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Jessie May Peters

First Published: September 24: 2015
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AstraZeneca:Oxford COVID-19 Vaccine Trial Results Show It Having an Efficacy of 90%: The Company Is Now to Seek Emergency Regulatory Approval

 

 

 

|| Monday: November 23: 2020 || ά. AstraZeneca has presented its positive high-level results from an interim analysis of clinical trials of AZD1222 Vaccine in the UK and Brazil, which showed the vaccine was highly effective in preventing COVID-19, the primary endpoint and no hospitalisations or severe cases of the disease were reported in participants receiving the vaccine. There were a total of 131 COVID-19 cases in the interim analysis. One dosing regimen, n=2,741, showed vaccine efficacy of 90% when AZD1222 was given as a half dose, followed by a full dose, at least, one month apart.

While another dosing regimen, n=8,895, showed 62% efficacy when given as two full doses, at least, one month apart. The combined analysis from both dosing regimens, n=11,636, resulted in an average efficacy of 70%. All results were statistically significant, p<=0.0001. More data will continue to accumulate and additional analysis will be conducted, refining the efficacy reading and establishing the duration of protection. An independent Data Safety Monitoring Board determined that the analysis met its primary endpoint, showing protection from COVID-19 occurring 14 days or more after receiving two doses of the vaccine. No serious safety events, related to the vaccine, have been confirmed. AZD1222 was well tolerated across both dosing regimens.

AstraZeneca will now, immediately, prepare regulatory submission of the data to authorities around the world, that have a framework in place for conditional or early approval. The Company will seek an Emergency Use Listing from the World Health Organisation for an accelerated pathway to vaccine availability in countries with low income. In parallel, the full analysis of the interim results is being submitted for publication in a peer-reviewed journal.

Professor Andrew Pollard, the Chief Investigator of the Oxford Vaccine Trial at Oxford, said, “These  findings  show  that  we  have  an  effective  vaccine, that  will  save  many  lives. Excitingly, we’ve found that one of our dosing regimens may be around 90% effective and, if, this dosing regime is used, more people could be vaccinated with planned vaccine supply. Today’s announcement is only possible thanks to  the  many  volunteers  in  our  trial  and  the  hard  working  and  talented  team  of  researchers based around the world.”

Mr Pascal Soriot, the Chief Executive Officer, said, “Today marks an important milestone in our fight against the pandemic. This vaccine’s efficacy and safety confirm that it will be highly effective against COVID-19 and will have an immediate impact on this public health emergency. Furthermore, the vaccine’s simple supply chain and our no-profit pledge and commitment to broad, equitable and timely access means it will be affordable and globally available, supplying hundreds of millions of doses on approval.”

The pooled analysis included data from the COV002 Phase II:III trial in the UK and COV003 Phase III trial in Brazil. Over 23,000 participants are being assessed, following two doses of either a half-dose:full-dose regimen or a regimen of two full doses of AZD1222 or a comparator, meningococcal conjugate vaccine, called, MenACWY or saline. The global trials are evaluating participants, aged 18 years or over from diverse racial and geographic groups, who are healthy or have stable underlying medical conditions.

Clinical trials are, also, being conducted in the US, Japan, Russia, South Africa, Kenya and Latin America with planned trials in other European and Asian countries. In total, the Company expects to enrol up to 60,000 participants globally.

The Company is making rapid progress in manufacturing with a capacity of up to three billion doses of the vaccine in 2021 on a rolling basis, pending regulatory approval. The vaccine can be stored, transported and handled at normal refrigerated conditions, 02-08 degrees Celsius or, 36-46 degrees Fahrenheit, for, at least, six months and administered within existing healthcare settings.

AstraZeneca continues to engage with governments, multi-lateral organisations and collaborators around the world to ensure broad and equitable access to the vaccine at no profit for the duration of the pandemic.

AZD1222: AZD1222 was co-invented by the University of Oxford and its spin-out company, Vaccitech. It uses a replication-deficient chimpanzee viral vector, based on a weakened version of a common cold virus, adenovirus, that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus, if, it later infects the body.

AstraZeneca: AstraZeneca is a global, science-led bio-pharmaceutical company, that focuses on the discovery, development and commercialisation of prescription medicines, primarily, for the treatment of diseases in three therapy areas: Oncology, Cardiovascular, Renal and Metabolism and Respiratory and Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. astrazeneca.com  

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World Leaders Join Forces to Fight the Accelerating Crisis of Anti-Microbial Resistance: One Health Global Leaders Group on Anti-Microbial Resistance

 

 

 

|| Friday: November 20: 2020 || ά. The heads of the Food and Agriculture Organisation of the United Nations:FAO, the World Organisation for Animal Health:OIE and the World Health Organisation:WHO have today launched the new One Health Global Leaders Group on Anti-microbial Resistance. Group members include heads of states, government ministers, leaders from private sector and civil society. The group is co-chaired by their Excellencies Mia Mottley, the Prime Minister of Barbados and Sheikh Hasina Wazed, the Prime Minister of Baangladesh.

The Group will harness the leadership and influence of these world-renowned figures to catalyse global attention and action to preserve anti-microbial medicines and avert the disastrous consequences of antimicrobial resistance. The tripartite organisations launched the group during World Anti-microbial Awareness Week 2020, 18-24 November 18-24, as part of their shared call for united action to preserve and protect anti-microbial medicines. The Group was created in response to a recommendation from the Inter-agency Co-ordination Group on Anti-microbial Resistance and supported by the Secretary-General of the United Nations.

The Director Generals described the rapid rise of anti-microbial resistance as one of the world’s most urgent threats to human, animal, plant and environmental health, endangering food security, international trade, economic development and undermining progress towards the Sustainable Development Goals. Anti-microbial resistance, also, leads to increased health care costs, hospital admissions, treatment failure, severe illness and death.

Anti-microbial resistance is making many infections harder to treat worldwide. WHO’s latest reporting shows that the world is running out of effective treatments for several common infections. “Anti-microbial resistance is one of the greatest health challenges of our time and we can not leave it for our children to solve.” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “Now is the time to forge new, cross-sector partnerships, that will protect the medicines we have and revitalise the pipeline for new ones.”

Misuse and overuse of anti-microbials in humans, animals and agriculture are the main drivers of anti-microbial resistance. Resistant micro-organisms can spread between humans, animals or the environment and the anti-microbial medicines used to treat various infectious diseases in animals and humans can be the same. “No single sector can solve this problem alone.” said QU Dongyu, Director-General of FAO. “Collective action is required to address the threat of antimicrobial resistance, across different economic sectors and country borders.”

