The numbers are staggering. Yet, amidst a blizzard of advertising and misinformation, most people don’t realize that alcohol is one of the world’s leading killers. Across the globe, approximately 3 million people each year die from alcohol-related causes.

Many people are aware of the toll of alcohol-related car crashes and are familiar with some long-term effects of heavy consumption, like liver disease. However,  alcohol use is also one of the most common risk factors for other preventable non-communicable diseases (NCDs), such as diabetes, heart disease, and stroke. 

There are also significant links between alcohol use and multiple types of cancer, including cancers of the head and neck, mouth, esophagus, liver, breast, and colon.  Globally, an estimated 741, 000 of all new cases of cancer in 2020 were attributable to alcohol consumption.  Alcohol contributes to infectious diseases such as tuberculosis and HIV/AIDS, and plays an insidious part in homicides, suicides, falls, acts of child abuse and violence against women.

Despite its harmful global footprint, alcohol often does not get attention worldwide as a public health issue. It’s time for that to change. 

COVID-19 and alcohol

Now is an especially urgent time – the COVID-19 pandemic appears to have driven increases in alcohol consumption, including the proportion of people drinking excessively to cope with isolation, anxiety, and stress.  

Furthermore, some countries have relaxed regulations on access to alcohol during the pandemic, allowing the alcohol industry to exploit the system and promoting alcohol as an essential item.  Substantial increases in deaths caused by excessive alcohol consumption during the COVID-19 pandemic in Brazil were documented by Vital Strategies in a recent study.

Although the industry markets alcohol consumption as a “lifestyle choice”, alcohol-related harm is an epidemic, driven by the industry that profits from it. A relentless focus on increasing sales includes capturing new customers that are less prone to drinking.

Though half the world’s adults do not use alcohol, the global numbers have been steadily growing due to marketing directed towards youth and women.

To make alcohol more palatable to these new potential customers, the industry markets alcohol brands to women using sweet flavors. Another form of marketing to exploit women by the alcohol industry is known as “pinkwashing,” the use of the color pink on products in an attempt to appeal to women and cynically link to breast cancer prevention programs.

Young and poor people are particularly affected

Evidence indicates that underage alcohol consumption and related harm is also a growing global problem. Youth who start using alcohol before age 15 are six times more likely to develop alcohol dependence than those who begin consuming alcohol at age 21.

The consequences of alcohol use are also magnified in countries with fewer economic resources. The less economically developed a country, the higher the attributable mortality and the burden of disease and injury per liter of alcohol consumed.  Alcohol-related health burdens are often greater in countries lacking effective regulation or with health systems with limited capacity to handle the burden of alcohol-attributable illnesses.

The good news is that there is a clear roadmap to address this issue. The most promising areas of global focus for alcohol policy include The WHO SAFER technical package, which calls on governments to use proven policies to reduce alcohol use including restrictions on where and when alcohol can be sold, restrictions on alcohol advertising, sponsorship, and promotion, and increasing the price of alcohol through taxes and other pricing policies.

WHO is also currently working on a new global alcohol action plan. Vital Strategies recently signed on to a joint statement that calls on WHO to prevent the alcohol industry from advancing its agenda within the action plan and to critically examine the industry’s efforts to tout the health benefits of alcohol consumption.

Government inactivity and industry interference in implementing the SAFER alcohol policies is causing suffering and lives lost to alcohol-related harms. Common sense, science-driven approaches can reduce alcohol-related injuries, illnesses, and deaths on a widespread scale.  The health and well-being of millions depend on governments’ willingness to act urgently.   

Adam Karpati
Princess Dina Mired

Adam Karpati, M.D., is Senior Vice President, Public Health Programs at Vital Strategies 

Her Royal Highness Princess Dina Mired of Jordan serves as Special Envoy for Noncommunicable Diseases at Vital Strategies

 

Image Credits: Drug Helpline .

plastic

Agricultural plastics pose large and growing threat to soils, food safety and human health – and need to be better managed as well as replaced with more sustainable alternatives, as well as more recycling and reuse of plastics consumed. 

These are the findings of a new report by the UN Food and Agriculture Organization, “Assessment of agricultural plastics and their sustainability: A call for action”, released this week.  

The agriculture sector used a massive 12.5 million tonnes of plastic in plant and animal production and 37.3 million tonnes in food packaging in 2019, according to the report.

But only a small fraction of those plastics are collected and recycled – with potentially toxic microplastics absorbed in soils, accumulating in food chains, and eventually consumed by animals and people.

“This report serves as a loud call to coordinated and decisive action to facilitate good management practices, and curb the disastrous use of plastics across agricultural sectors,” writes FAO Deputy Director-General Maria Helena Semedo, in the report, which is perhas the most high-profile call to action on the issue to date.

“Soils are one of the main receptors of agricultural plastics and are known to contain larger quantities of microplastics than oceans,” she also said in a Foreword to the report. “Microplastics can accumulate in food chains, threatening food security, food safety and potentially human health…..As the demand for agricutlturel plastics contiunues to grow, there is an urgent need to better monitor the quantities of plastic producs used and that leak into the enviornment from agriculture.

In terms of human health, plastics are increasingly ingested by fish, livestock and wildlife – and then consumed by people. That is leading to a gradual increase in the concentrations of microplastic particles, as well as associated toxins and pathogens, in human populations in many parts of the world – which may then increase peoples’ risks to cancers, reproductive and endocrine disorders and a wide range of other chronic diseases.

Torn single-use plastics abandoned, and buried into fields worldwide are leading to the accumulation of microplastics in soils

Growing demand

Today, however, demand for single use agro- plastics is soaring – and there is little awareness of risks or monitoring of actual impacts on soils, animals or people.

