IFPMA Director General Thomas Cueni (foreground) with moderator Claire Doole and Albert Bourla, David Ricks and Bill Anderson on screen.

Pharmaceutical giants have questioned why a waiver on intellectual property (IP) rights for COVID-19 vaccines is still on the table when they are battling to find markets for their vaccines amid order cancellations – including from the Africa Centre for Disease Control. 

“I’m stunned that the proposed IP waiver is still being debated while supplies of vaccines are far outstripping demand and some factories have been put to a halt because of missing orders,” Thomas Cueni, Director General of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) told a media briefing on Wednesday.

With almost a billion vaccines now being produced every month, countries’ lack of capacity to vaccinate is now the main barrier to stopping COVID-19, added Cueni.

In the first quarter of the year 13.7 billion vaccine doses were delivered and 11 billion doses administered, said Cueni.

“Now orders are slowing down. Countries as well as organisations such as Africa CDC, are not only asking for orders to be delayed but are cancelling them,” added Cueni.

“Leading voices are still calling out vaccine scarcity. I do understand the concern. Vaccines are not reaching all those who need them. But the cause is no longer the lack of supplies. It’s scarcity of vaccination, which is due to the lack of country readiness, absorption capacity and the lack of resources needed to get the vaccines into arms.”

Countries’ lack of capacity

Pfizer CEO Dr Albert Bourla also weighed in on country capacity, saying that the US government was offering 200 million free doses to the poorest countries of the world but they lacked the capacity to administer the vaccines.

“The problem is not if there is availability or access to pricing. The problem is that the infrastructure of these countries is very poor, so they cannot absorb them. They cannot run a vaccination campaign,” said Bourla.

Bourla added that one of the pandemic’s key lessons was that more attention should have been paid to preparing countries to vaccinate people.

He also described any move to remove IP on vaccines as “insane”, while Roche CEO Bill Anderson described it as “unproductive”.

Eli Lilly CEO David Ricks warned that pharmaceutical companies and investors would “never have invested” in trying to develop COVID-19 vaccines “if there was not the promise of IP”.

“The next investments on the unknown technology which we can repurpose for the next pandemic won’t be made if investors believe that IP will be undermined,” warned Ricks.

“What is a patent? It’s a promise to disclose our inventions in return for a period of exclusivity,” added Ricks. “You’ll get much less disclosure about inventions actually as a result of an IP waiver. There’ll be a strong incentive to retain know-how, retain the recipes for what we do, much like you see in some other industries.”

Collaboration successes

Bourla said one of the best aspects of the pandemic had been the collaborations between different the industry partners, where competitors worked together, as we as public-private collaboration, particularly with regulators. 

He commended particularly the US Food and Drug Administration, the European Medicines Agency and the Canadian, Israeli and Japanese regulators for their speedy reviews of industry data.

“What did not help was the politicisation – if you take a vaccine or not, or wear a mask or not. Tthat created tremendous damage to the global health,” said Bourla.

At the IFPMA briefing (clockwise): Pfizer CEO Albert Bourla, IFPMA Director General Thomas Cueni and moderator Claire Doole, Roche CEO Bill Anderson and Eli Lilly CEO David Ricks

Future COVID vaccines

The IFPMA noted that there was “increasing acceptance that society will have to live with COVID-19”, and that continued innovation remains essential to expand on the 10 vaccines that have so far received WHO Emergency Use Listing approval and the 18 different treatments that have been approved in the UK, USA, and EU. 

Bourla said that Pfizer and Moderna were working on “multivariant” vaccines but this was “very challenging”, as was developing a COVID-19 vaccine that offered robust protection for at least a year.

He hoped this would be ready for testing in the third quarter of the year.

A COVID-19 vaccination being administered in Senegal.

COVID-19 affiliated deaths last week were the lowest on record globally since the pandemic began two years ago. But the World Health Organisation (WHO) today emphasized that the pandemic remains a public health emergency and we must not drop our guards.

“This is the moment to work even harder to save lives,” said Dr Tedros Adhanom Ghebreyesus, the Director-General of WHO, at a press briefing on Wednesday in Geneva. 

“This virus has over time become more transmissible and it remains deadly, especially for the unprotected and unvaccinated that don’t have access to health care and antivirals. The best way to protect yourself is to get vaccinated and boosted when recommended,” he said. 

The briefing comes at the end of a meeting of the WHO Emergency Committee convened under the International Health Regulations (IHR). The committee discussed the capacities of states to respond to the pandemic, the problem of vaccine inequity, reduced testing and monitoring, and raised concerns about the inappropriate use of antivirals that may give impetus to drug-resistant variants. 

Ukraine and Ethiopia 

In the past 50 days since theRussia invasion of Ukraine, 4.6 million refugees have fled the country, and thousands of civilians, including children, have died, and there have been 119 verified attacks on health care workers.

Dr Tedros said that there is a need for humanitarian corridors to enable the delivery of medical supplies, food and water and the evacuation of civilians. He added that to date, the WHO had only received about half of the funding needed to support Ukraine for the first three months.  

Dr Michael Ryan, WHO’s Executive Director of Health Emergencies, said that there was a high risk of chemical contamination and exposure due to attacks, as well as compromised infrastructure associated with the chemical production, nuclear weapons and energy production.

Dr Michael Ryan at the WHO Press Briefing.

“We’ve been doing training and other support to the authorities in Ukraine in preparation for such an event. This is very different from the intentional use of chemicals as a weapon in war, which is against international Law and is a war crime,” said Ryan. This comes on the back of reports of the use of chemical weapons in Mariupol. 

With respect to Ethiopia, Tedors said that the siege by the Ethiopian and Eritrean forces continues to avert the humanitarian calamity and thousands of people from dying. Tedros, who is an Ethiopian and a former Minister of Foreign Affairs, said that the Tigray crisis is one of the most alarming humanitarian crises of our times.

