Today, the U.S. Food and Drug Administration is providing an update on its multipronged response to monkeypox in the United States, including its efforts in the areas of diagnostics, vaccines and therapeutics. The agency has also established a dedicated website to provide important information about the FDA’s ongoing regulatory activities related to monkeypox along with frequently asked questions. The FDA will provide updates as developments occur and will continue to work with federal public health partners and industry to ensure timely access to all available medical countermeasures.
“The FDA has been closely tracking reports of monkeypox transmissions in the United States with our federal public health partners and coordinating preparedness efforts accordingly,” said FDA Commissioner Robert M. Califf, M.D. “We understand that while we are still living with COVID-19, an emerging disease may leave people feeling concerned and uncertain, but it’s important to note that we already have medical products in place, specifically an FDA-approved vaccine for the prevention of monkeypox disease and an FDA-cleared diagnostic test. The FDA is using the full breadth of its authorities to make additional diagnostics and treatments available. We will continue to collaborate with our partners across all sectors to expand accessibility to countermeasures and bolster the tools in our arsenal as appropriate.”
The monkeypox virus is part of the same family of viruses as variola virus, the virus that causes smallpox (a virus that has been eradicated globally). Both monkeypox and smallpox fall into the category of “orthopoxviruses.” Monkeypox is generally not fatal and typically resolves on its own without treatment. The current outbreak in the U.S. usually presents as a rash on the body, face or genital area. Although there is a very low risk of dying, there have been reported complications including severe pain, at times requiring hospital admission.
Diagnostics
Since the first case of monkeypox in the U.S. was detected, the FDA has been working with commercial laboratories and manufacturers to make monkeypox tests more readily available to consumers who need them. The Centers for Disease Control and Prevention (CDC) has an FDA-cleared non-variola orthopoxvirus test that can detect monkeypox by a swab from a monkeypox lesion (rash or growth). At this time, this is the only FDA-cleared test. The FDA is not aware of clinical data supporting the use of other sample types, such as blood or saliva, for monkeypox virus testing. In July 2022, the FDA issued a safety communication advising people to use swab samples taken directly from a lesion when testing for the monkeypox virus.
The FDA-cleared monkeypox test is being offered by the CDC and throughout many laboratories that include the CDC’s public health Laboratory Response Network. In addition, federal public health authorities have worked with industry to make the test available through five large commercial laboratories. The agency is working closely with the CDC to increase production of its FDA-cleared test and the FDA has cleared the use of additional reagents and instruments to increase the throughput of the CDC test.
The FDA will continue to work with the diagnostic community to augment access to accurate testing to support the response.
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Vaccines
In 2019, the FDA approved the JYNNEOS Vaccine for the prevention of smallpox and monkeypox in adults 18 years of age and older determined to be at high risk of infection. JYNNEOS is the only vaccine approved for the prevention of monkeypox in the United States. Although clinical trials and data are limited because of the small number of cases until now, the immunological response to vaccine administration is consistent with effective prevention of the disease.
Following the emerging public health crisis closely, the FDA was aware that there were close to 800,000 doses of this vaccine pending release this fall following approval of additional manufacturing capabilities at one of the plants where the vaccine is made. With this in mind, the agency worked with HHS partners and expedited the submission of the required application for the company’s manufacturing changes in order to make these doses available to those in need. After accelerating the timeline for an inspection of the plant from fall to earlier this month, the FDA has finished its evaluation of the required information to validate product quality and has determined that the vaccine meets its quality standards.
On July 26, the agency approved a supplement to the biologics license for the JYNNEOS Vaccine, to allow for additional manufacturing capabilities at the facility. Given the emerging public health need, the FDA previously facilitated the shipment of manufactured doses to the U.S. so that they would be ready to be distributed once the manufacturing changes were approved. With the supplement approval, those manufactured doses may now be further distributed and administered. Additional doses manufactured at this plant can help address the need for this vaccine moving forward.
Therapeutics
There is no FDA-approved or authorized medicine for the treatment of monkeypox disease; however, TPOXX (tecovirimat), an antiviral medication, is being made available through the CDC under an FDA authority called Expanded Access or “compassionate use.” The FDA continues to work with the CDC to streamline their Expanded Access Program for monkeypox to facilitate access.
There are currently no human data demonstrating the efficacy of TPOXX for the treatment of monkeypox, or the safety and pharmacokinetic profile (which helps us understand what the human body does to a drug). Although expanded access program is available, conducting randomized, controlled trials to assess TPOXX’s safety and efficacy in humans with monkeypox infections is essential.
