WHO
Dr Gaya Gamhewage, Director, Prevention of Sexual Misconduct, WHO.

Four World Health Organization (WHO) staff or consultants had their contracts terminated as a result of sexual misconduct allegations in the last quarter of 2022 – the most of any year so far. 

The contracts of another three people had already been terminated between January and March of this year, Dr Gaya Gamhewage, WHO’s Director of Prevention and Response to Sexual misconduct, told the media on Wednesday. 

The revelations came on the heels of news on Monday that WHO had dismissed senior manager Temo Waqanivalu following the conclusion of a high-profile investigation of sexual misconduct charges, first brought by a British doctor who had attended the World Health Summit last October in Berlin. 

“In the last year, our investigation team acted on not just the cases that were highlighted in the media, but have completed 120 investigations into sexual misconduct,” Gamhewage said in the briefing, adding that “72 other investigations are ongoing.”

Gamhewage’s report was the most complete, in terms of numbers to date, of WHO actions since the agency WHO undertook a major revamp of its programmes for preventing and responding to allegations of sexual misconduct – including a major expansion of its investigations team. 

WHO overhaul came in wake of DRC sex scandal

The WHO overhaul came in the wake of media revelations of widespread sexual exploitation, abuse and harassment, including cases of rape, by dozens of WHO and other UN responders to the 2018-2020 Ebola outbreak. 

In 2021, after a scathing report by a WHO-mandated Independent Commission investigation pointing to major shortcomings in the agency’s  SEAH management,  WHO announced worldwide reforms in both its investigative and prevention policies. 

However while the Independent Commission report also called for “disciplinary sanctions” against the alleged DRC perpetrators found culpable, Gamhewage’s report on Wednesday did not include the outcomes of their cases. 

That’s because the UN’s Office of Internal Oversight Services (UN OIOS) – and not WHO – are managing those cases separately and have yet to deliver their final reports, she said. 

“We are not investigating the DRC cases. They are all with UN OIS,” Gamhewage told Health Policy Watch in response to a follow-up question. “We can only take action once we receive their reports.”    

WHO changed ‘how we work, our structures, our culture’

But she asserted that WHO’s overhaul of its own internal systems was significant. 

“WHO started changing how we work, our structures, our culture, our processes over the last 18 months,” she said. 

“Because of the many changes we’ve made..having much stronger investigations capacity that is benchmarked, that’s fast and fair…providing better victim support …are having a cumulative effect that is changing our organization.” 

While acknowledging the role played by the media in breaking some of the taboos around addressing sexual misconduct, Gamhewage insisted that WHO also is “making changes with or without media spotlight.”

And she issued a warning to media who have been covering the trail of sexual misconduct cases at the organisation saying that some stories risked violating the rights of victims and alleged perpetrators. 

“I want to caution that the media spotlight should not harm the due process that is owed to everybody involved,” she said, referring to the right of confidentiality of both victims and survivors. 

“It’s only when we protect these things will the disciplinary action that we take a stand. Otherwise, it can be appealed and nobody will win,” she said. 

Her remarks were echoed by WHO Director-General Dr Tedros Adhanom Ghebreyesus who added: “On the one hand, media helps; it’s the eyes and ears of the so keep doing that, we appreciate your work. On the other hand, I would like to stress that …. we see a lack of balance. In some of the reporting [there are] factual errors. And when we try to correct …  there is refusal from some of the media outlets even to correct the factual errors.” 

“So we believe that you are helping us, but at the same time, I would urge you to… really make journalism balanced.  And any factual issue you bring, we will take it seriously,” he promised.  

EU Health Commissioner Stella Kyriakides

Long-anticipated European Commission proposals to reform the European Union’s pharmaceutical legislation – the biggest shake-up in 20 years – were finally made public on Wednesday.

The reforms are aimed particularly at addressing access and price disparities between European states, ensuring that all EU citizens have access to the same products at the same price, EU Health Commissioner Stella Kyriakides told a media briefing.

“We are putting forward proposals to ensure that medicines reach patients everywhere in Europe, in a timely and equitable fashion,” said Kyriakides.

Aside from high prices and medicine shortages, the Commission is particularly concerned about “unmet medical needs, rare diseases and antimicrobial resistance (AMR)”. 

The proposals have six policy objectives, namely to:

  • create a single market for medicines, thus ensuring that all patients across the EU have “timely and equitable access to safe, effective, and affordable medicines”;
  • offer “an attractive and innovation-friendly framework” for research, development, and production of medicines in Europe;
  • speed up procedures significantly, particularly by reducing authorisation times for medicines to 180 days, so they reach patients faster;
  • enhance availability and ensure medicines can always be supplied to patients, regardless of where they live in the EU;
  • address antimicrobial resistance (AMR) and pharmaceuticals in the environment through a One Health approach;
  • Make medicines more environmentally sustainable.

 

One of its proposals involves cutting drug market exclusivity for new medicines from 10 to eight years, after which the market will be opened to generics.

However, drug companies that launch new medicines in all 27 EU member states within two years of development will still be able to get the extra two years’ exclusivity. In addition, manufacturers producing treatments for “unmet medical needs” will get an extra six months of protection.

As an incentive to manufacturers to develop new antibiotics, the EC proposes  “transferable exclusivity vouchers (TEVs)” for drug companies that give a year of protection to any of the company’s medicines.

The proposals also envisage the EU being able to set up manufacturing of vaccines and drugs using compulsory licenses during public health emergencies.