“But the world is not treating the human race the same way. Some are more equal than others,” he said referring to the negligible attention received by Afghanistan, Ethiopia, Yemen, and Libya versus the attention that is meted to Ukraine currently. 

Newer variants

According to Dr Maria Van Kerkhove, WHO’s Technical lead on COVID-19,  the new sub-variants of the Omicron variant– BA.4 and BA.5– have been reported from a number of countries, including South Africa, in Europe. She said that more sequencing and concerted global efforts to track and share the data on the virus are needed to understand the characteristics of the variants. 

Responding to the concerns about the reduced testing and tracking of COVID-19 cases, Ryan said that it was important to track the virus as it went “underground”.

“It will be very, very, very short-sighted at this time to assume that lower numbers of cases mean an absolute lower risk,” he said.

 “This virus has surprised us before… We need to do our jobs and track this virus as best we can while people get back to living as normal a life as possible. We in the scientific and public health community need to continue to track this virus closely in every single country.” 

Dr Maria Van Kerkhove,WHO’s Technical lead for COVID-19,

 Van Kerkhove added that the committee which met today outlined three main scenarios in the modified Strategic Preparedness, Readiness, and Response Plan (SPRRP) publication: a best case, a worst case, and a base case in terms of outlining what virus evolution and changes and how our countermeasures will react or react to those. There is also a fourth scenario, called ‘reset’ where there is so much change in the virus there will be a population that is susceptible again, and “it resets us.”

Vaccinate, vaccinate, vaccinate 

The updated SPRRP report highlights the need to achieve national COVID-19 vaccination targets in line with global WHO recommendations of at least 70% of all countries’ populations vaccinated by the start of July 2022.

“Countries really must start looking at their data breakdown by age and sex,” said Dr Soumya Swaminathan, WHO’s Chief Scientist, while highlighting the importance of boosting the population over the age of 60. 

Swaminathan added that a majority of countries plan to meet the 70% target, but a handful of countries have set their goal at less than 40%. “

Many of these countries have competing health priorities and so we need to make sure that as COVID vaccine uptake is expanded, scaled up, strengthened, and routine immunization services are also strengthened,” said Swaminathan.

Swaminathan mentioned that COVAX has the capability to cater to the vaccination needs of the vulnerable population, but there needs to be more focus on making sure the older, more vulnerable population is catered to and not left out despite the inequitable vaccine situation currently. 

“The inequity is not just in the overall distribution of vaccines, it is also occurring within countries in terms of not reaching those most likely to benefit from the vaccine and that’s particularly acute,” said Ryan.

He added that while 85% of the population over 60 years of age in Europe is fully vaccinated, the number for the same metric stands at 25% in Africa. 

“If we fail to vaccinate everyone, if we fail to continue diagnosing, if we fail to find the people who can benefit from treatment, then we will fail in the future, and in the next pandemic. So our success now will determine a successful future,” Ryan said. 

Image Credits: Flickr – Trinity Care Foundation, Georges Yameogo..

global health
Global Health Matters podcast host Dr. Garry Aslanyan, TDR

After Dr Garry Aslanyan became an avid follower of podcasts, he realized there was a dearth of material from the genre in his own global health field. So he set out to fill that gap with a new series featuring public health professionals and policymakers from around the world who have made a difference – and can inspire others as well. 

The Global Health Matters podcast hosted by Aslanyan, a public health professional  with TDR, the Special Programme for Research and Training in Tropical Diseases, co-sponsored by UNICEF, UNDP, the World Bank and WHO, is now entering its second season of broadcasts. It features a diverse mix of themes and line-up of speakers – has picked up an audience of followers in places as diverse as Yemeni villages and Ulaanbaatar, Mongolia.   

The first episode of Season 2 was launched on Tuesday, April 12. It focuses on “Championing Health Equity in South Africa.”

“The podcast gives people a unique peek into the experiences of people who are just like them,” Aslanyan told Health Policy Watch. “Listeners can relate to the guests and their experiences and compare what they themselves are living through – they can think, ‘can I do this?’ or ‘how does that work?’ or ‘what can this mean for me in my own setting or country?’”

The podcast began at the height of the COVID-19 pandemic, when new, virtual information tools became all the more important to people confined for days and weeks at home. The podcast series has already covered a broad range of innovative and inspiring research topics – from climate change and health  to science communication  and the challenge of ‘decolonizing global health.’ 

With a focus on sharing perspectives and voices from low- and middle-income countries, the series has already been downloaded more than 11,000 times by listeners in more than 130 countries, Aslanyan said. “The hope is to inspire listeners to do something in their day job with the information they heard,” Aslanyan said. 

South Africa at the nexus of the global health equity debate 

This week’s episode on “Championing health equity in South Africa” takes a long look at the country’s COVID vaccine campaign, whose successes and setbacks were a weathervane for the rest of Africa, as well as its precedent-setting examples in advocating for HIV medicines access, in light of the recent pandemic. 

“As of early March, 74% of those in high-income countries have been fully vaccinated against COVID-19, compared with just 11% of people in low-income countries. As the world commits to global access to medicines and vaccines, is this just on paper or a reality?” the podcast teaser states.  

“Can South Africa’s experience with tackling HIV/AIDS and COVID-19 point to future solutions for other low- and middle-income countries? How has intellectual property rights affected development of vaccines across Africa?”

Appearing on the podcast are three guests: human rights lawyer and activist Fatima Hassan; UNDP policy specialist Judit Rius Sanjuan; and Petro Terblanche, Managing Director of Afrigen Biologics, host of the new mRNA hub in South Africa.

Season 2 of Global Health Matters launched this week: Championing Health Equity in South Africa.

The goal: To inspire

Aslanyan said he started the series after becoming an active listener of podcasts himself. He fell for the audio genre because it runs against the current of 30-second social media soundbytes, providing more thoughtful and detailed coverage of issues in a digestible format – that listeners can tune into while they are travelling or doing something else. 

But when he searched for something that “really covers global health, I did not find much” – especially not one that featured voices from  low- and middle- income countries. So, he and his team decided to start their own series. 