The Group will provide political leadership to address this critical global challenge. It will elevate the need to prioritise best practices to address anti-microbial resistance at global, regional and national levels. And it will advise and advocate for the development and implementation of polices and legislation to govern the importation, manufacture, distribution and use of quality antimicrobial drugs across all sectors.

“Anti-microbial resistance is a current problem affecting  animal health, human health and the environment, we need to act today to protect their efficacy.” said Dr Monique Eloit, the Director General of OIE. “I am confident that this Group will advocate powerfully to implement legislation and mobilise key stake-holders to change anti-microbial use practices to protect our collective health and welfare.”

The Inter-agency Co-ordination Group:IACG on Anti-microbial Resistance was convened by the Secretary-General of the United Nations after the UN High-Level Meeting on Anti-microbial Resistance in 2017 following the request of the 2016 Political Declaration of the High Level Meeting on Anti-microbial Resistance. The IACG brought together partners across the UN, international organisations and individuals with expertise across human, animal and plant health, as well as, the food, animal feed, trade, development and environment sectors, to formulate a blueprint for the fight against antimicrobial resistance.

The World Health Organisation:WO: The World Health Organisation provides global leadership in public health within the United Nations system. Founded in 1948, WHO works with 194 Member States, across six regions and from more than 150 offices, to promote health, keep the world safe and serve the vulnerable. Our goals for 2019-2023 are to ensure that a billion more people have universal health coverage, to protect a billion more people from health emergencies, and to provide a further billion people with better health and well-being.

The Food and Agriculture Organisation:FAO: The Food and Agriculture Organisation:FAO is a specialised agency of the United Nations, that leads international efforts to defeat hunger. Our goal is to achieve food security for all and make sure that people have regular access to enough high-quality food to lead active, healthy lives. We believe that everyone can play a part in ending hunger.

The World Organisation for Animal Health:OIE: The OIE is the inter-governmental organisation, responsible for improving animal health worldwide. Founded in 1924, it is recognised as a reference organisation for international standards, relating to animal health and zoonoses by the World Trade Organisation:WTO and has a total of 182 Member Countries. The OIE maintains permanent relations with international and regional organisations and has Regional and Sub-regional Offices on every continent.

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Pfizer and BioNTech Conclude Phase Three Study of COVID-19 Vaccine Candidate: Meeting All Primary Efficacy Endpoints With an Efficacy Rate of 95%: Emergency Use Authorisation Application in Days

 

 

 

|| Wednesday: November 18: 2020 || ά. Pfizer Inc and BioNTech SE have today announced that, after conducting the final efficacy analysis in their on-going Phase Three Study, their mRNA-based COVID-19 vaccine candidate, BNT162b2, met all of the Study’s primary efficacy endpoints. Analysis of the data indicates a vaccine efficacy rate of 95%, p<0.0001, in participants without prior SARS-CoV-2 infection, first primary objective and, also, in participants with and without prior SARS-CoV-2 infection, second primary objective, in each case, measured from seven days after the second dose.

The first primary objective analysis is based on 170 cases of COVID-19, as specified in the study protocol, of which 162 cases of COVID-19 were observed in the placebo group versus eight cases in the BNT162b2 group. Efficacy was consistent across age, gender, race and ethnicity demographics. The observed efficacy in adults over 65 years of age was over 94%. There were 10 severe cases of COVID-19 observed in the trial, with nine of the cases occurring in the placebo group and one in the BNT162b2 vaccinated group.

To date, the Data Monitoring Committee for the Study has not reported any serious safety concerns, related to the vaccine. A review of unblinded reactogenicity data from the final analysis, which consisted of a randomised subset of, at least, 8,000 participants, 18 years and older in the phase two:three Study demonstrates that the vaccine was well tolerated, with most solicited adverse events, resolving shortly after vaccination.

The only Grade three, severe, solicited adverse events greater than or equal to 02% in frequency after the first or second dose was fatigue at 03.8% and headache at 02.0%, following dose two. Consistent with earlier shared results, older adults tended to report fewer and milder solicited adverse events, following vaccination.

In addition, the companies announced that the safety milestone, required by the US Food and Drug Administration:FDA for Emergency Use Authorisation:EUA has been achieved. Pfizer and BioNTech plan to submit a request within days to the FDA for an EUA, based on the totality of safety and efficacy data, collected to date, as well as, manufacturing data, relating to the quality and consistency of the vaccine. These data, also, will be submitted to other regulatory agencies around the world.

“The Study results mark an important step in this historic eight-month journey to bring forward a vaccine, capable of helping to end this devastating pandemic. We continue to move at the speed of science to compile all the data, collected thus far and share with regulators around the world.” said Dr Albert Bourla, Pfizer Chairman and CEO. “With hundreds of thousands of people around the globe, infected every day, we urgently need to get a safe and effective vaccine to the world.”

“We are grateful that the first global trial to reach the final efficacy analysis mark indicates that a high rate of protection against COVID-19 can be achieved very fast after the first 30µg dose, underscoring the power of BNT162 in providing early protection.” said Dr Ugur Sahin, MD, CEO and Co-founder of BioNTech. “These achievements highlight the potential of mRNA as a new drug class. Our objective from the very beginning was to design and develop a vaccine, that would generate rapid and potent protection against COVID-19 with a benign tolerability profile across all ages.

We believe, we have achieved this with our vaccine candidate BNT162b2 in all age groups, studied so far and look forward to sharing further details with the regulatory authorities. I want to thank all the devoted women and men, who contributed to this historically unprecedented achievement. We will continue to work with our partners and governments around the world to prepare for global distribution in 2020 and beyond.”

The Phase three clinical trial of BNT162b2 began on July 27 and has enrolled 43,661 participants to date, 41,135 of whom have received a second dose of the vaccine candidate as of November 13, 2020. Approximately 42% of global participants and 30% of US participants have racially and ethnically diverse backgrounds, and 41% of global and 45% of US participants are 56-85 years of age. The clinical trial participants took part in 150 clinical trials sites in United States, Germany, Turkey, South Africa, Brazil and Argentina. The trial will continue to collect efficacy and safety data in participants for an additional two years.

Based on current projections, the companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 01.3 billion doses by the end of 2021. Four of Pfizer’s facilities are part of the manufacturing and supply chain: St Louis, MO; Andover, MA; and Kalamazoo, MI in the US.; and Puurs in Belgium. BioNTech’s German sites will, also, be leveraged for global supply.

