Milestones :: Perspectives

WHO – SAGE [Strategic Advisory Group of Experts] Meeting
The next SAGE meeting will take place in Geneva from the 2-4 April 2019.
Draft agenda for SAGE April 2019 meeting  pdf, 76kb  [As of 25 March 2019]

Selected Agenda Items
:: Quality and Use of Immunization and Surveillance Data
:: Report from the Global Advisory Committee on Vaccine Safety (GACVS) meeting 5-6 December 2018
:: Update on the development of a Post-2020 Immunization Strategy
:: Malaria Vaccine
:: Polio the last mile
:: Meningococcal vaccines: Global Strategy
:: Ebola vaccines
:: Update on the SAGE Evaluation

Milestones :: Perspectives

Polio Eradication

Dr Tedros Adhanom Ghebreyesus, WHO Director-General and Chair of the Polio Oversight Board, issued a personal response [first text below] to the joint statement published in January by the Chairs of the main, independent, advisory and oversight committees of the GPEI [second text below].

March 2019
Dear Chairs of the GCC, IHR Emergency Committee, 1MB and SAGE,
On behalf of the Global Polio Eradication Initiative (OPEi) and as current Chair of the Polio Oversight Board, I would like to thank you for your recently-published joint communique on the polio eradication effort. Your assessment of the current global situation, and what needs to happen to achieve success, is as accurate as it is motivating. Thank you for this strong call for action.

Let me assure you: all partners of the OPEi fully agree with you.

As a global community, we have been engaged in this fight for 31 years now. Wild poliovirus cases now persist in only a handful of districts of just two countries – Pakistan and Afghanistan.

In January, I was joined by Dr Al Mandhari, Regional Director for the Eastern Mediterranean, and Dr Chris Elias, President of the Global Development Division at the Bill & Melinda Gates Foundation, as we visited both countries where we witnessed first-hand the tremendous efforts being undertaken to interrupt the remaining chains of wild polio transmission there. I have rarely been so impressed by public health efforts being undertaken as in these two areas, as both countries work hand-in-hand to tackle this joint epidemiological block, as both countries engage and mobilise all levels of public and civil society to support this effort.

As you rightly point out, eradication is an “all-or-nothing” approach. We either eradicate, or we do not. And the truth is, everything in place for success to be achieved. The Endgame Plan through 2013-2018 has brought us to the brink of being polio-free. And the Strategic Plan 2019-2023 aims to build on the lessons learned since 2013. Its aim is to increase performance everywhere, including using the proven tools of eradication and building blocks that have been established, while using opportunities to innovate using local knowledge and insights to overcome obstacles that in the past have seemed insurmountable. The key is to optimise all these approaches, and if the Plan is fully financed and implemented at all levels, a lasting polio-free world will be secured for all future generations to come.

That is why I commit to you today: we will rise to your call to action, and we will excel in our jobs, and this will lead to the success we all want to see. As you challenge us, we commit to making it our overriding objective to find and reach that last unvaccinated child before the poliovirus does. We will give the poliovirus nowhere to hide.

Your continued guidance, independent assessments and oversight will be critical to help us in securing this success. It is this guidance which has been instrumental in helping bring us to the threshold of a polio-free world, and it will be your continued guidance which will help us finally cross this threshold. Please continue with your assessments. Continue to critically evaluate what we are doing. Continue to issue your joint statements to draw attention to what needs to be done. We must have this oversight.

On behalf of our partners at Rotary International, the US Centers for Disease Control and Prevention (CDC), UNICEF, the Bill & Melinda Gates Foundation, and mostly on behalf of the children of the world, thank you!

Dr Tedros Ghebreyesus
Director-General, World Health Organization
Chair, Polio Oversight Board of the Global Polio Eradication Initiative

::::::

January 2019
Dear Polio Eradicator,

The global polio eradication effort is 31 years old.

The world is tantalizingly close to being free of polio. From 350,000 wild poliovirus cases every year in 1988, in 2018 the world reported just 29 cases of this devastating disabling disease because of extraordinary global efforts. Wild poliovirus transmission is endemic in only a handful of districts worldwide. The aim of the 2013-2018 Endgame Plan had been to be finished with this job by end 2018. This is not the case, and the Plan has to now be revised and extended through 2023.

This is an effort that cannot be sustained indefinitely: 31 years is long enough. It is resource intensive. It is intensive on the countries affected. It is intensive on donors. It is intensive on health services. It is intensive on communities. Most of all, it is intensive on those children and their families who bear the burden of this terrible disease, needlessly.

There is no reason why polio should persist anywhere in the world.

To succeed by 2023, all involved in this effort must find ways to excel in their roles. If this happens, success will follow.

This means stepping up the level of performance even further. It means using the proven tools of eradication and building blocks that have been established in parts of the world that have been free of polio for years. The vaccines, the cold chains, the networks of vaccinators, the surveillance capacity, the governance, policy, financing and oversight structures must be at peak levels of performance. There must be an unrelenting focus to tighten the management of the effort at all levels.

It also means looking for opportunities to innovate, using local knowledge and insights to overcome obstacles that in the past have seemed insurmountable. It means looking at new and different ways to reach children. It means really understanding the views of parents, and communities, who are unwilling to accept the vaccine and finding ways to address their concerns and come together with them. It means more effectively engaging with communities and better serving their needs than we have been doing thus far. Each person must dedicate themselves to one clear objective – to reach that very last child with polio vaccine.

Please commit to finding that very last child first, before the poliovirus does. Give the poliovirus nowhere to hide.

Whatever barrier to reaching that very last child, the programme has the expertise and experience to overcome it. Let everyone perfect what we know works. Let everyone free their mind to come up with new ideas and transformative solutions. We must all treat this as the public health emergency that it is.

As a global community, we have stood before where we stand today, with smallpox. The scourge of smallpox is gone, for which the world is a much better place. Let us make history again. It is time to finish the job of polio eradication now. The philosopher, poet and essayist Ralph Waldo Emerson said: “To leave the world a bit better, whether by a healthy child, a garden patch or a redeemed social condition, to know even one life has breathed easier because you have lived – this is to have succeeded.”

Eradicate polio, and make the world a better place for future generations.

Thank you.

Professor Alejandro Cravioto
   Chair of the Strategic Advisory Group of Experts on immunization (SAGE)

Sir Liam Donaldson
   Chair of the Independent Monitoring Board (IMB) of the Global Polio Eradication Initiative

Professor Helen Rees
   Chair of the Emergency Committee of the International Health Regulations (IHR) Regarding
      the International Spread of Poliovirus

Professor David Salisbury
   Chair of the Global Commission for the Certification of the Eradication of Poliomyelitis (GCC)

Featured Journal Content

Lancet Infectious Diseases
Apr 2019  Volume 19Number 4p339-448, e109-e147
http://www.thelancet.com/journals/laninf/issue/current

Editorial
Trust issues
The Lancet Infectious Diseases
In November, 2017, we published an Editorial on measles vaccination, calling for strong interventions to curb preventable diseases. 18 months later, how have things changed? As reported in a news story in this issue, 229,000 cases of measles were reported in 2018, and 98 countries reported an increase in cases compared with 2017. Measles is a global health crisis and it is getting worse. Although the reasons vary by country, mistrust and misplaced reluctance to vaccinate, largely related to unfounded fears over safety, are important contributing factors from the Philippines to France, from Ukraine to the USA. WHO has named vaccine hesitancy as one of the top ten threats to global health in 2019.

Lack of trust is also central to another of the world’s major health emergencies: the Ebola virus disease outbreak in DR Congo. The epidemic is focused in the northeast of the country, where conflict, political tensions, and social grievances have instilled fear and suspicion in much of the local population. 40% of new cases so far this year have been in people who died in the community (ie, they hadn’t been to a treatment centre), and a large proportion of cases, particularly in Katwa and Butembo, cannot be linked to any other patients, suggesting that unknown chains of transmission exist. If patients are wary of seeking proper care, and if contact tracing cannot be done, the outbreak will not be stopped.

Mistrust has also manifested with more direct and violent consequences in DR Congo. Médecins Sans Frontières (MSF) has reported dozens of attacks on its workers in the region. In February, two treatment centres were attacked and burned down, forcing MSF to suspend its activities in Katwa and Butembo. Joanne Liu, the president of MSF, has been quoted as describing the atmosphere towards the response as “toxic”.

The importance of community engagement to build trust was well recognised in the aftermath of the west Africa Ebola epidemic, but the difficulties of the DR Congo outbreak have led to the use of coercion against patients and their contacts, and a reliance on police and UN peacekeepers for security has further alienated the local population. MSF has criticised the use of coercion in DR Congo, and in an interview with STAT, Liu has said that “using police to force people into complying with health measures is not only unethical, it’s totally counterproductive“. WHO is taking a different tack: on March 9, it announced that it had sought further support from UN and local police forces to protect treatment centres, despite recognising the importance of “maintaining the neutrality of the response”.

As for trust in measles vaccination, a Danish study of more than 650,000 children once again confirms that measles, mumps, and rubella (MMR) vaccination is not associated with autism. But while the findings are welcome, the paper will not change the beliefs of anti-vaccination advocates. The safety of MMR was already well established before this study—a shortage of reliable scientific evidence is not the problem. And in countries such as the USA, the dangers of not vaccinating have been shown repeatedly, most recently in an outbreak of measles among mainly unvaccinated children in Washington and Oregon, as reported in our March issue. Rather, it is the abundance of misinformation and distrust of authority that must be addressed. Social media companies such as YouTube and Facebook have made changes to begin to stem the tide of misleading claims, but the impact of these initiatives remains to be seen.

