The World Health Organization (WHO) on Wednesday approved an eighth vaccine against COVID-19, which follows a slight uptick in new cases globally.
COVAXIN, made by Indian company Bharat Biotech, has received WHO emergency use listing (EUL), meaning it could soon be available to millions worldwide.
The EUL process assesses the quality, safety and efficacy of vaccines and is a prerequisite for their inclusion in the global solidarity initiative, COVAX.
‘Keep up the pressure’
It also allows countries to expedite their regulatory approval to import and administer doses.
“This emergency use listing expands the availability of vaccines, the most effective medical tools we have to end the pandemic,” said Dr. Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products.
“But we must keep up the pressure to meet the needs of all populations, giving priority to the at-risk groups who are still waiting for their first dose, before we can start declaring victory.”
COVAXIN was already being administered in India, where authorities had approved its use since January, although a third phase of clinical trials was still ongoing, according to media reports. Bharat Biotech later produced data showing the vaccine was around 78 per cent effective.
Meeting WHO standards
A WHO advisory group assessed COVAXIN under the EUL procedure, based on review of data on quality, safety, efficacy, a risk management plan and programmatic suitability.
The vaccine was determined to meet WHO standards for protection against COVID-19, and green-lit for worldwide distribution.
Last month, COVAXIN was also reviewed by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), which formulates specific policies on vaccines and recommendations for their use.
SAGE has recommended COVAXIN use in two doses, with an interval of four weeks, in all age groups over 18.
Easy storage requirements
The vaccine was found to have 78 per cent efficacy against COVID-19 of any severity, 14 or more days after the second dose. It is also extremely suitable for low and middle-income countries due to its easy storage requirements.
WHO said available data on vaccination of pregnant women is insufficient to assess its safety or efficacy in this population, though studies are planned.
There have been nearly 247 million cases of COVID-19 worldwide, and more than five million deaths, according to latest available WHO data.
Over three million new infections were reported last week, representing a slight upward trend, the agency said in its most recent COVID-19 epidemiological update, published on Tuesday.
The rise was led by a six per cent increase in weekly new cases in Europe, as all other regions reported declines or stable trends.
In fight against male cancer, caring for mental health is a growing priority
By Anthony King
At a hotel in the Scottish city of Aberdeen about 20 years ago, urologist James N’Dow and other doctors met a group of men who had suffered prostate cancer to ask for feedback on their care before and after surgery. The clinicians were stunned by the critical, albeit constructive, responses.
‘Frankly, they felt abandoned,’ said Professor N’Dow, who works at the University of Aberdeen. ‘When we discharged them after surgery, we thought their general practitioners were looking after them and their GPs thought we were.’
Minding the mind
Dealing with the emotional and mental toll of prostate cancer has grown in importance along with detecting and curing the disease itself. Prostate cancer is the second-leading cancer among men in Europe and is sometimes mistakenly viewed as a disease only of old age. It caused an estimated 335 500 cases, or 12.5% of cancers, in the EU in 2020.
Prof N’Dow heads an Innovative Medicines Initiative project – PIONEER – on prostate cancer that seeks to improve diagnosis and treatment. A parallel EU-funded initiative called FAITH is developing an electronic application for cancer survivors that could help spot if the “black dog” of depression is stalking them.
‘Depression is a big thing in post-cancer survivors,’ said Gary McManus, who leads FAITH and works at the Walton Institute for Information and Communication Systems Science in Waterford, Ireland.
Four in 10 men who have been treated for prostate cancer say they are anxious or depressed to some degree, with troubles worsening the more advanced the cancer, according to a 2020 study by Europa Uomo, a European advocacy movement for sufferers of the disease. Prostate cancer can increase the risk of suicide.
Stopping the spread
When prostate cancer is caught early enough, a man can be cured. If it spreads beyond the prostate, the cost of treatment is high and delivers minimal benefit. Usually, the disease will spread – metastasize – to the bones and lymph nodes.
‘It is not curable at that stage,’ said Prof N’Dow. ‘We are still picking up too many men with metastatic disease – and this is a failure of the system.’
Without treatment, the average period of survival from prostate cancer that has spread beyond the gland is about 21 months. With some newer therapies, some metastatic prostate cancer patients can survive five years or more.
