Pfizer’s COVID-19 vaccine during the manufacturing process.

In a bid to better respond to both domestic and global needs, as well as future threats, the Biden Administration plans to spend billions of dollars to expand US vaccine manufacturing capacity enabling production of 1 billion vaccine doses a year by mid-2022, two top White House officials told US media on Wednesday. 

The announcement comes just ahead of another move whereby the US Food and Drug Administration is expected to approve booster shot doses of the Pfizer-BioNTech Covid vaccine for all adults later this week. 

Currently, boosters are only recommended for Americans age 65 and older, but as US infection rates begin to rise again, leading experts such as Anthony Fauci, chief White House Medical advisor, have said that they think booster doses for most people will be inevitable to head off a mid-winter virus surge.  

Despite rising infection rates in many countries – WHO continues to oppose boosters 

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

WHO and health equity advocates have continued to strongly oppose the administration of booster doses by rich countries, saying that these rob poorer nations of doses for their first and second vaccines. 

On Sunday, WHO repeated its call for a “moratorium on COVID-19 boosters until the end of 2021” so that other countries could get first shots. 

“No more vaccines should go to countries that have already vaccinated more than 40% of their population until COVAX has the vaccines it needs to help other countries get there too,” said WHO, citing earlier remarks by WHO Director General Dr Tedros Adhanom Ghebreyesus.

“No more boosters should be administered except to immunocompromised people. 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.

White House manufacturing expansion – focused on domestic producers  

Dr David Kessler, chief science officer for White House COVID-19 response

The White House moves to expand manufacturing should help ease supplies abroad, officials pointed out. 

However, while Africa and other low- and middle-income regions have called for more investments on the continent and in other LMICs, the planned new US new investments will be based around manufacturing by US domestic suppliers:

“This effort is specifically aimed at building U.S. domestic capacity,” White House vaccine czar Dr David Kessler was quoted as saying. “But that capacity is important not only for the U.S. supply, but for global supply.”

Kessler, who helped speed the development and approval of AIDS drugs in the 1990s, is the White House Chief Science Officer for COVID Response – the initiative the former Trump administration had called ‘Operation Warp Speed’.

Speaking with reporters at a briefing on Wednesday, White House COVID-19 Response coordinator Jeff Zients said that along with battling COVID, the programme would help prepare the US and the world for a future pandemics, enabling production:  “within six to nine months of identification of a future pathogen.”  

Initiative expands government partnerships with private sector

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

The investment in vaccine manufacturing capacity is happening in the context of a thrust by the Biden administration to both challenge and woe industry. 

On the one hand, the government has waged a high-profile battle with Moderna, contending that three scientists at the National Institutes of Health should hold co-inventor rights over Moderna’s core mRNA vaccine patent – a demand that Moderna now seems to be conceding, at least partially. 

On the other, the need for expanded collaboration with the private sector was also a theme of statements last week by US Secretary of State Anthony Blinken after a virtual COVID-19 ministerial conference with about 40 other foreign ministers from around the world.

The investments would focus on US vaccine manufacturers with experience in producing mRNA vaccines – who need more help to scale up their capacity rapidly.  

As a first step, Biomedical Advanced Research and Development Authority (BARDA) will issue a call for inputs from experienced vaccine manufacturing companies, asking for responses within the next 30 days, Zients and Kessler said. 

Funding for the scale-up, estimated to cost “several billion” according to Kessler in an interview with the New York Times, which first reported on the initiative.  

The funding would come from the $1.9 trillion coronavirus relief bill that President Biden signed into law in March.

Biden has pledged to donate more than 1 billion coronavirus vaccine doses to other countries in order to vaccinate the global population as the international community struggles to overcome the pandemic, including 800 million doses through the WHO co-sponsored COVAX global vaccine facility initiative.  However only a fraction of those donated doses – or others promised from high -income countries, have so far been delivered. 

Zients said at the COVID-19 briefing that the administration has now shipped 250 million doses to 110 countries as of Wednesday.  A little more than 100 million US doses have been delivered through COVAX, while the rest were donated in bilateral arrangements.  

Some observers say that it is stockpiling of unused doses by wealthy countries, rather than boosters, remains a bigger factor foiling attempts to distribute vaccines more equitably.

In either case, it’s clear that vaccine hoarding is also a powerful driver.  According to independent reports by both civil society groups like Medicins Sans Frontiers, as well as industry observers such as AirFinity, between 600-900 million excess vaccine doses are currently languishing in rich country stockpiles – after existing vaccine priorities and boosters are considered. At least 241 million of those doses will also expire by the year’s end.

The excess doses of COVID-19 vaccines by the end of 2021 after vaccinating people ages 16 and up in ten high-income countries.

 

Image Credits: NBC, Pfizer, Twitter , https://covid19globaltracker.org/, MSF.

The number of tobacco users globally has dropped from 1.32 billion in 2015 to 1.3 billion, and is expected to decline to 1.27 billion smokers by 2025, according to the fourth World Health Organization (WHO) global tobacco trends report.

The report, released on Tuesday, revealed that 60 countries are now on track to achieving the global target of a 30% reduction in tobacco use between 2010 and 2025. Two years ago, only 32 countries were on track. 

WHO Director-General Dr Tedros Adhanom Ghebreyesus described the findings as  “encouraging” but noted that the world still had a long way to go. 

“Tobacco companies will continue to use every trick in the book to defend the gigantic profits they make from peddling their deadly wares,” said Dr Tedros. “We encourage all countries to make better use of the many effective tools available for helping people to quit, and saving lives.”

Tobacco kills an estimated 8.1 million a year, 7 million smokers and another 1.2 million people from second-hand smoke, according to the most recent WHO numbers. 

While the WHO report covers use of smoked tobacco, such as cigarettes, pipes, cigars, and smokeless tobacco products, such as oral and nasal tobacco, the use of electronic cigarettes was not analyzed in the report. This could distort the data provided, as e-cigarette use is on the rise, particularly among young people. 

To further reduce the number of people at risk of becoming ill and dying from a tobacco related disease, the report also urges countries to accelerate the implementation of measures outlined in the WHO Framework Convention on Tobacco Control (FCTC). 

Investment in cessation could help 152 million tobacco users quit 

Investing a mere $1.68 per capita each year in evidence-based cessation interventions such as brief advice, national toll-free quit lines, and SMS-based cessation support, could help 152 million tobacco users successfully quit by 2030, according to the new WHO Global Investment Case for Tobacco Cessation. 

WHO called for cessation services to be scaled up, along with strengthening tobacco control measures, and subsequently established a tobacco cessation consortium, which will bring together partners to support countries in scaling up tobacco cessation.