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The FDA has more information on TPOXX’s approval for smallpox under the “Animal Rule” regulations on its monkeypox webpage.
Rod: A creative force, blending words, images, and flavors. Blogger, writer, filmmaker, and photographer. Cooking enthusiast with a sci-fi vision. Passionate about his upcoming series and dedicated to TNC Network. Partnered with Rebecca Washington for a shared journey of love and art.
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Rod: A creative force, blending words, images, and flavors. Blogger, writer, filmmaker, and photographer. Cooking enthusiast with a sci-fi vision. Passionate about his upcoming series and dedicated to TNC Network. Partnered with Rebecca Washington for a shared journey of love and art.
Workers who are in frequent contact with potentially sick animals are at high risk of bird flu infection.
Costfoto/NurPhoto via Getty ImagesRon Barrett, Macalester College
Disease forecasts are like weather forecasts: We cannot predict the finer details of a particular outbreak or a particular storm, but we can often identify when these threats are emerging and prepare accordingly.
The viruses that cause avian influenza are potential threats to global health. Recent animal outbreaks from a subtype called H5N1 have been especially troubling to scientists. Although human infections from H5N1 have been relatively rare, there have been a little more than 900 known cases globally since 2003 – nearly 50% of these cases have been fatal – a mortality rate about 20 times higher than that of the 1918 flu pandemic. If the worst of these rare infections ever became common among people, the results could be devastating.
Approaching potential disease threats from an anthropological perspective, my colleagues and I recently published a book called “Emerging Infections: Three Epidemiological Transitions from Prehistory to the Present” to examine the ways human behaviors have shaped the evolution of infectious diseases, beginning with their first major emergence in the Neolithic period and continuing for 10,000 years to the present day.
Viewed from this deep time perspective, it becomes evident that H5N1 is displaying a common pattern of stepwise invasion from animal to human populations. Like many emerging viruses, H5N1 is making incremental evolutionary changes that could allow it to transmit between people. The periods between these evolutionary steps present opportunities to slow this process and possibly avert a global disaster.
Spillover and viral chatter
When a disease-causing pathogen such as a flu virus is already adapted to infect a particular animal species, it may eventually evolve the ability to infect a new species, such as humans, through a process called spillover.
Spillover is a tricky enterprise. To be successful, the pathogen must have the right set of molecular “keys” compatible with the host’s molecular “locks” so it can break in and out of host cells and hijack their replication machinery. Because these locks often vary between species, the pathogen may have to try many different keys before it can infect an entirely new host species. For instance, the keys a virus successfully uses to infect chickens and ducks may not work on cattle and humans. And because new keys can be made only through random mutation, the odds of obtaining all the right ones are very slim.
Given these evolutionary challenges, it is not surprising that pathogens often get stuck partway into the spillover process. A new variant of the pathogen might be transmissible from an animal only to a person who is either more susceptible due to preexisting illness or more likely to be infected because of extended exposure to the pathogen.
Even then, the pathogen might not be able to break out of its human host and transmit to another person. This is the current situation with H5N1. For the past year, there have been many animal outbreaks in a variety of wild and domestic animals, especially among birds and cattle. But there have also been a small number of human cases, most of which have occurred among poultry and dairy workers who worked closely with large numbers of infected animals.
Pathogen transmission can be modeled in three stages. In Stage 1, the pathogen can be transmitted only between nonhuman animals. In stage 2, the pathogen can also be transmitted to humans, but it is not yet adapted for human-to-human transmission. In Stage 3, the pathogen is fully capable of human-to-human transmission.Ron Barrett, CC BY-SA
Epidemiologists call this situation viral chatter: when human infections occur only in small, sporadic outbreaks that appear like the chattering signals of coded radio communications – tiny bursts of unclear information that may add up to a very ominous message. In the case of viral chatter, the message would be a human pandemic.
Sporadic, individual cases of H5N1 among people suggest that human-to-human transmission may likely occur at some point. But even so, no one knows how long or how many steps it would take for this to happen.
Influenza viruses evolve rapidly. This is partly because two or more flu varieties can infect the same host simultaneously, allowing them to reshuffle their genetic material with one another to produce entirely new varieties.
Genetic reshuffling – aka antigenic shift – between a highly pathogenic strain of avian influenza and a strain of human influenza could create a new strain that’s even more infectious among people.Eunsun Yoo/Biomolecules & Therapeutics, CC BY-NC
These reshuffling events are more likely to occur when there is a diverse range of host species. So it is particularly concerning that H5N1 is known to have infected at least 450 different animal species. It may not be long before the viral chatter gives way to larger human epidemics.
