A nurse takes the temperature of a child suspected of COVID-19 symptoms in a Lebanese public health centre.

An international pandemic treaty based on equity could be the antidote to current weaknesses and imbalances in the global response to COVID-19, according to a group of influential authors in a Lancet paper published on Tuesday.

A number of the authors are associated with The Independent Panel for Pandemic Preparedness and Response chaired by Helen Clark and Ellen Sirleaf Johnson, which was set up to assess the World Health Organization’s (WHO) response to COVID-19.

Based on a timeline developed by the panel that lays out the global COVID-19 response, the authors conclude that the International Health Regulations (IHR) are too weak, and the required country actions are too slow, to protect the world against pandemics.

Revised after the 2005 Severe Acute Respiratory Syndrome (SARS) outbreak, the IHR focus on balancing disease notification and health risks with international trade and travel considerations. They specify when and how Member States should notify WHO of a local disease outbreak, and what actions WHO and States should take after that notification. 

The IHR are currently the only legally binding international instrument governing countries’ obligations to report and respond to pathogens that could result in cross-border disease outbreaks and potential public health emergencies.  

In their review, the authors identified a number of significant IHR weaknesses, including: constraints on WHO reporting publicly about national events with pandemic potential; the need for greater specificity on the information that countries need to share with WHO; and a streamlined process to facilitate WHO verification of events within 24 hours of the first signals of an outbreak being received.

Special World Health Assembly

The article comes a few weeks before global leaders meet at a World Health Assembly special session (29 November – 1 December) to consider adopting an “instrument or treaty” to address pandemic preparedness and response. 

“It’s clear: if a new, fast-spreading pathogen were to emerge next month, the current IHR regime would not protect people and trade as intended,” said Dr Sudhvir Singh, lead author on the paper and an advisor to the Independent Panel.

“We suggest change to the IHR and a new treaty or another instrument that would result in more information shared faster, WHO able to investigate rapidly, all countries moving immediately to assess risk;  and tools, like tests and vaccines, available to all who need them.”

Georgetown University’s Dr Alexandra Phelan added that “COVID-19 has shown that the existing obligations under the IHR are insufficient for our interdependent and digital world.” 

 “Our analysis demonstrates that collectively, countries urgently need to update our international system to respond to the potential rapid spread of a high impact respiratory pathogen,” said Phelan.

“We have concrete suggestions for ways in which the IHR may be revised or amended, as well as the approach and issues that must be covered in any new legal framework, like a pandemic treaty.”  

Four reasons for a pandemic treaty

The authors advance four reasons why a pandemic treaty “presents the opportunity to enact comprehensive reform in pandemic preparedness and response”. 

“First, a pandemic treaty centred on the principle of equity would be an important signal of international commitment to guard against the entrenchment of global division and injustice.”

A pandemic treaty offers an opportunity to “develop and instil norms of equity, justice, and global public goods of pandemic preparedness and response”, they argue.

“Second, a pandemic treaty could provide high-level complementarity to the IHR and any potential post-pandemic reforms and proactive multidisciplinary approaches to zoonotic risk,” they argue.

Their third argument is that a treaty establishes greater accountability, outbreak support, and global access to vital public health information. 

Finally, a pandemic treaty could provide the opportunity to develop “a solid evidence base for non-pharmaceutical interventions” that might prevent the next outbreak from becoming a pandemic.

“The upcoming Special Session of the World Health Assembly is a critical opportunity for Member States to move ahead with strengthening the IHR and to agree on a process for negotiating a pandemic treaty. We must not lose this opportunity to protect global public health and future generations,”  said Phelan.

At a recent event hosted by G2H2, civil society organisations expressed fear that a pandemic treaty was a distraction from the TRIPS waiver.

But Björn Kümmel, deputy head of the global health unit in the German Federal Ministry of Health, disputed that there is any direct political link between the treaty and the TRIPS waiver.

Kümmel added that amending the IHR also would take time to negotiate.  And a key question here is: “would they be a game-changer for the next pandemic to come? Certainly not,” he added, noting that there is “no compliance mechanism that currently is foreseen in the IHR.”

Image Credits: UNICEF .

obama
Former US President Barack Obama speaking at COP26

Former US President Barack Obama openly criticized two of the world’s largest CO2 emitting countries – Russia and China, for their “dangerous lack of urgency” in discussing the pressing matters of climate change this past week during COP26.

Both Chinese President Xi Jinping and Russian President Vladimir Putin failed to make an appearance with other global leaders at the 26th United Nations Climate Change Conference in Glasgow, which Obama found to be “particularly discouraging,” as he addressed a room of climate experts at the event on Monday. 

“We need advanced economies like the US and Europe leading on [the issue of climate change]. But we also need China and India, we need Russia, just as we need Indonesia and South Africa and Brazil leading on this issue. We can’t afford anybody to be on the sidelines.” 

Obama noted that while there has been some progress made in the six years since the Paris Agreement, the legally binding international treaty on climate change, the world still falls short of their commitment to limit global warming to well below 1.5 C. 

“Here in Glasgow we see the promise of further progress. What is also true is that collectively and individually, we are still falling short. We have not done nearly enough to address this crisis.” 

“We are going to have to do more and whether that happens or not to a large degree is going to depend on you,” said Obama, calling for collective action from young people and politicians alike to take climate change seriously. 