Even when the cancer is aggressive, if it is restricted to the prostate gland a patient can be cured by surgery or radiation therapy – or a combination. Almost 95% of these patients are still alive up to 15 years after their diagnosis. Treatment can, however, affect a man’s urinary or erectile function.
Prof N’Dow hails recent EU recommendations to screen prostate cancer in men up to the age of 70 using a blood test and magnetic resonance imaging (MRI) scans based on an individual’s risk. Certain men over 50 and those of African descent or with a family history of prostate cancer are at heightened risk from this cancer and should be targeted for early detection.
Tracking the blues
Amid the efforts to improve detection and cures, FAITH’s planned app highlights the heightened focus on the psychological well-being of cancer patients.
Although it is being tested on people who have overcome lung and breast cancer, the app could be made to work for survivors of the disease in other parts of the body including the prostate.
In its study two years ago on anxiety or depression among men who have been treated for prostate cancer, Europa Uomo said 0.5% felt either one to an “extreme” degree and almost 4% to a “severe” extent. Nearly 11% and 28% fell into “moderate” and “slight” categories, respectively.
A tracker of sorts, the app is being developed by European technologists and cancer doctors working together. The tests are taking place at three hospitals in Ireland, Spain and Portugal.
At home, a wearable watch records movement and sleep patterns that get fed into a phone app. Patients must occasionally answer questions from the app, for example about dietary choices, while a voice module checks for any changes in a person’s speech that may indicate depression.
In all, 27 measurements are being tracked in a bid to uncover which ones could flag a downward trajectory in a patient’s mental health. Performance will be compared against clinical questionnaires that doctors already use to monitor patients.
‘Once the patient is signed out of the hospital, they’re often on their own,’ said McManus. ‘If the hospital gives this app to a patient, doctors can remotely monitor how the patient is getting on.’
The phone app will not send sensitive patient data to the Internet. Instead, an algorithm is updated on the phone and fed back to the development team, which helps improve the app’s performance.
‘We’ll build our algorithm and try to pick out these downstream trajectories,’ said McManus. ‘Then we are basically training the app.’ Eventually, if the app picks up worrying signals, ‘an alarm is raised in the hospital and the patient is contacted,’ he said.
The mental-health aspect of cancer diagnosis and care needs to be improved across Europe, according to Prof N’Dow, who said that this is a central goal of the European Association of Urology, where he is adjunct secretary general responsible for education.
‘The impact psychologically of the diagnosis or consequences of treatment is huge,’ he said. ‘This is something we understood in PIONEER.’
The project has sought to ensure that treatment comparisons take into account the impact on patient quality of life such as sexual, bowel or urinary function. Also crucial has been to identify those outcomes that matter most to patients.
That is why PIONEER has included patients themselves in discussions aimed at determining key unanswered research questions about prostate cancer.
‘Patients understand what they need,’ Prof N’Dow said. ‘Our job is to improve the lives of the most vulnerable and get them back to the life they knew before it was rudely interrupted by disease. The psychological well-being of the patient and their families should be recognized as central to that.’
Research in this article was funded via the EU. This material was originally published in Horizon, the EU Research and Innovation Magazine.
Central Asian Countries Show Commitment to a Cross-regional Approach to Pandemic Prevention
Government officials representing health, environment, and agriculture sectors from all of Central Asian countries participated in a regional ministerial meeting Protecting Livestock and Preventing Pandemics that took place in Almaty today. The participants reaffirmed commitment to cooperating on One Health–a cross-sectoral approach that aims to help the region prevent future pandemics. The participants signed a communiqué giving a formal start to the development of the Central Asia One Health Framework for Action and a call for joint resource mobilization in support of the initiative.
Managing global health risks requires full cooperation between the livestock, environmental and public health sectors, at the national, regional, and global levels. One Health is an integrated, unifying approach that aims to sustainably balance and optimize the health of people, animals, and ecosystems. It recognizes that the health of humans, domestic and wild animals, plants, and the wider environment are closely linked and inter-dependent.
“The case for collaboration on One Health in Central Asia could not be clearer,” said Tatiana Proskuryakova, World Bank Regional Director for Central Asia. “The region shares many common challenges but also strengths and opportunities that can help the region realize One Health. What we are witnessing now is Central Asia setting an example for other regions and countries on how to work together for future generations’ health and wellbeing”.