An anti-vaxxer in California, USA, for example, is vastly different from someone potentially exposed to Ebola in rural DR Congo. Yet there are similarities in their mistrust. A belief that vaccines cause autism or that Ebola is a government ploy likely has as much to do with wider grievances and distrust of authority as with the specifics of the scientific evidence and education. Part of the problem is that a lack of faith in government, the health-care system, and pharmaceutical companies is not always irrational. In DR Congo, the postponement of elections in the regions affected by Ebola has been considered to be motivated more by politics than by public health (the region is a stronghold for opposition to the ruling party). The poverty and conflict in the region have long been neglected. In the USA, the country is plagued by prescription opioid misuse fuelled by aggressive pharmaceutical marketing, the people of Flint, MI, have been without safe drinking water for 3 years, and the most basic drugs are often unaffordable because of profit-driven health care. Little wonder that some individuals question the authorities’ desire to prioritise their wellbeing. It is impossible to build trust while at the same time abusing it.

Featured Journal Content

DRC – Ebola

WHO reaffirms commitment to Democratic Republic of the Congo as Ebola outbreak nears 1000 cases amid increased violence

WHO calls on international community to join urgent push to end outbreak
Statement
23 March 2019   Geneva/Brazzaville/Goma
As the Ebola outbreak in the Democratic Republic of the Congo (DRC) approaches 1000 cases amid increased violence, WHO reaffirmed its commitment both to ending the outbreak and working with the government and communities to build resilient health systems.

Since the outbreak was declared in August 2018 there have been 993 confirmed and probable cases and 621 deaths in North Kivu and Ituri provinces.

“We use words like ‘cases’ and ‘containment’ to be scientific, but behind every number is a person, a family and a community that is suffering,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “This outbreak has gone on far too long. We owe it to the people of North Kivu to work with them in solidarity not only to end this outbreak as soon as possible, but to build the health systems that address the many other health threats they face on a daily basis.”

More than 96,000 people have been vaccinated against Ebola in DRC, along with health workers in Uganda and South Sudan. As of 21 March, 38 of 130 affected health areas have active transmission. More than 44 million border screenings have helped to slow the spread of Ebola in this highly mobile population. No cases have spread beyond North Kivu and Ituri provinces, and no cases have crossed international borders.

However, the risk of national and regional spread remains very high, especially when episodes of violence and instability impact the response.

“As we mourn the lives lost, we must also recognize that thousands of people have been protected from this terrifying disease,” said Dr Matshidiso Moeti, WHO Regional Director for Africa. “We are working in exceptionally challenging circumstances, but thanks to support from donors and the efforts of the Ministry of Health, WHO and partners, we have saved thousands of lives.”

WHO has more than 700 people in DRC and is working hard with partners to listen to the affected communities and address their concerns and give them greater ownership of the response, particularly in the current outbreak hotspots of Katwa and Butembo.

“The communities affected by this outbreak are already traumatized by conflict,” said Dr Tedros. ”Their fear of violence is now compounded by fear of Ebola. Community engagement takes time. There are no quick fixes. But we are learning and adapting to the evolving context every day.”

Despite the challenges, most communities accept response interventions. More than 90% of those eligible for vaccination accept it and agree to post-vaccination follow-up visits. Independent analysis of vaccination data indicate that the vaccine is protecting at least 95% of those who receive it in a timely manner. More than 80% of people also accept safe and dignified burials, a key to preventing onward transmission.

“Despite the increased frequency of attacks by armed groups, WHO will stay the course and will work with communities to end this outbreak together with the Ministry of Health and partners,” said Dr Tedros. “We need redoubled support from the international community, and a commitment to push together to bring this outbreak to an end.”

For the next 6 months, the combined financial need for all response partners is at least US$148 million. As of 19 March, US$ 74 million had been received.

“We count on donors to help close the funding gap so we can end this outbreak as soon as possible,” said Dr Tedros. “We will still be in DRC long after this outbreak has finished, working with the government and communities on the road to universal health coverage. We are committed to improving the health of the people of DRC now and in years to come.”

:: 34: Situation report on the Ebola outbreak in North Kivu  26 March 2019

:: Ebola virus disease – Democratic Republic of the Congo   28 March 2019

Emergencies

 
POLIO
Public Health Emergency of International Concern (PHEIC)
Polio this week as of 20 March 2019
:: Dr Tedros Adhanom Ghebreyesus, WHO Director-General and Chair of the Polio Oversight Board, has issued a personal response to the extraordinary joint statement published in January by the Chairs of the main, independent, advisory and oversight committees of the GPEI.  The joint statement is an impassioned plea by the Chairs of the Strategic Advisory Group of Experts on immunization (SAGE), the Independent Monitoring Board, the Emergency Committee of the International Health Regulations (IHR) Regarding International Spread of Poliovirus and the Global Commission for the Certification of the Eradication of Poliomyelitis (GCC) – the Chairs urged everyone involved in the GPEI to ensure polio will finally be assigned to the history books by 2023. [see above]
:: On 27 March 2019, the WHO’s Southeast Asia Region marked five years since being declared wild polio-free, with the last case in the Region detected in India on 13 January 2011. The five-year anniversary of SEARO certification celebrated success in India and across countries of the region, showcasing how countries have used the skills, knowledge and infrastructure built up by the polio programme after eradication and highlight lessons learned from the Region that are now being applied in other parts of the world.

 Summary of new viruses this week:
:: Pakistan – two wild poliovirus type 1 (WPV-1) cases and 15 WPV1-positive environmental samples;
:: Nigeria— two circulating vaccine-derived poliovirus type 2 (cVDPV2) cases, one cVDPV2-positive environmental.

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::::::

 Editor’s Note:
WHO has posted a refreshed emergencies page which presents an updated listing of Grade 3,2,1 emergencies as below.

WHO Grade 3 Emergencies  [to 30 Mar 2019]
Democratic Republic of the Congo
:: 34: Situation report on the Ebola outbreak in North Kivu  26 March 2019
:: Ebola virus disease – Democratic Republic of the Congo   28 March 2019

Syrian Arab Republic
:: Health situation – Al-Hol camp  16 March 2019

South Sudan
::  Kawthar defeats tuberculosis: improving access to diagnosis and treatment in rural areas in Syria  27 March 2019

Myanmar
:: WHO appeals for international community support; warns of grave health risks to Rohingya refugees in rainy season
Dhaka, 29 March 2018 – With a grossly underfunded health sector grappling to meet the needs of 1.3 million Rohingyas in Bangladesh’s Cox’s Bazar, the World Health Organization has appealed to the international community to contribute generously to enable appropriate and timely health services to this highly vulnerable population, now facing grave risks to their lives and health in view of the coming rainy season…

Yemen
:: Two years since world’s largest outbreak of acute watery diarrhoea and cholera, Yemen witnessing another sharp increase in reported cases with number of deaths continuing to increase
Muscat/Amman/Cairo, 26 March 2019 – “In Yemen, since the beginning of the year until 17 March, nearly 109 000 cases of severe acute watery diarrhoea and suspected cholera were reported with 190 total associated deaths since January. Nearly one third of the reported cases are children under the age of 5. This comes 2 years since Yemen witnessed the world’s largest outbreak when more than 1 million cases were reported.
“We fear that the number of suspected cholera cases will continue to increase with the early arrival of the rainy season and as basic services, including lifesaving water systems and networks, have collapsed. The situation is exacerbated by the poor status of sewage disposal systems, the use of contaminated water for agriculture, unreliable electricity to store food and    the displacement of families as they flee escalating violence, especially in Hudaydah and Tai’z.
“Our teams in Yemen are working day and night with a wide network of local partners to respond and stop the further spread and transmission of disease. Focusing on 147 priority districts, additional health, water, hygiene and sanitation supplies are being mobilized. Rapid response teams have been deployed. A total of 413 diarrhoea treatment centres and oral rehydration centres are operational in all 147 priority districts. Partners are repairing water and sanitation systems. In the past weeks, we scaled up chlorination activities to disinfect water in 95 priority districts and provided fuel and spare parts to keep going water supply and sanitation networks. A round of oral cholera vaccine campaign reached over 400 000 people in several districts. Meanwhile, community-based awareness-raising efforts reached 600 000 people in house-to-house campaigns since early 2019 to provide families with information on hygiene practices and improve the reporting of symptoms and seeking of treatment…

Bangladesh – Rohingya crisis – No new digest announcements identified  
Nigeria – No new digest announcements identified  
Somalia – No new digest announcements identified

::::::

 WHO Grade 2 Emergencies  [to 30 Mar 2019]
occupied Palestinian territory 
:: WHO strongly condemns killing of health worker in the West Bank, March 2019
The World Health Organization (WHO) strongly condemns the killing of Sajed Mazher, a first responder working with the Palestinian Medical Relief Society in the West Bank, occupied Palestinian territory…

Brazil (in Portugese) – No new digest announcements identified
Cameroon  – No new digest announcements identified
Central African Republic  – No new digest announcements identified
Ethiopia – No new digest announcements identified
Hurricane Irma and Maria in the Caribbean – No new digest announcements identified
Iraq – No new digest announcements identified  
Libya – No new digest announcements identified
MERS-CoV – No new digest announcements identified
Niger – No new digest announcements identified
Sao Tome and Principe Necrotizing Cellulitis (2017) – No new digest announcements identified
Sudan – No new digest announcements identified
Ukraine – No new digest announcements identified
Zimbabwe – No new digest announcements identified

::::::

WHO Grade 1 Emergencies  [to 30 Mar 2019]
Afghanistan
Chad
Indonesia – Sulawesi earthquake 2018
Kenya
Lao People’s Democratic Republic
Mali
Namibia – viral hepatitis
Peru
Philippines – Tyhpoon Mangkhut
Tanzania

::::::

WHO AFRO – Outbreaks and Emergencies Bulletin – Week 12/2019
Week 12: 18- 24 March 2019
The WHO Health Emergencies Programme is currently monitoring 65 events in the region. This week’s edition covers key new and ongoing events, including:
:: Cyclone in Mozambique and Zimbabwe
:: Ebola virus disease in Democratic Republic of the Congo
:: Humanitarian crisis in Mali
:: Humanitarian crisis in Central African Republic 

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::::::

