WHO representative, Francis Kasolo, left, with UNICEF representative, Anne-Claire Dufay as first COVAX vaccine doses arrive on 24 February 2021 in Accra, Ghana,

Within one year, Africa has gone from waiting for its first COVID-19 vaccine shipment from the WHO-supported global COVAX facility to having excess doses available that some countries are  struggling roll out efficiently.  Reflections on the first anniversary of the massive COVAX vaccine rollout. 

On 24 February 2021, Health Policy Watch reported the global COVAX facility delivered its first doses In Accra, Ghana’s capital city.  It was a feat that WHO Director General Dr Tedros Adhanom Ghebreyesus described then as the culmination of many months of planning, research, negotiation & coordination.

“But it’s just the beginning. We still have a lot of work to do to realize our shared vision for vaccine equity by starting vaccination in all countries within the first 100 days of the year,” he said.

One year later however, hundreds of millions of doses have now been received by more than 50 African countries, and the challenge now has shifted to the ability of countries to efficiently roll out available vaccines. 

Dr Phionah Atuhebwe, WHO Regional Office for Africa

Addressing journalists on Thursday, Dr Phionah Atuhebwe, “new vaccines introduction officer” at the WHO Regional Office for Africa, said when the first shipment of COVID-19 vaccines was received by the COVID facility to Ghana, it came with a wave of hope and excitement that the milestone would signal a turnaround in the pandemic that was raging through the world and the continent.

A year later, around 680 million doses have been delivered to Africa. 65% of these from COVAX, 6% from the African Vaccine Acquisition Trust, and the rest from bilateral deals and donations.

But the continent lags behind the rest of the world. “Only 13% of the African population has been fully vaccinated in comparison with 55% globally,” Atuhebwe said.

At the same time, the picture is not all gloomy, she said noting that “over 400 million doses of these have been administered amidst excitement and disappointments, some highs and many lows. Africa has taken on the largest vaccine rollout in its history.”


Aurélia Nguyen, managing director of the Office of the COVAX Facility, at Gavi, the Vaccine Alliance told reporters that despite the severe supply setbacks experienced for COVAX during most of 2021, a "new paradigm" is happening today.  

“I'm happy to say that COVAX is operating under a new paradigm with current supplies that is now able to meet demand,” she said. “We have the ability to be responsive to countries' individual vaccination strategies. And this means ensuring that countries have stocks in countries so they can administer literally as fast as they are able to. It also means operating longer term feasibility [assessments] on supply.”

Nagging problems remain with roll-out in the 18 countries in the region that have fully vaccinated less than 10% of their populations - including three countries that have not yet vaccinated even 1% of their population fully. Moreover, 29 countries have used less than 50% of the vaccine stocks that they currently have at hand. 

Among the 24 countries that are reporting complete data on vaccination, only 21% of adults over the age of 50 years have been fully vaccinated; and only 11% of people with comorbidities are reported to be fully vaccinated in 20 countries that are providing this data.

“Worryingly, a sizable proportion of the highest risk populations in Africa remains unvaccinated,” Atuhebwe told journalists.  And even if Omicron passed over region with comparably fewer deaths, lack of vaccination still leaves people more vulnerable to future SARS-CoV variants, experts worry.  

Still aiming for 70% target

Africa CDC director John Nkengasong says Agency is still aiming for 70% coverage

Even if Omicron is receding now, the WHO remains committed to a 70% vaccination goal for the continent - as a means of protection against future threats.  

“Countries have recognized this and are stepping up the pace rapidly as we race towards the mid-2022 target of fully vaccinating 70% of the world's population,” Atuhebwe said.

Of the 20 priority countries identified by the WHO in the African region for intensified support in vaccine rollout, 10 are currently conducting mass vaccination campaigns, which aim to reach at least 100 million people by the end of April.

Kenya setting an example

Kenya is one of the countries setting a new pace for scale-up.

During the first two weeks of the new campaign in February, Kenyan health services reportedly tripled the number of vaccine doses administered, as compared to the two previous weeks. In Guinea Bissau around 125,000 doses were administered during a two week campaign in February, as compared to 11,000 in the whole month of January, WHO officials reported.

WHO said mass vaccination campaigns will be rolled out in a phased approach in 2022 not only in these priority countries, but also in other countries across the continent. Gavi, UNICEF, Africa CDC, the World Bank and other partners are all working to support countries with the logistics, financing, planning and implementation of the campaigns, as well as helping to ensure that there is a robust social mobilization to drive demand for vaccines.

At a separate briefing, the Africa CDC forecasted that by the end of the first quarter of 2022, Africa will have received a total of nearly 304 million vaccine doses of vaccines from both AVAT and COVAX. 

AVAT’s Q1 2022 forecast is 44.6 million doses while Covax’s delivery forecast for the same period is 261.1 million. Some 13.2 million doses are also expected by AVAT as donations. Moreover, 25 African Union Member States are now offering booster shots (Pfizer BioNtech, J&J) following “full” vaccination with either a one- or two-dose regimen.

Strong coordination to get to 70%

Improved coordination among vaccine donors, AVAT, COVAX and African countries remains crucial if the continent will achieve the target of vaccinating 70% of its population by mid-2022, asserted Dr John Nkengasong, Director of the Africa CDC, in a separate briefing on Thursday. .

“COVAX and AVAT coordinate all the time. We talk all the time. We talk to vaccine donors and we speak to issues of expiration — what are the conditions of the vaccines you want to donate? When do they expire?

"We now take the responsibility to engage with member states. That is what we mean by coordination so that we don’t get ourselves in a situation where Donor A is giving vaccines to a country and Donor B is not aware,” Nkengasong said.

Loyce Pace, US Health and Human Services Assistant Secretary for Global Affairs at a briefing at the US Mission in Geneva on Wednesday, 23 February.

The United States will support Dr Tedros Adhanom Ghebreyesus in a second term as head of the World Health Organization – a move that is largely symbolic insofar as Tedros is running unopposed in the elections, scheduled for the 75th World Health Assembly, 22-28 May. 

Although over a dozen countries in Europe and elsewhere lined up as co-sponsors of Tedros’ bid for re-election last autumn, Loyce Pace, US Health and Human Services Assistant Secretary for Global Affairs, made what are probably the first overt expressions of support for Tedros’ candidacy, in a briefing with journalists on Wednesday. 

“It’s been really helpful to be able to work so closely with him,” Pace said in a conversation with a small group of journalists at the US Mission to the UN Geneva during a visit to city, where she was meeting with WHO, member states and other global health officials. 