Currently, only about 30% of the world’s population has access to appropriate tobacco cessation services, with many countries still lacking a national tobacco cessation strategy and only a few countries dedicating both personnel and budgets to cessation programs. 

Implementing cessation measures has been shown to result in a 2 – 15% increase in the proportion of tobacco users who quit tobacco use for 6 months or more, as opposed to no intervention. 

Notably, over 60% of smokers report that they want to quit, and over 40% have attempted to do so in the past year – though the report notes that many will fail without much-needed cessation assistance. 

Americas, Africa and SE Asia on track for 30% tobacco reduction

Key findings from the report show that reductions in tobacco have been seen across the Americas, Africa, and Southeast Asia.  

The WHO Americas region reports the steepest decline in tobacco prevalence rate, which has gone down from 21% in 2010 to 16% in 2020. 

The WHO regions of Africa and South-East Asia have also joined the Americas region to be on track to achieve a 30% reduction by 2025. 

However, the WHO Western-Pacific region is projected to become the region with the highest use rate among men, with more than 45% of men still using tobacco in 2025. 

Additionally, the WHO European region has more women using tobacco than any other region – 18%, with women in Europe the slowest to cut tobacco use. 

Approximately 231 million women used tobacco in 2020, with the highest use seen among women aged 55 – 64. 

All other regions are on track to reduce tobacco rates among women by at least 30% by 2025. 

In 2020, 22.3% of the global population used tobacco – accounting for 36.7% of all men and 7.8% of all women. 

E-cigarette research missing from report 

E-cigarettes
Observed estimates show e-cigarette use among young people is increasing.

While e-cigarettes were notably left out from the report, observed estimates did reflect the rise in use among adolescents, with the most startling prevalence rates found in Monaco of 41% of children aged 15 and 16 years old, followed by Lithuania (31%) and Poland (30%). 

Trends in the use of e-cigarettes and other nicotine delivery devices were not included in the report due to the lack of country data. But the data that does exist reveals the need to address a fast-growing and relatively unregulated market that continues to influence children and adolescents. 

Newer tobacco and nicotine products, including e-cigarettes, have evaded regulation, with the tobacco industry using deceptive advertisements to market these products to children and teens.   

Children who use these products are up to three times more likely to use tobacco products in the future, according to a WHO 2021 report on the tobacco epidemic released in July. 

Approximately 28 million children aged 13 – 15 currently use tobacco, despite the fact that most countries have made it illegal for minors to purchase tobacco products. 

Aggressive tobacco control needed

Although the report indicates notable progress in many regions of the world, Ruediger Krech, WHO Director of the Department of Health Promotion, emphasizes the need to push ahead in moving aggressively with tobacco control. 

“It is clear that tobacco control is effective, and we have a moral obligation to our people to move aggressively in order to achieve the Sustainable Development Goals,” said Krech.

“We are seeing great progress in many countries, which is the result of implementing tobacco control measures that are in line with the WHO FCTC, but this success is fragile. We still need to push ahead.” 

While one in three countries are likely to achieve the 30% reduction target, especially in low-income countries, upper-middle countries, on average, are making the slowest progress in reducing tobacco use. 

Some 29 countries lack sufficient data to know tobacco trends and need additional monitoring. 

WHO Meeting of the Parties to address illicit trade in tobacco products  

Starting also this week, in line with the release of the report and the investment case, is the Second Meeting of the Parties (MOP2) to the Protocol to Eliminate Illicit Trade in Tobacco Products.  

Up to $47 billion is lost globally to illicit trade in tobacco products. To further reduce this loss and improve the effectiveness of tobacco control legislation, representatives at MOP2 will consider ways of implementing the protocol, including securing the supply chain of tobacco products through tracking and tracing technologies.

Eliminating illicit trade could reduce cigarette consumption by almost 2% and increase tax revenues by an average of 11%. 

Ahead of MOP2, Head of the WHO FCTC Secretariat Adriana Blanco Marquizo highlighted the need to address illicit trade in tobacco, which has undermined global tobacco reduction efforts. 

“We have serious work to conduct at this meeting. Not only does the illicit trade in tobacco products undermine progress being made on taxing tobacco products, but illicit trade is linked to cross-border organized crime and other activities which threaten our security, ” she said. 


Discussions at MOP2 will be held from 15 – 18 November, days after the close of the Ninth Conference of the Parties (COP9), which convenes every two years to discuss ways in which the FCTC and its implementation can be improved. 

 

 

Image Credits: Johannes Zielcke, Mahdi Bafande/ Unsplash, Bastien Hervé / Unsplash.

Pfizer global headquarters in New York.

Pfizer has signed a voluntary license with the Medicines Patent Pool (MPP) to share the patents and knowledge to manufacture its new COVID-19 treatment drug, Paxlovid. 

According to the agreement, the MPP will be able to granting sub-licenses to qualified generic medicine manufacturers to supply the medicine in 95 countries, once regulatory authorization or approval has been granted.

All low- and lower-middle-income countries and some upper-middle-income countries in sub-Saharan Africa, as well as countries that have transitioned from lower-middle to upper-middle-income status in the past five years, are covered by the license, according to a statement from MPP.

“Pfizer will not receive royalties on sales in low-income countries and will further waive royalties on sales in all countries covered by the agreement while COVID-19 remains classified as a Public Health Emergency of International Concern by the World Health Organization,” according to the statement.

“Pfizer remains committed to bringing forth scientific breakthroughs to help end this pandemic for all people. We believe oral antiviral treatments can play a vital role in reducing the severity of COVID-19 infections, decreasing the strain on our healthcare systems and saving lives,” said Pfizer CEO Albert Bourla.

“This license is so important because, if authorized or approved, this oral drug is particularly well-suited for low- and middle-income countries and could play a critical role in saving lives, contributing to global efforts to fight the current pandemic,” said Charles Gore, Executive Director of MPP.

‘Potentially game-changing’

In a recent trial, Paxlovid showed an 89% reduction in the risk of COVID-related hospitalisation and death, Pfizer announced recently.

In the light of this “overwhelming efficacy”, Pfizer abandoned the final phase of the trial is  seeking emergency use approval for Paxlovid from the US Food and Drug Administration (FDA) before 25 November.

While the voluntary license with the MCC restricts the sale of Paxlovid to 95 countries, it allows manufacturing to take place anywhere.

“Pfizer’s license with the MPP will allow the rapid scale-up of manufacturing of what appears to be an effective and safe treatment for COVID-19,” said James Love, Director of Knowledge Ecology International (KEI), describing the license as “potentially game-changing”.

