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COVID-19 vaccine update: Who are the front-runners?

As the coronavirus continues its grip on the world, scientists across the globe are working to find a viable vaccine. Several candidates are in the final stages of testing, but researchers warn it could still take years.

After researchers in China published the genome sequence  of the coronavirus  in January, scientists around the world set to work on a vaccine. The first candidate began human trials on March 16.

It’s now joined by nearly 200 others being tracked by the World Health Organization  — 44 of which have entered human trials.

It normally takes years to test, produce and deploy vaccines. The fastest ever vaccine to be brought from clinical testing to market, the vaccine for mumps, took four years in the 1960s.

Scientists working on coronavirus vaccines are hoping to deliver one within 12 to 18 months. And the WHO hopes to roll out two billion doses of a vaccine by the end of 2021.

No coronavirus vaccines have yet been approved for general use internationally, but several candidates have reached the final stages of testing.

They are based on several different approaches, including active, inactivated, DNA, RNA/mRNA-based, virus vectors and protein subunits, and there are three test phases vaccines must pass before they are sent to regulatory authorities for approval.

Here’s an overview of the front-runners.

CoronaVac: Sinovac Biotech

CoronaVac, developed by Chinese firm Sinovac Biotech,  is one such inactivated type of vaccine racing toward the finish line. Study results from Phase 3 trials, which are currently being carried out with tens of thousands of volunteers in Brazil, Turkey and Indonesia, are expected to be available in November. Although clinical trials are still underway, CoronaVac was approved for emergency use in China in late August as part of a programme to vaccinate high-risk groups, such as medical workers. Initial results from studies on macaque monkeys showed that the vaccine produced antibodies that neutralized 10 strains of SARS-CoV-2. Preprint results from Phase 2 human trials show it produced antibodies with no severe adverse reactions.

Brazil plans to use the Chinese-made Sinovac Biotech coronavirus vaccine as part of its national immunization programme

BNT162b2: Pfizer & BioNTech

BNT162b2 is a messenger RNA (mRNA) vaccine from American-German duo Pfizer and BioNTech. It’s currently in Phase 3 trials with 44,000 volunteers in multiple areas around the world with high rates of coronavirus transmission. Preliminary testing in the first two phases showed the vaccine produces antibodies and T-cell responses specific to the SARS-CoV-2 protein. Developers say they could know by the end of October if the vaccine works or not and have enough data to determine its safety by the end of November. No mRNA vaccine has ever been approved for an infectious disease — but proponents say it could be easier to produce than traditional vaccines.

mRNA-1273: Moderna

Another mRNA vaccine in the works, the mRNA-1273 from US-based Moderna, entered its third phase with 30,000 people in late July. Initial results from Phase 1 showed both young and elderly volunteers produced coronavirus antibodies and reactions from T-cells. In the trial, half of the volunteers receive a vaccine, while the other half get a placebo. Developers will be able to do a first analysis when 53 people in the entire volunteer group get symptomatic COVID-19 — the efficacy of the vaccine depends on whether there are significantly fewer vaccinated people than unvaccinated among the 53 cases.

Experts warn that vaccines need to be studied even after they are rolled out

Two of the most favored vaccine candidates — from AstraZeneca and Johnson & Johnson — have been paused while their developers investigate adverse reactions among participants.

ChAdOx1 nCoV-19: AstraZeneca & Oxford University

ChAdOx1 nCoV-19 is a viral vector vaccine in Phase 3 of trials, with developers aiming to recruit 50,000 volunteers. Initial results from the first two clinical phases showed the vaccine triggered a strong immune response, producing antibodies and T-cell responses in volunteers. The study was put on hold due to an unexplained illness in one UK participant, and has since resumed in Brazil, South Africa and the UK, although the US trial is yet to recommence.