Twenty countries pledge to end public finance of international fossil fuel development

Although most nations have failed to be ambitious in their climate goals in the past week of COP26, said Obama, significant accomplishments and hard-won commitments have been made during the climate conference.  

One such commitment was for high-income countries to help low- and middle-income countries move away from fossil fuels. 

Back in September, US President Joe Biden told the UN General Assembly that the US would provide more than $11 billion in climate aid annually by 2024 to developing nations vulnerable to extreme weather and rising temperatures. 

In addition, the US and 20 other countries have pledged to stop publicly financing international fossil fuel development, with limited exceptions.  

“We will end new public direct support for the international unabated fossil fuel energy sector by the end of 2022,” the declaration read. 

The 20 countries that signed the pledge include Denmark, Italy, Finland, Costa Rica, Ethiopia, Gambia, New Zealand and the Marshall Islands, plus five development institutions including the European Investment Bank and the East African Development Bank. 

This deal does go further than a pledge made earlier in the year by the G20 to end international financing of coal-based power generation outside their own countries. 

However, this declaration does not include major Asian countries responsible for financing a majority of overseas fossil fuel projects. 

Climate change cannot be a partisan issue 

While collective action in fighting climate change requires international cooperation, Obama noted the geopolitical tensions that have arisen as a result of the pandemic, but called for the world to step up despite these tensions. 

“Climate change can’t be seen anywhere in the world as just an opportunity to score political points.”

“Saving the planet isn’t a partisan issue. Nature, physics, science, do not care about party affiliation,” he added.  

Climate change, in the US particularly, has become a partisan issue, causing what Obama referred to as a “lack of leadership on America’s part” and the “open hostility towards climate science at the very top of the [US] federal government” that resulted from former President Donald Trump’s four years in office.  

Obama also pointed out that the lack of a stable congressional majority has prevented him and current President Joe Biden from taking an even stronger stance on climate change. 

However, Obama remain sconfident that Biden’s Build Back Better Framework, which would set the US on course to meet its climate goals, would be passed in coming weeks.   

The legislation, once approved by the US Congress, would devote at least US $1.7 trillion dollars to reduce greenhouse gas emissions by over a billion metric tons by the end of 2030.

Young people have more at stake in the fight against climate change  

Greta Thunberg addresses climate strikers at Civic Center Park in Denver, Colorado. Thunberg is one climate activist Obama praised for inspiring millions in the fight against climate change.

Though Obama noted that at times, he was “doubtful that humanity can get its act together before it’s too late”, this cynicism was countered by the prevailing efforts of young climate activists around the world. 

Addressing all the young people, who Obama said, had “more stake in this fight than anybody else,” he said: 

“I want you to stay angry. I want you to stay frustrated. Channel that anger, harness that frustration.”

“Because that’s what’s required to meet this challenge. Solving a problem this big and this important has never happened all at once.”

Image Credits: COP26, Andy Bosselman, Streetsblog Denver/Flickr.

Rosamund Kissi-Debrah, mother of 11-year Ella, whose 2013 death from severe asthma was the first to be recognized by a court as caused by air pollution.

Greening cities, investing in urban bike lanes rather than new roads, and making plant-based foods cheaper and easier to access than ultra-processed foods. This is a doctor’s prescription for a healthier planet. 

As climate negotiators at Glasgow’s COP26 conference remain locked in debate over the big-picture ambition of targets for global CO2 emissions reductions, and how to finance them, health advocates are trying to raise the profile of climate policies that would yield far-reaching knock-on benefits to the health of almost everyone on earth – but particularly for children, women and people living in some the poorest nations of the world. 

“We have sacrificed children all around the world to air pollution,” said Rosamund Kissi-Debrah, noting that some 500,000 children a year die from air pollution. Kissi-Debrah was speaking at the COP26 “Triple Win Scenario” event on Friday, co-sponsored by the WHO and the World Resources Institute.

Kissi-Debrah’s 11-year-old girl daughter, Ella, was one of those victims. But her death from severe asthma in 2013 set a precedent: it was the first to be recognised by a court anywhere in the world as air-pollution induced.  

Like many Londoners, and many more urban dwellers in low- and middle-income cities around the world, Ella had lived in a heavily trafficked and heavily polluted neighbourhood. 

Shifting travel to greener modes, greening cities with more trees and making cities more walkable are among the climate strategies that health forces are advocating, and could all make a difference to the next generation. 

“Be serious, stop burning fossil fuels because those fossil fuels go into the air and into my lungs and yours. When you think about the planet, think about a couple of little, pink lungs,” said Dr Maria Neira, Director of the Department of Public Health, Climate & Environment, at the event. 

She noted that some 90% of the world’s population is exposed to unhealthy air pollution levels, leading to seven million deaths a year. 

Children among those worst affected

The COVID-19 pandemic and climate change have created a perfect storm for increased malnutrition, child wasting and stunting, and maternal anaemia in parts of Africa.

The fact that children are among those worst affected by climate change is underscored by a new review of the knowledge about climate change on child health, published by the Lancet on Sunday.

“Present and future generations of children bear and will continue to bear an unacceptably high disease burden from climate change,” states the review’s authors, a group of Swedish experts from the Karolinksa Institute and elsewhere.

“Through its far-reaching impact on all parts of society, climate change will challenge the very essence of children’s rights to survival, good health, wellbeing, education, and nutrition as enshrined by the Convention on the Rights of the Child and emphasised in the UN Sustainable Development Goals,” they note.