“The ability to get a more insightful, in-depth understanding of a topic is why this medium is appealing. And for us at TDR, most importantly, this allows people from around the globe to learn from the experiences of others and apply them to their own reality,” said Aslanyan. 

Although WHO’s Regional Office for Europe offers a ‘Health in Europe’ podcast, and WHO headquarters features a popular Science in Five video series, Global Health Matters is the only broad-based and regular global health podcast featured by WHO, where TDR is based. 

Aslanyan has postgraduate training in public health and health policy and systems. While not a trained media professional, he was driven by a clear public health mission: to inspire his colleagues in the field. 

“You may not immediately think somebody trained in public health to host a podcast, but I have done all kinds of work for organizations focused on global health,” Aslanyan explained. “I also have experience in innovation and advocacy and have worked in government departments in Canada before moving to Geneva where I really pushed the boundaries of national health.”

He said public health professionals need to be knowledgeable but also able to present things in a way that galvanizes the public around different causes. He had not thought of himself as that person before starting Global Health Matters, but since launch last year he hears from listeners that this is exactly the role he and his guests are fulfilling. 

“What makes me think that the podcast medium is amazing is the way that we reach cities, towns and villages in the most remote parts of the world, which is VERY satisfying – we know that from our stats,” Aslanyan says. 

What were some of the most popular episodes last year?

“COVID-19 in Africa: the role of research” helped debunk some of the myths around why there was less virus on the continent. 

Global Health Matters Episode 3.

An episode on “Climate change’s impact on health” looked at the impact of climate change on rural areas whose communities’ health and livelihood depends on the environment. A particular focus was on Maasai communities in northern Tanzania, where persistent droughts have made the people vulnerable to sleeping sickness, a disease spread by the tsetse fly.

There was also a piece on Communicating science, not fiction featured Natalia Pasternak, founder of Brazilian-based Instituto Questão de Ciência, which combats pseudoscience and advocates for evidence-based treatments. Natalia spoke of her own personal experience as a member of  WhatsApp groups for mothers that took a sudden turn into vaccine skepticism.

And thousands of kilometers away, in the Western Pacific, Navigating digital health waves featuring Dr Alvin Marcelo, Executive Director of the Asia eHealth Information Network, explained how the Philippine government allowed open access to data from COVID-19 tests, creating a big opportunity for health researchers and services, for instance better matching of COVID-19 test results from particular locations with availability of hospital bed spaces.

Natalia Pasternak, founder of Brazilian-based Instituto Questão de Ciência
Dr Alvin Marcelo, Executive Director of the Asia eHealth Information Network.

“Of course, we get feedback on every episode,” Aslanyan said. “It seems all of them have touched, inspired or at least piqued the interest of our listeners.”

He said that he and his team at TDR stepped into podcasting with no experience but they have already learned a lot. Season 2 builds on last year’s, bringing in additional topics such as science diplomacy, corruption in health, migration and health and diversity in global health. 

Aslanyan said he also hopes to add an even greater variety of personalities to the podcasts, including, potentially, some guests who are public health service recipients rather than providers.

He added that two universities in the global North and South are using some podcast episodes to assist students in understanding complex public health subjects – a  testimony to the information and clarity being provided by the show. 

“We think it gives learners the ability to relate to the topics they are studying,” Aslanyan said. In terms of the spread and reach of his audience- it’s both surprising and satisfying, Aslanyan adds.

“Sometimes I look at the analytics data showing the people listening to the podcast, and I think, my gosh, who are these eight people in that small city in Yemen who listened to me? I have no idea who they are, but they are there, in a place I don’t know, and I imagine they are probably working in public health.”

The first episode of Season 2 launched on Tuesday April 12. Find it here. Link here to all Season 1 episodes of Global Health Matters.  Find it on YouTube Championing Health Equity in South Africa

Follow @TDRnews on Twitter, TDR on LinkedIn and @ghm_podcast on Instagram for updates about upcoming shows.

Image Credits: WHO, GHM Show , GHM.

The second season of the Global Health Matters podcast series kicks off with a close-up look at South Africa’s health equity initiatives and champions. Health Policy Watch will be featuring episodes from the series throughout the coming year as part of a TDR-supported series. 

As the world commits to equitable access to medicines and vaccines, is this just on paper or a reality?  In the case of COVID-19, as of early April 2022, 74% of people in high-income countries had been fully vaccinated, compared with just 15% in Africa and 11% of people in low-income countries worldwide. 

With 30% of people fully vaccinated, South Africa, has one of the highest COVID vaccination rates in sub-Saharan Africa. And it has been an African leader in the manufacture of COVID vaccines, as well as a leader in the global campaign to waive intellectual property rights on COVID vaccines, tests and treatment – not to mention the historic role it played a generation ago in the legal battles that paved the way for the widespread manufacture of low-cost, generic antivirals for HIV treatment. 

Can South Africa’s experience with tackling HIV/AIDS and COVID-19 point to future solutions for other low- and middle-income countries? And how has the state of play regarding intellectual property rights for COVID health products affected development of vaccines across Africa? 

Global Health Matters podcast host Garry Aslanyan fields these and other questions to three leading South Africans scientists, policymakers and health activists, including Fatima Hassan (founder of the Health Justice Initiative), Petro Terblanche (Managing Director of Afrigen Biologics), and Judit Rius Sanjuan (Policy Specialist at UNDP). 

Click here to catch this episode, the first of the second season of TDR’s Global Health Matters podcast.  Find it on YouTube: Championing Health Equity in South Africa

Link here for all Season 1 episodes of Global Health Matters. 

Diabetes protest in South Africa

After years of being the neglected stepchild of global health, non-communicable diseases (NCDs) might finally be getting the urgent attention they need with Tuesday’s launch of an international NCD compact and presidential group.

The measures were announced at the International Strategic Dialogue on NCDs and Sustainable Development Goals (SDGs) co-hosted by the governments of Ghana and Norway and the World Health Organization (WHO).