“The licensed territory is large and underserved by vaccine manufacturers, making it inexpensive to manufacture therapeutics particularly important. The ‘manufacture anywhere’ feature of the license provides the right model for scaling manufacturing in a pandemic, where speed and decentralization are desired,” added Love.

“Pfizer deserves credit for engaging with the MPP and agreeing to transparency, open and pro-competitive licensing in the middle of a pandemic for this product.”

According to KEI’s analysis, the Pfizer license is similar to the voluntary license between the MPP and Merck for its COVID-19 treatment, molnupiravir, announced late last month.

However, the Pfizer license excludes 17 countries that were included in the Merck license, and adds seven others, and generally targets countries with lower per capita incomes. Countries excluded include Brazil, Cuba and Jamaica.

The Pfizer-MCC agreement also makes it possible for the sale of Paxloid outside the 95 countries in places where there is no patent or compulsory license, “as long as the manufacturer has licensed the patents, but not the know-how”, according to KEI. 

MSF condemns ‘restrictive’ deal

MSF’s Yuan Qiong Hu

However, Medecins Sans Frontieres (MSF) was less complimentary, with its senior legal policy officer Yuan Qiong Hu saying that the 95 countries included only covered 53% of the world’s population.

“We are disheartened to see yet another restrictive voluntary license during this pandemic while cases continue to rise in many countries around the world,” said Hu.

“Many upper-middle-income countries, such as Argentina, Brazil, China, Malaysia and Thailand, where established generic production capacity exists, are excluded from the license territory.”

Hu also condemned Pfizer’s stated intention to pursue a tiered-pricing strategy, punting a price of around $700 for a five-day course of the medicine in high-income countries, with prices for low and middle-income countries still under discussion.

“We know from experience [tired-pricing] is unnecessarily complex, keeps the decision-making power entirely in the hands of the pharmaceutical corporations, and results in higher prices in many countries,” said Hu.

No deaths, few hospitalisations

Paxlovid treatment requires 300 mg of the medicine twice a day, along with 100mg of an older anti-viral, ritonavir, typically for five days. Ritonavir is an antiretroviral medicine used to treat HIV that is no longer covered by patents.

“Pfizer should refrain from seeking any new monopolies on ritonavir, either solely or in combination with the other compound, as the drug remains an important part of some antiretroviral regimens for people living with HIV,” warned MSF’s Hu.

Interim analysis of the Paxlovid-Ritonavir trial on non-hospitalized adult patients with COVID-19 at high risk of progressing to severe illness, showed that only three (0.8%) of the 389 people who got the medicine within three days of symptoms went to hospital and none died.

In comparison, 27 (7%) out of the 385 patients on the placebo were hospitalised and seven later died.

Image Credits: AMR Industry Alliance, Coolcaesar/ Wikipedia.

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

While it pales in comparison to tobacco industry marketing, two new capital investment funds worth some $75 million to support low- and middle-income countries in their fight against tobacco are being created by signatories to the Framework Convention on Tobacco Control and a related Protocol on illegal sales.  Together, the funds would yield an estimated $3 million a year for developing new systems to regulate, track and reduce tobacco use.

While all eyes last week were on the Glasgow Climate Conference (COP26), another Conference of Parties – on the Framework Convention on Tobacco Ccntrol (FCTC) was taking place in Geneva and virtually. 

The FCTC’s COP9 is being followed this week by a Meeting of Parties to a new FCTC protocol that aims to eliminate illicit trade in tobacco products.  That trade, including both physical and online sales,  is a growing concern of countries – because of its potential to undermine new tax laws and other measures that curb tobacco’s harmful influence. 

The first fund, for $50 million, was approved by the FCTC’s COP9 last week, at the close of the week-long meeting of the Convention’s 181 member states.  

The second fund, for $25 million, is being considered during this week’s meeting of signatories to a related FCTC Protocol to Eliminate Illicit Trade in Tobacco Products, which has now been ratified by 64 FCTC member states. 

The new capital investment funds, aim to recruit investors from beyond the health sector, and create annual yields of earned revenues that may be put at the disposal of countries to help them refine and adapt their policy and regulatory tools in the tobacco control battle, Samuel Compton, FCTC spokesperson, told Health Policy Watch.

The funds will bolster the long-term stability of FCTC activities – which currently rely upon a biennial budget of some $19.1 million, covered by assessed contributions to FCTC signatories, and extra budgetary support.

In terms of managing the funds it is likely that the World Bank make take over the task, Compton said, supported by a board of experts in financial and investment management representing the six World Health Organization Regions, as well as civil society.

Tobacco kills an estimated 8.1 million people a year, according to the most recent WHO numbers, including 7 million smokers and another 1.2 million people from second-hand smoke. 

And market projections show that industry continues to expand – with expected growth of over  % 2.7 this year.  This expansion is occurring despite evidence that consumption of traditional tobacco products, according to a 2019 WHO report. Although those reports have not included e-cigarette use in their tracking.  

Illicit trade driving market expansion

Illegally manufactured or trafficked tobacco products also driving market expansion.

Along with e-cigarettes, another one of the drivers of expansion is the illicit trade in tobacco products – which is easier than ever before thanks to online trade, says FCTC spokesperson Samuel Compton, told Health Policy Watch. 

“WHO estimates that eliminating illicit trade could reduce cigarette consumption by almost 2% and increase tax revenues by an average of 11%,” said WHO’s Director General Dr Tedros Adhanom Ghebreyesus, in his opening remarks to the meeting of members of the protocol (MOP2) the second such meeting to take place.

“The global tax revenue potential from eliminating illicit trade in tobacco is about 47 billion US dollars annually,” he added, noting that the illicit tobacco trade is rooted in a wide range of driving forces, including, “weaknesses in governance and regulation, corruption, insufficient enforcement capacity, and organized crime networks.”

It includes both the black market sale of legally produced tobacco products – as well as black market production of tobacco products.

Both types of products are marketed and sold in informal markets, and online, at prices that undercut legal, taxed tobacco sales.  Under the terms of the FCTC, such tobacco taxes are supposed to designed and use in a way that deters tobacco consumption as well as providing funds to support public health programmes to fight tobacco addiction and use.  

Added Adriana Blanco Marquizo, Head of the Secretariat of the WHO FCTC, in her opening remarks at Monday’s MOP: 

“We know the tobacco industry tries to mislead governments, using the illicit trade argument to oppose the adoption of highly effective tobacco control measures, like increasing tobacco taxes. Refraining from increasing taxes is not the solution. But implementation of the Protocol is. Parties should respond with a comprehensive strategy to fight illicit trade by fully taking up its provisions.