The agricultural plastics industry forecasts, for instance, that growing global demand will lead to a 50% increase in the use of plastics simply for greenhouses, mulching, and silage films by 2030 – from 6.1 million tonnes in 2018 to 9.5 million tonnes. 

Crop production and livestock sectors are the largest plastics users, accounting for 10 million tonnes per year collectively. This is followed by fisheries and aquaculture with 2.1 million tonnes, and forestry with 0.2 million tonnes. 

Plastics in surface soil reduce crop yields

Ease of manufacture, physical properties and affordability make plastics the material of choice for many agricultural products. 

And yet while their use is largely intended to increase short-term fruit and vegetable yields, e.g. by protecting plants from extreme heat or cold, over time, the opposite has been found to be true.

The accumulation in surface soils of mulching film plastics  – a major category of agricultural plastic by mass – is linked to reduced yield.  

The report proposes a number of alternatives and interventions to reduce plastic use – and prolong the life cycle of plastics that are used, including:

  • eliminating use of the most toxic plastic products altogether
  • substituting plastic products with natural or biodegradable alternatives;
  • promoting reusable plastic productss. 

These recommendations are based on the 6R model – Refuse, Redesign, Reduce, Reuse, Recycle, and Recover.

Absence of international policies on agro-plastics use

Currently, no international policy addresses all aspects of plastic use in agricultural food chains. 

At the international level, the report recommends a two-pronged approach: 

  1. Developing a comprehensive voluntary code of conduct to cover all aspects of plastics throughout agri-food value chains.
  2. Mainstreaming specific aspects of the life cycle of agricultural plastics in existing international conventions, where appropriate. 

Semedo notes that the FAO will continue to play an integral role in the issue of agricultural plastics.

“Tackling agricultural plastic pollution is paramount to achieving more efficient, inclusive, resilient, and sustainable agri-food systems for better production, better nutrition, and a better life, leaving no one behind.” 

See also the 2019 report on Plastics and Health, by the Center for International Environmental Law, in association with a coalition of non-profit groups.

Report Details Health Crisis Hidden In Plastics Lifecycle

 

 

Image Credits: @Antoine Giret/ Unsplash, FAO – Assessment of Agricultural Plastics and their Sustainability – A Call to Action , FAO – Assessment of Agricultural Plastics and their Sustainability – A Call to Action.

South Africa has increased its vaccination drive in the face of Omicron

The virus reproduction number of the Omicron variant in Gauteng province – the epicentre of South Africa’s pandemic – is 3 – meaning that one infected person will infect three others on average.  That is the highest seen so far in the country’s COVID-19 pandemic history – and testimony to the highly infectious nature of the new SARS-CoV2 variant.

South Africa’s health minister, Dr Joe Phaahla, described this reproductive number as “something we have never seen” at a Friday media briefing.

During the country’s Delta-driven third wave, the number remained below 2. However, in some other countries, Delta’s reproduction number breached five, according to a Lancet study.

South Africa Reproductive Number Dec 2021 (National Institute of Communicable Diseases, South Africa)

Less severe so far – but early days

South African health minister, Dr Joe Phaahla

On the more positive side, Phaahla said that early data from the department’s national hospital surveillance showed that hospitalised COVID-19 patients had shorter stays, and fewer had severe disease, as compared to patients admitted in a similar time frame in the second and third waves. 

Moreover, some 70% of those hospitalised for COVID-19 were not vaccinated, he added.

He defined severity as any patient who developed acute respiratory distress syndrome, received oxygen, ventilation, was treated in high care or ICU or died.

However, he cautioned that severity data “has several limitations at the early phase of the wave when numbers are small”.

“Patients with mild symptoms are more likely to be admitted as a precaution, patients are diagnosed with COVID-19 incidentally when admitted for other reasons, and because there has not been sufficient follow-up time for severity and outcomes to have accumulated, which is typically up to 3 weeks after diagnosis,” explained Phaahla. 

While there had been an initial increase in hospital admissions for children under five (21% of all admissions), this had decreased to 8%. 

Many of the children had been admitted for other reasons and tested positive “incidentally”, stayed in hospital for less than five days and did not show features of severe disease, the Minister added.

Hospital at epicentre

Tshwane Omicron cases

Dr Mathabo Mathubela, head of the biggest hospital at the epicentre of South Africa’s Omicron infection, reported that her COVID-19 patients were displaying less severe symptoms than previous waves.

Of the 42 COVID-19 patients in her hospital on 2 December, nine needed oxygen, three were in high care and two in ICU. However, for 33 of the patients, COVID-19 was “coincidental” to their admission, said Mathubela, CEO of Steve Biko Academic Hospital in the Tshwane area of Gauteng.

Only six patients were vaccinated, with 24 unvaccinated and the status of eight unknown, she added.

WHO warns it’s too early to draw conclusions on severity

South African statisticians also are beginning to observe a reduced rate of hospital admissions in comparison to the total number of new Omicron infections, suggesting that vaccines and previous infections are providing some protection.

In a briefing on Thursday, however, the World Health Organization has warned that it is still too early to draw conclusions from the South African data on the severity of the new variant.

WHO Lead on COVID-19, Dr Maria Van Kerkhove, said that the South African population was young and had a high level of exposure to COVID-19 from previous outbreaks, which might lessen Omicron’s impact.

WHO Chief Scientist Dr Soumya Swaninathan also warned that it is too early to come to any conclusions about the efficacy of vaccines against Omicron as the only available studies showed a “wide variation” and samples were small.

In addition, a small South African study released late Tuesday suggested that people double-vaccinated with the Pfizer-BioNTech COVID-19 vaccine had significantly reduced protection against the Omicron variant, now reported in 57 countries.