Positive precedent, says MSF

Dimitri Eynikel, EU Policy Advisor for Médecins Sans Frontières (MSF) Access Campaign, said that “with some tweaks”, the reforms “could set a positive precedent towards enshrining access to medicines provisions in law”. 

“We applaud the proposal’s bid for greater transparency: obliging companies to open their books on all direct public funding received for the research and development of medicines is a critical step to ensure that medicines are priced appropriately and affordably for the people who need them,” said Eynikel.

“In addition, plans for granting more effective compulsory licenses by suspending data and market exclusivity would be historic, and should encourage other countries and regions to adopt similar measures to secure the availability of affordable medicines.”

But MSF is against the introduction of vouchers to encourage the development of new antimicrobials, warning that this could “prolong pharmaceutical monopolies, undermine generic competition and severely slow down people’s access to new and affordable medicines”. 

Pharma unhappy

However, the reaction from pharmaceutical companies has been less positive. The European Federation of Pharmaceutical Industries and Associations (EFPIA) says that the proposals will “undermine research and development in Europe while failing to address access to medicines for patients.”

EFPIA Director General Nathalie Moll laid the blame for slow access to medicines at the door of different systems in EU member states: “Fixing the tenfold variation in access to new medicines across the EU, requires all partners to urgently get round the table and address the real issues rather than unworkable EU-level legislation that is destined to fail.”

“Although the revised legislation was meant to improve Europe’s competitiveness, the ‘net’ impact of policies set out across these proposals, in their current form, puts European competitiveness at risk,’ said EFPIA president Hubertus von Baumbach.

Meanwhile, GSK Chief Executive Emma Walmsley told Reuters that weakening market exclusivity protections “could discourage companies from researching and launching treatments in Europe”.

Process

The European Parliament still has to pass the proposals, which means that there are still a number of opportunities for the proposals to be tweaked or changed.

However, MSF’s Eynikel appealed to EU member states and the European Parliament not to water down the provisions on transparency and compulsory licenses.

German MP Andrew Ullmann

Many challenges remain in negotiating an international pandemic treaty, experts tell a committee of the German Parliament.

As COVID-19 cases decline, multilateral polarization and a weary public leaves countries at risk should another global pandemic strike, German MP Andrew Ullmann stated on Monday at the German Parliament (Bundestag). 

The Bundestag’s Global Health Subcommittee held a technical briefing on the international pandemic accord currently being negotiated by World Health Organization (WHO) member states to ensure better global pandemic prevention, preparedness and response.

“It is imperative to complete reforms to address the gaps in international health crises management,” Ullmann said. “We need to strive for an ambitious pandemic agreement. But, of course, this is easier said than done since interests between countries show a strong divide.”

The pandemic accord aims to address areas currently not covered by the International Health Regulations (IHR) – the gobal laws to prevent the international spread of disease – and improve the international community’s ability to prevent and respond to pandemics in a just and effective manner.

“There were huge gaps in the COVID-19 response, and there are three key objectives. First, one must be better prepared – from the community to the country, to the regional to the global level. Two, to have a better chance at preventing future pandemics, and three, to have a better and more coordinated response, and that is the aim,” Steven Solomon, WHO’s Principal Legal Officer, told the hearing.

Steven Solomon, WHO Principal Legal Officer

According to the process agreed in December 2021 by governments at a special session of the World Health Assembly, the WHO’s highest decision-making body, an intergovernmental negotiating body (INB) will aim to produce a final draft of the pandemic accord for consideration by the 77th World Health Assembly in 2024.

Dr Clare Wenham, Associate Professor of Global Health Policy at the London School of Economics, told the hearing that the International Health Regulations were binding on member states but required maintaining a balance between “protecting against the international spread of disease and doing so in ways which are commensurate with the risk to international travel and trade, but it’s not a panacea.”

Dr Clare Wenham

Pointing out several other challenges surrounding the agreement and implementation of an international treaty, Wenham noted that “there have been challenges within the IHR around data sharing and whether there is free flowing and timely information being shared between countries and WHO.”

China, in particular, has come under heavy scrutiny and criticism for its perceived refusal to share information or data on COVID-19. 

WHO is a member-state agency but has no physical compliance mechanism to enforce its member states to implement regulations other than, as Wenham pointed out, “name and shame mechanisms.” 

“There are challenges with financing and cooperation issues, so governments of higher income countries are supposed to support and assist and collaborate with low-income countries to be able to improve their capacities to respond to a pandemic,” Wenham said. 

“Also, other governance issues have come up during the pandemic of COVID, such as a lack of consideration of secondary impacts or pandemic policy.” 

Secondary impacts include such things as the effect of lockdowns on people’s physical and mental health and the financial implications that saw businesses affected worldwide. 

Zero draft

The ‘zero draft’ of the accord, released in 2023, states that “all lives have equal value, and that therefore equity should be a principle, an indicator and an outcome of pandemic prevention, preparedness and response” stressed Dr Viviana Munoz Tellez of the South Centre, an intergovernmental organization based in Geneva that helps developing countries promote their common interests in the international arena. 

Munoz Tellez noted the deep inequalities between member states, also exacerbated by profit-driven medical and pharmaceutical services – which the poor can often not afford.  Parts of the draft treaty text are already facing strong private sector opposition for clauses that some see as impinging too much on market forces, or threatening patent protections on drugs and treatment.  

For instance, one of the clauses of the ‘zero-draft’ of the treaty proposes that 20% of pandemic-related products, such as vaccines or equipment, should be allocated to WHO or other global health partners, which will then ensure equal distribution among member states.

