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Coronavirus vaccine trials underway but outcome remains unclear

Mounir Jamil



Coronavirus vaccine trials underway but outcome remains unclear

As coronavirus vaccine trials take place all over the world, scientists gather data to help maximize research potential and to ensure a more efficient, effective and ethical study design. Despite rigorous vaccine efforts however, the picture remains unclear.

In mid-May, Moderna a US biotech firm exposed the first data from a trial. Its coronavirus vaccine triggered an immune response in individuals, and has protected mice from the lung infections caused by the coronavirus SARS-CoV-2. The results, which were announced in a press release, were translated as widely positive and caused stock prices to go up.

Other fast-tracked test for coronavirus vaccines indicate that they have prevented infections in the lungs of monkeys that were exposed to SARS-CoV-2, but not in other parts of the body. A vaccine that is being developed at the University of Oxford, has protected six monkeys from pneumonia, however, the animals’ noses fostered as much virus as those of unvaccinated monkeys.

Moderna’s coronavirus vaccine, co-developed with the US National Institute of Allergy and Infectious Diseases (NIAID) in Maryland, began safety testing on humans at the beginning of March. The vaccine is constituted of mRNA instructions that build on the coronavirus’s spike protein, it causes human cells to churn out the foreign protein, and alters the immune system. Even though such RNA-based vaccines can be easily developed, none have been licensed anywhere in the world yet.

In a press release, Moderna also reported that 45 participants in the study that have received one or two doses of their vaccine have developed a strong immune response to the virus. Researchers have measured virus recognizing antibodies in 25 of the participants and have successfully detected levels close to or even higher than those that were found in the blood of individuals that fully recovered from the virus.

However, it is still not clear if their responses are enough to protect people from the virus, due to the fact Moderna hasn’t shared its data, claims Peter Hotez, a vaccine scientist at Baylor College of Medicine and says that he is not sure if this is actually a positive result. He refers to an earlier May 15 bioRxiv preprint3 showing that most who actually recovered from the virus without need for hospitalization did not produce high levels of the neutralizing antibody that prevents the virus from infecting cells. Moderna has measured the potent antibodies in eight different trial participants and revealed that their levels were similar to the patients who recovered.

Hotez also expressed his doubts regarding initial results of the Oxford study, that found that monkeys produced modest levels of neutralizing antibodies after being administered only one dose of the coronavirus vaccines. He says it seems that those numbers need to be significantly higher to afford protection. The vaccine is composed from a chimpanzee virus that has been genetically modified to produce a protein for the coronavirus. Hotez added that the coronavirus vaccines being developed by Sinovac Biotech in Beijing seem to have shown a more promising antibody response in macaque monkeys after they were administered three doses.

Sarah Gilbert, an Oxford vaccinologist has co-led the study alongside Vincent Munster, a virologist at NIAD’s labs in Hamilton Montana. Gilbert mentioned that the Oxford monkeys were administered a really high dose of the virus after receiving the vaccine. This could be reason why the vaccinated animals had just as much SARS-CoV-2 genetic materials located in their noses as the control animals, although the vaccinated monkeys didn’t develop any sign of pneumonia. By administering high doses, the test ensures that the animals will be infected with the virus, however it might not replicate natural infections.

Even though assessing the efficacy of a coronavirus vaccine is challenging, the most recent data focuses on safety, according to researchers. The monkeys vaccinated at Oxford and Sinovac did not develop an exacerbated disease post-infection, which was a key fear because an inactivated vaccine that causes SARS (severe acute respiratory syndrome) manifested signs in macaques.

Moderna is set to begin phase II of the trial soon, which will involve 600 participants. It aims at beginning a phase III efficacy trial in July, to determine if Coronavirus vaccines are able to prevent disease in high-risk groups such as healthcare workers with underlying problems.

The team at Oxford have already enrolled over 1,000 participants for their UK trial. Some of the volunteers have received a placebo, allowing researchers to determine if the vaccine works in humans over the coming months. Gilbert says that the lack of problems present in the monkey study was very reassuring.