Pfizer is confident in its vast experience, expertise and existing cold-chain infrastructure to distribute the vaccine around the world. The companies have developed specially designed, temperature-controlled thermal shippers, utilising dry ice to maintain temperature conditions of -70°C±10°C. They can be used be as temporary storage units for 15 days by refilling with dry ice. Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment across their pre-set routes, leveraging Pfizer’s broad distribution network.

Pfizer and BioNTech plan to submit the efficacy and safety data from the Study for peer-review in a scientific journal once analysis of the data is completed. 

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Moderna’s COVID-19 Vaccine Candidate Meets Its Primary Efficacy Endpoint in the First Interim Analysis of the Phase Three COVE Study: Vaccine Efficacy of 94.5%

 

|| Monday: November 16: 2020 || ά. Moderna Inc, a bio-technology company, pioneering messenger RNA:mRNA therapeutics and vaccines to create a new generation of transformative medicines for patients, has today announced that the independent, NIH-appointed Data Safety Monitoring Board:DSMB for the Phase three study of mRNA-1273, its vaccine candidate against COVID-19, has informed Moderna that the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%.

This Study, known as the COVE Study, enrolled more than 30,000 participants in the US and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases:NIAID, part of the National Institutes of Health:NIH and the Bio-medical Advanced Research and Development Authority:BARDA, part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services.

The primary endpoint of the Phase three COVE Study is based on the analysis of COVID-19 cases, confirmed and adjudicated, starting two weeks, following the second dose of the vaccine. This first interim analysis was based on 95 cases, of which 90 cases of COVID-19 were observed in the placebo group versus five cases observed in the mRNA-1273 group, resulting in a point estimate of vaccine efficacy of 94.5%, p <0.0001.

A secondary endpoint analysed severe cases of COVID-19 and included 11 severe cases, as defined in the study protocol, in this first interim analysis. All 11 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group. The 95 COVID-19 cases included 15 older adults, ages 65+ and 20 participants, identifying as being from diverse communities, including, 12 Hispanic or LatinX, 04 Black or African Americans, 03 Asian Americans and 01 multiracial.

The interim analysis included a concurrent review of the available Phase three COVE Study safety data by the DSMB, which did not report any significant safety concerns. A review of solicited adverse events indicated that the vaccine was, generally, well tolerated. The majority of adverse events were mild or moderate in severity. Grade three, severe, events greater than or equal to 02% in frequency after the first dose included injection site pain, 02.7% and after the second dose included fatigue, 09.7%, myalgia, 08.9%, arthralgia, 05.2%, headache, 04.5%, pain, 04.1% and erythema:redness at the injection site, 02.0%.

These solicited adverse events were, generally, short-lived. These data are subject to change, based on on-going analysis of further Phase three COVE Study data and final analysis.

Preliminary analysis suggests a broadly consistent safety and efficacy profile across all evaluated sub-groups. As more cases accrue, leading up to the final analysis, the Company expects the point estimate for vaccine efficacy may change. The Company plans to submit data from the full Phase three COVE Study to a peer-reviewed publication.

“This is a pivotal moment in the development of our COVID-19 vaccine candidate. Since early January, we have chased this virus with the intent to protect as many people around the world as possible. All along, we have known that each day matters. This positive interim analysis from our Phase three Study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including, severe disease.” said Mr Stéphane Bancel, the Chief Executive Officer of Moderna.

“This milestone is only possible because of the hard work and sacrifices of so many. I want to thank the thousands of participants in our Phase one, Phase two and Phase three studies and the staff at our clinical trial sites, who have been on the front lines of the fight against the virus. They are an inspiration to us all. I want to thank the NIH, particularly, NIAID, for their scientific leadership, including, through years of foundational research on potential pandemic threats at the Vaccine Research Centre, that led to the discovery of the best way to make Spike protein antigens, that are being used in our vaccine and others.’’

‘’I want to thank our partners at BARDA and Operation Warp Speed, who have been instrumental to accelerating our progress to this point. Finally, I want to thank the Moderna team, our suppliers and our partners, for their tireless work across research, development and manufacturing of the vaccine. We look forward to the next milestones of submitting for an EUA in the US and regulatory filings in countries around the world, while we continue to collect data on the safety and efficacy of the vaccine in the COVE Study. We remain committed to and focused on doing our part to help end the COVID-19 pandemic.”

Based on these interim safety and efficacy data, Moderna intends to submit for an Emergency Use Authorisation:EUA with the US Food and Drug Administration:FDA in the coming weeks and anticipates having the EUA informed by the final safety and efficacy data with a median duration of, at least, two months. Moderna, also, plans to submit applications for authorisations to global regulatory agencies.

Moderna is working with the US Centres for Disease Control and Prevention:CDC, Operation Warp Speed and McKesson:NYSE: MCK, a COVID-19 vaccine distributor, contracted by the US government, as well as, global stake-holders to be prepared for distribution of mRNA-1273, in the event that it receives an EUA and similar global authorisations. By the end of 2020, the Company expects to have, approximately, 20 million doses of mRNA-1273 ready to ship in the US.

The Company remains on track to manufacture 500 million to one billion doses globally in 2021. On November 10, the American Medical Association:AMA issued a Current Procedural Terminology:CPT code to report vaccination with mRNA-1273, code: 91301. Moderna recently announced further progress towards ensuring the distribution, storage and handling of the vaccine can be done using existing infrastructure.

To learn more about Moderna’s work on mRNA-1273, visit.

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Worldwide Measles Deaths Climb 50% From 2016 to 2019 Claiming Over 207,500 Lives in 2019

 

|| Thursday: November 12: 2020 || ά. Measles surged worldwide in 2019, reaching the highest number of reported cases in 23 years.  Highlighted in a publication by the World Health Organisation:WHO and the United States Centres for Disease Control and Prevention:CDC, measles cases worldwide increased to 869,770 in 2019, the highest number, reported since 1996 with increases in all WHO regions. Global measles deaths climbed, nearly, 50% since 2016, claiming an estimated 207,500 lives in 2019 alone.

After steady global progress from 2010 to 2016, the number of reported measles cases climbed progressively to 2019. Comparing 2019 data with the historic low in reported measles cases in 2016, authors cite a failure to vaccinate children on time with two doses of measles-containing vaccines, MCV1 and MCV2, as the main driver of these increases in cases and deaths. Measles outbreaks occur when people, who are not protected from the virus, are infected and spread the disease to unvaccinated or under-vaccinated populations.  To control measles and prevent outbreaks and deaths, vaccination coverage rates with the required MCV1 and MCV2 must reach 95 percent and be maintained at national and sub-national levels. 