Ad26.COV2-S: Johnson & Johnson

Johnson & Johnson, who are also producing an adenovector vaccine, recruiting around 60,000 people in various different countries, paused trials  on October 12, saying an unexplained illness required an independent safety review. It is not uncommon for clinical trials to experience pauses, but it isn’t often that they are reported. Results from animal trials showed the vaccine produced “robust neutralizing” antibodies in macaques, and provided “complete or near complete protection” after a single dose.

Sputnik V: Gameleya National Center of Epidemiology and Microbiology

Russia’s Sputnik V, based on two adenovirus vectors, has also drawn widespread attention, after the Russian government approved it for general use on August 11 without completing Phase 3 trials. Results from the first two trials showed a strong immune response among the 76 participants.

Vaccine testing doesn’t end at Phase 3

While the speed at which these vaccines are progressing is unrivalled in humanity’s vaccinology history, experts warn we still have a long way to go to achieve a safe and effective vaccine.

Although clinical trials can show that a vaccine is safe and effective among tens of thousands and even hundreds of thousands of people, it’s not possible for these trials to encapsulate every possible side effect that could occur among certain people or after an extended period of time.

That’s why, even after a vaccine has been rolled out, it’s critical to monitor the safety and efficacy of vaccines, says Naor Bar Zeev, deputy director of the International Vaccine Access Center at the John Hopkins Bloomberg School of Public Health in the US.

“There is never certainty,” Bar Zeev told DW. This ongoing surveillance is sometimes referred to as ‘Phase 4’ in clinical trials — and it can take many years.

“I think the public expectation is that once a vaccine is available we go back to the way things were — we stop wearing masks, we stop social distancing. But that is a misjudgement of what a vaccine — at least in the initial phase — can do,” Bar Zeev said, emphasizing that the delivery and ongoing evaluation of widespread vaccine deployment is a lengthy process.

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‘Coronavirus is covert, clever and complicated,’ acknowledges leading Chinese virologist

China CDC Director-General Dr Gao urged international cooperation to continue the COVID-19 fight. Read this and other day 3 updates from Global Health Exhibition.

Increasing readiness for future global health emergencies

Interview with Dr George F. Gao, Director-General, Chinese Center for Disease Control and Prevention

In an interview sponsored by Lean Business Services, Dr George F. Gao, Director-General, China CDC looked at how COVID-19 may strengthen global preparedness in anticipation of the next pandemic.

Problematically, from China CDC’s point of view, the virus is “clever, covert and very complicated”, and while having experienced more than seven waves already in China owing to imported cases, they are still attempting to understand lessons from the first (in Wuhan).

The virus, he elaborated further, raises important questions and problems. Initially it was assumed that the coronavirus was like SARS, MERS and Ebola, yet it proved to behave very differently. “It’s very special,” he admitted, “Our common sense and knowledge of Ebola, MERS and Avian flu don’t work.”

While complicated, every imported transmission remains under control, with four provinces – Inner Mongolia, Shanghai, Tianjin and Anhui – presently experiencing outbreaks.

Dr Gao’s lab is working on developing a vaccine and the pathogenesis of the coronavirus, including trying to understand why there is immuno-suppresion. He stressed the need to go back to science.

So far much has been learned about the virus. After one year no intermediate host has been found, Dr Gao said. While people suspects bats as a close relative, no one has yet isolated the coronavirus anywhere in the world. The scientific community has to work hard to identify the origin of the virus, he continued, lest another outbreak emerges in 5-10 years time.

Dr Gao conceded that it was difficult to predict how the current pandemic would end – eventually herd immunity will be attained by the end of the pandemic’s last year – but there are approaches that the world can take to better control the outbreak. To reopen their economy, all countries must move back to community-level control – which works in China – meaning that public health workers, doctors and nurses are activated and report suspected cases as soon as possible.

He also suggested that innovations such as digital health and nucleic acid tests can play an important role. Everyone uses a smartphone, he said, and so a “health code” was introduced in China to establish a traveller’s health status (a colour code is assigned to each user depending on places they can acces). This allowed the speaker to travel recently to places such as Shenzhen and Zhuhai.