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Wearable tech market to more than double in growth by 2026

Inside Telecom Staff



Wearable tech

Over the years, fitness technology has grown from the bulky fridge-like mainframes to the sleek finesse of fitbits, containing more processing power than the computers that put a human on the moon.

For context, innovative tech has gone from having a dedicated room to a dedicated pocket, allowing us to work, study and monitor our health. 

Which is exactly why wearable tech is regarded as an emerging trend that integrates electronics to the daily activities and fits into the changing lifestyles and can be worn on any part of the body. As such, experts predict that the next market with this same growth potential will be wearable technologies market.

A report from Mordor Intelligence projects that the Wearable Technology Market was valued at USD 27.91 billion in 2020 and is expected to reach USD 74.03 billion by 2026 and work at a CAGR of 17.65 percent over the forecast period (2021 – 2026).

The report published that the ability to connect to the Internet and the establishment of data exchange between a network and a device is the driving factor that led to increases wearable tech. The study considered several wearable technologies, including Smartwatches, Head Mounted Displays, Smart Clothing, Ear Worn, Fitness Trackers, Sleep Aides and wellness devices among others.

The report tracks both the volume and value of these products at a global level and region level in specific. The wearable tech market has evolved owing to the emergence of sensors among other technology.

Incorporating these sensors into a dedicated wearable device driven by the impact of smartphones being used daily, on the GPS, or the IMU (consist of accelerometer, gyroscope, and magnetometer), the report explained, mentioning that they have helped the fitness tracking wearable to monitor body activities using these sensors. 

“The smartwatch category is also experiencing a rise, owing to the additional features, like the brand that suits the everyday lifestyle. Smartwatches are seeing a surge in new users, including the older population, because wearable makers, such as Apple and Fitbit, are adding health-monitoring features that appeal to older people and keep them updated about their health status in real-time,” the Mordor Intelligence report continued.

A perfect example of this is Apple’s features such as a fall detection app and an EKG monitor to the Apple Watch Series 4, while Fitbit added a feature to detect sleep apnea. According to the report, Apple’s 2019 fiscal year noted that it got nearly as much revenue from sales of its collection of wearable products and accessories as it derived from selling its old Mac computers which appears well on its way to becoming its second most significant line of products after the iPhone and its third-largest business category overall after its smartphone and services segment.

The company’s booming wearables and accessories segment helped to make up for the declining iPhone sales. In the period, sales of wearable and accessories products grew 54 percent in the last quarter of 2019 compared to the prior year to USD 6.5 billion, the report further explained.

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Chronic heart and kidney failure to be treated by implantable device

Karim Hussami



implantable device

While all sectors in our lives are being updated with the recent technological trends and ways to facilitate people’s lives, new technologies are being created to help people with their health amongst other issues.

As such, Paragate Medical, an NGT3 VC portfolio company, has developed a remote, implantable device solution for heart and kidney failure patients.

Most remote solutions use telematics to offer some type of remote monitoring, however founders Dr. Yair Feld, Nitai Hanani, and the team at Paragate have developed a solution that monitors and provides 24/7 home-based care to patients coping with chronic heart and kidney failure.

Mechanical bypass of the kidneys

Relatively recent research has shown that heart failure is a significant risk factor for kidney disease. As in, when the heart is no longer pumping efficiently, it becomes congested with blood, causing pressure to build up in the main vein connected to the kidneys and leading to congestion of blood in the kidneys, too.

Diuretics are currently the gold standard treatment but of the 26 million heart failure patients annually around the world, over one third are diuretic resistant, according to CORDIS, EU research results.

“Current solutions for fluid overload in diuretic resistant patients such as IV diuresis, ultrafiltration therapy and peritoneal dialysis all carry complications and are acute treatments which do not prevent recurrence,” the research said.