MCV1 coverage has been stagnant globally for more than a decade at about 84-85%.  MCV2 coverage has been steadily increasing but is only now at 71%.   Vaccination coverage against measles remains well below the 95% or higher, needed with both doses to control measles and prevent outbreaks and deaths.

“We know how to prevent measles outbreaks and deaths.” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “These data send a clear message that we are failing to protect children from measles in every region of the world.  We must collectively work to support countries and engage communities to reach everyone, everywhere with measles vaccine and stop this deadly virus.”

Although, reported cases of measles are lower in 2020, necessary efforts to control COVID-19 have resulted in disruptions in vaccination and crippled efforts to prevent and minimise measles outbreaks. As of November, more than 94 million people were at risk of missing vaccines, due to paused measles campaigns in 26 countries.  Many of these countries are experiencing on-going outbreaks.  Of countries with postponed planned 2020 campaigns, only, eight, Brazil, Central African Republic, Democratic Republic of Congo, Ethiopia, Nepal, Nigeria, Philippines and Somalia, resumed their campaigns after initial delays.

“Before there was a coronavirus crisis, the world was grappling with a measles crisis and it has not gone away.” said Ms Henrietta Fore, UNICEF Executive Director. “While health systems are strained by the COVID-19 pandemic, we must not allow our fight against one deadly disease to come at the expense of our fight against another. This means ensuring we have the resources to continue immunisation campaigns for all vaccine-preventable diseases, even, as we address the growing COVID-19 pandemic.”

Global immunisation partners are engaging leaders and public health professionals in affected and at-risk countries to ensure that measles vaccines are available and safely delivered and that care-givers understand the life-saving benefit of the vaccine.  On November 06, WHO and UNICEF issued an emergency call to action for measles and polio outbreak prevention and response.

“Measles virus easily finds unprotected children, adolescents and adults because it is so contagious.” said Dr Robert Linkins, Measles and Rubella Initiative Management Team Chair and Accelerated Disease Control Branch Chief at US CDC. “Infections are not only a sign of poor measles vaccination coverage but, also, a known marker or ‘tracer’, that vital health services may not be reaching populations most at-risk. Our collective efforts to reach children with vaccines now, ahead of the possible easing of COVID-19 travel restrictions and increased population movement, will save lives.”

The Measles and Rubella Initiative:MRI, which includes American Red Cross, the United Nations Foundation, the US. CDC, UNICEF and WHO and global immunisation partners like Gavi, the Vaccine Alliance, the Bill and Melinda Gates Foundation and others, are working to address the current measles crisis and ensure that resources are positioned to address immunisation delays for measles and all vaccines in every region of the world.  A bold strategy, released by MRI, Measles and Rubella Strategic Framework 2021-30, will help to address reversals in global progress toward measles elimination by bolstering strong, national immunisation systems, that can reach and protect children. This strategic shift by the partnership will focus on strengthening the routine delivery of all vaccines, and quickly and effectively detecting and responding to measles outbreaks.

“These alarming figures should act as a warning that, with the COVID-19 pandemic, occupying health systems across the world, we can not afford to take our eye off the ball when it comes to other deadly diseases. Measles is entirely preventable; in a time in which we have a powerful, safe and cost-effective vaccine nobody should still be dying of this disease.” said Dr Seth Berkley, CEO of Gavi, the Vaccine Alliance.

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Wealthy Countries Already Hoarding Breakthrough Vaccines: Amnesty International

 

|| Wednesday: November 11: 2020 || ά. Responding to the announcement by Pfizer-BioNTech that the COVID-19 vaccine it is developing has been found to be effective in 90 percent of people, Ms Tamaryn Nelson, Amnesty International’s Researcher on the Right to Health, said, “It is great news that the Pfizer-BioNTech vaccine is proving effective against COVID-19. However, it’s worrying that Pfizer-BioNTech has already struck deals with rich countries for more than a billion doses of its vaccine, leaving less than a quarter of its projected supply for the rest of the world. These kinds of bilateral deals risk undermining the potential benefits of scientific breakthroughs; Big Pharma profits must not be prioritised over the health of billions.

Pfizer-BioNTech must urgently clarify how it will maximise vaccine access in low and middle-income countries to save lives. It should, also, share its vaccine technology with other manufacturers via the WHO’s COVID-19 Technology Access Pool, so that the billions of vaccines we need can be produced as quickly and cheaply as possible. The pandemic will not be over until it is over for everyone.’’ she said.

Pfizer-BioNTech has already agreed deals for more than one billion potential doses of its vaccine, including, an initial 100m doses to the US, 30m to the UK, 120m to Japan, 20m to Canada, 01.5m to New Zealand and 200m to the EU. It has, also, agreed rights to a further 500m doses with the US and 100m with the EU.

Given the company’s projection that it could make 50m doses in 2020 and 01.3 billion in 2021, this leaves only a small fraction of potential doses for other countries. Each person receiving the vaccine needs two doses to be protected against COVID-19.

The World Health Organisation has set up the COVID-19 Technology Access Pool:C-TAP, a scheme for pharmaceutical companies to voluntarily share technology, data and property rights, related to COVID-19 vaccines. So far, no company has signed up and Pfizer’s CEO described it as ‘nonsense’ when it was launched in May.

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Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Success in First Interim Analysis From Phase Three Study: Vaccine Efficacy Above 90%

 

|| Monday: November 09: 2020 || ά. Pfizer and BioNTech have today announced its mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2 has demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of SARS-CoV-2 infection, based on the first interim efficacy analysis, conducted on November 08, 2020 by an external, independent Data Monitoring Committee from the Phase Three Clinical Study.

“Today is a great day for science and humanity. The first set of results from our Phase Three COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19.” said Dr Albert Bourla, Pfizer Chairman and CEO. “We are reaching this critical milestone in our vaccine development programme at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen. With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis.

We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.” After discussion with the FDA, the companies recently elected to drop the 32-case interim analysis and conduct the first interim analysis at a minimum of 62 cases. Upon the conclusion of those discussions, the evaluable case count reached 94 and the DMC performed its first analysis on all cases.

The case split between vaccinated individuals and those, who received the placebo, indicates a vaccine efficacy rate above 90%, at seven days after the second dose. This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a two-dose schedule. As the Study continues, the final vaccine efficacy percentage may vary. The DMC has not reported any serious safety concerns and recommends that the Study continue to collect additional safety and efficacy data as planned. The data will be discussed with regulatory authorities worldwide.

