Patients seeking essential health services during COVID-19 pandemic in Jangamakote Village, India.

There is “broad consensus” on the need for a “binding pact” to address the threat of pandemics, said World Health Organization (WHO) Director-General on Wednesday – a few days before the World Health Assembly special session devoted exclusively to discussing what many refer to as a pandemic treaty.

“The ongoing chaos of this pandemic only underlines why the world needs an ironclad global agreement to set the rules of the game for pandemic preparedness and response,” Tedros told the media at the WHO’s COVID-19 briefing in Geneva.

“This will be the subject of next week’s special session of the World Health Assembly. The world has treaties to manage other threats. Surely countries can agree on the need for a binding pact on the threats of pandemics?” added Tedros, who described the special session as a unique opportunity to develop a generational agreement.

 “I’m encouraged that there is now a broad consensus for the need for such an instrument. We will not achieve everything at the special session. But I hope it will serve as the launching pad for the development of an international agreement,” concluded Tedros.

Not everyone wants a Treaty

However, at the same time in another part of the city, civil society critics expressed concerns that a new Pandemic Treaty would fail to bring about the more fundamental changes that they say are needed in global finance and manufacturing mechanisms – so as to really improve the access of low- and middle-income countries to pandemic-related medicines and vaccines.  

Not only that, but critics fear that many low-income countries, still focused on fighting a pandemic, lack the human resources required to advance their interests in negotiations over a new Pandemic Treaty. 

The creation of such a new instrument could further fragment global health decision-making, removing certain responsibilities and powers from the direct control of the World Health Organization, said others in a panel discussion sponsored by the Geneva Global Health Hub (G2H2). 

The discussion focused on a new G2H2 report that reflected upon countries’ and civil society views about the treaty, entitled, “The Politics of a WHO Pandemic Treaty in a Disenchanted World.” 

Rather than focusing on a treaty, stakeholders should look more closely at debt relief and other economic measures that could strengthen health systems in developing countries, which are hobbled by years of internationally-imposed austerity, said Carlos Correa, director of the Geneva-based South Centre.  Without stronger, more durable health systems, countries will remain ill-equipped to battle disease threats, regardless of treaty provisions, he said.  

More regionally-based R&D and production of vaccines and medicines, stimulated by a World Trade Organization waiver on Intellectual Property restrictions to stimulate more sharing of pharma know-how is also critical, said Nicoletta Dentico, one of the paper’s co-authors.  

But she expressed fears that the drawn-out negotiations over the legal language on a treaty would obscure the need for needed reforms to trade and economic arrangements that deeply affected health.  

It is  “not coincidental” that critical WTO waiver discussions are taking place next week, at the same time as the World Health Assembly (WHA) meets on the pandemic treaty, Dentico added, expressing fears that the WHA negotiations would divert attention from the WTO talks, currently deadlocked by European opposition to the waiver initiative. 

The report highlighted a number of factors influencing various interest groups’ support for a pandemic treaty, including developing countries wanting a seat at the negotiating table.

At the same time, Dr Suerie Moon, co-director of the Global Health Centre of the Geneva Graduate Institute, put forward a more positive spin on the Pandemic Treaty proposal.

She compared it to a “potluck dinner” where everyone might bring their own “dish” to the table.  What remains to be seen, however, is if the “tastes will blend together and the wine will match the meal.”

Moon added that while the report adds valuable civil society perspectives to the debate, the two dozen key informat interviews upon which the research was based seemed to reflect too much of a “Eurocentric” viewpoint – and could have benefitted from more inputs from countries in the global South.

Image Credits: Flickr – Trinity Care Foundation.

Dr Tedros

Although the World Health Organization (WHO) continues to condemn COVID-19 vaccine boosters in the face of global vaccine inequity, a top official conceded that they looked increasingly likely in future.

“The first priority everywhere has got to be reaching the unvaccinated, most highly vulnerable populations,” stressed Dr Bruce Aylward, special advisor to the WHO Director-General.

 But he conceded: “Eventually we will need to get the boosters to sustain immunity. It looks more and more likely, but at this point, there’s still an awful lot of unvaccinated people out there”.

“This is not just a phenomenon of low-income countries,” stressed Aylward. “In much of  Europe, where we’re seeing the current outbreak, much of that is being driven by the unvaccinated of course, and many of the people ending up in ICUs and who are dying are unvaccinated folks.”

Last Friday, the US made boosters available to all adults ahead of Thursday’s Thanksgiving holiday, while a number of European countries are also offering boosters to all adults. A few months back, Israel curbed its fourth wave through a combination of boosters and reaching the unvaccinated.

Don’t Vaccinate Kids Yet

The WHO also cautioned against wealthy countries vaccinating children ahead of vulnerable populations in other countries.

“As a matter of global equity, as long as many parts of the world are facing extreme vaccine shortages, countries that have achieved high vaccine coverage in their high-risk populations should prioritize global sharing of COVID-19 vaccines through the COVAX facility before proceeding to vaccination of children and adolescents who are at low risk for severe disease,” urged the WHO in a statement released on Wednesday.

Instead, it urged “attaining high coverage of primary series – and booster doses as needed based on evidence of waning and optimizing vaccination impact – in highest risk subgroups, such as older adults” before vaccinating children.

Europe’s ‘false sense of security’

With Europe accounting for over 60% of new global COVID-19 cases this week, the WHO warned that vaccinations had given some countries “a false sense of security”, urging a return to masks, social distancing and avoiding crowds – alongside vaccinating the unvaccinated.

“In many countries and communities, we’re concerned about a false sense of security that vaccines have ended the pandemic and that people who are vaccinated do not need to take any other precautions. Vaccines save lives, but they do not fully prevent transmission,” WHO Director-General Dr Tedros Adhanom Ghebreyesus said on Wednesday.

Pointing out that vaccines only gave around 40% protection against the Delta variant, Tedros urged even the vaccinated to take precautions to avoid infection.

Dr Mike Ryan, executive director of Health Emergencies, said that social mixing in Europe had returned to “pre-pandemic levels”.

