Child COVID vaccinations – now the FDA has invited Pfizer to submit for approval of vaccines for under-5s.

What does the FDA know that we don’t? Hopefully a lot.

Without offering much detail, the FDA yesterday afternoon asked Pfizer to send over a rolling submission to amend its Covid-19 vaccine Emergency Use Authorization to include children 6 months to under 5 years of age.

The tricky part in making such a request is that last month, Pfizer announced that its vaccine (a 3 µg dose for the youngest population) had performed better in the 6- to 24-month-old population, than in children ages 2-4 – that is as compared to the results of the vaccine among 16- to 25-year-olds, in which high efficacy was demonstrated.

But the company wants to test a third jab for all of the under-5s to see if it will even out the results somehow for older tots. And it doesn’t seem to be changing its tune, even with this latest FDA request.

“Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants. If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose,” Pfizer CEO Albert Bourla said in a statement.

No safety concerns were identified in that prior analysis of the 3 µg dose data among children 6 months to under 5 years of age, Pfizer said.

While the FDA often requests that companies provide additional safety or efficacy data (usually before a new drug or vaccine is approved or authorized), the agency rarely requests a specific submission, but acting FDA commissioner Janet Woodcock said this is a priority right now for the agency.

But others are not so sure:

“I don’t think authorizing two doses in children ages 2 to 4 years of age where effectiveness in this age group hasn’t been confirmed is going to convince the majority of parents to vaccinate their children,” Norman Baylor, president and CEO of Biologics Consulting and a former head of the FDA’s vaccine office, told STAT News. “If the vaccine in this age cohort is a three-dose vaccine, FDA should review the data from the three-dose series before authorizing the vaccine.”

See ENDPOINTS News: FDA takes a rare step and asks Pfizer to submit a COVID-19 vaccine EUA for the youngest children.

Image Credits: Quinn Dombrowski.

Moderna and the nonprofit science research organization IAVI have administered the first doses in a Phase I clinical trial of an experimental HIV vaccine, delivered by messenger RNA (mRNA) – the technology that revolutionized vaccines against COVID-19.

The trial kicked off last week at George Washington University School of Medicine and Health Sciences in Washington, D.C. It is partially funded by the Bill & Melinda Gates Foundation.

The Phase I trial, IAVI G002, is testing the hypothesis that sequential administration of priming and boosting HIV immunogens delivered by messenger RNA (mRNA) can induce specific classes of B-cell responses and guide their maturation to generate broadly neutralizing antibodies (bnAb) that would protect against disease, a joint statement by Moderna and IAVI explained.

The immunogens being tested were developed by scientific teams at IAVI and the Scripps Research Institute, and will be delivered via Moderna’s mRNA technology.

“The search for an HIV vaccine has been long and challenging, and having new tools in terms of immunogens and platforms could be the key to making rapid progress toward an urgently needed, effective HIV vaccine,” said Mark Feinberg, CEO of IAVI – whose board includes prominent names from industry, research, The Global Fund, and the Africa Centers for Disease Control.

More than 36 million people have died of AIDS-related illnesses

As of June 2021, 28.2 million people were using antiretroviral therapy for the treatment of HIV, according to UNAIDS, and 37.7 million people were living with the disease in 2020.

Some 680,000 people died of AIDS-related illnesses in 2020. A total of 36.3 million people have died of AIDS since the virus exploded into a pandemic in the late 1980s.

Photo: UNAIDS/Sydelle Willow Smith

The mRNA vaccine strategy centers on stimulating the immune system to produce bnAbs against HIV, a process known as “germline-targeting.” Antibodies are produced by B cells, which start out in a “germline” state.

BnAbs are believed to be capable of neutralizing different HIV strains by binding to hard-to-reach but consistent regions of the virus surface. If it works, the germline targeting strategy could offer protection against millions of different HIV strains circulating in various parts of the world.

Last year, Dr William Schief, a professor at Scripps Research Institute and executive director of vaccine design at IAVI’s Neutralizing Antibody Center – who developed the HIV vaccine antigens  being evaluated in mRNA formats in this study – announced results from the IAVI G001 clinical trial, showing that an adjuvanted protein-based version of the priming immunogen induced the desired B-cell response in 97% of recipients.

Until now, no HIV vaccine candidate has been able to induce a protective bnAb response in humans.

The release said that “given the speed with which mRNA vaccines can be produced,” using the platform could shave off years from typical vaccine development timelines – like it did for the development of an emergency coronavirus vaccine.

“We believe advancing this HIV vaccine program in partnership with IAVI and Scripps Research is an important step in our mission to deliver on the potential for mRNA to improve human health,” said Moderna’s president Dr Stephen Hoge.

Image Credits: Moderna, UNAIDS/Sydelle Willow Smith.

Denmark’s capital, Copenhagen, is expected to return to pre-pandemic life as the country scraps most COVID-19 restrictions.

The world is “sick and tired” of COVID-19, World Health Organization (WHO) Director General Dr Tedros Adhanom Ghebreyesus acknowledged but warned that Omicron posed a substantial threat to global health, having caused 90 million infections in the past 10 weeks – more than all the cases recorded in 2021.

Tedros’s appeal came as Denmark lifted most COVID-19 restrictions including wearing masks this week despite registering over 40,000 new cases daily, with Norway and Sweden poised to follow suit. 

The UK eased many restrictions last month but kept masking, while South Africa’s Cabinet announced on Monday that people with asymptomatic COVID-19 no longer had to isolate and reduced quarantine days from 10 to seven.

Denmark’s rationale is that over 80% of its population is vaccinated, and that Omicron is substantially less infectious than previous variants.

But deaths in four of the WHO’s six regions have increased in the past week and Tedros urged countries to “protect their people using every tool in the toolkit” at a media briefing on Tuesday.

‘Premature to declare victory or surrender’

“It is premature for any country either to surrender or to declare victory. This virus is dangerous and it continues to evolve,” warned Tedros, adding that  the WHO is currently tracking for sub-variants of Omicron.

