The Access to COVID-19 Tools – the ACT-Accelerator – along with its COVAX Facility, is a groundbreaking global collaboration to accelerate development, production, and equitable access to COVID-19 tests, treatments, and vaccines. 

Launched at the end of April 2020, the ACT-Accelerator has secured $3 billion, critical for its start up, but it needs a further $35 billion – including an “immediate infusion” of $15 billion – Secretary-General António Guterres said at a high-level event to mobilize support for the initiative. 

“These resources are crucial now to avoid losing the window of opportunity for advance purchase and production, to build stocks in parallel with licensing, to boost research, and to help countries prepare to optimize the new vaccines when they arrive.”  

Any delay would further widen already vast inequalities, he warned. 

‘By helping others, countries help themselves’ Mr. Guterres outlined clearly that to reach that amount, donors’ paying in through official development assistance budgets, will not be sufficient. 
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It is time for countries to draw funding from their own response and recovery programmes. By helping others, they will help themselves – Secretary-General Guterres

“We need to think bigger. It is time for countries to draw funding from their own response and recovery programmes. By helping others, they will help themselves”, he said. 

The coronavirus pandemic is costing the global economy $375 billion a month and has destroyed around 500 million jobs so far. 

The Secretary-General called on developed countries – which have devoted many trillions of dollars to respond to the socio-economic impacts of the crisis in their own countries – to “invest a small fraction of that, to stop the spread of the disease everywhere.” 

“I call on all countries and partners to significantly step up in the next three months to provide much needed new and additional resources and to mobilize all partners and to put everyone behind a global response to deliver. Solidarity is self-interest,” he stressed. 

“Grasping that 21st-century truth is essential to end this crisis and emerge safer, smarter and stronger together,” he said, wrapping up his remarks. 

‘A test of solidarity’ 

Amid the devastation of COVID-19, science is offering solutions, in the form of new tests, therapeutics and – hopefully – vaccines, said Tedros Adhanom Ghebreyesus, Director-General of the UN World Health Organization (WHO), speaking alongside the Secretary-General. 

Science and solutions are, however, ineffective without solidarity, he added. 

The head of WHO explained that the ACT-Accelerator has already delivered “impressive results” in the form of making available 120 million new rapid tests for low- and middle-income countries and securing courses of dexamethasone. 

The financing gap for ACT-Accelerator stands at $35 billion … roughly equivalent to what the world spends on cigarettes every two weeks – WHO DG Tedros 

The COVAX facility, on its part, is supporting the development of vaccines, he continued, underlining that “now is the time to realize the full power of ACT-Accelerator.”  

With the $35 billion financing gap – roughly equivalent to what the world spends on cigarettes every two weeks - the WHO Director-General said that fully funded, the initiative will help control the pandemic, restore confidence and stimulate the growth of the recovery. 

“Frankly, this is not a financial challenge, it is a test of solidarity. This is a moment to say no to nationalism, and yes to our shared humanity,” he declared, adding “ultimately ACT is not delivering merely vaccines, diagnostics or therapeutics, it is delivering something far more important – hope.”  

Eliminate COVID-19 everywhere Philanthropist and Microsoft co-founder Bill Gates, also addressing the summit, said that a vaccine against COVID-19 will help save millions of lives as well as support the development of a plan to eliminate the disease globally.  

To achieve global elimination, he outlined three necessities: capacity to produce billions of vaccines, funding to pay for them, and systems to deliver them everywhere. 

“A vaccine can make COVID-19 a preventable disease, and no one should die from a preventable disease simply because the country they live in can’t afford the vaccine,” he added, urging action to ensure low- and lower-middle income countries can also access sufficient doses to protect their populations.    

“The only way to eliminate the threat of this disease somewhere, is to eliminate it everywhere,” said Mr. Gates.  

New agreement with pharma Mr. Gates announced that the Bill and Melinda Gates Foundation, earlier on Wednesday, had signed a new agreement with 16 pharmaceutical companies. 