“I want to thank the thousands of people, who volunteered to participate in the clinical trial, our academic collaborators and investigators at the study sites and our colleagues and collaborators around the world, who are dedicating their time to this crucial endeavour.” Dr Bourla said. “We could not have come this far without the tremendous commitment of everyone involved.”

“The first interim analysis of our global Phase Three Study provides evidence that a vaccine may effectively prevent COVID-19. This is a victory for innovation, science and a global collaborative effort.” said Professor Ugur Sahin, BioNTech Co-founder and CEO. “When we embarked on this journey 10 months ago this is what we aspired to achieve. Especially, today, while we are all in the midst of a second wave and many of us in lockdown, we appreciate even more how important this milestone is on our path towards ending this pandemic and for all of us to regain a sense of normality. We will continue to collect further data as the trial continues to enrol for a final analysis planned when a total of 164 confirmed COVID-19 cases have accrued. I would like to thank everyone, who has contributed to make this important achievement possible.”

The Phase Three Clinical Trial of BNT162b2 began on July 27 and has enrolled 43,538 participants to date, 38,955 of whom have received a second dose of the vaccine candidate as of November 08, 2020. Approximately, 42% of global participants and 30% of US participants have racially and ethnically diverse backgrounds. The trial is continuing to enrol and is expected to continue through the final analysis when a total of 164 confirmed COVID-19 cases have accrued.

The Study, also, will evaluate the potential for the vaccine candidate to provide protection against COVID-19 in those, who have had prior exposure to SARS-CoV-2, as well as, vaccine prevention against severe COVID-19 disease. In addition to the primary efficacy endpoints evaluating confirmed COVID-19 cases accruing from seven days after the second dose, the final analysis now will include, with the approval of the FDA, new secondary endpoints evaluating efficacy based on cases accruing 14 days after the second dose as well. The companies believe that the addition of these secondary endpoints will help align data across all COVID-19 vaccine studies and allow for cross-trial learnings and comparisons between these novel vaccine platforms. The companies have posted an updated version of the study protocol at https://www.pfizer.com/science/coronavirus.

Pfizer and BioNTech are continuing to accumulate safety data and currently estimate that a median of two months of safety data following the second and final dose of the vaccine candidate, the amount of safety data, specified by the FDA in its guidance for potential Emergency Use Authorisation, will be available by the third week of November. Additionally, participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose.

Along with the efficacy data, generated from the Clinical Trial, Pfizer and BioNTech are working to prepare the necessary safety and manufacturing data to submit to the FDA to demonstrate the safety and quality of the vaccine product produced. Based on current projections it is expected that the companies will be able to produce globally up to 50 million vaccine doses in 2020 and up to 01.3 billion doses in 2021. Pfizer and BioNTech plan to submit data from the full Phase Three Trial for scientific peer-review publication.

About Pfizer: At Pfizer, we apply science and our global resources to bring therapies to people, that extend and, significantly, improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including, innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures, that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all, who rely on us. We routinely post information, that, may be, important to investors on our website. 

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COVID-19: The Six-Month Anniversary of the Outbreak Coincides With Reaching 10 Million Cases and 500,000 Deaths: Globally the Pandemic Is Actually Speeding Up: We Will Need Even Greater Stores of Resilience Patience Humility and Generosity: We Have Already Lost So Much But We Can Not Lose Hope: Dr Tedros Adhanom Ghebreyesus

 

|| Monday: June 29: 2020 || ά. ‘’Tomorrow marks six months since WHO received the first reports of a cluster of cases of Pneumonia of unknown cause in China. The six-month anniversary of the outbreak coincides with reaching 10 million cases and 500,000 deaths. This is a moment for all of us to reflect on the progress we have made and the lessons we have learned and to recommit ourselves to doing everything we can to save lives. Six months ago, none of us could have imagined how our world and our lives would be thrown into turmoil by this new virus.

The pandemic has brought out the best and the worst of humanity. All over the world we have seen heart-warming acts of resilience, inventiveness, solidarity and kindness. ’But we have, also, seen concerning signs of stigma, misinformation and the politicisation of the pandemic.’’ The World Health Organisation:WHO Director-General Dr Tedros Adhanom Ghebreyesus said in his opening remarks at a media briefing on COVID-19 today, Monday, June 29. ‘’For the past six months, WHO and our partners have worked relentlessly to support all countries to prepare for and respond to this new virus.

Today, we are publishing an updated and detailed timeline of WHO’s response to the pandemic on our website, so the public can have a look at what happened in the past six months in relation to the response. It illustrates the range of WHO’s work to stop transmission and save lives.’’

Dr Adhanom Ghebreyesus further said that WHO has worked with researchers, clinicians and other experts to bring together the evolving science and distil it into guidance. Millions of health workers have enrolled in courses through WHO’s OpenWHO.org online learning platform. The Agency launched the Solidarity Trial, to find answers fast to which drugs are the most effective.

‘’We launched Solidarity Flights, to ship millions of test kits and tonnes of personal protective equipment to many countries. We launched the Solidarity Response Fund, which has raised more than $223 million for the response. Three major innovative solidarity activities.

And we have worked with the European Commission and multiple partners to launch the ACT Accelerator, to ensure that once a vaccine is available, it’s available to everyone, especially, those, who are at greatest risk. On Friday we launched the ACT Accelerator Investment Case, which estimates that more than $31 billion will be needed to accelerate the development, equitable allocation and delivery of vaccines, diagnostics and therapeutics by the end of next year.’’

Dr Adhanom Ghebreyesus went onto say, ‘’Over the weekend, WHO was proud to partner in the ‘Global Goal: Unite for Our Future’ pledging conference, organised by the European Commission and Global Citizen. The event mobilised new resources to respond to the COVID-19 pandemic globally, including, in support of the ACT Accelerator.

Although, a vaccine will be an important long-term tool for controlling COVID-19, there are five priorities, that every single country must focus on now, to save lives now. First, empower communities. Every individual must understand that they are not helpless, there are things everyone should do to protect themselves and others. Your health is in your hands.

That includes physical distancing, hand hygiene, covering coughs, staying home, if, you feel sick, wearing masks when appropriate and only sharing information from reliable sources.’’

‘’You may be in a low-risk category but, the choices you make could be the difference between life and death for someone else. Second, suppress transmission. Whether countries have no cases, clusters of cases or community transmission, there are steps all countries can take to suppress the spread of the virus. Ensure that health workers have access to training and personal protective equipment. Improve surveillance to find cases.