On Wednesday morning, however, Pfizer reported that a third booster of its vaccine would provide significant protection against Omicron, according to a laboratory study.

Meanwhile, South Africa’s health minister said on Friday that while restrictions had been effective in the past in stemming the rise in COVID cases, these “have had severe economic consequences, thus a careful assessment of risks is needed”. 

The South African government is still considering mandatory vaccination, which has the support of most business associations and large trade unions.

Image Credits: Gauteng Department of Health.

Violence against health workers has increased despite the adoption of a UN resolution in 2017.

Despite death threats from rebel Chechens and Russian forces, Dr Khassan Baiev saved and treated countless lives from both sides of the Chechen wars. He did not waver from what he considered was his ethical duty as a doctor, and yet he was targeted and punished for his actions. 

His story, and the stories of many other heroic healthcare workers, who continued to provide care despite the dangers they faced during conflicts, are brought to life in Leonard Rubenstein’s new book, Perilous Medicine: The Struggle to Protect Care from the Violence of War. 

While there has been increasing discussion regarding the problem of violence against healthcare workers, such conversations often do not include the voices of healthcare workers themselves. 

Rubenstein and other global health experts reflected on the need to humanize these experiences of health workers during a Global Health Centre’s (GHC) launch of Perilous Medicine, and also considered long-term solutions to an increasing trend of attacks against the health sector. 

Leonard Rubenstein, Professor of Practice, Johns Hopkins Bloomberg School of Public Health

“Right now we’re in a situation where the violence continues. There’s been international paralysis, and we need to find ways to assess what is an extremely serious problem,” said Rubenstein, a professor at Johns Hopkins University.

In addition to extensive research, first-hand experience, and compelling personal stories, Perilous Medicine also offers lessons from the international community on how to move forward to protect both people suffering in war and those on the front lines of health care in conflict-ridden places around the world. 

Five reasons why combatants justify attacks 

Rubenstein has created a framework of five reasons why combatants justified attacks on healthcare, namely: to prevent enemies from being treated and returning to fight; to undermine support for rebelling forces; for tactical advantage of taking over a hospital or health centre; refusing to distinguish between military and civilians; and to exploit distrust in government. 

The sources of restraint that can ameliorate or prevent harm to health workers include leadership, domestic or international pressure and accountability, Rubenstein added. 

However, while UN Security Council Resolution 2286, passed in 2016, was one such source of restraint, condemning violence and threats against the wounded and sick, against medical and humanitarian personnel exclusively engaged in medical duties, and against healthcare resources. But the attacks have only increased since.    

More than 700 healthcare workers and patients have died, and more than 2,000 have been injured in attacks on health facilities across 17 emergency-affected countries and fragile settings since December 2017, according to a WHO report released in August. 

Rubenstein called on the global health community to draw its attention towards this pressing issue that seeps into other sectors of health. 

“We need to go beyond the humanitarian, human rights community to address the problem. We talk about the need to develop health systems and universal healthcare – both of those are threatened when health systems are destroyed.” 

More than accountability needed 

Maciej Polkowski, Head of Health Care in Danger Initiative at the International Committee of the Red Cross

Beyond holding the right people accountable for these attacks, there is a need to create lasting change and diminish the violence by engaging with both government and civil society. 

“We often see [violence against healthcare] as merely a problem of accountability, as a collection of outrageous incidents that have to be met with international condemnation and criminal prosecution, if possible,” said Macief Polkowski, International Committee of the Red Cross (ICRC). 

But Polkowski notes that “the arsenal of responses we have at our disposal is far greater.”

“A lot can be done in terms of technical responses, advocacy – these can have practical and concrete effects in terms of diminishing some of these attacks.” 

These “untapped avenues” include engaging with Ministries of Health at the national level to working with professional medical associations. But these efforts require global solidarity and support from both parties.

“[Ministries of Health and medical associations] can take the next step of urging policy changes at the domestic level,” said Rubenstein.

This includes changing counterterrorism laws, demanding militaries adjust their rules of operating in the field, and making sure the voices of those in healthcare in conflict settings are heard. 

Local healthcare workers bear brunt of attacks

Aula Abbara, Honorary Senior Clinical Lecturer in Infectious Diseases at Imperial College and Chair of Syria Public Health Network

Shifting the focus away from the humanitarian workers of high-income countries, whose actions and stories often take center stage, Perilous Medicine instead highlights the individual stories of local healthcare workers.

“Healthcare workers that come from abroad, who come into these conflict settings, are often glorified, or treated as heroic. Whereas actually, the local healthcare workers are the ones who bear the brunt of such attacks on health care in their local communities, on their healthcare facilities, day in and day out,” said Aula Abbara of Imperial College and Chair of Syria Public Health Network. 

Abbara notes how tremendously important it is to talk to the healthcare workers directly involved in the line of conflict, as Rubenstein had done in his book.

“We can all state that more than 900 healthcare workers have been killed directly during the conflict, but every single one of those [who died] has a story.” 

Moderator Tammam Aloudat echoed Abbara’s sentiments about Perilous Medicine: “The genuine way of delivering stories in this work, the ability for us to actually see people rather than statistics, to talk about something that hurts rather than something that gets conceptualized as an academic exercise is one of great significance.” 

Image Credits: International Committee of the Red Cross, GHC.

Dr Richard Mihigo, WHO Africa Coordinator of Immunization and Vaccine Development,

There has been a substantial increase in COVID-19 vaccine deliveries to Africa in the past four weeks, with around 20 million doses arriving every week at present – but only six countries out of 54 African countries will reach the global target of vaccinating 40% of their population by the end of this year.