UN OCHA – L3 Emergencies
The UN and its humanitarian partners are currently responding to three ‘L3’ emergencies. This is the global humanitarian system’s classification for the response to the most severe, large-scale humanitarian crises. 
Yemen
:: Yemen Humanitarian Update Covering 7 – 21 March 2019 | Issue …

Syrian Arab Republic   – No new digest announcements identified

::::::

UN OCHA – Corporate Emergencies
When the USG/ERC declares a Corporate Emergency Response, all OCHA offices, branches and sections provide their full support to response activities both at HQ and in the field.
Ethiopia 
:: Ethiopia Humanitarian Bulletin Issue #5 | 4-17 March 2019

Somalia  – No new digest announcements identified

WHO & Regional Offices [to 30 Mar 2019]

27 March 2019 | News Release
Diseases cost African region $2.4 trillion per year
WHO launches an investment case to achieve SDGs and universal health coverage in Africa 
Praia, Cabo Verde, 27 March 2019 – The World Health Organization (WHO) estimates that nearly 630 million years of healthy life were lost in 2015 due to the diseases afflicting the population across its 47 Member States in Africa, now amounting to a loss of more than 2.4 trillion international dollars ($) from the region’s gross domestic product value annually.
Noncommunicable diseases have overtaken infectious diseases as the largest drain on productivity, accounting for 37 per cent of the disease burden. Other culprits for lost healthy years are communicable and parasitic diseases; maternal, neonatal and nutrition-related conditions; and injuries.
Around 47%, or $ 796 billion, of this lost productivity value could be avoided in 2030 if the Sustainable Development Goals related to these health conditions are achieved, WHO found.
“Four years into the implementation of countries’ efforts towards achieving UHC, current average expenditure on health in the Region falls short of this expectation,” the WHO Regional Director for Africa, Dr Matshidiso Moeti, writes in the foreword to A Heavy Burden: The Productivity Cost of Illness in Africa, which was launched during the second WHO Africa Health Forum this week in Cabo Verde.
As a target of Sustainable Development Goal 3, universal health coverage would require countries in the WHO African Region to spend, on average, at least $ 271 per capita per year on health, or 7.5% of the region’s gross domestic product…

26 March 2019 | News Release
Yemen witnessing sharp increase in reported cases of acute watery diarrhoea and cholera

22 March 2019   Statement
WHO reaffirms commitment to Democratic Republic of the Congo as Ebola outbreak nears 1000 cases amid increased violence

WHO calls on international community to join urgent push to end outbreak

[See Ebola above for detail]

::::::

 
Weekly Epidemiological Record, 29 March 2019, vol. 94, 13 (pp. 161–168)
:: Retrospective detection of Zika virus transmission in Paraguay – January to December 2016
:: Addendum to the Recommended composition of influenza virus vaccines for use in the 2019–2020 northern hemisphere influenza season

WHO Regional Offices
Selected Press Releases, Announcements

WHO African Region AFRO
:: In Madagascar, mothers show grit to protect their children as government, partners battle measles epidemic  29 March 2019
:: Diseases cost the African Region $2.4 trillion a year, says WHO  27 March 2019
:: WHO Mobilizes Urban-based Congolese Refugees in Uganda for Ebola action  26 March 2019
:: WHO reaffirms commitment to Democratic Republic of the Congo as Ebola outbreak nears 1000 cases amid increased violence  24 March 2019
 
 
WHO Region of the Americas PAHO
– No new digest announcements identified.
 
 
WHO South-East Asia Region SEARO
:: Marking five years of polio-free certification, WHO South-East Asia Region uses polio legacy to enhance overall immunization   SEAR/PR/1708
New Delhi, 27 March 2019: On this day in 2014, WHO South-East Asia Region was certified polio-free, proving wrong many public health experts who believed that the Region, which accounts for one-fourth of the global population, would be the last bastion for polio eradication. Five years on, the Region not only continues to maintain its polio-free status but is demonstrating how the polio legacy can effectively strengthen overall immunization and other programs…
 
 
WHO European Region EURO
:: Improving TB patient care in the Russian Federation with video-observed treatment 28-03-2019
 
 
WHO Eastern Mediterranean Region EMRO
:: WHO strongly condemns killing of health worker in the West Bank  27 March 2019
:: Yemen witnessing sharp increase in reported cases of acute watery diarrhoea and cholera
27 March 2019
:: Improving health outcomes for people with TB in Syria  27 March 2019
:: Polio immunization campaign in Somalia aims to leave no child under 5 behind  26 March 2019
:: WHO to release Arabic version of package on health system response to violence against women and girls
27 March 2019 ‒ As part of its effort to address violence against women and girls, the WHO Regional Office for the Eastern Mediterranean is launching an Arabic version of the WHO package on health system response to violence against women and girls. In releasing this evidence-based guidance, WHO seeks to ensure that preventing and responding to violence against women and…

WHO Western Pacific Region
:: Immunization gaps threaten gains on measles
29 March 2019   News Release  Manila, Philippines
Measles outbreaks in the World Health Organization (WHO) Western Pacific Region are putting babies, children and young people at risk and threatening progress towards wiping out the disease.
The Region had historically low levels of measles cases and no major outbreaks in 2017. This landmark decline was achieved through steady efforts to vaccinate all children against measles, but last year, measles cases in the Region increased by 250%, and more than two-thirds of cases were in the Philippines. So far this year, the Philippines has reported 23 000 cases with 333 deaths — already more than all of last year. Tragically, most of the cases were among children under 5 years old.
Measles can cause debilitating complications, including encephalitis, severe diarrhoea and dehydration, pneumonia, ear infections and permanent vision loss.
“In recent months, we’ve seen how swiftly and easily measles can make a comeback in communities where not enough children have been immunized,” said WHO Regional Director for the Western Pacific Takeshi Kasai…
 

CDC/ACIP [to 30 Mar 2019]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html

Latest News
CDC: Artesunate Now First-Line Treatment for Severe Malaria in the United States
Thursday, March 28, 2019
Only FDA-approved antimalarial drug, quinidine, has been discontinued

Ebola outbreak in eastern Democratic Republic of Congo tops 1,000 cases
Monday, March 25, 2019
CDC remains committed to bringing outbreak to an end
As of March 24, 2019, public health officials have documented that the Ebola outbreak in eastern Democratic Republic of Congo (DRC) has surpassed 1,000 cases; the current total number of confirmed and probable cases is 1009, including 625 deaths and 318 survivors. The outbreak is the largest in DRC’s history and the second largest outbreak recorded of Ebola ever (after the 2014-2016 outbreak in West Africa).
“This is a disappointing milestone. This remains a highly complex Ebola outbreak with active transmission in 13 of the 21 affected health zones,” said CDC Director Robert R. Redfield, M.D. “Despite this, CDC will continue to work 24/7 with our partners in DRC, in DRC’s neighboring countries, and around the world to prevent the spread of Ebola and bring this outbreak to an end.”…

MMWR News Synopsis for Friday, March 29, 2019
Enterovirus D68-Associated Acute Respiratory Illness — United States, July–October, 2017 and 2018
CDC recently established surveillance of children seen in emergency departments or hospitalized for acute respiratory illness at seven U.S. medical centers. Substantially more children tested positive for Enterovirus D68 (EV-D68) in the 2018 season compared with 2017.
EV-D68 is one of many known enteroviruses. It can cause mild to severe respiratory illness or no symptoms at all. EV-D68 infections typically peak during late summer and early fall in the United States. National reporting of EV-D68 is voluntary. To better understand annual trends of EV-D68 illness, seven U.S. medical centers, participating in CDC’s New Vaccine Surveillance Network (NVSN), are conducting surveillance among children either seen in emergency departments or hospitalized for acute respiratory illness (ARI). From July 1 – October 31, 2018, EV-D68 infections were detected in 358 children with ARI, compared with two during the same period in 2017. Continued active surveillance of EV-D68-associated ARI is key to understanding the circulation and seasonality of EV-D68.

Africa CDC   [to 30 Mar 2019]
https://au.int/en/africacdc
March 29, 2018
First Progress Report of the Chairperson of the Commission on the Africa Center for Disease Control
11 pages – PDF: https://au.int/sites/default/files/documents/34074-doc-auc.report.africa.cdc_.prc_.29.03.pdf
[Excerpt]
… 22. At this time, Africa CDC’s fulfilment of its mandate is hampered by small numbers of permanent staff supporting administrative functions at the secretariat. The majority of Africa CDC support currently comes from seconded or contracted staff. Efforts are underway to address these challenges.

23. Africa CDC has succeeded in developing bilateral partnerships with several nations outside the African continent. Within AU Member States, only the Republic of Kenya has provided a voluntary contribution of USD 1 million to support the Africa CDC. Sustainable support among Member States is critical for sustainable growth and expansion of Africa CDC.

24. Africa CDC is pursuing a mechanism for sustainable financing through businesses, the private sector, and African philanthropy. The Africa CDC private sector and philanthropy engagement strategy has been developed and presented to the Africa CDC Governing Board. This strategy has been aligned and coordinated with plans for Africa CDC Foundation. A priority
focus has been on identifying African companies dealing in telecommunications and other sectors. Finally, Africa CDC is engaging African philanthropists who have given historical support to the African health agenda.

V. OBSERVATIONS
25. Africa CDC has recorded notable achievements to mark its first year of existence. It is successfully fulfilling the mandate it received from the Assembly, even while it continually expands and develops new avenues for strengthening public health capacity on the African continent.

26. Member States have demonstrated their continued support and enthusiasm for Africa CDC by robust participation to produce various framework documents that will guide their public health activities at the national level. These framework documents include a strategy to introduce event-based surveillance at the continental, regional, and national levels; a framework to establish a national public health institute in every Member State; a framework
to address the threat of antimicrobial resistance.

27. In its inaugural year, Africa CDC responded to ten public health events in Member States with a limited technical staff (only ten epidemiologists are currently seconded to Africa CDC). These same epidemiologists also provide day-to-day administrative and management support to operations at the Africa CDC secretariat.