The single-most important intervention for breaking chains of transmission is not necessarily high-tech and can be carried out by a broad range of professionals. It’s tracing and quarantining contacts. Many countries actually have used non-health professionals to do contact tracing.

Third, save lives. Early identification and clinical care saves lives. Providing oxygen and dexamethasone to people with severe and critical disease saves lives. And paying special attention to high-risk groups, including, elderly people in long-term care facilities, saves lives. Japan has done this: it has one of the highest populations of elderly people but, its death rate is low and the reason is what we just said: many countries can do that, they can save lives.’’

Dr Adhanom Ghebreyesus emphasised the necessity as the Fourth important task: ‘’Fourth, accelerate research. We’ve already learned a lot about this virus but, there’s still a lot we don’t know and there are still tools we need. This week we will convene a second meeting to assess progress on research and development and re-evaluate research priorities for the next stage of the pandemic.

And fifth, political leadership. As we have said repeatedly, national unity and global solidarity are essential to implementing a comprehensive strategy to suppress transmission, save lives and minimise the social and economic impact of the virus. No matter what stage a country is at, these five priorities, if, acted on consistently and coherently, can turn the tide. WHO will continue to do everything in our power to serve countries with science, solidarity and solutions. The critical question, that all countries will face in the coming months is how to live with this virus. That is the new normal. Many countries have implemented unprecedented measures to suppress transmission and save lives.

‘’These measures have been successful in slowing the spread of the virus. But they have not completely stopped it. Some countries are now experiencing a resurgence of cases as they start to re-open their economies and societies. Most people remain susceptible. The virus still has a lot of room to move. We all want this to be over. We all want to get on with our lives.  But the hard reality is: this is not even close to being over. Although, many countries have made some progress, globally the pandemic is actually speeding up. We’re all in this together and we’re all in this for the long haul. We will need even greater stores of resilience, patience, humility and generosity in the months ahead. We have already lost so much but we can not lose hope.

This is a time for renewing our commitment to empowering communities, suppressing transmission, saving lives, accelerating research and political and moral leadership. But it’s, also, a time for all countries to renew their commitment to universal health coverage as the cornerstone of social and economic development and to building the safer, fairer, greener, more inclusive world we all want.’’

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The Corona Virus Changed Everyday Life: It Pays to Care for Your Well-Being: Your Well-Being Is the Well-Being of the Whole of Humanity That Is the Body of the Whole Society Together: One Alone Can Not Stay Well Unless the Whole Remains Well Together

 

 

|| Monday: June 15: 2020: Sirpa Sarlio Writing || ά.  The corona virus outbreak in spring has changed everyday routines. After the initial shock, some people are, even, better than before. For others, a possible new wave of the virus and their own future may be frightening and a source of anxiety. Managing daily life may be difficult.

Teleworking and relaxation of dashing off to hobbies have meant that many people have slept longer at night, life has been less hectic, rambling has made the nearby natural environment more familiar and the family has gathered round the dinner table, perhaps, more often than before. The corona virus epidemic has given many the impetus to quit smoking and help for this has been sought, for instance, through online services.

On the other hand, friends, relatives and co-workers are missed, a bottle of wine is emptied unnoticed, the favourite gym has closed and the refrigerator door is temptingly close. Lay-offs, redundancies and changes in consumer behaviour are reflected in the pay packet and in possibilities to look after one’s own well-being.

The epidemic and exceptional circumstances have heightened and increased previously identified disparities in health and well-being. The differences have, also, become more visible. Lifestyle and state of health can increase the risk of developing corona virus disease

The corona virus is a threat to health. Our knowledge of the risk factors for developing corona virus disease is still incomplete. We know, however, that lifestyle and state of health affect morbidity. For this reason, looking after your well-being, functional capacity and health is, even, more important.

For example, a varied diet with sufficient protective nutrients is important for the functioning of our defence system and our resistance to bacteria and viruses. Smoking impairs lung function and increases the risk of serious corona virus disease. The benefits of quitting smoking are quickly visible, among others as improved resistance.

Good respiratory health and general condition affect both morbidity and recovery. Adequate exercise, undoubtedly, has a positive effect on the condition of the respiratory and circulatory system. What’s more, adequate exercise and healthy nutrition can prevent Type Two Diabetes and lower blood pressure. In addition, they help with weight management.

Studies indicate that many non-communicable diseases, such as, Hypertension and other cardiovascular diseases, as well as, Type Two Diabetes, appear to increase the risk of developing more serious forms of COVID-19 disease. The majority of patients in intensive care are overweight and obese.

We live in uncertainty. We don’t know, if, the second wave of the corona virus will strike later. Nor do we know how we will succeed in returning to so-called normal life. That is precisely why you should care for your health and well-being. It is important to support others to do the same.

The corona virus outbreak in spring has increased people’s wish to help their neighbours and fellow human beings, either by themselves or through the work of organisations. It is positive that many have found new forms of community spirit and new ways of doing things, such as, remote exercise lessons and concerts or, for example, window theatre. Hopefully, these will remain permanent features of everyday life and will produce joy, also, in future. We need many kinds of practices, from neighbourhood assistance to remote yoga and from virtual dining groups to courtyard and balcony concerts. No one should be left alone.

It is, also, positive that many municipalities, companies and organisations have developed new ways of working and making people’s daily lives easier. Digitalisation, for example, has, also, developed in exceptional circumstances, as, if, by accident.

Organisations deserve credit for being actively involved in the corona virus situation, both in preventing harm and inequality and in caring for the problems, that have arisen.

::: Sirpa Sarlio is a Ministerial Adviser at the Ministry of Social Affairs and Health: Government of Finland ::: 

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Obesity-Related Diseases Among Top Three Killers in Most Countries: Since 1975 Obesity Has Nearly Tripled and Now Accounts For Four Million Deaths Worldwide Every Year: The World Bank Report on the Silent Epidemic of the World Death of Obesity

 

 

|| Tuesday: February 11: 2020 || ά.  Long believed to be a problem, exclusive to countries with high-income, evidence shows that over 70 percent of the world's two billion overweight and obese individuals live in countries with low or middle income. Faced with increasing disability, mortality, health care costs and lower productivity, obesity is a growing concern for all countries regardless of income level, according to a new World Bank Report launched on February 06.

Obesity has a major impact on national economies and on human capital by reducing productivity and life expectancy and increasing disability and healthcare costs. It is projected that in the next 15 years, the costs of obesity will total more than US$07 trillion in developing countries. The Report ‘Obesity: Health and Economic Consequences’ on an impending global challenge, states that obesity-related diseases are now among the top three killers across the globe, except in sub-saharan Africa. Recent data show that, since 1975 obesity has nearly tripled and now accounts for four million deaths worldwide every year.