“In this agreement the companies commit to, among other things, scaling up manufacturing at an unprecedented speed, and making sure that approved vaccines reach broad destruction as early as possible”, he said. 

The next necessity to eliminate COVID-19, is the funding to pay for those vaccines.  

Mr. Gates said that the pharmaceutical industry has committed to make the products as affordable as possible, through donations, tiered pricing and foregoing profits, and underlined the need for public funding, to procure vaccines for all. 

“This is where the ACT-Accelerator comes in,” said Mr. Gates, applauding the United Kingdom for donating enough money to purchase hundreds of millions of doses of vaccines for poor countries. “I want to encourage other countries to do the same”, he said. 

“Finally even when we have the manufacturing capacity and the funding lined up, we will need to strengthen health systems to achieve the broad coverage to deliver the vaccine, and monitor for outbreaks”, he said, adding that lessons learnt from polio eradication efforts can be used for that purpose. 

With the right diagnostics, health workers can also sound the alarm if a future disease jumps from animal to humans, said Mr. Gates, adding: “In other words, we can also be building the systems that will help reduce the damage of the next pandemic.”

The updated recommendations from the World Health Organization (WHO), come as the northern hemisphere braces for the seasonal bug, which claims hundreds of thousands of lives from respiratory-related causes every year.

“There has in fact been an increased demand and we’re hearing now that countries that are trying to get influenza vaccine cannot get it”, said Dr Ann Moen, Chief, Influenza Preparedness and Response at the WHO.

The aim of the announcement by the Strategic Advisory Group of Experts on Immunization (SAGE) is to prevent national health care systems from becoming overwhelmed - and to prevent “confusion” when treating people for respiratory diseases that can be difficult to tell apart, Dr Moen told journalists in Geneva.

SAGE approach

“Based on a set of considerations, including alleviating the added burden on health care systems and vulnerable populations and managing potentially limited supplies of influenza vaccines, SAGE has recommended…among the five risk groups (that) health workers and older adults are the highest priority groups for influenza vaccination during COVID-19 pandemic,” she said.

Previously, SAGE identified five vulnerable groups: pregnant women - the highest priority - children, older adults, those with underlying medical conditions and health workers, in no particular order.

If possible, all these groups should continue to be vaccinated as “the best way to reduce disease”, Dr Moen said, adding that the measure been in place for 50 years with no known adverse side-effects.

Cure for a killer

Although the influenza jab would not protect people from coronavirus - a new disease for which there is so far no cure - “it keeps you out of hospital”, she continued.

The WHO official noted that seasonal influenza affects individuals in every country and results “in up to one billion cases, three to five million severe cases, and on average 290,000 to 650,000 deaths, respiratory-related deaths annually”.

Indications that there might be a potential influenza vaccine shortage date back to April, when countries placed orders with pharmaceutical manufacturers, conscious of the increased burden that the COVID-19 pandemic might place on their health care systems.

Annually, around 500 million doses of vaccine are produced.

Responding quickly to increased demand for inoculations can be relatively slow, Dr Moen explained, as the most common way to produce it involves large numbers of chicken eggs.

“We have heard that from our industry associations (that) they have been able to increase some of the orders for some of the countries and they’ve made additional vaccine that they’ve been handing out, but overall it does seem to be there’s a higher demand than there is numbers of vaccines.”

Infections at ‘historic lows’

The development comes amid remarkably low infection rates of influenza in the southern hemisphere, which have been attributed to COVID-19 protection measures, including travel restrictions.

“There really just is not a lot of flu” in the global south, Dr Moen said, citing Australia, New Zealand, South America and South Africa.

Testing usually indicated a 10 to 30 per cent influenza infection rate among the population, she continued, but this year, just one per cent of tests have turned up positive.

“This really is historic lows in terms of flu circulation,” she added. “And we feel confident this is not due to lack of testing or lack of surveillance.”