Maria Van Kerkhove, WHO COVID-19 Technical Lead

WHO technical lead on COVID-19, Dr Maria Van Kerkhove, said it was essential to cut transmission rates to avoid the development of new variants and to protect people from “long COVID”.

“The more the virus circulates, the more opportunities it has to change. We have the Delta variant, which is the most transmissible SARS-COV2 virus we’ve seen to date ,and Delta is evolving as well,” warned Van Kerkhove.

“We have decent genomic sequencing around the world, but we don’t have eyes and ears in all countries in terms of what is circulating and how these viruses are changing.,” she added.

The WHO was looking through future scenarios to try to predict how much more the virus will change and if there was the potential for “future immune escape” which could weaken vaccines, she added.

The WHO was also concerned about “long COVID, this post-COVID condition that we are only beginning to learn about” that affected all parts of the body, she added.

“We’re working with partners around the world to understand what in fact it is, how long these longer-lasting symptoms remain in some individuals, why these symptoms affect all parts of the body. We don’t even have good estimates of how many people will suffer from long COVID,” said Van Kerkhove.

“So until we know, it is prudent to drive transmission down as much as we can with simple measures that we know work. These proven public health and social measures that we mention don’t mean lockdown. They mean physical distancing, they may mean wearing masks, they mean avoiding crowds, investing in ventilation where we live where we study where we work.”

 

Image Credits: WHO.

sputnik
Sputnik V Vaccine

Russia’s Sputnik V COVID-19 vaccine demonstrates an 80% efficacy six to eight months after the second dose – a higher efficacy than officially published mRNA vaccines, announced the Russian Direct Investment Fund (RDIF) in a press briefing on Wednesday.

The efficacy data is based on “real-world data from the Ministry of Health of the Republic of San Marino”, according to the RDIF and has not yet been published.

This has led the Sputnik team to assert that adenoviral vaccines such as Sputnik V provide for longer efficacy than mRNA ones, such as the Pfizer and Moderna, “due to longer antibody and T-cell response”.

The Pfizer-BioNTech vaccine, while 90% effective against COVID-19 hospitalizations for all variants including Delta, had declining efficacy, falling from 88% within one month after receiving two doses to 47% after six months. 

Sputnik V efficacy is significantly higher than Pfizer vaccine after 6-8 months

Sputnik’s efficacy data from 18,600 fully vaccinated people found efficacy was at 80%  in the six to eight months after a second jab, while the hospitalization rate with COVID infection was only 0.75 per 1,000 people during the entire mass vaccination campaign in the country from February to November 2021.

Over 70% of the adult population of San Marino have been vaccinated with Sputnik V. 

Vaccine cocktails, the future of COVID vaccines 

Kirill Dmitriev, CEO of the Russian Direct Investment Fund.

Going forward, RDIF CEO Kirill Dmitriev proposed vaccine combinations as a possible solution to COVID-19, including a potential combination with their one-shot vaccine, Sputnik Light, and mRNA vaccines.  

“We believe the future of vaccines is about cocktails. It’s about combining different vaccines to help prolong immunity.”

He added: “We are pro-boosters, but we believe the combination of vaccines should be explored much more.”

Sputnik Light has shown 70% efficacy against the Delta variant and is being promoted as a booster for non-Russian vaccines. 

As a vaccine cocktail, Sputnik V combines two adenoviruses – human adenovirus serotype 26 and human adenovirus serotype 5.

Sputnik V success in Argentina 

Dmitriev pointed that Argentina, which uses Sputnik and other vaccines, had a remarkable 35% decline in cases over the last four months. 

Russia will lift its ban on flights to Argentina, as well as Bangladesh, Brazil, Mongolia, and Costa Rica, from 1 December, as a result of the declining cases. 

The Sputnik team will be publishing additional data on long-term vaccine response from different countries, including those in Latin America, which Dmitriev noted was “very important” in showcasing the efficacy and safety of the vaccine. 

“It’s very important that this data is not coming just from Russia. We have an abundance of data on Sputnik, on more than 100 million people who were vaccinated outside of Russia, and that allows us to speak on the safety and efficacy of our vaccine – as one of the safest and one of the most efficient.” 

WHO Emergency Listing Approval expected by end of year, despite setbacks

Sputnik V is expected to be approved by the World Health Organization for emergency use listing (EUL) by the end of the year, according to Dmitriev.

“We are working with WHO but Sputnik is already saving tens of hundreds of millions of lives around the world,” he said.

Sputnik V is currently approved for use in 71 countries, with a total population of four billion people, and is the “second-largest vaccine in the world by numbers of registration from different countries.”

RDIF applied for EUL back in February but the process has been dogged by problems, including WHO inspectors flagging a number of concerns when visiting manufacturing sites in Russia, including control of aseptic operation and filling. Russia had also postponed planned inspections of the Sputnik manufacturing sites back in October.

COVID cases decline in Russia, but surge in rest of Europe

Russia has far fewer new COVID cases than most of Europe.

While Russia’s coronavirus death toll still hovers near all-time highs, the number of new infections continues to decline, in contrast to the rising surge occurring in many other countries in Europe. 

The state coronavirus task force reported 35,681 new confirmed cases, reflecting a steady downward trend since early November when the daily numbers topped 41,000. 

This is despite the country’s low vaccination rate – only 37.46% of the population is fully vaccinated.

A more expressed drop in COVID-19 cases is expected if the country continues to follow precautionary measures, infection disease specialist Yevgeny Timakov told Russian news agency TASS. 

“Stabilization process will take about a month, followed by the decline in the disease rate if there is control over infections sources at least in terms of wearing masks. Then everything will be normal and we will celebrate the New Year smoothly,” the expert said.

In comparison, the rest of Europe is currently experiencing a surge in COVID infections, with several countries reporting record-high infection rates, prompting governments to introduce full and partial lockdowns, as well as mandatory vaccinations.