Paragate’s IPUD (Implantable Peritoneal Ultrafiltration Device) is a minimally invasive and fully implantable device that serves as a mechanical bypass of the kidneys. It actively, continuously, and non-aggressively removes excess fluid from the body to keep patients balanced at home.

How does it work?

IPUD improves the clinical condition of fluid overloaded patients by continuously removing extracellular fluids with a unique implantable peritoneal ultrafiltration device, operating non-aggressively and independently from the kidneys’ function.

The device is minimally invasive and the flat absorption device interfaces with the intraperitoneal membrane and applies a hydrostatic pressure gradient. It then continuously and slowly absorbs systemic isotonic extracellular fluid and drains it to the urinary system preventing recurred accumulation.

The device has a projected service life of 3 years and recharging the device has been made simple for the patients via wireless charging, needed on a weekly basis.

The company conducted successful preclinical studies and is planning to begin the clinical trials this year.

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New British technology identifies 800,000 high-risk patients from COVID-19

Inside Telecom Staff



New British technology identifies 800,000 high-risk patients from COVID-19

A new technology introduced by the UK has helped clinicians identify 800,000 adults who may be at higher risk from COVID-19 contagion and placed them under high priority to receive the vaccine as part of the country’s vaccination program.

This technology – which was developed by subgroup of NERVTAG, led by the University of Oxford and funded by the National Institute for Health Research (NIHR) – analyses a combination of risk factors based on medical records, to assess whether somebody may be more vulnerable than was previously understood, helping clinicians provide vaccination more quickly to them and ensuring patients can benefit from additional advice and support.

According to a statement published by the British government, the analysis is made possible via new technology and emerging evidence regarding the impact of the disease on different groups and who could be most vulnerable – which means further steps can be taken to protect those most at risk.

“The model’s data-driven approach to medical risk assessment will help the NHS identify further individuals who may be at high-risk patients from COVID-19 due to a combination of personal and health factors,” Deputy Chief Medical Officer for England Dr Jenny Harries said.

Harries added that this action ensures those most vulnerable to COVID-19 can benefit from both the protection that vaccines provide, and from enhanced advice, including shielding and support, if they choose it.

Up to 1.7 million patients have been identified. Those within this group who are over 70 will have already been invited for vaccination and 820,000 adults between 19 and 69 years will now be prioritized for a vaccination, the government said in its statement.

The patients identified through the risk assessment will be sent a letter from NHS England in the coming days explaining that their risk factors may help identify them as high clinical risk and that they are included within the support and advice for the clinically extremely vulnerable.

“They will be invited to receive a COVID-19 vaccine as soon as possible if they have not already had the jab, and will be given advice on precautionary measures, including shielding where this is current advice. Their GPs are also being notified,” the British government’s statement explained.

The research – commissioned by England’s Chief Medical Officer Chris Whitty and funded by the National Institute of Health Research – found there are several health and personal factors, such as age, ethnicity, and body mass index (BMI), as well as certain medical conditions and treatments, which, when combined, categorizes persons as high-risk patients from COVID-19.

“The independent validation from the Office of National Statistics (ONS) is considered the ‘gold standard’ in quality assurance. The ONS has shown that the model performs in the ‘excellent’ range, and accurately identifies patients at highest risk from COVID-19,” Sarah Wilkinson, Chief Executive of NHS Digital, which has been using the model, said.

According to the government’s statement, the University of Oxford had turned their research into a risk-prediction model called QCovid, which has been independently validated by the ONS and is thought to be the only COVID-19 risk prediction model in the world to meet the highest standards of evidence and assurance.

“The QCovid model, which has been developed using anonymized data from more than 8 million adults, provides nuanced assessment of risk by taking into account a number of different factors that are cumulatively used to estimate risk, including ethnicity,” Lead researcher Professor Julia Hippisley-Cox, a general practitioner and Professor of Clinical Epidemiology and General Practice at University of Oxford’s Nuffield Department of Primary Care Health Sciences, said.

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