Dr Maria van Kerkhove, the WHO’s lead on COVID-19, cautioned that “now is not the time to lift everything all at once”.

“We have always urged caution in applying interventions as well as lifting those interventions in a steady and slow way,” said Van Kerkhove, although she acknowledged that countries are in very different situations around the world, and there was no “one solution”. 

Responding to South Africa’s changes to its isolation policies, Van Kerkhove said while the WHO recommended isolation is to prevent onward transmission some countries had so many cases they had to shorten isolation period and quarantine period “because they need to keep operating”.

“Most people still transmit the [Omicron] virus right around the time they develop symptoms from about two days before symptom onset up through the first five to nine days if you’re mild. It can be longer if you have severe disease,” added Van Kerkhove.

Dr Maria Van Kerkhove

Celebrate a new phase of disease control

Dr Michael Ryan, WHO Executive Director of Health Emergencies, said that the Scandinavian countries had a very high vaccination rates and strong health systems.

Every country in the world was trying to calculate “how do we have maximum protection of our population while minimising the impact on our society and our economy”, added Ryan.

He urged them not to “follow blindly” the decisions of other countries but to make decisions “based on your current epidemiology, your demographics, the population of risk, your vaccination levels, your population immunity, your access to tools, the strength of your health service”.

He also said that countries also needed to allow individual choice: “There are many, many people in my own personal view, who will be well advised to continue wearing masks in crowded situations and public transport even if it’s not mandated by government”.

In addition, “communities need to understand that measures may have to be reintroduced in order to moderate transmission if there is an unexpected rise in transmission or a new variant emerges”

Ryan urged “flexibility, agility, the ability to adjust, making good decisions based on your situation, and being ready to change that if needed”.

“We should be in some ways, celebrating when countries get to another stage of disease control, but at the same time being cautious and know that not all paths are straight,” he added.

Omicron sub-variants

Dr Tedros said that the WHO was researching four sub-variants of Omicron, including BA.2 which is more infectious that the original variant (BA.1).

Van Kerkhove said that there was some evidence that the prevalence of BA.2 was increasing in countries including Denmark and in India but that “there’s not a lot of information that we have on this particular sub-variant yet”.

“There is a suggestion from some of the initial data on BA.2 that there’s a slight increase in growth rate above BA.1. But what beyond that the data is really quite limited.”

New SARS-CoV2 origins group report weeks away

Van Kerkhove confirmed that the new Scientific Advisory Group for the Origins of Novel Pathogens (SAGO) had already had six meetings since it was constituted in late November.

Made up of 27 people, the WHO Secretariat expected guidance from SAGO “in the next few weeks” on the way forward in trying to ascertain the origins of SARS-CO-V2.

They were working on three issues: developing a framework for the study of any emerging pathogen; looking at the origins of this particular pandemic, building upon previous missions that have gone to China, and thirdly, looking at all of the literature and evidence that exists to look at studies that have been conducted since the original team had returned form China last March. 

“This group is currently working on their first set of recommendations to WHO on what is needed next, focusing on the urgent needs in terms of the studies that are necessary,” said Van Kerkhove.

 

Image Credits: Febiyan/ Unsplash.

Gaudenz Silberschmidt, WHO Director of Health and Multilateral Partnerships.

The World Health Organization (WHO) is considering changing how it relates to non-state actors (NSAs), but some of these organisations are concerned that the changes envisaged by the global body may weaken their voices.

In 2016, the WHO’s World Health Assembly (WHA) adopted a Framework for Engagement with NSAs – known as FENSA –  to enable closer collaboration with a wide range of organisations to respond to national and global health challenges. An initial evaluation of its implementation was conducted in 2019, and a two-year timeframe was set to fully operationalise the framework.

Over the past weekend, the WHO Executive Board considered a report on progress to implement FENSA , as well as inputs from various NSAs on how their relationships with the global body could be improved.

According to the report, the WHO said it seeks to improve NSAs’ role, voice and contribution in its governance system including by introducing a global constituency for NSAs and grouping NSA statements accordingly. While welcoming the WHO’s intentions, a number of NSAs noted that the proposal could weaken and soften the NSAs’ contributions to WHO’s agenda. 

International humanitarian medical non-governmental organization Médecins Sans Frontières (MSF) expressed concern with the proposal, saying that it fails to acknowledge the value of diversity and expertise inherent in NSA. 

MSF’s Dr Maria Guevara

“The creation of a global constituency and the grouping of NSA statements risk diluting these voices and limiting their meaningful participation in the dialogue and in finding solutions to current health challenges,” MSF’s Dr Maria Guevara argued. 

The International Council of Nurses said that while it supports informal meetings before WHO meeting, it called for more notice and added that the selection of the agenda items must be agreed on between NSAsand WHO member states. 

“After testing [introducing] constituency statements at the 75th WHA, we strongly encourage consultation with NSAs before making a final decision on their implementation,” said the ICN, adding that constituency statements should not prevent individual statements.

In its submission, the European Society for Medical Oncology (ESMO) also called for the WHO to allow non-state actors to still be able to make individual statements on issues that are in line with their core areas of expertise. To accommodate the contribution of more non-state actors, the society called for the WHO to publish each non-state actor’s statement on its website and for these to be included in meetings’ official minutes.

“Non-state actors can submit individual statements on the WHO website and in a way that they are translated and reported in the official minutes of WHO meetings, allowing non-state actors for each agenda item,” ESMO’s Gracemarie Bricalli recommended.

Meanwhile, the Save the Children Fund called on WHO Member States to also prioritize interactions with NSAs, especially the civil society, by actively participating in informal sessions and systematically sharing draft documents and resolutions for civil society organizations to engage in policy making.

It also slammed the WHO Secretariat over lack of time and support provided to NSAs regarding new processes, including constituency statements. It said the process lacked transparency and open dialogue among the different actors.

