06Jun

Vaccinations against such common diseases as measles, hepatitis and human papillomavirus saved 37 million deaths in low- and middle-income countries over the last two decades and by 2030 will have prevented 32 million more.

And no group has benefited more than the youngest children.

According to research reported last month in The Lancet, deaths among children under 5 from the 10 diseases i n the study would have been 45% higher if they had not been vaccinated.

“There has been a much-needed investment in childhood vaccination programs in low-income and middle-income countries (LMICs) and this has led to an increase in the number of children vaccinated,” observed study co-author Dr. Caroline Trotter of the University of Cambridge UK. “Our modelling has provided robust evidence on the effectiveness of vaccination programs in LMICs and indicated what might be lost if current vaccination programs are not sustained.”

The study involved 16 independent research groups modelling the impact of childhood vaccination programs against 10 diseases in 98 LMICs. Multiple models were applied for each pathogen. Estimates of impact were based on past and future coverage of individual vaccines, vaccine effectiveness and data on deaths caused by the diseases, and on the years of healthy life lost due to premature death and disability from the diseases.

By comparing a scenario with no vaccination programs in place to scenarios when vaccinations programs were implemented, the study estimated the impact on deaths and on years of healthy life lost due to premature death and disability from the diseases.

Measles vaccinations offered the greatest impact, the researchers found. Between 2000 and 2030, the study estimated they will have prevented 56 million deaths.

Over the lifetime of people born in those three decades, being vaccinated against all 10 diseases in the study is estimated to prevent 120 million deaths, of which 65 million are children younger than five years. 58 million of deaths would be prevented by measles vaccinations alone and 38 million by hepatitis B vaccines.

Considering just those born in 2019, the study estimated that increases in vaccine coverage and introductions of additional vaccines will mean a 72% reduction in lifetime mortality caused by the 10 pathogens.

Said Neil Ferguson, a co-author of the report and a professor at Imperial College London, UK, “Our study signifies the huge public health benefits that can be achieved from vaccination programs in low-income and middle-income countries.

“By projecting up until 2030 in these 98 countries we have provided insight on where investments in vaccine coverage should be directed to achieve further gains.”

Photo by CDC

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Jun 6, 2023

How COVID Is Changing Clinical Trials

Amidst all the uncertainty about a COVID vaccine, at least this one thing is certain: it is changing how clinical trials are conducted.

Instead of taking years to move apotential vaccine from laboratory to trial, the US’s Operation Warp Speed has moved two of six prospective COVID vaccines into Phase 3 recruitment in under six months. Two more are expected to begin Phase 3 recruitment this month.

In the United Kingdom, a different type of clinical trial showed it is possible to enroll 12,000 patients, test several different existing treatment candidates and have the first significant results in fewer than 100 days.

Even given the substantial differences between the government-run health care system of the UK and the private, decentralized US system, there are lessons – “ideas,” Nicole Mather calls them in an article for the journal Nature – researchers here can apply to accelerate trials.

Describing how the UK’s RECOVERY trial went from concept to first, actionable results in such a short time, Mather identifies five differences with traditional trials:

  1. The trial protocol took only 20 pages to detail the design, and data and regulatory requirements. It was flexible enough to allow trial arms to be stopped or added.
  2. It got approvals in 9 days, versus the typical 30-60.
  3. Recruitment paperwork was simplified.
  4. Data collection and processing was accelerated through the UK’s DigiTrials hub, which provides centralized support for clinical trials.
  5. Results were quickly made public.

Though the RECOVERY program has its critics – objections center on releasing results without first being peer-reviewed and structural issues – Mather says it shows how a centralized health data system and a streamlined design and approval process can accelerate the timeline.

“We’ve gone so far towards managing risk that we’ve created layers of bureaucracy that absorb time and money, and, paradoxically, increase the risk that beneficial treatments are not tested,” she writes.

That view is echoed by Martin Landray, deputy chief investigator of RECOVERY, who said the way the National Institute for Health Research cut red tape was “fabulous.” “Many academic and commercial trials have accumulated so much extra baggage over the years, such as long case report forms and 10 page patient consent forms,” he said in an interview with The BMJ.

Digital entry for the RECOVERY trial made consent and subsequent data collection quick and simple, The BMJ article reports.

Leveraging data systems is an important lesson, says Mather, who is life-sciences lead at IBM Services in London, which was a partner in the DigiTrials project. Because of the UK’s National Health System, much information was already available for trial study patients, simplifying the participation process.

That would be a much greater challenge in the US because of its private medical system, although the strong push over the last decade to digitize medical records is making the portability of patient data easier.

The UK RECOVERY program has given momentum to accelerating clinical trial processes. To build on it, says Landray, “We now need to apply the lessons from this approach to other major health challenges such as heart disease, cancer, arthritis, and mental health.”

Photo by JC Gellidon on Unsplash

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Jun 6, 2023

The Unsung Heroes of the Pandemic

Nurses and doctors who treat patients with COVID-19 are rightfully celebrated as heroes of the pandemic. First responders, hospital orderlies, janitors, housekeepers and medical workers playing a support role in the fight against the virus are being cheered loudly and publicly and on social media posts worldwide.

Those are the ones we see and hear about daily. Yet there is another group of professionals laboring behind the scenes, often remotely, whose vital work goes unsung. These are the case managers — nurses or social workers in most cases — who, explains Wil Shelton, “coordinate with physicians, nurses, mental health and insurance companies, and family and friends of the patient, their client.”

His wife is one.

“Case managers are in a battle behind the scenes, huddling daily to plan for the next six months. But mostly these men and women are alone, hunched over computers in trenches of their bedrooms or living rooms, making frantic phone calls, staying focused on the needs of patients even when their families need them, too.”

In just one week, Shelton says, his wife helped cancer patients unable to see their oncologist because offices are closed. She worked with the family of a 2-year-old asthma patient discharged home because his doctor’s office, too, was closed. Then there were the terminally ill patients who contracted COVIC-19 and had to be isolated from family when, he notes sadly, “time with them matters most.”

That doesn’t even include the administrative tasks like finding an empty bed, handling records, tracking patients and hunting down busier-than-ever doctors and nurses.

“All of these situations bring tears, confusion, fear, and loss — all of which my wife, and case managers like her, are supposed to alleviate from a remote location with little support and in the middle of a system plagued by glitches and breakdowns,” says Shelton.

“Please,” he ends his post, speaking to all of us, “Be kind to your case worker. He or she is making a great sacrifice to ensure the best outcome for you.”

Photo by National Cancer Institute on Unsplash

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