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The Rise of Thermostable Vaccines: A Story of Future Innovation and Global Impact

thermostable

The Rise of Thermostable Vaccines: A Story of Future Innovation and Global Impact

In the world of public health, few advancements hold as much promise as thermostable vaccines. These remarkable innovations are rewriting the rules of immunization, offering a beacon of hope for communities worldwide. Join us on a journey through the landscape of vaccine development, where science meets humanity in the quest to safeguard lives and build a healthier future.

The Quest for Stability In the early 21st century, traditional vaccines faced a formidable challenge: the need for constant refrigeration. This requirement posed a significant barrier to global immunization efforts, particularly in remote and underserved regions. But amidst this challenge, a new frontier emerged – thermostable vaccines.

Breaking Barriers, Saving Lives Thermostable vaccines hold the key to overcoming logistical hurdles that once hindered vaccine distribution. With the ability to withstand fluctuations in temperature, these vaccines promise to reach the farthest corners of the globe, bringing protection to those who need it most.

The Tuberculosis Breakthrough In 2023, the world witnessed a pivotal moment in the fight against tuberculosis. The Access to Advanced Health Institute unveiled a groundbreaking thermostable vaccine, poised to combat one of humanity’s oldest foes. With its innovative design and enduring stability, this vaccine offered hope to millions grappling with the burden of TB.

Lessons from COVID-19 The COVID-19 pandemic underscored the urgent need for resilient vaccines. As nations grappled with the complexities of vaccine distribution, thermostable formulations emerged as a beacon of hope. Pfizer-BioNTech and Moderna led the charge, developing thermostable versions of their COVID-19 vaccines to navigate the challenges of global distribution.

Equity and Access At the heart of the thermostable vaccine revolution lies a commitment to equity and access. Organizations like UNICEF rallied behind the cause, spearheading efforts to ensure that no community is left behind. From rural villages to bustling urban centers, thermostable vaccines are leveling the playing field, offering equal protection to all.

Regulatory Roadblocks Yet, the path to widespread adoption is not without its obstacles. Regulatory hurdles loom large, demanding rigorous testing and scrutiny. Vaccine developers navigate a maze of approvals, striving to meet the stringent standards set forth by regulatory agencies. Despite the challenges, the pursuit of safety and efficacy remains paramount.

A Vision for Tomorrow As we gaze towards the horizon, the future of immunization shines bright. Thermostable vaccines stand as a testament to human ingenuity and resilience, offering a lifeline to generations yet unborn. With each milestone, we inch closer to a world where preventable diseases are a relic of the past, and health is a universal right.

A Call to Action In the tapestry of global health, every thread counts. As we celebrate the triumphs of thermostable vaccines, let us heed the call to action. Let us stand united in our commitment to build a world where health knows no boundaries, and every life is cherished. Together, we can turn the tide of history and pave the way for a brighter, healthier future.

About Author

Namrata Bukshet isn’t just a market researcher; she’s a detective, a storyteller, and a champion for healthier lives. Her journey began with a Bachelor of Pharmacy degree and a thirst for knowledge that led her to pursue a Post Graduate Diploma in Pharmaceutical Management. Her curiosity for consumer behaviour and market trends burned bright. She delved deep into the world of lifestyle disorders, conducting extensive research that sheds light on the intricate dance between personal choices and societal pressures. This exploration culminated in a groundbreaking paper on “E-Biz: India’s 1st G2B Online Portal,” presented at an international conference, where her insights resonated with a global audience.

Report Source: https://www.towardshealthcare.com/insights/thermostable-vaccine-market-sizing

 

FDA

Understanding FDA Oversight for Global Healthcare Products

According to Deloitte, the healthcare industry is on the way to becoming 26% of the GDP, exceeding $12 trillion by 2040. The development of new drugs and high-tech medical devices continues to evolve, providing much needed care for individuals with various ailments, and contributing hefty profits to manufacturers. Though it can appear the healthcare industry is quite lucrative, it is up to multiple global regulatory bodies to ensure drugs and medical devices meet strict standards, ensuring safety for patients, providers, and manufacturers.