28. While three of the Africa CDC RCC have had successful political launches, they require substantial human resource support to ensure that the technical aspects of Africa CDC’s strategic plan is successfully implemented at the regional level. Without each RCC, Africa CDC has limited ability to encourage public health coordination among Member States. It is crucial to ensure that the West Africa and North Africa are launched in 2018. I look forward to nominating a North African technical public health institution motivated and equipped to provide support to the entire region, cognizant of the diverse array of needs represented in North Africa.

29. I encourage Member States to participate actively in the public health platform established by the Regional Collaborating Centres. Laboratory networks, coordination during public health events, and information exchange are critical elements of the RCC mandate.
End

China CDC 
http://www.chinacdc.cn/en/

New website launched…no “news” or “announcements” page identified. Link to National Health Commission of the People’s Republic of China not responding at inquiry [30 Mar 2019]

Announcements

Paul G. Allen Frontiers Group    [to 30 Mar 2019]
https://www.alleninstitute.org/news-press/
No new digest content identified.
 
 
BMGF – Gates Foundation  [to 30 Mar 2019]
http://www.gatesfoundation.org/Media-Center/Press-Releases
No new digest content identified.
 
 
Bill & Melinda Gates Medical Research Institute    [to 30 Mar 2019]
https://www.gatesmri.org/
The Bill & Melinda Gates Medical Research Institute is a non-profit biotech organization. Our mission is to develop products to fight malaria, tuberculosis, and diarrheal diseases—three major causes of mortality, poverty, and inequality in developing countries. The world has unprecedented scientific tools at its disposal; now is the time to use them to save the lives of the world’s poorest people
No new digest content identified.
 
 
CARB-X   [to 30 Mar 2019]
https://carb-x.org/
CARB-X is a non-profit public-private partnership dedicated to accelerating antibacterial research to tackle the global rising threat of drug-resistant bacteria.
No new digest content identified.
 
 
CEPI – Coalition for Epidemic Preparedness Innovations  [to 30 Mar 2019]
http://cepi.net/
29 Mar 2019
The woman who helped to stop an Ebola epidemic in Nigeria
By Niniola Soleye
In 2014-2016, West Africa experienced the largest Ebola outbreak to date. Thanks to the heroic work of Dr Ameyo Stella Adadevoh and others, Nigeria steered clear of what could have been a very deadly outbreak of the disease. Tragically Dr Adadevoh lost her life to Ebola, but her legacy lives on today through the Dr Ameyo Stella Adadevoh Health Trust…

29 Mar 2019 – Comment
You can’t beat epidemics without equitable access to vaccines
By Richard Hatchett, CEPI CEO
We’re developing vaccines against emerging infectious diseases. Getting them to the people who need them, when they need them, regardless of ability to pay, is not just important for access, it’s the only way to beat epidemic… CEPI is 100% committed to equitable access. This commitment drives every aspect of our work and is key to our success as a global health organisation…
 
 
EDCTP [to 30 Mar 2019]
http://www.edctp.org/
The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials
Latest news
No new digest content identified.
 
 
Emory Vaccine Center [to 30 Mar 2019]
http://www.vaccines.emory.edu/
No new digest content identified.
 
 
European Medicines Agency  [to 30 Mar 2019]
http://www.ema.europa.eu/ema/
News and press releases
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 March 2019
CHMP, 29/03/2019
 
 
European Vaccine Initiative  [to 30 Mar 2019]
http://www.euvaccine.eu/news-events
Latest news
GHIT supports further development of a new asexual blood-stage malaria vaccine candidate
29 March 2019
Goal of new project is to further advance the development of a new vaccine candidate based on the PfRipr5 protein of…
 
 
FDA [to 30 Mar 2019]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
March 29, 2019 –
Statement by FDA Commissioner Scott Gottlieb, M.D., Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D. and Director of FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D. on Expanded Access –Looking Forward
…But sometimes, even in circumstances where the availability of a medicine through EA would appropriately balance these considerations, such access is not available. This is often true when it comes to the ability of patients to continue to use a promising medicine after the completion of a clinical trial.
We are writing to encourage sponsors to offer EA in such circumstances, when continued access to a promising medicine at the completion of a clinical trial would be appropriate under the EA programs.
Although we often focus on EA as providing access to patients who cannot enter clinical trials, EA can also be considered as a mechanism for those who have participated in a trial in order to allow them to continue receiving a drug that may have provided benefit. At the end of a trial, sponsors may continue to provide treatment to participating patients through an extension study to gather additional rigorous information that’s needed to support the subsequent marketing application. Alternatively, if the purpose is primarily to provide the drug to patients who continue to need it, an EA program may be used for either moderately sized populations (intermediate EA) or large size populations (treatment EA), often when most studies in support of approval have been completed. As another option, a sponsor could authorize a patient’s own physician to obtain a single patient EA investigational new drug (IND) application…
 
 

Fondation Merieux [to 30 Mar 2019]
http://www.fondation-merieux.org/
No new digest content identified.

 
Gavi [to 30 Mar 2019]
https://www.gavi.org/
Latest News
27 March 2019
Leadership training for supply chain managers expands to five African countries
Over 22 private sector partners will support the innovative training and mentorship programme.
Nairobi/Accra,– The Strategic Training Executive Programme (STEP) for supply chain managers is expanding to five African countries, including Kenya, Ghana, Mozambique, Madagascar and the Democratic Republic of the Congo (DRC), thanks to financial and in-kind support from the International Federation of Pharmaceutical Wholesalers (IFPW). The expansion of STEP is the result of significant country demand for stronger capacity in supply chain management. By the end of 2020, Gavi and IFPW expect more than 600 immunisation supply chain leaders to graduate from STEP programmes across Africa and Asia.
“STEP has become an essential component of Gavi’s support to strengthen supply chain management in low-income countries,” said Gavi Deputy CEO Anuradha Gupta. “With country demand increasing, what began as an effort to foster regional supply chain expertise in East Africa has extended well beyond this goal. Our continued partnership with IFPW allows even more Gavi-supported countries to benefit from improved management of health supply chains,” she added…
 
 
GHIT Fund   [to 30 Mar 2019]
https://www.ghitfund.org/newsroom/press
GHIT was set up in 2012 with the aim of developing new tools to tackle infectious diseases that devastate the world’s poorest people. Other funders include six Japanese pharmaceutical

March 28, 2019
GHIT Fund Announces Appointment of Catherine Ohura as New CEO and Executive Director
The Global Health Innovative Technology Fund (GHIT) today announced the appointment of Catherine Ohura as the organization’s new CEO and Executive Director. Ohura brings depth and breadth of expertise and invaluable experience working for R&D and Commercial functions. In the R&D function, Ohura worked in clinical operations, regulatory affairs, quality assurance, project management, finance/resource management, portfolio management, and governance creation/management…

March 28, 2019
GHIT Fund Announces New Investments: A Total of 2.86 Billion Yen in Drug for Schistosomiasis, Dengue, Malaria and Tuberculosis, Vaccines for Leishmaniasis and Malaria, and Diagnostics for Tuberculosis
The Global Health Innovative Technology (GHIT) Fund announced today a total of 2.86 billion yen (US$25.8 million*) to support 10 partnerships to develop new lifesaving drugs, vaccines, and diagnostics for malaria, tuberculosis, dengue, leishmaniasis, and schistosomiasis. This includes three new projects and seven that will receive continued funding. (Appendix 1)
“We are thrilled to see our portfolio continue to advance and accelerate, to expand and evolve. This marks now a total of 17 billion yen (US$153 million*) invested in over 80 global product development partnerships aimed to leverage Japanese science and pharmaceutical capabilities through global partnership. Side by side with our partners, GHIT continues to drive ahead looking to deliver lifesaving tools to save millions of lives.” said, said BT Slingsby, the CEO of GHIT.
Currently, there are 50 ongoing projects including 27 discovery, 15 preclinical, and eight clinical trials in the GHIT portfolio…

Global Fund [to 30 Mar 2019]
https://www.theglobalfund.org/en/news/
News
No new digest content identified.

Hilleman Laboratories [to 30 Mar 2019]
http://www.hillemanlabs.org/
No new digest content identified.

Human Vaccines Project [to 30 Mar 2019]
http://www.humanvaccinesproject.org/media/press-releases/
No new digest content identified.

IAVI  [to 30 Mar 2019]
https://www.iavi.org/newsroom
March 27, 2019
IAVI Announces First-in-Human Clinical Trial of Native-like HIV Envelope Vaccine Candidate
NEW YORK — MARCH 27, 2019 — The International AIDS Vaccine Initiative (IAVI) announced the start of a Phase I clinical trial (IAVI W001) to test a novel HIV vaccine candidate, BG505 SOSIP.664 gp140. The aim of the trial is to assess the safety of the candidate and to determine if vaccination induces the human immune system to produce proteins known as neutralizing antibodies (NAbs).
Mark Feinberg, M.D., Ph.D., president and CEO of IAVI, said, “This trial is unique because it represents the fruition of decades of scientific research to engineer this promising vaccine candidate. Much important work was done in the late 1990s and early 2000s to attempt to stabilize the HIV envelope protein in its native configuration, but this difficult work took several more years to achieve.”
BG505 SOSIP.664 gp140 is based on the HIV envelope protein (Env), which is shaped like a three-pronged spike. This configuration, known as a trimer, is a target for antibodies produced by the human immune system after infection. Some of these antibodies are able to block viral entry into cells.
The BG505 SOSIP.664 gp140 trimer was engineered by a team directed by John P. Moore, Ph.D., at the Weill Cornell Medical College, Rogier Sanders, Ph.D., now at the University of Amsterdam Academic Medical Center, and Andrew B. Ward, Ph.D., and Ian A. Wilson, D.Phil., at Scripps Research. The outcome of their work was an important advance in stabilizing the highly fragile Env protein in a native-like configuration.
This is one of the first clinical trials of a native-like Env trimer, and the first time that this particular trimer is being evaluated in humans…

IFFIm
http://www.iffim.org/library/news/press-releases/
No new digest content identified.