This is according to Dr Richard Mihigo, WHO Africa Coordinator of Immunization and Vaccine Development, who said that “millions of people are without protection against COVID-19 and this is simply dangerous and untenable”. 

Most countries had used 60-80% of their allocations, and only two were lagging behind with only 10% of supply used, Mihingo told the regional body’s media briefing on Thursday

However, Mihingo said the WHO, UNICEF and COVAX had appealed to all countries that were donating vaccines to ensure that they were not expiring soon.

“We have seen the issues that have been created by the vaccines that are coming with a very short shelf life, as these pose additional challenges when it comes to the rollout of these vaccines,” he said.

Nigeria faced media criticism this week for destroying one million doses donated from Germany, but it transpired that they had been due to expire within a month of delivery.

Serum Institute of India ‘let Africa down’

In response to the claim from the Serum Institute of India (SII) that it was halving the production of its Astra Zeneca vaccines because of low demand including from Africa, Mihingo pointed out that it was SII that had stopped supplying Africa.

Mihingo said that the SII’s decision to suspend all the export of vaccines to COVAX in April had “created a lot of issues in this region”. 

“Some countries were left without provision of a second dose,” added Mihingo. “In the meantime, countries moved on and looked for alternatives. And if we look at the current pipeline in the COVAX forecasts, this is quite very promising. We are expecting to receive between 800 million to almost one billion doses through COVAX [this year] and this number is going probably to double next year. 

“I think we have now enough vaccines that are going to come through the COVAX mechanisms, and the challenge is now in deploying them,” he added.

Earlier in the day, Dr John Nkengasong, Executive Director of Africa Centres for Disease Control (CDC) said bluntly that the SII had “acted unprofessionally”, let Africa down and created mistrust when it had suspended its vaccine exports despite having committing to supplying African countries via COVAX.

Omicron in 11 African countries

WHO Africa virologist Dr Nicksy Gumede-Moeletsi

While 57 countries worldwide have identified the COVID-19 Omicron variant, only 11 of these are in Africa – and only six in southern Africa, which is on the receiving end of travel bans from around 70 countries.

Of the 14 countries in southern African, Botswana, South Africa, Namibia and Zambia have officially notified the World Health Organization (WHO) Africa of the presence of Omicron, and Zimbabwe is also expected to confirm the variant’s presence, said WHO virologist Dr Nicksy Gumede-Moeletsi. 

Mozambique has also reported cases, according to the Africa Centre for Disease Control and Prevention (CDC).

Gumede-Moeletsi added that around 50 of the 55 African member states had the ability to do genome sequencing of viruses themselves.

A regional genomic sequencing laboratory based in South Africa is currently supporting the 14 southern African countries and has increased its samples sequenced to 5000 every month.

However, the continent has experienced a 88% increase in COVID-19 cases in the past week, with 79% of these new cases coming from southern Africa followed by 14% in the northern region, according to the Africa Centre for Disease Control and Prevention (CDC).

“We are watching the situation in South Africa very carefully and over the past seven days,  we have seen a major increase in the number of cases, almost 255% increase in the number of cases.. And an almost 12% increase in hospitalisations,” said Mihingo.

“Encouragingly emerging data from South Africa suggests that Omicron may cause less severe disease,” he added, with only 6.3% of ICU cases being related to COVID-19 cases.

Africa collaborates on genome sequencing

WHO head of operational partnerships Dr Thierno Balde

Nigeria, Ghana, Uganda, Senegal and Tunisia have also confirmed the presence of Omicron.

Professor Christian Happi, Director of the African Center of Excellence for Genomics of Infectious Diseases (ACEGID) at Redeemer’s University in Nigeria, said that a “handful” of Omicron cases had been detected in Nigeria but the country was not experiencing a surge.

Happi’s centre is providing laboratory training in genomic sequencing to 16 other African countries.

Describing Africa’s genome sequencing ability as “very robust although not consistent in all countries”, Happi said there were also centres of excellence in Ghana and Senegal.

“What is beautiful about what is happening during this pandemic is that there is strong cooperation among African countries. We are collaborating, and we’re supporting all African countries,” said Happi.

Condemning the travel bans against African countries that had detected Omicron, WHO head of operational partnerships, Dr Thierno Balde, appealed to countries to “apply the International National Health regulations, especially by implementing the scientific evidence-based interventions at the point of entries” rather than travel bans.

He said some countries appeared to be reconsidering their “hasty and emotional” decisions, and the WHO hoped to see the reversal of the travel bans that were having a serious economic impact on countries.

Happi described Canada’s refusal to accept PCR tests from South Africa for its citizens travelling back from that country, as “ridiculous”.

“If Canada is accepting the existence of Omicron that was detected in South Africa, then it’s ridiculous for them not to accept testing from that country. It is not only discriminated but very ridiculous,” said Happi.

 

Teachers in Kenya getting vaccinated. Will everyone now need a booster shot?

Shortly after the release of research showing reduced efficacy of the two-jab Pfizer-BioNTech COVID-19 vaccine against Omicron infection, but better protection with boosters, the World Health Organization (WHO) cautioned that more research is still needed to draw definite conclusions about vaccine strategies in the face of the new variant wave. 

A South African study released late Tuesday showed that people double-vaccinated with the Pfizer-BioNTech COVID-19 vaccine had significantly reduced protection against the Omicron variant, now reported in 57 countries.

On Wednesday morning, Pfizer reported that a third booster of its vaccine would provide significant protection against Omicron, according to a laboratory study.

“Sera obtained from vaccinees one month after receiving the booster vaccination neutralized the Omicron variant to levels that are comparable to those observed for the wild-type SARS-CoV-2 spike protein after two doses,” according to a statement from Pfizer.