Despite the lack of an apparent threat, countries in the global north should remain vigilant, amid rising infection rates across many countries and regions, Dr Moen insisted.

She added: “We are seeing some sporadic outbreaks in some areas of the world and so we really fully believe that as society opens back up, we’ll probably start to see flue circulate again back to more normal proportions.”

AstraZeneca is a global, science-led biopharmaceutical 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 & Metabolism, and Respiratory & Immunology.

The following statement was issued Sep 9 on AstraZeneca Oxford SARS-CoV-2 vaccine, AZD1222, COVID-19 vaccine trials temporary pause:

"As part of the ongoing randomised, controlled clinical trials of the AstraZeneca Oxford coronavirus vaccine, AZD1222, a standard review process has been triggered, leading to the voluntary pause of vaccination across all trials to allow an independent committee to review the safety data of a single event of an unexplained illness that occurred in the UK Phase III trial.

"This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials.
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In large clinical trials, illnesses will happen by chance and must be independently reviewed. AstraZeneca is working to expedite the review of the single event to minimise any potential impact on the trial timeline. We are committed to the safety of our participants and the highest standards of conduct in our trials.

Pascal Soriot, Chief Executive Officer, said: “At AstraZeneca we put science, safety and the interests of society at the heart of our work. This temporary pause is living proof that we follow those principles while a single event at one of our trial sites is assessed by a committee of independent experts. We will be guided by this committee as to when the trials could restart, so that we can continue our work at the earliest opportunity to provide this vaccine broadly, equitably and at no profit during this pandemic.”

Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. 

AstraZeneca said Wednesday that the patient had neurological symptoms associated with a spinal inflammatory disorder called transverse myelitis, pending a final diagnosis, Reuters reported.

It was concluded by an independent review panel the illness was not related to the vaccine.
Dr. Samir Gupta, associate professor of medicine at the University of Toronto, said that "it's not a routine thing to stop a massive trial mid-course like this."

Dr. Sumon Chakrabarti, an infectious disease specialist at Trillium Health Partners in Toronto, told CBC News Network that if the patient does have transverse myelitis, he or she will likely be tested for different types of infections to see if a cause can be determined.

"I've seen many of these cases myself, and we often come up with viral causes," he said.

Dr. Andrew Morris, an infectious disease specialist at Sinai Health, the University Health Network and the University of Toronto said he was  concerned there wouldn't be access to the vaccine, which is in advanced stages of development, reported CBC News. 

Morris said  three billion doses have been reserved by governments around the world and by the COVAX Facility, which aims to provide access to 172 countries, including many in the developing world and added that  many countries are pinning their hopes on this vaccine.

Morris also expressed his concern that the media coverage will discourage people from enrolling in vaccine studies.

The study by UNAIDS, the UN agency working to stamp out HIV and AIDS, outlines how the world can leverage and build resilient health systems that address both pandemics. 

“Our decades-long fight against HIV offers essential lessons. By heeding those lessons and working together, we can ensure that national health responses deliver on the promise of the 2030 Agenda for Sustainable Development and the health and well-being of all”, said UN Secretary-General António Guterres. 

Seize the moment The report is entitled COVID-19 and HIV: 1 moment, 2 epidemics, 3 opportunities—how to seize the moment to learn, leverage and build a new way forward for everyone’s health and rights. 

It reveals how key lessons learned in combating HIV can support accelerated action against COVID-19 without jeopardizing ongoing response to HIV and other health emergencies, thus providing a “unique opportunity” to reimagine systems for health, according to UNAIDS chief Winnie Byanyima. 

 “All eyes are on health, health systems and health care, with countries wanting to be better equipped to deal not only with COVID-19 but also to create healthier, more resilient societies,” she said.  

“We can seize this opportunity by learning from HIV and from COVID-19 to make important changes to develop rights-based, equitable, people-centred systems for health.”  