On a final note, he concluded that while it will be “very difficult” to stop the next pandemic from happening – suggesting it was like Tom facing Jerry from the old cartoons – the global community must work together.

He also emphasised the need to maintain a good relationship with nature, saying that humanity is destroying the habitat of virus-carrying animals. Human factors and behaviours are contributing a lot, he pointed out, reminding that there were four class-1 pandemics in the previous century, along with sporadic outbreaks such as Ebola.

Interview with Syra Madad, Senior Director, System-wide Special Pathogens Program, NYC Health Hospitals

In the last 10 months, COVID-19 has put the world back 10-15 years in terms of infectious disease goals, stressed Syra Madad, Senior Director, System-wide Special Pathogens Program, NYC Health Hospitals, U.S. Due to COVID-19, infectious diseases such as malaria, HIV, and TB, etc., are being masked all around the world.

She explained: “When hospitals get overwhelmed, PPE gets reused and because of which there might be some cross-contamination. However, the good factor has been that since COVID-19 is a respiratory disease, people are wearing masks and these preventative measures are helping in controlling the viral flu.”

According to Madad, technology can play a key role in managing infectious diseases. She said that if several of the processes are automated, it saves time when it comes to training and relying on the human factor to keep up the volume.

“There are certain aspects where we can leverage technology more, in terms of scaling up and having a robust infrastructure,” she highlighted. “For example, while contact tracing is a manual process, if we can augment it better then we don’t have to strain the contact tracing workforce. Today, some apps can track clusters and prevent outbreaks. Also, several decision support tools are being developed by the military such as POCT tests to diagnose pathogens. Our frontline doctors don’t have access to it, and while it is important to innovate and it is also essential to provide these to the frontlines.”

When asked about how COVID-19 will end, Madad stressed that it is an individual responsibility to do what is right but there is also the need to have good public policy and governance in place and provide a conducive environment so that people can do the right thing.

“It is important to realise that such outbreaks are inevitable but what is not inevitable is the way governments respond to these threats. They need to stop hazards from becoming catastrophes and can’t have bubble gum and band-aid solutions! Governments need to invest in preparedness, as it has immense return on investment. Preparedness includes having good public health infrastructure in place that can be scaled up. The best part is we know what to do and have the tools. We have made such amazing advancements, but we just need to make sure that we don’t end up in a similar situation in the future,” she concluded.

A look at the resilience of value based healthcare systems

In a Lean Business-sponsored session moderated by Jwaher Moteb AlSaud, Chief Beneficiary Affairs Officer at PHAP-MOH, Saudi experts considered how KSA’s healthcare system is transforming from fee-for-service healthcare model to a value-based healthcare system, and benefits to different stakeholders.

The notion of “value” was perceived differently by each.

Dr. Mohammad Ibrahim Alsaghier, CEO at Health Holding Company, described three values. The first is personal, around keeping citizens healthy, while the cost of care is not high; the second is a value to the system and payer, so that the largest percentage of the population is kept healthy without significant cost (the cost is more preventative); third, the value to the technical team, to ensure that the best medical care is affordable to the community.

Dr Shabab Saad AlGhamdi, Secretary General at CCHI, believes that VBH will help the entire system – regulators, payers and providers – in Saudi Arabia to grow. Payers would like better value in their investment, and the provider would like to do a good job. Having value as a strategic pillar at national level would help facilitate the move to proactive healthcare and improve the health status of the population, along with sustaining the affordability of care. He added that CCHI adopted this in its strategic transformation to be become an internationally leading organisation and improve the quality of care and satisfaction, and ensured better guiding principles.

Marwan Arbalawi, Director of Digital Health at Lean Business, said that putting the individual as the focus is the goal of VBH, and in particular providing high value care at low cost.

Role of technology

According to Dr Shabab, it’s not possible to realise value until digitalisation is achieved. He spoke of a unified electronic services platform for Saudi Arabia called National Platform for Health Insurance and Exchange Services, comprising insurance services and unified medical records, to help achieve more granular data, whereupon a baseline can be measured and improved on.