While double-vaccinated people had a “more than a 25-fold reduction in neutralization titers” against Omicron, they would likely still still be protected against severe disease thanks to their T cells which are not affected by the Omicron mutations, according to Pfizer.

“Although two doses of the vaccine may still offer protection against severe disease caused by the Omicron strain, it’s clear from these preliminary data that protection is improved with a third dose of our vaccine,” added Pfizer CEO Albert Bourla.

Late Wednesday, South Africa’s medicine regulatory authority approved boosters for all adults over 18 who had been vaccinated at least six months ago, and for all immunocompromised people over the age of 12 vaccinated at least 28 days ago. No other southern African countries have authorised boosters yet, although the region was the first to detect Omicron.

WHO says Pfizer results are preliminary & top priority remains jabs for the unvaccinated

Dr Kate O’Brien, WHO Director of Immunization, Vaccines and Biologicals,

In a press briefing later Wednesday afternoon, Dr Kate O’Brien, WHO Director of Immunization, Vaccines and Biologicals, said that the WHO was “very much interested” in the Pfizer findings, but these were preliminary and only concerned one vaccine. 

“We are still very much in a Delta pandemic and so vaccinating all people, especially those at highest risk of disease, with our existing vaccines, continues to be the top priority,” O’Brien told the global body’s COVID-19 briefing on Wednesday.

WHO has spoken out repeatedly against mass administration of booster shots – saying that available vaccine supplies should instead be focused on getting jabs to less-developed countries, mostly in Africa, where less than 40% of  people have yet to get jabs.

Meanwhile, WHO Director-General Dr Tedros Adhanom Ghebreyesus called on all countries to share information about Omicron speedily, as what was happening in South Africa might not be the same as the rest of the world.

“Cases in South Africa are increasing quickly,” Dr Tedros told the media briefing. “However Omicron was detected when transmission of Delta was very low so it had little competition. It will therefore be important to monitor carefully what happens around the world to understand whether Omicron can outcompete Delta.”

WHO Lead on COVID-19, Dr Maria Van Kerkhove, added that the South African population was young and had a high level of exposure to COVID-19 from previous outbreaks, which might lessen Omicron’s impact.

WHO Chief Scientist Dr Soumya Swaninathan also warned that it is too early to come to any conclusions about the efficacy of vaccines against Omicron as the only available studies showed a “wide variation” and samples were small.

New South African findings also show reduced efficacy from two-shot vaccines against Omicron

On Tuesday night, Alex Sigal of the Africa Health Research Institute in South Africa released research on 12 double-vaccinated people, which found a 41-fold reduction in neutralising Omicron. Six of the 12 subjects had also previously been infected by SARS-COV2 and five of these showed a high level of protection against Omicron.

However, the research showed that the variant still used the ACE receptor to bind to the spike protein.

But Swaminathan stressed that “[these studies] are only looking at one element, just the neutralising antibodies”.

“It’s premature to conclude that this reduction in neutralising activity would result in a significant reduction in vaccine effectiveness. The immune system is much more complex, with the T cells and the memory B cells. What we really need now is a coordinated research effort and not jumping to conclusions, study by study,” she added.

The WHO expects information about how infectious Omicron is on Friday, and said that a number of high-level scientific committees were examining Omicron.

WHO Chief Scientist Dr Soumya Swaninathan

WHO expert bodies are examining Omicron

“The technical advisory group for virus evolution is assessing Omicron’s effect on transmission, disease severity, vaccines, therapeutics and diagnostics and the effectiveness of public health and social measures,” said Dr Tedros.

The joint advisory group on COVID-19 therapeutics is analysing the possible effects of Omicron on treatment of hospitalised patients. 

The Research and Development Blueprint for Epidemics is convening researchers to identify knowledge gaps, and the studies needed urgently to answer the most pressing questions. And the technical advisory group for COVID-19 vaccine composition is assessing impacts of Omicron on current vaccines, said Dr Tedros.

Describing the idea that viruses became less virulent as they evolved as “something of an urban myth”, the WHO’s Assistant Director-General for Health Emergencies, Dr Mike Ryan, said that even if this was the case with Omicron, if it generated more cases this would put pressure on health systems and more people die. 

“That’s what we can avoid. We cannot do anything about maybe the inherent qualities of a virus but we can prevent our systems coming under pressure,” stressed Ryan – through vaccination, masks and reducing social contact. 

Lift the travel bans – end ‘travel apartheid’

Dr Tedros thanked Switzerland and France for lifting their travel bans on southern Africa and called on other countries to do the same.

However, on Monday the UK added Nigeria to its red list, while many countries are only likely to reassess the bans after a month – way too late to salvage the Christmas tourist season in southern Africa.

The moves by developed countries to shut out travelers from southern Africa, or all of Africa in some cases, were last week denounced as “travel apartheid” by UN Secretary General Antonio Guterres.

Guterres said it was “unacceptable to have one of the most vulnerable parts of the world’s economy condemned to a lockout when they were the ones who  revealed the existence of a new variant.”

His comments were echoed this week by Nigeria’s Ambassador to the UK, Sarafa Tunji Isola, who told the BBC that “the reaction in Nigeria is that of travel apartheid.”

“Because Nigeria is actually aligned with the position of the UN secretary general that the travel ban is apartheid, in the sense that we’re not dealing with an endemic situation, we are dealing with a pandemic situation, and what is expected is a global approach, not selective,” Isola said.

Image Credits: Wish FM Radio.

Dr Michel Sidibe, WHO’s Mariangela Simao and representatives from African medicine national regulatory authorities.