Reshaping the trajectory
The good news is that people can take basic measures to slow down the evolution of H5N1 and potentially reduce the lethality of avian influenza should it ever become a common human infection. But governments and businesses will need to act.
People can start by taking better care of food animals. The total weight of the world’s poultry is greater than all wild bird species combined. So it is not surprising that the geography of most H5N1 outbreaks track more closely with large-scale housing and international transfers of live poultry than with the nesting and migration patterns of wild aquatic birds. Reducing these agricultural practices could help curb the evolution and spread of H5N1.
Large-scale commercial transport of domesticated animals is associated with the evolution and spread of new influenza varieties.ben/Flickr, CC BY-SA
People can also take better care of themselves. At the individual level, most people can vaccinate against the common, seasonal influenza viruses that circulate every year. At first glance this practice may not seem connected to the emergence of avian influenza. But in addition to preventing seasonal illness, vaccination against common human varieties of the virus will reduce the odds of it mixing with avian varieties and giving them the traits they need for human-to-human transmission.
At the population level, societies can work together to improve nutrition and sanitation in the world’s poorest populations. History has shown that better nutrition increases overall resistance to new infections, and better sanitation reduces how much and how often people are exposed to new pathogens. And in today’s interconnected world, the disease problems of any society will eventually spread to every society.
For more than 10,000 years, human behaviors have shaped the evolutionary trajectories of infectious diseases. Knowing this, people can reshape these trajectories for the better.Ron Barrett, Professor of Anthropology, Macalester College
This article is republished from The Conversation under a Creative Commons license. Read the original article.
SAN DIEGO, CA, USA /EINPresswire.com/ — Missing teeth can have obvious consequences for your smile, but many people are not aware of how tooth loss affects their oral health, general well-being, and even their facial shape. Once a tooth is detached from the gums, there is no tooth root to stimulate the underlying jawbone; unfortunately, this often causes the bone structure to recede and lose volume. Bone loss can raise a number of aesthetic and functional concerns — particularly when a tooth has been without a replacement for a significant amount of time — including the shifting of surrounding teeth, an increased risk of gum disease, and changes in your jaw structure. In general, greater bone loss is experienced the longer an absent space remains unfilled. While jawbone recession can be debilitating, San Diego cosmetic dentist Landon Libby, DDS discusses potential solutions for bone loss to prevent further damage and regenerate additional bone density.
According to Dr. Libby, implant dentistry can offer a myriad of benefits for individuals with missing teeth, including the ability to maintain bone volume and preserve the full integrity of the jawbone after tooth loss. Using dental implants, implant dentistry aims to replace a missing tooth with an artificial tooth root and a custom-made restoration indistinguishable from a patient’s natural teeth. A titanium post is implanted into the jawbone during treatment, which serves as the “replacement” tooth root. Unlike other tooth replacement options that are not surgically affixed to the underlying bone, dental implants and implant-supported restorations promote new bone regeneration. Not only can this enhance a patient’s oral health and strengthen their jawbone, but implant restorations are also considered to look and feel the most similar to natural teeth. Best of all, implants can be used to replace a single tooth, multiple teeth in a row, or even a full dental arch.
It’s important to understand that every patient may not be a good candidate for dental implants, and bone grafting may be necessary prior to treatment to provide more support for implant placement. As a multi-stage process involving oral surgery, Dr. Libby stresses the importance of selecting an experienced, compassionate, and qualified dental team to place implants and provide a seamless patient experience.
About Landon Libby, DDS Dr. Landon Libby is a Mission Valley-based cosmetic dentist who provides cosmetic, restorative, and family dentistry treatments for patients in and around San Diego. As a DOCS-certified dentist with training in sedation dentistry, Dr. Libby strives to enhance patient comfort during every stage of treatment and redefine what it means to “go to the dentist.” After receiving his Doctor of Dental Surgery (DDS) from the Loma Linda University School of Dentistry, Dr. Libby went into private practice and has been serving the dental needs of the San Diego community for years. Dr. Landon Libby is available for interview upon request.
PUNE, MAHARASHTRA, INDIA /EINPresswire.com/ — Healthcare Education Market Perspective
The Global Healthcare Education Market size was worth USD 103.64 billion in 2022 and is estimated to grow to USD 202.75 billion by 2030, with a compound annual growth rate (CAGR) of approximately 8.75% over the forecast period. The report analyzes the healthcare education market’s drivers, restraints/challenges, and their effect on the demands during the projection period. In addition, the report explores emerging opportunities in the healthcare education market.
