be currently infected with or had recent known exposure to a person infected with SARS-CoV-2.

Myron J. Levin, MD, Professor of Pediatrics and Medicine, University of Colorado School of Medicine, US, and principal investigator on the PROVENT trial, said: Millions of people in the US and around the world remain at serious risk for COVID-19 because their immune systems do not generate a sufficient immune response, even after receiving all recommended doses of vaccine. I am excited to offer my patients EVUSHELD as an easily-administered new option that provides long-lasting protection that could help them return to their everyday lives.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: We are proud to play a leading role in fighting the COVID-19 pandemic and, with EVUSHELD, we now have the first antibody therapy authorized in the US to prevent COVID-19 symptoms before virus exposure, while also providing long lasting protection with a single dose. EVUSHELD neutralizes all previous SARS-CoV-2 variants to date, and we are working quickly to establish its efficacy against the new Omicron variant. We thank our clinical trial participants, the investigators, scientists, and government agencies and our colleagues at AstraZeneca who have all contributed to the development of EVUSHELD.

Brian Koffman, MDCM (retired), MS Ed, Co-Founder, Executive Vice President and Chief Medical Officer of the CLL (Chronic Lymphocytic Leukemia) Society, US, said: One of the primary questions I keep getting asked by patients is When can I hug my grandchildren again? As a physician and person with a weakened immune system, l am filled with hope now that EVUSHELD will soon be available to those who cant count on vaccination alone to provide the protection they need.

EVUSHELD is a combination of two long-acting monoclonal antibodies and is the only antibody therapy authorized in the US for COVID-19 pre-exposure prophylaxis and the only COVID-19 antibody delivered as an intramuscular dose (150mg tixagevimab and 150mg cilgavimab).

About 2% of the global population is considered at increased risk of an inadequate response to a COVID-19 vaccine.1,2 About seven million people in the US are immunocompromised and may benefit from EVUSHELD for pre-exposure prophylaxis of COVID-19.1,3,4 This includes people with blood cancers or other cancers being treated with chemotherapy, and those taking medications after an organ transplant or who are taking immunosuppressive drugs for conditions including multiple sclerosis and rheumatoid arthritis.5-9

The primary data supporting the EVUSHELD EUA are from the ongoing PROVENT Phase III pre-exposure prevention trial, which showed a statistically significant reduction (77% at primary analysis, 83% at median six-month analysis) in the risk of developing symptomatic COVID-19 compared to placebo, with protection from the virus continuing for at least six months. More follow-up is needed to establish the full duration of protection provided by EVUSHELD. Data from the Phase III STORM CHASER post-exposure trial and the EVUSHELD Phase I trial also supported the EUA. EVUSHELD was well-tolerated in the trials.

EVUSHELD and SARS-CoV-2 variants

Studies are underway to provide information on the impact of the new Omicron variant (B.1.1.529) on EVUSHELD.10,11 Of the Omicron binding site substitutions relevant to EVUSHELD that have been tested to date in preclinical assays, none have been associated with escape from EVUSHELD neutralization.10,11 In vitro findings demonstrate EVUSHELD neutralizes other recent emergent SARS-CoV-2 viral variants, including the Delta and Mu variants.10

EVUSHELD is being developed with support from the US government, including federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority in partnership with the Department of Defense; Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, under Contract No. W911QY-21-9-0001.

AstraZeneca has agreed to supply the US government with 700,000 doses of EVUSHELD. The US government has indicated that it plans to distribute these doses to states and territories at no cost and on a pro rata basis.

AstraZeneca is progressing with filings around the globe for potential emergency use authorization or conditional approval of EVUSHELD in both COVID-19 prophylaxis and treatment.

EVUSHELD is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of EVUSHELD under Section 564(b)(1) of the Food, Drug and Cosmetic Act, 21 U.S.C. 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

IMPORTANT SAFETY INFORMATION

EVUSHELD (tixagevimab co-packaged with cilgavimab) has not been approved, but has been granted an Emergency Use Authorization (EUA) by FDA. There are limited clinical data available and serious and unexpected adverse events may occur that have not been previously reported with EVUSHELD use.

Contraindication:

EVUSHELD is contraindicated in individuals with previous severe hypersensitivity reactions, including anaphylaxis, to any component of EVUSHELD.

Warnings and Precautions:

Hypersensitivity Including Anaphylaxis

Serious hypersensitivity reactions, including anaphylaxis, have been observed with IgG1 monoclonal antibodies like EVUSHELD. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive therapy. Clinically monitor individuals after injections and observe for at least 1 hour.