“It is a global problem that we have – a number of countries that are not able to meet even basic capacities for pandemic prevention, and that response to the COVID pandemic, we saw, was highly inequitable,” Munoz Tellez told the subcommittee’s hearing. “In that sense, there has been this drive to say that part of the response for future pandemics is to have equity at the center.

“Private sector had the upper hand as we’ve generally seen overall in the R&D system right now. So we think this is also a very important opportunity for the pandemic treaty to improve the global system from research and development that responds better to public health needs, not just profit incentives.”

Despite the many challenges remaining, Ullmann is hopeful that all parties will be willing to compromise and “contribute to a just and efficacious global health policy.” 

“Failing cannot be an option as the next pandemic can be just around the corner, and no single government or institution can address this threat by itself,” the German lawmaker added in an email to Health Policy Watch, just after the briefing ended.  

“For sure, it is imperative to break the cycle of panic and neglect once and for all.”

Protestors in Washington DC.

Protestors gathered outside Ugandan embassies worldwide on Tuesday for a global day of action against that country’s Anti-Homosexuality Bill, which criminalises all LGBTQ people and proposes a series of punishments ranging from fines to the death penalty.

 

Violence against people suspected of being LGBTQ has already surged in the past month since Uganda’s Parliament passed the Bill with almost unanimous support.

However, Ugandan President Yoweri Museveni declined last week to sign the Bill into law, sending it back to parliament last week with the instruction that it be “reinforced and strengthened”.

While Museveni also congratulated MPs for rejecting “the pressure from imperialists”, he has been under intense pressure from the United Nations, US and European Union members not to sign the Bill.

In addition, Uganda’s Deputy Attorney General has written to the Speaker highlighting why the Bill is unconstitutional, particularly focusing on the death penalty clauses.

Since the Bill was passed a month ago, hate crimes and violence against LGBTQ people have risen sharply, according to the Human Rights and Awareness and Promotion Forum (HRAPF), a legal aid organisation.

HIV services have also been affected, with some LGBTQ patients being afraid to attend clinics for fear of being arrested, according to The Lancet.

In the past month, HRAPF has handled 59 cases involving LGBTQ or suspected LGBTQ persons. Forty of these cases “involved violence and violations targeting the victims purely on the basis of their presumed sexuality, and affected a total of 85 persons”. 

“In one of these cases, a group of six people were arrested and charged with having carnal knowledge against the order of nature because the area local chairperson saw a video from a gay porn site in which one of the actors looked like one of the victims,” according to HRAPF, which itself faces fines simply for assisting LGBTQ clients.

“In the most recent case, an athlete who was suspected to be a transgender woman was arrested by a mob, forcefully undressed and then forced to march through the streets naked while the crowd heckled her, threw objects at her, took her photos/ videos and even fondled her.”

Meanwhile, a report released on Monday points out that Western governments and aid agencies – including the UK, Dutch, Norwegian and US governments  – have donated $40 million to Ugandan anti-LGBTQ religious groups such as the Inter-Religious Council of Uganda since 2014.

While the report acknowledges that there is no evidence “that any of this money specifically paid for anti-LGBTQI activities”, it adds that the aid and partnerships “can boost groups’ credibility, their reputations, and their access to power and other finance”. 

Kenya follows Uganda

A Kenyan Member of Parliament, Peter Kaluma, has tabled an almost identical Bill to his parliament shortly after returning from a meeting in Uganda where leaders of a US anti-LGBTQ group, Family Watch International (FWI), delivered keynote addresses.

FWI has a long history of involvement in anti-LGBTQ activities in Africa and was involved in promoting the forerunner of the current Uganda Bill, the so-called “kill the gays” Bill passed in 2014 but stopped by the courts on a technicality.

FWI founder and leader Sharon Slater has doggedly pursued an anti-LGBT agenda for years, making a wide variety of claims including that LGBT people are more likely to be paedophiles. Slater, has also played a hand in the extreme anti-LGBTQ Bill before Ghana’s parliament.

Slater, a Mormon from Arizona, has also been campaigning for years for African governments to ban comprehensive sexuality education in schools.

A proponent of “conversion therapy”, a discredited approach that aims to change a person’s sexuality, Slater has apparently convinced Museveni that such ‘therapy’ should be promoted in the Bill to encourage people to renounce their homosexuality.

Family Watch International’s Sharon Slater addresing Ugandan politicians

Geopolitical complications 

While the Anti-Homosexuality Bill has drawn condemnation from European governments and the US, this has been muted as Western governments are in a race to woo African governments away from Russia and China. Russia also persecutes LGBTQ people and has a similar anti-rights agenda as Uganda.

Meanwhile, South Africa, which outlaws discrimination against citizens on the basis of sexual orientation, is the only African country to mount protests against the Bill.

The opposition Economic Freedom Fighters, which has significant youth support, has marched to the Ugandan Embassy in Pretoria. Meanwhile, on Tuesday the Secretary General of the ruling African National Congress said that discrimination and persecution were against the African Charter, and called on all states to “ensure that their citizens enjoy their full human rights”.

Donald Trump listens to Fauci
President Donald Trump listens as Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, speaks to the press in 2020.

An expert investigation into the US response to the COVID-19 pandemic has concluded that the country’s performance was the most disappointing in the world. 

The investigation’s report was launched on Tuesday as a book, Lessons from the COVID War, providing an in-depth analysis of America’s response to the pandemic and the aftermath by the COVID Crisis Group, an independent group of experts.