The newly constituted African Medicines Agency (AMA) will be key in assisting the African Union (AU) to achieve its aim of producing 60% of vaccines on its own soil by 2040.

This emerged at a two-day meeting of the Partnership for Africa Vaccine Manufacturing (PAVM) hosted by Rwanda this week. The PAVM was set up six months ago by the AU and Africa Centre for Disease Control and Prevention (CDC) to drive vaccine development. 

Major global pharmaceutical companies Pfizer, BioNTech, Moderna and Johnson and Johnson told delegates that vaccine manufacturing required long-term, capital intensive investment.

But they also stressed the need for a harmonised regulatory environment to ensure the smooth and speedy assessment and registration of vaccines and medicines.

That’s something that the AMA, could provide, once the agency is fully operational.  The AMA Treaty formally came into force on 5 November after the AMA treaty was formally signed and ratified by 15 African countries.  Altogether some 28 of Africa’s 55 countries have aligned with the treaty by signing and or ratifying it, as the continent ‘counts down’ to full buy-in from AU nations – with Uganda as the most recent country to ratify the treaty instrument.

But major countries like South Africa, Nigeria and Kenya are among the 27 countries that have yet to sign. 

Differing skills

Michel Sidibe, the AU Special Envoy for the AMA, said that the agency needed to “create a safe environment for investment”.

“You will not attract investors if you have some countries with 40% of fake drugs or substandard drugs,” said Sidibe. “A harmonised regulatory system will help us to create a safe environment for investment from our own continent, and with partners who want to come and invest in our countries.”

He added that “if we produce vaccines and drugs and we don’t have a mechanism on our continent to fast track the authorization process, it will not be helpful for our countries”.

Country medicine regulators appeal for training

While skills at the different country medicine regulators differ considerably, a panel featuring five national regulators, including South Africa, Morocco and Ethiopia, appealed for more support as the continent prepares to manufacture vaccines.

Tumi Semete-Makokotlela, head of the South African Health Products Regulatory Authority (SAHPRA), said that harmonisation of processes across all 55 African states was important “so that we can rely on each other’s decisions”.

She also appealed for investment in the regulators’ capabilities so that they could “do full lifecycle product management” from oversight of the clinical trials to product approval, pharmacovigilance and post-regulatory monitoring of products. 

Professor Bouchra Meddah, Director of Pharmacy and Medicines in Morocco’s Ministry of Health, also appealed to the Africa CDC, AMA and the World Health Organization (WHO) to provide technical assistance and staff training to all the regulators so that they were “all at a sufficient level in order to manufacture the vaccine”. 

Heran Gerba, Director-General of Ethiopia’s  Food and Drug Authority, called for medical products’ approval processes to be expedited and efficient, adding that Ethiopia had an electronic regulatory information system for licencing,  registration, pre-import permits and for imports, which had improved efficiency.

The regulators have some experience in working together at the African Vaccines Regulatory Forum (AVAREF), which was set up in 2006 by the WHO to improve regulatory oversight of clinical trials conducted in Africa. AVAREF has also played an important role in accelerating the review of Ebola vaccines.

AU Special Envoy for the AMA, Michel Sidibe

WHO benchmarks

The WHO benchmarks regulators and currently only two on the African continent – Ghana and Tanzania – have maturity level three, defined as a “stable, well-functioning and integrated regulatory system”.

However, Dr Mariângela Simão, WHO Assistant Director-General or Drug Access, Vaccines and Pharmaceuticals, said 44 African countries had been assessed using the global benchmarking and “a few others are on a fast track to achieve maturity level three”.

“Ideally, I would like to have at least half of the countries in five years times with maturity level three,” said Simao.

Dr Margareth Ndomondo-Sigonda, Head of Health Programmes at the AU Development Agency, NEPAD, said the AU wanted to assist countries to get maturity level three primary through regional centres of excellence.

These regional centres could, amongst other things, create legal frameworks to support harmonisation of vaccine manufacturing regulatory models; develop vaccine manufacturing knowledge; build leadership skills and develop sustainable financing mechanisms, she said.

Sidibe urged that AMA “should become a reality quickly”. 

“We should do whatever we can to quicken the pace of implementation and operationalisation,” he stressed. “It will help us to tap into the African Free Trade Agreement”.

The AMA treaty has been ratified and deposited by 18 African countries at present, with Uganda the most recent to have signed.  See the interactive map here: 

 

 

An AU session early next year is to determine the seat of the new Agency.  Meanwhile, the buy-in from other major AU nations, particularly South Africa and Kenya, as well as Nigeria, will be much-awaited milestones in the full operationalizing of the AMA vision. 

See more resources and details on the developing African Medicines Agency here on our Health Policy Watch ‘countdown’ site.

The ‘African Medicines Agency Countdown’

 

USAID has assisted Sudan with its cold chain storage for COVID-19 vaccines.

The US Agency for International Development (USAID) has set up a new global initiative to accelerate COVID-19 vaccination efforts, called the Initiative for Global Vaccine Access (Global VAX), the agency announced on Monday

Global Vax’s aim according to USAID, is to “get COVID-19 shots into arms and enhance international coordination to identify and rapidly overcome access barriers to save lives now, with a priority on scaling up support to countries in sub-Saharan Africa”.

Global VAX will coordinate the US government’s COVID-19 vaccination efforts. The US government has already committed more than $1.3 billion for vaccine readiness, and USAID Administrator Samantha Power announced an additional $400 million in American Rescue Plan Act funds, from the  US Congress, to augment this work. 

“Global VAX includes bolstering cold chain supply and logistics, service delivery, vaccine confidence and demand, human resources, data and analytics, local planning, and vaccine safety and effectiveness,” according to the agency.