Clinically Significant Bleeding Disorders

As with any other intramuscular injection, EVUSHELD should be given with caution to individuals with thrombocytopenia or any coagulation disorder.

Cardiovascular Events

A higher proportion of subjects who received EVUSHELD versus placebo reported myocardial infarction and cardiac failure serious adverse events. All of the subjects with events had cardiac risk factors and/or a prior history of cardiovascular disease at baseline. A causal relationship between EVUSHELD and these events has not been established. Consider the risks and benefits prior to initiating EVUSHELD in individuals at high risk for cardiovascular events, and advise individuals to seek immediate medical attention if they experience any signs or symptoms suggestive of a cardiovascular event.

Adverse Reactions:

The most common adverse events are headache, fatigue and cough.

Use in Specific Populations:

Pregnancy

There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. EVUSHELD should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus.

Lactation

There are no available data on the presence of tixagevimab or cilgavimab in human milk or animal milk, the effects on the breastfed infant, or the effects of the drug on milk production. Maternal IgG is known to be present in human milk.

Pediatric Use

EVUSHELD is not authorized for use in pediatric individuals under 12 years of age or weighing less than 40 kg. The safety and effectiveness of EVUSHELD have not been established in pediatric individuals.

AUTHORIZED USE

EVUSHELD (tixagevimab co-packaged with cilgavimab) is authorized for use under an EUA for the pre-exposure prophylaxis of COVID-19 in adults and pediatric individuals (12 years of age and older weighing at least 40 kg):

EVUSHELD has been authorized by FDA for the emergency use described above. EVUSHELD is not FDA-approved for any use, including use for pre-exposure prophylaxis of COVID-19.

EVUSHELD is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of EVUSHELD under section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

LIMITATIONS OF AUTHORIZED USE

See Full Fact Sheet for Healthcare Providers for examples of medical conditions or treatments that may result in moderate to severe immune compromise and an inadequate immune response to COVID-19 vaccination, the justification for emergency use of drugs during the COVID-19 pandemic, information on available alternatives, and additional information on COVID-19.

The FDA Letter of Authorization is available for reference, as well as the Fact Sheet for Patients, Parents And Caregivers.

SARS-CoV-2 Viral Variant

There is a potential risk of treatment failure due to the development of viral variants that are resistant to tixagevimab and cilgavimab administered together. Prescribing healthcare providers should consider the prevalence of SARS-CoV-2 variants in their area, where data are available, when considering prophylactic treatment options.

Reporting Adverse Events

The prescribing healthcare provider and/or your designee must report all SERIOUS ADVERSE EVENTS and MEDICATION ERRORS potentially related to EVUSHELD within 7 calendar days from the healthcare providers awareness of the event (1) by submitting FDA Form 3500 online, (2) by downloading FDA Form 3500 and then submitting by mail or fax, or (3) contacting the FDA at 1-800-FDA-1088 to request this form.

In addition, please fax a copy of all FDA MedWatch forms to AstraZeneca at 1-866-742-7984.

Report adverse events by visiting https://contactazmedical.astrazeneca.com, or calling AstraZeneca at 1-800-236-9933.

Notes

EVUSHELD

EVUSHELD, formerly known as AZD7442 is a combination of two LAABs - tixagevimab (AZD8895) and cilgavimab (AZD1061) - derived from B-cells donated by convalescent patients after SARS-CoV-2 virus. Discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020, the human monoclonal antibodies bind to distinct sites on the SARS-CoV-2 spike protein13 and were optimized by AstraZeneca with half-life extension and reduced Fc receptor and complement C1q binding. The half-life extension more than triples the durability of its action compared to conventional antibodies and could afford up to 12 months of protection from COVID-19 following a single administration;14-16 data from the Phase III PROVENT trial show protection lasting at least six months.17 The reduced Fc receptor binding aims to minimize the risk of antibody-dependent enhancement of disease - a phenomenon in which virus-specific antibodies promote, rather than inhibit, infection and/or disease.18 EVUSHELD is delivered as an IM dose of 150mg tixagevimab and 150mg cilgavimab administered in two separate, consecutive injections.

In August 2021, AstraZeneca announced that EVUSHELD demonstrated a statistically significant reduction in the risk of developing symptomatic COVID-19 in the PROVENT trial; efficacy was 83% compared to placebo in a six-month analysis announced on November 18, 2021. In October 2021, AstraZeneca announced positive high-level results from the EVUSHELD TACKLE Phase III outpatient treatment trial. EVUSHELD is also being studied as a potential treatment for hospitalized COVID-19 patients as part of the National Institute of Healths ACTIV-3 trial and in an additional collaborator hospitalization treatment trial.