‘Skim off’ most critical reforms on pandemic response with IHR rule revisions

Pace also spoke about the new US proposal to reform the International Health Regulations that govern WHO and member state responses to disease outbreaks – in a resolution that Washington wants to put before the upcoming WHA session.

The reforms were detailed in an exclusive report by Health Policy Watch published Wednesday. They would create clear criteria and timelines for countries to assess and report emerging disease threats to WHO, and WHO to other member states – within a matter of days.

Pace said the reform of the IHR was “really looking at how we can approach targeted amendments” to improve pandemic response – while longer-term negotiations over a broader pandemic convention or other multilateral agreement get underway.

“And so, so we really tried to just skim off what we thought would be the most critical enhancements that could be made…whether we’re talking about improved alert systems or, or other components, and some of the issues that are maybe tougher to tackle than others,” she said.

Greater opportunity to work in ‘partnership’ in DG’s second term

On the re-election of the WHO Director-General, Pace added, “In his first term, I think Tedros has always signaled his responsiveness to feedback from all member states. And we’ve seen that to be true in this administration, over the past year, certainly. So that’s encouraging.”

But she underlined that “Term Number 2 – that will overlap … with more time working with the Biden administration. And so that presents yet another opportunity to really think deeply and look closely at what we we do together moving forward.”

Indeed, Tedros first three years as WHO director general were rocky ones for WHO-US relations. Then US President Donald Trump, never a fan of the UN system, grew increasingly antagonistic to WHO and its DG as the COVID pandemic spread – accusing both of being China-leaning, before announcing that the US would pull out of the organization altogether in July 2020.

On January 21, 2021, just after being inaugurated, new President Joe Biden revoked Trump’s moves. In a video appearance at a WHO governing board meeting the same day,  Biden’s chief medical advisor Anthony Fauci greeted Tedros warmly as a trusted colleague and “dear friend“.  

Pressing Restart – United States Rejoins World Health Organization; “Leadership Is the Ultimate Vaccine” Says Top WHO Official

More transparency ?

However, behind the scenes, the Biden administration, Pace included, have not not been without their criticism of WHO and Tedros.

US officials have said that WHO needs to become more transparent about its budget planning and financial management – before Washingon would agree to a European initiative to increase fixed member state contributions along the lines of a German proposal – aimed at creating more budget stabiity for the world’s global health agency.

In her comments Wednesday Pace alluded only indirectly to such tensions, saying:

“I have no doubt that that openness on his part, on behalf of his team, will change.

“Given that the US is back so robustly and ready and willing to engage, I see even greater opportunity to work in partnership with him on that,” she added, without elaborating. 

Support for WTO waiver  – as negotiations resume in earnest 

Pace also reaffirmed the US support for a temporary waiver on intellectual property rights on COVID vaccines, as negotiations over the log-jammed measure resumed this week in the World Trade Organization.  

In October of 2020, India and South Africa brought forward a resolution to waive the WTO agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) for COVID vaccines – saying this would help jump-start more production and reduce prices for low- and middle income countries. But European Union opponents have blocked approval of the waiver for months, tabling counter measures for more limited technical changes to IP rules in a polarizing debate. 

Now, however, there are signs that the two sides are resuming talks in earnest with the aim of reaching agreement for the WTO’s 12th Ministerial Conference (MC12). The WHO MC12, postponed last November due to the pandemic, is now set for the week of 13 June in Geneva.

On Tuesday, following a meeting of the WTO’s TRIPS Council, Geneva-based trade officials said that talks had been “difficult but are moving in the right direction,” quoting WTO Deputy Director-General Anabel González. 

Bilateral dialogue between ministers and senior officials of the opposing WTO member blocs have intensified in the past weeks and days, and González has hopes that with some additional dedicated work a compromise could be reached soon, the officials reported. 

European Commissioner Ursula von der Leyen also said that she believed a “bridge” could be created between the positions on the waiver issue – after South Africa’s Cyril Ramaphosa called out Europe for blocking the initiative at the European Union-African Union Summit last week.  

Said Pace of the TRIPS waiver: “It’s something that we continue to speak to. You’re well aware also of our stance on the TRIPS waiver and our support of a TRIPS waiver for vaccines.”

But she added that:  “The President also has called for voluntary tech transfer. And that came through, hopefully, clearly in the summit he convened last year.” 

Scaling up regional vaccine manufacture and distribution

Pace also spoke of the need to scale up regional manufacturing of vaccines – as well as overcoming bottlenecks to actual vaccine distribuition.

 “And I mean by that, I mean shots in arms. You can talk about distribution, but it really has to make it to the end user, if you will, it’s something that we saw first-hand in our own country,” said Pace, referring to vaccine hesitancy and supply chain breaks that have characterized the US vaccine rollout.

Pace said the United States has been investing in South Africa, India, Senegal, and elsewhere, to try and spur investments in vaccines and other medical products to fight COVID.

Short-term, she also said that delivery of promised vaccine donations is “critical”, although not enough on its own. 

 “So obviously, we’ve shared 450 million vaccines with the world to date. And we’ve made a commitment to share over a billion. But it’s not just about sharing,” said Pace.

Doctors reviewing a patient’s medication in a rural TB clinic in South Sudan.

The Global Fund to Fight AIDS, Tuberculosis and Malaria is seeking $18-billion for its next three-year funding cycle – a $4billion increase over the previous period – in part to offset the impact of COVID-19.

“In the face of the catastrophic impact of COVID-19 on the fight against HIV, TB and malaria, the choice is stark: We either increase funding, or we abandon hope of finally defeating these epidemics by 2030,” Peter Sands, Executive Director of the Global Fund told the launch of the Seventh Replenishment on Wednesday. 

The launch was hosted jointly by the presidents of the Democratic Republic of the Congo, Kenya, Rwanda, Senegal, and South Africa.

“We must increase support to countries to build more resilient, sustainable and inclusive systems for health. This is crucial for ending HIV, TB and malaria, defeating COVID-19 and protecting people from future infectious disease threats around the world,” Sands added.

According to the fund’s investment case report, the total projected needs for HIV, TB and malaria for 2024- 2026 in the countries where it operates is $130.2 billion – a 29% increase over the 2021-2023 period. 

“This sharp increase reflects the fact that across all three diseases, we have gone backwards or stalled during the COVID-19 pandemic,” according to the report. “In order to hit the Social Development Goal 3 target of ending AIDS, TB and malaria as public health threats by 2030, we need to speed up progress to reduce deaths and new infections. This will inevitably require more money.”

 

It estimates that its $18 billion budget would enable it to save 20 million lives, cut HIV, TB and malaria deaths by 65% and strengthen health systems to reinforce pandemic preparedness.

