Samples of SARS-CoV2 variants obtained and monitored by WHO, in collaboration with partners, expert networks, national authorities, institutions and researchers.

The war against COVID-19 has changed with the emergence of the highly transmissible and deadly Delta variant, said an internal US Centers for Disease Control and Prevention (CDC) slide presentation.

The document, which has not yet been released, was obtained by the Washington Post and calls for a new and more aggressive masking and vaccination strategy in the US to combat the spread of the Delta variant.

Most alarmingly, it warns that people with breakthrough infections, which are cases that occur despite full vaccination, may be as contagious as unvaccinated people. 

“We are dealing with a different virus now,” Dr Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases and the Chief Medical Advisor to President Joe Biden, told NPR on Tuesday.

“This is not the original virus that we were dealing with. This has different capabilities [and is] much more efficient in transmitting from person to person,” he said.

Delta variant more transmissible than Ebola, common cold and smallpox

The Delta variant (B.1.617.2), first identified in India in October 2020, has been described by WHO officials as the “fastest and fittest” variant. The variant has been sweeping across the world, now reported in 132 countries. 

The newest variant of concern is “considerably more transmissible” than previous variants and has a viral load approximately a thousand times higher than the original virus, said Fauci in a closed-door meeting on 29 July with Members of Congress. 

Estimates suggest that an individual infected with the Delta variant will pass the disease on to between five and nine other people, while the original virus would be passed on to two to three people. 

This indicates that the Delta variant is more transmissible than MERS, SARS, Ebola, the common cold, the seasonal flu, and smallpox. The variant spreads as easily as chickenpox, according to the federal health document. 

Delta variant is more transmissible than MERS and SARS, Ebola, the common cold, the seasonal flu and 1918 flu, and smallpox, according to the CDC.

“I think people need to understand that we’re not crying wolf here. This is serious,” Dr Rochelle Walensky, Director of the CDC, told CNN. “It’s one of the most transmissible viruses we know about. Measles, chickenpox, this – they’re all up there.”

The data presented in the internal document was “sobering,” said Walensky. 

The Delta variant may also cause more severe disease than previous strains of SARS-CoV2. Studies conducted in Canada and Scotland found that people infected with the variant are more likely to be hospitalized, while a study from Singapore indicated that patients are more likely to require oxygen, admission into an intensive care unit, or develop pneumonia.  

More drastic action is needed to deal with Delta threat

The CDC’s new masking guidelines for vaccinated people, which were introduced on Tuesday, were based on the data presented in the document. 

“To reduce the risk of being infected with the Delta variant and possibly spreading it to others, wear a mask indoors in public if you are in an area of substantial or high transmission,” said the updated guidelines.

The new guidelines, however, didn’t go far enough in the context of the threat posed by the Delta variant.

“Given higher transmissibility and current vaccine coverage, universal masking is essential,” said the document. 

“The measures we need to get this under control, they’re extreme,” said Walensky. 

“Nonpharmaceutical interventions are essential to prevent continued spread with current vaccine coverage,” the document said. 

Along with universal masking and community mitigation strategies, the document recommends a vaccine mandate for healthcare personnel to protect vulnerable populations.

The CDC also faces the daunting communication challenge of emphasizing the efficacy of the COVID vaccines in preventing severe illness and death, while improving the public’s understanding of breakthrough infections and acknowledging that vaccinated people are transmitting the virus.

Immunized people as vectors for SARS-CoV2 virus

Although unvaccinated people account for the bulk of virus transmission, vaccinated people can also be vectors for the SARS-CoV2 virus, found a new CDC report released on Friday.

The report was based on an outbreak of 469 cases of COVID in Barnstable County, Massachusetts, following a series of large public gatherings in early to mid-July. Approximately 74% of cases occurred in fully vaccinated people and 89% of the cases were caused by the Delta variant.

Among those with a breakthrough infection, 79% reported symptoms, the most common being cough, headache, sore throat, muscle aches, and fever.

The report concluded that, as population-level vaccination coverage increases, vaccinated people are likely to represent a larger proportion of COVID cases. Breakthrough infections are also expected to occur with greater frequency among groups at risk of primary vaccine failure, such as those with compromised immune systems or those over the age of 60. 

The authors suggested that even areas without high COVID transmission should expand prevention strategies by requiring masks indoors and limiting capacity at gatherings.

Vaccinated people may be as contagious as unvaccinated people

Inoculated people infected with the Delta variant carry tremendous amounts of the virus in the nose and throat, said CDC officials. The vaccine-induced antibodies largely remain in the blood, so vaccinated individuals won’t have local immunity in the nose or throat. 

This means that they will be able to transmit the virus to others while they are infected and contagious. 

People with breakthrough infections may be as contagious as unvaccinated people, found the internal CDC document.

There are currently 35,000 symptomatic infections reported per week among 162 million vaccinated Americans. 

“Vaccines prevent more than 90% of severe disease, but may be less effective at preventing infection or transmission,” said the internal CDC slide presentation. “Therefore, [there will likely be] more breakthrough and more community spread despite vaccination.”

This, however, doesn’t undermine the efficacy of vaccines. The risk of severe disease or death is reduced ten-fold or greater in vaccinated individuals and the risk of infection is reduced three-fold.

Infections, hospitalizations, and deaths on the rise in the US

Infections in the US have increased 145% in the past two weeks, accompanied by rising rates of hospitalizations and deaths, particularly in areas with low vaccination rates. 

According to CDC estimates, over 80% of recent COVID cases in the US have been caused by the Delta variant.

Cases in all but one state have risen in the past seven days.

The current number of new COVID cases is higher than the peak reported last summer and hospitalizations have reached the same level as this time last year, before vaccines were available. Hospitalizations are much more common now among patients aged 30 to 39 years old, compared to those over the age of 70. 

“This sudden turn of events threatens to undermine the significant progress we have made this year to overcome the pandemic,” said Representative James E. Clyburn, Congressperson and Chair of the Select Subcommittee on the Coronavirus Crisis, at a briefing with CDC officials on Thursday. 

“Getting vaccinated remains the most effective way to save lives and stop the spread of the Delta variant,” said Clyburn.

In a recent attempt to revive vaccine efforts, US President Joe Biden will require all federal workers and members of the military to either get vaccinated or face regular testing, social distancing, and mask wearing. 

He urged companies and local governments to follow his lead. “This is a pandemic of the unvaccinated,” said Biden at a press conference on Thursday. “People are dying and will die who don’t have to die. If you’re out there unvaccinated, you don’t have to die. Read the news.”

Some 90 million Americans are eligible for a vaccine but have not yet gotten one. 

“With incentives and mandates, we can make a huge difference and save a lot of lives,” said Biden, who also urged states to offer US$100 to anyone willing to get a jab. 

This move, however, has been criticized by some as rewarding the unvaccinated.

https://twitter.com/LawrenceGostin/status/1420911833305784327?s=20

Image Credits: WHO, CDC.

A special global initiative to respond to the Delta variant has been set up, as COVID-19 cases are expected to reach 200 million within the next two weeks.

Meanwhile, 70% of African countries will miss the World Health Organization’s (WHO) target to vaccinate 10% of their populations against COVID-19 by the end of September, and deaths on the continent have increased by 80% in the past month.

WHO Director-General Dr Tedros Adhanom Ghebreyesus made these announcements as part of the global body’s media briefing on Friday.

The Rapid ACT-Accelerator Delta Response (RADAR) has been launched with an urgent call for $7.7 billion for more tests, treatments and vaccines to address the variant’s rapid spread, said Tedros.

“We need more research and development to ensure that tests, treatments, vaccines and other tools remain effective against the Delta variant and other emerging variants. And of course, we need more vaccines,” said a tired-looking Tedros, who recently returned from trips to the Tokyo Olympics and opening WHO offices in Bahrain and Kuwait.