David and Goliath struggle with tobacco – parallels that of fossil fuels

All tobacco products, including electronic cigarettes, increase the risk of heart disease

Other than timing, there are other comparisons between the David and Goliath battle against big tobacco seen at COP9 and the battle to phase out fossil fuels waged at Glasgow’s COP26. 

While the oil and gas sector will earn about $2.1 trillion in 2021 – and were said to have the largest contingent of lobbyists at this year’s COP26 – climate conference participants failed to come up with a clear way forward to raise the estimated $100 billion annually in finance that low- and middle-income nations say that they need to fight climate change effectively – and wind down fossil fuel dependency more rapidly. 

Similarly, as compared to the tens of billions spent on marketing by the tobacco industry, which will earn revenues of $786 trillion in 2021, global and national budgets to fight big tobacco remain miniscule. 

Only about $66.2 million of international development assistance for health was dedicated to tobacco control activities in 2019, according to a 2020 analysis published in the peer-reviewed journal, Tobacco Induced Diseases. 

Considering that, along with the roughly $9.55 million annual FCTC budget, still leaves an estimated $27.4 billion funding gap in monies urgently needed to fight tobacco use, according to a 2019 report by the Framework Convention Alliance, FCA. 

Tracking and reporting on progress

And in the world of tobacco control, there are also challenges in tracking and reporting progress against global goals – comparable to those faced by countries tracking fossil fuel phase-out, or “phase-down” – as per the final language adopted by the Glasgow Climate Conference on Saturday.

For instance, while WHO says tobacco use worldwide is declining, recent WHO reports have tracked only smoked tobacco products – excluding the growing market in e-cigarette sales. 

And there are clear signs that e-cigarette use is on the rise, particularly among young people.

That raises questions about how much of the decline in tobacco use is real – and how much is merely a shift to another form of tobacco dependency?

At the same time, WHO points to progress made by countries in adopting more health-conscious tobacco legislation, regulation and taxing.  

“Even during the COVID-19 pandemic, there has been progress on tobacco control,” said Dr Tedros Adhanom Ghebreyesus, in his remarks to the MOP.

“5.3 billion people are now covered by one of the best practice tobacco control measures, including increased taxes on tobacco,” he said, referring to the WHO basket of best practices for health, tax and educational that countries can adopt to stop tobacco use. 

Image Credits: WHO/Pierre Albouy, Chris Vaughan, WHO.

A protest banner highlighting COP26’s exclusion of indigenous communities from talks.

While China and India’s last-minute refusal to commit to an end to fossil fuel at COP26 has caused depression and despair amongst many developing country delegates and climate activists, the mental health of millions is already severely affected by what climate disasters have done to their lives.

Humidity and heatwaves are linked to increased suicides, according to a new report released on Monday. Almost one-third of people caught in floods experience post-traumatic stress. Predicted massive climate-related conflict and increased climate migration are also triggers for mental distress.

“When we talk about the mental health impact of climate change, many people think I am talking about eco-distress and eco-anxiety but that’s not really what I’m talking about,” said psychiatrist Dr Lisa Page, co-chair of the UK Royal College of Psychiatry’s Planetary Health and Sustainability Committee.

Instead, said Page, she was referring to the direct and indirect impacts of climate crises on mental health.

“A systematic review that was published recently showed that around if you’re flooded, around 30% of people will develop post-traumatic stress disorder (PTSD) and probably around 20% of people will develop either depression or anxiety,” Page told a meeting hosted by the UK Royal College of Psychiatrists, Royal College of Paediatricians and Child Health Workers and Royal College of Physicians on the sidelines of COP26 last week.

Turning to heat, Page pointed to statistics from the UK Office for National Statistics for summer 2020 which showed that all-cause mortality went up during each of the three recorded heatwaves, with over 2500 excess deaths in England alone.

“That’s mostly in the over 65. But we know from other evidence that it’s not just the frail elderly. It is also people with major mental illness, examples being dementia, severe and enduring illnesses like psychosis, and people with substance misuse problem,” said Page.

Monday’s report in Nature, based on data from 60 countries between 1979 and 2016, found statistically significant increases in suicide – but related to more to humidity than heatwaves. Women and younger people were particularly affected, and the countries affected were as varied as Sweden and Guyana.

One of the scientific reasons advanced for this is that some medicines for mental health inhibit the body’s ability to effectively thermoregulate. This results in heat stress and the exacerbation of certain mental health conditions, including bipolar ‘disorders’, schizophrenia, dementia and developmental ‘disorders’ including autism.

Page cited indirect impacts such as loss of land, forced migration, and changes patterns in infectious diseases as possibly more significant than heat and floods.

“Forced migration, particularly migration that might involve unexpected migration, or migration after conflict, has very significant and very serious effects on mental health, and can  lead to higher incidence of psychosis, for example, in migrating populations,” said Page.

“There have been recent dire predictions about increases in conflict as a result of climate change and I can’t think of any other human activity that leads to more mental disorder than conflict,” said Page. “And finally, we get to eco-distress and eco anxiety.”

What about grief and loss?

Child psychiatrist Dr Lynne Jones, has been establishing and running mental health programmes in conflict areas and after natural disasters since 1990, including Iraq, Sierra Leone, Ethiopia, Uganda, post-tsunami Indonesia, post-Earthquake Haiti and with migrants in Europe and Central America.

“For millions of people, climate change is not a future threat but a current catastrophe,” said Jones, speaking from Bosnia where she is working with migrants. 

“Climate-fuelled disasters were the number one driver of internal displacement in the last decade. The word climate change is totally inadequate. These disasters are the result of climate breakdown and ecological collapse and I prefer the term planetary crisis to encompass both.”

In 2020, Central America suffered the worst Atlantic hurricane season ever recorded, which displaced more than half a million people, while Madagascar has been in a climate-induced famine for the past four years, said Jones.

“The developing brain needs adequate nutrition, maternal love, play and stimulation. And if any of these absent, there’s likely to be lifelong damage and an enormous loss of human potential,” stressed Jones.

Jones worked in a refugee camp in Chad following a climate-induced conflict and was struck by how mothers were too depressed and lacking in energy to interact with their babies.

“I know that PTSD and traumatic stress and acute stress problems are a major issue of the conflict. But what doesn’t get talked about, as a direct effect of conflict and disaster, is grief and loss. It is the most important mental health effect. It’s not a disorder,” said Jones.

“The problem is how do you mourn if you can’t hold a funeral because your house has been destroyed? Or all the neighbours are also mourning and feel they can’t come because they’re dealing with their own grief so you don’t have that community connection? And what if there’s no body because it was lost at sea, or buried in a mass grave, or abandoned in flight? These are the problems of grief and loss that I don’t see discussed?”