The Global Fund has also developed a new strategy that intensifies the focus on building people-centered and integrated systems of health and “reinforces the emphasis on tackling the inequities, human rights-related barriers and gender inequalities that hinder progress against the three diseases”. 

Global Fund strategy

The fund has also resolved to use its resources to build pandemic preparedness and response. It aims to do so by investing approximately $6 billion in supporting health workers; strengthening laboratories, diagnostic tools, supply chain management, information and financial systems; tackling antimicrobial resistance, including drug-resistant TB; reinforcing community systems; and accelerating the shift toward patient-centered, differentiated models of care. 

“We are extremely grateful to their Excellencies Presidents Kagame, Kenyatta, Ramaphosa, Sall, and Tshisekedi for co-hosting the high-level Preparatory Meeting to launch the Global Fund’s Seventh Replenishment,” emphasized Dr Donald Kaberuka, Chair of the Global Fund Board. 

“This demonstrates their commitment and leadership in the fight against the three epidemics within their respective countries and illustrates Africa’s strong engagement and partnership with the Global Fund. Today, they are calling on the world to join them in their determination to reach this ambitious goal to end HIV, TB and malaria by 2030 and build strong national health systems to respond to emerging pandemics.”  

In the 20 years since the Global Fund was created, it has saved 44 million lives and cut the death toll from the three diseases by 40%. But the Global Fund’s Results Report revealed significant progress has been lost because of the COVID-19 pandemic and global resource needs have increased. This is why the Global Fund funding needs are higher than in 2019 for the Sixth Replenishment.  

US President Joe Biden will host the Global Fund’s Seventh Replenishment Conference later in 2022.

Image Credits: WHO/John Rae Photography.

Republic of Korea’s Minister of Health Kwon Deok-Chul

The Republic of Korea will serve as the global biomanufacturing training hub for all low- and middle-income countries that want to produce biologicals, including vaccines, insulin, monoclonal antibodies and cancer treatment, the World Health Organization (WHO) announced on Wednesday.

Meanwhile, five more countries will also receive support from the WHO-supported global mRNA tech transfer and training hubs in South Africa and Korea.  Those include Bangladesh, Indonesia, Pakistan, Serbia and Vietnam. 

A large facility outside Seoul that is already carrying out biomanufacturing training will expand its operations to accommodate trainees from other countries, supported by the Berlin-based WHO Academy.

“The facility will provide technical and hands-on training on operational and good manufacturing practice requirements and will complement specific training developed by the mRNA vaccine technology transfer hub in South Africa,” according to the WHO.

Making the announcement at a media briefing on Wednesday, WHO Director-General, Dr Tedros Adhanom Ghebreyesus described the hubs as “strategic solutions to inequality”.

“One of the key barriers to successful technology transfer in low- and middle-income countries is the lack of a skilled workforce and weak regulatory systems,” added Dr Tedros.

“Building those skills will ensure that they can manufacture the health products they need at a good quality standard so that they no longer have to wait at the end of the queue.”

Republic of Korea’s Minister of Health Kwon Deok-Chul said that just 60 years ago, his country had been one of the poorest countries in the world but that with help from the WHO and the international community, it had “transitioned into a country with a strong public health system and bio-industry”.

“Korea deeply cherishes the solidarity that the international community has shown us during our transition. By sharing these lessons we’ve learnt from our own experience in the past, we will strive to support the low- and middle-income countries in strengthening their biomanufacturing capabilities so that we could pave the way together towards a safer world during the next pandemic,” said Deok-Chul.

In stark contrast, secrecy surrounds the status of COVID-19 vaccination rollouts in the Republic of Korea’s northern neighbour. This month, COVAX scaled back vaccines it had allocated to North Korea as it had failed to arrange shipments.   It has also declined vaccine donations from a range of countries including China and is not known to have procured a single vaccine although its borders remain closed.

More countries join mRNA hub

As for the five new countries in Asia and Europe that will also receive training support from the WHO global mRNA hub: 

“These countries were vetted by a group of experts and proved that they had the capacity to absorb the technology and, with targeted training, move to production stage relatively quickly,” according to the WHO. 

“Indonesia is one of the countries that continuously supports vaccine equity and equal access to COVID-19 vaccines for all countries, including through transfer of vaccine technology and know-how to developing countries,” said Retno Lestari Priansari Marsudi, Minister of Foreign Affairs, Indonesia.

“This transfer of technology will contribute to equal access to health countermeasures, which will help us to recover together and recover stronger. This is the kind of solution that developing countries need. A solution that empowers and strengthens our self-reliance, as well as a solution that allows us to contribute to global health resilience.”

Indonesian Foreign Minister Retno Lestari Priansari Marsudi at Wednesday’s media briefing alongside Dr Tedros.

“Support from the World Health Organization in this process is of essential importance for the development of continuing, quality and safe production of vaccines and medical products,” said Dr Zlatibor Loncar, Minister of Health, Serbia. “The development of new technology means the development of professional knowledge of Serbian experts and training of new young staff, as the absolute national priority.”  

”Although Viet Nam is a developing country, we have had a lot of experience in vaccine development over the past decades,” said Dr Nguyen Thanh Long, Minister of Health, Viet Nam. 

“Our National Regulatory Authority (NRA) has also been recognized by WHO. We believe that in participating in this initiative, Viet Nam will produce the mRNA vaccine not only for domestic consumption but also for other countries in the region and the world, contributing to reducing inequalities in access to vaccines.”

Argentina and Brazil were the first countries from the region of the Americas to receive mRNA technology from the global hub in South Africa, joining the initiative in September 2021. Companies from those countries are already receiving training from the technology transfer hub. 

Break cycle of dependency

“If we want to achieve better global and regional health outcomes, including better preparedness for future health emergencies, we must break our region’s cycle of dependency in a highly concentrated global vaccine market,” aid Argentina’s health minister Dr Carla Vizzotti.

Despite the barriers, Argentina has vaccinated over 80% of its people, she added.

While the WHO said that “numerous countries” responded to the call for expressions of interest from the technology transfer hub in late 2021, it would prioritise countries that do not have mRNA technology but already have some biomanufacturing infrastructure and capacity. 

WHO Chief Scientist Dr Soumya Swaminathan added that the WHO had still not given up on getting BioNTech-Pfizer and Moderna to share its technology and know-how.

Quest for pan-coronavirus vaccine 

Meanwhile, earlier this week the Coalition for Epidemic Preparedness Innovations (CEPI), announced that it will partner with a consortium comprised of the Translational Health Science and Technology Institute (THSTI), an autonomous institute of the Indian government’s Department of Biotechnology, and Indian biotech company Panacea Biotec, to develop a pan-coronavirus vaccine against MERS, SARS-CoV, SARS-CoV-2 and its variants.