Dr Maria van Kerkhove, WHO Lead on COVID-19, said while the WHO was working with groups across the world to “get a better handle on the Delta variant”, some laboratory studies suggested that the variant was able to replicate faster in human airways and that those infected had higher viral loads than with previous earlier versions of the virus.

“What we do know is that public health and social measures do work against the Delta variant,” stressed Van Kerkhove.

“We know that our vaccines are safe and effective against severe disease and death. And so those who have access to the vaccine, when it’s your turn, please get vaccinated and make sure that you get the full course.”

Dr Maria van Kerkhove, WHO Lead on COVID-19

Africa might not vaccinate 10% of citizens by end of year

Once again, Tedros sounded the alarm about Africa’s slow vaccine rollout: “Around 3.5 million to 4 million doses are administered weekly on the [African] continent, but to meet the September target this must rise to 21 million doses at the very least each week.

“Many African countries are prepared well to roll out vaccines, but the vaccines have not arrived. Less than 2% of all doses administered globally have been in Africa, less than 2%. Just 1.5% of the continent’s population are fully vaccinated.”

Dr Bruce Aylward, WHO’s representative on COVAX, said that Africa might not even vaccinate 10% of its citizens by the end of the year.

“There’s enough absorptive capacity that they could easily hit 30-40% coverage,” said Aylward. “So our key goal, and what I spent my days doing, and an awful lot of other people like the Director-General, is trying to look at how do we shift more product into that pipeline, so that we can make sure that realistically, we’re well over 20% to 30% by the end of this year.”

But, said Aylward, the decision to supply African countries rests with “CEOs and the boards of companies that manufacture vaccines”.

“We should never be talking about ‘what do we think is going to happen in Africa versus America versus Europe’. We should have the same standard, we should have the same ambition, we should have the same aspiration and be driving for the same coverage levels, right. So if Europe gets to 70-60%, by the end of this year, why should Africa not get there as well?”

Massive fireworks display for crowd of 11,000 athletes and just 950 spectators at Olympic opening ceremony 23 July

Tedros defends Olympics visit 

When asked whether his attendance at the Tokyo Olympics was an endorsement of the Games, which has seen a spike in COVID cases in Japan, Tedros said he had attended the opening ceremony and addressed the Olympic Organising Committee to spread the message of global solidarity to do better against the pandemic.

He appealed to all Olympic athletes to become “ambassadors of solidarity” to defeat the pandemic when they went back to their countries.

“There is no zero risk, but Japan has tried its best,” added Tedros.

“When I was attending the official opening, I saw the torch bearer with a mask and the torch, and that picture still means a lot to me. It shows that we are doing this in very difficult conditions. We’re doing this when we’re taken hostage by a dangerous virus, but at the same time it shows me the determination to fight back.”

While admitting that Tokyo had seen an increase of around 3000 COVID cases in the past 24 hours, WHO Director of Health Emergencies Dr Mike Ryan said that the Olympics’ risk management was “extremely comprehensive”

“The Director General’s trip was to highlight the need for the world to come together, the need for the world to act together, the need for the world to reduce the inequities that are truly driving this pandemic and focus on what are the true drivers of this pandemic,” said Ryan.

“ And the true drivers of this pandemic are not within the Olympic Games. They’re really related to the deep inequities we have in the distribution and availability of vaccine, the deep inequities in health that we have around the world. And his call was a call to the world at a moment of unity of sport: we need a moment of unity amongst health systems, amongst governments, amongst everybody to play fair.”

WHO expects China’s co-operation on virus origin, despite its recent refusal

Zeng Yixin, Vice Minister of the National Health Commission.

In relation to China’s recent refusal to agree to phase two of the planned WHO virus origins research in its country, Ryan said he expected that the country would cooperate.

“There’s a lot of rhetoric out there. The one consistent thing we’ve heard from all countries has been, ‘let’s not politicise the science’ and the next thing that happens is the science is politicised. 

“We believe we have the basis to move forward. We have a set of studies that can be taken forward. We want to bring together the scientific advisory group on origins to help take that forward. We want to bring members of the international team into that process to maintain continuity with the previous process. And we want to reassure our colleagues in China that this process is still, and always has been, driven by science,” said Ryan.

“The objectives that we all want is to control COVID-19, to establish the origins of the virus and put in place what measures we can to prevent a further re-emergence of a similar virus in the future.”

Details of African mRNA hub released

WHO Director-General Dr Tedros Adhanom Ghebreyesus

To boost Africa’s vaccine manufacturing capacity, Tedros released details of the WHO’s partnership with a number of South African companies and the Africa Centres for Disease Control (CDC).

The partnership’s responsibilities, set out in a letter of intent, follows the WHO’s announcement last month of the first COVID-19 mRNA vaccine technology transfer hub in South Africa to enable “vaccine security for Africa in the future”.  

Two South African companies, Afrigen Biologics and the Biologicals and Vaccines Institute of Southern Africa (Biovac), will provide the site, staff and expertise for the hub, while the South African Medical Research Council (SAMRC) will assist with clinical trials and getting products to market.

“Inequitable manufacturing and distribution of vaccines is behind the wave of death, which is now sweeping across many low- and middle-income countries that have been starved of vaccine supply,” said Dr Soumya Swaminathan, WHO Chief Scientist in a media release on Friday.

“Building vaccine manufacturing capacity in South Africa is the first step in a broader effort to boost local production to address health emergencies and strengthen regional health security.” 

“At the Medicines Patent Pool (MPP), we look forward to offering our intellectual property expertise and experience, and to working closely with WHO and partners”, said Charles Gore, Executive Director of MPP. 

“Within the consortium, MPP will provide appropriate intellectual property analysis, define and negotiate terms and conditions of the agreements, provide alliance management and make use of our established robust selection process to allow further technology recipients to benefit.”

Afrigen is a biotechnology company incorporated in South Africa, which established the first adjuvant formulation laboratory in Africa and has a pipeline of vaccines in development. Afrigen has built strong research and development partnerships with leading Universities in South Africa and across Africa.

“We have recently completed a facility suitable for the establishment of a fully integrated mRNA pilot scale production, formulation and fill finish platform,” said Prof Petro Terblanche, Managing Director of Afrigen. “Our platform and facilities are well positioned to deliver on the hub’s objectives, and  Afrigen will focus on ensuring the technical, scientific, quality control and quality assurance and regulatory teams so as to implement the mRNA Hub for Africa.”

Biovac is a South African specialist vaccines company that was established to revive local human vaccine production in Southern Africa. 

“Biovac sources and supplies a comprehensive range of vaccines required by the South African government and its neighbouring countries including childhood disease vaccines among others, and more recently COVID-19 vaccines,” said Biovac CEO Morena Makhoana. 

“It is a long-held desire of Biovac to ensure that the full value chain of vaccines is developed in our continent and our aim is to assemble state of the art manufacturing capacity and help ensure the transfer of mRNA technology and know-how as quickly as possible.”

 

Image Credits: @Olympics , China Daily.

Healthcare professional administering a COVID-19 vaccine at Yankee Stadium in the Bronx, New York in February.

This article is the first in a series on COVID-19 booster vaccines, which is an evolving discussion as more evidence emerges about the performance of vaccines against variants.

A vigorous debate is underway in the global health community over the potential benefits of COVID booster vaccines for healthy people who have already received a full course of a WHO-approved vaccine, with Pfizer pushing hard for boosters to address variants.

Israel announced on Wednesday that it would administer boosters for people over the age of 60 starting next week, joining Hungary, Turkey, Thailand, Bahrain and the United Arab Emirates – although the US is holding back for now.

