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MedTech

J&J single-dose COVID-19 vaccine 85% effective

Inside Telecom Staff

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J&J single-dose COVID-19 vaccine 85% effective

Johnson & Johnson (J&J) announced late last week its single-dose COVID-19 vaccine that proved to be 85 percent effective in preventing severe disease across all regions studied, 28 days after vaccination in all adults 18 years and older.

The J&J single-dose COVID-19 vaccine – which was developed by its Janssen Pharmaceutical Companies – underwent phase 3 of trial testing, with data based on 43,783 participants accruing 468 symptomatic cases of COVID-19.

The phase 3 trial is being conducted at the height of the COVID-19 pandemic in eight countries and three regions, at a time when disease spread has accelerated throughout the world resulting in people having increased exposure to the virus.

“J&J embarked on the global effort to combat the COVID-19 pandemic a year ago, and has brought the full force of our capabilities, as well as tremendous public-private partnerships, to enable the development of a single-shot vaccine. Our goal all along has been to create a simple, effective solution for the largest number of people possible, and to have maximum impact to help end the pandemic,” Alex Gorsky, Chairman, Board of Directors and Chief Executive Officer, Johnson & Johnson, said in a statement.

The phase 3 study is designed to evaluate the efficacy and safety of the J&J single-dose COVID-19 vaccine candidate in protecting moderate to severe cases, with co-primary endpoints of 14 days and 28 days following vaccination, the company statement highlighted.  

Among all participants from different geographies and including those infected with an emerging viral variant, J&J single-dose COVID-19 vaccine candidate was 66 percent effective overall in preventing moderate to severe cases, 28 days after vaccination.

The onset of protection was observed as early as day 14. The level of protection against moderate to severe infection was 72 percent in the United States, 66 percent in Latin America and 57 percent in South Africa, 28 days post-vaccination.

Forty-one percent of participants in the study had comorbidities associated with an increased risk for progression to severe COVID-19 (overall 41 percent), obesity (28.5 percent), type 2 diabetes (7.3 percent), hypertension (10.3 percent), HIV (2.8 percent); also, other immunocompromised participants were in the study.

Protection was generally consistent across race, age groups, including adults over 60 years of age (N= 13,610), and across all variants and regions studied, including South Africa where nearly all cases (95 percent) were due to infection with a SARS-CoV-2 variant from the B.1.351 lineage.

The company intends to file for U.S. Emergency Use Authorization (EUA) in early February and expects to have product available to ship immediately following authorization. It expects to share more information on specifics of deployment as authorizations are secured and contracts are finalized.

J&J’s anticipated manufacturing timeline will enable it to meet its 2021 supply commitments, including those signed with governments and global organizations.

“A one-shot vaccine is considered by the World Health Organization to be the best option in pandemic settings, enhancing access, distribution and compliance. Eighty-five percent efficacy in preventing severe COVID-19 disease and prevention of COVID-19-related medical interventions will potentially protect hundreds of millions of people from serious and fatal outcomes of COVID-19, Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at J&J, said in the statement.

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MedTech

Telemedicine to save healthcare industry $21 billion by 2025

Inside Telecom Staff

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telemedicine

It is without a shadow of a doubt that telemedicine was the champion of the health technology sector during the pandemic, allowing patients the ability to receive consultations and treatments by their doctors without the need for in-person appointments.

The COVID-19 pandemic brought with it a tidal wave of technological acceleration across all forms of the tech sphere, with telemedicine leading the line from 2020’s $14.8 billion investments in digital health fundraising, according to a report by Mercom Capital Group.

The report highlighted that while equity investments in telemedicine rose 139 percent to $4.3 billion, other areas like data analytics and mobile health apps also earned strong support from investors.

But while news over MedTech investments took over headlines – telemedicine was also categorized as one of the most cost-effective technologies for the healthcare industry as it is set to save $21 billion globally by 2025, driven by teleconsultation services and rising from $11 billion in 2021, a new report by Juniper Research stressed.

This represents a growth rate of over 80 percent in the next four years. The concept of telemedicine involves the remote provision of healthcare services and includes technologies such as teleconsultations, remote patient monitoring and chatbots.