Leveraging innovative delivery It highlights examples of how infrastructure for HIV response is being leveraged during the pandemic, including through innovative and community-led service delivery. 

For example, some 280,000 new health-care workers trained by the United States President’s Emergency Plan for AIDS Relief, are currently serving as first responders to COVID-19 in several low- and middle-income countries. 

Additionally, 17 HIV treatment reference centres in Morocco, are being used in the first line of response for treating disease caused by the virus.  

Increase investments 

The report was released at the start of the two-day Virtual Fast-Track Cities 2020 conference on urban HIV and COVID-19 responses, which concludes on Thursday. 

As countries continue to grapple with the new coronavirus, UNAIDS stressed that they must take steps to limit any interruption to HIV-related services. At the same time, supply chains providing essential commodities and technologies for HIV and other global health priorities must also be able to function.

“COVID-19 has caused significant loss of life in many communities, but notably in those where inequities make people more vulnerable to ill health. Leveraging of the HIV infrastructure and workforce has helped to mitigate what might have been a far worse situation”, said José M. Zuniga, President/Chief Executive Officer of the International Association of Providers of AIDS Care, co-organizers of the conference.  
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“However, with current HIV spending substantially off-track, the world urgently needs to increase investments in the responses to both HIV and COVID-19 and not siphon off one to respond to the other.” 

Citing “recent studies”, WHO revealed that sepsis kills 11 million people each year, many of them children, and disables millions of others.
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“The world must urgently step up efforts to improve data about sepsis so all countries can detect and treat this terrible condition in time,” WHO chief Tedros Adhanom Ghebreyesus said. 

Improved data needed

Against the backdrop that most studies had been conducted in the hospitals and intensive care units of high-income countries – with little evidence from the rest of the world – WHO underscored the “urgent need” for better data.

Furthermore, different definitions of sepsis, diagnostic criteria and hospital discharge coding, compound the difficultly in developing a clear understanding of the true global burden of this life-threatening infection.

“This means strengthening health information systems and ensuring access to rapid diagnostic tools, and quality care including safe and affordable medicines and vaccine”, the top WHO official spelled out.

What is sepsis?

Sepsis occurs in response to an infection. When it is not recognized early and managed promptly, it can lead to septic shock, multiple organ failure and death, according to the UN health agency. 

And patients who are critically ill with severe COVID-19 and other infectious diseases are at higher risk of developing and dying from it.

WHO pointed out that only half of sepsis survivors will completely recover, the rest will either die within one year or be burdened by long-term disabilities.

Hardest hit

The deadly infection disproportionately affects vulnerable populations, including newborns, pregnant women and people living without means, where WHO says approximately 85 per cent of sepsis cases and sepsis-related deaths occur.

Moreover, children account for almost half of the 49 million cases each year, most of which could have been prevented through early diagnosis and appropriate clinical management. 
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Obstetric infections, including complications following abortion or infections following caesarean section, are the third most common cause of maternal mortality, the UN report revealed.

Global estimates show that for every 1,000 women giving birth, 11 women experience infection-related, severe organ dysfunction or death.

Healthcare sepsis

Sepsis frequently results from infections acquired in healthcare settings. 

The report finds that almost half of sepsis patients in intensive care units acquired the infection in the hospital while noting that an estimated 27 per cent of those with sepsis in hospitals and 42 per cent in intensive care units, will die. 

The world must urgently step up efforts to improve data about sepsis -- WHO chief

WHO identified antimicrobial resistance as a major challenge in treating sepsis as it complicates the ability to combat infections, especially in healthcare facilities.

Changing the odds

The UN health agency elaborated on interventions to prevent as many as 84 per cent of newborn sepsis-related deaths, which include improved sanitation, water quality and infection prevention methods – such as hand hygiene – but stressed that these be coupled with early diagnosis, appropriate clinical management and access to safe and affordable medicines and vaccines.