CEPI will provide funding of up to $12.5m to support the development of vaccine candidates and advance the manufacturing process, according to the coalition. 

 

Loyce Pace, Assistant Secretary for Global Affairs, US Department of Health and Human Services, addresses the WHO Executive Board meeting, 24-29 February, 2022.

In the wake of the chaotic, and often failed, global response to the COVID pandemic, the United States is not waiting for an elaborate international treaty or convention on future pandemics, which will take years to negotiate. 

Instead, Washington wants to fast track a series of nitty-gritty, but far- reaching changes in the existing International Health Regulations that govern WHO and member state emergency alert and response – for consideration at this year’s World Health Assembly, 22-28 May.   

The US proposal for major IHR rule changes, obtained by Health Policy Watch, has been a topic of discussion in a series of closed-door meetings of WHO member states, which are considering ways to reform the existing IHR, as well as advancing a whole new WHO convention or other international instrument on pandemic prevention and response.

The US proposal, delivered to WHO’s Director General Dr Tedros Adhanom Ghebreyesus in late January, is also featuring in the agenda of US Health and Human Services Assistant Secretary for Global Affairs, Loyce Pace, currently on a visit to Geneva.  See related Health Policy Watch story.

The US is expected to lead a parallel track of tightly-paced “informal” member state negotiations to reach consensus on an IHR reform resolution for approval at this year’s 75th WHA, which is only three months away. 

The US proposals are presented as a detailed series of text additions and deletions in the 2005 IHR rules.  The amendments set out more defined criteria, terms and timelines for alerts, notification, and response to emerging disease threats or outbreaks. The proposed rule revisions clearly aim to “incentivise”  countries to collaborate more closely with expert WHO pathogen SWAP teams in the event of an emerging threat – while avoiding an outright requirement. 

The proposed rules also specifically ask member states to share the “genetic sequence data”  of suspect pathogens right away. 

And they call for WHO to develop new “early warning criteria for assessing and progressively updating the national, regional or global risk posed by an event of unknown costs or sources.”  Such criteria, would in turn, better define, member state’s responsibilities for both monitoring and rapidly reporting on threats.  

US initiative breaks taboo about reforming IHR

Dr Tedros Adhanom Ghebreyesus, WHO Director General speaking at the WHA special session in November 2021, where member states agreed to develop a new multilateral pandemic accord

It’s unclear how the top WHO echelon will react to the changes – which have not yet been posted by WHO in the online agenda for the 75th WHA meeting, 22-28 May.

Notably, Tedros has been personally identified with advancing negotiations on a much broader multilateral instrument, such as a new pandemic convention or treaty.  That approach also ahs been backed by a large bloc of European states, and it received conditional approval in a special WHA session last year, including lukewarm US support. 

So In contrast to the grand political vision and extended timeline of a new accord, digging into a set of very prescriptive revisions to the IHR, may, in fact prove to be more politically difficult for WHO’s leadership.

That is particularly the case since major member states, notably Russia and China, are already at odds with the US over geopolitical issues ranging from the Ukraine to Taiwan.  And even in normal times, they and other more authoritarian regimes would likely balk at any  US initiative that creates stronger compliance mechanisms – perceived as an infringement on sovereignty.   

Quiet welcome from WHO insiders

But as a set of practical proposals to address the real problems that the pandemic has laid bare, the US move may be quietly welcomed by many WHO insiders – as well as European and other allies.  Civil society groups have also been cynical about the ambitions around a new multilateral treaty instrument – worrying about the excessive time and energy such negotiations might entail. 

 “Overall, I am happy that the US has proposed these amendments because it breaks this surreal dogma that has been in WHO for the past ten years, that the IHR should never be amended,” said one former WHO official, speaking to Health Policy Watch on condition of anonymity.

“The US took the initiative, and said there are flaws in the design, let’s change the design,” the former official added.

By submitting it to WHO formally in January, the US has ensured that the reform proposals must be put on the WHA agenda already in May, and be publicly debated there: “So clearly the US wants to put pressure.  It wants to go quickly to get some kind of agreed package.

“I think there will be push back on this ‘draconian’ timeline for alert and notification,” the former official added.  “But the purpose is good.  It’s a way to increase transparency. 

WHO empowered to share information about risks within 48 hours 

The US proposal creates a series of clear timelines and trigger points regarding the responsibilities of a member state with a suspected disease threat to notify WHO  – and WHO to notify other member states – both within a framework of two days each.

Significantly, member states would be required to inform WHO about emerging threats identified by its national IHR focal point within 48 hours, and then accept any WHO offer to “collaborate” on further assessment.

US proposal for more specific text on member state responsbilities to notify WHO within 48 hours about an outbreak risk – including genetic sequence data.

WHO, in turn, would be mandated to make widely available within 48 hours the information it has about a significant emerging  – if the member state rejects the collaboration.

“If the State Party does not accept the offer of collaboration within 48 hours, WHO shall, when justified by the magnitude of the public  health risk, immediately share with other States Parties the information available to it, whilst encouraging the State Party to accept the offer of collaboration by WHO,” states the proposed amendment to Article10-4.

This, in contrast to existing language, which does not explicitly mandate collaboration with WHO on threats, and requires open-ended WHO “consultations” before the Agency even makes available information about emerging threats to other member states or the public- something that currently delays notifications for weeks and months.  

Underlined text represents additions, mandating WHO to immediately share information about disease risks to other member states ,within 48 hours, if the member state experiencing the disease threat or outbreak, refuses to collaborate: US proposal for revisions in IHR 2005

‘Yellow light’ – Regional and intermediate public health emergency warnings

The rules also would give WHO the authority to declare a public health emergency threat at the intermediate and regional level – rather than only globally – as it does now. 

Creation of a kind of “yellow” warning light before declaration of a full-scale global emergency has long been discussed in connection with the SARS-COV-2 pandemic, as a measure that could have alerted countries earlier about risks of the fast-spreading coronavirus infection in the first weeks – even when the epidemic remained geographically confined to Asia.  

And in the case of other emergencies, such as the West African 2014 Ebola outbreak, and prior coronavirus outbreaks of MERS in the Middle East as well as the first 2003 SARS outbreak in Asia – a much more regional spread of pathogens was more immediately obvious than the dynamics of global transmission. 

Finally, the amendments would create an IHR  “compliance” committee for monitoring member states’ adherence to the IHR rules, which are legally binding.  A compliance mechanism, a standard feature of most international treaties, has been a gaping omission in the existing IHR system,  observers say. 