The research identified teleconsultations, a service that enables patients and physicians to interact remotely, as a key service that will enable these significant savings. “However, it cautioned that savings would be restricted to developed nations where access to required devices and Internet connectivity is prevalent,” the report noted.

As a result, it predicted that over 80 percent of savings will be attributable to North America and Europe by 2025.

Deregulation of telemedicine

The new report, Telemedicine: Emerging Technologies, Regional Readiness & Market Forecasts 2021 2025, estimated that over 280 million teleconsultations were performed in 2019. However, this rose to 348 million in 2020, owing to the COVID-19 pandemic.

It anticipated that the activities of third-party healthcare service developers will be crucial in accelerating the deployment of emerging telemedicine services and increasing the uptake amongst healthcare providers.

However, the report predicted that the significant investment into integrating telemedicine services, and the requirement of data protection, such as HIPAA (Health Insurance Portability and Accountability Act) in the US, will discourage adoption amongst smaller healthcare providers.

To foster the adoption of telemedicine services, the report recommended that healthcare regulatory bodies continue to deregulate telemedicine services to minimize any remaining barriers to entry for smaller healthcare providers.

“Any deregulation must ensure that patient confidentiality is not undermined. Additionally, we recommend that innovative and emerging teleconsultation services are integrated into existing healthcare technologies, such as electronic health records, to maximize their benefits to healthcare providers,” research author, Adam Wears, remarked.

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MedTech

Panel suggests WHO should have more power to stop pandemics

Associated Press

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A panel of independent experts who reviewed the World Health Organization’s response to the coronavirus pandemic says the U.N. health agency should be granted “guaranteed rights of access” in countries to investigate emerging outbreaks, a contentious idea that would give it more powers and require member states to give up some of theirs.

In a report released Wednesday, the panel faulted countries worldwide for their sluggish response to COVID-19, saying most waited to see how the virus was spreading until it was too late to contain it, leading to catastrophic results. The group also slammed the lack of global leadership and restrictive international health laws that “hindered” WHO’s response to the pandemic.

Some experts criticized the panel for failing to hold WHO and others accountable for their actions during COVID-19, describing that as “an abdication of responsibility.”

Lawrence Gostin of Georgetown University said the panel “fails to call out bad actors like China, perpetuating the dysfunctional WHO tradition of diplomacy over frankness, transparency and accountability.”

The panel was led by former Liberian President Ellen Johnson Sirleaf and former New Zealand Prime Minister Helen Clark, who were tapped by WHO last year to examine the U.N. agency’s response to COVID-19 after bowing to a request from member countries.

“The situation we find ourselves in today could have been prevented,” Johnson Sirleaf said.

Beyond the call to boost WHO’s ability to investigate outbreaks, the panel made an array of recommendations, such as urging the health agency and the World Trade Organization to convene a meeting of vaccine-producing countries and manufacturers to quickly reach deals about voluntary licensing and technology transfer, in an effort to boost the world’s global supply of coronavirus shots.

The panel also suggested that WHO’s director-general — currently Tedros Adhanom Ghebreyesus of Ethiopia — should be limited to a single seven-year term. As it stands, the WHO chief is elected to a five-year term that can be renewed once.

The suggestion to limit the tenure of WHO’s top leader appeared in part designed to ease the intense political pressure that WHO director-generals can face. Last year, the Trump administration repeatedly inveighed against the agency’s handling of the pandemic — taking aim at WHO’s alleged collusion with China.

An Associated Press investigation in June found WHO repeatedly lauded China in public while officials privately complained that Chinese officials stalled on sharing critical epidemic information with them, including the new virus’ genetic sequence.

Clark said the global diseases surveillance system needed to be overhauled — with WHO’s role strengthened.

“WHO should have the powers necessary to investigate outbreaks of concern, speedily guaranteed rights of access, and with the ability to publish information without waiting for member state approval,” she said.

Sophie Harman, a professor of international politics at Queen Mary University of London, said the panel’s recommendations were unlikely to be entirely welcomed by WHO’s member countries, and thus, unlikely to be implemented.

“Which states would actually allow WHO in to investigate an outbreak without their permission?” she asked.

Many doctors fatigued after treating COVID-19 patients said any reform of WHO should include an evaluation of its ability to properly assess the science of an emerging health threat.