“Climate change threatens to exaggerate the vulnerabilities of children and other populations at risk and could substantially hamper future progress and possibly even reverse the improvements made in child survival and wellbeing during recent decades,” concludes the review, suggesting that climate change needs to be better integrated into the SDG goals that cover children’s health overall.”

Glasgow moment for health advocates 

Woman receives food assistance after widespread flooding the Horn of Africa and East Africa in 2020, linked by meterologists to climate change.

But air pollution is only one of a range of ways in which our addiction to fossil fuels is delivering a double whammy to health – and children’s health in particular. 

Other, even more direct impacts include deaths and illness from extreme heat, storms, flooding, fires and drought. In addition, reduced food production capacity, an expanding geographic range for many infectious diseases, and increasing risk of new animal-borne diseases leaping from the wild to burgeoning cities – as SARS-CoV2 did – are imminent threats too.

Given the rapid pace of climate change, “it won’t be long before the entire population of the world is affected, directly or indirectly,” said Julia Gillard, chair of the board of the UK-based philanthropy, Wellcome Trust and former Australian Prime Minister. 

Gillard was speaking at the COP26 “Global Conference on Health and Climate Change,” co-hosted by the World Health Organization (WHO) in Glasgow on Saturday.

At the conference, co-sponsored by Wellcome, three UK-based universities and civil society groups, speakers warned of the burgeoning global health crisis that would result from inaction on climate change. 

“We are used to talking about climate as an environmental challenge, an economic challenge, an equity challenge. But it is also one of the most urgent health challenges facing us all today,” said Gillard.

Integrated policies not just global goals

Sir Andy Haines, Professor of Environmental Change and Public Health at the London School of Hygiene and Tropical Medicine, speaking at the COP26 Climate and Health Summit.

Tackling the root sources of climate change more rapidly can generate immediate savings for health systems and societies. 

But that will require not only big picture targets but a complete rethinking of policies, regulations, taxes and finance incentives at national and local levels, experts at the conference pointed out. 

“We need people to work together for integrated solutions,” said Professor Andy Haines of the London School of Hygiene and Tropical Medicine, who has written extensively on the planetary limits of not only temperature but also water, agricultural and forest ecosystems, which humankind needs to preserve to survive and thrive. 

Integration means recognising, for instance, that “the minister of transport is probably more a minister of health than the minister of health”, said Richard Smith, president of the UK Health Alliance on Climate Change.

Commitment to ending financing for fossil fuel

Twenty-six countries, including the US, UK, Canada and Italy, as well as the European Investment Bank and the French development agency, Agence Française de Développement, signed a commitment late last week to “end new direct public support for the international unabated fossil fuel energy sector by the end of 2022, except in limited and clearly defined circumstances that are consistent with a 1.5°C warming limit and the goals of the Paris Agreement”.

The signatories also committed to prioritising their support “fully towards the clean energy transition”, using their resources to “enhance what can be delivered by the private sector”. They also commit to trying to persuade other governments, export credit agencies and public finance institutions to implement similar commitments into COP27 and beyond.

According to WHO climate scientist Dr Diarmid Campell-Lendrum, $5.9 trillion is spent on direct and indirect subsidies to the fossil fuel industry each year.

“We need to stop spending money on the wrong things and start spending it on the right things,” said Campbell-Lendrum, who cycled 1,600 km from Geneva to the Glasgow summit to drive home his point.  

He bore with him a letter calling for more climate action, signed by some 300 organisations, representing some 45 million health care professionals around the world.  In London, Campbell-Lendrum was met by a raft of other climate cycle enthusiasts who continued the relay, getting the letter to Glasgow, where it was delivered to the COP26 leadership. 

https://twitter.com/i/status/1454817969276690436

Image Credits: Christine Olson/Flickr, IFRC, Paul Chappells.

AMA countdown - July 2024 Gauge

Thirty-nine of the African Union’s 55 member states have now signed and/or ratified the African Medicines Agency Treaty, as of 6 July 2024, with Kenya, the Democratic Republic of Congo and Cape Verde amongst the latest to swing behind the treaty.

As the countdown for other nations to sign continues, Health Policy Watch is tracking progress on our AMA Countdown, website developed in collaboration with the African Medicines Agency Treaty Alliance.  Here you can find the latest data on who has signed the treaty, ratified the treaty – and who is yet to sign – as well as links to sources and resources related to the African Medicines Agency Treaty process:

Multimedia available for download:

Find up-to-date infographics describing what countries have signed, signed and ratified, and signed, ratified and deposited the AMA treaty – in .png and interactive formats available for embed or download.

AMA countdown - July 2024 map

African Union FAQs on the AMA Treaty

Click to access 41269-doc-AMA_FAQs_rev.pdf

Official African Union infographic repository

Multilingual links to the AMA Treaty: 

The AMA Treaty in English:

The AMA Treaty in French:

The AMA Treaty in Arabic:

The AMA Treaty in Portuguese:

African Medicines Agency Treaty Alliance:

AMATA joint statement, 5 November 2021, at the time that the AMA Treaty came into force.

Pharmacy at Zouan health centre, Cote d’Ivoire; creation of an African Medicines Agency is intended to streamline regulatory approvals, improving quality and availability of medicines.