The Food and Drug Administration (FDA) has these processes in place both in the US and internationally, regulating imported and exported goods to prevent exploitation and maximize safety, preventing fraudulent drugs and devices from entering the market. Below you’ll find valuable information concerning how the FDA oversees global trade and what regulations exist for these manufacturers.

How Does the FDA Oversee International Trade?

Anything product or device that affects the health of the body will be regulated by the FDA.

 Their reach extends into different areas of the healthcare, agricultural, and consumer goods industries, including:

  • Tobacco products;
  • Cosmetic products;
  • Pet food;
  • Veterinary devices;
  • Vaccines;
  • Surgical implants, prosthetics, and other medical devices;
  • Over-the-counter and prescription drugs;

The FDA will review these goods that are imported and exported from and to other countries to make sure they fit within proper safety parameters and will not harm the public. Both commercial and personal imports will be subject to review– these goods can be denied entry if they are deemed illegal to sell, contaminated, or willfully mismarketed.

One case study in particular offers a glimpse into how the FDA can exert its regulatory powers over product manufacturers. The FDA reserves the right to inspect the premises of any manufacturer that operates within the scope of their control and can inspect facilities overseas that intend to import goods to the US. When reviewing the premises of Nippon Fine Chemical Co., Ltd in Japan, FDA inspectors were prevented by Nippon staff members from viewing the quality control lab, something that indicated improper operational procedures to the inspectors.

The FDA diligently followed up on complaints of contaminated drugs distributed from this manufacturer. Their findings, which were limited due to the imposition of the workers, forced the FDA to bar the manufacturer from exporting any goods to the US. 

Drug and Medical Device Import Regulation Processes

There are a few different ways the FDA regulates the production and trade of drug and medical device goods. For imported drug and medical device products, you cannot ship unapproved pharmaceuticals and devices, even if they are not for commercial use. Any drug and medical device products may be inspected by the US Bureau of Customs & Border Protection upon entry to the country. 

Overseas drug manufacturers importing goods to the US must register their businesses with the FDA: Federal Register Notice, which includes providing information about all the commercial drugs and devices produced and distributed by the manufacturer. Should the FDA require a more thorough review of the imported goods, the manufacturer has the ability to send the shipment to a third storage location, where the FDA will be able to access and assess the goods accordingly. From there, this information will undergo an Automated Electronic Review, which involves using analytics software to determine the risk of injury when using the imported goods. 

Customs should always be notified of the shipment and arrival of commercial healthcare products. When shipping products to the US, manufacturers must include information about their company and facility, the products included in the shipment, and any registration or approval confirmation for the production of the drug. This communication can be handled by a broker through a system provided by Customs called the Automated Commercial Environment, which provides a correspondence link between the broker/manufacturer, Customs, and the FDA.

The FDA always retains the right to refuse imports that do not comply with the Federal Food, Drug, and Cosmetic Act, except for in certain cases, such as with imports that are not intended for use or sale in the US. Manufacturers can submit an appeal, which may include updating the product or shipping details to comply with the Act.

Meeting FDA Standards and Establishing Safety Protocols in Drug and Medical Device Manufacturing

As long as you have every intention to produce and distribute a safe product, you will naturally fall in line with FDA regulations. To prepare for importing goods, set up a strategic plan that involves outlining your objectives, managing the import plan, and delegating tasks accordingly, along with setting clear objectives so your team understands the regulatory process and what steps are required of them.

First and foremost, the manufacturing facility and processing plant for drugs and medical devices must be sanitary. All products must be packed in a sanitary manner as well. Drugs and medical devices must not have any evidence of “adulteration”, which refers to contamination through filth or illegal substances.

It is also crucial to have accurate labels on all of your products that are imported to the US. Should one shipment of goods be labeled for pharmaceuticals, they should never contain X-ray equipment, prosthetics, or any other products that are outside of what has been specifically labeled.

