Indian-made 'freeze-free' vaccine carrier to undergo field trials

Agencies
February 9, 2018

New Delhi, Feb 9: This week, the first commercially available freeze-free vaccine carrier will begin introductory field trials in Nepal. This follows the World Health Organisation (WHO) announcement that the Indian-made carrier using PATH's "Freeze-Safe" reference design passed WHO Performance, Quality, and Safety (PQS) laboratory tests for User Independent Freeze Prevention, which prequalifies it for use in global immunisation programs.

This is the first low-cost carrier innovation available to address the widespread and long-standing problem of vaccines freezing in the cold chain during the "last mile" of outreach to infants and children.

Currently in low - and middle - income countries, health workers carry millions of temperature-sensitive vaccines next to ice packs inside vaccine carriers to reduce heat exposure, but this risks freezing the vaccines if ice packs are not conditioned (carefully warmed to around 0°C).

Freezing can irreversibly compromise vaccine potency, resulting in inadequate protection from disease for people receiving vaccines. When health workers suspect temperature damage, the vaccine or medication is often discarded - at great cost to health care programs.

PATH's breakthrough solution mitigates the risk of vaccines being damaged by freezing or heat in carriers and eliminates the step of conditioning ice packs, reducing health worker burden. Frozen ice packs can be inserted immediately into the carrier thanks to a built-in barrier that shields the vaccines from reaching negative temperatures and excessive heat.

Many of the newer vaccines that protect children and infants from life-threatening diseases and infections, such as for human papillomavirus, pneumonia, and rotavirus, are freeze sensitive and cost far more than other vaccines. In 2015, the United Nations Children's Fund (UNICEF) procured approximately USD 1.7 billion worth of vaccines for immunization programs, of which more than USD 1.2 billion were freeze sensitive.

"Our priority is maintaining vaccine potency for the millions of people living in remote communities. In the future, vaccine carriers that prevent freezing will become the new standard for immunization programs," said Pat Lennon, who leads the cold chain team at PATH.

In order to rapidly accelerate introduction of this innovation, PATH put the Freeze-Safe reference design into the public domain for any manufacturer to use in their vaccine carrier products.

PATH staff in Seattle and New Delhi, India, has provided technical advice to three product manufacturers who have adopted the technology. India-based AOV International's product AFVC46 is the first carrier to receive WHO-PQS approval and will be available for purchase through the UNICEF Supply Division catalog.

"The Freeze-Safe vaccine carrier is a great example of Indian industry helping solve a global public health challenge. This 'Made in India' freeze-preventive vaccine carrier can help health workers in India and globally to administer lifesaving vaccines that do not freeze and could help save millions of lives," said Neeraj Jain, Country Director of PATH's India country program.

PATH estimates that more than 2 million new and replacement carriers will be needed by 2020 for the 73 Gavi-member countries. To accelerate scale-up of the Freeze-Safe innovation, PATH is conducting field trials, supporting efforts to integrate the carriers into existing health systems, and working with manufacturers as well as adapting the innovation for use in other cold chain equipment.

"Vaccine carriers that prevent vaccines from freezing while in transit and yet are low cost and easy to use can save millions of children's lives. These are exactly the type of cutting-edge solutions we need to immunize every child," said Dr. Benjamin Schreiber, Deputy Immunization at UNICEF.

PATH has worked to advance technologies, policies, and programs to address vaccine freezing issues across the supply chain from formulation to the last mile since 1996, and on the Freeze-Safe innovation since 2012. This work aligns with UNICEF; Gavi, the Vaccine Alliance; and WHO strategies to maintain vaccine potency and improve immunization cost efficiencies and coverage.

This project was made possible with support from the Bill & Melinda Gates Foundation.

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News Network
February 26,2020

New York, Feb 26:  A new wearable sensor that works in conjunction with artificial intelligence (AI) technology could help doctors remotely detect critical changes in heart failure patients days before a health crisis occurs, says a study.

The researchers said the system could eventually help avert up to one in three heart failure readmissions in the weeks following initial discharge from the hospital and help patients sustain a better quality of life.

"This study shows that we can accurately predict the likelihood of hospitalisation for heart failure deterioration well before doctors and patients know that something is wrong," says the study's lead author Josef Stehlik from University of Utah in the US.

"Being able to readily detect changes in the heart sufficiently early will allow physicians to initiate prompt interventions that could prevent rehospitalisation and stave off worsening heart failure," Stehlik added.

According to the researchers, even if patients survive, they have poor functional capacity, poor exercise tolerance and low quality of life after hospitalisations.

"This patch, this new diagnostic tool, could potentially help us prevent hospitalizations and decline in patient status," Stehlik said.