At the same time, WHO called on the global community to improve high-quality data collection; scale-up global advocacy, and funding research; develop rapid, affordable diagnostic tools; and educate health workers and communities to infection risks and the need to promptly seek care. 

The vaccine procurement and distribution effort, involving over 170 economies, has the potential to become the world’s largest and fastest ever operation of its kind. 

“This is an all-hands on deck partnership between governments, manufacturers and multilateral partners to continue the high-stakes fight against the COVID-19 pandemic,” said Henrietta Fore, UNICEF Executive Director.
 
“In our collective pursuit of a vaccine, UNICEF is leveraging its unique strengths in vaccine supply to make sure that all countries have safe, fast and equitable access to the initial doses when they are available.” 

UNICEF is the world’s largest single vaccine buyer, procuring more than 2 billion doses of various vaccines annually for routine immunization and outbreak response on behalf of nearly 100 countries.  

On behalf of COVAX Facility 

UNICEF, in collaboration with the Revolving Fund of the Pan American Health Organization (PAHO), will lead efforts to procure and supply doses of COVID-19 vaccines on behalf of the COVAX Global Vaccines Facility for 92 low- and lower middle-income countries whose vaccine purchases will be supported by the mechanism. 
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In addition, UNICEF will also serve as procurement coordinator to support purchases by 80 higher-income economies, which have expressed their intent to participate in the COVAX Facility and would finance the vaccines from their own budgets, the UN agency said in a news release on Friday. 
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UNICEF will undertake these efforts in close collaboration with the World Health Organization (WHO), Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations (CEPI), PAHO, World Bank, the Bill and Melinda Gates Foundation, and other partners.  

The COVAX Facility is open to all countries to ensure that no country is left without access to a future COVID-19 vaccine. 

Market assessment and next step Some 28 manufacturers have shared their annual production plans for COVID-19 vaccines –through 2023 – with UNICEF, which in a market assessment said the drug makers are willing to collectively produce “unprecedented quantities” of vaccines over the coming 1-2 years. 

However, manufacturers signalled that investments to support such large-scale production of doses would be highly dependent on, among other things, whether clinical trials are successful, advance purchase agreements are put in place, funding is confirmed, and regulatory and registration pathways are streamlined. 

A key next step, UNICEF said, will be ensuring self-financing economies sign up for the COVAX Facility by 18 September, which will allow COVAX to support early, at-risk investments in increasing manufacturing capacity on a broad scale. 

‘Critical partner’ for success 

“UNICEF has been critical partner in Gavi’s success over the last two decades,” said Gavi’s Chief Executive Officer Seth Berkley. 

Over the 20 years, Gavi has reached over 760 million children with life-saving vaccines, preventing more than 13 million deaths. 

“[UNICEF] helped us reach more than half the world’s population with life-saving vaccines … This expertise and experience will be important in ensuring that COVAX – as a global effort to procure and deliver safe and effective COVID-19 vaccines, on an accelerated timeframe, and at an unprecedented scale – can protect the most at-risk, wherever they may be in the world.” 

Together we can work to end the acute stage of this pandemic – Dr. Berkley, Gavi CEO

“Together we can work to end the acute stage of this pandemic, including its devastating impact on individuals, communities, and economies,” added Dr. Berkley. 

Vaccines for all The COVAX Global Vaccines Facility is the vaccine pillar of the ACT-Accelerator, an initiative launched in April to speed up development of medicines to treat COVID-19 and make them available to people everywhere. 

It is operated by Gavi, the Vaccine Alliance; CEPI, and WHO, alongside multinational and developing country vaccine manufacturers. 
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The Facility works to ensure as many countries as possible cooperate to pool development, procurement and allocation of any COVID-19 vaccines. 