No country’s performance in dealing with the pandemic was more disappointing than that of the US, according to the group. They came to this conclusion as the US excess deaths during the pandemic were around 40% higher than that of Europe, despite the US possessing deeper scientific knowledge about the virus and spending trillions of dollars to address it. 

Donald Trump’s politicking during the start of the pandemic when he was president is heavily criticised, with the authors concluding that his politicisation of the pandemic was a “comorbidity”. 

The book also examines the race to develop an effective vaccine against COVID-19 (Operation Warp Speed), COVID origins and the policies adopted by the federal and state governments. 

The COVID Crisis Group was born in 2021 out of a need to analyse the country’s COVID-19 response given that the pandemic killed more Americans than all US wars combined since the US War of Independence. The group consisted of 34 members – physicians, public health and policy experts led by Philp Zelikow, who led the official commission that looked into the 9/11 attacks. 

Lab-leak theory

The report examines both the lab leak theory and the animal-human transmission theory of COVID-19, but doesn’t support either of these due to lack of sufficient evidence in both cases. 

The origins of COVID-19 has been a controversial topic as some believe that the virus might have broken out into the general population from the high-security laboratory that conducts research on coronaviruses at the Wuhan Institute of Virology in China.

However, this theory has been disputed by many other eminent scientists and the World Health Organization (WHO), who believe that COVID-19 might have originated from a spillover event at a wet market in Wuhan province. 

The book comes down heavily on the US Centers for Disease Prevention and Control (CDC) and says that the agency took on a reactive role in a pandemic instead of proactively leading the way. 

Elaborating on the activities that went behind the development of successful mRNA vaccines against COVID, the book says that both Pfizer and Moderna enjoyed tremendous support from the federal government, either through upfront investment into development or as advance purchase guarantees that ran to billions of US dollars. It also emphasises how “Operation Warp Speed”, as it was known then, was a success only because of a perfect alignment of many other factors around it. 

Image Credits: flickr/The White House. Official White House Photo by Andrea Hanks.

A healthcare worker gives a child a dose of the world’s first malaria vaccine, RTS,S. A second malaria vaccine has now been approved.

IBADAN, Nigeria – There are high hopes that the R21/Matrix-M malaria vaccine recently approved by Ghana and Nigeria will be manufactured in Africa in the not-to-distant future – a brighter-than-usual prospect for this World Malaria Day (25 April).

Earlier this month, Ghana’s Food and Drugs Authority (FDA) approved the R21/Matrix-M malaria vaccine manufactured by the Serum Institute of India (SII) for use in children aged from five months to three years, the age group at the highest risk of death from malaria. 

This was despite the vaccine not yet being given World Health Organization (WHO) prequalification approval. 

SII, the manufacturing and commercialisation license holder for the vaccine, described Ghana’s approval as the “first crucial step [that] will enable the vaccine to help Ghanaian and African children to effectively combat malaria”.

“The licensure of the R21/Matrix-M Malaria Vaccine for use in Ghana is a significant milestone in our efforts to combat malaria around the world. We remain steadfast in our commitment to scaling up production of the vaccine to meet the needs of countries with high malaria burden and to support global efforts towards saving lives,” said Adar Poonawalla, SII CEO.

Shortly afterwards, Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) also granted a “registration approval” for the vaccine to SII. The agency said it had received the dossier of the vaccine and it had been subjected to independent review at two levels. 

The agency added that the vaccine’s dossier substantially complied with best international standards, and that its Joint Review Committee had concluded the vaccine data was robust and met the criteria for efficacy, safety, and quality. 

Local production?

Ghana’s regulator announced that the application for regulatory approval had been submitted by SII’s ‘local agent’, DEK, which expects to eventually manufacture the vaccine locally.

“The status of the [Ghana] FDA Lab creates a great advantage for the local agent who hopefully will be manufacturing the malaria vaccine in Ghana in the near future,” the agency stated.

A few days after the regulatory approval, a ground-breaking ceremony of the DEK Vaccines Limited’s vaccine fill-and-finish plant was held. The company is a private sector-led consortium of Ghanaian pharmaceutical companies.

At the ceremony, Ghanaian President Nana Addo Dankwa Akufo-Addo, said it “will help our nation realise the dream of becoming self-sufficient in the manufacture of vaccines”.

Meanwhile, Nigeria’s regulator announced Fidson Healthcare Ltd, a major local bourse-listed player in the country’s pharmaceutical industry, as the vaccine’s Marketing Authorization Holder (MAH). This authorizes the Nigerian firm licensed to distribute, sell and commercialize the vaccine in Nigeria.

The Nigerian government also revealed in September 2022 that it had signed a local vaccine manufacturing agreement involving Biovaccines Nigeria Limited (a joint venture between the Federal Government of Nigeria and May & Baker Nigeria Plc), and SII.

“The government has approved 15% of the vaccines that UNICEF normally supplies to Biovaccines to supply through contract manufacturing with the Serum Institute of India. With that, the institute will now be comfortable enough to come and join Biovaccines Nigeria in building its manufacturing plant here in Nigeria in Ota,” Nigerian health minister, Osagie Ehanire said.

From Oxford to West Africa via India

An infant receiving the RTS,S malaria vaccine in Ghana in 2019. 

Designed and developed at the University of Oxford, the vaccine has been tested in the United Kingdom, Thailand, and several African countries. 

A Phase Three trial that is underway in Burkina Faso, Kenya, Mali and Tanzania has enrolled 4,800 children and the results are expected later this year. 