For the findings, published in the journal Circulation: Heart Failure, the researchers followed 100 heart failure patients, average age 68, who were diagnosed and treated at four veterans administration (VA) hospitals in Utah, Texas, California, and Florida.

After discharge, participants wore an adhesive sensor patch on their chests 24 hours a day for up to three months.

The sensor monitored continuous electrocardiogram (ECG) and motion of each subject.

This information was transmitted from the sensor via Bluetooth to a smartphone and then passed on to an analytics platform, developed by PhysIQ, on a secure server, which derived heart rate, heart rhythm, respiratory rate, walking, sleep, body posture and other normal activities.

Using artificial intelligence, the analytics established a normal baseline for each patient. When the data deviated from normal, the platform generated an indication that the patient's heart failure was getting worse.

Overall, the system accurately predicted the impending need for hospitalization more than 80 per cent of the time.

On average, this prediction occurred 10.4 days before a readmission took place (median 6.5 days), the study said.

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News Network
June 20,2020

Washington, Jun 20: Pregnant and postpartum women are usually at a high risk of depression and anxiety - one in seven women struggle with symptoms in the perinatal period and the coronavirus pandemic is exacerbating those struggles according to a recent study.

The study was published in Frontiers in Global Women's Health, which found that the likelihood of maternal depression and anxiety has substantially increased during the health crisis.

"The social and physical isolation measures that are critically needed to reduce the spread of the virus are taking a toll on the physical and mental health of many of us," said Dr. Margie Davenport of the University of Alberta, Canada, who co-authored the study.

For new moms, those stresses come with side effects.

"We know that experiencing depression and anxiety during pregnancy and the postpartum period can have detrimental effects on the mental and physical health of both mother and baby that can persist for years," said Davenport.

Such effects can include premature delivery, reduced mother-infant bonding, and developmental delays in infants.

The study surveyed 900 women - 520 of whom were pregnant and 380 of whom had given birth in the past year - and asked about their depression and anxiety symptoms before and during the pandemic.

Before the pandemic began, 29 percent of those women experienced moderate to high anxiety symptoms, and 15 percent experienced depressive symptoms. During the pandemic, those numbers increased - 72 percent experienced anxiety and 41percent experienced depression.

Because lockdown measures have affected daily routines and access to gyms, researchers also asked women whether their exercise habits had changed. Of the women surveyed, 64 percent reduced their physical activity since the pandemic began, while 15 percent increased and 21 percent experienced no change.

Exercise is a known way to ease depression symptoms, so limited physical activity may result in an uptick in depressive symptoms. Indeed, the study found that women who engaged in at least 150 minutes of moderate physical activity a week had significantly lower symptoms of depression and anxiety.

The findings are somewhat limited given the fact that researchers could not survey women before the pandemic began (since they could not know a pandemic would occur). The women surveyed could only offer their pre-pandemic symptoms in hindsight.

Also, while the researchers asked women about their symptoms using validated measures, only mental health care professionals can validly diagnose an individual with depression or anxiety.

The study was specifically interested in the impact of COVID-19 on new moms, but Davenport says maternal mental health is a critical issue no matter the time.

"Even when we are not in a global pandemic, many pregnant and postpartum women frequently feel isolated whether due to being hospitalized, not having family or friends around or other reasons," she said.

"It is critical to increase awareness of the impact of social (and physical) isolation on the mental health of pregnant and postpartum women," Davenport added.

Increased awareness makes diagnosis and treatment - the ultimate goal - more likely.

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Agencies
June 20,2020

The World Health Organisation has warned that the COVID-19 pandemic is entering a "new and dangerous" phase. Thursday saw the most cases in a single day reported to the WHO.

Tedros Adhanom Ghebreyesus said the day had seen 150,000 new cases with half of those coming from the Americas and large numbers also from the Middle East and South Asia, the BBC reported.

He said the virus was still spreading fast and the pandemic accelerating.

He acknowledged people might be fed up with self-isolating and countries were eager to open their economies but he said that now was a time for extreme vigilance.

Maria van Kerkhove, technical lead of the WHO's COVID-19 response, told a press conference the pandemic is "accelerating in many parts of the world".

"While we have seen countries have some success in suppressing transmission and bringing transition down to a low level, every country must remain ready," she said.

Mike Ryan, the head of the WHO's Health Emergencies Programme, said that some countries had managed to flatten the peak of infections without bringing them down to a very low level.

"You can see a situation in some countries where they could get a second peak now, because the disease has not been brought under control," he said.

"The disease will then go away and reduce to a low level, and they could then get a second wave again in the autumn or later in the year."

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