 

Signatories to the new African Medicines Agency Treaty have now reached 28 countries – more than half of the African Union’s 55 member states – with the balance tipping as Uganda signed the treaty instrument last week.  

On Friday, 5 November, after more than a decade of preparations, the African Medicine Agency (AMA) treaty also came into force officially – clearing the way for the AMA to begin operations as a formal entity. 

And support for the treaty seemed to be picking up momentum with Cote d’Ivoire also signing the treaty on 29 October just ahead of Uganda’s signature on 3 November. 

See all the data here on our special website: African Medicines Agency Countdown, where we will be tracking all the latest developments in stories and interactive infographics.

Despite the building support for the AMA, it will take more time, money and most of all – signatories from more of Africa’s powerhouse nations – to ensure that the new AMA entity can fulfill its mandate to ensure more rapid access to safer, newer and higher quality medicines across the continent.

South Africa, Nigeria, Kenya and Ethiopia are among the 27 AU member states that have yet to even sign, yet alone ratify, the treaty document, which was first approved by the African Union in 2019.

But with the AMA treaty coming into full force, exactly one month after the first 15 countries ratified and deposited the treaty instrument, no one is losing time.  An AU meeting, set for February 2022, will select a country to host the new AMA headquarter and operations. 

Following that, formal structures will have to be set up and money raised to support its many crucial tasks.

While a long road remains, AMA special envoy, Michel Sidibé said that the treaty’s entry into force is a ‘historic moment’.

COVID pandemic has sharpened the need for a continent-wide medicines agency 

The African Medicines Agency Treaty Alliance (AMATA), a coalition of patient civil society groups, academic institutions and industry, congratulated the first 15 African countries to ratify and deposit the treaty. 

AMATA called upon all other AU member states to quickly follow suit. Some 28 countries have so far signed the treaty, the majority in western Africa.  Among those signatories, 10 have yet to ratify the treaty and three have still to deposit their ratifications with the African Union.

The COVID-19 pandemic has sharpened the need for a continental agency that is able to fast-track approval for crucial vaccines and other medical products, AMATA said in its satement Friday: “COVID-19 has demonstrated that health security will only be achieved through concerted efforts and cross-border collaboration. 

“We call on all AU Heads of State to seize this historic opportunity to have one regulatory affairs oversight across the continent to enhance national, regional and continental regulation of medical products and oversee rapid and effective market authorization of safe, quality, effective and accessible medical products, for the good of all African people.” 

AMATA also  called on the AMA Governing Board to rapidly move to put into place: 

  • A solid governance structure;
  • Robust regulatory infrastructures;
  • Adequate financial and human resources.

AMATA also asked that the AMA governing board  “recognise patients as key partners in the management structures and development of the agency”.

Need for more AMA treaty signatories and quick operationalization

Dr Maïmouna Diop Ly , AMATA board member

AMATA executive board member Dr Maïmouna Diop Ly told Health Policy Watch that three critical tasks lay ahead in order for the agency to be successful.

“There is a need to ensure that a critical number of countries sign the treaty to enable a quick operationalization of AMA,” said Diop Ly.

“The statutory organs – the conference of state parties, governing board, secretariat and technical committees – should be put in place to ensure its functionality,” she added. 

“Finally, the allocation of adequate resources from countries’ contribution and partners is needed and should be part of the discussion of 2022 national budgets,” concluded Diop Ly, who is a health specialist with the African Development Bank and an advisor to the Senegal-based public health NGO, Speak-Up Africa.

Potential lies to reduce market barriers to new medicines and fight fakes  

Andy Gray, senior lecturer in pharmacology at the University of KwaZulu-Natal in South Africa, said that AMA’s greatest potential lies “in the field of harmonisation of regulatory systems, which should reduce the barriers to market entry in Africa”. 

“The AMA is not intended to be a supranational regulator, and will not make decisions in the way the EMA does, but it could help in bringing national medicines regulatory authorities together, simplifying systems and reducing redundancy,” explained Gray.

Over a quarter of the continent’s medicines are substandard or falsified, while only 2% are produced in Africa, according to AUDA.

Through the harmonized regulatory framework, norms and standards, AMA will enable better access and equity to safe, quality medicine, medical products to African patients.

This will also bring access to new and innovative technology for vaccines, medicine, medical devices, etc that will serve patients. 

The huge challenge of expanding universal health coverage – including health  insurance –  can also be advanced more systematically, with the support of new AMA structures – which should ease affordable access to medications, experts say. 

Proposed nearly a decade ago  

A continental medicine agency was first proposed a decade ago, and African Union member states adopted the AMA treaty almost three years ago. But the treaty could only be enforced once 15 AU member states had formally notified the AU Commission that they had ratified the treaty. 

This happened 30 days ago, when Cameroon became the 15th country to do so, thus setting in motion the formal establishment of the agency.

The main aims of the AMA, as listed by the AU Development Agency (AUDA), are to:

  • Support the growth of local pharmaceutical production
  • Evaluate medical products to treat priority diseases identified by the AU
  • Regularly inspect, coordinate and share information about products that are authorised for marketing.
  • Coordinate reviews of clinical trial applications for vaccines and assess product dossiers such as bio-similars. AMA will also coordinate joint inspections of Active Pharmaceutical Ingredients (API) manufacturing sites.
  • Collaborate with Regional Economic Communities (RECs) and National Medicines Regulatory Authorities  (NMRAs) to identify substandard and fake medical products
  • Develop common standards and regulations, which will ensure that the continent’s legislation is harmonised.