IFRC   [to 30 Mar 2019]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
Americas, Venezuela
IFRC to bring humanitarian aid into Venezuela
The President of the International Federation of Red Cross and Red Crescent Societies (IFRC) has announced that IFRC will have unhindered access to bring humanitarian aid into Venezuela to support a major scale up of medical care and other assistance by the Venezuela Red Cross.
29 March 2019

Afghanistan, Asia Pacific
Afghanistan: Ten million Afghans face severe hardship after extreme weather
Ten million people in Afghanistan – more than a quarter of its population – face severe acute food insecurity and need urgent help after floods and drought, say the Afghan Red Crescent Society and the International Federation of Red Cross and Red Crescent Societies (IFRC).
28 March 2019

Africa, Mozambique
Mozambique: Red Cross races to stop new disaster following confirmation of first cholera cases
News that the first cases of deadly cholera have been confirmed in Mozambique has accelerated Red Cross and Red Crescent disease prevention activities in the vulnerable communities that have been devastated by Cyclone Idai. Jamie LeSueur, head of operations with the International Federation of Red Cross and Red Crescent Societies (IFRC) in Beira, said: “We will all have to move extremely fast to stop these isolated cases from becoming another major disaster within the ongoing crisis of Cyclone Idai.
27 March 2019

Mozambique
Mozambique: “Speed, quality and scale of response critical to preventing disease outbreaks,” says IFRC Secretary General
Geneva/Nairobi/Beira, 25 March 2019 – The Red Cross and Red Crescent network is speeding up efforts to prevent disease outbreaks in the aftermath of Cyclone Idai, with the arrival today of an Emergency Response Unit that will provide sanitation for 20,000 people every day. Two emergency field hospitals will follow. “After a disaster of this magnitude, the speed, quality, and scale of our response is critical to to stop the risk of waterborne disease outbreaks like cholera,” said the Secretary General of the International Federation of Red Cross and Red Crescent Societies (IFRC), Elhadj As Sy, at a media briefing at the United Nations in Geneva today. “As flood waters recede, hundreds of thousands of people still lack water, shelter and health care. We now see even more clearly the real consequences of this disaster.”
25 March 2019

Asia Pacific, Indonesia
Indonesia: Six months after Sulawesi triple disaster, survivors face slow and complex recovery
Palu/Kuala Lumpur, 25 March 2019 – Six months after Sulawesi was hit by a powerful and shallow earthquake, tsunami and liquefaction, survivors face a painfully slow and complex recovery. On 28 September 2018, a series of strong earthquakes struck Centr …
25 March 2019
 
 
IVAC [to 30 Mar 2019]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
No new digest content identified.

IVI [to 30 Mar 2019]
http://www.ivi.int/
IVI News & Announcements
No new digest content identified.

JEE Alliance [to 30 Mar 2019]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

 
MSF/Médecins Sans Frontières  [to 30 Mar 2019]
http://www.msf.org/
Selected News; Project Updates, Reports [as presented on website]
Cyclone Idai & Southern Africa flooding
The first six days after Cyclone Idai in Zimbabwe
Voices from the Field 29 Mar 2019

Cyclone Idai & Southern Africa flooding
Malawi: “This time, the flooding has destroyed houses, not lives”
Voices from the Field 29 Mar 2019

Cyclone Idai & Southern Africa flooding
MSF emergency response to Cyclone Idai and flooding
Crisis Update 29 Mar 2019

Palestine
March of Return protestors abandoned after year of suffering
Project Update 28 Mar 2019

Cyclone Idai & Southern Africa flooding
Mozambique declares cholera cases in Beira in wake of Cyclone Idai
Project Update 28 Mar 2019

Cyclone Idai & Southern Africa flooding
Mozambique flooding and response: both enormous in scale
Project Update 27 Mar 2019

Venezuela
MSF’s work across Venezuela
Interview 27 Mar 2019

Yemen
MSF treats exponential increase in cholera cases since start of 2…
Press Release 27 Mar 2019

Central American Migration
People fleeing put at risk through dangerous government migrati…
Voices from the Field 26 Mar 2019

Iraq
The aftermath of the conflict in Hawija: “My only hope is to get b…
Project Update 26 Mar 2019

DRC 2018 Ebola outbreaks
Crisis update – March 2019
Crisis Update 25 Mar 2019
 
 
NIH  [to 30 Mar 2019]
http://www.nih.gov/news-events/news-releases
March 28, 2019
Harnessing T-cell “stemness” could enhance cancer immunotherapy
— Study sheds light on one way tumors may continue to grow despite the presence of cancer-killing immune cells.
 
 
PATH [to 30 Mar 2019]
https://www.path.org/media-center/
No new digest content identified.
 
 
Sabin Vaccine Institute [to 30 Mar 2019]
http://www.sabin.org/updates/pressreleases
No new digest content identified.
 
 
UNAIDS [to 30 Mar 2019]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements

27 March 2019
Liberia’s catch-up plan takes shape

27 March 2019
UN and AU working together for sustainable development

26 March 2019
Modelling the next set of HIV data

25 March 2019
Only half of HIV-exposed babies are tested for HIV
 
 
UNICEF  [to 30 Mar 2019]
https://www.unicef.org/media/press-releases
Selected Press Releases/Reports/Statements

Press release
Participation in sport can improve children’s learning and skills development, new Barça Foundation and UNICEF report finds
The report launches today at an international consultation on sport for development for children at the FC Barcelona Auditorium
28/03/2019

Press release
Cyclone Idai: More than 1.5 million children urgently need assistance across Mozambique, Malawi and Zimbabwe – UNICEF
UN children’s agency launches US$122 million humanitarian appeal amidst worst disaster to hit southern Africa in decades
27/03/2019

Statement
Two years since world’s largest outbreak of Acute Watery Diarrhea and Cholera, Yemen witnessing another sharp increase in reported cases with number of deaths continuing to increase
Statement by Geert Cappelaere, UNICEF Regional Director in the Middle East and North Africa and Dr Ahmed Al Mandhari, WHO Regional Director for the Eastern Mediterranean
26/03/2019

Press release
Participation in sport can improve children’s learning and skills development, new Barça Foundation and UNICEF report finds26/03/2019

Press release
Participation in sport can improve children’s learning and skills development, new Barça Foundation and UNICEF report finds26/03/2019

Press release
Participation in sport can improve children’s learning and skills development, new Barça Foundation and UNICEF report finds26/03/2019

Statement
Statement by UNICEF Executive Director Henrietta Fore on village attack in Mali
24/03/2019

Press release
Participation in sport can improve children’s learning and skills development, new Barça Foundation and UNICEF report findsUNICEF Executive Director Henrietta Fore wraps up visit to affected area of Beira one week after Cyclone hit
23/03/2019
 
 
Vaccine Confidence Project  [to 30 Mar 2019]
http://www.vaccineconfidence.org/
No new digest content identified.
 
Vaccine Education Center – Children’s Hospital of Philadelphia  [to 30 Mar 2019]
http://www.chop.edu/centers-programs/vaccine-education-center
March 2019
Newsletter
Announcements: Webinar update and reminder, autism Q&A revised, vaccine safety issues 
 
 
Wellcome Trust  [to 30 Mar 2019]
https://wellcome.ac.uk/news
Opinion | 29 March 2019
We want to champion new conversations with the public about health
by Lucy McDowell
Wellcome wants to promote new practices in public dialogue to involve a broader, more diverse range of people in discussions about health challenges and how we face them

The Wistar Institute [to 30 Mar 2019]
https://www.wistar.org/news/press-releases
No new digest content identified.

World Organisation for Animal Health (OIE) [to 30 Mar 2019]
http://www.oie.int/en/for-the-media/press-releases/2019/
No new digest content identified.

::::::

BIO [to 30 Mar 2019]
https://www.bio.org/insights/press-release
No new digest content identified.

DCVMN – Developing Country Vaccine Manufacturers Network [to 30 Mar 2019]
http://www.dcvmn.org/
No new digest content identified.

IFPMA [to 30 Mar 2019]
http://www.ifpma.org/resources/news-releases/
No new digest content identified.

PhRMA [to 30 Mar 2019]
http://www.phrma.org/press-room
No new digest content identified.

Journal Watch

   Vaccines and Global Health: The Week in Review continues its weekly scanning of key peer-reviewed journals to identify and cite articles, commentary and editorials, books reviews and other content supporting our focus on vaccine ethics and policy. Journal Watch is not intended to be exhaustive, but indicative of themes and issues the Center is actively tracking. We selectively provide full text of some editorial and comment articles that are specifically relevant to our work. Successful access to some of the links provided may require subscription or other access arrangement unique to the publisher.