“We welcome all opportunities to engage with member states and the Secretariat to ensure the meaningful engagement of NSAs including when it comes to the development of a civil society engagement strategy.”

IPPF’s Estelle Wagner

The International Planned Parenthood Federation (IPPF) urged Member States to compel the Secretariat to constitute a diverse working group of member states and civil society organizations to review and develop proposals and report back at the 152nd executive board meeting next year on more robust recommendations to involve NSAs at the WHO beyond making general statements on agenda items.

“More than ever, the pandemic has shown the essential role of NSAs in the work of the WHO and we look forward to a constructive and transparent process to define mechanisms for truly meaningful engagement with WHO governing bodies beyond generalized statements at the end of agenda items,” the federation’s Estelle Wagner stated. 

Canada, USA and UK side with NSAs

Canada’s Elizabeth King

The government of Canada noted that the positions of NSAs on topical issues need to be taken more seriously, adding member states need to hear from NSAs before positions are finalized. It pledged its continuous support for meeting with NSAs prior to the WHA in May, adding that sufficient notice should be provided.

Canada also supported that NSAs should continue to have the option to deliver individual statements on all agenda items to ensure that member states benefit from the diversity of NSAs’ views. 

“This could be combined with a reasonable limit to the number of individual statements an NSA can deliver,” Canada stated.

Canada and the United Kingdom also agreed that the WHO Secretariat should work with NSAs to identify the agenda items where constituency statements would be more valuable, rather than identifying them independently.

“We’d like to reaffirm that hearing and understanding the voices of non state actors in all of our efforts to more meaningfully engage will increase our chances of success,” Canada’s Elizabeth King concluded. 

The US said the priority should be on ensuring WHO’s engagements and involvement of NSAs in its agenda are more meaningful and routine.

It noted that NSAs were critical to the development of vaccines, therapeutics and other medical medical countermeasures, as well as their distribution and delivery to individuals across the globe. By working together with NSAs, the United States said the WHO and the global health community can become more effective, efficient and avoid duplication or miscommunications that could undermine joint aims and efforts. 

A concluding remark from Gaudenz Silberschmidt, Director of Health and Multilateral Partnerships at the WHO said the global health body is committed to making the engagements and interactions between NSAs, member states and the WHO Secretariat to be more meaningful.

The challenge, according to him, is that the increased number of agenda items and interest have put pressure on the time for interventions for NSAs and delegates. He announced plans to organize a meeting with NSAs in February 2022 to consult both on the planning of the informal pre-meeting and on the constituency statements.

“We propose to include a session on those engagement modalities in the informal pre-meeting of the World Health Assembly,” he added.

Billions of masks and gloves have been discarded during the pandemic.

Almost four times the usual medical waste was generated in New Delhi during the height of India’s COVID-19 pandemic in May 2021 when all COVID-19 waste was mistakenly classified as infectious, according to a new report issued by the World Health Organization (WHO) on Tuesday. 

Most of the approximately 87,000 tonnes of personal protective equipment (PPE) procured between March 2020- November 2021 through a joint UN emergency initiative is expected to have ended up as waste.

Over 140 million test kits, with a potential to generate 2,600 tonnes of waste and 731,000 litres of chemical waste have also been shipped, according to data from the United Nations (UN) COVID-19 supply portal.

But the report authors warn that the portal’s data represents “a small fraction of global procurement”.

“It does not take into account any of the COVID-19 commodities procured outside of the [UN] initiative, nor waste generated by the public like disposable medical masks,” they point out.

One estimate suggests that up to 3.4 billion single use-masks were discarded every day in 2020.

Over the past two years, over 296-million people have been confirmed with COVID-19.

“Each of these cases, as well as hundreds of millions more people – because of exposure to COVID-19, travel, work or leisure obligations – will undergo COVID-19  testing.  

“Finally,  over nine billion doses of COVID-19 vaccines have been administered, covering 35% of the global population. Billions more are planned. These activities all produce an enormous amount of COVID-19-related waste, a proportion of which is potentially infectious,” the report notes.

About a third of all healthcare facilities (and 60% in the least developed countries) are not equipped to handle existing waste loads, let alone the additional COVID-19 load. Much of this will end up in landfills.

Mistaken classification of all COVID waste as hazardous

“Many facilities and countries mistakenly classified 100% of COVID-19 healthcare waste as hazardous, rather than the 10–15% level typically generated from routine health service provision,” according to the report.

“ A  number of major cities and countries that have experienced a large number of cases issued guidance that all waste generated by COVID-19 patients should be classified and treated as infectious. 

“This is despite the fact that SARS-CoV-2 is an enveloped virus, which means that it is inactivated relatively quickly by environmental factors such as sunlight or heat.  Most  evidence  indicates  that  the  main  route  of  transmission  of  the  virus  is  directly  from  person to person through exhaled respiratory particles, not fomites.”

It points to gloves as one of the most commonly overused or misused items of PPE. In many cases, gloves are not necessary and proper hand-washing would suffice – such as vaccinations,  measuring temperature and blood pressure – don’t need gloves.  

“Overuse of gloves was a longstanding problem even before COVID-19, resulting in unnecessary financial costs and adverse environmental impacts,” according to the report.

“It is absolutely vital to provide health workers with the right PPE, “said Dr Michael Ryan, Executive Director, WHO Health Emergencies Programme. “But it is also vital to ensure that it can be used safely without impacting on the surrounding environment.” 

Dr Maria Neira, Director of WHO Environment, Climate Change and Health

Reuse, recycle, don’t burn

The report lays out a set of recommendations for integrating better, safer, and more environmentally sustainable waste practices into the current COVID-19 response and future pandemic preparedness.

These include safe and reusable gloves, aprons and masks; using recyclable or biodegradable materials, and using non-burn waste treatment technologies, such as autoclaves (steam-cleaning machines).