Under the terms of the licensing agreement with Vanderbilt, AstraZeneca will pay single-digit royalties on future net sales.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries, and its innovative medicines are used by millions of patients worldwide. For more information, please visit http://www.astrazeneca-us.com and follow us on Twitter @AstraZenecaUS.

References

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EVUSHELD (formerly AZD7442) long-acting antibody combination authorized for emergency use in the US for pre-exposure prophylaxis (prevention) of...

People due to receive their Covid-19 booster vaccine in coming weeks will primarily be offered the Moderna dose at HSE vaccination centres.

The HSE is reported to have large supplies of Moderna due to expire next month, so that will be the main vaccine administered over coming weeks to the over-60s, over-50s, healthcare workers and younger people in vulnerable groups though it will be restricted to people over 30.

Anecdotally there are indications some people may be reluctant to take the Moderna vaccine. This may be due to Irish stocks about to expire shortly and/or confusion about its efficacy. This follows the companys chief executive Stphane Bancel warning last week the Moderna jab may not be as effective against Omicron as it had been with the Delta variant.

The HSE has confirmed recipients will have no choice on what vaccine they are given.

What type of coronavirus vaccine is the Moderna jab?

It is a new kind of synthetic mRNA vaccine the Pfizer/BioNTech vaccine is from the same stable. They provide excellent protection against severe illness and hospitalisation and have played a critical role in reducing Covid-19 deaths since being approved. A downside, however, is that they must be stored at very cold temperatures.

In a half-dozen studies published earlier this year the Moderna jab appears to be more protective over the long term than the Pfizer-BioNTech jab. Protection against symptomatic infection was 93.1 per cent for people aged 60 and above who originally received the Oxford/AstraZeneca jab and 94 per cent for BioNTech/Pfizer recipients a fortnight after the booster shot was administered.

Should people be worried about receiving a soon to be out-of-date vaccine?

In short no, as they retain the ability to boost antibody production within currently approved time spans though inevitably potency wanes over time. The Pfizer, Moderna, AstraZeneca, and Janssen (Johnson&Johnson) vaccines were put on the market with emergency use authorisation of up to six months.

This compares with a shelf life of two to three years for most vaccines and other medicines. This is an inevitable consequence of getting the vaccines out of the door as quickly as possible , chief scientist at the Royal Pharmaceutical Society Gino Martini told the journal BMJ.

Months later,these emergency expiry dates remain in force for these vaccines. For approved Covid-19 vaccines, the initial shelf lives were based on data available at the time of submission for regulatory approval.

The long-term shelf life has not been extended for any of the vaccines. A shelf life extension would require supporting evidence from relevant stability studies. Vaccine manufacturers are monitoring batches of vaccines with the aim of providing a longer shelf life; probably the usual two years.

What about the Omicron threat?

While Moderna said existing vaccines including its mRNA version will probably be less effective against the Omicron variant, most experts believe they will continue to provide significant protection against severe disease and hospitalisation. It should be stressed, however, definitive indication has yet to emerge. That will be a matter of weeks, if not days.

Moderna has confirmed it is developing an Omicron-specific booster though manufacturing the new vaccine would take time. Tens of millions of doses could be available in the first quarter of 2022, but scale-up would not happen until the second quarter provided it is shown such boosters are required.

What is the latest indication on the benefits of mixing vaccines?

Evidence supporting a mixing of vaccine doses has hardened over recent months. A study this week shows combining a first dose of the AstraZeneca Covid-19 vaccine with a second dose of either the Moderna or the Novavax jabs results in far higher levels of neutralising antibodies and T-cells compared with two doses of the AstraZeneca jab.

This finding also has important implications for lower-income countries that have not yet completed their primary vaccination campaigns as it suggests you do not need access to mRNA vaccines and therefore ultra-cold storage facilities to trigger an extremely potent Covid-19 vaccine response.

The study also bolsters confidence that using the Moderna vaccine as a booster dose in people who have previously received the AstraZeneca jab should result in high levels of neutralising antibodies and T-cells.

It follows separate data published last week suggesting the Pfizer and Moderna booster jabs can dramatically strengthen the bodys immune defences.