The announcement was made at a ministerial meeting of key international development partners from around the world, convened by Power.

“The emergence of COVID-19 hotspots and variants including Delta and Omicron further underscore the importance of our global fight. Vaccinating the world is the best way to prevent future variants that could threaten the health of Americans and undermine our economic recovery,” according to USAID.

Global VAX includes:

  • $315 million to support vaccine delivery and get shots in arms in low and middle-income countries.
    This investment will support country-specific needs to ramp up vaccination rates and get more shots in arms. These activities include investing in cold chain and supply logistics to safely store and deliver vaccines; supporting national vaccination campaigns; launching mobile vaccination sites for hard-to-reach and rural populations; assisting countries in vaccine policy-making and planning for strategic health care worker and resource deployment; and supporting the development of health information systems to better evaluate vaccine distribution equity and monitor vaccine safety.
  • $10 million to support in-country vaccine manufacturing.
    This investment will support countries poised to produce vaccines themselves to help them build regulatory capacity, transfer “know-how” to train emerging manufacturers, and provide strategic planning and other assistance. This will enable countries to boost vaccine manufacturing locally, which not only diversifies international production, but also has the potential to drive new investments in local economies and create jobs. This investment strategically complements the U.S. International Development Finance Corporation’s investments to scale regional manufacturing of COVID-19 vaccines.
  • $75 million for additional support for USAID’s Rapid Response Surge Support.
    USAID’s Rapid Response Surge Support delivers life-saving resources to COVID-19 hotspots, or areas experiencing surges in cases. This investment will help strengthen oxygen market systems to improve reliable oxygen production and delivery—often the most critical and in-demand resource needed in communities experiencing COVID-19 surges.

 

Image Credits: USAID.

 

Pharma Panel: Moderator Glaudina Loots (South African government), Sai Prasad (Bharat), Holm Keller (BioNTech), Patrock van der Loo (Pfizer), Adrian Thomas (J&J), John Lepore (Moderna) and Charles Wolf (Sanofi)

The African Union has made steady progress to manufacture vaccines on the continent, but this is a complicated, expensive endeavour that required long-term commitment, Big Pharma companies warned.

Welcoming delegates to the Partnership for African Vaccine Manufacturing (PAVM) reportback six months after it was set up, Rwandan President Paul Kagame said building pharmaceutical manufacturing on the continent had become a matter of life-and-death.

“Africa’s challenges during the COVID pandemic in securing timely access to tests, therapeutics and vaccines have served as a constant reminder that we need to be doing things for ourselves,” said Kagame.

“That does not mean acting alone. Vaccine research and production is fundamentally a global enterprise. We therefore have to work in partnership with each other as Africa and also with key partners around the world,” said Kagame.

He said that the recent ratification of the African Medicines Agency treaty was an important development.

“It is essential to maintain the momentum and fully establish this agency without which Africa cannot independently authorise and register medicines and vaccines,” said Kagame.

He also hailed agreements reached between Rwanda and Senegal and the German company, BioNtech, to start the production of mRNA vaccines as early as next year, as well as the mRNA tech transfer hub set up in South Africa by the World Health Organisation (WHO), which “is working with South African companies to build valuable knowledge best for our continent”.

“These initiatives underway in various countries are evidence of a strong momentum which must be supported and sustained. Because of this terrible pandemic, an opportunity has been created to fundamentally change the pharmaceutical production landscape on our continent,” he concluded.

Africa CDC’s John Nkengasong

Dr John Nkengasong, executive director of the Africa Centres for Disease Control and Prevention (CDC), stressed that partnerships were central to the continental goal of producing 60% of vaccines it needed by 2040. Currently, this figure is 1%.

Nkengasong said one of the meeting’s aims was to get agreement on “an AU-endorsed approach for facilitating regulatory approval processes, which will be packed with what we call potential pathways that we can use because of the speed at which the continent is moving in producing vaccines”.

Options for vaccine authorisation, as presented by Dr Nkengasong.

Complexity of vaccine development

Later in the day, a panel addressed by key Pharma companies stressed the complexity and expense of vaccine development.

Sanofi’s Charles Wolf said that “very long term agreements, and stable negotiations, are vital, vital for vaccine stability”.

Pfizer representative responsive for Africa, Patrick van der Loo, said that for most of his company’s vaccines, tech transfers for formulation and fill finish took around three years.

In July, Pfizer signed a letter of intent with the Biovac Institute in South Africa to manufacture the Pfizer-BioNTech COVID-19 vaccine for distribution within the African Union. 

“To facilitate Biovac’s involvement in the process, the tech transfer, the onsite development, the equipment installation activities, have begun basically immediately,” said Van der Loo.

“We expect that the Cape Town facility will be incorporated into our supply chain by the end of this year,” he added, saying that the company would get the drug substance from facilities in Europe soon and manufacturing of finished doses will commence early in 2022.

“At full operational capacity, the annual production there will exceed 100 million finished doses and all these doses will exclusively be distributed within the 55 member states that make up the African Union,” he added.

However, he warned that challenges experienced in South Africa included unstable power supply and water shortages.

Step-by-step approach

Adrian Thomas of Johnson and Johnson (J&J), which has a partnership with the South African pharmaceutical company, Aspen, said that this relationship was being built in a “thoughtful way, step-by-step building on strength and experience”.

“The overarching message that we have for Africa is that we support, and want to be part of, the long-term strategy for manufacturing internally and across the industry. But it’s it is going to be critical to look at multiple platforms and make sure that we distribute the risk across platforms across diseases and have stepwise progress. It has to be sustainable for the long term,” he stressed.

Moderna’s John Lepore said it was exciting that Africa had a continental strategy for vaccine manufacture – the only region in the world to do so.