Dmitriev attributed the spike in Europe’s cases to the decrease in efficacy of the mRNA vaccines, which a large percentage of Europe is vaccinated with, and called the rise in cases “alarming”.

“There shouldn’t be a breakout in cases. We believe that all vaccines are important and they protect from severe infections and hospitalizations, and yet, the number of cases that we see in Europe is really alarming,” he said.

Image Credits: Sputnikvaccine/Twitter.

Austrian police tackle anti-lockdown protesters in Vienna over the weekend.

Other European countries may follow the example of Austria, which entered a nationwide lockdown on Monday, as COVID-19 cases continue to surge across the region.

New COVID-19 cases increased by over 3,5 million in a single week, and deaths by over 50,000, according to the latest report from the European Centre for Disease Prevention and Control (ECDC). 

German health minister Jens Spahn grimly warned on Monday that, by the end of winter, Germans could either be “vaccinated, recovered or dead”. ICU beds in the country are under pressure as Germany recorded 45,326 new daily cases on Tuesday and 309 new deaths, according to the Robert Koch Institute. 

As civil protests mounted and debate raged across Europe over COVID certificates and vaccine mandates, WHO’s headquarters remained largely silent about exactly what policies countries should follow, saying primarily that countries should pursue a “risk-based approach.”   

However, WHO’s European Regional Director Hans Kluge has been more assertive on both, saying that along with more mask wearing, requiring a COVID pass for entry to entertainment or workplaces “is not a restriction of liberty, rather it is a tool to keep our individual freedom.” 

“In order to live with this virus and continue our daily lives, we need to take a ‘vaccine plus’ approach,” said Kluge in a statement on Tuesday.

“This means getting the standard doses of vaccine, taking a booster if offered, as well as incorporating preventive measures into our normal routines,” said Kluge. Only 48% of Europeans report wearing a mask indoors

Kluge also appealed to citizens to “do everything we can by getting vaccinated and taking personal protective measures, to avoid the last resort of lockdowns and school closures”.

“We know through bitter experience that these have extensive economic consequences and a pervasive negative impact on mental health, facilitate interpersonal violence and are detrimental to children’s well-being and learning,” he added.

After that, outright vaccine mandates should be a “last resort” but that a “legal and societal debate would be “very timely,” Kluge said in a weekend interview with the BBC.   

The WHO expects “high or extreme stress” on hospital beds in 25 countries, and “high or extreme stress” in intensive care units (ICU) in 49 out of 53 countries between now and 1 March 2022.

In the absence of urgent action, WHO’s sprawling European region, which extends from the United Kingdom to Russia and the Central Asian republics of the former Soviet Union, could see another 500,000 deaths by March, Kluge warned. 

Austria sets out the toughest vaccine mandates seen so far in Europe 


Austria’s 20-day lockdown – which has closed all but essential businesses and largely confined people to their homes – is necessary to safeguard the country’s public health system, according to Chancellor Alexander Schallenberg.

Describing the measure as “drastic”, Schallenberg said that the lockdown was the only way out of the current crisis.

Austria also intends to introduce mandatory vaccinations on 1 February, which Schallenberg told the CNN was necessary as around 33% of Austrians – almost two million people – were still unvaccinated despite a year of intensive vaccination campaigns. He said there were a number of reasons, including mistrust of science, and political campaigning against vaccinations, including by the Freedom Party, one of the three biggest parties in the country’s parliament. 

Schallenberg said those who refused to get vaccinated would face an “administrative fine”, although the amount has not yet been set, and that there is a precedent for this in other countries such as France and Italy in regard to certain groups of people, as well as compulsory smallpox vaccine mandates in the 1940s.

Cases in Austria, Netherlands and Belgium are currently among the highest in Europe – reaching or exceeding 1,400 new infections a day. However, Slovakia has the highest case rate per 100,000 people, while Slovenia and Czechia are also struggling.

Statistic: Incidence of coronavirus (COVID-19) cases in the past seven days in Europe as of November 22, 2021, by country (per 100,000 population) | Statista
Find more statistics at Statista

Vaccine rates below EU average in Switzerland, Poland and elsewhere 

Switzerland and Poland, in contrast, are seeing only about half as many new cases a day. But with vaccination rates in countries like Switzerland and Poland even lower than those in Austria, health authorities there are also bracing for increases in the months ahead.   


Even so, large protests against COVID-19 vaccine passes, lockdowns and vaccine mandates were held over the past weekend in at least seven European countries including Austria, Germany, Italy and France. 

They are also potentially super-spreader events as few protestors wore masks.  

Protests in the Netherlands and Brussels turned violent with protestors overturning and setting police vehicles afire, while police barricaded protestors and fired water cannons in response. 

ECDC  warns of ‘high and rapidly increasing’ case rate

The European Centers for Disease Control (ECDC) has described the current phase of pandemic as being characterised by “a high and rapidly increasing overall case notification rate and a slowly increasing death rate”, with countries with the lowest vaccination rates worst affected.

Twenty of the 29 EU countries reporting data on hospital and ICU admissions or occupancy reported increases by mid-November, according to the ECDC.

Latvia has been under lockdown since late October. In the first two weeks of November, Latvia’s COVID-19 mortality rate increased to 268.6 deaths per one million population, the third-highest in the European Union (EU) and the European Economic Area (EEA) after Romania and Bulgaria. Romania and Bulgaria also have the lowest vaccination rates in the region, at 38% and 25% respectively.

Path out of restrictions lies in high vaccination rate 

Meanwhile, a new discussion paper published by the Centre for Economic Policy Research suggests that, once a country has reached a high threshold of vaccinations, their effect on mortality is sufficient that governments do not have to adopt hard lockdown measures.

The economists tested whether the UK experience, which has a vaccination rate of 83,5% to 89,8% (two doses) across its four counties, and where deaths have remained low despite a surge in new infections and few social controls, could apply in other countries. 


By examining data from 208 other countries from early 2020 to this month, the economists – from the universities of Southern California and Tel Aviv, the Asian Development Bank and the Internals Monetary Fund – concluded that “in the presence of a sufficiently high share of inoculated individuals, governments can shade down containment measures, even as infections are still rampant, without significant adverse effects on mortality”.