Responding to the medical crisis caused by COVID-19, the International Alliance of Patients’ Organizations (IAPO) helped to set up a lobby group, the African Medicines Agency Treaty Alliance (AMATA), to push for the speedier establishment of the agency.

AMA ‘critically important’ says United States   

Meanwhile, Jessie Lapenn, the US Ambassador to the African Union, described the AMA as critical important to improving health security in Africa. 

“The  AMA will be another critically important African institution that is part of the broader architecture that will be crucial for strengthening the continent’s health security,” Lapenn said at Thursday’s Africa Centres for Disease Control media briefing.

“The US government and US private sector are very much looking forward to collaboration with AMA,” Lapenn added.

Along with Cameroon, other countries to have both ratified the AMA and “deposited the instrument of ratification” at the AU (a letter from the head of state informing it of ratification) are predominantly west and north African, and/ Francophone nations, including: Algeria, Benin, Burkina Faso, Gabon, Guinea, Mali, Mauritius, Niger, Seychelles, and Sierra Leone.

That may be due, in part, to the fact that the AU’s Special Envoy on the AMA is Michel Sidibé, Mali’s ex-Minister of Health. 

Now it will be up to southern, eastern and northern Africa to catch up – although Rwanda, Namibia and Zimbabwe have also been among the first to have ratified and deposited the treaty instrument.  They were followed by Uganda, which signed the treaty on November 3. 

https://twitter.com/sabrinah_nati/status/1456617479430709249

Pharma groups welcome AMA’s creation  

Pharmaceutical companies have long complained about how complicated it is to get medicines approved in Africa and how long it takes – particularly in comparison to Europe, which processes applications via a  central European Medicines Agency (EMA).

A significant number of African countries’ national medicine regulatory authorities are under-resourced and lacking in expertise.

Greg Perry, Assistant Director-General of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), welcomed the landmark moment where the treaty has now come into force, describing it as “one step closer to achieving a continent-wide regulatory agency”.

“We look forward to the full implementation of the AMA, which will be a game-changer for all Africans to access safe, effective and quality medical products in a timely manner,” said Perry.

-Updated on 8 November, 2021

Image Credits: James Oatway/IMF – Healthcare Focus , ©EC/ECHO/Anouk Delafortrie, LinkedIn.

Pfizer’s experimental pill works by inhibiting replication of SARS-CoV2 virus.

Pfizer Friday announced that its experimental COVID-19 oral antiviral drug PAXLOVID™ reduced risks of hospitalization and death by 89% among patients who received the drug within the first three days of their illness. The company said it had stopped its Phase 2/3 trial on the drug owing to the success rate seen in an interim analysis of 1,219 adults enrolled in the study – who also had chronic health conditions placing them at higher risk of severe COVID.  

Pfizer is the second pharma firm, after Merck Sharp & Dohme (Merck), to announce highly promising results for an oral drug treatment that reduces serious COVID-19 illness – although the Pfizer results were even more stunning.

PAXLOVID™ has the potential to eliminate up to nine out of ten hospitalizations, Albert Bourla, Chairman and Chief Executive Officer, Pfizer, said in a press release. 

It’s a gamechanger,” Pfizer CEO Albert Bourla told @megtirrell about its Covid-19 antiviral drug. “This is a fantastic demonstration of the power of science.”

If approved for emergency use by the United States Food and Drug Administration (US FDA), PAXLOVID™ would become the first oral COVID antiviral of its kind. The novel treatment includes a newly- designed SARS-CoV-2-3CL protease inhibitor used in combination with a common anti-HIV drug, ritonavir.

Bourla told CNBC that the filing for the drug is expected to be submitted before the U.S. Thanksgiving holiday on Nov. 25.

Pfizer’s results more impressive than Merck’s

The Pfizer announcement follows Merck’s announcement last month that it’s new oral pill, molnupiravir,  had reduced the risks of hospitalization and death by some 50% among people with mild or moderate COVID.

The Merck pill, which was approved by UK regulators last week, introduces errors into the genetic code of the SARS-CoV2 virus that it targets, slowing virus replication.

Pfizer’s reported  results were even more impressive, however.  Based on a primary analysis of interim data from 1,219 at-risk adults who were enrolled by September 29, 2021, only three people administered the drug within three days of sympton onset were hospitalized through day 28 of their illness, with no deaths. In the control group, 27 people were hospitalized, with seven subsequent deaths.

When the company decided to stop recruiting more patients, their enrollment had reached 70 percent of the planned 3,000 patients across North and South America, Europe, Africa, and Asia.

Pfizer drug is based upon a novel protease inhibitor, PF-07321332, that blocks the activity of the enzyme that the coronavirus needs to replicate. Co-administration of ritonavir means that protease inhibitor remains active in the body for longer periods of time to combat the virus. Treatment involves the administration of three PAXLOVID™ pills, twice a day, for five days. 

Pfizer says it will also ensure equitable access to new drug formulation

While Merck’s molnupiravir pill is set to be licensed for generic production in most low- and middle-income countries, Pfizer said that it will offer PAXLOVID™ worldwide, through a tiered pricing approach – while maintaining control of its IP. 