Proposal on table of WHO talks this week   

While Washington has provided support, in principle, to a new pandemic convention or other multilateral accord, it has never been as enthusiastic about the proposal as Europe, noting that it will take years to negotiate.  Preliminary deliberations by a a new Intergovernmental Negotiating Body, which begn Thursday (February 24) are set to continue through June 2023 – and would only come before the WHA in 2024. 

In contrast, the US proposal on IHR reform would already  go before the World Health Assembly at its upcoming May session, as per the letter from the US Mission in Geneva to the WHO Director General  20 January 2022 – noting that its submission to the WHA agenda was made within the four-month deadline. . 

The US message to the WHO DG underlined, “the critical importance of strengthening the IHR (2005) along with other efforts to strengthen the ability of the WHO and Member States to prevent, detect and respond to future public health emergencies of international concern.”

Pace, when asked for her take on the IHR reform proposal, at a media briefing Wednesday at the US Mission in Geneva, said:

“We really tried to skim off what we thought would be the most critical enhancements that could be made.  In terms of what they entail, whether we are talking about improved alert systems or other components, some of the issues are maybe tougher to tackle than others.

“I think what is encouraging for us is that we had close to 50 member states signing onto this approach. We are really quite hopeful that we will see success in this effort, sooner rather than later.”

But Pace acknowledged that the first real litmus test of the US initiative will be Thursday, at the initial formal session of a new “Intergovernmental Negotiating Body” on pandemic response reform: “When it comes to the instruments of this process, we are really mindful of the process kicking off tomorrow.”

On 24 February 2021, a plane carrying the first shipment of COVID-19 vaccines distributed by the COVAX Facility landed at Kotoka International Airport in Accra.

On the eve of the first anniversary of the delivery of COVID-19 vaccines to Africa via COVAX, the continent’s leading vaccine advocates have pledged not to accept anything less vaccinating 70% of Africans against the virus by mid-year – a tall order given that only around 10% have been vaccinated.

However, to assist in reaching this target, the US on Tuesday announced new funding for the vaccination drive in Nigeria, Africa’s most populous country.

Meanwhile, World Health Organization (WHO) Director-General Dr Tedros Adhanom Ghebreyesus told the ‘Ports to Arms’ summit being held in Nigeria that while COVAX only has enough vaccines to cover 45% of the continent, other sources including the African Vaccine Acquisition Team (AVAT) will “provide the means for countries to reach the global target of 70% by mid-2022”.

“We must now turn our attention to addressing the crucial question of how we turn vaccines into vaccinations – or how we get vaccines from ports to arms,” said Tedros, adding that health workers, older adults, and those with underlying medical conditions, must remain the urgent and immediate focus.

Support for TRIPS waiver

Tedros reiterated WHO support for the proposal from South Africa and India for a temporary waiver of intellectual property rights under the TRIPS agreement for the duration of the pandemic in order to reach the 70% target.

“Achieving the 70% target in all countries is essential for ending the pandemic as a global health emergency and driving a truly inclusive global recovery. It will also help prevent the emergence of new variants, which could be more severe or transmissible next time around,” said Tedros.

To help achieve this target, the WHO, UNICEF and Gavi have initiated a COVID-19 Vaccine Delivery Partnership, to assist government-led vaccine strategies through political engagement, delivery funding, technical assistance and surge support, added Tedros.

“This partnership will bring the tools, training, and expertise to strengthen cold chains and logistics, deploy vaccinators, mobilize funding, strengthen data systems, engage communities, and plan and coordinate operations,” he added.

From Ports to Arms: WHO Africa Director Dr Matshidiso Moeti, ACT Accelerator envoy Dr Ayoade Alakija and CEPI CEO Richard Hatchett

COVAX anniversary

Seth Berkley, head of the global vaccine alliance, Gavi, said that Wednesday (24 February) marked the first anniversary of the first COVAX delivery on African soil. But since then, COVAX has delivered about 440 million doses now to 51 countries on the continent. Of these, 60 million had been delivered to Nigeria, the continent’s most populous country, with 30 million more allocated to the country.

“The challenge is to make sure that the absorption capacity of countries is such that those doses can be used quickly and get to the people that them,” said Berkley.

Echoing Berkley’s call, Dr Ayoade Alakija, the convenor of the “Ports to Arms” conference, stressed that Africa would not accept anything less than the 70% vaccination rate.

‘Not about vaccine hesitancy’

Atul Gawande, Assistant Administrator of USAID, announced a new partnership with the government of Nigeria under the US government’s Initiative for Global Vaccine Access known as Global Vax.

Nigeria will get an additional $33.3 million to help ensure COVID-19 vaccines reach people who need them, said Gawande, adding that the US had already donated $143 million to the country to address the pandemic.

“This additional funding to Nigeria will support activities that simply go to where our partners find they needed the most. And that can be anything from needing to build the cold chain supply and logistics, to addressing vaccine confidence or driving mobile vaccination units,” said Gawande.

He paid tribute to the country for administering six million COVID-19 vaccine doses in January, a 30% increase on the previous month.

“We clearly have a long way to go with just 30% of this population vaccinated. But what Nigeria is showing us is what we want to show the world. This isn’t about vaccine hesitancy. It’s not about an unwillingness to be vaccinated. It’s about making sure that access is closer to people. It’s nearer to people and that when we do people actually do take the vaccine,” said Gawande.

Richard Hatchett, CEO of the Coalition for Epidemic Preparedness Innovations’ (CEPI’s), described mRNA technology as “game-changing technology that offers the potential for African countries to leapfrog over those alleged decades that it will take to catch up and achieve self-sufficiency”.

Image Credits: UNICEF/Kokoroko.

The formula milk industry is using  ‘unethical’ marketing tactics to influence new parents and pregnant women to substitute breast milk for formula milk in breach of the international standards on infant feeding practices and is detrimental to child nutrition and health, according to a new report by the World Health Organization (WHO) and the United Nations Children’s Fund (UNICEF).

The report was based on a survey of over 8,500 pregnant women and parents and 300 health workers in Bangladesh, China, Mexico, Morocco, Nigeria, South Africa, the United Kingdom and Vietnam. It was complemented by in-depth interviews of mothers, and marketing executives in China. 

Some 51% of new parents and pregnant women surveyed had been victims of “systematic and unethical” marketing strategies by the formula milk industry in violation of the International Code of Marketing of Breast-milk Substitutes. 

“This report shows very clearly that formula milk marketing remains unacceptably pervasive, misleading and aggressive. Regulations on exploitative marketing must be urgently adopted and enforced to protect children’s health.” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General in a press release.” “Let’s stop the commercialisation of our children’s health.” 