The impact of vaccinations on mortality was so significant that the economists were confident that lockdown measures could be dialled down despite finding that vaccines’ impact on new infections was “insignificant”. 

Israel’s experience – booster campaign & learning from mistakes 

The paper also described how Israel’s attempts to remove its “COVID-19 pass” restrictions for entry to restaurants and other venues too early on led to surging caseloads over the summer – which peaked at world-record rates of new infections per capita in early September – or nearly 10,000 cases a day in a country of nine million people”.  

The country later reversed course, reimposing COVID-19 pass restrictions, mask mandates in closed spaces, and limits on venues, while launching a massive booster campaign.  

While “daily mortality was initially zero,” hospitalizations and also deaths increased by mid-September, as well,  “before receding to around seven daily deaths at the end of October”, according to the paper.

“The decrease in new infections since the mid-September peak is probably due to a vigorous booster campaign that raised total vaccinations to 180 per hundred individuals”, the paper argues.

That, along with the preferential treatment of vaccinated individuals in public events as well as continued restrictions on  international travel, probably played a lesser role in dimming the infection’s fires, they argue:

“Be that as it may, this opens the door for the hope that, following a sufficiently potent accumulation of vaccinations, infections are likely to recede as well.” 

Image Credits: CNN.

Spanish Minister of Science and Innovation Diana Morant at the announcement of the license.

The first non-exclusive license for a COVID-19 health tool – a serological antibody test that checks for the presence of anti-SARS-CoV-2 antibodies – has been finalised by the World Health Organization’s (WHO) COVID-19 Technology Access Pool (C-TAP) and the Medicines Patent Pool (MPP).  

The license, announced on Tuesday in partnership with the Spanish National Research Council (CSIC), will facilitate the rapid manufacture and commercialization of CSIC’s COVID-19 serological test worldwide. 

WHO Director-General Dr Tedros Adhanom Ghebreyesus commended the CSIC, a public research institute, for “offering worldwide access to their technology and know-how.” 

“This is the kind of open and transparent licence we need to move the needle on access during and after the pandemic. I urge developers of COVID-19 vaccines, treatments and diagnostics to follow this example and turn the tide on the pandemic and on the devastating global inequity this pandemic has spotlighted.”

MPP Executive Director Charles Gore hailed CSIC for sharing its test, noting that there has been “too much selfish behaviour” during the pandemic.

Gore added that, as MPP had recently concluded a deal to licence and distribute two anti-viral treatments for COVID-19 with Merck and Pfizer, “the importance of diagnostic testing has increased ten-fold”.

Launched in 2020 by the WHO Director-General and the President of Costa Rica, C-TAP aims to pool technologies to boost manufacturing capacity and expand access to COVID-19 health products.   

Test is easy to use and royalty-free for LMICs 

The test is relatively simple and suitable for basic laboratory infrastructure, and if being offered royalty-free to low- and middle-income countries to promote equitable access to COVID-19 tools.

“This licence is a testament to what we can achieve when putting people at the centre of our global and multilateral efforts,” said Carlos Alvarado Quesada, President of Costa Rica, the founding country of C-TAP.  

“It shows that solidarity and equitable access can be achieved and that it is worthwhile continuing to support the principles of transparency, inclusiveness and non-exclusivity that the C-TAP defends.”

In July, WHO called on pharma companies developing therapeutic options for those with severe COVID-19 to waive exclusivity rights or issue transparent, non-exclusive licensing agreements, such as the one finalized with CSIC, in an effort to address ongoing global vaccine inequity. 

In order to sell the tests in low- and middle-income countries, companies producing the technology will need to supplement this manufacturing with performance data in the European population. 

CSIC president Rosa Menendez noted how this type of technology, and all COVID-19 technologies in particular, need solutions that reach all countries, especially those most vulnerable. 

“In this sense, we would like this action by CSIC, of taking part in the international initiatives of MPP and WHO, to become an example and a reference for other research organizations in the world,” she said.

The technology currently has four different serological tests, of which one has the potential to distinguish the immune response of COVID-19 infected individuals from vaccinated individuals. 

Health Action International (HAI) Senior Policy Adviser, Jaume Vidal, described the agreement as “a milestone for global health and a major step toward achieving more equitable access to health technologies”.

“The first product ever to be licensed to C-TAP is an example of public return on public investment in action. It is also evidence of the political will necessary to address protracted issues currently affecting the global response to the pandemic, such as limited manufacturing capabilities or obstacles to technology transfer,” said Vidal.

“The Spanish government is leading by example,” added Vidal. “Not only are they pushing for non-exclusive licensing through the Medicines Patent Pool (MPP) of a critical health technology and committing funding to C-TAP, but have also come out in support of the TRIPS waiver proposal currently under discussion at World Trade Organisation (WTO).”

Zoleka Mandela lost her 13-year-old daughter in a car crash

Two parents who lost their children in car crashes urged governments to adopt better road safety policies on the World Day of Remembrance for Road Traffic Victims on Monday.

South African Zoleka Mandela’s daughter died in a Johannesburg crash on her 13th birthday, while Australian Peter Frazer’s 23-year-old daughter was killed by a truck on Hume Highway on her way to university.

“As a mother who lost her daughter to road traffic injury, I can tell you that the pain never goes away,” said Mandela, now the Global Ambassador for the Child Health Initiative.

Describing the rates of death and injury on our roads as “monstrously high”, Mandela – the granddaughter of iconic leader Nelson Mandela – said that solutions were completely within their grasp of governments. 

“Low-speed streets, particularly with a vulnerable and traffic mix; safe crossings and sidewalks; action on drink driving; safe vehicles and helmets,” said Mandela. “Road traffic injuries are predictable and preventable.”

She also called for “a shift from car dependence to zero-carbon active travel; a shift to public transportation cleaner air and lower CO2 emissions.