Arbalawi agreed that technology initiatives need to be supported to achieve VBH, suggesting that technology will enable regulators, providers and payers to “do their job”. He further elaborated by saying that payers will like to see data where they can see the right care is provided at reasonable cost; regulators would want patients to be treated in the right way in accordance with standards; and providers will be in favour of providing new ways of care.

Dr. Mohammad stated that levers need to be built into the system, but there is huge political will today with a Vision 2030 as a major enabler. He added there is a strong feeling that a lot of care cannot be provided without measuring outcomes, and so there is a push towards achieving this.

He stressed that providers believe in VBH – there is a movement behind it – quoting an example of a first five year plan to move towards VBH that was reviewed the previous week. It was an important moment, he said, in the history of the transformation of healthcare.

Jwaher Moteb AlSaud stated that the best examples of value-based healthcare were enabled by government, and described the journey towards achieving it as interesting.

Introducing VBH to the insurance market

Dr Shabab said a key driver of change is sustainability, and VBH is a “win, win, win” situation for all stakeholders: for payers, where they can have steady growth of business; providers can compete transparently; and employers can maintain some control of pay at the end of the year. The ultimate beneficiary is the customer, who has better access, better quality of care, and better satisfaction.

All these needs are included in CCHI’s strategy and aligned with the national strategic guiding principles from the Vision Realization Program (VRP). There were five strategic pillars followed by CCHI, two of which he described.

He explained the first as prioritising quality and satisfaction for the beneficiary – the end user. The CCHI is surveying nationally customers on this basis to determine areas of improvement. The CCHI is additionally collecting data from payers and providers to drive quality of outcome.

Second, there is a need to enable the private sector. Dr Shabab described a love-hate relationship between payer and provider. The CCHI is now making it a requirement for all payers to adopt care management and population outcomes (all international payers are mandated to do so, he added).

Value-based imaging

At this session, Carlos Francisco Silva, MD, EDiR, Radiologist, Member – Management & Quality Section, Portuguese Society of Radiology and Nuclear Medicine (SPRMN), Sertubal, Portugal, discussed the concept of value in radiology. He said that value equals to outcomes divided by cost. The outcomes include quality, efficacy and safety.

He further highlighted that radiology faces the problem of 30 per cent of waste in imaging exams due to tests and procedures that are unnecessary. Some of the frequent mistakes that can lead to this waste include forgetting to compare previous CT/MRI reports, missing information, a valid information request but about the wrong patient, and missing/erroneous lab data.

“Good IT support is crucial for radiologists to integrate the necessary software and clinical decision support tools, otherwise they will lose too much time,” he stressed.

Furthermore, according to Silva, even though physicians are aware of the problem they continue to order low-value tests and procedures. He shared findings where the reasons for this included malpractice concerns (87 per cent), desire to reduce uncertainty (84 per cent), “just to be safe” (78 per cent), and desire to keep patients happy and on patient’s insistence (>70 per cent).

He added: “While value-based care needs to be relationship-centric, radiologists need to work as a team, and align clinicians’ value and goals to achieve better patient outcomes.”

The road towards value based health care

The role of supply chain in optimizing healthcare costs – Sponsored by Nupco

This session explored how much money can be saved from unifying and optimizing the supply chain. Tariq Alahmadi, Program Manager, NUPCO, said that demand-driven solutions can be used to optimise supply chain management. There is an increased need to monitor customer demand and identify and agree on solutions to deliver products at a suitable time to patients and healthcare provider. The performance of these systems also needs to be continuously monitored to make modifications if required.

“KSA is a huge market with more than 300 hospitals and 4,000 primary centres,” he highlighted. “To reach all these customers, you need to streamline the ordering process to have clear visibility. Therefore, one of the major investments in the supply chain processes in the country has been in automation to provide better solutions. Automation results in cost-savings by streamlining activities.”