Image Credits: Disha Shetty .

 

Checking blood sugar levels in Kenya for control of diabetes.

The inflated costs of insulin and control of its price and supply – are barriers preventing people with diabetes from accessing this life-saving medicine, according to a report released by the World Health Organization (WHO). 

Insulin is the basis of diabetes treatment, essential for nine million people with type 1 diabetes who cannot make the hormone that controls the blood glucose level, and 63 million people living with type 2 diabetes, with limited or diminishing insulin.

It reduces the risk of kidney failure, blindness and limb amputation – but half the people living with type-2 diabetes cannot afford it.

Around 90% of the market tightly controlled by three multinational companies: Novo Nordisk, Eli Lilly, and Sanofi, according to the WHO report.

With a higher number of people today being diagnosed with diabetes, the WHO has said that unaffordable insulin, stakes of multi-billion dollar companies in manufacturing and supply, and storage of the life-saving medicine are the main barriers of access to insulin.

According to the report, released to coincide with World Diabetes Day on 14 November, the use of insulin analogues, or synthetic insulin, has increased in high-and middle-income countries although it is significantly more expensive than human insulin. 

Eighty percent of the 420 million people living with diabetes live in low- and middle-income countries.Type-2 diabetes is the most common type of diabetes and access to affordable insulin and treatment is critical to their survival. 

There is a globally agreed target to halt the rise in diabetes and obesity by 2025. Currently, over a million deaths each year are directly attributed to diabetes.

Lower-income countries bear the brunt

Insulin was discovered a century ago and the scientists then had sold its patent for a dollar to encourage its use for saving lives and not to make profits.

“Unfortunately, that gesture of solidarity has been overtaken by a multi-billion-dollar business that has created vast access gaps. WHO is working with countries and manufacturers to close these gaps and expand access to this life-saving medicine for everyone who needs it,” said WHO Director-General, Dr Tedros Adhanom Ghebreyesus. 

According to an article in the  latest edition of The Lancet, 25% of the seven million insulin patients in the United States, a high-income country, struggle with its high cost. Controversial insulin pricing practices, including price-fixing, has led to repeated market failures and continued unnecessary deaths in the U.S, the Lancet article showed.

The pricing landscape is also uneven and reveals a lack of transparency in the way prices are set, according to the report. The benefits of cheaper biosimilar insulins are not enjoyed by many countries, including lower-income ones. 

Although three-quarters of type-2 diabetics live outside North America and Europe, yet these two regions accounted for 60% of revenue worth US$16.6 billion in 2020.

The report highlights that there are a “significant number of underserved markets” in lower-income countries and in the WHO African Region, WHO South-East Asia Region and WHO Eastern Mediterranean Region. 

The market for insulin and diabetic care has shifted from human insulin, which can be produced at relatively low cost, to more expensive analogues or synthetic insulins, which are up to three times the cost. This has financially burdened lower-income countries. 

One of the studies cited in the report showed that the lowest-paid unskilled government workers in the 13 low-and middle-income countries studied would need to spend six to eight days of wages to purchase 1000 IU insulin analogue doses in the public sector and 7–16 days’ wages to purchase the same in the private sector.  To buy human insulin would need four days’ of wages n the public sector and two-four days in the private sector. 

Expensive insulin is not the only problem

The report also highlighted the issue of access to devices and equipment for monitoring glucose levels. These are necessary for the detection of the disease and its complications and are responsible for shaping insulin use and diabetes care. 

In low-, middle-and upper middle-income countries, less than 50 percent of primary health care facilities have the needed supplies for measuring glucose and the apparatus for screening diabetes complications.

Half to one-third of these tested devices were able to meet the standards of International Organization for Standardisation (ISO). 

All forms of human insulin are no longer under patent protection. There is a lack of biosimilar human insulin approved by stringent regulatory authorities. Currently, intellectual property barriers created by patents on devices and secondary patents have implications on pricing and affordability, the report said. 

So what is the solution? 

WHO recommends the increased local production of insulin and associated devices to cater to the demands of the population without having to pay a premium to large conglomerates.

Locally produced quality-assured insulins and associated devices may also improve to scale up production and operational costs.

Currently, case studies in six low-and middle-income countries showed that there was a  cumulative mark-up of 8.7% to 565.8% for insulin, depending on country and health system context. 

The WHO report also highlights the need to improve the collection and publication of data on diagnostic, pricing and usage of insulins and associated devices. 

Pharma response –  high prices and access barriers are due to a wider range of supply chain factors

In a response to the WHO report, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) took issue with the WHO claim that market dominance by the three largest insulin producers is the root cause of high prices in many low-and middle-income countries.

The IFPMA cited a recent report by the IQVIA Institute, a pharma research firm, which surveyed 32 low- and middle-income countries finding “no correlation between the three largest companies’ market shares” and the average cost of insulin per day, adding that “other factors are evidently driving average costs per day for patients.”

The report also notes that six large global biosimilar manufacturers and 12 other manufacturers are operating in the countries surveyed.

“By way of example, one innovative biopharma company, Novo Nordisk, has committed to supplying human insulin in 76 LMICs at a cost of $2-3/vial – which equates to 8 or 12 cents per day for LMIC country purchasers that are governments or UN/humanitarian organizations, respectively, said the IFPMA statement.

“And yet LMIC patients are still not getting access to insulin (or quality diabetes care) at the point of care.  The reasons for this are complex and multi-faceted and do not fit a single narrative…. We recommend that all stakeholders acknowledge this reality, ‘roll up our sleeves’ and tackle it in a constructive, collaborative way while toning down the rhetoric.

“From an LMIC patient perspective, organizations like PATH have highlighted the serious problems caused by massive pricing markups along the supply chain, which impact patients at the point of care.  We also recommend a greater focus on the essential devices required to measure a patient’s blood glucose and to administer insulin safely and effectively.  These elements go hand in hand with supporting patients with quality diabetes care, and (according to PATH and other organizations) often represent by far the greatest out-of-pocket cost for PLWDs.

Concluded the IFPMA: “The pricing landscape is also uneven and reveals a lack of transparency in the way prices are set, according to the report. For example, biosimilar insulins (essentially generic versions) could be more than 25% cheaper than the originator product, but many countries, including lower-income ones, are not benefitting from this potential saving,” it stated, referring again to Novo Nordisk’s public commitment to sell insulin at $3/vial and $2/vial to UN/humanitarian organizations.

It called for more “innovative approaches and multi-stakeholder partnerships to address the various barriers to access…. which are often overlooked and poorly understood.