David Tomlinson, a British physician who has been campaigning for health workers during the pandemic in the U.K., said WHO “failed on the most fundamental aspect” in its scientific leadership of COVID-19. He said WHO’s failure to acknowledge that much coronavirus transmission happens in the air has “amplified the pandemic.”

WHO has said coronavirus spread can happen in limited circumstances in the air but recommended against mask-wearing for the general public until last June.

Clare Wenham, a professor of global health policy at the London School of Economics, said the report overall was good, but questioned its support for the U.N.-backed program for coronavirus vaccines called COVAX, which relies on a “donation” model. Of the millions of COVID-19 vaccines administered to date, developing countries have received just 7%, WHO said this week.

“(COVAX) is not addressing one of the main problems, which is we need to rapidly ramp up production of the vaccines and distribution of vaccines,” she said. “And it’s still working on the model of a finite number that’s only able be produced by a certain few manufacturing locations.”

Overall, she suggested politicians needed to budge more than technical institutions like WHO.

“The problems aren’t technical. The problems are political. The problems are about like: How do you get governments to behave and think about things beyond their own borders?” Wenham said. “I don’t think that has been resolved.”


GENEVA (AP) — By MARIA CHENG and JAMEY KEATEN Associated Press.

AP Medical Writer Maria Cheng reported from London.

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MedTech

AI-powered tech offers music for anxiety and pain

Karim Husami

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AI-powered tech

British health tech start-up MediMusic has created an app and a streaming device called the MediBeat that dispenses personalized playlists to reduce anxiety and pain in patients using a ‘digital drip’ to administer the most calming music.

As such, patients could soon be prescribed soothing music selected by artificial intelligence (AI) to ease anxiety and pain, after an encouraging trial of a Hull health tech start-up’s new app.

The AI-powered tech could be used in treatment of dementia, pre/post operation, chronic pain, dentistry, and Alzheimer’s Disease through to improving motor response as part of a physical rehabilitation program.

Initial clinical NHS trials at Lancashire Teaching Hospitals NHS Foundation Trust, found the use of MediMusic saw an up to 22 percent reduction in heart rate in patients with dementia during the COVID-19 pandemic. It can also be used in hospitals, care homes and dentist surgeries.

So how does the app work?

According to a nationwide NHS Staff Survey with nearly 600,000 responses, almost half of NHS staff in England (44 percent) have reported feeling unwell from work related stress during 2020, the highest rate recorded in the past five years.

The MediMusic app works with the patient’s age, gender, nationality, and ethnicity and based on sociological and psychological science, it then compiles in seconds the 20-minute playlist of soothing music to calm them.

Playlist running order is designed to reduce heart rate and stress hormones like cortisol and promotes relaxation through hormones like dopamine and oxytocin. The music is played through earphones and the MediBeat streaming device and a heart rate monitor worn on the wrist.

Dr Jacqueline Twamley, academic research and innovation manager at the Centre for Health Research & Innovation at Lancashire Teaching Hospitals NHS Foundation Trust said: “The results have been very impressive. We used MediMusic on 25 patients suffering from dementia during the COVID-19 pandemic. One 75-year-old patient had vascular dementia and was known to have sundowning behaviour, which presents as agitation.”

“The initial findings are so positive that we’re now looking at how it can help ease anxiety and stress in doctors and nurses working in critical care on the frontline of caring for COVID patients,” he added.

Music therapy has already been proven in several previous studies to reduce anxiety by 44 percent and pain by 28 percent. This has resulted in a reduction in the need for relevant medication by 24 percent.

The brain responds to music more than any other stimulus. MediMusic’s algorithms extract the relevant features from the digital DNA of a piece of music, resulting in a fingerprint for healthcare use.

Using AI, machine learning (ML) and the data about the patient, the AI-powered tech then automatically creates playlists from music streaming services within a couple of clicks and plays the music through a streaming device called the MediBeat and a pair of headphones.

Gary Jones, CEO and co-founder of MediMusic said: “We’ve always felt the music can soothe our soul but now we have compelling evidence that it can help our mind and body too. With MediMusic, we’ve managed to digitally fingerprint the DNA of music so we can prescribe the right type of music as medicine.”

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