Medical professionals watching webinar on online platform. People having virtual class flat vector illustration. Online education, medicine concept for banner, website design or landing web page
Healthcare Education Market Developments
• In 2023, HealthStream (US) purchased Electronic Education Documentation System, LLC (US). This acquisition will broaden Healthstream’s ecosystem by bringing a cutting-edge, cloud-based continuing education management system for healthcare organizations and delivering cutting-edge solutions in the form of Software-as-a-Service (SaaS).
• In 2022, To promote access for surgeons and benefit more patients across the US, GE Healthcare (US) and DePuy Synthes (US) worked together to make GE Healthcare’s OEC 3D Imaging System and DePuy Synthes’ extensive product line more widely available.
Increasing need for skilled healthcare workers to drive market growth
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The market for healthcare education is expanding significantly due to the increasing need for skilled healthcare workers. The market for healthcare education is being significantly shaped by the growing demand for qualified healthcare workers. The demand for skilled physicians, nurses, allied health workers, and administrators who can deliver high-quality healthcare services is rising as the world’s population continues to expand and get older. The rising incidence of chronic illnesses and complicated medical disorders that need specialized care has increased this demand. Additionally, the need for healthcare professionals is growing outside conventional clinical responsibilities. The demand for non-clinical positions such as healthcare administrators, informatics experts, and others is also growing. As a result, healthcare education incorporates a variety of academic fields to produce a workforce that is well-rounded and able to meet the many demands of the healthcare sector.
Healthcare Education Market: Regional Landscape
Asia Pacific dominated the Healthcare Education market in 2022
There is a sizable and constantly expanding population in the Asia Pacific region, which generates a sizable demand for healthcare services. The demand for qualified and trained healthcare personnel grows proportionally as healthcare systems enlarge to meet this demand. Additionally, greater investments in healthcare infrastructure, including educational institutions, have been made as a result of the Asia Pacific region’s economic expansion. Governments and commercial organizations are becoming more aware of how crucial a strong healthcare education system is to the development of healthcare services.
Healthcare Education Market Top Players: Stryker (US), SAP (Germany), Adobe (US), Infor (US), Oracle (US), HealthStream (US), Symplr (US), Elsevier (Netherlands), Articulate (US), PeopleFluent (US), Fujifilm Corporation (Japan), GE Healthcare (US), Trivantis Corporation (US), Koninklijke Phillips (Netherlands), Siemens Healthineers (Germany), Coursera (US), and IBM (US).
Healthcare Education Market: Segmentation
The global healthcare education market has been segmented into provider, delivery mode, application, and end-user.
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Based on universities, educational platforms, and medical simulation are segments of the global healthcare education market. The university segment to improve the business and department workers, the requirement for continuous learning in a field that is rapidly evolving, partnerships with healthcare organizations, and the emphasis on patient-centered care and interprofessional collaboration are all factors driving the growth of universities and academic institutions in the market for healthcare education solutions. The aforementioned elements help healthcare education programs grow and evolve to satisfy industry demands.
Based on delivery mode, the market is classified into classroom-based, and e-learning. In 2022, the e-learning processing category dominated the global market. Due to a variety of online learning platforms, students have access to educational resources like lectures, videos, quizzes, and other resources in a digital setting. Students can learn at their own pace and convenience in e-learning environments, which usually offer flexibility. Coursera, Blackboard, and Moodle are a few popular e-learning platforms. Because of the COVID-19 pandemic, e-learning platforms have proliferated as a medium of delivery, and this trend is anticipated to continue during the projected period. The overall revenue for Coursera in 2022 was US$523.8 million, a 26% increase over 2021, while the gross profit was US$249.5 million, a 33% increase over 2021.
Based on application, the market is classified into neurology, cardiology, and pediatrics. In 2022, the cardiology category dominated the global market. It is anticipated that factors including the increased prevalence of cardiovascular diseases (CVD), technological improvements, and online courses will raise demand for educational solutions. According to the WHO’s 2021 update, CVDs encompass illnesses like coronary heart disease, cerebrovascular disease, rheumatic heart disease, and others.
Based on end-users, the market is classified into students and physicians. In 2022, the student category dominated the global market. Student prospects have increased as a result of the growing accessibility and availability of healthcare education alternatives, notably online and remote learning options. Students can learn at their own pace, from any location, at any time, and with the help of digital tools and online platforms. This accessibility makes it easier for people from different backgrounds to enter the healthcare industry by allowing students to pursue healthcare education while juggling other responsibilities.
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Ron Barrett, Professor of Anthropology, Macalester College
This article is republished from The Conversation under a Creative Commons license. Read the original article.