Mike Bloomberg, the WHO Global NCD Ambassador, told the Accra meeting via video that global investment in NCDs was a “pitiful 1-2% of global health funding”.

Very few countries are on track to achieve the United Nations Sustainable Development Goal (SDGs) 3.4, which commits member states to “reduce by one-third premature mortality from NCDs through prevention and treatment, and promote mental health and wellbeing by 2030”.

But the NCD Alliance says that the compact and Presidential Council on NCDs (NCD Presidential Group) “could be a turning point in the fight against chronic diseases, which is responsible for 74 % of deaths annually”, finally demonstrating the political will needed to address the world’s biggest killer.

 

WHO member states and leaders will be encouraged to sign up to both the compact and the presidential group and “align strategies and operations with universal commitments made to accelerate and scale up the global collective efforts to prevent and control NCDs and achieve universal health coverage”, according to an outcome document from Tuesday’s meeting.

“The NCD Compact is a living document and will be updated on a yearly basis by its current and future signatories among Heads of State and Governments to navigate in preparation of the next UN High-level meeting on NCDs in 2025 and going forward towards 2030,” the document states.

“Two years into the global COVID-19 pandemic, there can no longer be any doubt about the case for investing in NCDs,” said Katie Dain, CEO of the NCD Alliance.

“COVID-19 has upended health systems, drained economies and disproportionately affected people living with NCDs. This pandemic must be a wake-up call for governments and political leaders to value, prioritise and invest in healthy societies, NCD prevention and strong 

According to the NCD Alliance, 39 million lives could be saved before 2030 if an additional $18 billion is annually on implementing packages of cost-effective NCD interventions, tailored to local disease burden and risk factors. 

“This would also generate an average net economic benefit of $2.7 trillion, or $390 per capita, equal to a 19 to one return on investment,” said the alliance, referring to recent research published in The Lancet.

The Accra meeting was addressed by a variety of high-profile leaders, particularly from Africa and the Caribbean, including a number of First Ladies who have an active international forum aimed at preventing NCDs.

Co-host Norweigan Prime Minister Jonas Gahr Støre said that most of the premature deaths from NCDs can be avoided, and governments “must intensify our efforts to prevent and control them”.

Barbados Prime Minister Mia Mottley lamented that only 14 countries were on track to achieving SGD 3.4, 11 years after the first UN high-level meeting on non-communicable diseases and seven years after the adoption of the SDGs.

September meeting

The President of Ghana will chair the first meeting of the Presidential Council on NCDs, which will take place in September during the 77th session of the UN General Assembly in New York.

Meanwhile, the International NCD Compact 2022-2030 contains strategic priorities to accelerate action and encourage countries to reach SDG targets on NCDs by 2030.

 According to the NCD Alliance, 41 million people die every year due to an NCD and annual deaths from NCDs are projected to escalate to 52 million by 2030. 

“To put these figures into perspective, in 2020 annual deaths from tuberculosis, malaria and HIV/AIDS reached 1.5 million, 627,000, and 680,000 respectively.

Meanwhile, deaths attributed to the COVID-19 pandemic, from its beginning in 2019 to April 2022, are nearing six million, and 60-90% of these deaths are in people living with one or more NCD.

Image Credits: Kerry Cullinan.

The last Ebola patient leaves a treatment centre in the Democratic Republic of Congo at the end of March 2021, marking the countdown to declaring the end of that pandemic.

The World Health Organization (WHO) convened public hearings for only the second time in its history on Tuesday, asking interested parties what substantive issues should be contained in its proposed international instrument on pandemic preparedness and response.

The first and only other WHO hearings were held 22 years ago in the run-up to the adoption of the Framework Convention on Tobacco Control, according to WHO principal legal officer Steven Solomon.

Welcoming the public hearing, WHO Director-General Dr Tedros Adhanom Ghebreyesus said that informed opinion and active public cooperation are of the utmost importance to improve health, and it was important to learn from the COVID-19 pandemic to ensure the world is “better prepared” for the next pandemic. 

Tedros had been mandated by last year’s World Health Assembly Special Session to convene public hearings to inform the work of the Intergovernmental Negotiating Body (INB) which is in charge of negotiating the pandemic instrument or treaty.

INB co-chair, South Africa’s Dr Precious Matsoso, described the hearings as “remarkable” and “historic”.

Dr Precious Matsoso, INB co-chair

Narrow responsibility

However, the Civil Society Alliance for Human Rights in the Pandemic Treaty warned that the consultative process risks being “inadequate”.

“While this week’s public hearings reflect the INB’s stated objective to consult the public to some extent, it has interpreted its responsibility to do so very narrowly,” according to the alliance.

“The INB has allocated minimal time to engaging with the wide range of stakeholders who could inform the process and improve both the legitimacy and quality of the Treaty that emerges.”

Dr Meg Davis, from the Global Health Centre at the Graduate Institute in Geneva, also said that participants had been given no indication of whether or how their submissions would be included in the negotiations and recommended policymaking models to ensure meaningful civil society engagement.

A number of organisations gave two-minute speeches focusing on a wide range of issues including ‘One Health’, research and development (R&D) and intellectual property rights at the hearings, which continue on Wednesday and then reconvene in mid-June.

Equity means sharing Research and Development

Professor Suerie Moon, co-director of the Global Health Centre at the Graduate Institute in Geneva.

All member states have committed to equity at the heart of any pandemic instrument, but Professor Suerie Moon, co-director of the Geneva Graduate Institute’s Global Health Centre, told the hearings that “equity requires collective research and development of vaccines, drugs and diagnostics”.

Pointing out that COVID-19 has led to the development of technology transfer hubs in South Africa and the Republic of Korea, Moon warned that “there’s a risk that new factories will sit idle in the next emergency unless the new international instrument forges agreement on obligations to share knowledge, data and intellectual property before and during future emergencies”. 