Last week, Merck and the Medicines Patent Pool signed an agreement that paves the way for MPP to sign contracts with generic drug manufacturers to produce and sell their treatment molnupiravir at discounted prices to more than 105 countries worldwide, once the drug receives approval by the World Health Organization.

Pfizer, in contrast, said that its tiered pricing would be “based on the income level of each country to promote equity of access across the globe.

“High and upper-middle income countries will pay more than lower income countries,” Pfizer said, adding that it had already entered into advance purchase agreements with “multiple countries and is in negotiations with several others” – without naming which.

“Pfizer has also begun and will continue to invest up to approximately $1 billion to support the manufacturing and distribution of this investigational treatment, including exploring potential contract manufacturing options to help ensure access across low- and middle-income countries, pending regulatory authorization.”

Image Credits: Wikimedia Commons, peterschreiber.media/Shutterstock .

Dr Tedros

Europe is now the epicentre of the COVID-19 pandemic and what it is experiencing now provides lessons for the rest of the world, according to World Health Organization (WHO) officials addressing a media briefing on Thursday.

In addition, the lack of a systematic, multilateral approach to address this pandemic has only underscored the need for a global agreement on how to address future pandemics, asserted WHO Secretary-General Dr Tedros Adhanom Ghebreyesus. 

Cases in Europe have increased by over 55% increase over the last four weeks despite an ample supply of vaccines and tools. Germany reported 33,949 new COVID-19 infections on Wednesday, its highest daily increase since the start of the pandemic last year.

“We only have to look at the roller-coaster epidemiologic curve [over the past two years] to know that when you’re coming down the mountain you usually about to go back up another one,” said Dr Mike Ryan, WHO Executive Director of Health Emergencies.

“The fact that Europe is climbing that mountain again should really make everyone in the rest of the world stand up. It’s a warning shot for the world to see what’s happening in Europe despite the availability of vaccines.”

Governments put the onus back on individuals

Ryan said that Europe’s cases had been fuelled by increased summer social mixing, more indoor activities as the weather cooled, a reduction in restrictions and – crucially – “the onus has been put back on individuals to continue into individual risk management with little support from the governments”.

“In European countries that have high vaccination levels in vulnerable groups, transmission has been transferred into younger age groups so you have intense transmission without a necessarily huge increase in hospitalisations and deaths,” said Ryan. 

But countries with relatively low vaccine uptake are “facing a very difficult situation” particularly if vaccine uptake has not been high in vulnerable groups, he added.

“Is there a possibility where we can reach a state where we have gained control over transmission in 2022? Absolutely. Is there the possibility that we can remove the death, the severe hospitalizations and death in 2022? Absolutely. We could have done that already. But we haven’t,” added Dr Maria Van Kerkhove, WHO lead on COVID-19.

Future lies in a binding pandemic treaty

“We have no shortage of reports, reviews and recommendations, but we have a shortage of action,” added Tedros. 

“It’s clear what needs to happen: better governance for global health security, including a binding treaty on pandemic preparedness and response,” he said.

“Better financing to strengthen the capacities of all countries, especially the most vulnerable; better systems and tools to prepare for, prevent, detect and respond rapidly to outbreaks with epidemic or pandemic potential and strengthened, empowered and sustainably finance WHO at the centre of the global health architecture.”

Ryan added: “The way we’re dealing with our transnational health issues at the moment is we’re trying to deal with a global threat using individualised solutions.

“We need agreement at a global level on what is to be done to protect the health of the world’s population.”

 

Elhadj As Sy

Elhadji As Sy, the co-chair of the Global Preparedness Monitoring Board (GPMB), also made a strong appeal for an agreement on future pandemics.

The board, an initiative of the WHO and the World Bank, has made five recommendations for global leaders to address COVID-19 as well as future pandemics.

“First, agree at the November 2021 special session of the World Health Assembly (WHA) on the need to adopt an international agreement on pandemic preparedness and response and establish a process for taking forward negotiations,” said As Sy. 

A special session of the WHA is being convened on 31 November – 1 December to consider an international agreement to address future pandemics.

Additional proposals from the GPMB were for a global summit of heads of state and other stakeholders on pandemic preparedness and response; substantially increase the funds to WHO, and “establish a new financial intermediary fund for pandemic preparedness and response”.

As Sy also expressed disappointment at last weekend’s meeting of G20 leaders.

“Honestly, we had hoped for firm financial commitments to fully fund global efforts to curb the pandemic,” he said.

“We had hoped for an agreement to establish a financing mechanism that would provide predictable financing at the scale required to prevent further future pandemics. But what we got was a commitment to keep talking about it.” 

 

 

Prof Marion Koopmans (2nd right) chairs the Chinese and WHO-International team presentation of its findings on the SARS-CoV2 virus origins in Wuhan.

A US organisation that promotes transparency in health policy decisions, Right to Know, has asked the World Health Organization (WHO) to remove 10 of the 26 candidates it had recently named to a new Scientific Advisory Group for the Origins of Novel Pathogens (SAGO) – due to alleged conflicts of interest – and replace them with a list of other candidates that it has proposed.

Coinciding with the letter’s publication, the WHO briefly re-opened nominations for SAGO for three days this week – without any initial elaboration – although a WHO spokesman later said that the Agency was looking for more “diversity” among the SAGO nominees.

