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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Agencies
May 18,2020

China, where the novel coronavirus originated, has reported 111 cases since beginning of May, which shows the infection rate has dipped, and 3 deaths since April 27, according to the WHO. A Shanghai-based Noida doctor says China is close to winning the battle against COVID-19, and the combination of zinc, hydroxychloroquine (HCQ) and antibiotic azithromycin has been able to save the lives of coronavirus patients.

Speaking to media persons, Dr Sanjeev Choubey, Medical Director Internal Medicine at St. Michael Hospital said this combination has been adopted as a line of treatment for patients infected with coronavirus, and as a result patients are recovering, decreasing their need for intensive care.

What is the line of treatment for COVID-19 patients, which also include asymptomatic patients?

The combination of zinc, hydroxychloroquine and antibiotic azithromycin has produced positive results, and it helped in the recovery of many COVID-19 patients. The combination -- Ascorbic Acid, B-complex, Zinc, Selenium, L-carnitine, Vitamin B-12 and Glutathione normal saline should be administered on patients twice a week for at least 6 weeks. This is COVID-19 treatment protocol for prophylaxis, and it implies both asymptomatic and symptomatic along with other medicine support.

Based on your experience on COVID-19 in China, after how many tests, is it safe to call a person coronavirus free?

The coronavirus should be performed at least 9 times, before terming a patient COVID-19 free. It is a standard in China. This procedure has worked in China and it will also work in India. Minimum five tests should be mandatory through RT-PCR.

Does coronavirus majorly attack the respiratory system or it could lead to organ failure too?

Line of treatment should not be just looking at the respiratory system, as the problem lies somewhere else. COVID-19 attacks many vital organs in the body. In China, a coronavirus patient died from a stroke. In the autopsy it was found that the innermost layer in the arteries was swollen. It was concluded that coronavirus had inflamed the layer of the arteries leading to clotting, which was a factor in generating a heart attack. Therefore, COVID-19 is not just a respiratory problem.

Amid the coronavirus pandemic, should autopsy be made mandatory in the case of unpredictable death or where reasons for death are not unknown?

Patients below 50 years, who die suddenly and the reasons are not known, then it should be mandatory to conduct the autopsy. After death, coronavirus is active in the body for five days, and it fades away on day 6. Therefore, if an autopsy is done then it will help in understanding this disease. In China, we have seen young COVID-19 patients, aged 22 and 28, succumbed to strokes.

Since the beginning of May, India has recorded more than 2,000 cases everyday in the first week, then it jumped past 3,000 mark in the second week. Finally, the tally is 4,987 on May 17. At 90,927 cases, has India progressed into community transmission or Stage3?

Yes, India has moved into Stage 3. The data suggests that 3,000 to 4,000 active COVID-19 cases, who are asymptomatic, are moving around and spreading the infection. The research has indicated that COVID-19 from an infected person spreads in 30 minutes to non-infected persons. The relaxation on the lockdown will certainly contribute to a high infection rate.

Do you think India has reached its peak in COVID-19 cases, or the sharp rise will continue till July end?

It seems India has already reached its peak and cases will begin to come down from June end or beginning of July first week. If social distancing norms are followed then certainly things can improve, but if not followed then it may get worse. High population density is a major contributor for the increase in cases. The government should continue to focus on finding hotspots, and urge people to follow the rules, eventually it is for people’s own benefit.

Has China won the battle against COVID-19?

It seems China has won the battle by not opening up Wuhan. The Chinese are following a COVID-19 patient’s engagement program, where the authorities continuously interact with people infected with the disease. The Government of India should reward people who follow the guidelines; it will help in setting up a positive trend in the society.

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News Network
May 13,2020

California, May 13: A fasting-mimicking diet could be more effective at treating some types of cancer when combined with vitamin C, suggests a new study conducted by the scientists from USC and the IFOM Cancer Institute in Milan.

In studies on mice, researchers found that the combination delayed tumour progression in multiple mouse models of colorectal cancer; in some mice, it caused disease regression. The results were published in the journal Nature Communications.

"For the first time, we have demonstrated how a completely non-toxic intervention can effectively treat an aggressive cancer," said Valter Longo, the study senior author and the director of the USC Longevity Institute at the USC Leonard Davis School of Gerontology and professor of biological sciences at the USC Dornsife College of Letters, Arts and Sciences.

"We have taken two treatments that are studied extensively as interventions to delay ageing-- a fasting-mimicking diet and vitamin C -- and combined them as a powerful treatment for cancer," added Longo.