“It’s unlikely, however, that countries or companies will do so out of the goodness of their hearts,” added Moon. “To make such sharing feasible, we have to tie it to commitments to jointly finance research and development to share pathogen samples and genomic sequencing data. In other words, the key idea is collective research and development for collective benefit.”

Acknowledging that intellectual property was a difficult issue, Moon nonetheless said that if equitable access was to become a reality “the new instrument must include the nuts-and-bolts provisions to make sharing technology for pandemics the new normal”. 

To address IP, Knowledge Ecology International (KEI) recommended that governments should “agree to collectively use exceptions to intellectual property rights that are permitted in existing trade agreements and treaties”.

“A model for this is the WIPO Marrakesh Treaty for the Blind, which mandates its members to use exceptions in copyrights to enhance global access to works made accessible to persons who are blind or have other disabilities,” according to KEI’s James Love.

KEI also proposed “a robust chapter on transparency”, adding that “the lack of transparency in many areas for the current pandemic is an appalling and unnecessary policy failure, and one that both makes it more difficult to manage a pandemic response, and undermines the public’s trust in institutions”.

Rachael Crockett from the Drugs for Neglected Diseases initiative (DNDi) stressed the need to co-ordinate R&D as a substantive element of the new instrument. DNDi wants R&D priority setting, and “globally agreed norms and binding rules that govern the R&D process, including transparency and open sharing of research, data, knowledge, technology, and equitable allocation of health tools”.

Sharing pathogens

IFPMA’s Grega Kumer

Grega Kumer from the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) said “any system should be built on what worked well during the COVID pandemic, in particular, immediate sharing of pathogens and a robust response from the IP based private sector”. 

The IFPMA presented eight core principles, including that the negotiation process should be “inclusive and transparent, involving the private sector and all critical contributors to pandemic preparedness efforts”.

“Any system should allow for immediate access of pathogens and genetic sequence data and correct the negative effects of access and benefit-sharing legislation,” said Kumer.

The IFPMA also supports more equitable access to tests, treatments and vaccines “based on medical need, thus enhancing solidarity and facilitating emergency financing to institutions procuring for developing countries”, and the protection of supply chains ”from arbitrary export restrictions and other trade barriers”. 

“While the public sector might play a larger role in pandemic setting, the system should build on the private sector strengths for R&D, manufacturing and distribution,” he concluded.

One Health is key

The need for any pandemic instrument to adopt a One Health approach also emerged as a key theme.

Dame Sally Davies, speaking for the UN Global Leaders Group on Antimicrobial Resistance (AMR), said that they wanted AMR to be integrated alongside a primary focus on pandemics. 

“The next pandemic could be drug-resistant, or could depend on antimicrobials to mitigate it,” said Davies, saying that one health surveillance needed to be at the heart of any pandemic treaty to enable “rapid, transparent and responsive protection”. 

Governance principles

The Panel for a Global Health Convention believes the instrument must be governed by four non-negotiable principles, according to Dame Barbara Stocking.

“Solidarity, because we’re all in this together, and solidarity is in our own self-interest,” explained Stocking. “Equity: there must be equal access to vaccines and treatments, but also an equal voice in decision-making. Transparency in reporting data and samples. Accountability, as the lack of accountability of countries is the fundamental reason that we are in disarray.”

The hearings continue at 8am CET on Wednesday and can be followed live.

Image Credits: WHO African Region.

WHO’s Dr Kate O’Brien and SAGE chairperson Dr Alejandro Cravioto

The Human Papillomavirus (HPV), which is the cause of most cervical cancer cases, can be treated with a single vaccine dose instead of the two doses currently being given, according to the World Health Organization’s (WHO) Strategic Advisory Group of Experts on Immunization (SAGE).

SAGE chairperson Dr Alejandro Cravioto told a media briefing on Monday that, after reviewing all available evidence, the group concluded that a single vaccine was effective against HPV in girls and women aged nine to 20, but that women aged 21 and over needed two doses given six months apart.

As HPV is generally sexually transmitted, vaccination is also recommended for boys and men who can carry the virus and infect women – and SAGE now also recommends a single dose for younger boys and men too.

Only 13% of HPV target group is vaccinated

The WHO described the new recommendation as a “game-changer” for the prevention of the disease as it would enable more doses of the vaccine to reach more girls.

“The HPV vaccine is highly effective for the prevention of HPV serotypes 16 and 18, which cause 70% of cervical cancer,” said Cravioto. 

“SAGE urges all countries to introduce HPV vaccines and prioritize multi-age cohort catch up of missed and older cohorts of girls. These recommendations will enable more girls and women to be vaccinated and thus preventing them from having cervical cancer and all its consequences over the course of their lifetimes.”

Meanwhile, the WHO described cervical cancer as being “almost entirely preventable” and “a disease of inequity of access”, adding that it was concerned by the slow introduction of the HPV vaccine into immunization programs and low coverage, especially in poorer countries.

In 2020, only 13% of the global target population had received two doses, with WHO citing barriers as challenges of supply, cost and delivering a two-dose regimen to older girls who are not part of childhood vaccination programs. 

Dr Nono Simelela, WHO Assistant Director-General for Strategic Programmatic Priorities: Cervical Cancer Elimination.

WHO Assistant Director-General Dr Nono Simelela said that single-dose recommendation “has the potential to take us faster to our goal of having 90 per cent of girls vaccinated by the age of 15 by 2030”.

“We need political commitment complemented with equitable pathways for the accessibility of the HPV vaccine. Failure to do so is an injustice to the generation of girls and young women who may be at risk of cervical cancer,” added Simelela.

SAGE also recommended that hepatitis A could also be treated with a single vaccine. 

China’s CanSino Bio vaccine expected to get WHO approval

SAGE also evaluated the data on the Chinese CanSino Bio (Ad5-nCOV-S) vaccine, but will only release the outcome of this discussion if the WHO grants the vaccine emergency use listing (EUL) – “hopefully in the next few weeks”, according to Cravioto.