In response to a query from Health Policy Watch, WHO spokesperson Tarik Jasarevic said that the agency is  “seeking greater diversity across the technical areas represented in SAGO”. He added that WHO was specifically encouraging additional applications from the fields of social science, anthropology, ethics, political science and biosafety or biosecurity – signalling that the reopening of applications may indeed be related to the criticism by Right to Know and others about the continuing lack of expertise in laboratory biosafety among members of the SAGO group.

In regard to the USRTK criticisms of specific candidates, Jasarevic told Health Policy Watch that WHO was “still reviewing comments received during the two-week period” – following the naming of the group on 13 October.  

The new WHO SAGO expert group is tasked with following upon on the controversial issue of the origins of SARS-CoV2 – to try to determine if the virus leapt to humans as a result of a direct infection by a bat, infection from another intermediate animal host, or as a result of a laboratory accident at the Wuhan Institute of Virology, which was researching bat-borne coronaviruses.  Most recent scientific studies suggest that the SARS-CoV2 is likely to have originated in bats – the question is how the virus was then transmitted to humans.

The open letter to WHO by the US-based Right to Know, (USRTK), a non-profit investigative research group, claims that the 10 SAGO appointees have conflicts of interest that are in violation of the WHO terms of reference for the group.

Objections stem from candidates’ remarks discrediting lab leak theory, and associations with EcoHealth Alliance

Right to Know’s objections to the 10 candidates stem largely from disparaging remarks that were reportedly made by some of the experts had made about the theory that the SARS-CoV2 virus may have escaped from a laboratory; Those views, says Right to Know, would prejudice the work of the SAGO group. 

The Right to Know letter also called out  direct or indirect associations between certain SAGO appointees and the EcoHealth Alliance – which maintained a series of contracts and scientific collaborations with the Wuhan Virology Institute that critics have said led it to protect WIV from allegations of a possible lab leak.

EcoHealth is headed by Peter Daszak, a vocal member of the first, now-disbanded WHO independent scientific group set up last year to look into the origins of SARS-COV2. 

Daszak was not appointed to SAGO amid controversy over the contractual and research ties between his organisation and the Wuhan Institute of Virology on the study of coronaviruses in bats and humans. 

However at least one of the new SAGO candidates, Dr Supaporn Wacharapluesadee is a  subcontractor on a large NIH grant to EcoHealth Alliance, claimed Right to Know, in their letter, stating, “her lab at Chulalongkorn University [Thailand] is slated to receive a $1.07 million subcontract.”  Another appointee, Dr Christian Drosen, had collaborated with EcoHealth and the Wuhan Institute of Virology, stating that r. Drosten’s funding and continued research collaborations rest on the zoonotic potential of bat coronaviruses. For these reasons, Dr. Drosten has a personal stake in SAGO’s outcome, because it is to his personal and professional advantage to declare a zoonotic origin for SARS-CoV-2.

This, too, disqualifies him from being a SAGO member,” stated the letter, adding, “Anyone with personal, financial or academic ties to the EcoHealth Alliance (including grant funding, co-authorship or other research collaboration) or the Wuhan Institute of Virology, cannot be a SAGO member, because such ties could impair their judgment in an investigation of zoonotic and/or lab origins of SARS-CoV-2,” according to Right to Know. “Any such ties constitute an impermissible conflict of interest.”

The group also charged that other SAGO candidates, including Dr Christian Drosten, Katherin Summermatter and Marion Koopmans have made public remarks at conferences or in letters to scientific journals openly disparaging the lab escape theory – including one comparison with “meteorites and “snake origins” by Koopmans,  demonstrating their lack of objectivity.

Right to Know also wants a further six candidates removed simply because they served in the first WHO-convened global study of the origins of SARS-CoV-2. These are Vladimir Dedkov,  Elmoubasher Farag, Thea Fischer, Hung Nguyen-Viet, John Watson and Yungui Yang.

Letter proposes adding more biosafety experts & WHO critics to SAGO team

Right to Know  also proposed replacing the ten people that it says have conflicts of interest with more biosafety experts, and scientists who have criticized the WHO SARS-CoV2 origins investigation for its lack of attention to the lab escape narrative.  Among those names are Richard Ebright, a professor of chemical biology at Rutgers University, and one of the leading critics of the WHO process so far.

Ebright described as a “charade” the first WHO-led investigation into the origins of the virus, which concluded a lab escape was highly unlikely. In an interview in May with Health Policy Watch, he repeatedly stated that the lab escape theory needs to be pursued with equal vigour, alongside the theory that the virus emerged naturally.

“At this point in time, all scientific data related to the genome sequence of SARS-CoV-2 and the epidemiology of COVID-19 are equally consistent with a natural-accident origin or a laboratory-accident origin,” Ebright told Health Policy Watch – adding that the proximity of the Wuhan virology institute to the epicenter of the first coronavirus outbreak adds to concerns about a biosafety incident.

 

Global Group of Scientists Calls For Fresh Investigation Into Origins of SARS-CoV2 Virus

Fears that political bias will taint further investigations

Some scientists fear, however, that the lab escape theory has also gained additional traction as a result of political tensions between the United States and China – making it more difficult to untangle reality from a rife of conspiracy theories that began circulating during the administration of former US President Donald Trump. 

A recent report in August by US Congressional Republicans, for instance, also continued to push the lab leak theory.