While the regulator in Nigeria has also recommended an in-country Phase Four clinical trial or pharmacovigilance study in the implementation, given the peculiarity and heterogeneous nature of malaria in Nigeria, it noted that the efficacy results from the vaccine’s clinical trials contributed to its decision to approve it.

Last year, the Oxford researchers and their partners reported from a Phase 2B trial that a booster dose of R21/Matrix-M at one year, following a primary three-dose regime, maintained high efficacy against malaria, and continued to meet the WHO’s Malaria Vaccine Technology Roadmap goal of a vaccine with at least 75% efficacy. 

This followed 2021 results from the Phase 2B trial reporting that R21/Matrix-M demonstrated high-level efficacy of 77%. Recent data from the large phase III trial also show high levels of efficacy and a reassuring safety profile. 

Prof Adrian Hill, chief investigator for R21/Matrix-M programme, and Director of the Jenner Institute at the University of Oxford, described the regulatory approval of the vaccine as the culmination of 30 years of malaria vaccine research at Oxford. 

“I congratulate our superb clinical trial partners in Africa who have generated the dataset supporting the safety and efficacy of the vaccine in children,” Hill said. 

The vaccine contains Novavax’s Matrix-M which is a saponin-based adjuvant that enhances the immune system response, making it more potent and more durable. The Matrix-M adjuvant stimulates the entry of antigen-presenting cells at the injection site and enhances antigen presentation in local lymph nodes. This technology has also been used successfully in Novavax’s COVID-19 vaccine and is a key component of other development-stage vaccines.

An approval without a WHO prequalification

Unlike the developments surrounding the approval of the COVID-19 vaccines in the African countries that largely followed a prequalification approval by the WHO, both Ghana and Nigerian regulators went ahead to approve the vaccine without any WHO approval. 

In addition to affirming their regulators’ competence and authorization to undertake such approvals, Dr Franklin Asiedu–Bekoe, Director of Public Health in Ghana, told Health Policy Watch that the vaccine – the second malaria vaccine that the country is rolling out – will be closely reviewed by the country’s team of scientists.

“In Ghana, we have 93 districts that are now using the TRS,S. There are a number of districts that are yet to be using it. So if we have a vaccine, which is good, I think nothing stops us from using it,” he argued.

Moreover, Prof William K. Ampofo, Secretary of the Presidential Committee on Vaccine Manufacturing and Development, Ghana, added that the approval was in response to the manufacturer’s application.

“The vaccine was approved based on the application by the manufacturer Serum Institute. It was not an independent decision by the Ghana FDA. It was in response to the application by the Serum Institute for the R21 vaccine based on the data that had been accumulated,” Ampofo told Health Policy Watch.

Local manufacturing elements of both approvals

In the weeks before regulatory approval for the R21 vaccine, Ghana officially expanded access to the WHO-approved RTS,S malaria vaccine. Four years on, more than 4.5 million doses of the vaccine have been administered through the countries’ routine immunization programmes. 

“Community demand for the vaccine is high and the vaccine is well accepted in African communities, even when additional visits to vaccination clinics are required to receive the four-dose schedule,” WHO revealed. 

But RTS,S rollout has been plagued with concerns regarding its comparatively minimal efficacy, high cost and limited supply. 

In sharp contrast, R21’s demonstrably higher efficacy (more than 75% over 12 months) and comparatively lower cost ($3 compared with RTS,S’ $5 per dose) made it even more attractive to African countries – along with the manufacturer’s announcement of potential manufacturing capacities of more than 200 million doses annually.  

But beyond these essential factors are also considerations for local manufacturing from the outset of the vaccine’s introduction in Africa.

WHO and Gavi falling in line

Even though the WHO prequalification certification has not yet approved the R21 vaccine, the WHO has expressed its support for the vaccine, acknowledging on its website that a second malaria vaccine may be coming forward.

“The WHO prequalification process is also underway. WHO will continue the thorough and efficient review of the R21 vaccine and awaits the submission of additional analyses by the vaccine developer,” the global health body said.

Dr Phionah Atuhebwe, New Vaccines Introduction Officer at WHO AFRO Regional Office, added that the WHO is already evaluating the vaccine’s safety, efficacy, quality and programmatic suitability.

“Ghana and Nigeria have not jumped the gun because it is expected that, at national level within their jurisdiction, the national regulatory authorities can also review data once they have received information from different vaccine developers,” she said.

Gavi’s Aurelia Nguyen

Aurelia Nguyen, Chief Programme and Strategy Officer for Gavi, the Vaccine Alliance, also told Health Policy Watch that the alliance is prepared to provide funding for the R21 malaria vaccine. 

“It is a hugely exciting development with the approvals that we’ve seen in Ghana and Nigeria. This is all moving us forward towards having a second vaccine,” Nguyen said. 

She noted that the restricted supply of the RTS,S made it “really important” to have several tools, in addition to affordability.

“It’s not just about the volumes, it’s also about the affordability. Serum Institute has made a very important public commitment in terms of keeping the cost of the vaccines to $3 or less. So we really look forward to them honoring that commitment because ultimately, it will mean that more people are protected,” Nguyen concluded.

Image Credits: WHO/Fanjan Combrink, WHO/M. Nieuwenhof, WHO.

“No child should die of a vaccine-preventable disease,” said WHO Director-General Tedros Adhanom Ghebreyesus.

The world’s largest global health organizations have announced a partnership to reverse the years-long backslide in global childhood vaccination rates caused by the COVID-19 pandemic. 