The National Immunisation Advisory Committee (Niac) has decided not to recommend the Moderna booster vaccine for eligible people aged under 30 years as a precaution. A similar approach has been taken by authorities in France and the Scandinavian countries after early data showed a higher rate of myocarditis in young males who received Moderna compared to those who were administered Pfizer.

For those aged 30 and over, Niac advises the Pfizer vaccine or a half-dose of Moderna should be administered after a six-month interval, though for operational reasons a minimum interval of five months may be used.

There are early indications the infection rate is slowing down among those aged 75-79 due to the administration of boosters. Covid-19 infections have already fallen among those aged 80 and over, where booster coverage is above 80 per cent. It also describes as encouraging a decrease in the number of infections among healthcare workers.

The rise rapid rise of Omicron elsewhere, which is likely to be replicated in Ireland soon, is the big new complicating factor. So all bets are off until clarity on the exact extent of that threat emerges.

Link:
Q&A: All you need to know on getting the Moderna vaccine as a booster - The Irish Times

Humans have always been fascinated with the concept of immortality but what seems to be even more exciting to some is the thought of using technology to make immortality a real-world application. A movement called transhumanism is even devoted to using science and technology to augment our bodies and our minds, and to allow humans to merge with machines, eradicating old age as a cause of death. So the big question is can we really evade death?

From Hans Moravecs classic book Mind Children to Gene Roddenberrys iconic TV series Star Trek: The Next Generation, the idea of uploading a persons feelings, memories, and experiences onto a machine, has been explored in many popular non-fiction and fiction works. However, whether or not mind uploading could become a reality, like 3D printers, robots, and driverless cars? We are yet to find out.

Mind uploading describes a hypothetical process of separating a persons consciousness (which involves their emotions, thought process, experiences, and basically everything that makes a person unique), then converting it into a digital format, and finally transferring the digital consciousness into a different substrate, like a machine.

The process would conceivably incorporate different steps, like mind copying, mind transfer, mind preservation, and whole brain emulation (WBE). Here is a detailed overview of how mind uploading can actually work:

The human brain regularly performs complex processes with the help of its 86 billion neurons that function simultaneously in a large neural network. And the complexity does not stop there. There aremore than 125 trillion synapsesjust in the cerebral cortex alone. That is a lot of information and storage capacity. Some have suggested that, in order to completely replicate an individual's brain, it would be necessary to first dissect the brain.

However, mind uploading advocates claim that noninvasive brain scans can provide sufficient resolution for copying the brain without actually killing the person to do it. The information stored in our brain would then be used to create aconnectome, a complete map of the neural connections in the brain, created using incredibly precise scanning of the neurons, and the synapses.

However, to date, we only have a complete connectome for a 1.5-millimeter roundworm called Caenorhabditis elegans, which has just 302 neurons and about seven thousand synaptic connections.In 2014, theOpenWorm projectwhich mapped the brain replicated it as software and installed it in a Lego robot which was capable of the same sensory and motor actions as the biological model.

Building a human connectome is clearly a much more complicated process. Even in the case of the C. elegans, researchers had to work for more than a decade to understand the organisms neuronal pathway.

Now imagine how much time and resources will be required for the identification of about 86 billion neurons, determination of their precise location, and tracing and cataloging of their projections on one another. Building and interpreting even a single human connectome is inconceivable using existing technologies.

Another proposed method of getting information from the brain is through a brain-computer interface (BCI). There are already existing implanted devicesthat can translate some types of neuronal information into commands, and arecapable of controlling external software or hardware, such as a robotic arm.However, modern BCIs are only very slightly related to the theoretical BCIs which would be needed to allow us to transfer our brain states into a digital medium.

Brain-computer interfaces which would allow mind uploading would need a technology similar to modern-day brain scanning technology. Some suggest that downloading consciousness would require technology capable of scanning human brains at a quantum particle level.

Elon Musks Neuralink is one company working on aspects of mind-uploading. They are designing a neural implant which would work "like a Fitbit in your skull". It would have many micron-scale electrode threads connected to different parts of the brain. While this technology is showing some promise in allowing humans to interface with computers in a limited way, it is not close to the technology needed to upload an entire brain.

Neuralinks website mentions that their chip will kick off a new kind of brain interface technology and as it develops further, they will be able to increase the channels of communication with the brain, accessing more brain areas and new kinds of neural information.

Some wealthy individuals who wish to live foreverare opting to preserve their brains and sometimes bodies through cryopreservation. In theory, in the future when human connectome technology is fully developed, their consciousness could then be retrieved and uploaded. An American cryonics company Alcor Life Extension Foundation already stores around 180 cryopreserved human bodies (with more preserving just their head) at its Phoenix-based facility.