If you would like to suggest other journal titles to include in this service, please contact David Curry at: david.r.curry@centerforvaccineethicsandpolicy.org

American Journal of Infection Control
April 2019 Volume 47, Issue 4, p351-478
http://www.ajicjournal.org/current

Major Articles
Infection control influence of Middle East respiratory syndrome coronavirus: A hospital-based analysis
Jaffar A. Al-Tawfiq, Rana Abdrabalnabi, Alla Taher, Shantymole Mathew, Kamal Abdul Rahman
p431–434
Published online: November 27, 2018

American Journal of Infection Control
April 2019 Volume 47, Issue 4, p351-478
http://www.ajicjournal.org/current

Brief Reports
Understanding influenza vaccination rates and reasons for refusal in caregivers and household contacts of cancer patients
Stephanie A. Price, Sara Podczervinski, Kim MacLeod, Lois Helbert, Steven A. Pergam
p468–470
Published online: December 4, 2018

American Journal of Preventive Medicine
April 2019 Volume 56, Issue 4, p477-630
http://www.ajpmonline.org/current

Research Articles
Influenza Vaccination Coverage Among Pregnant Women in the U.S., 2012–2015
Helen Ding, Katherine E. Kahn, Carla L. Black, Alissa O’Halloran, Peng-Jun Lu, Walter W. Williams
p477–486
Published online: February 16, 2019

American Journal of Preventive Medicine
April 2019 Volume 56, Issue 4, p477-630
http://www.ajpmonline.org/current

Compressed Influenza Vaccination in U.S. Older Adults: A Decision Analysis
Kenneth J. Smith, Glenson France, Mary Patricia Nowalk, Jonathan M. Raviotta, Jay DePasse, Angela Wateska, Eunha Shim, Richard K. Zimmerman
e135–e141
Published online: February 14, 2019

American Journal of Preventive Medicine
April 2019 Volume 56, Issue 4, p477-630
http://www.ajpmonline.org/current

Review Articles
Human Papillomavirus Vaccine Interventions in the U.S.: A Systematic Review and Meta-analysis
Ana M. Rodriguez, Thuy Quynh N. Do, Michael Goodman, Kathleen M. Schmeler, Sapna Kaul, Yong-Fang Kuo
p591–602
Published online: February 15, 2019
Abstract
Context
Despite current recommendations, human papillomavirus vaccine uptake remains low. A systematic review and meta-analysis assessed the effectiveness of interventions targeting human papillomavirus vaccine initiation and completion among children, adolescents, and young adults aged 9–26 years.
Evidence acquisition
Three electronic databases (CINAHL, OVID, and Web of Science) were searched for articles published in English peer-reviewed journals between January 2006 and January 2017 of U.S. studies that evaluated intervention strategies and reported post-intervention human papillomavirus vaccine initiation or completion rates among individuals aged 9–26 years. Study characteristics and outcomes were extracted. Data were collected in 2016 and analyzed in 2017.
Evidence synthesis
Reviewers screened 983 unique titles and abstracts, read 241 full-text articles, and extracted data from 30 articles meeting the inclusion criteria (12 behavioral, ten environmental, four informational, and four combination strategies). Published EQUATOR (Enhancing the Quality and Transparency of Health Research) guidelines were used to assess study quality. Random effects meta-analyses were conducted. The meta-analyses included 17 RCTs and quasi-experiments involving 68,623 children, adolescents, and young adults. The pooled relative incidence estimates were 1.84 (95% CI=1.36, 2.48) for human papillomavirus vaccine initiation and 1.50 (95% CI=1.23, 1.83) for completion. Behavioral and informational interventions doubled human papillomavirus vaccine initiation (relative incidence estimate=2.04, 95% CI=1.36, 3.06 and relative incidence estimate=1.92, 95% CI=1.27, 2.91, respectively). Behavioral interventions increased completion by 68% (relative incidence estimate=1.68, 95% CI=1.25, 2.27).
Conclusions
Evidence supports behavioral interventions for increasing human papillomavirus vaccine initiation and completion. Future studies are needed to assess the effectiveness of interventions in reaching diverse populations and reducing missed opportunities for human papillomavirus vaccination.

American Journal of Public Health
April 2019  109(4)
http://ajph.aphapublications.org/toc/ajph/current

INDUSTRY SUPPORT
Pharmaceutical Industry Support of US Patient Advocacy Organizations: An International Context
Government, Health Law, Health Policy, Ethics
So-Yeon Kang, Ge Bai, Laura Karas and Gerard F. Anderson
109(4), pp. 559–561
Abstract
Objectives. To examine whether the share of pharmaceutical industry funds allocated to patient advocacy organizations (PAOs) is disproportionately large in the United States relative to other industrialized countries and to compare pharmaceutical companies’ disclosure practices across industrialized countries.
Methods. We examined funding of PAOs among the 10 largest pharmaceutical companies in 2016. We compared funding allocated to organizations across 8 large industrialized countries and pharmaceutical companies’ disclosure practices in each country.
Results. Only 6 of the 10 largest pharmaceutical companies disclosed their financial transactions with PAOs in the United States. All 10 companies disclosed transactions in France, Germany, and the United Kingdom, with varying levels of disclosure in other countries. In 2016, the 6 companies that disclosed transactions in the United States allocated 74% of their patient advocacy funding ($88 million) in the United States.
Conclusions. The disproportionate funding of US PAOs in the absence of any disclosure requirements suggests that the United States should consider adoption of regulatory actions to enhance the transparency of relationships between the pharmaceutical industry and PAOs, and to ensure the integrity of public health decision-making.

BMC Medical Ethics
http://www.biomedcentral.com/bmcmedethics/content
(Accessed 30 Mar 2019)

Research article
|   28 March 2019
Responsible data sharing in international health research: a systematic review of principles and norms
Authors: Shona Kalkman, Menno Mostert, Christoph Gerlinger, Johannes J. M. van Delden and Ghislaine J. M. W. van Thiel
Abstract
Background
Large-scale linkage of international clinical datasets could lead to unique insights into disease aetiology and facilitate treatment evaluation and drug development. Hereto, multi-stakeholder consortia are currently designing several disease-specific translational research platforms to enable international health data sharing. Despite the recent adoption of the EU General Data Protection Regulation (GDPR), the procedures for how to govern responsible data sharing in such projects are not at all spelled out yet. In search of a first, basic outline of an ethical governance framework, we set out to explore relevant ethical principles and norms.
Methods
We performed a systematic review of literature and ethical guidelines for principles and norms pertaining to data sharing for international health research.
Results
We observed an abundance of principles and norms with considerable convergence at the aggregate level of four overarching themes: societal benefits and value; distribution of risks, benefits and burdens; respect for individuals and groups; and public trust and engagement. However, at the level of principles and norms we identified substantial variation in the phrasing and level of detail, the number and content of norms considered necessary to protect a principle, and the contextual approaches in which principles and norms are used.
Conclusions
While providing some helpful leads for further work on a coherent governance framework for data sharing, the current collection of principles and norms prompts important questions about how to streamline terminology regarding de-identification and how to harmonise the identified principles and norms into a coherent governance framework that promotes data sharing while securing public trust.

BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed 30 Mar 2019)

Forum
‘Fit-for-purpose?’ – challenges and opportunities for applications of blockchain technology in the future of healthcare
Blockchain is a shared distributed digital ledger technology that can better facilitate data management, provenance and security, and has the potential to transform healthcare. Importantly, blockchain represen…
Authors: Tim K. Mackey, Tsung-Ting Kuo, Basker Gummadi, Kevin A. Clauson, George Church, Dennis Grishin, Kamal Obbad, Robert Barkovich and Maria Palombini
Citation: BMC Medicine 2019 17:68
Published on: 27 March 2019

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 30 Mar 2019)

Research article
Strategies to improve maternal vaccination acceptance
In England, influenza and pertussis vaccination has been recommended for all pregnant women since 2010 and 2012 respectively. However, in some areas, vaccination uptake rates have been low. A qualitative study…
Authors: R. Wilson, P. Paterson and H. J. Larson
Citation: BMC Public Health 2019 19:342
Published on: 25 March 2019

Clinical Trials
Volume 16 Issue 2, April 2019
https://journals.sagepub.com/toc/ctja/16/2

Ethics
Making the case for completion bonuses in clinical trials
Emily A Largent, Holly Fernandez Lynch
First Published December 20, 2018; pp. 176–182
Preview
Attrition is a serious problem in many clinical trials. The practice of offering completion bonuses—financial incentives offered to participants on the condition that they remain in a trial until they reach a prespecified study endpoint—is one means of addressing attrition. Despite their practical appeal, however, completion bonuses remain ethically controversial due to concern that they will coerce or unduly influence participants to not exercise their right to withdraw from a trial. Although this interaction with the right to withdraw does render completion bonuses conceptually distinct from other incentive payments offered to research participants, we argue here that completion bonuses are never coercive and, in the context of effective institutional review board oversight, are unlikely to be unduly influential. Nonetheless, because completion bonuses may in some cases still encourage unreasonable continued participation in a study, additional safeguards are appropriate. Rejecting completion bonuses entirely is, however, unnecessary and would problematically fail to address the significant ethical problems associated with participant attrition.

Clinical Trials
Volume 16 Issue 2, April 2019
https://journals.sagepub.com/toc/ctja/16/2

Reviews
Conducting clinical trials—costs, impacts, and the value of clinical trials networks: A scoping review
Colene Bentley, Sonya Cressman, Kim van der Hoek, Karen Arts, Janet Dancey, Stuart Peacock
First Published January 10, 2019; pp. 183–193
Conclusion
Key findings from the review are: 1) delayed trial activation has costs to budgets and research; 2) poor accrual leads to low-value trials and wasted resources; 3) the pharmaceutical industry can be a pragmatic, if problematic, partner in clinical research; 4) organizational know-how and successful research collaboration are benefits of network/cooperative groups; and 5) there are spillover benefits of clinical trials to healthcare systems, including better health outcomes, enhanced research capacity, and drug cost avoidance. There is a need for more economic evaluations of the benefits of clinical research, such as health system use (or avoidance) and health outcomes in cities and health authorities with institutions that conduct clinical research, to demonstrate the affordability of clinical trials, despite their high cost.

Ethics & Human Research
Volume 41, Issue 2  Pages: 1-40  March-April 2019
https://onlinelibrary.wiley.com/journal/25782363
The Scientific Value and Validity of Research

Articles
A Framework for Assessing Scientific Merit in Ethical Review of Clinical Research
Ariella Binik, Spencer Phillips Hey
Pages: 2-13
First Published: 20 March 2019
ABSTRACT
Ethics guidelines and commentary suggest that a central function of research ethics committees is to assess the scientific merit of the protocols they review. However, some commentators object to this role, and evidence suggests that the assessment of scientific merit is a significant source of confusion and animosity between ethics committees and clinical investigators. In this essay, we argue that ethics committees should assess the scientific value and validity of research protocols and that new decision‐making tools are needed to help them do so in a systematic, transparent, and reliable way. We present a novel ethical framework that can assist in this task.