An estimated 67 million children missed at least one essential vaccination between 2019 and 2021 and 50 million of these didn’t receive any vaccines – setting back childhood vaccination rates to their lowest level since 2008. 

But the “Big Catch-Up”, billed as an “extended effort” to restore vaccination levels in children to at least pre-pandemic levels and shore up essential health services for immunization programmes, does not contain any new financial commitments. 

Participants include the World Health Organization (WHO), UNICEF, the vaccine alliance Gavi, the Bill & Melinda Gates Foundation and a number of national and global health organizations. 

In the past three years, the overburdening and disruption of health services by COVID-19 containment efforts eroded over a decade of gains in routine childhood immunization levels. 

The vaccination schedules of millions of children around the world were knocked-off course, exposing them to life-threatening viruses that can be prevented by existing vaccines.

Dr Kate O’Brien, WHO director of immunization and vaccines, told reporters the “Big Catch-Up” partnership does not involve any new financial commitments to bolster global childhood vaccination efforts.

Dr Kate O’Brien, WHO director of immunization and vaccines, told reporters on Monday that preliminary estimates indicate that the backslide in childhood vaccinations has led to “at least” a five percent increase in mortality among children. 

“Every one of these lives that are lost is on top of the mortality that already exists because of the imperfection of the coverage and immunization programmes,” O’Brien said. “There will continue to be these children who are at risk going forward unless they are caught up.”

Over 100 countries recorded declines in childhood vaccination rates during the pandemic, but three-quarters of the 25 million children who missed vaccinations in 2021 live in just 20 low- and middle-income countries. These will be a “particular focus” for the global coalition. 

“Millions of children and adolescents, particularly in lower-income countries, have missed out on life-saving vaccinations, while outbreaks of these deadly [preventable] diseases have risen,” said WHO director-general Tedros Adhanom Ghebreyesus. “Catching up is a top priority. No child should die of a vaccine-preventable disease.”

Inequality is still behind vaccine access 

When UNICEF first began tracking childhood vaccination rates in 1980, just one in 10 children in the world’s poorest countries would “ever see a trained health worker or be immunized” before their first birthday. By the start of the next decade, seven in 10 children around the world were protected by vaccines – rising steadily to a height of 86% in 2019. 

Despite decades of progress, the story of children not receiving essential childhood vaccines remains one of inequality and poverty. 

One in five children in the world’s poorest households today are ‘zero-dose’, meaning they have never received a vaccine of any kind, according to UNICEF’s 2023 State of the World’s Children report released last week. In West and Central Africa, that number rises to nearly one in two, compared to one in 20 in the wealthiest countries. 

“Routine vaccines are typically a child’s first entry into their health system and so children who miss out on their early vaccines are at added risk of being cut out of healthcare in the long run,” UNICEF executive director Catherine Russel said. “The longer we wait to reach and vaccinate these children, the more vulnerable they become and the greater the risk of more deadly disease outbreaks.”

Asked about the role of vaccine scepticism in dropping child vaccination rates, O’Brien stressed that while the global proliferation of misinformation around vaccines is “deeply concerning” – UNICEF found vaccine confidence dropped in 52 out of 55 countries – it remains a minor factor compared to income. 

“The main reason that kids are unvaccinated is not anti-vax [beliefs],” O’Brien said. “The main reason why children are unvaccinated has to do with access to services, quality of services, and the full availability of programmes.”

Big ambitions, no extra funding 

No new funding to support the goal of returning childhood vaccination rates to pre-pandemic levels is included as part of the “Big Catch-Up”. 

“We’ve done an assessment of the resources that are out there, and we do feel that the resources are there,” O’Brien. “There are substantial resources already in-country and still available to countries through many different mechanisms.”

Meanwhile, Medecins sans Frontieres (MSF) highlighted that children in conflict zones were particularly affected.

“Despite the progress made in expanding global vaccination coverage, nearly 11 million of the un- and under-vaccinated infants live in fragile or humanitarian settings, including countries affected by conflict, and remain the most vulnerable to disease outbreaks,” said Dr Sharmila Shetty, Vaccines Medical Advisor for MSF’s Access Campaign.

Africa’s burden

According to estimates by WHO and UNICEF, the number of zero-dose and under-immunized African children rose by 16% between 2019 and 2021 to a cumulative total of about 33 million, nearly half the global figure.

At a WHO AFRO press briefing last Thursday, Gavi, The Vaccine Alliance, revealed it is working in Sierra Leone and Ghana to ensure that the millions of children and adolescent girls who missed out on vaccines during the pandemic are protected.

“We’re very, very happy to be marking in a few days, the 2023 edition of the Africa Vaccination Week, and it’s a really good opportunity for us to take stock and to remind ourselves of what we have achieved but also what we are dealing with in terms of recovering from a pretty unprecedented emergency during the pandemic,” said Aurelia Nguyen, Gavi’s Chief Programme and Strategy Officer.

Nguyen said that Gavi is working closely with its partners to support countries in making up lost ground and building stronger, more resilient systems. The efforts will focus on on hard-to-reach communities and implementing national programmes that are able to reach children and communities more effectively.

Gavi is also focusing on the human papillomavirus (HPV) vaccine program, which was one of the hardest hit during the pandemic. With cervical cancer being the most common cause of cancer death in nearly half of sub-Saharan African countries, Nguyen noted that the HPV vaccine can prevent up to 90% of cervical cancer cases. 

So far, Gavi said it has supported 20 African countries to produce the HPV vaccine and received $600 million in extra investment last year to revitalize the program and strengthen health systems.