Alahmadi stressed that when supply chain processes offer end-to-end visibility, only then will they be able to provide benefits and deliver orders promptly. This is where digitalisation could play a key role.

He said: “One of the issues we are facing is that visibility of the end-user is not clearly captured all the time. I believe providing this visibility may decrease cost leakage. One of the aspects contradicting cost savings is you need much more investment; the question is how to provide better networking and the answer is it requires one-time major investment in digitalisation of services.”

One of the other major issues, according to Alahmadi, is lack of standardisation. “Cost saving is clear when these 300 hospitals have a unified catalogue, as this would lead to cost savings in the procurement side. Quality has to be there all the time and can’t be compromised. Standardisation is one of the first steps that healthcare entities, both public and private, need to agree on to have better cost-saving methodologies.

“Focusing on streamlining services such as dispatching, will add more value to the supply chain.”

Leaders Session: Health Information Management Update – Addressing the latest updates, challenges and solutions for healthcare and insurance providers

At the session, leading American Association Experts shared best practices and leading industry standards and educational offerings in Coding, Clinical Documentation Improvement (CDI) and Revenue Cycle Management (RCM).

As part of the Coding & CDI: Best practices presentation, Melanie Endiscott, Senior Director, International Education and Training, AHIMA, said clinical documentation represents what is going on with the patient, which is turned to standardised coding, which turns to reports for reimbursement, quality reporting, public health, medical research, etc. “The standardised coding supports best possible patient outcomes,” she added.

There are seven characteristics of high-quality clinical documentation: complete, consistent (should not be contradictory), timely, clear (thorough), precise, legible, and reliable.

There are a lot of codes out there said Endiscott, for example, in the U.S. there are over 60,000 codes and 10,000 outpatient codes. In Australia, there are over 22,000 diagnosis codes and billing has over 6,000 codes. KSA also uses these Australian codes. “KSA has been using this for years. The challenge is going to be to ensure the codes are being applied consistently across the country. Fortunately, there are many technologies available such as AI that will assist in ramping up that workforce,” she highlighted.

While Joseph Fifer, CEO, Healthcare Financial Management Association (HFMA), gave a presentation on the ‘Revenue cycle management: Best practices from the U.S. and education opportunities.’ He said that KPIs help forecast performance and recognise signs of improvement or slippage, identify where labour, technology and other resources are likely to have the most impact and help determine if it makes financial sense.

“We need database decision making that is at the heart of the revenue cycle management,” he added.

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Pfizer, Moderna testing their vaccines against UK coronavirus variant – CNN

(Reuters) – Pfizer Inc and Moderna Inc are testing their COVID-19 vaccines against the new fast-spreading version of the virus that has emerged in Britain, CNN reported on Tuesday.

Moderna expects immunity from its vaccine to protect against the variants and is performing more tests in the coming weeks to confirm, the company said in a statement to CNN. cnn.it/38qpbFl

Pfizer said it is “generating data” on how well blood samples from people immunized with its vaccine “may be able to neutralize the new strain from the UK,” according to the report.

Pfizer and Moderna did not immediately respond to Reuters’ requests for comment.

The discovery of the new strain sowed a fresh wave of panic in a pandemic that has killed about 1.7 million people and infected more than 77.15 million worldwide.

The main worry is that the new variant is 40%-70% more transmissible.

Scientists have said there’s no evidence that vaccines currently being deployed in the United Kingdom – made by Pfizer and BioNTech – or other COVID-19 shots in development will not protect against this variant, known as the B.1.1.7 lineage.

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Immunodiagnostics firm signs deal to supply lung cancer blood test to NHS Trust

Immunodiagnostics company Oncimmune Holdings has signed a commercial contract to supply its EarlyCDT Lung blood test to NHS Norfolk & Waveney Clinical Commissioning Group. 

The company has also signed a commercial contract to supply EarlyCDT Lung blood test into the NHS Lung Health Check Programmes in Wessex and Yorkshire as part of the iDx-LUNG evaluation programme.