“Significant change at all levels, from the global to the hospital floor, in how we manage the health care waste stream is a basic requirement of climate-smart health care systems, which many countries committed to at the recent UN Climate Change Conference,” said said Dr Maria Neira, WHO Director of Environment, Climate Change and Health. 

Meanwhile, Dr Anne Woolridge, Chair of the Health Care Waste Working Group at the  International Solid Waste Association (ISWA), says that the “safe and rational use of PPE will not only reduce environmental harm from waste, it will also save money, reduce potential supply shortages and further support infection prevention by changing behaviours”.

The tens of thousands of tonnes of extra medical waste from the response to the COVID-19 pandemic has put tremendous strain on health care waste management systems around the world, threatening human and environmental health and exposing a dire need to improve waste management practices, according to the report. 

 

Image Credits: Brian Yurasits/ Unsplash, Hermes Rivera/ Unsplash, Planetary Health Eastern Africa Hub.

Amoth and Tedros
WHO Executive Board Chair Dr Patrick Amoth and Director-General Dr Tedros at Friday’s EB150 session.

An innovative WHO “Health for Peace Initiative” that aims to build bridges in conflict zone and humanitarian settings through global health initiatives ran into some rough waters at last week’s Executive Board meeting – with the United States saying that it should include a human rights element – while Russia warned WHO against “politicizing” its agenda.  

The initiative, conceived in 2019-2020, was planned and developed together with the International Labour Organization, the UN Peacebuilding Support Office, and the Swiss-based organization Interpeace, with some initial projects now being implemented in areas like the Ukraine. 

The initiative builds on earlier WHO “Bridges for Peace” projects that took place during the 1980s and 1990s. But this new GHPI edition also aims to “work on conflict” by ensuring that such programmes help address conflict’s underlying causes – while avoiding unintentionally fuelling of tensions. 

Other aims of the initiative include developing “innovative ways to address conflict, strengthen resilience to violence and empower people to (re)build peaceful relations with each other”.

It aims to covers a wide range of areas – from infectious diseases to maternal and child health, nutrition, tobacco use and health systems strengthening. 

Synopsis of the health for peace initiative.

Russia – don’t stray into other areas

However, some leading member states gave the initiative a mixed reception in a discussion WHO Executive Board on Friday, the day before the 150th session closed. 

Russia warned WHO that it needs to to avoid “politicising” its agenda, asking for more discussion about the nuts and bolts of the initiative.

It also warned WHO against “straying” into areas beyond its mandate, saying focusing on the core WHO mission of strengthening health systems already helps build trust between countries. 

“Russia continues to speak out against the politicization of the WHO agenda… We call upon WHO to strictly follow its mandate and not stray into other areas, those covered by other [United Nations] bodies, specialized agencies and so on,” Russia’s EB  representative said.

Russia also highlighted that the initiative had launched, based on discussion with only 24 countries and partners.

“This issue has not been investigated by governing bodies of the WHO at another stage,” the Russian representative said. “We believe that there should be more broad discussions.”

Representatives from WHO’s Eastern Mediterranean region also appeared hesitant, with one delegate stressing that “first and foremost, we should avoid causing any harm.”

“Many interventions of health for peace will only be successful if they are well prepared and well designed, and therefore we need to coordinate our experiences and expertise,” he said. 

US asks for human rights inclusion

Health for Peace Initiative as it was presented at the Paris Peace Conference in 2020.

In contrast, the United States asked that human rights be included as one of the pillars of the initiative. 

While the US supports the draft of the GHPI, it said that the country “regrets that the text … fails to incorporate human rights as a fundamental pillar in addition to peace and development.

“The WHO has an important role to play in promoting respect for human rights and fundamental freedoms in coordination with other UN agencies,” the US representative said.

Building vaccine confidence, including the need to address issues of vaccine misinformation and disinformation, could also be a valuable arena in which the new GHPI could act.  

In response to the concerns, WHO officials stated that discussions on the initiative with member states are ongoing, and would be managed in an open and inclusive manner.

“I think that we have been very open to date,” said a WHO emergencies official. “It’s not a political initiative. Obviously, political decisions do have an impact on health and on peace and we’re all aware of this.”

‘There cannot be health without peace’ 

“There cannot be health without peace, and there cannot be peace without health,” WHO Director-General Tedros Adhanom Ghebreyesus, who has championed the initiative, has explained. 

“Health can also be a bridge to peace.  Health can contribute to peace by delivering services equitably to all people in society- especially disadvantaged groups,” he said in a recent message. “This can also help address the triggers of conflict, such as unequal access to health care, which can often leave to feelings of exclusion and resentment.

“Equitable health services strengthen community trust, which in turn contribute to health systems and peacebuilding efforts.” 

Data and technology sharing key to managing pandemics

In other discussions Friday, China, Singapore and Indonesia all stressed the need to address benefits and information sharing. 

“The current pandemic has shown us how important it is to make such information free and publicly available,” a representative from Singapore said, noting that the country “sees the sharing of such data … as part of ‘global public goods’” and that should be included in a larger conversation on the financing of such goods.

Singapore also recommended that WHO establish a global health threats fund, invested in by nations based on pre-agreed contributions as a means of being better prepared for the next pandemic. 

“We would like to caution against lies in the lack of levels of preparedness with regard to the response to pandemics around our region,” a second representative from the Eastern Mediterranean region said. “We would like to see the continuation of the support for our preparedness in this regard.”

He said that there should be better coordination among member states with regard to health, security, and preparation of emergency plans and plans with regard to specific diseases. 

Image Credits: WHO EB 150.

food
Food experts proposed a return to ‘real’ food over what is just ‘edible’

The explosion of unhealthy diets received considerable attention at last week’s WHO Executive Board meeting, as well as at last year’s UN Food Systems Summit – as key contributors to the global epidemic of chronic diseases such as obesity, diabetes, and cardiovascular diseases – which have also exacerbated the health risks of billions of people to COVID-19.