You should also be careful and compliant when filling out any paperwork associated with the imports of healthcare goods. Register your business and the import appropriately, give notice of the shipment to Customs, and offer any and all additional paperwork the FDA may require upon their initial inspection of the goods. Should you refuse or not meet any of these standards, the FDA can detain the products until a hearing has been brought forth. If the goods are deemed illegal or not in compliance with FDA standards, they will be sent back to the exporter or they can be destroyed, causing you as a manufacturer to lose out on a great deal of money.

market

Pediatric Pharma Boom: Surging to $363.86 Billion by 2032, Transforming Child Health Globally!

The global pediatric drugs market is undergoing a significant transformation, poised to reach a staggering USD 363.86 billion by 2032 from its estimated USD 115.6 billion in 2022. This remarkable growth, at a CAGR of 12.2%, is fueled by a surge in pediatric disorders and an increasing global pediatric population. The pharmaceutical landscape is witnessing groundbreaking innovations tailored specifically for children, driven by initiatives like the WHO’s prioritization of pediatric antibiotic compositions.

Innovation Driving Market Growth:

Advancements in pediatric research, a broader spectrum of clinical trials, and increased investment in personalized medications for children are propelling the pediatric drugs market forward. Pharmaceutical and biotechnology companies are focusing on developing drugs designed for the unique needs of pediatric patients. For instance, Aurobindo Pharma’s release of an HIV triple combination medicine for pediatric patients in low- and middle-income countries showcases the industry’s commitment to pediatric drug formulations.

Recent Pediatric Oncology Drug Approvals:

The pharmaceutical sector is witnessing remarkable progress in pediatric oncology drugs, with recent FDA approvals including Debrafenib and Trametinib for treating low-grade glioma in children aged 1 and older. Nivolumab, approved for adults and children aged 12 and above with melanoma, and Crizotinib for refractory inflammatory myofibroblastic tumor in pediatric patients aged 1 and older, reflect the industry’s dedication to addressing childhood cancers.

Specialized Pharmaceuticals Driving Growth:

The demand for specialized pharmaceuticals tailored to pediatric requirements is escalating, driven by the rising prevalence of health issues such as obesity, diabetes, asthma, and neurological disorders in children. The pharmaceutical industry recognizes the unique physiological and developmental characteristics of children, leading to increased research and development efforts for drugs specifically designed for this demographic.

Respiratory Disorders Dominating the Market:

Respiratory disorder drugs hold the largest market share in the pediatric drugs market, driven by compromised immunity, heightened pollution levels, and increased allergen exposure leading to chronic respiratory disorders like Chronic Obstructive Pulmonary Disease (COPD). The market is further fueled by initiatives to develop drugs for rare autoimmune disorders, contributing to the overall growth of the pediatric drugs market.

Rising Prevalence of Diseases in Pediatric Population:

The pediatric drugs market is witnessing robust growth due to the increasing incidence of chronic disorders, including anorexia, asthma, diabetes, childhood cancer, and attention deficit hyperactivity disorder (ADHD). The surge in chronic disorders emphasizes the crucial role of pediatric drugs in safeguarding and improving the well-being of children globally.

Advancement in Healthcare Infrastructure:

The escalation of healthcare investment is playing a pivotal role in shaping the trajectory of the pediatric drug market. Increased healthcare expenditure, coupled with efforts to enhance healthcare infrastructure, is fostering market growth. The awareness among parents, caregivers, and healthcare practitioners is also contributing to the demand for pediatric medications, with governments introducing incentives to encourage research and development in this field.

Market Segmentation:

The pediatric drugs market is segmented by drug type, route of administration, distribution channel, and geography. Key drug types include antibiotics, analgesics, antipyretics, respiratory drugs, gastrointestinal drugs, central nervous system drugs, vaccines, and others. The route of administration encompasses oral, topical, parental, and distribution channels include hospital pharmacies, retail pharmacies, and online pharmacies.