Globally, only 44% of babies less than six months old are exclusively breastfed. The breastfeeding rates around the world have increased very little in the past two decades, but the sales of formula milk have more than doubled in roughly the same time, the press release said. 

Women’s self-reported exposure to formula milk marketing in preceding year

The $55 billion-per-year formula milk industry uses an array of techniques such as unregulated and invasive online targeting of new mothers and parents, sponsored advice networks and helplines, promotions and free gifts, and practices to influence training and recommendations among health workers to influence mothers and parents into choosing formula milk over breast milk for their children, according to the report.

 Top three channels where formula milk marketing is seen or heard among mothers

Need for policy change and intervention

According to the report, called How marketing of formula milk influences our decisions on infant feeding, there is a need for more serious political intervention. Political leaders at the highest level, public health institutions, health professionals and their associations, and civil society must step up to identify and halt the risks and pervasiveness of such formula milk marketing. 

“We need robust policies, legislation and investments in breastfeeding to ensure that women are protected from unethical marketing practices – and have access to the information and support they need to raise their families.” said UNICEF Executive Director Catherine Russell. 

Formula milk marketing had reached 92% of women surveyed in Vietnam and 97% of women surveyed in China, thereby increasing their likelihood of choosing breast milk substitutes. These women were significantly more likely to see nutrition as “more comprehensive and balanced in formula’” than breast milk. 

In Bangladesh, 72% of women who exclusively formula-fed their children had received a recommendation to feed formula from a health professional.

Meanwhile, a Mexican woman interviewed confirmed that her paediatrician had suggested a brand of formula milk for her: “Yes, the paediatrician suggested one and that’s what I chose, I didn’t do much research. I trusted what the paediatrician told me, that’s why I didn’t remember the ads.”, said a woman interviewed for the survey in Guadalajara, Mexico.

The report, which was commissioned by WHO, UNICEF and funded by the Bill and Melinda Gates Foundation,  recommends banning health workers from accepting sponsorship from companies that market foods for infants and young children for scholarships, awards, grants, meetings, or events.

It also recommends countering the targeted messages of the formula industry and creating awareness through informational messaging and advertising, investing in training and building the skills of health professionals , and by tightening the current rules of marketing breast milk substitutes.

In addition, the report recommends building a secure digital ecosystem to weed out misleading adverts and protect children’s health from falling prey to commercial and unregulated marketing. Furthermore, it argues that there is a need to support mothers, breastfeeding and health systems, and also to give impetus to maternity and parental leaves. 

Breastmilk is best

The benefits of breastmilk are scientifically proven to outweigh those of formula milk. Breastfeeding for six months and continued breastfeeding for up to two years or beyond, offers children a powerful line of defence against all forms of malnutrition, including wasting and obesity. It also acts as a ‘first’ vaccine for children by providing protection against common childhood illnesses. 

A switch to formula milk is not scientifically recommended and leads to increased infant morbidity and mortality, and are causes of suboptimal breastfeeding that are responsible for an estimated 823,000 deaths among children each year, according to a paper published in BMJ Global Health last week. 

Proportion of women who received recommendations from health professionals to use a formula product

The paper also called for scientific journals to cut ties with breastmilk substitute makers and the formula industry if they want to protect infants and young children from being at risk of malnutrition, illness and death.

The formula industry uses health professional financing and engagement through courses, e-learning platforms, sponsorship of conferences and health professional associations and advertising in medical/health journals to influence health professionals into prescribing and promoting formula milk over breast milk.  

Unscientific claims 

The research shows ways that formula milk companies have exploited and entered markets for their products, such as  “allergies and sensitivities” to enjoy more sales and business opportunities and circumvent restrictions on formula milk company representatives visiting health facilities. 

Formula milk is positioned as close to, equivalent and sometimes superior to breast-milk, presenting incomplete scientific evidence and inferring unsupported health outcomes, the report noted. The ingredients in formula milk which are listed as ”informed” or ”derived” from breastmilk and claimed to be linked to child developmental outcomes were found to not be supported by scientific evidence. 

According to the marketing executives interviewed for the report, formula milk companies’ engagement through digital channels has been intensified by the Covid-19 pandemic. The targeted ad campaigns are based on search histories, cookies and online profiles.

Time to revamp the code? 

The survey showed that women reported being targeted by online marketing through promotions based on their search behaviour for infant feeding advice and information.

Speaking at the launch of the report, Helen Clarke, Former Prime Minister of New Zealand and Board Chair of the  Partnership for Maternal, Newborn and Child Health, questioned whether it was time for the Code to be completely overhauled since those rules are not in the digital age.

”The code needs to be brought up to date with the new media for advertising, which is so pervasive and can be very, very harmful,” said Clark.

Helen Clark, Former Prime Minister of New Zealand and Board Chair of the Partnership for Maternal, Newborn and Child Health

“Formula marketing does have a direct impact on survival health, and development, both of children and women,” said UNICEF’s Dr Nigel Rollins at the launch. “It does disrupt access to impartial truthful information and support that is so necessary for parents to make decisions and this is an essential human right.” 

WHO calls on governments, health professionals, and the baby food industry to put an end to the ‘exploitative’ formula milk market and to abide by the Code provisions. These provisions include publicly committing to full compliance with the Code and subsequent World Health Assembly resolutions globally.

A 2020 report by WHO, UNICEF and IBFAN shows that of the 194 countries that were analysed in their report, 136 had provisions for some form of legal measure related to the International Code of Marketing of Breast-milk Substitutes and subsequent resolutions adopted by the World Health Assembly.

It noted that the legal restrictions in most countries did not fully cover marketing that occurs in health facilities as only 79 countries had banned the promotion of breast-milk substitutes in health facilities, while 51 had provisions that prohibited the distribution of free or low-cost supplies within the healthcare system.

Image Credits: WHO/C. Black, WHO, WHO/UNICEF, HOW THE MARKETING OF FORMULA MILK INFLUENCES OUR DECISIONS ON INFANT FEEDING, WHO UNICEF Report .

Bill Gates meeting with Pakistani President Arif Alvi in Islamabad during a visit to Pakistan on 17 February

ISLAMABAD – The timing couldn’t have been worse. 

On the same day that Bill Gates, completed his maiden visit to Pakistan to cheer on the country’s progress towards polio eradication, WHO and Malawi health authorities announced that a small child thousands of kilometers away in Malawi had been ill with polio – infected by a Pakistani strain of wild poliovirus (WPV type-1).   