Now, what is really needed, post-pandemic, is a return to healthy and sustainable ‘real’ foods that both dimish these disease risks – as well as the risks of another pathogen escape from the wild into human societies as a result of unsafe and unsustainable food practices – particularly around both wild and domestic meat production and consumption.

This was a key message of a group of civil society experts at a recent panel – who also drew a distinction between what is merely “edible” food and what is “real”, healthy food.  

Making that seemingly simple distinction will be crucial post-COVID recovery to stem rising noncommunicable diseases while also ensuring that our planet remains within the boundaries of sustainable food production as well as making , nutrition experts emphasized during a recent Geneva Global Health Hub (G2H2) event. 

The event, “Sustainable healthy diets: Why are they so crucial after COVID-19?”, was hosted in collaboration with the Society for International Development (SID).

Featured speakers from Mexico, Brazil, and Colombia discussed a broad range of proposed solutions that would alter the way food is produced, distributed, and consumed.  

Exiting the corporate food system

Attaining healthier and more sustainable diets requires an ‘exit’ from the corporate food system, said Hernando Salcedo Fidalgo, of the Colombian NGO, FIAN. “The exit must make a distinction between real foods over what we call ‘edible products’”.

Fidalgo described solutions as a “continued process” that would have to begin at the very foundations of government – with approaches that distinguish between “real food and just edible products.” 

SID Director Nicoletta Dentico added: “If we don’t want to see things as they are, for the reality they represent, after years of the pandemic – this is going to be a kind of criminal blindness.” 

Mexico as a case study example of the need to return to traditional ‘real’ foods 

A sustainable healthy diet requires increased vegetable and fruit intake, as well more whole grains.

At the session, Mexico was cited as one example of a country in the crosshairs of pressures from corporate food manufactuers – who have undermined the once healthy diet of indigenous Mexican foods, leading to soaring problems with obesity and diabetes.

Reverting back to a traditional Mexican diet – rich in beans, fibre and micronutrients – is one way to both promote both sustainability and health,  said Juan Angel Rivera Dommarco, Director-General of the National Institute for Public Health in Mexico. 

“Our food system is really contributing to the degradation of the planet, and at the same time has created an epidemic of obesity and chronic illness without solving the undernutrition problems of the world.”

He bemoaned the gradual encroachment of meat, fat, and sugar-heavy  ‘American diets’ into Mexico.  

“We lost so many years of building healthy diets in Mexico as a result of trying to imitate the consumption of food in the north, which is not a good example at all,” he noted. 

The traditional Mexican diet means reverting to a diet high in vegetables, fruits, legumes, nuts or seeds, and whole grains – except in rural areas, where whole grains are already highly consumed. 

Milk and dairy intake also would need to be increased across rural populations, but decreased in urban ones. 

Substantial reductions in ultra-processed foods and reduced animal-source protein would also be needed to return back to the traditional Mexican diet. 

Average cost (MXN$) per capita per day of current Mexican diet vs Mexican healthy and sustainable diet

Moving towards this healthy diet would also be beneficial to the Mexican economy, Dommarco added.

The current average Mexican diet has been costed at $3.54 per day, whereas a traditionally healthy and sustainable Mexican diet would cost $3.06, while that proposed by the EAT-Lancet Commission would cost $2.52.

Shift government subsidies from ‘wrong foods’ to healthy ones 

Schools are one place to implement healthy food use.

Noting that the Mexican government currently offers too many subsidies for the “wrong foods”, he called on politcymakers to shift money and policy support to healthier foods – also providing  a model for other countries to follow.  

Working with GISAMAC (Inter-Sectoral Group for Health Agriculture Environment and Competitiveness), Dommarco has helped to develop a Mexican toolkit with a full set of policy proposals to address the need for healthy diets in the country. 

Their proposals included increasing the availability of healthy foods in underserved areas, prioritizing these foods for government subsidies and procurement, and prioritizing healthy, fresh foods in school nutrition programs. 

Taxes from sugar-sweetened beverages and ultra-processed junk food should be doubled, with tax revenues used to ensure drinking water in underserved communities, he added. 

Policies from the toolkit emphasize a multisectoral and multisystemic intervention, including not only food systems and the food environment, but education, nutrition, community, and health systems.

“The idea is that we really need a set of policies rather than one single policy that has a multi-systemic view,” said Dommarco. 

Image Credits: Noranna/Flickr, Juan Rivera Dommarco , Juan Rivera Dommarco, Flickr: Bart Verweij / World Bank.

Researchers find two antibodies in common in people with long-COVID, the lingering post-infection condition that was recognised by the World Health Organization (WHO) last October. But scientists say symptoms and how many people develop the virus are still unclear.

Unconscious and intubated Covid-19 patients are treated in Vila Penteado Hospital’s ICU, in the Brasilandia neighbourhood of Sao Paulo.

By Maayan Hoffman

A sizable portion of the 370 million people infected with SARS-COV2 experience Post-Acute COVID Syndrome (PACS), otherwise known as “long COVID”. Doctors and scientists are starting to grapple with why people develop the syndrome and how to prevent and treat it.

Their discoveries could have important implications on future healthcare.

Researchers from the University Hospital Zurich announced last week that they had discovered an “antibody signature” that could help identify which patients are at the highest risk for developing long COVID.

Specifically, they found that low levels of IgM and IGg3 antibodies were more common in those who developed the syndrome than those who did not.

The team followed 134 individuals who tested positive for the virus for up to a year after the initial infection. They found that when combined with the patient’s age, how mild or severe a case of coronavirus the person experienced, and whether or not the individual suffered from asthma, the antibody signature was able to predict the risk of long COVID.

These antibody levels, of course, cannot be measured before a person becomes infected with the virus and therefore this method cannot be used as a pre-virus prediction of the syndrome. However, early identification of patients at elevated risk for long COVID could facilitate the study of targeted treatments, the researchers wrote in their paper, which was published in Nature Communications.