The event in Almaty builds on the discussions held during a meeting in Tashkent in July 2022 when participants agreed on the need to prepare the Central Asia One Health Framework for Action that could provide a blueprint for the countries in the region to move forward with concrete actions, as well as would include a roadmap for investments at national and regional levels.
More specifically, the Regional One Health Framework for Action aims to contribute to addressing three high-level goals shared among Central Asian countries: pandemic prevention and preparedness, resilience of food systems, and improving regional trade and the competitiveness of agriculture. In addition, the Framework for Action will identify focus areas and mechanisms for regional collaboration, and include a One Health dashboard to monitor progress, while facilitating policy responses to emerging issues.
“Investing in One Health is an investment in humanity’s future. The proposed investment framework helps governments and development partners to avoid the cycle of panic-and-neglect and direct financial resources. This integrated, risk-based approach requires compliance with international health standards and promotes country ownership, while recognizing its global public goods nature. The vast majority of investments in One Health will also result in significant co-benefits, including improving food safety, preserving biodiversity and reducing GHG emissions” said Martien van Nieuwkoop, the World Bank’s Global Director for Agriculture and Food. “The World Bank is collaborating with several countries in Central Asia on this approach, and we are encouraged by the region’s resolve to work together to invest in One-Health as an important building block for pandemic prevention, preparedness and response”.
The development of the Framework for Action will support regional dialogue between networks of decision makers and technical staff, including epidemiologists, veterinarians, and environmental specialists from the three operational sectors. This will be especially useful in cases of transborder disease outbreaks, as it would enable sharing of information, quick integration of new knowledge, and regional action.
Countries Need to Fundamentally Change Health Systems to Better Prepare for Future Shocks
As the experience from COVID-19 has shown, countries need to take transformative action to build stronger, more resilient health systems, says a new World Bank report. Boosting health system resilience now reaps large dividends when emergencies occur. To do so, governments need to improve their health sector governance, cross-sectoral partnerships based on a One Health approach that prioritizes health service delivery, and pandemic prevention, preparedness, and response (PPR).
According to the new report, Change Cannot Wait: Building Resilient Health Systems in The Shadow of COVID-19, resilient health systems are integrated systems that are aware of threats and risk drivers; agile to respond to evolving needs; absorptive to contain shocks; adaptive to minimize disruptions; and able to leverage lessons learned to transform after a crisis. These systems also integrate essential public health functions to help prevent, manage, and mitigate impacts of other challenges, such as climate change, ageing populations, and fragility and conflict.
“Investing in resilient health systems requires long-term commitment and action by governments,” said Mamta Murthi, Vice President for Human Development, World Bank. “With shrinking health budgets following the COVID-19 crisis response, countries need to set priorities for their health spending, including on areas such as public health, disease prevention, and primary health care to protect human capital and ensure health services for all, especially the poorest and most vulnerable.”
The report identifies several actions governments can take to make their health system more resilient:
- Investing in robust public health institutions and agile, evidence-based decision making for health crises
- Improving awareness and early warning functions
- Expanding community health workforce and building multi-disciplinary competencies for PPR
- Prioritizing and tracking investments in PPR
- Strengthening risk communication and community engagement
- Investing in primary health care with integrated public health functions
- Enhancing quality legal and regulatory frameworks
“Pandemic prevention, preparedness, and response is integral to strong health systems. A country that is not prepared cannot be resilient,” said Juan Pablo Uribe, World Bank Global Director for Health, Nutrition & Population and the Global Financing Facility. “Investments in health system resilience need to go hand-in-hand with the broader health agenda, including advancing toward Universal Health Coverage (UHC), to enable equity.”
This report proposes a three-tiered framework to help countries prioritize spending options based on their impact on resilience. The framework proposes risk reduction, prevention and community preparedness as most important tier one activities, followed by tier two with a focus on detection, containment and mitigation activities. Tier three which is the most expensive part includes advanced case management and surge response.
The World Bank has long been committed to helping low- and middle-income countries build stronger, more resilient health systems and provide quality, affordable health services to everyone. Our $34 billion global health portfolio includes over 240 projects that help countries take a comprehensive approach to improving health outcomes, especially for poor and vulnerable people, by strengthening primary care and key public health functions.
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