Geographical Landscape:

North America dominates the pediatric drugs market, driven by rising healthcare spending, a supportive regulatory framework, and a significant pediatric patient demographic. Asia-Pacific is poised for significant growth, fueled by an expanding pediatric population and increased healthcare investments.

Key Market Players:

Leading pharmaceutical companies such as Pfizer Inc., Novartis International AG, GSK plc., Sanofi S.A., AstraZeneca plc, Merck & Co., Inc., Johnson & Johnson, Roche Holding AG, Eli Lilly and Company, and Abbott Laboratories are at the forefront of shaping the pediatric drugs market.

Conclusion:

The pediatric drugs market is experiencing unprecedented growth, driven by innovation, a focus on specialized pharmaceuticals, and a rising prevalence of pediatric disorders. The industry’s commitment to addressing the unique therapeutic needs of children, coupled with advancements in healthcare infrastructure, positions pediatric drugs as a crucial component in safeguarding the health and well-being of the global pediatric population.

Report Source: https://www.towardshealthcare.com/insights/pediatric-drugs-market

smart healthcare HRSA

Revolutionizing Healthcare: The Meteoric Rise of Smart Healthcare and Its Global Impact

Introduction:

The healthcare landscape is undergoing a transformative journey, fueled by the integration of advanced technologies. The global smart healthcare market is on a trajectory of unprecedented growth, projected to reach an estimated USD 1,097.27 billion by 2032, with a staggering 18.5% Compound Annual Growth Rate (CAGR) from 2023-2032. At the heart of this revolution is the surging popularity of telemedicine, a testament to the paradigm shift from passive patient care to active participation empowered by technology.

From Passive Patients to Active Participants: Empowering Healthcare with Technology:

Smart healthcare harnesses cutting-edge technologies, including Artificial Intelligence (AI), the Internet of Things (IoT), and big data analytics, to enhance the quality and efficiency of healthcare services. Telemedicine, electronic health records (EHR), remote patient monitoring, and healthcare information exchange (HIE) are among the innovative solutions driving this sector forward. This shift is not just about improving patient outcomes but also about enhancing the overall healthcare experience and increasing operational efficiency in healthcare organizations.

Telemedicine: Bridging Healthcare Gaps Virtually:

Telemedicine, or telehealth, stands as a frontrunner in the smart healthcare revolution. Allowing healthcare professionals to diagnose and treat patients remotely, telemedicine has become indispensable, particularly in regions facing a shortage of healthcare professionals. As of 2022, it held the lion’s share in the smart healthcare market, contributing to 37.27% of the revenue and is projected to grow at a remarkable CAGR of 12.3% from 2023 to 2032.

The Impact of Telemedicine:

The adoption of telemedicine is propelled by factors such as the scarcity of healthcare professionals, the need for remote monitoring of chronic patients, and the growing demand for virtual consultations. Telemedicine’s significance was further underscored during the COVID-19 pandemic, proving its capability to provide medical care without physical visits to healthcare facilities.

Smart Healthcare Goes Global: Europe and Asia Pacific Leading the Charge:

The global adoption of smart healthcare is not uniform, with Europe and Asia Pacific leading the charge. Europe, accounting for 33.04% revenue share in 2022, is expected to maintain a substantial position with a CAGR of 10.8% from 2023 to 2032. Asia Pacific, projected to register the fastest growth at a CAGR of 13.0% (2023-2032), is embracing smart healthcare due to increasing demand, investments in healthcare infrastructure, and rising chronic diseases.

RPM and Smart Healthcare: Transforming Patient Care:

Remote Patient Monitoring (RPM) is emerging as a game-changer in healthcare, allowing continuous monitoring and care outside traditional healthcare settings. Integrated with wearables and mobile apps, RPM enables early intervention, personalized care, and reduced hospital readmissions. With an aging population and a surge in chronic diseases, RPM is crucial for managing complex medical needs.