Following due diligence by the NHS, the company has also been notified that The National Institute for Health and Care Excellence (NICE) has selected the EarlyCDT Lung blood test for Diagnostics Assessment Guidance. This decision follows the publication by NICE in March 2020 of the positive Medtech Innovation Briefing 209 (“MIB”) on “EarlyCDT-Lung for cancer risk classification of indeterminate pulmonary nodules”. The successful completion of this assessment will further support wider market adoption of EarlyCDT Lung in the NHS.

Norfolk & Waveney Clinical Commissioning Group

Under this commercial contract, Norfolk & Waveney will be evaluating the use of the EarlyCDT Lung blood test in a clinical setting. A successful conclusion to this contract, combined with guidance from NICE, is anticipated to support the adoption of the EarlyCDT Lung blood test into the clinical pathway for the early detection of lung cancer across NHS East of England.

The first phase of the commercial contract, which is scheduled to start in January 2021, will focus on patients with Indeterminate Pulmonary Nodules (“IPNs”). The second phase will see the EarlyCDT Lung blood test used in a screening setting with people at risk recruited in selected GP practices in Great Yarmouth, Norfolk. The contract is unconstrained, albeit the evaluation is scheduled to be completed in both settings within 12 months.

Wessex and Yorkshire iDx-LUNG programme

Oncimmune has been selected to supply the EarlyCDT Lung blood test on commercial terms into the iDx-LUNG programme which will collect blood samples from 15,000 people attending the NHS England’s Lung Health Check Programme delivered through mobile CT scanning sites across Wessex and Yorkshire.

As well as targeting increased survival rates, an aim of the iDx-LUNG programme is to streamline the process of detecting incident lung cancers in the community and so reduce the NHS resource needed to find each new lung cancer case. The current optimal method of checking lung health, CT scanning, is resource-intense and expensive, with diagnosis and treatment of lung cancer currently costing the NHS an estimated £307 million every year.

Oncimmune is in dialogue with other regional health systems in the UK for use in lung cancer diagnostic programmes, and NICE Guidance will provide further supporting evidence of the clinical utility of the test in conjunction with existing NHS delivery programmes.

NICE Guidance

Following a positive MIB in March 2020, the NICE Topic Selection Oversight Panel further considered the merits of the EarlyCDT Lung blood test in July 2020 upon submission of additional evidence by Oncimmune and have now notified the Company that EarlyCDT Lung has been selected for Diagnostics Assessment Guidance. This Guidance evaluates new, innovative diagnostic technologies in order to help NHS staff make efficient, cost-effective and consistent decisions about adopting new products in support of innovation, transformation and improving healthcare delivery. The diagnostics assessment process for EarlyCDT Lung commenced in November 2020.

Dr Adam M Hill, CEO of Oncimmune said: “Detecting lung cancer early is key to improving chances of survival, whether patients have a nodule or not. The body of evidence supporting the use of EarlyCDT Lung in patients at risk of lung cancer continues to build and is increasingly compelling. Indeed, following the Grail, Inc. announcement, it is excellent to see the NHS increasing its focus on the early detection of cancers in order to help meet its goal of diagnosing three-quarters of all cancers at an early stage by 2028.

“In addition to commercial evaluations of the implementation and the use of the EarlyCDT Lung blood test in Wessex, Norfolk and Yorkshire, we are especially delighted to have been selected by NICE for full guidance.

“The successful publication of our co-funded Early detection of Cancer of the Lung Scotland (“ECLS”) study with the NHS, which demonstrated a 36% reduction in late stage diagnoses of lung cancer which have the worst survival, has been followed by intense discussions with the NHS, leading to due diligence throughout the last six months. As a result of those discussions, we are delighted to be working with the NHS in three regions to start the work of implementing our simple blood test into clinical care to significantly improve the chances of survival for patients with lung cancer through early detection.”

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