Ethics & Human Research
Volume 41, Issue 2  Pages: 1-40  March-April 2019
https://onlinelibrary.wiley.com/journal/25782363
The Scientific Value and Validity of Research

Anticipatory Waivers of Consent for Pediatric Biobanking
Jane A. Hartsock, Peter H. Schwartz, Amy C. Waltz, Mary A. Ott
Pages: 14-21
First Published: 20 March 2019
ABSTRACT
As pediatric biobank research grows, additional guidance will be needed about whether researchers should always obtain consent from participants when they reach the legal age of majority. Biobanks struggle with a range of practical and ethical issues related to this question. We propose a framework for the use of anticipatory waivers of consent that is empirically rooted in research that shows that children and adolescents are often developmentally capable of meaningful deliberation about the risks and benefits of participation in research. Accordingly, bright‐line legal concepts of majority or competency do not accurately capture the emerging capacity for autonomous decision‐making of many pediatric research participants and unnecessarily complicate the issues about contacting participants at the age of majority to obtain consent for the continued or first use of their biospecimens that were obtained during childhood. We believe the proposed framework provides an ethically sound balance between the concern for potential exploitation of vulnerable populations, the impetus for the federal regulations governing research with children, and the need to conduct valuable research in the age of genomic medicine.

Genome Medicine
https://genomemedicine.biomedcentral.com/articles
[Accessed 24 Nov 2018]

Research
Encircling the regions of the pharmacogenomic landscape that determine drug response
Authors: Adrià Fernández-Torras, Miquel Duran-Frigola and Patrick Aloy
Citation: Genome Medicine 2019 11:17
Published on: 26 March 2019
Abstract
Background
The integration of large-scale drug sensitivity screens and genome-wide experiments is changing the field of pharmacogenomics, revealing molecular determinants of drug response without the need for previous knowledge about drug action. In particular, transcriptional signatures of drug sensitivity may guide drug repositioning, prioritize drug combinations, and point to new therapeutic biomarkers. However, the inherent complexity of transcriptional signatures, with thousands of differentially expressed genes, makes them hard to interpret, thus giving poor mechanistic insights and hampering translation to clinics.
Methods
To simplify drug signatures, we have developed a network-based methodology to identify functionally coherent gene modules. Our strategy starts with the calculation of drug-gene correlations and is followed by a pathway-oriented filtering and a network-diffusion analysis across the interactome.
Results
We apply our approach to 189 drugs tested in 671 cancer cell lines and observe a connection between gene expression levels of the modules and mechanisms of action of the drugs. Further, we characterize multiple aspects of the modules, including their functional categories, tissue-specificity, and prevalence in clinics. Finally, we prove the predictive capability of the modules and demonstrate how they can be used as gene sets in conventional enrichment analyses.
Conclusions
Network biology strategies like module detection are able to digest the outcome of large-scale pharmacogenomic initiatives, thereby contributing to their interpretability and improving the characterization of the drugs screened.

Global Health: Science and Practice (GHSP)
Vol. 7, No. 1   March 22, 2019
http://www.ghspjournal.org/content/current

EDITORIALS
Scale and Ambition in the Engagement of Private Providers for Tuberculosis Care and Prevention
William A. Wells
Global Health: Science and Practice March 2019, 7(1):3-5; https://doi.org/10.9745/GHSP-D-19-00074
The tuberculosis (TB) community knows the importance of engaging private providers to reach critical TB targets, and knows how to engage successfully. The next challenge is to transition such efforts to government stewardship and financing in order to reach scale.

Globalization and Health
http://www.globalizationandhealth.com/

Review
A narrative review of health research capacity strengthening in low and middle-income countries: lessons for conflict-affected areas
Authors: Gemma Bowsher, Andreas Papamichail, Nassim El Achi, Abdulkarim Ekzayez, Bayard Roberts, Richard Sullivan and Preeti Patel
Citation: Globalization and Health 2019 15:23
Published on: 26 March 2019
Abstract
Conducting health research in conflict-affected areas and other complex environments is difficult, yet vital. However, the capacity to undertake such research is often limited and with little translation into practice, particularly in poorer countries. There is therefore a need to strengthen health research capacity in conflict-affected countries and regions.

In this narrative review, we draw together evidence from low and middle-income countries to highlight challenges to research capacity strengthening in conflict, as well as examples of good practice. We find that authorship trends in health research indicate global imbalances in research capacity, with implications for the type and priorities of research produced, equity within epistemic communities and the development of sustainable research capacity in low and middle-income countries. Yet, there is little evidence on what constitutes effective health research capacity strengthening in conflict-affected areas. There is more evidence on health research capacity strengthening in general, from which several key enablers emerge: adequate and sustained financing; effective stewardship and equitable research partnerships; mentorship of researchers of all levels; and effective linkages of research to policy and practice.

Strengthening health research capacity in conflict-affected areas needs to occur at multiple levels to ensure sustainability and equity. Capacity strengthening interventions need to take into consideration the dynamics of conflict, power dynamics within research collaborations, the potential impact of technology, and the wider political environment in which they take place.

Health Economics, Policy and Law 
Volume 14 – Special Issue 2 – April 2019
https://www.cambridge.org/core/journals/health-economics-policy-and-law/latest-issue

SPECIAL ISSUE: Frontiers of Health Policy Research
If the enhancement of human freedom is both the main object and the primary means to development (Sen, 1999), then good individual and population health are both ends and means to development and freedom in all countries, regardless of their current ranking on the Human Development Index or other indexes on wealth, prosperity and well-being…

This special issue on the ‘frontiers in health policy research’ focuses attention on three distinct areas of inquiry. One set of papers analyses efforts to improve the quality of care and increase the value of care that health systems purchase. A second set of articles focuses on issues of health behaviour and social determinants of health. Finally, the third set of articles presents differing views on how to predict the adequacy of supply of medical professionals. The range of these articles illustrates, not only the exciting breadth of health policy research, but the degree to which scholars within this field are addressing issues of high importance to policy makers around the world. We think it is fair to claim that all of the articles address issues that are on the ‘frontier’ of health policy in the sense that they attempt to provide answers to questions that policy makers around the world are currently grappling with…

Health Research Policy and Systems
http://www.health-policy-systems.com/content
[Accessed 30 Mar 2019]

Commentary
Studying social accountability in the context of health system strengthening: innovations and considerations for future work
There is a growing body of research on the role of social accountability in bringing about more accessible and better-quality healthcare. Here, we refer to social accountability as “citizens’ efforts at ongoing meaningful collective engagement with public institutions for accountability in the provision of public goods” (Joshi, World Dev 99:160–172, 2017). These processes have multiple interrelated components and sub-processes and engage a range of actors in community-driven, often unpredictable and context-dependent actions, which pose many methodological challenges for researchers. In June 2017, scientists and implementers working in this area came together to share experiences, discuss approaches, identify research gaps and consider directions for future studies. This paper shares learnings from this discussion.
Authors: Victoria Boydell, Heather McMullen, Joanna Cordero, Petrus Steyn and James Kiare
Citation: Health Research Policy and Systems 2019 17:34
Published on: 29 March 2019

JAMA
March 26, 2019, Vol 321, No. 12, Pages 1135-1228
http://jama.jamanetwork.com/issue.aspx

Viewpoint
HIV in the United States – Getting to Zero Transmissions by 2030
Ingrid Katz, MD, MHS; Ashish K. Jha, MD, MPH
free access
JAMA. 2019;321(12):1153-1154. doi:10.1001/jama.2019.1817
This Viewpoint discusses 3 challenges that need to be overcome to meet the new US goal of reducing HIV transmissions to zero by 2030: prevention in high-risk communities, reducing infected individuals’ viral loads to undetectable levels, and addressing socioeconomic, racial, and geographic HIV-associated disparities.

JAMA
March 26, 2019, Vol 321, No. 12, Pages 1135-1228
http://jama.jamanetwork.com/issue.aspx

Editorial
Ending the HIV Epidemic – A Plan for the United States
Anthony S. Fauci, MD; Robert R. Redfield, MD; George Sigounas, MS, PhD; Michael D. Weahkee, MHA, MBA; Brett P. Giroir, MD

JAMA
March 26, 2019, Vol 321, No. 12, Pages 1135-1228
http://jama.jamanetwork.com/issue.aspx
Viewpoint

The True Cost of Measles Outbreaks During the Postelimination Era
Maria E. Sundaram, MSPH, PHD; L. Beryl Guterman, MSPH; Saad B. Omer, MBBS, MPH, PhD
free access
JAMA. 2019;321(12):1155-1156. doi:10.1001/jama.2019.1506
This Viewpoint reviews measles outbreaks in the United States since the year 2000 attributable to vaccine hesitancy, refusal, and exemption, and specifies the costs to individuals, society, and health systems as a result.

Journal of Medical Ethics
April 2019 – Volume 45 – 4
http://jme.bmj.com/content/current

Original research
Does One Health require a novel ethical framework?
(16 February, 2019) Free
Jane Johnson, Chris Degeling
Abstract
Emerging infectious diseases (EIDs) remain a significant and dynamic threat to the health of individuals and the well-being of communities across the globe. Over the last decade, in response to these threats, increasing scientific consensus has mobilised in support of a One Health (OH) approach so that OH is now widely regarded as the most effective way of addressing EID outbreaks and risks. Given the scientific focus on OH, there is growing interest in the philosophical and ethical dimensions of this approach, and a nascent OH literature is developing in the humanities. One of the key issues raised in this literature concerns ethical frameworks and whether OH merits the development of its very own ethical framework. In this paper, we argue that although the OH approach does not demand a new ethical framework (and that advocates of OH can coherently adhere to this approach while deploying existing ethical frameworks), an OH approach does furnish the theoretical resources to support a novel ethical framework, and there are benefits to developing one that may be lost in its absence. We begin by briefly explaining what an OH approach to the threats posed by EIDs entails before outlining two different ways of construing ethical frameworks. We then show that although on one account of ethical frameworks there is no need for OH to generate its own, there may be advantages for its advocates in doing so.