“These barriers include availability and pricing issues, to ensure there are appropriate, affordable products (insulin, other medicines, devices, diagnostics) at the point of care but go far beyond this. They include, for example, regulatory approval and policy issues; supply chain issues including cold chain; inventory management and aggregation of products; and other holistic issues such as lack of capacity in health systems, poor health literacy and empowerment of PLWDs, and inadequate financing.”

Action zone at the COP26 venue in Glasgow, Scotland where this rotating globe hanging from the ceiling reminds delegates of what they are trying to save.

As the Glasgow Climate Conference winds to a close, the final COP26 declaration appears destined to contain watered-down language on fossil fuel phase-out, and no clear way forward for the $100 billion in finance needed by low-income countries. Against that landscape, Médecins Sans Frontières Dr Maria Guevara talks about why health is the elephant in the room – and needs to be more central to future climate debates.  

GLASGOW –  As the final negotiations in Glasgow in Scotland wound to a close with a weakened text on fossil fuel phase-out likely, and no clear commitment from rich countries for a promised $100 billion annually to finance the green transition – the health aspects of the climate crisis are another one of the issues on the cutting floor.  Although the “devastating impacts of the coronavirus disease 2019 pandemic” and the “right to health” are mentioned in passing in the preamble of the draft COP26 decision, health has not been a driver of COP26 debates or decisions. The health impacts of climate change are not quantified nor are the potential health benefits of mitigation. 

This is despite the fact that tens of millions of people in rich and poor countries alike are already suffering from the health impacts of extreme weather and other climate-related events, as reflected in recent reports by WHO and a Lancet Countdown series. Nowhere is this more evident than in fragile states and conflict zones of the developing world, where the climate crisis has placed an additional burden on fragile health systems. As a result, leading humanitarian groups from Médecins Sans Frontières  to the International Committee of the Red Cross (ICRC) increasingly see climate as critical to their future crisis response. 

Dr Maria Guevara is the International Medical Secretary for Médecins Sans Frontières (MSF).

Dr Maria Guevara, International Medical Secretary for (MSF),  or Doctors Without Borders, was representing the organization this year at COP – and officially participating in the conference for the first time ever.  She sat down with Health Policy Watch to explain why she felt MSF’s presence at climate talks is increasingly important: 

“Health and humanitarian emergencies have always been at the heart of what we do,” Guevara said, speaking at the action hub area of the COP venue, where a giant rotating globe is suspended from the ceiling, reminding the delegates what they are here to save. 

Latest reports from the UN suggest that if countries meet their current climate pledges, the global temperature will rise by 2.2°C to 2.4°C by the end of this century. That is a virtual death sentence for large parts of the world already hit by the rising sea levels, heatwaves and toxic air. 

“But what’s going to be different is [the climate crisis] is more intense, more uncertain, more unpredictable. And the vulnerable will be even more vulnerable, which we’re seeing already today.”  says Guevara. 

Climate emergencies have compounded impacts of conflict and natural disasters

Dead and dying animals in Arbajahan, Kenya, in 2019. Global warming is increasing droughts, flooding, and other ecosystem changes across large parts of Africa.

MSF’s mandate is emergency response – often in conflict situations.  But in recent years, climate emergencies have compounded the overwhelming global health and humanitarian situation, she notes. 

With temperatures rising, droughts or flooding are becoming ever more frequent in the Middle East, the Horn of Africa, and other places where chronic conflicts already are raging.  Against this landscape, climate change adds to food insecurity and hunger and increases the transmission of infectious diseases  – which are central to the mission of groups like MSF. 

Guevara cited, as an example, a maternal and child facility that MSF is running in the Balochistan region of Pakistan, where rising temperatures are raising a whole new set of challenges.

“When it’s 50°C outside, and women are giving birth and having to be in a facility, we still have to maintain a core temperature to maintain the [stability of] newborns, including premature babies,” explained Guevara. 

Premature babies that lack adequate physiological mechanisms to adequately control their body temperatures are typically kept in incubators in their first days or weeks of life. But when ambient air temperatures rise too high, incubators fail to operate properly – in the absence of reliable air conditioning. 

And yet air conditioning is extremely difficult to maintain in low-resourced settings with unreliable electricity – as well as contributing to even more climate change.  

Need to rethink health systems globally  

Incubators at a modern newborn care facility in Afghanistan. Healthcare is energy-intensive. Yet many rural maternal and children care facilities lack adquate electricity, or any electricity at all, leaving mothers and newborns as victims. 

That is just one of the multiple dilemmas faced by relief groups, attempting to respond to immediate crises while also reducing their carbon footprint.

“We’ve been really looking at how we run our facilities in a changing climate,” concludes Guevara, explaining that there are no easy answers. 

On the one hand, high-end health facilities  in high income countries are huge carbon emitter – guzzling enormous amounts of electricity for heating and cooling, as well as water and disposable plastic products.  A 2019 estimate by Healthcare Without Harm found that if the global healthcare system was a country, it would be the fifth largest global carbon emitter. 

Recognizing that, around 50 countries pledged to decarbonize their health systems at this year’s COP. But at the same time, health facilities in low-income settings often lack access to reliable electricity for even basic services.  

Despite those dilemmas, MSF is making attempts to reduce its own carbon footprint where it can do so, for instance, by replacing plastics with more sustainable materials.  

It is also looking at greener health facility designs that would incorporate the use of solar-powered electricity alongside air conditioning “sustainable setups that would allow us to continue to run our maternal child health hospitals where it needs to.”

Convergence of health theme with core climate conversations still not happening 

Along with the absence of health, as such, on the COP-26 official agenda, the lack of adequate representation at the COP26 from vulnerable communities has been a focus of protest.

However, health needs to play a much larger role in climate debates, says Guevara, insofar as health is so heavily impacted by climate change in multiple domains.

At this year’s COP,  the topic received marginally more attention than in the past – with a full-fledged Health Pavilion in the official COP “Blue Zone” conference spaces. 

There also was a day-long conference Health and Climate Conference on the margins of COP26, organized by WHO, civil society and a consortium of UK universities, as well as health-focused events in the Blue Zone Health Pavilion, which touched upon climate in relation to children’s health, air pollution, sustainable cities, and more. 

But what remains missing is the convergence of  the core topics of climate negotiations with key global health priorities – and this needs to change, says Guevara. 

“I think it should be the compass of the decisions of any policy,” she said. “We should be going for our collective well-being and health. And it is because of that, it [health conversations] should be front and center.”  

As a starting point for that, the health impacts of climate change, as well as the health benefits of effective climate mitigation and adaptation, should be clearly referenced in the negotiated text of climate decisions.  