“We have committed to spend up to $500 million to produce a factory that can make up to 500 million doses. And it’s really the [PAVM] strategy that gives us the confidence to make that investment,” said Lepore.

“We’re currently doing our own due diligence to make the final site selection, and when we look at the key criteria we need to be successful, they match very well with the strategy that already been developed by the African Union, and the African CDC.”

Production of Sinopharm’s inactivated COVID-19 vaccine candidate.

Not just fill-finish

Unlike the other companies that were mostly involved in fill-finish arrangements with African companies, BioNtech’s Holm Keller said that it wanted its malaria and TB vaccines be manufactured in Africa “end-to-end for drug substance and drug product”

“We have started working on a factory set up that would produce formulated drug bulk,” said Keller. “BioNtech’s focus will be on drug substance and not on fill-finish.”

He added that his company intended to  start building the first factory in a few months in 2022, although he did not disclose where this would be other than to mention meetings in Ghana and South Africa.

Sai Prasad, CEO of Indian manufacturer Bharat, stressed that the “complexity of vaccine  development and manufacturing cannot be overstated”. 

“It takes sometimes decades to develop vaccines. It takes a big amount of investment – usually more than $100 or $200 million, irrespective of whether it is fill-finish or drug substance. 

“And when you make those investments, there has to have stability over a 20 or 30 year period for a vaccine manufacturing company or a product development company to take root and take shape.”

The PAVP meeting continues on Tuesday.

Image Credits: Sinopharm.

Ambassador Grata Endah Werdaningtyas, co-chair of the Working Group on Strengthening WHO Preparedness and Response to Health Emergencies

Now that the World Health Assembly Special Session has overwhelmingly resolved to negotiate a “pandemic accord”, the urgent work of producing a workable plan to tackle future pandemics begins.

This was the view of speakers – most of whom have been integrally involved in “pandemic accord” discussions – addressing an event convened by the Global Health Centre at the Graduate School of International and Development Studies (IHEID) and the United Nations Foundation on Friday.

Colin McIff, co-chair of the Working Group on Strengthening WHO Preparedness and Response to Health Emergencies (WGPR) that brokered the pandemic accord decision, said the two mandates of group were almost “in conflict”.

The first was to assess the International Health Regulations (IHR) that currently govern health emergencies, scanning them for gaps, and the second was to examine the benefits of setting up a WHO instrument on pandemic preparedness and response. 

“These were very challenging mandates,” said McIff, who is Deputy Director of Global Affairs at the US Department of Health and Human Services.

“What we did as a bureau [of the WGPR] very early on was agree that the only way to achieve progress was to keep them as integrated as possible.”

“It was necessary to look at the existing tools and and regulations like the IHR, before looking at a new instrument and to define what those gaps are,” said McIff. 

By the fourth WGPR meeting, the issue of equity was put squarely on the table by the Africa group, added McIff.

The WHASS showed that “there was consensus among Member States, both to take forward a new instrument and to take concrete meaningful steps to strengthen the IHR and to tackle some of these key issues like equity, like sample sharing, like One Health issues”, he added.

Colin McIff, co-chair of the Working Group on Strengthening WHO Preparedness and Response to Health Emergencies (WGPR)

Elusive issue of equity

Indonesia’s Ambassador Grata Endah Werdaningtyas, the other WGPR co-chair, said the pandemic treaty is “a little bit burdened by the hopes of a lot of member states in terms of finding the final solution of our problem”.

“The treaty itself is not a panacea. It has to work in coherent alignment with the existing mechanisms that we have, including the IHR,” she stressed. “The treaty will not stand on its own.”

Werdaningtyas conceded that inequity would not be solved by a new instrument but could be addressed by, for example, “building core capacity in terms of supply compliance and in terms of strengthening our health system”.

WGPR member Dr Malebogo Kebabonye said that WHO member states now had to define how a pandemic accord would work, says, adding that the working group would continue to operate until mid-2022 as it still had to conclude proposals on how to strengthen the IHR.

Pandemic focus, not panacea

Prof Ilona Kickbusch

Despite the WHO now referring to the new instrument as an “accord”, Professor Ilona Kickbusch, said she insisted on it being called a treaty.

She said clarity needed to be reached about its focus – and that it could not be about solving all the problems in global health over the past 75 years, as some seemed to think.

“There is no process of proclaiming a pandemic. If there is to be one, what would this trigger?” asked Kickbusch, chair of the Global Health Center’s International Advisory Board. 

She also said there was an urgent need for increased financing.

“My hair stands on end when I see the expectations on the WHO emergency programme [in comparison to] its budget.

Impatience is giving way to anger

Preeti Sudan, a member of the Independent Panel for Pandemic Preparedness and Response

However, speakers also expressed frustration that the final text of a pandemic accord would only be presented to the 2024 Wold Health Assembly.

“The pandemic is still raging, reinventing itself, throwing up new challenges. Financing is required urgently, the WHO needs to be strengthened. It needs independent financing. How do we do that?” asked Preeti Sudan, a member of the Independent Panel for Pandemic Preparedness and Response.

“Do we need do we then wait for 2024? How do we address issues of inequity? The situation is dynamic and extremely serious.”

Elhadj As Sy, Co-Chair of the WHO Global Preparedness Monitoring Board, also appealed for urgency.

“What we really have not really taken into account fully is the degree of impatience that is really growing among citizens and communities,” he said.

“That is translating into anger. And that is translating into mistrust and then we should not let that continue. Because then we will not only have a health problem or a pandemic to deal with but a much bigger societal and political issue that will threaten all our efforts.”

Elhadj As Sy, Co-Chair of the WHO Global Preparedness Monitoring Board