Vaccines are still a scarce resource and giving third doses to people in wealthy countries means diverting doses from vulnerable people in poor countries, the WHO has warned. Some critics have added that the move is unethical and that it opens the door to the development and global circulation of new variants.

But the pharmaceutical industry, and other booster shot proponents have argued that boosters could be needed in the future, citing lab-based data showing that antibody responses wane six months after the second jab, but rise again following a third jab. 

Booster shot proponents, including a number of leading scientists in Israel, which is now seeing a surge in COVID cases, have also cited new data suggesting that vaccine protection may be waning among older people whose immune systems are weaker  – along with being less effective in protecting people against the Delta variant. 

To address the Delta variant, both Pfizer and Moderna aim to develop new formulations of their vaccines to target more of the SARS-CoV2 spike protein, with plans to roll those new vaccines out by the end of the year.  But a debate is also raging over whether boosters of the existing vaccine are needed even before that among certain groups of people.

Too early to tell?

IFPMA Director-General Thomas Cueni

“Manufacturers and developers are studying the need for boosters based on whether there is waning immunity over time and cross-protection against variant strains,” Thomas Cueni, the head of the International Federation of Pharmaceutical Manufacturers (IFPMA), told Health Policy Watch. “Based on these learnings, companies are also advancing studies of both boosters and new formulations to address SARS-CoV2 variants emerging across the globe.

“If data from studies demonstrate, when available, that there is a need for a booster dose of a vaccine, or a new variant-specific vaccine, we will share the necessary information and work with governments on new agreements or updates to existing agreements to supply booster doses or variant-specific vaccines, subject to regulatory authorization,” he added.

However, booster skeptics have charged that lab-based metrics like antibody responses to vaccines are not a watertight proxy for the real-life performance of vaccines or for immunity against SARS-CoV-2. They have argued that it is too early to tell whether booster shots are needed in the general population.

Still, there appears to be consensus that booster jabs could save lives and precious hospital capacity if they were prioritized in immuno-compromised patients, who are roughly twice as likely to die from COVID-19 as healthy people and often display woefully inadequate antibody responses, even after receiving two vaccine jabs [see related story]. 

Going forward, policymakers will have to re-evaluate whether vaccine policies should aim to prevent infection and symptomatic disease, or whether it is more realistic to prevent severe disease and death – in light of gaping vaccine shortages and the rapid spread of new variants like Delta, public health experts told Health Policy Watch.

Dr Michael Osterholm, Director of the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, said that there are still too many unknowns.

“What we’re really looking for are these larger studies but that takes time. What’s important is what happens in the next six months or the next year,” he told Health Policy Watch in an interview. “Do [fully vaccinated people] get infected or not? Do they have waning immunity? The pandemic has only been around for 1000 days. We just don’t know yet.”

US health protection agency says boosters not needed for now 

After a private meeting between Pfizer and US regulators about a third booster jab earlier this month, the US Centres for Disease Control (CDC) and the US Food and Drug Administration (FDA) responded that “Americans who have been fully vaccinated do not need a booster shot at this time”.

“We are prepared for booster doses if and when the science demonstrates that they are needed….People who are fully vaccinated are protected from severe disease and death, including from the variants currently circulating in the country such as Delta,” said a joint statement from CDC and FDA in early July. 

“People who are not vaccinated remain at risk. Virtually all COVID-19 hospitalizations and deaths are among those who are unvaccinated.”

But this week, a leaked CDC report revealed that a person infected with the Delta variant may infect five to nine others on average – making it at least twice as contagious as the original SARS-Co-v2 lineage and as infectious as chicken pox. In addition, the report found that vaccinated people may be as likely to spread the virus as unvaccinated people. Those findings, first reported by the Washington Post, are thought to have pushed the CDC to reverse its mask mandate to recommend that everyone – including those fully vaccinated – wear masks in certain settings in public indoor events.

Thailand, UAE and Bahrain are already giving boosters 

Meanwhile, Thailand, United Arab Emirates (UAE) and Bahrain have pushed ahead with a booster jab in healthy people who have received both shots of Sinopharm, Sinovac, and AstraZeneca vaccines – all viewed as less efficacious than the mRNA vaccines produced by Pfizer and Moderna. 

Soon, other large G-7 nations like the United Kingdom, the United States, and Germany, may also follow suit following fresh concerns that two vaccine shots, even of the most effective vaccines, may not be sufficient to prevent SARS-CoV-2 infection and mild disease against highly contagious variants like Delta.

Yet large-scale data from the UK, Qatar, and Israel, demonstrates that vaccines confer robust protection against hospitalization and death from SARS-CoV-2 – and that those trends persist against variants like Delta.

In addition, a multi-country study supported by Pfizer involving almost 45,000 people revealed that, with the Beta variant, vaccine efficacy against infection drops from 96% to 84% after six months. 

The study, which is not yet peer-reviewed, also stressed that efficacy against hospitalisation stands at 97% after six months. Those findings, researchers said, demonstrate that the Pfizer vaccine “prevents COVID-19 effectively” six months after the second jab:

“The data in this report demonstrate that BNT162b2 [Pfizer] prevents COVID-19 effectively for up to six months post-dose two across diverse populations, despite the emergence of SARS-CoV-2 variants, including the B.1.351 [Beta] lineage, and the vaccine continues to show a favourable safety profile,” concluded the study.

It adds that “ongoing follow-up is needed to understand the persistence of the vaccine effect over time, the need for booster dosing, and timing of such a dose….booster trials to evaluate safety and immunogenicity of BNT162b2 are underway to prepare for this possibility.”

These findings come on the heels of an earlier study in some 40,000 people in the UK, published in the New England Journal of Medicine (NEJM), which, similarly to the Pfizer study, found that two shots of Pfizer still confer strong protection against symptomatic disease, with a protection of 88% against the Delta variant, in comparison to 94% against Alpha, the variant first discovered in the UK. 

The NEJM study indicates that fully vaccinated people are likely to be well protected against variants like Delta, if they receive both shots, concluded the authors of the study.

“Overall, we found high levels of vaccine effectiveness against symptomatic disease with the delta variant after the receipt of two doses,” the authors said. “These estimates were only modestly lower than the estimate of vaccine effectiveness against the alpha variant,” they added, noting that similar trends were seen with the AstraZeneca vaccine.

However, they warned that a single dose of the Pfizer/BioNTech vaccine conferred substantially less protection against Delta compared to Alpha – with a drop in effectiveness from 50% to 31% for symptomatic disease, respectively. 

In US, 97% of people hospitalized for COVID-19 are unvaccinated 

In the US, too, it appears that fully vaccinated people develop mild but not severe disease or death. Rochelle Walensky, the Director of the US Centers for Disease Control (CDC), has said that 97% of hospitalised COVID-19 patients in the US are unvaccinated – suggesting that achieving high vaccination coverage can effectively curb transmission, hospitalisation and deaths from COVID for now.

“We are seeing outbreaks of cases in parts of the country that have low vaccination coverage because unvaccinated people are at risk,” said Walensky. And communities that are fully vaccinated are generally faring well.

“The good news is that if you are fully vaccinated, you are protected against severe COVID, hospitalisation, and death, and are even protected against the known variants — including the Delta variant — circulating in the country,” Walensky.

“If you are not vaccinated, you remain at risk. And our biggest concern is that we are going to continue to see preventable cases, hospitalisations, and, sadly, deaths among the unvaccinated.” 

High-risk groups in poorer countries should be vaccinated first

The WHO, meanwhile, has taken a strong stance against boosters in healthy people who are fully vaccinated, asserting that scarce vaccine doses need to be directed first of all to countries and populations where health workers and older people haven’t yet been vaccinated at all. 