An mRNA based COVID-19 vaccine also developed by the Chinese company was cleared for clinical trials last week. Currently, there are no mRNA vaccines available in China.

WHO’s Director of Immunization, Dr Kate O’Brien, expressed concern that only around 65% of healthworkers globally were vaccinated against COVID-19, and a similar number of people over the age of 60.

In addition, 21 countries had vaccinated less than 10% of citizens, said O’Brien – 14 countries in the African region, four in the eastern Mediterranean region, and then one each in the Americas, the Western Pacific and the Southeast Asian region.

“These are countries that are working really hard to advance their programmes now that supply is no longer the issue,” said O’Brien.

SAGE admitted that there was a lack of data about the efficacy of non-mRNA vaccines’ efficacy against Omicron.

As far as the spread of Omicron in Hong Kong was concerned, Cravioto said the high mortality rate in older people was related to that age group’s reluctance to be infected rather than an indictment on Chinese-produced vaccines. However, he said

Ukraine operating theatre destroyed

The World Health Organization (WHO) has verified 108 attacks on health care in Ukraine as of Monday in which 73 people have died and 51 have been injured. That is 19 more attacks on health facilities than the already deadly toll of 91 attacks that had been verified by WHO as of early Friday afternoon, and as reported at a press conference by WHO’s Regional Director Hans Kluge in Lviv. 

Meanwhile, the Office of the UN High Commissioner for Human Rights (OHCHR) has recorded 1,793 civilian deaths and 2,439 injuries since the start of the Russian invasion on 24 February and Sunday.

Most of the civilian casualties have been caused by “explosive weapons with a wide impact area”, including shelling from heavy artillery and rocket, missile and air strikes.

https://data.humdata.org/visualization/ukraine-humanitarian-operations/

“OHCHR believes that the actual figures are considerably higher, as the receipt of information from some locations where intense hostilities have been going on has been delayed and many reports are still pending corroboration,” according to a statement from the office.

“This concerns, for example, Mariupol (Donetsk region), Izium (Kharkiv region), Popasna (Luhansk region), and Borodianka (Kyiv region), where there are allegations of numerous civilian casualties. These figures are being further corroborated and are not included in the above statistics.”

According to the Prosecutor General’s Office of Ukraine, 176 children had been killed and at least 336 injured as of Sunday.

Image Credits: WHO.

The vast majority of people who died of COVID-19 had a non-communicable disease – yet investment in NCD prevention is pitiful.

More than two years after the novel coronavirus erupted into a global pandemic, the world is beginning to settle into a new normal. COVID-19 changed how we live and work in ways that will continue long after the pandemic subsides. Digital and automation technologies are here to stay, work is done remotely, and shopping and entertainment have gone online.

But the COVID-19 pandemic also laid bare an indisputable truth: the destructive path carved by the infectious SARS-CoV2 virus was only the tip of the iceberg. Studies have estimated that 60-90% of COVID-19 deaths have been of people living with one or more chronic conditions, like obesity, heart or kidney disease, or cardiovascular diseases. And people living with non-communicable diseases (NCDs) are still experiencing the collateral damage of the pandemic, due to severe disruptions to essential health services.

The lack of investment in NCD prevention and care over the years has vastly amplified the toll of the COVID-19 pandemic.

The bigger, long-term pandemic that we face  

Responsible for 74% of all deaths globally, NCDs are the even bigger, long-term pandemic that we face. Governments and global institutions have been learning many harsh lessons about the need to build back better, with more resilient health systems and more equitable access to quality, affordable treatment. But too often this has been a slogan without much substance behind it. We now need to see real changes taking hold.

Beyond COVID, there is a strong and urgent imperative for investment in NCDs, which now cause 15 million premature deaths of people between the ages of 30 and 70 each year, 85% of them in low- and middle-income countries.

This makes action and investment in NCDs a prerequisite for resilience, pandemic preparedness and health security, not to mention for meeting the most critical health challenges of the next decade in countries at all stages of development.

Yet financing for NCDs has stagnated at a pitiful 1-2% of development assistance for health for two decades. If we look at development assistance that has gone towards health system strengthening which also helps people living with NCDs we can add a further 5%, but that is simply inconsequential when compared to government handouts for fossils fuels and agriculture, which climb to $1.8 trillion annually – and more importantly, when compared to the magnitude of disease and economic burden of NCDs. 

 Still hope to see healthier populations by 2030

In 2015, all UN member countries committed to the Sustainable Development Goals (SDGs) to achieve a better and more sustainable future for all, including SDG target 3.4 to reduce NCD premature mortality by one-third by 2030. This and other NCD commitments should not lose priority because of the COVID-19 pandemic. They should actually gain priority.

Although the vast majority of countries are well off-track to meet SDG 3.4, a March 2022 paper published in The Lancet shows that there is still hope. All countries – and especially low- and middle-income countries (LMICs) – can achieve or nearly achieve SDG 3.4 to reduce premature NCD mortality by one-third by 2030 by introducing a cost-effective package of NCD prevention and treatment interventions.

Investment in the mitigation of NCDs boosts productivity by cutting the number of wasted lives.

The paper presents an NCD investment framework that aims to support LMICs in getting back on track towards achieving SDG target 3.4 in the wake of the COVID-19 pandemic. It is centred around a package of 21 cost-effective interventions; essentially, a feasible and pragmatic roadmap to healthier populations and more resilient health systems.

There are 15 clinical interventions, like screening and early detection for diabetes and cervical cancer, and cardiovascular disease prevention programmes. Many of these can be implemented at primary health care level. There are also six policy interventions, focused on taxing and regulating tobacco and alcohol, and measures to reduce intake of sodium and transfats. All of the interventions are aligned with WHO recommendations for NCD programmes, helping ensure a more coordinated NCD and pandemic response.

The paper provides guidance on the types of interventions that can best accelerate progress on NCDs in 123 LMICs, and the resources required to implement these interventions. While the clinical interventions are meant to be selected according to national needs and contexts, the policy interventions are crucial for all countries, accounting for nearly two-thirds of the health gains of any locally tailored NCD package. These actions could also generate significant revenue, which can then be reinvested in health.