WHO officials hastened to say that the polio case in the 3-year-old girl in Lilongwe, diagnosed after she experienced an onset of paralysis, did not threaten Africa’s hard-earned  “polio free” status – because it was an “imported case” of the deadly virus.  It was only after repeated queries by Health Policy Watch, that WHO acknowledged that neither the young girl or her family members had recently traveled to Pakistan – meaning that she became infected locally.   

But in fact, the particular genetic strain of the wild poliovirus that popped up in Lilongwe Malawi, hasn’t even been seen in Pakistan since 2019, Pakistani authorities there later stated – raising questions about if and how the virus may indeed be circulating more widely now in the African country.  

It was only in August 2020 that Africa was declared free of wild poliovirus.  Pakistan is getting closer to that goal as well. 

But the surfacing of a Pakistani wild poliovirus strain in Africa, underlines the challenges still faced to global elimination of polio – not to mention control and elimination of other diseases. And if more cases of wild poliovirus occur in Malawi, the whole continent’s wild polio-free status could be threatened – even if WHO is loath to state that publicly.   

Three month delay in WHO announcement of Malawi polio outbreak   

The other conundrum raised by the episode is one of timing – the apparent three-month long delay in identifying and reporting the wild poliovirus case.

The WHO African Regional Office announcement took place on 17 February 2022. But the child’s polio symptoms were first reported in November, 2021. 

“The three-year-old girl in Malawi experienced onset of paralysis on 19 November 2021, and stool specimens were collected for testing on 26 and 27 November,” stated a Global Polio Elimination Initiative report, also dated 17 February 2022.

“Sequencing of the virus conducted in February by the National Institute for Communicable Diseases in South Africa and the U.S. Centers for Disease Control and Prevention confirmed this case as WPV1,” the GPEI statement continued.   

So far, no one has been able to explain why there was a three-month delay in sequencing the virus and announcing the case – when new SARS-CoV2 variants were being identified by the same laboratories within days or weeks.  

But only four days later, WHO Director General Dr Tedros Adhanom Ghebreyesus commended Malawi’s President Lazarus Chakwera for  “rapid action and transparency” in responding to the outbreak.

Analogue era of reporting – in digital age

A similar pattern occurred last October, when WHO reported a Ziki outbreak in India – four months after a cluster of new cases actually occurred and were diagnosed.

It raises, once more, again thorny questions, once more, about the snail’s speed at which national governments report, laboratories examine and WHO publicly releases sensitive “disease outbreaks news” – that national governments may find embarrasing. 

Fault lines in the chain of alert and response have come under heightened scrutiny during the COVID pandemic – something The Independent Panel described it as an “analogue” system operating in a digital age.

WHO’s alert and response system “seems to come from an earlier analogue era and needs to be brought into the digital age,” observed panel co-chair Helen Clark, former Prime Minister of New Zealand, in a media briefing on 21 January 2021. 

The SARS-CoV2, the virus was probably circulating in Wuhan for weeks, if not months, before the first public report was made by Wuhan health authorities on 31 December 2019, experts now believe. After the first public reports, it took WHO another full month to declare an international health emergency, Clark noted.     

Imported case – but circulating locally  

Another issue raised is how you define an “imported” case of a disease.

When WHO described the Malawi polio case as “imported” that meant that “laboratory analysis shows that the strain detected in Malawi is linked to the one that has been circulating in Sindh Province in Pakistan”, WHO African Regional Office,  Dr. Modjirom Ndoutabe, told Health Policy Watch, in an interview.

Neither the child nor her parents had been to Pakistan, he affirmed.

“When we are talking about importation, it will be an adult passive vector who traveled from an infected country to the polio-free country,” he explained. Laboratory analysis of the virus strain showed that it is genetically linked to a wild poliovirus found circulating in Pakistan in 2019, Ndoutabe added.

This was confirmed by Pakistan’s Dr. Rana Mohammad Safdar, Director General of the Ministry of National Health Services. However, the same virus strain has not been seen in Pakistan since 2020, he told Health Policy Watch. 

“Origin is, of course Pakistan, but remains to be investigated where it survived as hidden circulation,” Safdar said.

Heading off a wider outbreak 

An oral polio vaccine is administered to a child.

Meanwhile, WHO’s African Region polio coordinator, Ndoutabe, admitted that the virus “may be spreading silently”, elsewhere in the environment. 

Just one infected child can contaminate water sources, as well as other people who come into contact an infected persons stool – and the virus can also multiply and thrive in untreated sewage, he observed.

If the virus indeed spreads further, then it could compromise the recently-gained status of Africa being free of wild poliovirus Type 1.  That, in additon to the vaccine-derived polio cases that some 16 African countries continue to battle.    

In the wake of Malawi’s polio case, the Global Polio Eradication Initiative (GPEI) team based at WHO’s Brazzaville Regional Office is deploying a team to Lilongwe to support coordination, surveillance, data management, communications, and operations, WHO said.  

Ndoutabe  expressed confidence that Malawi health authorities could head off a wider outbreak, saying: “We can stop it very quickly with excellent vaccine campaigns.” 

Gates – Pakistan faces ‘hardest phase’ of eradication effort 

Meanwhile, in his first-ever visit last week to Pakistan, Gates, the billionaire philanthropist and co-chair of the Bill and Melinda Gates Foundation (BMGF), declared that not a single case of wild poliovirus has been reported in that country in the last fourteen months.

“It has been over a year since wild polio paralyzed a child in Pakistan, presenting an incredible opportunity to stop this disease for good,” Gates said in a tweet. 

Malawi’s case aside, Pakistan and Afghanistan are the only countries left in the world still struggling to eliminate wild poliovirus. 

Officials at Pakistan’s ministry of National Health Services Regulation and Coordination told Health Policy Watch that they believe Pakistan is indeed very close to eradicating the wild polio virus Type 1 that remains endemic in the country  – although the virus continues to be identified in stool samples collected by surveillance in a few sites in the country’s northwestern province.

“Two samples in the south of province Khyber Pakhtunkhwa were tested positive in December while all other sites were negative,” a senior official said, asking to remain anonymous. 

This was formally confirmed by a BMGF statement about Gates’ visit and meeting with Pakistan’s President Arif Alvi, and Prime Minister Imran Khan.  The BMGF statement noted that “wild poliovirus was detected in sewage samples in Khyber Pakhtunkhwa, a province located in the northwestern region of the country, in December 2021”.

During his visit, Gates commended Pakistan’s commitment to “the hardest phase” of the eradication effort. 

“This is the final, and hardest, phase of the eradication effort, but by keeping up the momentum and staying vigilant, Pakistan has an opportunity to make history by ending polio for good,” he said.