“Some countries and regions are actually ordering millions of booster doses before other countries have had supplies to vaccinate their health workers, and the most vulnerable. I ask you, who would put firefighters on the front line without protection – and who are most vulnerable to the flames of this pandemic? Health workers are on the front lines,” the WHO head Dr Tedros Adhanom Ghebreyesus said earlier this month.

“Currently, data shows us that vaccination offers long lasting immunity against severe and deadly COVID-19. The priority now must be to vaccinate those who have received no doses and protection,” the WHO DG added. 

In light of the gaping shortage of vaccines in low- and middle-income countries, as well as the scarcity of data about the benefits of boosters in healthy people, prioritizing vulnerable populations appears to be a viable policy option, at least for now, experts told Health Policy Watch.

“There isn’t much evidence regarding the third shot in healthy people who are fully vaccinated,” Antoine Flahault, the Director of Geneva University’s Institute of Global Health, told Health Policy Watch. “I am not sure that the priority is to give a third shot to entirely vaccinated populations when large parts of the world remain still very poorly covered.

“I would suggest to ask regulatory authorities (e.g. EMA) to take a position rather than proposals coming from manufacturers which can always be prone to forms of conflicts of interest,” he added. “[Boosters] must be decided by bodies totally independent from producers.”

At the same time, German’s Health Minister Jens Spahn, while visiting Geneva earlier this month, asserted that vaccine shortages elsewhere are not a good reason to hold off on boosters in high-income countries that already have large groups fully vaccinated.

“I think we should be able to do both [administer boosters and vaccinate high-risk groups in other countries]. I want both to be possible for us to be able to provide a third vaccination, while also providing our first vaccination to everyone around the world…One shouldn’t come on the account of the other,” he said at an event at the Geneva Graduate Institute, adding that he expected vaccine surpluses, rather than shortages, by 2022.  

Re-evaluating the aims of vaccine policies

It appears that policymakers have reached a crossroads where they could either attempt to prevent COVID infection, transmission, and mild disease altogether – or instead try to prevent severe hospitalisations and death in vulnerable groups, Eyal Leshem, Director of the Center for Travel Medicine and Tropical Diseases at Israel’s Sheba Medical Center, told Health Policy Watch. 

But as the coronavirus continues to mutate and vaccine doses remain scarce in poorer countries, preventing infection and transmission of SARS-CoV-2 in the whole population is bound to be a “challenging goal” for now, he added.

“We are learning now that achieving population immunity is going to be a challenging goal in a world where the virus mutates and the vaccine is less effective in preventing infection and mild disease with new variants,” said Leshem. “We know this from other pathogens, where the purpose of the vaccine is to prevent severe hospitalisations and death [protective immunity] rather than to completely prevent infection [sterilizing immunity]. Those are two different approaches to public health protection now.

“If you want to protect persons against severe disease and hospitalisations, then your target population are those that are at highest risk,” he said. 

First in a series on COVID-19 booster vaccines. See the second article, COVID Vaccine Boosters in Immuno-compromised People – Could They Also Help Curb Development of New Variants ?

Image Credits: Flickr – New York National Guard.

Protesters and police clashed during a march against France’s health pass, which requires proof of vaccination against COVID-19 or a negative test to enter many public venues.

As more high income countries adopt COVID-19 passes for entry to venues like sporting and cultural events, restaurants and even workplaces, public opposition to the use of the public health tool is also growing – despite the fact that these same countries enjoy very widespread access to vaccines and rapid COVID tests. 

However, countries like France and Italy, which saw noisy demonstrations over the passes last weekend, are now registering record numbers of registrations for vaccines – suggesting that the new measures may also be effective in convincing the vaccine-hesitant to finally get their jab.

The passes are being touted by over a dozen European governments as a way to reopen economies and societies despite the sharp, recent rises in new COVID cases, driven by the steady global spread of the more contagious Delta variant.

In Europe, uptake of domestic passes follow on the European Union-wide adoption of the COVID Digital Certificate  on 1 July, to ease restrictions on international travel within the EU and beyond, but verifying an individual’s vaccination status, recent negative test result, or recovery from a COVID infection.

Some 13 EU member states have now established plans to extend the COVID pass system for domestic use. The new rules typically require digital or paper documentation of a certificate before entry into bars, restaurants, museums, indoor sports venues, and other cultural or entertainment sites.  

Denmark, Austria, Cyprus, France, Germany, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Portugal, Ireland, and Slovenia are among those who are already enforcing domestic health passes. 

Switzerland, which is part of the European Schengen free travel zone, has meanwhile, only implemented such a pass system for large scale events with over 1,000 participants and nightclubs. For smaller events, as well as restaurants, sporting, cultural, and leisure facilities, the use of a COVID pass is discretionary. 

The United Kingdom also is discussing implementing a vaccine pass system for large scale indoor events by the end of September. Israel, which abandoned virtually all COVID restrictions after a mass vaccination campaign pushed new cases to nearly zero, has now re-instituted its Green Pass programme for virtually all indoor venues in the face of new infections that now exceed 1000 people a day.   

Some US states & employers will require proof of vaccination

The Biden Administration ruled out introducing mandatory federal vaccine passes in the US in early April, but some states have decided to introduce their own measures. California and New York will require state employees and healthcare workers to show proof of vaccination or get tested weekly. Unvaccinated health workers will be required to wear a face mask.  Google and Facebook also announced Wednesday that they would require vaccines for workers at US offices. 

California plans to implement the measures in early August, while New York will adopt them in mid-September.

“It’s like drunk drivers, you don’t have the right to go out and drink and drive and put everybody else at risk, including your own life at risk,” said Gavin Newsom, Governor of California, at a press briefing on Monday. “Those non-pharmaceutical interventions like face coverings and masking were necessary in the absence of vaccines, but with these vaccines, we can extinguish this virus once and for all.”

The Department of Veterans Affairs, which runs one of the nation’s largest health systems, announced on Monday that it would mandate vaccines for healthcare personnel working in Veterans Health Administration facilities. Also on Monday, nearly 60 major health care professional organizations released a joint statement calling for all health care employers to require their employees to be vaccinated against COVID-19.

Protestors decry ‘discrimination’ – but move is incentivizing vaccination   

Switzerland, which is part of the Schengen area, has implemented a pass system for large scale events with over 1,000 participants.

Protests over the passes have erupted almost everywhere where the measure has been introduced – with particularly noisy outcries seen over last weekend in Europe, from Paris to Rome and other major cities across Italy – on city streets that were largely empty only a year ago, under a COVID-imposed lockdown.

But at least half a million vaccination appointments were made within 24 hours of the first Italian announcement of the green pass measure. The pass, to take effect on 6 August, will also be available to those who have only received one vaccine jab. 

“We registered an increase in bookings ranging from +15% to +200% depending on the region,” said Francesco Figliuolo, Italy’s COVID-19 Emergency Commissioner, on an Italian TV news show Tg5. “In Friuli Venezia Giulia we registered +6,000%.”

The new Italian pass announced last week, would be needed to enter gyms, swimming pools, museums, cinemas, theatres, sports stadiums, and indoor seating in bars and restaurants.

“The Green Pass is not arbitrary, but a necessary condition not to shut down the economy,” said Italian Prime Minister Mario Draghi at a press conference on Thursday. “Without vaccinations, everything will have to close again,” he added.

Freedom or ‘selfishness’

In France, the Senate approved a bill on Saturday to introduce mandatory vaccination requirements for certain professions, notably healthcare workers – who must be vaccinated by 15 September. As for the general public, a health pass showing proof of full vaccination or a negative COVID test would be required for adults to gain access to indoor dining and leisure spaces from the beginning of August. A pass showing proof of a negative COVID test will be required for children over the age of 12 from the end of September. 

