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 8,2020

As Europe and the US loosen their lockdowns against the coronavirus, health experts are expressing growing dread over what they say is an all-but-certain second wave of deaths and infections that could force governments to clamp back down.

"We are risking a backslide that will be intolerable," said Dr Ian Lipkin of Columbia University's Center for Infection and Immunity.

Around the world, German authorities began drawing up plans in case of a resurgence of the virus. Experts in Italy urged intensified efforts to identify new victims and trace their contacts. And France, which has not yet eased its lockdown, has already worked up a "reconfinement plan" in the event of a new wave.

"There will be a second wave, but the problem is to which extent. Is it a small wave or a big wave? It is too early to say," said Olivier Schwartz, head of the virus unit at France's Pasteur Institute.

In the US, with about half of the states easing their shutdowns to get their economies restarted and cellphone data showing that people are becoming restless and increasingly leaving home, public health authorities are worried.

Many states have not put in place the robust testing that experts believe is necessary to detect and contain new outbreaks. And many governors have pressed ahead before their states met one of the key benchmarks in the Trump administration's guidelines for reopening -- a 14-day downward trajectory in new illnesses and infections.

"If we relax these measures without having the proper public health safeguards in place, we can expect many more cases and, unfortunately, more deaths," said Josh Michaud, associate director of global health policy with the Kaiser Family Foundation in Washington.

Cases have continued to rise steadily in places such as Iowa and Missouri since the governors began reopening, while new infections have yo-yoed in Georgia, Tennessee and Texas.

Lipkin said he is most worried about two things: the reopening of bars, where people crowd together and lose their inhibitions, and large gatherings such as sporting events, concerts and plays. Preventing outbreaks will require aggressive contact tracing powered by armies of public health workers hundreds of thousands of people strong, which the US does not yet have, Lipkin said.

Worldwide the virus has infected more than 36 lakh people and killed over a quarter-million, according to a tally by Johns Hopkins University that experts agree understates the dimensions of the disaster because of limited testing, differences in counting the dead and concealment by some governments.

The US has recorded over 70,000 deaths and 12 lakh confirmed infections, while Europe has reported over 140,000 dead.

This week, the researchers behind a widely cited model from the University of Washington nearly doubled their projection of deaths in the US to around 134,000 through early August, in large part because of the easing of state stay-at-home restrictions. Newly confirmed infections per day in the US exceed 20,000 and deaths per day are running well over 1,000.

In hard-hit New York City, which has managed to bring down deaths dramatically even as confirmed infections continue to rise around the rest of the country, Mayor Bill de Blasio warned that some states may be reopening too quickly.

"My message to the rest of the country is learn from how much effort, how much discipline it took to finally bring these numbers down and follow the same path until you are sure that it is being beaten back," he said on CNN, "or else, if this thing boomerangs, you are putting off any kind of restart or recovery a hell of a lot longer."

A century ago, the Spanish flu epidemic's second wave was far deadlier than its first, in part because authorities allowed mass gatherings from Philadelphia to San Francisco.

"It is clear to me that we are in a critical moment of this fight. We risk complacency and accepting the preventable deaths of 2,000 Americans each day," epidemiologist Caitlin Rivers, a professor at Johns Hopkins, told a House subcommittee in Washington.

President Donald Trump, who has pressed hard to ease the restrictions that have throttled the economy and thrown more than three crore Americans out of work, pulled back Wednesday on White House plans revealed a day earlier to wind down the coronavirus task force.

He tweeted that the task force will continue meeting indefinitely with a "focus on SAFETY & OPENING UP OUR COUNTRY AGAIN".

Underscoring those economic concerns, the European Union predicted the worst recession in its quarter-century history. And the US unemployment rate for April, which comes out on Friday, is expected to hit a staggering 16 per cent, a level last seen during the Great Depression of the 1930s.

Governors continue to face demands, even lawsuits, to reopen. In Michigan, where armed demonstrators entered the Capitol last week, the Republican-led Legislature sued Democratic Governor Gretchen Whitmer, asking a judge to declare invalid her stay-at-home order, which runs at least through May 15.

In hard-hit Italy, which has begun easing restrictions, Dr Silvio Brusaferro, president of the Superior Institute of Health, urged "a huge investment" of resources to train medical personnel to monitor possible new cases of the virus, which has killed about 30,000 people nationwide.

He said that contact-tracing apps which are being built by dozens of countries and companies are not enough to manage future waves of infection.

German Chancellor Angela Merkel said after meeting with the country's 16 governors that restaurants and other businesses will be allowed to reopen in the coming weeks but that regional authorities will have to draw up a "restriction concept" for any county that reports 50 new cases for every 100,000 inhabitants within a week.

Lothar Wieler, head of Germany's national disease control centre, said scientists "know with great certainty that there will be a second wave" of infections.

Britain, with over 30,000 dead, the second-highest death toll in the world behind the US, plans to extend its lockdown but has begun recruiting 18,000 people to trace contacts of those infected.

In other developments, the US Centers for Disease Control and Prevention said nearly 5,000 coronavirus illnesses and at least 88 deaths have been reported among inmates in American jails and prisons. An additional 2,800 cases and 15 deaths were reported among guards and other staff members.

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Agencies
July 2,2020

London, Jul 2: The World Health Organisation says smoking is linked to a higher risk of severe illness and death from the coronavirus in hospitalised patients, although it was unable to specify exactly how much greater those risks might be.

In a scientific brief published this week, the U.N. health agency reviewed 34 published studies on the association between smoking and Covid-19, including the probability of infection, hospitalisation, severity of disease and death.

WHO noted that smokers represent up to 18% of hospitalised coronavirus patients and that there appeared to be a significant link between whether or not patients smoked and the severity of disease they suffered, the type of hospital interventions required and patients' risk of dying.

In April, French researchers released a small study suggesting smokers were at less risk of catching Covid-19 and planned to test nicotine patches on patients and health workers — but their findings were questioned by many scientists at the time who cited the lack of definitive data.

WHO says "the available evidence suggests that smoking is associated with increased severity of disease and death in hospitalized Covid-19 patients. It recommends that smokers quit.

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Agencies
May 25,2020

Singapore, May 25: COVID-19 patients are no longer infectious after 11 days of getting sick even though some may still test positive, according to a new study by infectious disease experts in Singapore.

A positive test "does not equate to infectiousness or viable virus," a joint research paper by Singapore's National Centre for Infectious Diseases and the Academy of Medicine, Singapore said. The virus "could not be isolated or cultured after day 11 of illness."

The paper was based on a study of 73 patents in the city-state.

The latest findings may have implications on the country's patient discharge policy. The discharge criteria is currently based on negative test results rather than infectiousness.

Singapore's strategy on managing COVID-19 patients is guided by the latest local and international clinical scientific evidence, and the Ministry of Health will evaluate if the latest evidence can be incorporated into its patient clinical management plan, according to a report by the Straits Times.

So far, 13,882, or about 45% of the total 31,068 Covid-19 patients in Singapore have been discharged from hospitals and community facilities. Singapore reported 642 new Covid-19 cases as of noon on Saturday.

The government has been actively screening pre-school staff as it prepares to reopen pre-schools from June 2. On Friday, two pre-school employees tested positive for the novel coronavirus, bringing the total number of confirmed cases among pre-school staff to seven, according to the Ministry of Health.

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