The Report stresses that in order to avoid the rise of obesity in future generations, governments and development partners must adopt a comprehensive approach. Effective primary health systems will be crucial together with a strong focus on preventative measures, such as, mandating the labelling of processed foods; increasing consumer education; reducing salt and sugar-sweetened beverages; and investing in early childhood nutrition programmes. In other words, education is a must. Investing in education and life-long learning is vital. People need to have the knowledge in order to be able to not only becoming aware of all the vital issues of health, well-being, nutrition and healthy foods and drinks and equally the vital necessity of following a healthy, engaged and active life and living but, also, using that, being able to make informed choices and follow them through.

Factors, escalating the obesity epidemic include ultra-processed and sugary foods, reduced physical activity and higher incomes, which, often, go hand in hand with a higher consumption of unhealthy foods. “As countries grow economically and per capita income rise, the devastating impacts and burden of obesity will continue to shift toward the poor.” says Dr Meera Shekar, the Global Lead for Nutrition at the World Bank and Co-author of the Report along with Dr Barry Popkin from the University of North Carolina.

In China between 2000 and 2009, health care costs associated with obesity grew from half a percent to more than three percent of China’s annual health care expenditure. In Brazil, obesity-related health care costs are expected to double, from less than US$06 billion in 2010 to more than US$10 billion in 2050.

In addition to directly increased health care costs, there are, also, indirect costs, associated with, for example, reduced work productivity, absenteeism and early retirement, which affect individuals and societies. Many countries across the globe are, also, suffering from what is referred to as the ‘double burden of malnutrition’, high stunting and increasing obesity rates, further compromising their human capital.

“One of the most effective ways to address obesity and other non-communicable diseases is by ramping up investments in affordable, quality primary health care.” says Dr Muhammad Pate, the Global Director for Health, Nutrition and Population at the World Bank. “This makes sense both from a health and an economic perspective. Putting more resources on the frontlines to detect and treat conditions early, before they become more serious, saves lives, improves health outcomes, reduces health care costs and strengthens preparedness.”

The Report, also, highlights the importance of strong fiscal policies, such as, taxation of unhealthy foods; and enhancing urban design, such as, playgrounds in schools and walking and bicycle paths. Financial support for the preparation of the Report was provided by the Government of Japan through the Japan Trust Fund for Scaling Up Nutrition. 

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WHO Re-appoints Dr Matshidiso Moeti For Another Term As the Regional Director For Africa

 

|| Wednesday: February 05: 2020 || ά. The WHO Executive Board, currently holding its 146th session in Geneva, has re-appointed Dr Matshidiso Moeti for a second term as WHO Regional Director for Africa and Dr Hans Kluge as Regional Director for Europe in his first term. “I am greatly honoured to have been appointed to serve a second term as the WHO Regional Director for Africa and I would like to thank you for the trust you have shown.” said Dr Moeti.

“As Africa increasingly faces the double burden of diseases, the next five years in public health will be crucial in laying a strong foundation to reverse this burden.” Dr Moeti, who is from Botswana, said that she would accelerate action towards attaining universal health coverage so that everyone can access care without financial hardship. Despite significant health challenges in the African region, which serves 47 countries, progress is being made in strengthening health systems, combating diseases and improving people’s health. Recent efforts by Member States include policies to tackle tobacco use, vaccines for cervical cancer and Malaria prevention, as well as, joint initiatives to procure medicines affordably.

As the first woman WHO Regional Director for Africa, Dr Moeti was elected as WHO Regional Director for Africa on February 01, 2015. In 1999, she joined the WHO Regional Office for Africa and has served as Deputy Regional Director, Assistant Regional Director, Director of Non-communicable Diseases, WHO Representative for Malawi, Co-ordinator of the Inter-Country Support Team for the South and East African countries and Regional Advisor for HIV:AIDS.

Before joining WHO, Dr Moeti worked as Team Leader of the Africa and Middle East Desk in Geneva, 1997-1999 with the Joint United Nations Programme on HIV:AIDS:UNAIDS. She, also, worked with the United Nations Children's Fund:UNICEF as Regional Health Advisor for East and Southern Africa and with Botswana’s Ministry of Health as a clinician and public health specialist.

Dr Moeti holds a degree in Medicine, M.B.B.S and a Master’s degree in Public Health, MSc in Community Health for Developing Countries, from the Royal Free Hospital School of Medicine, University of London and the London School of Hygiene and Tropical Medicine, respectively. She was awarded an Honorary Fellowship of the London School of Hygiene and Tropical Medicine and an Honorary Doctorate from the University of Health and Allied Sciences, Ghana.

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Tackle the Unacceptable Inequalities Between Cancer Services in Rich and Poor Countries: This Could Save Seven Million Lives: When Will the World Accept That Without Universal Healthcare There’s No Other Way to Get Health Equality So That Diseases Like Cancer Does Not Become a Death Sentence to the Poor Millions in the Poorer Countries Which Is What It Is Now

 

|| Tuesday: February 04: 2020 || ά. Global cancer rates could rise by 60 per cent over the next 20 years unless cancer care is ramped up in countries with low and middle income, the World Health Organisation:WHO has warned. Less than 15 per cent of these nations offer comprehensive cancer treatment services through their public health systems, compared with more than 90 per cent among their richer counterparts, according WHO.

“At least seven million lives could be saved over the next decade, by identifying the most appropriate science for each country situation, by basing strong cancer responses on universal health coverage and by mobilising different stake-holders to work together.” said Dr Tedros Adhanom Ghebreyesus. WHO Director-General. Seven million lives: how massive a number of human lives can be saved from death! Only, if, there’s Universal Health Coverage, that has the required investment for the level and degree of challenge!

Coinciding with the World Cancer Day, Tuesday, February 04, WHO and it’s specialised International Agency for Research on Cancer:IARC have released two Reports: one aimed at setting the global agenda on the disease; the other focused on research and prevention. The Reports highlight numerous proven interventions, such as, controlling tobacco use, which is responsible for a quarter of all cancer deaths, vaccinating against hepatitis B to prevent liver cancer and eliminating cervical cancer by vaccinating against HPV.

“This is a wake-up call to all of us to tackle the unacceptable inequalities between cancer services in rich and poor countries.” said Dr Ren Minghui, the WHO’s Assistant Director-General, overseeing Universal Health Coverage policy, as well as, communicable and non-communicable diseases.