Full mRNA vaccination protects against long COVID

A separate study by researchers in Israel found that individuals who received two shots of the Pfizer coronavirus vaccine were much less likely to develop long COVID symptoms than those who were unvaccinated – suggesting that vaccination protects against long COVID.

These results were not observed in individuals who received just a single dose. Participating vaccinated and infected individuals reported no additional long COVID symptoms than individuals who were never infected with the virus.

The study was published this month on the pre-print health server MedRxiv and has not been peer-reviewed.

A child receives a vaccine through the Maccabi Health Fund in Israel in December 2021.
A child receives a vaccine through the Maccabi Health Fund in Israel in December 2021 (Credit: Maccabi)

The scientists, led by Prof Michael Edelstein of Bar-Ilan University, examined 10 commonly reported post-COVID symptoms – fatigue, shortness of breath, joint pain, chest pain, headache, palpitations, physical limitations, depression and insomnia – among 3,000 participants. They said that there was between a 50% and 80% reduction in seven of the 10 most common symptoms four to 11 months among the vaccinated participants compared to the unvaccinated.

“A double comparison of vaccinated vs. unvaccinated COVID-19 cases followed by comparing vaccinated COVID-19 cases to people reporting no infection enabled us to show not only that vaccinated people were experiencing much fewer long COVID symptoms than unvaccinated people, but that that they did not report any more symptoms than people never infected,” Edelstein said.

He noted that the results seemed “logical.”

“If we believe that these symptoms are related to the infection – caused by the virus itself – it makes sense that if you are vaccinated, even though you can still get infected, those who do get infected have less copies of the virus in the body and it hangs around in the body for less time, so it would have less opportunity to affect the body long term,” Edelstein said.

He added that the study indicates that even those who are at less risk of developing severe COVID-19 should get jabbed, since these individuals seem to be at equal risk of developing long COVID.

The study only included adults over the age of 18, but Edelstein said that the team hopes to examine the effect of the vaccine on long COVID in children, too.

Up to 57% of COVID survivors could have long COVID symptoms

He added that what is needed is a universal definition or understanding of long COVID in order to enable better studies.

The World Health Organization (WHO) rolled out a definition of PACS last October but noted that “the definition may change as new evidence emerges and our understanding of the consequences of COVID-19 continues to evolve.”

According to WHO, long COVID occurs around three months from the onset of the virus, lasts for at least two months and “cannot be explained by an alternative diagnosis.” It lists fatigue, shortness of breath and cognitive dysfunction as common symptoms, but said others could apply and that symptoms could fluctuate or relapse over time.

It is also unclear how many people actually develop long COVID. Edelstein cited Israeli studies that indicate around 30% of people infected with coronavirus will develop the syndrome, while some studies say closer to 60% of virus sufferers will have some form of PACS for up to six months.

What proportion of symptoms are attributable to the virus and whether or not these symptoms can be detected in a clinical setting could impact the future of long COVID treatment, Edelstein said.

“It is one thing reporting shortness of breath and another detecting reduced lung volume on standardized, objective testing in a clinical setting,” he said.

Over the weekend, a small study in the United Kingdom revealed that some people who reported long-lasting breathlessness after COVID infection may have hidden lung damage.

Scientists used a Hyperpolarized Xenon Magnetic Resonance  (MRI) scan to pick up on lung abnormalities not identified by routine scans. They found that for the majority of people with long COVID, the xenon gas they inhaled during the MRI moved less effectively from the lungs into the bloodstream than it did among healthy, never infected individuals.

The spectrum of medical imaging
The spectrum of medical imaging

“Hyperpolarised xenon MRI requires the patient to lie in an MRI scanner and breathe in one litre of xenon gas that has had its atomic structure altered so it can be seen using MRI,” according to the study. “Xenon is an inert gas that behaves in a very similar way to oxygen, so radiologists then can observe how the gas moves from the lungs into the bloodstream.”

The study included 11 non-hospitalized long COVID patients and 12 hospitalized patients, as well as 13 health controls. It was published by the NIHR Biomedical Research Centre, Oxford and has not yet been peer-reviewed.

Researchers said that they plan to expand the study to include at least 200 patients.

Long COVID therapeutics on the horizon?

Doctors and scientists are also focusing on developing long COVID therapeutics. An article published on Clinical Trials Arena stated that 65% of planned COVID trials for 2022 will focus on therapeutics, according to a GlobalData report, but said that the majority of the long COVID trials (76.5%) are only in Phase I or Phase II.

At least four long COVID drug trial readouts are expected in 2022, the report said, with each treatment targeting a different long COVID symptom or group of symptoms.

These include PureTech, which is working on a drug for lung tissue damage stemming from a prior COVID-19 hospitalization; Axcella Health, which is working with Oxford university on a drug to reduce inflammation and restore mitochondrial function; Massachusetts General Hospital and 9 Meters Biopharma are studying a treatment for multisystem inflammatory syndrome; and MGC Pharma is assessing the potential of its ArtemiC Support for effectiveness in treating long COVID symptoms such as dyspnea, cough, asthenia, anosmia, ageusia, headache and mental confusion.

Edelstein said that researching long COVID is urgent and essential because the syndrome “is going to be one of the major concerns going down the line.”

He explained that while the acute phase of the pandemic will eventually end, “that is not necessarily going to be the end of the impact of COVID-19, which could be felt for years due to the virus’s long-term effects.”

Long COVID could have “massive implications on the burden that will be on healthcare services in the future.”

Image Credits: Ninian Reid/Flickr, Maccabi Health Services, Martin Tornai, Wikimedia Commons .

Dr Patrick Amoth, Chair of the Executive Board,

As the 150th Executive Board Meeting of the WHO closed Saturday, attention focused on the inability of the WHO governing board to reach consensus on critical issues that it had debated – including a more sustainable financing framework as well as a clear way forward on a proposed new pandemic legal accord, reforms of global pandemic response and related WHO emergency operations. 