France’s new mandatory health pass will be required to enter restaurants, bars, theatres, and museums, among other venues.

While over 160,000 French demonstrators took to the streets at the same time – it was clear that the new policy is prompting record numbers of people to book vaccination appointments. Some 1.7 million appointments were made  in just the first 24 hours following President Macron’s initial speech on the COVID pass initiative, and 3.7 million were booked in the first week after he spoke in mid-July,

“You will have understood that vaccination is not obligatory straight away, but we are going to extend the health pass to its maximum to encourage as many of you as possible to get yourselves vaccinated,” said Macron in a televised address. 

Overall, there has been a 59% weekly increase in turnout for first doses, reported one French analyst, Guillaume Rozier. 

While protestors have even cloaked their opposition to the passes in the charged language and symbols of racist Nazi exclusion during World War II, such as the yellow star, public health and government officials have stressed exactly the opposite message.

In fact, they say, COVID passes are an example of the kind of social solidarity, and mutual responsibility of one citizen for another, that is required to beat the pandemic.

“What is your freedom worth if you say to me ‘I don’t want to be vaccinated,’ but tomorrow you infect your father, your mother or myself?” French President Emmauel Macron told the press, during a visit to a hospital in French Polynesia on Saturday.

“That is not freedom, that is irresponsibility and selfishness.” 

More demonstrations are planned in towns and cities across France on Saturday 31 July, the largest of which are expected to take place in Paris. Some 3,000 police officers will be deployed to the capital, where more than 10,000 people are expected to join four protests.

Green passes could be as effective as lockdowns, says one public health expert 

Several countries have arranged to implement a domestic vaccine pass to regulate entry into certain venues.

The “extended use [of the health pass] has not yet been evaluated, but it could prove to be as effective as lockdown, since it amounts to confining all the non-vaccinated who will not have access to bars, restaurants, cultural, social, sporting and festive life, unless they present negative tests every 48 hours,” Antoine Flahault, Director of the University of Geneva’s Global Health Institute told Euronews. 

“And the extended use of the health pass is much less socially and economically punishing [compared to lockdowns],” Flahault added. “We will soon know if it keeps its promises and avoids the saturation of French and Italian hospitals.”

Debate over COVID certificates is ‘like a debate over deck chairs on the Titantic’ 

Other observers point out that the debate over the COVID passes is largely a luxury of the rich – living in societies with enough access to vaccines and tests so that they can indeed be required of every citizen.  But green passes won’t extricate the world from the pandemic – in the absence of low vaccine access in low and middle-income countries.

“I am very troubled about the widespread ignorance in Europe and Switzerland over the problem of global vaccine inequity,” Dr Sara L.M. Davis, Senior Researcher at the Global Health Center, told Health Policy Watch. Over 75% of the 3.5 billion vaccines distributed globally have gone to just ten countries, she points out.

And globally, new cases are now increasing at worrisome rates with the highly transmissible Delta variant sweeping across the world, and cases rising again in the Americas, European and Western Pacific regions, with particular hotspots in countries such as the United Kingdom, Indonesia and Brazil. 

Africa has been in the midst of its worst wave to date. And at the same time, only 1.6% of the population of Africa have been fully vaccinated, as compared to 37% of the population in Europe and North America.  With such low vaccination rates in so many parts of the world, the virus will continue to propagate and spur more new and potentially dangerous variants – no matter what measures are taken in Europe, experts such as Davis warn. 

“Under these circumstances, I think debating the use of vaccine certificates to access restaurants or nightclubs for me and my friends in Switzerland is a little like debating the arrangement of the deck chairs on the Titanic. Unless we have global vaccine justice we’ll all be underwater,” said Davis. 

Image Credits: DW News, Al Jazeera English.

Tanzanian and US officials celebrate the arrival of the first COVID-19 vaccines in the country, part of a donation from the US.

Tanzania has finally started to administer COVID-19 vaccinations, amid a 16-fold increase in vaccine deliveries to Africa in this week alone in comparison to the whole of June.

Tanzanian President Samia Suluhu publicly received the vaccine on Wednesday, a sharp contrast to her predecessor, John Magufuli, who died in March after months of denying the existence of COVID in the country.

Tanzania’s vaccine rollout is the result of a donation of 1,058,000 doses of Johnson and Johnson COVID vaccine from the US government.

After receiving her J&J dose, Suluhu urged Tanzanians to follow her example, noting that the country was not an island but is a part of the interlinked global ecosystem.

Addressing an Africa Centre for Disease Control and Prevention (CDC) press briefing on Thursday, centre director Dr John Nkengasong welcomed the development.

“I just came back from Tanzania and I had a conversation with the leadership. The president was very supportive. We spoke about the COVID pandemic very openly and freely. We are committed to working with them to roll out the one million doses of vaccine that they just received as part of US supply. We are very encouraged. The minister of health was extremely supportive and we look forward to doing our little best to support that effort,” Nkengasong said.

Burundi and Eritrea are now the only African countries that have not started to vaccinate their citizens against COVID-19.

“We continue to engage with Burundi and Eritrea. In the coming weeks, we will be intensifying our efforts there to understand the gaps and areas where we can support them,” Nkengasong said. 

Africa CDC Director Dr John Nkengasong

Leaving no country behind

Nkengasong noted that the battle against COVID cannot be won by leaving any country behind. Instead, he said efforts should be geared towards ensuring all the countries on the continent are supported to take required steps toward quickly stemming the spread of the pandemic.

Dr Matshidiso Moeti, World Health Organization (WHO) Regional Director for Africa, told the briefing that four million doses had been delivered to the continent in the past week in comparison with just 245,000 doses in June. 

“COVAX aims to ship 520 million doses to Africa by the end of 2021. COVID-19 vaccine and deliveries from the African Union’s Africa Vaccine Acquisition Trust (AVAT) are picking up, with a projected rise to 10 million each month from September. Around 45 million doses are expected from AVAT by the year’s end,” Moeti said.

The WHO also revealed that COVAX had reached a deal with Sinopharm and Sinovac which will rapidly supply 110 million more doses of COVID vaccines to low-income countries. 

COVAX and the World Bank are also introducing a new cost-sharing arrangement through which low-income countries can purchase doses beyond the fully donor-subsidized doses they are already receiving from COVAX.

Dr Matshidiso Moeti, WHO Regional Director for Africa

Overall cases are falling but 22 countries report increases over 20%

As more vaccine doses are increasingly becoming available to African countries, the number of cases is also falling with the continent recording its second week of falling case numbers after an unbroken eight-week surge. 

According to the WHO, reported case numbers fell by 18% from over 282,000 to 230,500 in the week ending on 25 July. But 22 countries reported increases of over 20% and reported deaths rose in 17 African countries. 

“Africa is still in the throes of a third wave. The limited slowdown in cases is heartening and cause for a very cautious optimism, but we are far from out of the woods yet. We must all stay vigilant,” said Moeti.

Across the continent, the case fatality rate (CFR) is 2.5% which is higher than the global value of 2.1%. Furthermore, four African countries – Egypt, Sahrawi Republic, Somalia and Sudan – are reporting a CFR higher than 5%.

Dilemma of safely reopening schools 

While noting that reopening schools could lead to a surge in COVID cases, Moeti also noted that continual closure of schools could threaten girl child education. She described this as a dilemma for several African countries. 

To deal with this, she said countries should prioritise efforts aimed at safely reopening schools, which she said would require additional investment.

“Certainly, if young people are going to going back to school, which is a very important objective, then there needs to be a lot of investment in ensuring that this does not result in superspreader events within the classroom and children taking the infection back home where they are likely to infect parents that may be vulnerable to falling seriously ill and dying,” she said. 