“I think it is a work in progress for us to start to put all our actions through the climate lens. But it’s getting there and we hope that we can add our voice to the table and our experiences because what we’ve been able to do in low-resource settings will be part of the solutions as well to whatever our future climate is.”

Disha Shetty is reporting for Health Policy Watch from COP26 as a part of the 2021 Climate Change Media Partnership, a journalism fellowship organized by Internews’ Earth Journalism Network and the Stanley Center for Peace and Security. Follow her on Twitter @dishashetty20

Disha Shetty on left, moderating a COP26 event on climate air pollution and health on 7 November with Maria Neira, WHO: Ani Dasgupta, President and CEO, World Resources Institute; Rosamund Kissi-Debrah, Co-Founder, Ella Roberta Family Foundation; and
Olumide Idowu, Nigerian climate change activist

Image Credits: Brendan Cox / Oxfam, World Bank, Disha Shetty .

A French official checks a woman’s COVID-19 certificate, providing evidence of vaccination or a recent PCR test.

It may be too late for many European countries to avoid harsh measures to try to curb the intense transmission of COVID-19, according to World Health Organization (WHO) officials on Friday.

“Almost two million cases of COVID-19 were reported in Europe last week, the most in a single week in that region since the pandemic started,” WHO Director-General Dr Tedros Adhanom Ghebreyesus told the global body’s media briefing.

“Almost 27,000 deaths were reported from Europe, more than half of all COVID-19 deaths globally last week.”

High rates of infections are being experienced both in more vaccine-hesitant countries in Eastern Europe, as well as in countries with some of the world’s highest vaccination rates in Western Europe – reflecting the fact vaccinations alone are not enough to halt the virus, according to the WHO.

A number of European countries have already started to clamp down on public activities. The Netherlands is poised to introduce a three-week partial lockdown including a 7pm closing time for restaurants this weeked, while Austria expects to introduce more restrictions on unvaccinated people.

Last month, Russia – part of the WHO Europe region – ordered all unvaccinated people over 60 and with underlying conditions to stay at home until February as it battles its worst case load amid vaccine hesitancy.

At least 12 European countries including Italy, France, Germany, Portugal, Greece and Belgium now require people entering public places such as restaurants, museums and concernts to show proof of vaccination or a recent test with a COVID digital certificate, with Denmark being the most recent to introduce such a measure this week. Some countries are also applying the passes in workplaces, particularly schools and health facilities.  

Restrictive measures

“Quite frankly, some countries are in such a difficult situation now that they’re going to find it hard not to put in place restrictive measures at least for a short period of time to reduce the intensity of transmission,” said Dr Mike Ryan, WHO’s head of health emergencies.

“Other countries can re-engage with communities around masks, around avoiding crowded spaces, around limiting their contact with others, work from home and many other initiatives and very importantly increasing vaccine coverage in high-risk populations,” stressed Ryan.

However, each country would have to assess their own unique situations – weighing vaccination levels and “what level of compliance can be expected from the implementation of personal measures versus government-mandated measures”, he added. 

Predictable surge after curbs lifted

WHO’s COVID-19 lead, Dr Maria Van Kerkhove described the surge in Europe as “predictable” given that most restrictions on social mixing and masks had been lifted.

However, the European surge was also showing “quite strongly how effective vaccines actually are in terms of reducing hospitalizations and reducing deaths”, she added.

New research from the UK has shown that an unvaccinated person has a 32 times higher risk of death than a vaccinated person, said Ryan, but these vaccines had to reach the most vulnerable people.

Places with high vaccination rates of vulnerable people were seeing cases increase but this had not translated into pressure on health systems. But in countries where there were significant pockets of vulnerable people unvaccinated, the same incidence or even lesser incidence of disease will lead to pressure on the health system, added Ryan.

WHO remains opposed to boosters in Europe

Despite the stiff WHO warnings about the possible need for stricter lockdown measures, WHO officials have continued to recommend against the wider uptake of booster shots in Europe or other high-income countries.

WHO has maintained that there is insufficient evidence for boosters, which also divert vital vaccine supplies from countries that haven’t even yet had one jab.  And on Friday Tedros once again appealed for a moratorium on boosters until the end of 2021, so that available doses can be channelled to countries that have not yet reached the WHO goal of 40% vaccination coverage.  He pointed out that, every day, there are six times more boosters being administered globally than first or second doses in low-income countries.

Even so, it appears that boosters are being administered with ever increasing frequency in high-income countries seeing surges – with 92 high- to -middle income countries initiating booster programmes for at least some population groups.

US Chief Medical Officer Anthony Fauci recently hailed the successful Israeli booster campaign as a model that others will have to follow. Israel was one of the first countries to initiate mass administration of boosters in August after it became clear that vaccine immunity from the first two shots had waned significantly after five month. The campaign  drove down new infections from one of the word’s highest levels to levels below that of almost any country in Europe or North America today.

There are now signs that boosters are helping to reduce new infection rates and hospitalizations in the United States, although they are only available to people over age 65, and at least stabilise persistently high rates in the United Kingdom, where people over age 50 can now get a third jab.

According to WHO, 25% of the doses administered every day worldwide are now booster doses, as compared to only 5% two weeks ago.

WHO remains mum on COVID-passes requiring proof of vaccination or testing

Resistance to both lockdowns, as well as much milder measures “COVID pass” rules, is strong in a number of European countries. Large protest rallies have taken place recently in a number of Swiss, German and French cities.

In Switzerland a national referendum is planned for 28 of November to vote on whether to maintain the new system of COVID passes required in almost any indoor venue outside of a private home.

Scope of Switzerland’s COVID Pass

In anticipation of the vote, a series of large demonstrations have been underway – protesting the COVID certificates that are the main focus of controversy. French and Italian opponents of COVID certificates also are eyeing the Swiss debate and the precedent that may take shape on referendum day.

WHO has largely recommended against the use of COVID vaccine or PCR test passes for international travel – pointing to the inequalities between rich and poor countries in accessing vaccines.

But it has refrained from entering into the fray over domestic use of COVID certificate in countries where vaccines are universally available.

Asked about the issue by Health Policy Watch, a WHO spokesperson responded Friday evening saying that the organization was “still checking” for a response.

–Elaine Fletcher contributed to this story

  • Updated 14.11.2021

Image Credits: Mat Napo/ Unsplash, https://www.ge.ch/en/covid-19-certificate/scope-covid-certificate.

moderna

Moderna has fired back against claims made by US National Institutes of Health (NIH)  that its scientists at the National Institute of Allergy and Infectious Diseases (NIAD) helped to invent the crucial component of the pharma company’s COVID-19 vaccine, stating that the mRNA sequence was “selected exclusively” by Moderna scientists. 