Vaccine hesitancy and reaching children in areas of civil unrest 

Children in Pakistan display their finger nail died purple – proof they have been vaccinated against polio.

Other challenges include vaccine hesitancy and reaching children in insecure areas, said the BMGF and Pakistani government statements.

Dr Shahzad Baig, the coordinator of the health ministry’s National Emergency Operations Center (NEOC) – highlighted the need to halt virus circulation in border areas shared by Pakistan and Afghanistan – in the throes of crisis and with refugees crossing the border daily. 

Against that landscape, Pakistan’s Polio Eradication Programme continues to work closely with Afghanistan’s new Taliban government in efforts to halt poliovirus transmission across shared corridors and amongst highly mobile population groups, Baig underlined. Reversing years of vaccine hesitancy, the new Afghan leaders have committed to continue polio vaccination efforts on their side of the border. See related Health Policy Watch story. 

Baig also commended the growing synergies between the activities of WHO-supported Expanded Programme on Immunization (EPI) and Polio Eradication Programme (PEI) – to carry out routine vaccination campaigns that offer multiple health services at the same time.

In 2022, for instance, targeted polio vaccination campaigns across all four provinces in Pakistan will be followed by health camps that offer communities free routine vaccinations, nutrition services, and referrals to health facilities.  

https://healthpolicy-watch.news/93812-2/

Image Credits: UNICEF Pakistan, Pakistan, President's Media Team , WHO.

At the National TB Centre in Abovian, Armenia, Dr Shahidul Islam examines a patient with drug-resistant TB

There is finally “cause for optimism” in the quest for a tuberculosis vaccine, Dr Anthony Fauci, director of the US National Institute of Allergy and Infectious Disease (NIAD), told the opening of the sixth Global Forum on TB Vaccines on Tuesday.

Before the COVID-19 pandemic, TB was the most deadly global infectious disease yet there has been little progress on vaccine development for TB for decades as it is seen as a disease of the poor.

Acknowledging that there were still “basic knowledge gaps” about TB, Fauci said that “there have been significant research advances and there is cause for optimism in the context of our research advances”. 

The only licensed TB vaccine, BCG, was discovered 100 years ago and only provides moderate protection against severe forms of TB in babies and young children but does not stop TB transmission in teens and adults.

There are currently 15 TB vaccine candidates, including three in phase 3 trials and two others preparing for Phase 3 trials.

But Fauci cautioned that “incremental changes alone are not sufficient and not acceptable” – particularly in light of how COVID-19 had set back advances in TB. 

He also expressed his concern about the rise of “vaccine hesitancy” – even for vaccines as efficacious as those for COVID-19 – and warned that more attention needed to be paid to “effective messaging” about vaccines.

Multi-platform portfolio for vaccines

Dr Tedros

“Public funding for TB vaccine research remains inadequate and industry engagement is low owing to the lack of market incentives, but there are solutions,” WHO Director-General Dr Tedros Adhanom Ghebreyesus told the meeting, which is being hosted by France.

“The pandemic has demonstrated the value of a multi-platform portfolio of vaccine candidates, including mRNA and viral vector technologies. This approach could transform vaccine development efforts for other diseases including TB,” said Tedros.

He identified three essential ingredients to find a TB vaccine: public-private partnerships to bring together expertise and funding; strong political leadership, backed by substantial financial resources and thirdly, “equitable access must be considered early with need prioritised above the ability to pay”. 

Mark Feinberg, Co-Chair of the Global Forum, said that the CVID-19 pandemic had shown that “how quickly and creatively we act is what counts”.

“In particular, the speed with which mRNA vaccines can be produced offers real hope that, through application of cutting-edge science, we can harness a more nimble and responsive approach to vaccine design and testing.,” Science is our way out of the tuberculosis epidemic,” stressed Feinberg.

Drug-resistant TB

 Antimicrobial resistance (AMR) is now killing more people each year than HIV or malaria and is tipped to be the world’s most lethal health challenge by 2050. TB drug resistance accounts for nearly a third of the 3,500 daily deaths from AMR.

Virologist Philippe Sansonetti,  Emeritus Professor at the Institut Pasteur and College de France, said that the development of a TB vaccine was essential to reduce drug-resistance.

“We need vaccines because they protect against antibiotic resistance by reducing the burden of disease,” said Sansonetti. Drug-resistant TB is a significant problem worldwide, caused by incorrect use of TB medication.

“It’s been calculated that more than 300,000 tonnes of antibiotics are released every year on the planet, essentially un-degraded,” said Sansonetti. This was causing a significant reduction in microbial diversity and accelerating antibiotic resistance.

The European Commission’s Jean-Eric Paquet, Director-General of Research and Innovation, assured the forum that multidrug-resistant TB was a “key focus” of its Innovative Medicines Initiative, a partnership with European pharmaceutical companies.

What it will take to end TB by 2030

Carol Nawina

Carol Nawina, who is living with HIV in Zambia, said she had struggled with TB for years.

“According to current modelling, we will be able to end TB by 2030 if a vaccine becomes available by 2025. And for that to happen, we need to fast-track the trials, particularly Phase 2 trials,” said Nawina, who works for the Community Initiative for Tuberculosis, HIV/AIDS and Malaria plus related diseases (CITAMPlus).

She added that TB vaccines received just $118 million in research funding in 2020, only  9 million more than 2018 levels., and that funding for TB vaccine development is “completely lacking”.

“The COVID pandemic has shown us that the world has the money. The question is does it care about people who died from TB the same way it cares about people who died from COVID?” asked Nawina, urging the European Union and host country France to “commit to champion this effort to ensure an operational TB vaccine by 2025”.

Image Credits: End TB.

Residents in the European Union will soon have access to a single electronic database with information about all medicine available in the region, following the European Medicines Regulatory Network’s adoption of a common standard for electronic product information (ePI). 

“This will enable any EU resident to get up-to-date information on all medicines available to patients in the EU through an ever-expanding range of electronic channels,” according to the European Medicines Agency on Tuesday.

This information will include the package insert for patients on how the product should be used and the summary of product characteristics (SmPC) for healthcare professionals, explaining how it should be prescribed. 

“The EU ePI Common Standard will support the provision of harmonised electronic information on medicines within the EU and is a step towards improved delivery of information for patients, consumers and healthcare professionals to aid their informed decision-making,” according to the EMU.

It added that developing the common standard was one of the key deliverables of an ePI project run by the European Medicines Agency (EMA), National Competent Authorities (NCAs) and the European Commission (EC) in 2021.

A follow-on pilot project supported by the EU’s funding programme EU4Health will develop tools and guidance to pilot the use of ePI prior to implementation. 

 

Image Credits: Shutterstock.