“As we think about many, many challenges ahead, we also are considering the opportunities and we have a young and growing population, and so it’s really our responsibility and opportunity to make sure that we don’t leave any child behind with immunization,” said Nguyen.

  • Additional reporting by Paul Adepoju.

Image Credits: WHO / Billy Miaron.

The working group on amending the IHR met in Geneva last week (20-24 Februar 2023).

Negotiations to tighten up the World Health Organization’s (WHO) International Health Regulations (IHR) to make them pandemic-ready made “excellent progress” – but it still faces enormous obstacles.

WHO member states spent four days last week addressing 100 of the 300 proposed amendments to the IHR, dealing particularly with compliance, implementation, and public health response. 

In describing the “excellent progress”, co-chair of the Working Group of the IHR (WGIHR), New Zealand’s Dr Ashley Bloomfield, said that discussions also “considered critical areas such as core capacities for surveillance and response, collaboration and assistance”. 

In addition, six newly proposed articles and one new annex were put on the table.

Fellow Co-Chair, Saudi Arabia’s Dr Abdullah Assiri described the tone of the meeting as positive and constructive.

“Countries are in the driving seat of this process as they need to implement the IHR, deliver on the obligations, and make the key decisions needed to respond to public health threats,” said Assiri.

Pandemic weaknesses

The IHR were originally adopted to set out agreed approaches and obligations for countries to prepare for, and respond to, disease outbreaks and other acute public health events with risk of international spread. 

However, they proved inadequate during the COVID-19 pandemic, as pointed out by WHO Director-General Dr Tedros Adhanom Ghebreyesus.

“During the COVID-19 pandemic, the international community has learned a great deal about how the IHR functions in a public health emergency of international concern. But the pandemic also revealed deep inequalities in the global health architecture at the national and global levels,” said Tedros.

“It’s important to note that currently, the IHR are the only universal instrument for global health security that the world has,” added Tedros.“That’s why bold but well-targeted amendments are so vital.” 

“The IHR rely on the worldwide application of obligations for international cooperation and assistance in respect of human rights and the underlying principles of solidarity,” said Tedros.

“The process of amending the IHR offers an opportunity to strengthen and extend these principles, but these adjustments to the IHR also have practical implications, as we have learned from many outbreaks in recent years, especially during the early stages of a potential public health emergency.”

Incentives for pathogen sharing

Tedros said that the IHR’s incentive structures are not well-aligned, as some states that quickly notified WHO were “sometimes penalised by travel and trade restrictions”. He added they should be amended to encourage rather than punish transparency and IHR compliance.

Huge challenges remain to be resolved, however, particularly around pathogen sharing. The Africa group wants the WHO to establish a repository for cell lines to accelerate the production and regulation of generic products and vaccines.

Meanwhile, Bangladesh also wants the WHO to set up a database of the ‘recipes’ of vaccines and medicines needed during public health emergencies of international concern, as well as know-how related to their manufacturing.

Image Credits: WHO.

WHO Director General Dr Tedros Adhanom Ghebreyesus describes WHO’s policy reforms in prevention of sexual exploitation, abuse and harassment in a January 2023 meeting with the WHO Executive Board0, following a string of cases in Geneva and elsewhere.

The World Health Organization (WHO) has dismissed a senior manager at its Geneva Headquarters, Temo Waqanivalu, on charges of sexual misconduct following a six-month investigation into allegations that he harassed a young British doctor at the World Health Summit in Berlin last October. 

This is the first high-profile dismissal of an official at WHO’s headquarters following a string of recent complaints and investigations involving personnel in Geneva, in WHO regional offices, and the WHO’s Ebola response team that operated in the Democratic Republic of Congo (DRC) from 20180-2020.     

“Temo Waqanivalu has been dismissed from WHO following findings of sexual misconduct against him and corresponding disciplinary process,” WHO spokesperson Marcia Poole told Health Policy Watch in response to a query on Monday. 

The WHO response came exactly six months and one week after Dr Rosie James first tweeted that she had been “sexually assaulted” by a WHO staff member while attending an evening reception at the World Health Summit in Berlin, which WHO co-sponsored. 

At the time, WHO Director-General Dr Tedros Adhanom Ghebreyesus responded by saying that he was “sorry and horrified” and urged her to file a complaint. 

James expresses relief following close of six-month investigation 

Dr Rosie James

In the end, the investigation took six months to complete. But that, WHO officials have stressed that six months is in fact the time frame set by the organization to ensure due process for both the complainant and the accused in such cases.   

Speaking to Health Policy Watch, James said that it “feels good that it is (hopefully) over.”

She said that she had received news from WHO of the dismissal in a letter on Monday.  But in the letter, the organisation also warned her against talking about the investigation saying “…. In this regard you are kindly reminded of the undertaking of confidentiality that you signed.” 

“I’m scared to say anything,” she told Health Policy Watch. “But it’s a relief to know that hopefully, I was the last woman to be affected by him.

“I hope that this gives confidence to other women to report cases, knowing that this case was taken seriously,” she added.  

She said that the process had been more emotionally stressful than she had anticipated – adding that access to some kind of counselling framework would have been helpful. 

“Having some support offered would have been nice, like a list of contact services that I could have available,” she added. “I think they did send me the email of one doctor or something, but I just felt like it was a really isolating process because I wasn’t allowed to talk with anyone.”

“Speaking up is [although not easy!] and option, she added in a Tweet.