“If, people have access to primary care and referral systems, then, cancer can be detected early, treated effectively and cured. Cancer should not be a death sentence for anyone, anywhere.”

While the Reports show that progress can be achieved, the challenge will be for countries to select cancer treatments taking into consideration cost, feasibility and effectiveness. Dr Elisabete Weiderpass, the IARC Director, said that there had been tremendous advances in cancer research over the past five decades, leading to a reduction in deaths.

She said, ‘’High-income countries have adopted prevention, early diagnosis and screening programmes, which together with better treatment, have contributed to an estimated 20 per cent reduction in the probability of premature mortality between 2000 and 2015 but, low-income countries only saw a reduction of five per cent. We need to see everyone benefitting equally.”

::: Caption: A Research Assistant, left, receives training from a Biologist at the National Cancer Institute of Columbia: Image: PAHO:Jane Dempster :::

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The Chinese Novel Corona Virus 2019: The Facts and Evidence So Far

 

|| Monday: February 03: 2020 || ά. A new strain of corona virus, officially, named, 2019-nCoV, which has caused respiratory diseases in China and spread to, at least, 23 other countries, has been declared a Public Health Emergency of International Concern:PHEIC by the World Health Organisation:WHO. Here are the basic facts about the virus for people to know. At least, 361 people have died from the Novel Corona Virus, which first appeared in the Chinese city of Wuhan in December 2019.

More than 17,200 cases have been confirmed in China and according to experts, the numbers of people being infected by the virus is expected to rise in the coming weeks. Although, the vast majority of cases have been in China, the virus, which can cause Pneumonia, is worrying global health authorities. Some 151 cases have been confirmed in 23 countries and the first death outside of China was recorded in The Philippines. Most of those, affected by the virus had travelled from Wuhan, the epicentre of the outbreak.

A public health emergency of international concern is declared by the WHO, which is declared in cases of ‘an extraordinary event’, which constitutes ‘a public health risk to other States through the international spread of disease’ and ‘potentially, requires a co-ordinated international response’. This definition implies a situation, that is ‘serious, unusual or unexpected; carries implications for public health beyond the affected State’s national border; and may require immediate international action’.

Speaking at a meeting of the WHO Executive Board on Monday, the Agency’s Director-General, Dr Tedros Adhanom Gebreyesus, explained that the decision to announce a PHEIC was made because of signs of human to human transmission outside China and WHO’s concern regarding what might happen, if, the virus were to spread in a country with a weaker health system.

Dr Ghebreyesus, also, noted the importance of containing the virus in China. He said, “If, we invest in fighting at the source, then, the spread to other countries is minimal and, also, slow. If, it’s minimal and slow, what is going outside can, also, be controlled easily. It can get even, worse. But, if, we give it our best, the outcome could be, even, better.”

Several countries have, already, put travel restrictions in place but, Dr Ghebreyesus pointed out that WHO is not recommending measures, that unnecessarily interfere with travel and commerce.  

What is a Corona Virus: Corona Viruses consist of a core of genetic material, enclosed within an envelope of protein spikes, which resembles a crown or, in Latin, corona. They are a large group of viruses, that cause respiratory diseases and, sometimes, gastrointestinal symptoms.

Diseases can range from the common cold to Pneumonia, which can be fatal. In most people symptoms are mild but, some types can cause severe disease. These include Severe Acute Respiratory Syndrome:SARS, first discovered in China in 2003 or Middle East Respiratory Syndrome:MERS, which originated in Saudi Arabia in 2012. MERS caused more than 2,400 cases and 850 deaths and more than 800 people were killed by SARS.

It has been estimated that 20 per cent of patients, infected with the novel corona virus 2019-nCoV have severe symptoms. People, who have other health problems, such as, Asthma, Diabetes and cardiovascular disease are, particularly, vulnerable.

How deadly is Novel Corona Virus: As of Monday February 03, 361 people had died from Novel Corona Virus:2019-nCoV. This represents about two per cent of cases. By comparison, around 25 per cent of MERS cases resulted in the death of the patient.

However, at this stage, it is still too early to determine how deadly the virus is: thousands of patients are being tested, with around 2,110 in a serious condition and it is not yet known how these cases will evolve.

Where does the virus come from: The first cases of Novel Corona Virus occurred in a group of people with Pneumonia, linked to a seafood and live animal market in Wuhan, where many fish, reptiles, bats and other live and dead animals were traded. The disease, then, spread from those, who were sick, to family members and healthcare workers.

Corona Viruses circulate in a range of animals and can, sometimes, make the jump from animals to humans, via a process known as, a ‘spill-over’, which can occur due to a mutation in the virus or increased contact between animals and humans.

It is not yet known how Novel Corona Virus was first transmitted to humans: in the case of MERS, it is known that people caught the virus via direct or indirect contact with infected camels and SARS originated in civet cats.

Is the virus transmitted from person to person: The transmission of the virus from person to person has occurred mainly in the city of Wuhan, the epicentre of the outbreak but it occurred in other parts of China and outside the country as well.

The exact way that the disease is transmitted is yet to be determined but, in general, respiratory diseases are spread via drops of fluids when someone coughs or sneezes or by touching a surface infected with the virus. According to Chinese scientists, people, who get the virus are contagious, even, before they show symptoms. The incubation period, the period from when the infection occurs until symptoms develop, is between one and 14 days.

How fast is the virus spreading: A large number of new cases are being reported on a daily basis, in the 24 hours period between February 01 and February 02, for example, over 2,590 new cases were confirmed in China but, this is not surprising, as more and more controls are being put in place to detect and confirm infections.

The total number of cases is expected to be much greater in the coming weeks.

What can I do to protect myself: There is no vaccine currently available to treat Novel Corona Virus but, WHO is recommending several precautionary and hygienic measures.

For example:

::: Avoid direct contact with people, suffering from acute respiratory infections,

::: Wash your hands frequently, especially, after direct contact with sick people or their surroundings,

::: Avoid direct contact with farm animals or wild animals, living or dead,

::: People with symptoms of a severe respiratory infection should try to keep their distance from other people and cover their nose and mouth when sneezing or coughing.

Detailed information on Novel Corona Virus, including, daily situation reports, can be found on the WHO website.

The best advice is to seek, find and read information from bona fide agencies and organisations, such as, the World Health Organisation about any of the issues, relating to the development of this virus.

::: Caption: A digital illustration of the Corona Virus shows the crown-like appearance of the virus: Image: Centres for Disease Control and Prevention :::

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