Convergence of Self-care, Wellness, and Smart Healthcare:

The convergence of self-care, wellness, and smart healthcare is reshaping the healthcare landscape. Smart healthcare technologies, integrated with wearables and mobile apps, empower individuals to take control of their health. This proactive approach is vital in preventing illnesses, fostering better health outcomes, and reducing healthcare costs in the long run.

Data Defence: Addressing Privacy and Security Challenges:

As smart healthcare relies on sensitive patient data, data security and privacy are paramount. Robust security measures, compliance with regulations like HIPAA and GDPR, regular security audits, and education for patients and employees are essential. Blockchain technology is also being explored to ensure a decentralized, tamper-proof record of patient data.

App-Based PERS: Redefining Emergency Response Systems:

App-based Personal Emergency Response Systems (PERS) are revolutionizing emergency response by providing individuals with immediate access to services via smartphones. Affordable and feature-rich, app-based PERS offer more than just emergency response, incorporating medication reminders, fall detection, and activity tracking. However, challenges such as dependence on reliable internet connectivity and potential privacy concerns should be addressed.

Conclusion:

The smart healthcare revolution is reshaping the healthcare landscape, offering a future where technology empowers individuals to actively participate in their well-being. From the virtual embrace of telemedicine to the transformative potential of RPM and the convergence of self-care and wellness, smart healthcare is a beacon of progress. As we navigate the data security challenges and embrace innovative solutions like app-based PERS, the global impact of smart healthcare is poised to create a healthier, more connected world. With Europe and Asia Pacific leading the way, the journey from passive patients to active participants in healthcare has just begun. The next decade promises to be a remarkable era of technological advancements, improved healthcare outcomes, and a global community taking charge of its well-being.

Report Source: https://www.towardshealthcare.com/insights/smart-healthcare-market-new-technology-meets-medicine

smart healthcare HRSA

DEVELOPED COUNTRIES ARE THE LARGEST IMPORTERS OF HEALTHCARE PROFESSIONALS

Living Longer

Personal and home health aides, registered nurses, and medical and nursing assistants are among the fastest growing occupations in the United States. The U.S. Bureau of Labor Statistics projects 1.2 million new personal and home health aide positions – and the need for another 372,000 registered nurses – by 2028. Due to the shortage of qualified healthcare workers, immigrants held 15 percent of all registered nursing positions in the United States in 2016. On April 22, President Trump signed an Executive Order to pause immigration due to COVID-19, but exempted physicians and nurses.

This is not uncommon in developed countries with a growing aging population who are living longer. About eight percent of nurses in Canada are foreign-trained, 15 percent in the UK, 19 percent in Switzerland and 27 percent in New Zealand. The numbers are higher for foreign-trained doctors: 24 percent in Canada, 28 percent in the UK, 27 percent in Switzerland and 42 percent in New Zealand.

Training for Export

India has the world’s highest number of medical schools and is the world’s largest source of immigrant physicians. An estimated 69,000 Indian-trained physicians worked in the United States, UK, Canada and Australia in 2017, according to the OECD. India is second only to the Philippines in training nurses. Nearly 56,000 Indian-trained nurses work in those same four countries, equal to about three percent of total registered nurses in India.

The Philippines has an established international nursing training program and is the largest exporter of nurses globally – accounting for roughly 25 percent of all overseas nurses worldwide. About 85 percent of employed Filipino nurses work in one of more than 50 countries around the world. In the United States, an estimated 20 percent all the registered nurses in California are Filipino. It’s a strong professional cadre. The Philippine Nursing Association of America represents over 145,000 Filipino nurses and has its own theme song.

% foreign trained nurses and docs in OECD

The “Brain Drain” Concern

Health care professionals migrate for many reasons: continuing education, better pay, the opportunity to send remittances to their families and home nation, the prestige of practicing in another country, and others. Filipino nurses in the United States earn 15 times more than those working in the Philippines. Filipino nurses working abroad remit about $1 billion to the Philippines every year, a substantial portion of total remittances which drives 13 percent of the Philippines’ GDP.