Waqanivalu can still appeal the dismissal    

Temo Waqanivalu with his former team in WHO’s Department of Noncommunicable Diseases (NCDs).

Speaking on behalf of WHO, spokesperson Marcia Poole said that “any administrative decision including dismissal from service may be appealed through the [WHO] internal justice system, and ultimately by filing a complaint before the International Labour Organization Administrative Tribunal.”

But meanwhile, she added that “WHO participates in the UN ‘ClearCheck’ screening database and perpetrators of sexual misconduct are entered into the database as a matter of standard process to avoid their hiring or re-hiring by UN agencies.

“Sexual misconduct of any kind by anyone working for WHO – be it as staff, consultant, partner – is unacceptable,” added Poole.

With regards to Jame’s remarks on her experience of the process, Poole told Health Policy Watch, “Over the past year-and-a-half, WHO has been implementing a comprehensive programme of reform across the entire organisation to prevent sexual misconduct and ensure that there is no impunity if it does and no tolerance for inaction. 

“We encourage all those who may have been affected by sexual misconduct to come forward through our confidential reporting mechanisms. All cases will be reviewed promptly.”

“We are listening to survivors and applying lessons learnt throughout the process so that we can realise our ambition to become ‘best in class’ when it comes to preventing and responding to SEA [sexual exploitation and abuse].”

Former frontrunner for Western Regional Office position 

Dr Temo K Waqanivalu
Dr Temo K Waqanivalu, a senior WHO staffer accused of sexual misconduct, is also campaigning to become Director of WHO’s Western Pacific Regional Office.

Prior to the incident in Berlin in October 2022, Waqanivalu was considered to be a front-runner in the race to become WHO’s next director of the Western Pacific Region. The former regional director, Takeshi Kasai, was recently dismissed from the post as a result of unrelated charges of harassment and racism.    

After being named publicly as the alleged perpetrator of the incident in Berlin as well as harassing a woman at a WHO workshop in 2017 in Japan, those hopes faded. 

According to media reports that surfaced in January, Waqanivalu had allegedly pursued and groped a woman at the Japan workshop who complained to a WHO ombudsperson. But the woman reportedly was discouraged from pursuing a formal complaint at that time.  

Waqanivalu, who has been on leave for the past six months, previously led WHO’s work on the integrated delivery of non-communicable disease services (NCDs).

In the case of James’s complaint, her decision to go public with the allegation of misconduct put a spotlight on the case from the beginning – even though she did not name the perpetrator at the time. 

There also were witnesses to the incident that occurred at the World Health Summit, a public WHO event. That places the case squarely within the scope of a  new WHO policy, which applies to a broad range of people interacting with WHO and in “locations where WHO staff and/or collaborators operate.” 

Image Credits: Twitter/@rosiejames96, Twitter/@@waqanivalut, WHO campaign brochure.

Air pollution
Air pollution is the 10th leading cause of death in the European Union.

Air pollution causes over 1,200 premature deaths per year in people under the age of 18 in the Europe and significantly increases the risk of disease later in life, according to European Environment Agency (EEA) air quality assessment published on Monday. 

“Despite improvements over past years, the level of key air pollutants in many European countries remain stubbornly above World Health Organization (WHO) health-based guidelines, especially in central-eastern Europe and Italy,” according to the EEA. The agency’s report covers the 27 members of the European Union as well as some non-EU EEA members such as Switzerland, Norway, and Liechtenstein.

Some 97% of the urban population is exposed to annual concentrations of fine particulate matter (PM2.5) above the 2021 WHO annual guideline of 5 micrograms per cubic meter (µg/m3), the report stated.

Traffic, heating, and industry are the main sources of air pollution in Europe, and while emissions have declined, air pollution levels are still not safe – particularly for children.

Sector contributions to primary emissions of major hazardous air pollutants in the EU (2020).

Low birth weight, asthma, allergies and reduced lung function

Children are more vulnerable to air pollution than adults as they have higher and faster breathing rates, taking in more air per kilogram of body weight and breathe air closer to the ground where some pollutants, especially from vehicle exhaust, are emitted and become concentrated. 

“Moreover, children inhale a larger fraction of air through their mouths than adults. Due to this increased oral breathing, pollution penetrates deep into the lower respiratory tract, which is more permeable,” according to the EEA.

Their bodies and organs, including their lungs, are also still in development, which further increases risk and their immune systems are weaker than those of adults.

Children are more vulnerable to air pollution than adults (European Environmental Agency).

“Maternal exposure to air pollution during pregnancy is linked to low birth weight and risk of pre-term birth,” according to the agency.

“After birth, ambient air pollution increases the risk of several health problems, including asthma, reduced lung function, respiratory infections and allergies. It also can aggravate chronic conditions like asthma, which afflicts 9% of children and adolescents in Europe, as well as increasing the risk of some chronic diseases later in adulthood.”

There is also growing evidence that air pollution affects children’s brain development, contributes to cognitive impairment, and that it may play a role in the development of some types of autism.

The agency recommends that particular attention should be paid to improving air quality near schools and kindergartens, such as growing vegetation to screen pollution.

“Air pollution levels across Europe are still unsafe and European air quality policies should aim to protect all citizens, but especially our children, who are most vulnerable to the health impacts of air pollution,” said EEA Executive Director Hans Bruyninckx.

“It is urgent that we continue to step up measures at EU, national and local level to protect our children, who cannot protect themselves. The surest way to keep them safe is by making the air we all breathe cleaner.”

Image Credits: Mariordo, European Environment Agency (EEA).