‘Drive so others survive’

Peter Frazer, Australian road safety advocate, lost his daughter in a car crash.

Frazer said that his daughter, Sarah, had broken down at the side of one of Australia’s major highways on her way to start studies as a photojournalist. A truck ploughed into her and a tow-truck driver, killing them both on a road that was too narrow to enable her to pull off safely.

“We must all drive as if our loved ones are on the road ahead. We must drive so others survive. We already have the technology and know-how to massively reduce trauma,” said Frazer, who started and leads the Safer Australian Roads and Highways (Sarah), in memory of his daughter.

Dr Etienne Krug, the World Health Organization (WHO) Director of the Department of the Social Determinants of Health, said that 1.3 million lives were lost every year in vehicle crashes.

The WHO launched its Global Plan for the Decade of Action for Road Safety (2021 – 2030) late last month, which has the ambitious target of preventing at least 50% of road traffic deaths and injuries by 2030.

Abdulla Shahid, President of the United Nations, told the remembrance that, aside from deaths, around 50 million people were also injured in road crashes annually.

“Today, we pause to pay tribute to the fathers, mothers, sons and daughters, friends and colleagues whose lives were cut short,” said Shaid. “We remember those suffering from life-impacting injuries as a result of reckless driving and unsafe road systems. Each is an individual tragedy and a source of profound grief and pain.”

The UN will host a High-Level Meeting on global road safety from 30 June to 1 July 2022, preceded on 3 December by a planning meeting to be hosted by Shahid.

 

 

Michigan’s Lieutenant Governor, Garlin Gilchrist II gets his COVID booster shot on Friday. Moving ahead of today’s US FDA recommendation, a few US states have already begun rolling out boosters to all adults six months after their second jab.

The United States Food and Drug Administration (US FDA) on Friday gave its greenlight to the mass rollout of both Pfizer and Moderna COVID booster shots to all adults over the age of 18, from six months after a person’s second vaccine dose.  J&J vaccine boosters would be authorized after just two months of the single jab vaccine.

The US Centers for Disease Control was due to meet later Friday on a policy recommendation to expand booster shot eligibility to all American adults accordingly – CDC Director Rochelle Walensky was expected to sign off on the recommendation immediately.

“This is a very encouraging step to further protect Americans, especially as we enter the winter months,” said White House press secretary Jan Psaki in a press briefing Friday afternoon.

Boosters of Moderna and Pfizer’s mRNA vaccines have been repeatedly decried by the World Health Organization as pumping global vaccine inequities while lacking an adequate evidence base.

“No more boosters should be administered except to immunocompromised people,” said WHO’s Director General Dr Tedros Adhanom Ghebreyesus earlier this month. “Most countries with high vaccine coverage continue to ignore our call for a global moratorium on boosters at the expense of health workers and vulnerable groups in low-income countries who are still waiting for the first dose.”

The decision was not without its naysayers – some critics pointed out that the critical FDA decision was made largely on the basis of industry data of its clinical trials, but without reference to the FDA’s expert Vaccines and Related Biological Products Advisory Committee, VRBPAC, which usually weighs in first.

The FDA decision was being cheered, however, by many US experts as a correct response to mounting medical evidence about waning immunity after the first two jabs, as well as a nimble way of warding off another winter COVID wave.

“I’ve said since January that Pfizer/Moderna are three dose vaccines,” said Peter Hotez, a vaccine expert at Texas Children’s Hospital and popular media commentator.

Signal to Europe

The US moves will also surely be seen as a signal to European policymakers – facing sharply rising case rates accompanied in some countries, such as The Netherlands, by partial lockdowns.

In Europe, boosters have not been widely administered yet beyond immuno-comprised individuals and people over the age of 65.  The United Kingdom has been the boldest so far – gradually scaling down eligibility ages.  On Monday, UK officials announced that the age limit for booster eligibility would be lowered once again to people aged 40-49 who received their second shot more than six months ago.

Boosters sharply opposed by WHO – but appeals likely to be ignored

In most African countries, less than 15% of people have received even one vaccine dose, and in many countries, less than 5%.

The booster shot trend has been sharply opposed by the World Health Organization as siphoning off vaccines that are badly needed in low- and middle-income countries to merely administer a first dose.

WHO has repeatedly called for a  moratorium on booster shots until the end of the year for everyone except immunocompromised people – so as to reach a 40% vaccine coverage goal in under-vaccinated countries – including most of Africa.

WHO scientists have contended that even if infection rates are rising right now in the northern hemisphere, as Europe and North America head into winter, people with two jabs remain good immunity against serious disease and hospitalization – which is a more central aim of vaccination that preventing simple infections.

However, WHO’s appeal may be increasingly ignored by countries anxious to head off another winter surge in case rates – in countries that were the epicenter of the COVID storm at its outset in 2020, riding another major wave last winter.

The dilemmas become particularly acute when those surges are also leading to more hospitalization – straining health care services.

Israel’s booster drive cited by US expert Anthony Fauci as example

 Israel’s experience has been widely cited in the United states, which has seen a steady rise in new infections over the past month. In Israel, COVID infection rates soared to the highest in the world in August – pushing hospitals to their limits.

At that point a massive booster campaign was implemented, which officials there now admit was a “calculated gamble”.  Along with stricter social distancing measures in bars and restaurants, the campaign drove case rates down to one of the lowest in the developed world.

But more significantly, the Israeli campaign drove down the incidence of serious infections and hospitalizations among older people, most at risk, said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, in an interview with CNN.

Recent data from Israel shows that people age 60 and older who received a booster were less likely to become severely ill than vaccinated people who had not received a booster. Rates of severe disease, however, remained highest among those who weren’t vaccinated at all.  In the biggest Israeli study to date, covering some 728,000 people and published 29 October in The Lancet, the booster was estimated to be 93% effective in preventing hospital admissions, and 81% effective in preventing deaths – in comparison to people who received only two doses.