The bottom line for NCD investment

 As the paper demonstrates, implementing the most efficient package of interventions in each world region would require $140 billion in new spending over 2023–30, equivalent to $18 billion per year. This investment could avert 39 million deaths and generate an average net economic benefit of US$2.7 trillion, or US$390 per capita. This means that benefits outweigh costs by 19 to one.

LMIC ministries of health would need to contribute around 20% of their budgets to the priority NCD interventions. Many countries would also need external support (bilateral, multilateral, philanthropy, private sector), particularly in light of the economic impacts of COVID-19.

For the first time, we have a price tag for tackling NCDs in LMICs – and it’s peanuts alongside current NCD treatment costs and economic losses due to premature death and disability. For instance, in 2021, health expenditure for diabetes reached $966 billion; the annual cost of obesity is projected to top $1.2 trillion globally by 2025; the total economic loss due to cardiovascular disease in LMICs was estimated at $3.7 trillion between 2011 and 2015.

The paper provides further evidence that underscores the urgent need to invest now in proven strategies to save lives and prevent and treat NCDs. Investments in NCDs are not only cost-effective, but they can also save money even within a short timeframe. The bottom line is that governments can reap substantial economic rewards, in both the short- and long-run, by taking bold action on NCDs and thus ensuring the security and fiscal sustainability of their health systems. This requires a view of health as an investment not a cost, and one that requires long-term thinking.

Trailblazing the road to recovery

Leaders must shift their priorities to achieving healthier populations, with impactful action for NCD prevention and care. Some countries are taking bold steps. India’s budget for 2021 more than doubled national healthcare and wellbeing spending from previous levels. The Philippines increased the taxation of tobacco products during the COVID-19 pandemic, with a share being earmarked to bolster capacity for universal health coverage to reach the poorest communities.

Meanwhile, Latin America has made big gains for healthy diets. Recognising a high number of COVID-19 cases among overweight children and adults, the Mexican states of Oaxaca and Tabasco banned the sale of junk food and sugary drinks to people under 18 in 2020, with more states planning to follow suit. 

Front of package labels in Mexico

A Mexican nationwide front-of-packaging warning labelling law also entered into effect in 2020, requiring black stop signs on packages of foods high in added sugar, fats, calories and sodium. Various Caribbean nations have implemented taxes on sugary beverages and made advances to control marketing of junk food in and near schools.

These are just a sample of the actions being taken around the world, and are reason for optimism that real progress can be made. What we need now to accelerate this progress is strong leadership that is committed to putting health and health security first. NCD action and investment must no longer be seen as an afterthought to infectious diseases and neglected within health services, but as fundamental to resilience, security, equity, and economic stability.

As Heads of State and Governments meet this week in Ghana for the International Strategic Dialogue on NCDs and the SDGs, we call on leaders to take the bold action so urgently needed. Whether NCDs and their prevention are addressed by future policy action will make or break the effectiveness of the pandemic response. 

Katie Dain is the Chief Executive Officer of the NCD Alliance.

David Watkins, University of Washington, is the lead author of a recent Lancet NCD 2030 Countdown series article on pathways and investments to accelerate NCDs progress.

Interactive map reproduced with permission from Politico Studio, based on data from WHO’s 2020 NCDs Progress Monitor.

Image Credits: WHO/A. Loke, World Health Organization , World Heart Federation / WHO.

pfizer
Paxlovid

Pfizer has so far refused an invitation from the Geneva-based Drugs for Neglected Diseases Initiative (DNDi) to cooperate on a study exploring whether the treatment window of its successful antiviral drug, Paxlovid, could be extended from 5-7 days using another drug compound in addition, Dr Nathalie Strub-Wourgaft, Director of DNDi’s COVID-19 Response, told Health Policy Watch. 

DNDi wants to test if the key active ingredient of Paxlovid, nirmatrelvir, could be offered in combination with an inhaled corticosteroid, budesonide, in order to extend the treatment window of the life-saving COVID treatment by two more days, Strub-Wourgaft said in an interview. 

Extending the treatment window is critical for patients in low-income countries because the currently-approved formulation of Paxlovid must be commenced within 3-5 days of COVID symptoms. 

Meanwhile ANTICOV, a major DNDi-sponsored trial of COVID treatments underway in ten African countries, has revealed that one-half of COVID patients present for treatment after the five day cut-off date.  

ANTICOV clinical trial.

That makes the current Paxlovid combination less than suitable for low- and middle-income country (LMIC) conditions, said Strub-Wourgaft. She is one of the coordinators of the ANTICOV Consortium, a group of 26 African and global research organizations engaged in the clinical trial research on novel COVID drugs for LMICs.  

On 15 March, DNDi issued a  public statement expressing its concern that “efforts to conduct urgently needed studies in low- and middle-income countries (LMICs) utilizing the novel oral antiviral, nirmatrelvir/ritonavir (Paxlovid), are being blocked by Pfizer, which developed the drug.

Paxlovid, which uses the common HIV drug ritonavir in combination with nirmatrelvir, has been found to reduce the risk of hospitalization or death by a stunning 89% in patients at high risk of severe COVID-19 disease. But the treatment needs to be taken within three to five days of patients developing symptoms.

According to DNDi, “an interim analysis done in the context of the ongoing ANTICOV clinical trial conducted in 10 African countries showed that of the 1180 patients enrolled, more than half present for care after day 5.

“To overcome this challenge, it is necessary to explore whether using Paxlovid with other drugs could widen the ‘treatment window’ to at least seven days,” DNDi said in its statement.

DNDi also wants to investigate if the drug could be “beneficial for immune-suppressed patients who are the most vulnerable to disease progression but were excluded from phase 3 trials.” 

DNDi, a Geneva-based not-for-profit research and development organisation, works to deliver new treatments on neglected diseases and serving neglected groups in low- and middle-income countries.