WHO Director-General Dr Tedros Adhanom Ghebreyesus

The World Health Organization (WHO) aims to reduce new hepatitis B and C infections by 90% and deaths by 65% by 2030 but to achieve this goal, the global health body needs countries to scale up hepatitis services including prevention, testing, and treatment.

On World Hepatitis Day on Wednesday, WHO Director-General, Dr Tedros Adhanom Ghebreyesus, speaking at a virtual event under the theme “Hepatitis can’t wait”, said many countries still don’t have access to these lifesaving tools and urged everyone to “get to work”.

Over 354 million people worldwide are living with chronic hepatitis; over 8000 new infections of hepatitis B and C occur every day, and more than one million deaths from advanced liver disease and liver cancer occur every year.

Despite the setback of the COVID-19 pandemic and the varying responses to the hepatitis responses, the director-general noted some success stories including the large-scale expansion of hepatitis C treatment, and the reduction of hepatitis B infections in children as well as expanded coverage of infant vaccination. 

“This means that we’re making progress in reducing the risk of liver cancer and cirrhosis, in future generations,” said Dr Tedros.

Last week WHO released the first guidelines on hepatitis C virus self-testing – an innovation that will help normalize testing and allow people to do it in the privacy of their own homes. Last month it launched the first-everglobal guidance for countries seeking to validate elimination of hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection as a public health problem.

While a few countries, including Egypt, Mongolia, and Rwanda have made strides in eliminating hepatitis, many are lagging due to, among others, lack of funding, high prices, and lack of education about hepatitis.   

Hepatitis – the “silent pandemic”

Referring to viral hepatitis as the “silent pandemic”, Pan American Health Organization (PAHO) Director Carissa Etienne said the region of the Americans has strengthened its political commitment by including viral hepatitis in the PAHO elimination initiative. 

Regional plans to eliminate viral hepatitis include partnerships that will for the first time include viral hepatitis in the Caribbean framework on HIV and AIDS. Other services include all 52 countries in the Americas introducing a vaccine against Hepatitis B to all infants during the first year of life.

Etienne however noted some of the limitations to hepatitis services include limited allocation of domestic resources to finance national responses, high prices of medicines and laboratory tests, and limitations to access to generic HCV medicines.

“Despite the policy uptake and the revolution in hepatitis therapeutics, we have not observed a consistent scale-up of testing and treatment of hepatitis B and C, particularly in Latin America and the Caribbean,” she said, adding that countries like Argentina, Brazil, Colombia, and Mexico have been able to implement a sustainable national response to viral hepatitis and to accelerate access to the diagnosis and treatment, particularly for hepatitis C.

“People living with hepatitis cannot wait and we owe it to them to deliver and…to leave no one behind.” 

Mongolia’s successful ‘healthy liver’ program

Mongolia’s Health Minister Dr Enkhbold Sereejav

In Mongolia, chronic hepatitis infections and liver diseases are the leading causes of death, accounting for an estimated one in 10 deaths. Over 95% of liver cancer is associated with hepatitis B and C infections and about one in 10 people live with chronic hepatitis B, and one in 20, live with chronic hepatitis C.

To address this socio-economic and health issue, the government of Mongolia in 2017 launched a public health program called the healthy liver program offering universal screening, diagnosis, and treatment of viral hepatitis, as well as liver cancer caused by viral hepatitis. 

“As a result of this successful program to eliminate HCB and control HPV, about 65% of the target population have been screened, ” said Mongolia’s Health Minister Dr Enkhbold Sereejav. 

Destigmatize hepatitis and support those living with the infection

Dr Sue Wong, President of the World Hepatitis Alliance

While hepatitis treatment services are crucial, the stigma of living with the infection has in some instances made prevention, screening, and treatment difficult.

But that was not the case for Dr Sue Wong, president of the World Hepatitis Alliance, who found out she had hepatitis B after donating blood in college.

“I did not face the stigma and discrimination which have kept so many people from pursuing or even interrupted their careers in healthcare. I also did not face the rejection and abandonment that many experience from family members or significant others because of their diagnosis,” said an emotional Wong.

Detailing her journey with hepatitis B, Wong said her husband was able to get vaccinated and was protected. Her four children are also free of infection as they all received the hepatitis B birth dose within 12 hours of birth.

“I am so relieved that our four children are free of the infection, and we’ll have a hepatitis free future, but millions of mothers cannot say the same,” said Wong, adding that only 43% of infants worldwide get the hepatitis B birth dose, with mothers facing the burden of having passed the infection to their children because they cannot access testing, vaccines or treatment. 

Wong called on greater access to vaccines to help save lives.

“It is, after all, our lives, our families, and the future of our children…”

 

A billion COVID-19 vaccine doses should be reallocated from high-income countries to low- and middle-income countries (LMICs) by September, and of another billion by mid-next year, former President of Liberia Ellen Johnson Sirleaf and former Prime Minister of New Zealand Helen Clark, told United Nations member states on Wednesday.

The pair, who co-chaired the Independent Panel for Pandemic Preparedness and Response which evaluated the global COVID-19 response, were briefing an informal UN plenary meeting on their findings and recommendations.

These include that a Global Health Threats Council is established, the World Health Organization (WHO) is strengthened and empowered, and a pandemic treaty is adopted to guide future pandemics.

“While in some places, vaccines are blunting the worst of COVID-19’s impact, for too many countries, supplies are so limited, and prospects for access pushed so far into the future, that hope is turning to despair,” Sirleaf told the meeting.

Ongoing disaster

Describing the COVID-19 pandemic as “an ongoing disaster”, Sirleaf added that the panel believes it “could have been averted if the countries of the world had heeded the many warnings and prepared their health and surveillance systems – and then when the outbreak began if they had moved together in mutual transparency and solidarity”.

Clark reported that the Panel had found “geopolitical tensions and nationalism had weakened the multilateral system which was designed to keep the world safe”. 

“Vaccine inequity is a key factor in the wave of death we’re seeing across Africa, Asia and Latin America,” said Clark.

“It’s astonishing and self-defeating that pharmaceutical manufacturers continue not to share the technology or know-how which could help quickly scale manufacturing. Because of that, we see the temporary waiver of patents under the WTO’s TRIPS agreement as a key tool which should be at countries’ disposal and urge a swift resolution to the protracted discussion on that,” she added.

WHO Director-General Tedros Adhanom Ghebreyesus sent a message to the meeting, which was delivered by Dr Mike Ryan, Executive Director of  the WHO’s Health Emergencies Programme.

“One of the major gaps exposed during this pandemic has been the lack of international solidarity and sharing: the sharing of pathogen data, epidemiological information, specimens, resources, technology and tools such as vaccines,” said Tedros.

Expressing support for the panel’s proposal for a treaty on pandemic preparedness and response, Tedros said: “We need a generational commitment that outlives budgetary cycles, election cycles and media cycles; That creates an overarching framework for connecting the political, financial and technical mechanisms needed for strengthening global health security.”

At the World Health Assembly in May, Member States agreed to hold a Special Session of the Assembly in November to consider developing a WHO “convention, agreement or other type of international instrument on pandemic preparedness and response”, he added.

“We call on all Member States to engage in this process. We must seize the moment. In the coming months and years, other crises will demand our attention, and distract us from the urgency of taking action now.”

Image Credits: University of Oxford.

UN Deputy Secretary General Amina Mohammed

World leaders have been given clear pointers on how to transform the global food system to be more equitable, nourishing and resistant to climate change, at the end of a three-day United Nations pre-summit attended by over 17,000 delegates.

Focus now shifts to the Head of State-level summit in New York in September, but UN Deputy Secretary General Amina Mohammed stressed that “anything we do must always include those at the center of our food systems: smallholder farmers, indigenous peoples and especially women and youth”.