The researchers said that while fasting remains a challenging option for cancer patients, a safer, more feasible option is a low-calorie, plant-based diet that causes cells to respond as if the body were fasting.

Their findings suggest that a low-toxicity treatment of fasting-mimicking diet plus vitamin C has the potential to replace more toxic treatments.

Results of prior research on the cancer-fighting potential of vitamin C have been mixed. Recent studies, though, are beginning to show some efficacy, especially in combination with chemotherapy.

In this new study, the research team wanted to find out whether a fasting-mimicking diet could enhance the high-dose vitamin C tumour-fighting action by creating an environment that would be unsustainable for cancer cells but still safe for normal cells.

"Our first in vitro experiment showed remarkable effects. When used alone, fasting-mimicking diet or vitamin C alone reduced cancer cell growth and caused a minor increase in cancer cell death. But when used together, they had a dramatic effect, killing almost all cancerous cells," said Longo.

Longo and his colleagues detected this strong effect only in cancer cells that had a mutation that is regarded as one of the most challenging targets in cancer research.

These mutations in the KRAS gene signal the body is resisting most cancer-fighting treatments, and they reduce a patient's survival rate. KRAS mutations occur in approximately a quarter of all human cancers and are estimated to occur in up to half of all colorectal cancers.

The study also provided clues about why previous studies of vitamin C as a potential anticancer therapy showed limited efficacy. By itself, a vitamin C treatment appears to trigger the KRAS-mutated cells to protect cancer cells by increasing levels of ferritin, a protein that binds iron.

But by reducing levels of ferritin, the scientists managed to increase vitamin C's toxicity for the cancer cells. Amid this finding, the scientists also discovered that colorectal cancer patients with high levels of the iron-binding protein have a lower chance of survival.

"In this study, we observed how fasting-mimicking diet cycles are able to increase the effect of pharmacological doses of vitamin C against KRAS-mutated cancers," said Maira Di Tano, a study co-author at the IFOM, FIRC Institute of Molecular Oncology in Milan, Italy.

"This occurs through the regulation of the levels of iron and of the molecular mechanisms involved in oxidative stress. The results particularly pointed to a gene that regulates iron levels: heme-oxygenase-1," added Tano.

The research team's prior studies showed that fasting and a fasting-mimicking diet slow cancer's progression and make chemotherapy more effective in tumour cells while protecting normal cells from chemotherapy-associated side effects. The combination enhances the immune system's anti-tumour response in breast cancer and melanoma mouse models.

The scientists believe cancer will eventually be treated with low-toxicity drugs in a manner similar to how antibiotics are used to treat infections that kill particular bacteria, but which can be substituted by other drugs if the first is not effective.

To move toward that goal, they say they needed to first test two hypotheses: that their non-toxic combination interventions would work in mice, and that it would look promising for human clinical trials.

In this new study, they said that they've demonstrated both. At least five clinical trials, including one at USC on breast cancer and prostate cancer patients, are now investigating the effects of the fasting-mimicking diets in combination with different cancer-fighting drugs.

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Agencies
March 27,2020

New Delhi, Mar 27: The Centre has restricted sale and distribution of "hydroxychloroquine" declaring it as an essential drug to treat the COVID-19 patients and meet the requirements of emergency arising due to the pandemic.

The Ministry of Health and Family Welfare on Thursday made the announcement making it clear that the order "shall come into force on the date of its publication in the official Gazette".

In the order, the government declared that the Central government is "satisfied that the drug hydroxychloroquine is essential to meet the requirements of emergency arising due to pandemic COVID-19 and in the public interest, it is necessary and expedient to regulate and restrict the sale and distribution of the drug 'hydroxychloroquine' and preparation based thereon for preventing their misuse".

"Now, therefore, in exercise of the powers conferred by Section 26B of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central government hereby directs that sale by retail of any preparation containing the drug Hydroxychloroquine shall be in accordance with the conditions for sale of drugs specified in Schedule H1 to the Drugs and Cosmetics Rules, 1945."

The order came at a time when the novel coronavirus claimed 16 lives and infected over 600 people across India.

The announcement regarding ban of sale and distribution of the drug was made by the government earlier but it issued an official Gazette notification on Thursday signalling that hydroxychloroquine -- an anti-Malaria drug -- will work as a medicine for treating coronavirus infected patients as well.

Recently, the national task force for COVID-19 constituted by Indian Council for Medical Research (ICMR) has recommended hydroxy-chloroquine as a preventive medication.

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