Tackling vaccine inequities – and uncovering the root causes of serious COVID disease

In terms of the continuing vaccine inequalities between the global north and south, some commentators have argued that vaccine hoarding of excess doses by rich countries may be an even bigger equity bottleneck than booster doses.

Others continue to ponder what are the drivers between the strikingly low case rates in most of SubSaharan Africa – South Africa excepting – and chronically high case rates elsewhere in Latin America, India and the Europe.

While partially due to under-reporting, some researchers have speculated that Africa’s generally lower rates may also be partially explained by immunity acquired from other, prior diseases, including possibly malaria.

That, at least, was the conclusion of researchers with the Uganda-based Malaria Consortium, which recently published a study in The Lancet Microbe, suggesting that people with high prior exposure to malaria also may have less severe forms of COVID-19.

The study, which analysed the results of 597 COVID patients at treatment centers in Uganda, found that 30% of the proportion of people with low previous exposure to malaria had suffered severe or critical COVID, as compared to only 5.4% of poeple with high previous malaria exposure.

“The results suggest that if you’ve had a high previous exposure to malaria, you’re likely to control or manage COVID-19 better,” said Jane Achan, senior research manager at the Malaria Consortium in a blog post.

Insufficient progress on delivering pledged doses to COVAX – across most high-income countries

Regardless of mitigating factors, the fact that vaccine rates in some 80 countries have not yet reached the 40% mark, and remain under 5% in much of Africa, continues to frustrate global health officials that see the inequalities as both an ethical stain as well as a health security risk for the rest of the world – creating more fertile territory for COVID variants to flourish long-term.

The US administration’s response to global vaccine constraints has been firstly donations,  followed by negotiated deals with Pfizer and other manufacturers for vaccine supplies at cost to LMICs, and a call for the rapid expansion of its own domestic vaccine manufacturing capacity – to respond to needs in both the domesitc and global markets. But the donations have so far failed to be delivered; similarly Pfizer’s promised supplies as well as more domestic production will only rev up in 2022.

At home, meanwhile, some states have already moved ahead of the US FDA and CDC, issuing their own recommendations that approved booster shots for adults six months after their first jab.

“Vaccines are the best way to protect ourselves, our loved ones, and everyone around us,” tweeted Michigan’s Lieutenant Governor, Garlin Gilchrist II on Friday.  “Today I got my booster, I encourage Michiganders to get their primary doses- for themeslves and their kids 5 and up – or their boosters when eligible.”

https://twitter.com/LtGovGilchrist/status/1461751602554015762

Image Credits: @LtGoVGilchrist, https://covid19globaltracker.org/.

Opening ceremony for the second meeting of the Protocol to Eliminate Illicit Trade in Tobacco Products (MOP2) at WHO headquarters in Geneva.

While the world was focused last week on the Glasgow Climate Conference (COP26), officials from 160 countries and the European Union gathered virtually to address another urgent global crisis – the crisis in tobacco consumption that is one of the largest causes of death worldwide, year after year.

Otherwise known as COP9, the ninth Conference of Parties to the WHO Framework Convention on Tobacco Control (FCTC), made significant strides with comparatively little attention – apart from partisan campaigns that denigrated the WHO and the global health treaty.

The fact that such negative messages align with the interests of cigarette companies should come as no surprise. There is clear urgency for this work: tobacco use kills more than 8 million people every year. The FCTC is central to ending the global tobacco epidemic.

At the same time, progress is a threat to the rich and powerful vested interests of tobacco companies.  As with efforts to address climate change, advancing proven policies to save lives from tobacco is a hard-won battle.

Worryingly, in the week before COP9, new research published by industry watchdog STOP, suggested that big tobacco – cited by governments as the main barrier to treaty implementation – had taken advantage of the COVID-19 crisis to advance its interests. Industry efforts during the pandemic delayed and weakened health policies to reduce tobacco use in several countries.

Influence of vested interests is key theme at both COP meetings

Global tobacco industry interference ratings (STOP). Countries in yellow and light green experience the least interference – those in red and burgundy, the most.

The influence of vested interests was a key theme at both COP meetings – the one addresing the climate crisis and the one addressing the public health crisis of tobacco use. Industry rhetoric aimed to portray health policies as part of a ‘nanny state’ or even ‘authoritarian.’ Even more insidious were disingenuous claims that regulating industry harms the poorest in our society, when this group often bears the brunt of unhealthy and unsustainable policies – whether they are related to climate change or tobacco use.

The virtual format for COP9 meant there was a shorter, pared-down agenda, with several issues deferred to COP10 in 2023 when they can be discussed and agreed upon in person. These include topical issues like more systematic regulation and disclosure of the contents of tobacco products, including products like waterpipes, smokeless tobacco and heated tobacco products.

Some delegations were understandably concerned that the industry could use this deferral to further influence policy between now and the next meeting in 2023, although expert reports on the key issues, which were published at COP9 could be used to help guide national policy development in the interim.

In a first-ever COP that was fully open to accredited media, news reports also noted how some countries’ interventions appeared to be designed to delay discussions at COP9, reflecting the interests of powerful tobacco companies.

For example, delegations from the Dominican Republic and the Philippines, which included officials from departments such as trade & industry, finance, agriculture and foreign affairs, argued that tobacco is a positive force in their country, while not fully addressing the costs or harms of tobacco use. Such industry-aligned activity was so pronounced within the Philippines delegation that the Philippines’ Department of Health was compelled to issue a statement disassociating itself from statements made by its other delegates.

Virtual pro-vaping event on COP9 sidelines tried to divert attention

The tobacco industry is using deceptive advertising to promote its products, according to WHO.

Industry-friendly rhetoric was abundant on the virtual sidelines of COP9 too. One group created a virtual pro-vaping event it tried to cast as an alternative to COP9; it was amplified by a flurry of social media activity and press releases.

Despite all this chatter, however, the more than 1,200 delegates present made progress, and the results represent a global consensus.