“Just as food brings us together as cultures and communities, it can bring us together around solutions. But what is clear is there is no one-size-fits-all solution. Our diversity is our strength and reflects the complexity of our world,” Mohammed told the closing plenary in Rome on Wednesday.

She said that the summit would focus on a ‘statement of action’ that “affirms the diversity of our food systems and the complexities, but also the central role that is played by indigenous peoples producers, women and youth”. 

A number of countries have developed “national pathways for food systems transformation” to deliver the sustainable development goals (SDGs) by 2030, said Mohammed.

“The priorities from national pathways were shared by many ministers in Rome. They point to the need for urgent, inclusive, people-centred and nature-positive systems change that is based on the best science and reflects local and national realities within a global context,” said Dr David Nabarro, senior advisor to the summit.

The three-day conference was attended by more than 500 delegates from 108 countries in person, including 62 ministers, and a further 17,000virtual delegates from 190 countries. Host nation Italy’s Minister of Foreign Affairs, Luigi Di Maio, said that the recent G20 Matera Declaration on food security, was “a prime example of how joint political action can lead to broader results on the ground.”

Katrín Jakobsdóttir, Prime Minister of Iceland, called for political leadership, saying, “We have to be brave and politically focused to eliminate harmful practices and at the same time advance what has been proven to be positive, human and nature-friendly. It takes courage to transform at the same time our value systems and our food systems.”

The United States in partnership with the United Arab Emirates and with the support of Australia, Brazil, Denmark, Israel, Singapore, the UK and Uruguay, has already set out its Agriculture Innovation Mission for Climate (AIM for Climate) initiative, to increase and accelerate global research and development on agriculture and food systems in support of climate action.

Japan, meanwhile, outlined its alignment with the European Union on the importance of innovation to transforming food systems, along with a balanced diet, while emphasising the need for solutions adapted to regional contexts.

Transforming food systems to contend with and tackle climate change was also a priority, particularly among Small Island Developing States, the countries facing the worst impacts of rising global temperatures.

“Today we are still able to consume our main traditional staple root crop, pulaka, but only very sparingly,” said Katepu Laoi, Tuvalu’s Minister for Local Government and Agriculture. 

“Our government recognises that providing sustainable, adequate food supply chains for the people of Tuvalu will be increasingly more challenging due to extreme weather events, which have been worsened by climate change.”

 

A new report calls out the animal health industry for fuelling superbug resistance as a result of uncontrolled use of antibiotics and other drugs in intensively farmed livestock.

Antimicrobial resistance (AMR), fostered by the wanton use of antibiotic-laced feed and growth-boosting supplements for livestock and poultry, could lead to the “next pandemic”, warns the first-of-its-kind report on AMR that focuses on the long-ignored global animal health sector. 

The new report, Feeding Resistance, on the growing threat of superbug risks associated with animal health products, was issued last week by a group of forward-looking investors ahead of the opening of this week’s major UN pre-summit on food systems in Rome. 

Globally, some 70% of antibiotics and other antimicrobial drugs are fed to livestock and poultry, accelerating the risk of widespread antimicrobial resistance, warns the report, released by an investor network called the FAIRR Initiative last week.

(A) Largest five consumers of antimicrobials in livestock in 2010. (B) Largest five consumers of antimicrobials in livestock in 2030 (projected). (C) Largest Increase in antimicrobial consumption between 2010 and 2030. (D) Largest relative increase in antimicrobial consumption between 2010 and 2030. CHN, China; USA, United States; BRA, Brazil; DEU, Germany; IND, India; MEX, Mexico; IDN, Indonesia; MMR, Myanmar; NGA, Nigeria; PER, Peru; PHL, Philippines. (PNAS, 2015)

Critical drugs are still being marketed by the industry, worth some US$ 47 billion annually, as growth promoters and preventative medications, leading to their misuse and overuse in the world’s 70 billion animals raised in industrial livestock complexes, charges the report.

The report analysed publicly-available data from 10 of the largest publicly-listed animal health companies that manufacture and sell antimicrobials for use among livestock, poultry and also in fish farms, and which comprise about 40% of the sector overall.  

Intensive, industrial-style livestock and poultry production comprises the majority of those animals today that eventually end up as meat in supermarkets and on restaurant menus in developed countries – and increasingly in emerging economies as well. 

“For animal health companies, antibiotics and other antimicrobials are a volume business. The overuse and misuse of these products in animal agriculture is a significant contributor to the global risk of AMR, catalysed by manufacturing, marketing and sales practices,” the report states.

“The animal health sector is failing to live up to its responsibilities to manage the risks we all face from antibiotic resistance,” said Jeremy Coller, the British philanthropist who is the chair of FAIRR. “It’s absolutely necessary for animal pharma to improve its antibiotics stewardship.”

Industry labelling of antibiotics as animal growth products contributes to AMR

Livestock applications of antibiotics in metric tons/year, among the few dozen countries reporting use. (The Antibiotic Footprint)

In particular, the FAIRR report calls out 10 of the world’s leading animal health companies, which represent roughly 40% of the sector, for failing to adequately address and reduce AMR risks. 

These include Dechra Pharmaceuticals PLC (UK), Elanco Animal Health Inc (USA), Jinhe Biotechnology Co. Ltd. (China), Merck / MSD (USA), Orion Oyj (Finland), Phibro Animal Health Corporation (USA), Vetoquinol (France), Virbac (France), Zoetis Inc. (USA) and  Zydus Cadila / Cadila Healthcare (India).

“By labelling products for growth promotion and prophylaxis, animal health companies are directly influencing how farmers administer antibiotics to their animals,” said Jo Raven, senior manager at FAIRR and co-author of the report.

Sales of antibiotics represent approximately 24% of the total animal health market, and between 7-43% of individual companies’ total revenue, with figures likely to be higher if expanded to include all antimicrobials, the report found. 

The impacts can be immediate on the farmworkers themselves – even before drug-resistant bacteria or viruses spread more widely into the population, he warned.

Assessment of industry exposures to AMR risks

Antibiotic ‘severely restricted by WHO for human use – promoted by industry for everyday, non-medicinal use in humans

Ugandan dairy farmer Tony Kidega has taken a keen interest in turning the tide of antimicrobial resistance (AMR) in his country. -as part of a pilot project under way there

Raven cited a German study that found that up to 86% of humans who work with pigs directly – mainly veterinarians and farmers – carry livestock-associated MRSA, which can be a dangerous bacterial infection in the chronically and ill, resistant to many leading antibiotics.

Data from China and Viet Nam, collected as recently as 2018, illustrates the scale of the problem. In Viet Nam’s heavily agricultural Mekong Delta region, the use of antibiotics as prophylaxis can account for as much as 84% of total antibiotic use in animal agriculture.  In China, the use of such antibiotics for growth promotion accounts for an estimated 53% of total antibiotic use in livestock.

The report found that none of the10 largest publicly-listed animal health companies have a comprehensive strategy to mitigate the impact of AMR, nor do they have responsible marketing policies for use of antimicrobials in agriculture. It suggests that this is a particular problem in emerging markets where product labels can be a farmers’ only guide around when to use drugs and what doses.

In emerging markets, in particular,  “sales, marketing and package sizing practices contribute to growing AMR… ” the report states, and companies operating in such markets “do little to change the ingrained behaviour of their routine use for growth promotion or prophylaxis.”

For instance, the report cites the example of a product called Winmyco – sold by the Indian firm Zydus Cadila in 25kg bags and described as a “growth promoter” – which contains the antibiotic tylosin, categorised by the WHO in a 2016 report as a high-priority drug “critically important” for human health.

“This antibiotic is severely restricted for use in humans, yet is being promoted for everyday use for non-medical purposes in animals,” the report warns.