In a call to Governments everywhere to take greater steps to tackle non-communicable diseases (NCDs), the World Health Organization (WHO) said that the pandemic has exposed the fact too little has been achieved, even though these illnesses account for seven in 10 deaths worldwide.
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WHO Director General Tedros Adhanom Ghebreyesus, said the coronavirus had “preyed on people” with NCDs, and that the risk factors they face “are increasing vulnerability to COVID-19, infection, and the likelihood of worse outcomes, including in younger people.”

Clear disruption revealed

The four most common NCDs are cardiovascular disease, cancer, diabetes and chronic respiratory diseases; together, they contribute to more than 40 million deaths a year, said Dr Bente Mikkelsen, Director, WHO Division of Noncommunicable Diseases.

“The most recent study shows that there is a disruption in healthcare services including NCD diagnosis and treatments in 69 per cent of cases”, she said. “In cancer, there are the highest numbers, with 55 per cent of people living with cancer (having) their health services disrupted.”

Dr Mikkelsen noted that those living with one or more NCDs were among the most likely to become severely ill and die from the new coronavirus.

Indigenous communities hit

Studies from several countries had indicated this, she said, highlighting how data on indigenous communities in Mexico, showed that diabetes was the most commonly found disease among COVID-19 fatalities.

Research also found that in Italy, of those who succumbed to COVID-19 in hospital, 67 per cent suffered from hypertension and 31 per cent had type 2 diabetes.

Worryingly, the WHO medic also noted that another study had indicated that the world is not on track to meet Sustainable Development Goal (SDGs) pledges on NCDs by 2030 – namely to reduce by a third the number dying before they reach 70 years of age.

Diabetes ‘going in the wrong direction

’Only 17 countries are set to achieve these targets for women and only 15 were on course to do the same for men, Dr. Mikkelsen said, noting that premature mortality for diabetes was now “going in the wrong direction”.

Over the last 20 years, some 200 million men and women have died prematurely, according to WHO, which has a series of NCD “best buy” recommendations for all countries to implement.
The need to take action is urgent, the UN health agency believes, as in the next decade, another 150 million people will die from NCDs.

Poorest countries bear greatest burden

Developing countries will experience the heaviest burden, with the chances of dying from a NCD being three times higher in Fiji and Mongolia, than in Norway or Japan.

“People living with NCD all over the world (are) waiting for us, for WHO to support countries and for countries to really act on the commitments made,”  Dr. Mikkelsen said, in a call for universal access to medicines, vaccines, diagnostics and technology to prevent, screen, and diagnose NCDs early.

“Today our primary task is to defeat the COVID-19 pandemic and also to take the learning from it and rebuild, recover and build back”, she said. “To rebuild lives and livelihoods. But we must not simply return to where we were.”

‘We can and will end the pandemic’

In his regular end of week briefing, WHO chief Tedros Adhanom Ghebreyesus, adopted an optimistic tone, telling journalists that although many challenges remain, WHO was “encouraged by the progress we have made against this new virus”, over the course of the past eight months.

“With national unity and global solidarity, we can and will end the COVID-19 pandemic”.

Tedros thanked those countries and economies who have announced this week that they will be joining the COVAX effort to accelerate the development and production of a new coronavirus vaccine, ensuring its equitable distribution.

There are now 78 high and medium-performing economies which have pledged their involvement, in the “Access to COVID-19 Tools (ACT) Accelerator”-led project, “and the number is growing”, he said.

“I urge those who have not yet joined to do so by the 18th of September”.

Vaccine unlikely, until middle of next year

In a related development, WHO spokesperson Dr. Margaret Harris, said that there were unlikely to be widespread vaccinations to provide protection against COVID-19 until the middle of next year.
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Phase three testing of many candidate vaccines was still ongoing, she told journalists in Geneva, without naming any, adding that this final safety protocol would likely take a significant amount of time before any are licensed nationally and approved for use.
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Until a vaccine is ready, everyone should continue to respect basic hygiene and other preventative measures, Dr. Harris continued, such as physical distancing, washing hands and wearing masks.