Included in these positive decisions was an agreement to establish a new sustainable funding mechanism to support countries’ and global FCTC implementation, with a hoped-for $2-3 million annually in additional resources. There was also explicit support for the FCTC Secretariat’s efforts to increase transparency: as per the agreement by delegates to open the meeting to accredited media in addition to accredited non-state observers (as well as countries and territories that are not formal FCTC parties). Opening and closing sessions also were broadcast live.

At a regional level, nearly all the delegates from the Americas region issued a joint statement to confirm that they had voluntarily signed and submitted Declaration of Interest forms, in line with a decision at COP8 to help reduce industry interference. Delegates from across Africa called out tobacco industry tactics and called for the tobacco industry to be held liable for the harm it has caused. Both regions are strategic targets for tobacco companies working to expand their markets and grow their profits in emerging economies.

COP9 Declaration – protecting policy from industry influence

Global tobacco industry interference ratings (STOP). Countries in yellow and light green experience the least interference – those in red and burgundy, the most.

The culmination of the week was the approval of the COP9 Declaration, in which Parties agreed to accelerate implementation of the Framework Convention, and make efforts to protect policy from industry influence to support COVID-19 recovery. Governments were also encouraged to implement parts of the treaty that protect policy from industry interference.

This will not, of course, stop tobacco companies from trying to recast themselves as a solution to the problem they created. This is an issue that echoed through this week, at the subsequent Meeting of Parties to the Protocol to Eliminate Illicit Trade in Tobacco Products (MOP2). Evidence shows that, even while the tobacco industry promotes flawed, proprietary solutions to address tobacco smuggling, it may be complicit in the illicit trade of its own products.

We are reminded, meanwhile, by WHO’s latest report on tobacco trends, also published this week, that there are still more than a billion tobacco users around the world, not including e-cigarettes and heated tobacco products. Tobacco companies are producing and selling trillions of deadly cigarettes every year, while their rhetoric steers public conversation away from that inconvenient fact.

As Health Policy Watch said in its report on COP9, it’s a David and Goliath struggle. Taking action in line with the COP9 declaration would be a true win-win for health. With political will and support from the FCTC Secretariat and other organizations, governments can make real progress to reduce tobacco use before COP10 in 2023. The time to act is now.

Gan Quan is the Director of Tobacco Control at The Union, and a partner in STOP, a tobacco industry watchdog, funded by Bloomberg Philanthropies. He has over 17 years of experience in tobacco control advocacy and research in Asia, North America and globally. Gan Quan has a PhD in Public Health from the University of California – Berkeley.

Gan Quan, director of tobacco control at The Union, a Partner in STOP

Image Credits: City of Bengaluru, WHO/Pierre Albouy, Global Tobacco Industry Interference Index 2021 (STOP), STOP: Global Tobacco Industry Interference Index 2021.

First long-acting injectables to treat HIV approved by NICE.

People living with HIV in England and Wales may be eligible for injectable antiretroviral treatment every two months, rather than daily pills.

Two injectable drugs, cabotegravir and rilpivirine, were recommended for use by the UK National Institute for Health and Care (NICE) on Thursday after trials proved they work as effectively as daily tablets, according to their draft guidance. 

To be eligible for cabotegravir with rilpivirine, people must already have a low and stable viral load. 

The Scottish Medicines Consortium has also approved the injections for adults living with HIV in Scotland.

Cabotegravir (also called vocabria), which is made by Viiv Healthcare, and with rilpivirine (also called Rekambys), made by Janssen, are the first long-acting antiretroviral injections available for HIV. 

“Clinical trial results show that cabotegravir with rilpivirine is as effective as oral antiretrovirals at keeping the viral load low,” according to NICE.

“Both cabotegravir and rilpivirine are administered as 2 separate injections every 2 months, after an initial oral (tablet) lead-in period.”

Meindert Boysen, deputy chief executive and director of the Centre for Health Technology Assessment at NICE, said that while  HIV is still incurable, the virus “can be controlled by modern treatment”.

“For some people, having to take daily multi-tablet regimens can be difficult because of drug-related side effects, toxicity, and other psychosocial issues such as stigma or changes in lifestyle,” added Boysen.

“The committee heard that stigma remains an issue for people living with HIV and can have a negative impact on people’s health and relationships,” he added.

“We are pleased therefore to be able to recommend cabotegravir with rilpivirine as a valuable treatment option for people who already have good levels of adherence to daily tablets, but who might prefer an injectable regimen with less frequent dosing,” added Boysen.

Pill fatigue 

antiretroviral
People living with HIV typically have to take daily pills to lower viral load.

“HIV unfortunately remains a stigmatised condition. Although we’re working hard to tackle the stigma surrounding HIV, this new injectable treatment option could help people in house-shares for example who do not wish to share their HIV status and will no longer have to worry about hiding their medication,” said Debbie Laycock, head of policy at HIV charity, Terrence Higgins Trust.

“Pill fatigue is also an issue for some people living with HIV who struggle with the idea of taking antiretroviral drugs every day,” added Laycock.

“Long-acting injectable treatment is also a better option for those who have difficulty swallowing medication. Therefore, the institute’s approval provides a welcome additional treatment option for people living with HIV across England and Wales.”

The United Kingdom has a relevantly small, concentrated HIV epidemic, with an estimated 101,600 people living with HIV in 2017. An estimated 13,000 people will be eligible for the injectable treatment in England

Added Laycock: “This is a great step forward as we work towards ending new cases of HIV by 2030. The institute’s decision brings great potential for HIV prevention including long-lasting pre-exposure prophylaxis (PrEP) in the future.”

Image Credits: PharmacyMagUK/Twitter, Flickr.

Dr Ali Ahmed Yahaya, WHO Africa lead on antimicrobial resistance.

Over four million Africans a year could die as a result of antimicrobial resistance (AMR) by 2050, according to WHO’s Africa Region at the start of World Antimicrobial Awareness Week on Thursday.  And if global action isn’t taken to head off risks, nearly nine million of the estimated 10 million people dying around the world from AMR by 2050, will be either Africans or Asians. 