WHO, FAO and OIE have failed to address industry practices – despite long-term risks to humans and agricultural production

AMR risks across the animal agriculture value chain.

 WHO cites AMR as one of the top 10 global public health threats facing humanity.  A 2019 UN report estimated that drug-resistant bacteria kills roughly 700,000 people a year –  with a prediction that it would hit 10 million by 2050 if AMR continues at its current rate.

But the World Health Organization (WHO) and the global health community have largely focused on the injudicious use, or overuse, of antibiotics in human populations. Global health policymakers have largely sidestepped the potentially bigger challenges posed by uncontrolled administration of such drugs to animals.

Many antimicrobials such as tylosin, which are used both in human and animal health, are not even mentioned in the new WHO AWaRe classifications of antibiotics that guides global health policymakers and professionals about drugs that should be reserved or restricted for only the most urgent medical uses.  So despite being noted by WHO as “critically important” to human health in its comprehensive 2016 report, there is in fact no clear, up-to-date guidance from the the global health agency about the extent that such drugs could or should be used in animal health as well.

Despite signals of change – such as the formation of a “One Health” initiative with the World Organization for Animal Health (OIE) and the Food and Agriculture Organization (FAO), none of the UN agencies are tracking data or aggressively promoting the problems associaed with unfettered antimicrobials use in animal husbandry.

The World Bank has meanwhile warned that AMR could lead to an 11% decline in livestock production in low-income countries by 2050.

A pig pokes his head out of a barn in Oosterhout, Netherlands – where air pollution produced by livestock in rural areas has been linked to higher rates air pollution – and during the pandemic, more COVID-19 deaths.

Along with being a major contributor to AMR, intensive livestock production is also a major driver of climate change – with livestock consuming some two-thirds of the world’s grain and cereals production, which in turn drives deforestation and ground water pollution.  Ruminant livestock also are major emitters of methane, a powerful climate changing gas, and residues from livestock excrement mixes with other air pollutants to form airborne particulate matter that contributes significantly to air pollution in regions such as Europe.  

“AMR cannot be solved without stewardship and cooperation from this industry which manufactures, markets and sells antimicrobial products to protein producers to treat the animals we eat,” said Coller, warning that: “An AMR crisis threatens to make even routine operations such as a hip or knee replacement life-threatening because we may no longer have effective antibiotics available to treat patients in recovery.”

Vaccines and probiotics can replace medicines – and reduce reckless antibiotic use

Inspecting a pig’s health in Busia, western Kenya.

The report calls for increasing farmer/consumer, public and policymaker awareness of the risks associated with the overuse and abuse of antimicrobials in animal health products – so as to exert pressure on industry to reduce their use. 

It also calls on companies to increase their marketing to farmers of practical alternatives and measures that can reduce the need for antimicrobial products – which include antiviral and antiparasitic medicines along with antibiotics. 

Those can include: the better use of diagnostic tools; more use of vaccines; and more use of novel preventative and curative medicines. Proven treatments include: probiotics, prebiotics, immunotherapeutics, and in-feed enzymes, as well as bacteriophages (the deployment of harmless viruses that can infect and kill harmful bacteria). 

“Many of these alternatives show positive outcomes or have promise but require further development and widening of use in order to be cost-effective. Some animal health companies are recognising the commercial opportunities associated with alternatives to antibiotics,” states the report. 

New alternatives could be “extremely valuable” and could become the preferred option for farmers worldwide, it concludes.

Other sales and marketing measures, such as reducing package sizes to reduce the risk of unused or expired medicines being released into the environment, are also important, the report recommends. Labelling also should be clearer to prevent misuse of drugs.

Currently, animal health companies take an inconsistent approach to these measures.  For example, where farmers lack access to veterinarians, particularly in emerging markets, often the product label is their only guide to uses, dosage, method of application, and expiry date.

Addressing antibiotic residues in wastewater

Current manufacturing practices, including the WHO’s Good Manufacturing Practice (GMP) certification, which is the global standard for manufacture of pharmaceuticals – also fail to address antibiotics discharge in wastewater generated by factories producing animal drugs.  

“This means untreated wastewater releases antibiotic residues into the environment around factories increasing the risk of resistance,” Raven pointed out.

Encouraging meaningful industry commitments

On the more positive side, some of the large animal health companies have publicly committed to invest $US 10 billion collectively in alternatives by 2025, with the aim to develop 100 new vaccines, 20 new diagnostic tools, 20 nutritional enhancement tools, and 30 other products that will help to reduce the need for antimicrobials.

They include Boehringer Ingelheim, Ceva Sante Animale, Elanco Animal Health, IDEXX Laboratories,  Merck & Co., Phibro Animal Health Corporation, Vetoquinol, Virbac, Zenoaq and Zoetis.

Those commitments need to be fulfilled – and more, FAIRR asserts – for the well-being of industries themselves as well as the health of people the world over at risk from AMR.

“Animal health companies that do not increase their exposure to alternatives are likely to face increased financial pressures in the medium to long-term as the animal protein sector looks beyond antibiotics and towards preventive care and alternative treatment options as its first line of defence for protecting welfare and animal health,” states the report. 

“This report is a vital contribution to building the momentum needed to ensure the protection of the animal health sector from damaging practices and increasing regulatory risk,” says Coller.

Image Credits: pxfuel, Charyse Reinfelder, Global trends in antimicrobial use in food animals, PNAS 2015 , antibioticfootprint.net, Tony Kidega, Flickr: Dutchairplaneshooter, ILRI / Charlie Pye-Smith.

More affordable second-line ARVs will soon be available following an innovative pricing agreement.

People living with HIV in low-and middle-income countries will soon have access to generic second-line antiretroviral drugs at a much cheaper price following an innovative agreement between Unitaid and the Clinton Health Access Initiative Inc (CHAI).

The new pricing agreement announced on Monday will see pharmaceutical company Hetero Labs manufacture a generic combination of darunavir boosted with ritonavir (DRV/r) for $210 per patient, per year, much cheaper than the well-established but suboptimal alternative option, lopinavir/ritonavir (LPV/r).

 “It is vital that all those living with HIV who cannot stay on first-line treatment have access to a quality second-line product, and we are proud of our work with CHAI to make this happen,” said Unitaid Executive Director Dr Philippe Duneton.

Less toxic than other protease inhibitors, Darunavir is also easier to take

Darunavir (DRV) in combination with ritonavir is a best-in-class protease inhibitor. DRV has proven to be effective in patients who have never been treated for HIV and those who have experienced multi-drug resistance. Less toxic than existing protease inhibitors used in second-line treatment,  DRV is also easier to take.

Despite being available in the United States and other high-income countries for over a decade, low- and middle-income countries still lack access to an affordable, quality generic version of the drug.  Second- and third-line therapies are however critical for people living with HIV where first-line treatment may not be an option, due to medication resistance or intolerance.

Until the announcement by Unitaid and CHAI, DRV/r was too expensive for national treatment programmes in low- and middle-income countries to afford.

Best-in-class second-line HIV treatment is long overdue

Kenly Sikwese, HIV advocate and head of the African Community Advisory Board (AfroCAB), which advocates for better, more affordable HIV medicine, welcomed the announcement saying the board had been advocating for the use of DRV in second-line since 2011, and that the new agreement was a critical step in addressing the “longstanding inequity in access to this optimal HIV treatment in low- and middle-income countries”.

“We look forward to seeing policymakers across the globe move expeditiously forward to accelerate access to this very important drug for communities.”

Joy Phumaphi, CHAI Interim Co-CEO, said access to this second-line HIV treatment is long overdue and people living with HIV in low- and middle-income countries will now be able to access the same high-quality second-line medication as those in high-income countries, “enabling more patients to remain on treatment and save lives”. 

Image Credits: Commons Wikimedia.