Still looking for ways to access nirmatrelvir

DNDi drug development.

Strub, in her comments to Health Policy Watch, suggested that DNDi, which has a good track record of building cooperation with the pharma industry, was still trying to obtain the drug somehow – or even persuade Pfizer to collaborate. 

“We would like to test nirmatrelvir/ritonavir in combination, as well, with inhaled budesonide or maybe fluoxetine (brand name Prozac),” said Strub-Wourgaft. 

“We issued a statement to say that we had asked Pfizer to get access to nirmatrelvir, to work with us on this trial. They denied. We’re continuing to try to get access to this drug.”

“We think this [combination] would extend the window of treatment to seven days of symptoms. In the study that they [Pfizer] have done, which is a great study showing really fantastic results, they looked at patients who had five days of symptoms before they were enrolled. 

“And we have seen for now, in our study in Africa, that half of the patients come after five days of symptoms,” she said. 

Such delays are typical because COVID diagnosis and treatment services are less widely available and it thus takes people longer to get diagnosed, even if they are symptomatically ill.  

“There are critically important public health research questions that must be answered quickly – particularly in low- and middle-income countries where access to vaccines remains low,” added Strub-Wourgaft, in the DNDi statement. 

“It is difficult to understand any rationale for refusing to cooperate in the midst of a global pandemic, and this sets a dangerous precedent since there are many other promising antivirals in the pipeline and these novel treatments will also require follow-on research to determine their optimal use in resource-limited settings.”

MPP deal with Pfizer – not enough 

Pfizer recently signed a deal  with another Geneva-based group, the non-profit Medicines Patent Pool, that will allow  35 new manufacturers to produce and supply generic versions of Paxlovid to some 95 low- and middle income countries – in what the company has said is a move to lower the drug’s cost and expand access in low-income countries. 

But that deal has also been criticised for failing to cover dozens of other middle-income and upper-middle income countries that will have to purchase patented versions of the drug.  

Although Pfizer had also said that it would create a tiered pricing system for Paxlovid, drug price advocates say that the price remains too high in many settings. In the United States, the government pays Pfizer about $530 for a five day course, although the pills also are in short supply in some US communities.   

In addition, most  of Pfizer’s Paxlovid supply for the first half of 2022 has already been bought up by rich countries, meaning that LMICs will only be able to get about 10 million doses of the drug in the near term.   

Pfizer’s Paxlovid Goes Generic in 95 Countries – Too Little, Too Late, say Access Advocates

 

However, even considering the MPP deal and other preferential pricing mechanisms, the fact remains that the version of Paxlovid currently being produced is not an optimal fit for many LMICs, Strub-Wourgaft said.  

“So  for now, if we were to be able to give them Paxlovid, under the current conditions, half of them would not even have access,” she told Health Policy Watch.

MPP deals with generic manufacturers may not enable supplies to ANTICOV 

DNDi is also concerned about the potential difficulty of obtaining generic versions of Paxlovid  to conduct the new ANTICOV combination studies, the company has said. 

“The terms of the Pfizer/Medicines Patent Pool (MPP) licensing agreement to the new generics manufacturers could be interpreted to mean that sub-licensees cannot provide nirmatrelvir/ritonavir for use in the sorts of combination studies that DNDi and others wish to conduct, unless they have explicit written approval from Pfizer.

“Some generic manufacturers are also encountering difficulties obtaining Paxlovid as a ‘reference drug’ so that they can conduct the necessary bioequivalence studies to show regulators that their generic version has the same effect in the body, effectively blocking availability of generics for both research and clinical use”, DNDi added in its statement. It has therefore asked Pfizer to not only provide access to nirmatrelvir/ritonavir (Paxlovid) for the DNDi-coordinated ANTICOV trial and other relevant clinical trials, but also to:

  • Remove any ambiguities or restrictions in the Pfizer-MPP licensing agreement that could prevent sub-licensees from supplying such research studies (or publicly clarify that no such restrictions exist);
  • Provide access to Pfizer’s originator product as a ‘reference drug’ so that any interested generic manufacturer can conduct the necessary bioequivalence studies for regulatory approval; and
  • Allocate sufficient quantities of Paxlovid specifically for LMICs and remove all barriers to access to generic nirmatrelvir/ritonavir to enable scale up for care and treatment in LMICs.

“Every effort should be made to ensure that clinical studies for COVID-19 treatment are conducted in low- and middle-income countries, and that any products developed reach vulnerable populations,” said Dr John Amuasi, head of the Global Health and Infectious Diseases Research Grou at Kumasi Center for Collaborative Research in Tropical Medicine in Ghana and a principal investigator for ANTICOV. 

“We must not arrive at a situation where research priorities are determined by the actions or inactions of any company.”

Pfizer response – committed to well-controlled trials

In response to a request from Health Policy Watch, a Pfizer spokesperson did not provide any clarification of the reasons behind the company’s refusal to participate in the DNDi trial – aimed a making the treatment more suitable to low-income settings.

“Pfizer appreciates the importance of gathering additional data and information for governments to help maximize the public health response to the COVID-19 pandemic,” said the spokesperson, adding that the company is committed to “well-controlled, hypothesis-driven clinical studies that can provide data that will be accepted by global regulatory agencies.

“Additional studies of PAXLOVID are underway or are being explored, and we will continue to share information as we have it,” the spokesperson added.

In addition, “Right now, we are focusing our efforts and resources in a way that maximizes availability of our overall supply, to help ensure access to patients as quickly as possible,” the spokesperson said, noting that the company remains “confident” in the clinical trial results, which showed an 88-89% efficacy rate for the drug, when it was administered to non-hospitalized, high-risk patients within 3-5 days of symptom onset.

-Updated 9 April with correction on the price of Paxlovid paid by the US government for patients in the USA and on 11 April with details of Pfizer response.

Image Credits: Bobbi-Jean MacKinnon, DNDI/Twitter, DNDi.