Drug-resistant tuberculosis is a growing phenomenon, while malaria parasites also are becoming resistant to once-effective first-line anti-malarial treatments.

“Antimicrobials – including antibiotics, antivirals, antifungals, and anti parasites – are the backbone of modern medicine,” explained World Health Organization (WHO) Director-General Dr Tedros Adhanom Ghebreyesus.

“They allow us to treat deadly infections successfully, and make essential health services safer for everyone. However, the overuse and misuse of antimicrobials are the main drivers of drug-resistant pathogens,” he warned in a recorded message as events were held all over the world to draw attention to the threat posed by the growing trend of “superbugs” resistant to existing drugs and treatment.

In light of the growing threats, six global and regional organisations on Wednesday issued an appeal for stronger policies to fight AMR. They included the World Health Organization (WHO), the Food and Agriculture Organization of the United Nations (FAO), the World Organisation for Animal Health (OIE), the UN Environment Programme (UNEP),  the Africa Centres for Disease Control and Prevention (Africa CDC), and the African Union Inter-African Bureau for Animal Resources (AU-IBAR).

The FAO’s Regional Representative for the Near East and North Africa, Dr Abdulhakim Elwaer, said that his organisation, together with the WHO and OIE were establishing AMR multi-stakeholder partnership platforms across all sectors to implement an AMR global action plan.

FAO’s Dr Abdulhakim Elwaer

COVID-19 illustrates ease of infection spread

Projection of deaths annually from AMR by region as of 2050 in business-as-usual scenario, show Africa and Asia bearing the brunt of the burden. Source: Review on Antimicrobial Resistance: Wellcome Trust & HM Government, 2014

“The COVID 19 pandemic has shown the ease with which infections can spread, threaten global health security, and destabilise economies, lives and livelihoods,” Elwaer told an African regional AMR meeting on Thursday.

“Trans-boundary animal diseases and zoonotic diseases have a devastating impact on animal production, food security, trade, public health, and economy,” he warned, calling for the responsible use of antimicrobials in animal and plant health.

The estimate of 4.1 million deaths annuall in Africa by 2050 is part of a broader assessment of global health risks that concluded some 10 million people a year could die from AMR by 2050 – mostly in Asia and Africa.  The estimates from the review, conducted in 2014 by an independent commission, co-sponsored by the UK government and the Wellcome Trust, were also highlighted in a major UN assessment of AMR trends and risks, No Time to Wait, published in 2019 just before the COVID pandemic took off.

Worldwide, agriculture is one of the biggest users of antibiotics alongside human health – and in some developed countries like the United States animals may even be the largest consumers of these life-saving drugs.

Dr Yahaya Ali Ahmed, the WHO’s Africa Team Lead for AMR, said that routine administration of antibiotics to animals as a prophylaxis against disease, and to promote growth, is now also a growing practice on the continent – and that is driving resistance too.

In addition, inadequate treatment of sewage, particularly emissions from health care facilities that use and inevitably discharge medicine residues in their waste, provides a media where resistant microbes may breed and multiply.

“Animals might also acquire resistance from water contaminated with human sewage. We have several issues in our region, specifically inadequate hospital sewage systems,” added Ahmed.

“These examples highlight that there is really an interface between humans, animals, plants and the environment,” said Ahmed. “If a single sector tries to work alone, it will fail and this is why we really need to adopt an integrated and holistic multi-sectoral, ‘One-Health’ approach in combating AMR.”

Wildlife and aqua-culture

OIE Africa representative Dr Karim Tounkara Africa said that his organisation was working to integrate environmental, aquatic and wildlife issues into the region’s One Health approach.

“OIE developed a wildlife health framework in 2020 aiming at reducing the risk of disease emergence and protecting wildlife health,” said Tounkara.

The wildlife framework aimed to “improve member states’ capacity to manage the risk of pathogen emergence in wildlife and at the human animal ecosystem interface, whilst taking into account the protection of wildlife”, said Tounkara.

“The second objective is about enabling OIE members to improve surveillance systems, early detection and the reporting and management of wildlife of diseases,” he added.

Antibiotic shortages may also drive inappropriate use – leading to AMR

While drug resistance develops from overuse and incorrect use in both people and in animals, it can also be an outcome of antibiotic shortages – when an antibiotic that is already vulnerable to resistance is routinely prescribed because a better one is unavailable.

“In Uganda, doctors write prescriptions based on availability rather than suitability,” according to a report from the Center for Disease Dynamics, Economics & Policy (CDDEP) published in 2019. 

In addition, poor medicines regulation in Africa also drives a black market trade – including fake medicinal treatments.  Widespread use of fakes, which may contain weakened formulations of antibiotics or other inappropriate treatments, also enable drug resistant microbes to flourish, leading to more AMR.

Despite the pandemic, Europe sees reductions in antibiotic use between 2019-2020

There has been widespread concern that the COVID-19 pandemic may be stimulating AMR trends – in light of the widespread administration of antibiotics to COVID patients to prevent secondary infections – even in cases when the risks were very low.

Nonetheless, Europe saw a net decline in antibiotic use in 2019-2020, according to a recent report by the European  Centre for Disease Prevention and Control (ECDC). The report, showcased at ann event sponsored by the ECDC and the European Union, found that virtually all of the member states of the European Economic Community (EEC) had reduced their antibiotic consumption by 18% in 2019-2020. Bulgaria was the only country that reported increased antibiotic use.

This decrease could be explained by a reduction in respiratory tract infections, thanks to the use of masks, phyical distancing and other measures introduced to curb COVID-19, reported the ECDC.

Even so, the risks of AMR in most regions of the world are mounting – and with them the risk that AMR will lead to the routine loss of more and more lives – if not the next pandemic.

“The World Bank has estimated that, if nothing is done to address the factors driving AMR, it will have the same impact and cost as much as COVID-19, not once, but annually, year after year,” warned Hans Kluger, the WHO’s European Regional representative, at the EU event.

Image Credits: WHO / M. Edwards, Source: Review on Antimicrobial Resistance: Wellcome & UK Govt. .