“We do not agree that NIAD scientists co-invented claims to the mRNA sequence of our COVID-19 vaccine,” a tweet from a thread on intellectual property by the company said on Thursday.

The thread continued: “The mRNA sequence was selected exclusively by Moderna scientists using Moderna’s technology without input of NIAID scientists, who were not even aware of the mRNA sequence until after the patent application had already been filed.” 

However, Moderna does recognize the “substantial role that the NIAID has played in helping to develop Moderna’s COVID-19 vaccine,” and has said that it has, in fact, included NIAID scientists as co-inventeres on published patent applications where they have made inventive contributions.  

Genetic sequencing dispute; Moderna turned ‘people’s vaccine into rich people’s vaccine’ 

In a story first reported by the New York Times on Tuesday, Moderna had excluded three NIH scientists as co-inventors of a central patent for the company’s COVID-19 vaccine in its application filed in July. 

But the NIH has asserted that three of its scientists at the NIAD, Dr John Mascola, Dr Barney Graham, and Dr Kizzmekia Corbett, helped design the genetic sequence used in Moderna’s vaccine, and should be included on the patent application. 

Had federal researchers been named as co-inventors in the patent, the government would have almost exclusive right to license the vaccine to other manufacturers, opening access to low- and middle-income countries who are still lagging behind in vaccination rates. 

“Recognition as the vaccine’s joint inventor can help the U.S. government finally responsibly steward the vaccine’s use, including by helping secure access for the billions of people still awaiting a safe path out of the pandemic,” said Peter Maybarduk, director of US-based advocacy group Public Citizen’s Access to Medicine, in a statement.

“But Moderna has turned this people’s vaccine into a rich people’s vaccine; refusing to share technology with WHO or developing country manufacturers and sharing very few doses with COVAX while overcharging poor nations.”

Both Moderna and Pfizer have been lambasted by WHO’s Director General Dr Tedros Adhanom Ghebreyesus in the past for offering and planning COVID boosters while billions in LMICs await their first jab.

NIH not backing down from claims

Speaking to Reuters, NIH Director Dr Francis Collins made clear that the NIH, the government’s biomedical research agency, was not backing down. 

 “I think Moderna has made a serious mistake here in not providing the kind of co-inventorship credit to people who played a major role in the development of the vaccine that they’re now making a fair amount of money off of.”

Advocacy group Public Citizen has pointed out Moderna’s failure to name NIH scientists as joint inventors, imploring NIH to “ensure the contributions of federal scientists are fully recognized,” in a letter to Director Collins last week.  

“NIH is showing a modicum of verve at last, suggesting it will not allow federal scientists’ role in the invention of the NIH-Moderna vaccine to be erased,” said Maybarduk. 

Moderna has received around $10-billion in US government money to develop its vaccine but has not responded to US government pressure to share the vaccine technology with low and middle-income countries.

Image Credits: Gavi .

covaxin
Covaxin

Following World Health Organization approval last week, interim data from a phase 3 trial of BBV152, a COVID-19 vaccine developed in India, reports 77.8% efficacy against symptomatic COVID-19. 

The study, published in The Lancet, indicated that BBV152 induced a robust antibody response, with the majority of adverse events, including headache, fatigue, fever, and pain at the injection site, were mild and occurred within seven days of vaccination. 

BBV152, also known as Covaxin, is an inactivated whole virion vaccine developed by India-based Bharat Biotech. The vaccine has recently received emergency use approval (EUL) from WHO for people aged 18 and older, and is administered in a two-dose regimen, 28 days apart. 

The trial conducted an efficacy analysis of 24,419 randomly-assigned participants across 25 hospitals in India who received either two doses of the vaccine or a placebo between 16 Nov 2020 – 17 May 2021.

Vaccine cold-chain requirements make it suitable for low- and middle-income countries

covaxin
Covishield and Covaxin Drive in India

Covaxin’s ability to be stored and transported between 2-8 degrees Celsius has made it suitable for  low- and middle-income countries.

Jing-Xin Li and Feng-Cai Zhu of the Jiangsu Provincial Center for Disease Control and Prevention in China, who were not involved with the study, say “the roll-out of BBV152 might ease the ultra-cold chain requirements of other SARS-CoV-2 vaccine platforms, increase the finite global manufacturing capacity, and improve insufficient supply of vaccines which disproportionately affects low-income and middle-income countries.” 

Bharat Biotech said the WHO EUL approval will help countries “expedite their regulatory approval processes to import and administer Covaxin.” 

“It allows procurement by UNICEF, the Pan-American Health Organization (PAHO), and the GAVI COVAX for distribution to countries in need,” a company press release said. 

The Gavi managed COVAX global vaccine facility has not  yet  signed an agreement with Bharat Biotech, with India delaying committing supplies to the COVAX global sharing effort, sources told Reuters.  

The world’s biggest vaccine maker resumed exports of COVID-19 doses in October, for the first time since April. It has sent about 4 million doses to countries such as neighboring Bangladesh and Iran, but none to COVAX.  

The vaccine has, however, been distributed widely already in India, with 121 million doses administered since the beginning of the country’s big COVID surge in the spring of 2021. 

Covaxin gears up for major distribution abroad 

Airfinity’s COVID Vaccines Revenue Forecasting predicts 545 million Covaxin doses to be sold to low-middle-income countries in 2022.

Following the WHO approval and publication of its Phase 3 results, Covaxin is gearing up for major distribution abroad.

Airfinity’s COVID-19 Vaccine Market Forecast 2021 – 2022, which covers global demand scenarios, supply and production, and revenue of COVID vaccine, has predicted 545 million Covaxin doses will be sold to low-middle-income countries in 2022.

As many as 96 countries have already recognized Covaxin, with Hong Kong the latest to approve the vaccine for international travelers. 

Canada, the US, Australia, Spain, the United Kingdom, France, Germany, Belgium, Russia, and Switzerland, are among the 96 nations to recognize both Covaxin and Covishield, another India-manufactured vaccine. 

Further research needed against COVID-19 variants 

The next step for studies of BBV152, noted Li and Zhu, should be long-term monitoring of vaccine efficacy against COVID-19 and its efficacy against variants. 

This is to “identify whether the vaccine provides ongoing protection when any variation of concern replacement (other than the variants of concern investigated in the study) has occurred,” they said. 

Preliminary analysis of efficacy found Covaxin to be 65% effective against symptomatic COVID-19 from the delta variant. 

Additionally, there was no decrease in efficacy against the alpha variant (B.1.1.7) and marginal reductions in efficacy against other variants of concern, including delta and gamma variants.

Image Credits: Mohammed Naseeruddin/Twitter, Airfinity.