International mobility of health workers is accelerating. The number of migrant doctors and nurses working within OECD countries increased by 60 percent over the last decade, along with significant increases in intraregional mobility and migration of healthcare workers among developing countries.

Public health groups including the World Health Organization (WHO) are concerned that health care immigration reduces the number of professional health workers available to serve their home countries. Developing countries are often especially in need of more personnel. Declaring 2020 the Year of the Nurse and Midwife, WHO says 18 million more health care providers are needed worldwide to achieve universal health coverage by 2030. To address the “brain drain” concern, WHO developed a voluntary Global Code that promotes adequate staffing of national health systems and “ethical international recruitment of health personnel”.

Mobility and “Ethical Recruitment”

In a 2019 joint study, the WHO and World Trade Organization (WTO) examined the relationship between free trade agreements that improve health worker mobility and the recruitment goals of the Code. The study primarily reviewed so-called “Mode 4” commitments that deal with the temporary presence of foreign natural persons supplying trade in health-related services.

Commitments have been made by 139 WTO members to liberalize trade in services. Of those, 69 members have taken at least one commitment relating to the provision of health services, from hospital care to midwife services. The commitments vary widely, enabling education and skills exchanges, investment, mobility for charitable purposes, and the protection of health worker welfare.

As an example, the Indonesia–Japan Economic Partnership Agreement includes development assistance by Japan’s International Cooperation Agency to support nursing education in Indonesia. In 2019, Japan updated its Economic Partnership Agreements with Indonesia, the Philippines and Vietnam to extend the period of time a nursing candidate can stay in Japan to obtain national nursing qualifications and healthcare worker certifications.

The joint WHO-WTO study makes no real conclusion about the compatibility of the Code with greater mobility through trade agreements. It suggests that further analysis such as economic needs tests or labor market tests could help sending and receiving countries understand the impact of healthcare worker service exports on sustainable development.

call out on HC worker impact (1)

COVID-19 is Shifting the Global Healthcare Trade Landscape

COVID-19 may be accelerating two key trends in healthcare work, while at the same time reversing (perhaps temporarily) the trend of job growth by inducing layoffs in the industry.

Telemedicine:

Encompassing remote patient assessment and monitoring as well as health education, the global telemedicine market was projected to grow from $70 billion in 2020 to $266.8 billion by 2026. COVID-19 is accelerating the trend. In March, the U.S. government announced it would temporarily pay clinicians to provide telehealth services for Medicare beneficiaries and would expand the communications platforms that could be used.

Telemedicine has long been encouraged in developing countries, supported by international development agencies and non-government organizations. It can help overcome short-staffing limitations and provide support for local clinicians through overseas physicians who can confirm a diagnosis and collaborate on treatment plans as part of global trade in services.

Robotics:

Robotics are being deployed to decrease COVID-19 risks to frontline healthcare workers. A field hospital in Wuhan, China serving 20,000 patients was staffed by robots that monitored patients’ vital signs through smart bracelets and rings that synced with an AI platform. Other robots served food, drinks and medicine to patients, while other autonomous droids sprayed disinfectant and cleaned the floors. Other countries like South Korea and Lebanon are using robots to measure temperatures, distribute hand sanitizer and perform disinfecting services.

Layoffs and Mobility Restrictions:

COVID-19 is causing governments to retrench in some countries that export healthcare workers,. In March, the Philippine Overseas Employment Administration (POEA) temporarily suspended the deployment of all health care workers “until the national state of emergency is lifted,” freezing the fulfillment of existing contracts with hospitals around the globe. Meanwhile, routine healthcare has been stymied due to ongoing stay-at-home directives, causing massive financial distress to the healthcare industry and significant layoffs.

In all of these ways, COVID-19 may be changing the outlook for cross-border global healthcare services for years to come.

_____________________________________________________________

Sarah Smiley is a strategic communications and policy expert with over 20 years in international trade and government affairs, working in the U.S. Government, private sector and international organizations.

This article originally appeared on TradeVistas.org. Republished with permission.