At the same time,  recent genetic mapping studies found that other SARS-CoV2 virus variants were circulating elsewhere in China in late 2019, and those bore a greater similarity to the closest related bat coronaviruses than the virus sequences first identified and mapped in Wuhan.  That suggests that the source of infections could have been outside the city and through some kind of natural spread through the animal chain – rather than an escape from a Wuhan lab.

And at the same time, the fact that Wuhan’s food markets also were the focus point of many, if not all, of the first infections, still suggests some kind of food borne link to the outbreak – other researchers have pointed out.

Along with pursuing the research on the origins of SARS-CoV2, SAGO will also advise the WHO Secretariat on other technical and scientific considerations regarding emerging and re-emerging pathogens, and will be composed of experts acting in a personal capacity. 

The first SAGO meeting is supposed to take place later this month.

Image Credits: CGTN, @PeterDaszak.

 

 

The World Health Organization (WHO) has issued an emergency use listing (EUL) for India’s Covaxin, making it the eighth COVID-19 vaccine to be approved by the global body. 

“The emergency use listing expands the availability of vaccines, the most effective medical tools we have to end the pandemic,” said Dr Mariangela Simao, WHO Assistant-Director for Access to Medicines and Health Products on Wednesday.

“But we must keep up the pressure to meet the needs of all populations, giving priority to at-risk groups who are still waiting for their first dose, before we can start declaring victory,” she added.

Covaxin has been developed by the Indian pharmaceutical company, Bharat Biotech, and is formulated from an inactivated SARS-CoV-2 antigen.

It was found to be 78% effective against COVID-19 of any severity, 14 or more days after the second dose. 

The vaccine was assessed by the WHO’s Technical Advisory Group (TAG), which determined that the vaccine meets WHO standards for protection against COVID-19, and its benefits far outweigh the risks.

The WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), also reviewed the vaccine, and recommended it be used in two doses, with a dose interval of four weeks for people 18 and above.  However, data on vaccination of pregnant women remains insufficient, and studies in pregnant women are being planned in the future. 

Listing enables supply to COVAX 

Following EUL approval, the pharma company said in a tweet, “Bharat Biotech is motivated to mitigate the worldwide pandemic.” 

Days prior, the company celebrated its approval for use in Australia and for travel to Oman without quarantine, with Prime Minister of India Narendra Modi commenting on the “post-COVID partnership of India and Australia.”  

The Indian government has already approved the use of the vaccine for children from the age of two in October. 

Covaxin was approved by India back in January while its third phase clinical trials were still underway. Data in March showed the indigenous COVID vaccine showed an efficacy trend of 81% during an interim analysis of Phase 3 trials. 

Covaxin is already being used in 21 Indian states, according to Suchitra Ella, co-founder of Bharat. More than 105 million Covaxin doses have been administered so far in the country.  

The vaccine is suitable for low- and middle-income countries as it can be stored in a normal fridge at 2 to 8 degrees C. India’s regulatory body for pharmaceuticals and medical devices,  the Central Drugs Standard Control Organization recently been approved an extension of its shelf life for up to 12 months from the date of manufacture. 

WHO EUL also means that Covaxin can be distributed by COVAX. In addition, it means that Indians who have been vaccinated with Covaxin are likely to be able to travel internationally as most countries have agreed to recognise WHO-approved vaccines.

Indonesia has granted emergency use authorization (EUA) for the COVID-19 vaccine developed by Novavax, which will be made by the Serum Institute of India (SII) and sold under the brand name Covovax.

“This marks the first regulatory authorization worldwide of a protein-based COVID-19 vaccine based on Phase 3 clinical data demonstrating efficacy and a favourable safety profile,” said Novovax CEO Stanley Erck, adding that it was the first of many authorizations that the company expects in the coming weeks and months.

Novavax and SII have also filed for authorization of the vaccine vaccine in India and the Philippines. It has also applied for Emergency Use Listing (EUL) with the World Health Organization (WHO) and will supply the global body with additional supplemental filing “shortly”, it added.

Novavax recently also completed rolling submissions for authorization with regulatory agencies in the UK, European Union, Canada and Australia. Novavax expects to submit a full application to the US Food and Drug Administration by the end of the year.

“The first authorization of Novavax’ COVID-19 vaccine exemplifies our commitment to equitable global access and will fill a vital need for Indonesia, which despite being the fourth most populous nation on earth, continues to work to procure sufficient vaccine for its population,” said Erck.

The vaccine is stored at 2° to 8° Celsius (normal refrigeration).

“Access to a supply of a safe and highly effective vaccine, coupled with the ease of its distribution, should be a critical enabler to help Indonesia control the current coronavirus outbreak,” said SII CEO Adar Poonawalla. “We continue to work with urgency to ensure the first protein-based COVID-19 vaccine option in Indonesia is available for all awaiting its arrival.”

In two Phase 3 trials, the PREVENT-19 trial in the US and Mexico, demonstrated 100% protection against moderate and severe disease and 90.4% efficacy overall, according to the company – although it has not been tested on the Delta variant.

It is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2 using “recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein”, and paired with Novavax’ patented “saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies”, said the company. 

The US government gave Novovax a contract worth $1.6 billion to develop its vaccine and to provide 100 million doses to the government.

Novavax also has committed to supply 1.1 billion doses of its vaccine to COVAX. However, it has been hampered by manufacturing problems.