Despite six days of hours-long discussions, EB agreement to increase WHO member states´  assessed contributions to 50% of the budget by 2028-29, remained elusive. Nor could EB members even agree on a way forward for changing the format for voluntary contributions – using newer, and more innovative fundraising models, such as the ¨replenishment drives¨ that have made other non-profit global health organizations like Gavi and The Global Fund even more financially robust than WHO. 

Decision to extend mandate of Sustainable Finance working group keeps hopes alive

WHO Director General Dr Tedros Adhanom Ghebreyesus on Saturday, the closing day of the EB´s 150th session

In his closing remarks, Dr Tedros Adhanom Ghebreyesus, Director-General of the WHO, noted that while a conclusion on funding for WHO, which is a crucial issue, could not be reached at the meeting, the decision to extend the mandate of the working group on sustainable financing until the World Health Assembly demonstrated optimism.

“I sincerely hope that by working together, we can make substantive progress on this issue,” the DG said.

In advance of this year’s World Health Assembly, Tedros said that the WHO Secretariat also will further develop proposals, in consultation with Member States, on strengthening the global health architecture for emergency preparedness, response and resilience.

“In doing so, we will take into consideration the preliminary findings of the Working Group on strengthening WHO Preparedness and Response to Health Emergencies, and recommendations of recent review panels and committees,” he said.

However, that Working Group, as well, failed to reach agreement on key reforms, such as bolstering WHO´s mandate to make visits early on to sites of suspected pathogen outbreaks. 

Long, unwieldy agenda proves frustrating  

Dr Clemens Martin Auer, Austria´s EB representative and vice-chair

Before officially declaring the meeting closed, Dr Patrick Amoth, Chair of the Executive Board, also stressed the need for discussions on how to improve the efficiency of WHO’s Executive Board meetings, and other member state fora, in order to ensure that member states can help WHO to perform more effectively.

In all, the board reviewed over 55 agenda items and sub items.  That, Amoth admitted, was ambitious, given the number of days available.

“This resulted in longer sessions than we anticipated,” the chair added. 

While he also described the sessions as ´rich and engaging´ other member states were more blunt about the fruits of hours, upon hours of rhetorical statements by member states  – which obscured real debate and discussions about key decision points.  

EB Vice Chair, Dr Clemens Martin Auer, Austria´s Special Envoy for Health, said that the Executive Board´s inability to come to any real conclusions not only harms WHO´s ability to perform, but leaves it in a ¨critical¨ situation.

“We have reached the situation where we still don’t act accordingly to what we are supposed to do. We are still not living up to what we have to do, colleagues. We have to be aware that we haven’t concluded on anything and that we are leaving this organization in a critical situation,” he said.

Auer warned that failure of governance, not by the WHO Secretariat, but by member states failing to get their act together on how to implement better governance — could make the organization progressively less relevant – and create a vacuum into which other global actors such as the G-20 would step.

“We are contributing to further fragmentation when it comes to global health issues and also emergency issues and we pay the price of non-inclusivity and that’s a high price. Don’t talk, act. Don’t say, show. Don’t promise proof,” Auer told member states.

Hours and hours talking 

Last June, a G-20 High Level Panel proposed the creation of a ¨Global Health Threats Board¨ including health and finance representatives of the world´s major economies, working in conjuction with the WHO and another proposed body, a Global Health Threats Council, that would be overseen by the UN Secretary General´s office. 

During the EB, a US State Department spokesperson said that President Joe Biden wants to support the creation of such a new financing mechanism, housed at the World Bank, to ensure a reliable source of investments for helping countries increase their own global health emergency preparedness – rather than remaining so dependent on donor aid. 

The US and other supporters have stressed that such initiatives should not detract from the central role of WHO´s global health support to countries and emergency response. 

And indeed, as if to underline the central role the WHO will continue to play, US Secretary of State Anthony Blinken also announced an additional $280 million more in fuding to the agency in late December.  

If that funding were to be added to the $ 365 million annually Washington provided last year, it might even put the US ahead of Germany once again as the WHO´s top donor for 2022. That, despite a statement by WHO Director General Tedros, on the opening day of last week´s EB session, to the effect that Germany is now WHO´s biggest donor. 

Greater efficiences a challenge both inside WHO and within its governing board

But money aside, the struggle for greater efficiencies remains a challenge – both inside WHO and among the member states’ own governing board. 

Dr Ahmed Mohammed Al Saidi, Oman’s Minister of Health corroborated Auer´s call on the board members to actively seek more efficient ways of doing things in order to achieve desired results.

“We need to find a more efficient way of doing things and implementing them. We spent hours and hours talking, but let’s find a way where we can do things more efficiently. It can be by limiting the interventions and making it easier for the Executive Board members via retreats during which we have free time to talk about issues that matter to health care, not in our countries, but worldwide,” he concluded.

Other EB members also complained that even certain tactical procedures, such as the bundling together of numerous reports, action plans, and updates into the same EB document, made it more difficult to wade through the various background documents.

In an age in which written presentations to busy executive boards typically rely heavily on indexing, infographics, bullet points, graphics and other visual aids, EB documents continue to be drafted like the text-heavy academic theses of the mid-20th century style –  which makes it almost impossible to quickly read and seize key messages, issues of debate, decision and action points.

Similarly, EB member state statements remain heavy on rhetorical flourish – but lacking slides, visuals or even, in many cases, a written text, to support better understanding.

The old-fashioned, and very indirect, style of the deliberations certainly also serves certain diplomatic goals – allowing countries to voice criticism in nuanced, coded language that is inscrutable for most outsiders, preserves decorum and avoids out-and-out conflict.

Still, the formulas of presentation are often as obscure as the countries´ commentaries on them.

Notably, some items, such as the NCD agenda, covered over a dozen different issues, from healthy foods to mental health, wrapped up into one long run-on document followed by annexes – with nary even a table of contents.