However, some experts also claim that such cryonic techniques may damage the brain beyond repair.

Recently, an MIT graduate Robert McIntyre, rekindled the brain preservation hype when he announced his Y-Combinator backed startup Nectome is building some next-generation tools to preserve brains in the microscopic detail needed to map the connectome.

While previously working at a cryo research firm 21st Century Medicine, McIntyre along with cryobiologist Greg Fahy developed a method that combines embalming with cryonics. Fahy suggests that through this technique they could preserve the entire brain to the nanometer level, including the connectome. They even received an $80,000 science prize from the Brain Preservation Foundation for preserving a pigs brain so well that every synapse inside it could be seen with an electron microscope.

One element of this process that may give some pause for thought, however, is that the "brain embalming" needs to take place while the person is still alive. The company hopes the process will be allowed as part of doctor-assisted suicide programs. Even if it does not lead to an uploading technology, any brains that Nectome manages to preserve might help in the research towards building the human connectome.

Once all the neural activity is mapped out and the connectome is ready, the next step would be to digitize it. According to a rough estimate published in Scientific American, the memory storage capacity of the human brain could be around 2.5 Petabytes (2,500 TB).

While the popular notion is that we only use 10% of our brain, neurologists say this is actually a myth and we actually use almost all of our brain, all the time. That's a lot of storage.

Apart from the storage, we will require a computer architecture on which the brain can be reconstructed in the form of computable code. And there is the issue of power for that architecture.Today, a computer with the same memory and processing power as the human brain would require around 1 gigawatt of power, or "basically a whole nuclear power station to run one computer that does what our 'computer' does with 20 watts," according to Tom Bartol, a neuroscientist at the Salk Institute.

In computing, artificial neural networks (ANN) have been created which are inspired by the biological neural networks. An ANN is based on a collection of connected units or nodes which loosely model the neurons in a biological brain. However, there are some major differences between an ANN and a human (or animal) brain:

Also, the human brain uses approximately 300 times more parameters (neurons combined with synapses) as compared to GPT3, the largest artificial neural network ever built.

Once all the requirements are fulfilled and the artificial brain is ready, the mind can now be uploaded into a simulation, such as a virtual world,like the metaverse, or into a network of artificial brains connected to each other in a swarm (also called hive mind). Another transhumanist idea suggests that the mind can also be uploaded on a humanoid robot. Uploading into a physical robot would require robots that are a lot more functional than any that currently exist.

However, if the consciousness is uploaded as a substrate-independent mind (SIM), and if the SIM is deemed to be conscious, then it will also need toexist in a place and be able to interact with things. This will require virtual reality that is identical to how humans experience actual reality, everything from tasting a soda to feeling the pain of a car accident. All of this will require yet more storage capacity, signal bandwidth, and power.

Neuroscientist Michael Hendricks from McGill University called mind uploading an abjectly false hope in his 2015 report published in the MIT Technology Review. According to Hendricks, scientists still dont know exactly what kind of technology can allow them to replicate a human mind.

In his report, Hendricksalso raised doubts about the success of current or foreseeable freezing methods for brain preserving, as well as methods for retrieving the information stored in the human brain. Furthermore, as an expert on the neural activity of the C. Elegans roundworm, he says that having a connectome is by itself not a sufficient condition to simulate a nervous system.

Even once we figure out the technical side of whole brain emulation, there's still the philosophical part of the equation. Would that emulation still be you? Answering that will require a great deal of thinking about what it is that constitutes consciousness and identity something there is no clear answer to.

Another study reveals, that depending on their personal views on death, suicide, fiction, philosophy, and science, some people may show great support for mind uploading, while others strongly disapprove of any such practice.

Sure, mind uploading has the potential to change human lives forever, but this is also why the advent of this sci-fi technology in the real world might also give rise to a lot of conflicts revolving around its ethical and social impact on humanity.

Steve Jobs once said, "Death is very likely the single best invention of Life. It is Life's change agent. It clears out the old to make way for the new." If this is true, then defeating death by mind uploading may in fact be self-defeating. It would allow a few individuals to go on, but at the expense of everything and everyone else.

For now, a number of scientists, researchers, and tech companies are working towards making mind uploading a reality. Whether they would be successful or not, and how our society would react to consciousness transfer, only the future could tell.

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Will We Ever Cheat Death and Become Immortal With Mind Uploading? - Interesting Engineering