As the US EB representative Loyce Pace observed at one point such bundling together of so many action plans and statements into one document, made it all the more difficult for EB members to weed through, and consider all of the important issues being raised. 

National health systems are needed in tackling global health threats.

As the world enters the third year of the COVID-19 pandemic, an increasing number of important efforts are underway to strengthen global health security.  However, it is vital that, while strengthening our global health architecture, we do not lose sight of the fundamental role played by national level health systems in tackling global health threats.

Throughout this and previous pandemics, the strength of countries’ national health systems has been a critical success factor against pathogens. For example, even many countries with well-organised, well-financed and well-staffed health systems suffered throughout COVID-19. Viewed through these lenses, global health security may exist only as the sum total of the performance of all national health systems of all countries, rather than as a standalone and separate entity.

Since the onset of the pandemic, we have seen a plethora of new institutions and new ideas for improving global health governance. These include the Access to COVID-19 Tools (ACT) Accelerator and the COVAX Facility in April 2020, the Independent Panel on Pandemic Preparedness and Response proposal in May 2021 for a Global Health Threats Council and the World Health Assembly (WHA) agreement in December 2021 to proceed with the negotiation and drafting of a new international instrument to strengthen pandemic prevention, preparedness and response.

It is hoped that these new international institutions and platforms will support better pandemic governance and financing at the global level. However, although a strong global focus is essential for ensuring equitable distribution of those goods that are necessary for fighting COVID-19 and future pandemics, national efforts must be equally prioritised. 

In other words, global leaders must resist two great temptations: the desire to build new institutions instead of strengthening existing ones such as the WHO and the International Health Regulations, and the tendency to ‘securitize’ health at the global level instead of implementing strong public health measures at the national level.

Three functions to achieve resilient health systems

global health security
One interlocking function needed is resilient healthcare systems.

Global health security demands strong and resilient health systems that can prevent, detect and respond to infectious disease threats, wherever they occur in the world.  Therefore, we propose a new understanding that approaches this goal through the lens of three interlocking functions at the national level. 

The first key function is building resilient national healthcare systems. It is critical that they have built-in surge capacity (including for primary healthcare) to manage patients who have been infected and require care, while at the same time continuing and sustaining routine health services for those who have not been affected.  In addition to deaths from infection during the COVID-19 pandemic, there have been an excess of deaths of non-infected persons over what would be expected, likely due to the fact that they were not able to access routine health care, especially that which required frequent attention.  The same occurred in West Africa during outbreaks of Ebola in 2014 – health facilities could not accommodate most of the patients with Ebola infection resulting in a high level of death from Ebola virus diseases, and also, the number of deaths from children who could not get care for malaria and other childhood diseases because of the lack of resilience in the health system was documented as being higher than the number of deaths from Ebola virus disease.   

The second key function is developing strong core public health capacities that meet the WHO’s International Health Regulations. Countries with early detection surveillance systems that identified outbreaks rapidly at the start of the pandemic, and those that had strong response mechanisms including outbreak responses – especially Singapore, Japan, and South Korea – showed the importance of strong public health core capacities to manage pandemics.  And rather than using blunt lockdowns of the entire economies, they were able to save lives by outbreak investigation, identification of sources of infection and then shutting them down with precision, rather than blunt lockdowns.    

Thirdly, countries need to invest in broader supportive environments that enable the health and wellbeing of their populations. Infection with SAR CoV2, as with many other viral and bacterial infections, resulted in more serious illness and death among the elderly and those with comorbidities such as diabetes, cardiac disease and obesity.  By using smart regulations and other healthy-lifestyle-enabling measures, governments can ensure populations are healthier and more resistant to serious illness after infection, decreasing morbidity and mortality in an outbreak and/or pandemic. Healthy populations also require adequate health financing, strong health literacy and health-seeking behaviours, and improving the social determinants of health, like education, housing and working conditions.

Synergistic approach as opposed to mutually exclusive strategies

This synergistic approach to universal health coverage, health security, and health promotion is necessary to prepare for future pandemics. Currently, many countries seem to assume that public health, universal health coverage and creating the enabling environment for healthy populations are mutually exclusive strategies.  This can be due to limited resources and/or donor funding pushing governments towards “false choices”. 

Such false distinctions are further enhanced by the “global nature” of global health security with accountability towards the international community, contrasted with the domestic nature of universal health coverage and health promotion, with accountability towards local voters, taxpayers and citizens. 

A strategy focused on the three interlocking functions provides countries with a middle way – an integrated approach that equally prioritises national and global health security. Each of the functions has a strong conceptual framework and large body of evidence to support its positive impact on global health security.  Each is closely aligned with well-established and highly-visible health frameworks. 

 It will take political and health leaders with courage, vision and ambition to rethink some of the many vertical (albeit well-meaning) global implementation and funding streams to ensure that they serve to strengthen these three functions and not bypass or weaken them. They will need understanding and support from the global health community.

If implemented correctly, the three interlocking functions would be mutually synergistic, with progress in one function accelerating or enhancing progress in another. Taken together, they represent a more balanced approach to global health security and reduce the risk of over-globalizing, over-engineering or over-securitizing health. By better linking these three functions within WHO, and within its guidelines for epidemic and pandemic preparedness, WHO technical support to countries could provide better preparedness and response capacity for the next major outbreak or pandemic.

Biographies

Professor David Heymann is professor of infectious disease epidemiology, London School of Hygiene & Tropical Medicine.

Professor Ilona Kickbusch is the Founder of the Global Health Centre at the Graduate Institute in Geneva.

Chikwe Ihekweazu is the WHO assistant Director General of health emergency intelligence, the former Director General of the Nigeria Centre for Disease Control (NCDC) and was previously the Acting Director of the West Africa Regional Centre for Disease Control.

Doctor Swee Kheng Khor is a physician specializing in health systems & policies and global health, focusing on south-east Asia.

 

 

Image Credits: Nigeria Centre for Disease Control , Flickr: Maxim Malov/CDC.