Journal of Medical Internet Research
Vol 21, No 3 (2019): March
https://www.jmir.org/2019/3

JMIR Public Health Surveill 2019 (Mar 27); 5(1):e12480
Characterizing Trends in Human Papillomavirus Vaccine Discourse on Reddit (2007-2015): An Observational Study
Yuki Lama, Dian Hu, Amelia Jamison, Sandra Crouse Quinn, David A. Broniatowski

Journal of the Pediatric Infectious Diseases Society (JPIDS)
Volume 8, Issue 1, March 2019
https://academic.oup.com/jpids/issue

PIDS ANNUAL AWARDS
Vaccine Hesitancy, History, and Human Nature: The 2018 Stanley A. Plotkin Lecture
Gary S Marshall
Journal of the Pediatric Infectious Diseases Society, Volume 8, Issue 1, March 2019, Pages 1–8, https://doi.org/10.1093/jpids/piy082
Navigating the waters of vaccine hesitancy requires a view towards history and a deep understanding of how humans think. Getting children vaccinated is as much, or more, about connecting with people as it is about communicating scientific information.

Journal of the Pediatric Infectious Diseases Society (JPIDS)
Volume 8, Issue 1, March 2019
https://academic.oup.com/jpids/issue

INVITED REVIEW
Advancing Pediatric Antibacterial Drug Development: A Critical Need to Reinvent our Approach
Gary J Noel; Sumathi Nambiar; John Bradley
Journal of the Pediatric Infectious Diseases Society, Volume 8, Issue 1, March 2019, Pages 60– 62
Abstract
The Clinical Trials Transformation Initiative convened with several groups in the pediatric antibacterial drug development community with the goal of identifying challenges and recommending ways to improve current practice. Attention to 5 major areas hold the promise of making new antibiotics available for use in children as soon as possible after they are approved for use in adults.

The Lancet
Mar 30, 2019  Volume 393Number 10178p1261-1384
https://www.thelancet.com/journals/lancet/issue/current

Articles
Scaling up prevention and treatment towards the elimination of hepatitis C: a global mathematical model
The revolution in hepatitis C virus (HCV) treatment through the development of direct-acting antivirals (DAAs) has generated international interest in the global elimination of the disease as a public health threat. In 2017, this led WHO to establish elimination targets for 2030. We evaluated the impact of public health interventions on the global HCV epidemic and investigated whether WHO’s elimination targets could be met.
Alastair Heffernan, Graham S Cooke, Shevanthi Nayagam, Mark Thursz, Timothy B Hallett
Open Access

The Lancet
Mar 30, 2019  Volume 393Number 10178p1261-1384
https://www.thelancet.com/journals/lancet/issue/current

The Lancet Commissions
Building a tuberculosis-free world: The Lancet Commission on tuberculosis
Michael J A Reid, et al
Tuberculosis can be treated, prevented, and cured. Rapid, sustained declines in tuberculosis deaths in many countries during the past 50 years provide compelling evidence that ending the pandemic is feasible. Yet this disease—which has plagued humanity since before recorded history and has killed hundreds of millions of people over the past two centuries—remains a relentless scourge. In 2017, 1·6 million people died from tuberculosis, including 300 000 people with HIV, representing more deaths than any other infectious disease. Moreover, in many parts of the world, drug-resistant forms of tuberculosis threaten struggling control efforts. The world can no longer ignore the enormous pall cast by the tuberculosis epidemic. Going forward, the global tuberculosis response must be an inclusive, comprehensive response within the broader sustainable development agenda. No one-size-fits-all approach can succeed.

Lancet Global Health
Apr 2019  Volume 7Number 4e385-e532
http://www.thelancet.com/journals/langlo/issue/current

Editorial
Access to medicines—business as usual?
The Lancet Global Health
High medicine prices are never far from the headlines, affecting access for everyone from those living in the world’s most advanced economies to those in the least developed. The pharmaceutical industry, projected to be worth almost $1·6 trillion by 2020, is widely vilified for its role in this. Pharmaceutical companies are notoriously opaque in disclosing the exact costs involved in bringing a new medicine to the market. Industry-sponsored research suggests that the overall cost is around $2·6 billion.

Pressure is mounting on the industry. In February, seven global pharmaceutical company executives appeared before a Senate Finance Committee to answer questions on the high cost of prescription medicines in the United States. In 2016, the UN Secretary General’s High-Level Panel on Access to Medicines called on the sector to report on its actions to improve access and establish “direct board-level responsibility and accountability on improving access”. So, how has the industry responded?

The latest Access to Medicine Index, published last November, found that while all 20 pharmaceutical companies assessed have some form of access initiative in place, a small group of companies account for the most activity. The Index also identified company best practices, for example, programmes offering discounted prices or donating products. These initiatives are a step in the right direction but their actual impact on access is unclear.

In this month’s issue, Peter Rockers and colleagues report on the impact of one such initiative—Novartis Access, a new programme providing a portfolio of medicines for non-communicable diseases (NCDs) including cardiovascular diseases, type 2 diabetes, respiratory illnesses and breast cancer, at a wholesale price of $1 per treatment per month. Using a cluster-randomised controlled trial (RCT), the authors evaluated the effect of Novartis Access on the availability and price of NCD medicines in health facilities and homes in the first programme country, Kenya. After 15 months the authors found that the programme significantly increased the availability of amlodipine and metformin at health facilities but had no effect on the availability or price of the portfolio overall. They also found no impact on availability of the medicines at the household level.

Reducing the price of NCD medicines as part of an industry-led initiative did not translate into a change in access in Kenya, at least not during the first year. There are several possible reasons for this lack of uptake, including limited awareness of the programme, timing of regulatory approval and import, the medicines offered might not be the most sought-after treatments for NCDs, and the choice of distributor may have inadvertently excluded those who prefer to purchase their medicines from the private sector.

In an accompanying commentary, Imran Manji and Sonak Pastakia discuss how a wholesale price of $1 per treatment per month might not actually represent a discount, for example, hydrochlorothiazide, an alternative to amlodipine, typically costs less than $0·30 per month and might be preferred by both patients and providers. They note that “deriving impact from enhancing availability of medications is much more complicated than just having the products on shelves” and point to the need for collaboration with all levels of the health system. The World Health Organization (WHO) has addressed the multidimensional nature of improving access and the importance of a health systems approach in its draft Roadmap for Access 2019–2023, which outlines ten priority areas, including fair pricing, management of intellectual property, and procurement and supply chain management.

The findings might not be positive, but Rockers’ study is an important and overdue addition to the literature on industry-led efforts to improve access to medicines—an area that has been understudied so far. By scrutinising their access programme in an RCT, subjecting it to the rigours of peer review and publishing in an open-access journal, Novartis is setting the standard for how the industry should transparently report on its social programmes.

For now, it’s business as usual, but the debate over pricing and access is not showing any signs of abating. Last week, Italy’s Minister for Health, Giulia Grillo, proposed a draft resolution that aims to provide WHO “with an authoritative mandate to strengthen WHOs technical work on the transparency of the costs of research and development, and the transparency of prices.” We look forward to discussions of this proposal and further developments at the 72nd session of the World Health Assembly in May.

Lancet Global Health
Apr 2019  Volume 7Number 4e385-e532
http://www.thelancet.com/journals/langlo/issue/current

Articles
Effect of Novartis Access on availability and price of non-communicable disease medicines in Kenya: a cluster-randomised controlled trial
Peter C Rockers, Richard O Laing, Paul G Ashigbie, Monica A Onyango, Carol K Mukiira, Veronika J Wirtz
Summary
Background
Novartis Access is a Novartis programme that offers a portfolio of non-communicable disease medicines at a wholesale price of US$1 per treatment per month in low-income and middle-income countries. We evaluated the effect of Novartis Access in Kenya, the first country to receive the programme.
Methods
We did a cluster-randomised controlled trial in eight counties in Kenya. Counties (clusters) were randomly assigned to the intervention or the control group with a covariate-constrained randomisation procedure that maximised balance on a set of demographic and health variables. In intervention counties, public and non-profit health facilities were allowed to purchase Novartis Access medicines from the Mission for Essential Drugs and Supplies (MEDS). Data were collected from all facilities served by MEDS and a sample of households in study counties. Households were eligible if they had at least one adult patient who had been diagnosed and prescribed medicines for one of the non-communicable diseases targeted by the programme: hypertension, heart failure, dyslipidaemia, type 2 diabetes, asthma, or breast cancer. Primary outcomes were availability and price of portfolio medicines at health facilities, irrespective of brand; and availability of medicines at patient households. Impacts were estimated with intention-to-treat analysis. This trial is registered with ClinicalTrials.gov (NCT02773095).
Findings
On March 8, 2016, we randomly assigned eight clusters to intervention (four clusters; 74 health facilities; 342 patients) or control (four clusters; 63 health facilities; 297 patients). 69 intervention and 58 control health facilities, and 306 intervention and 265 control patients were evaluated after a 15 month intervention period (last visit February 28, 2018). Novartis Access significantly increased the availability of amlodipine (adjusted odds ratio [aOR] 2·84, 95% CI 1·10 to 7·37; p=0·031) and metformin (aOR 4·78, 95% CI 1·44 to 15·86; p=0·011) at health facilities, but did not affect the availability of portfolio medicines overall (adjusted β [aβ] 0·05, 95% CI −0·01 to 0·10; p=0·096) or their price (aβ 0·48, 95% CI −1·12 to 0·72; p=0·500). The programme did not affect medicine availability at patient households (aOR 0·83, 95% CI 0·44 to 1·57; p=0·569).
Interpretation
Novartis Access had little effect in its first year in Kenya. Access programmes operate within complex health systems and reducing the wholesale price of medicines might not always or immediately translate to improved patient access. The evidence generated by this study will inform Novartis’s efforts to improve their programme going forward. The study also contributes to the public evidence base on strategies for improving access to medicines globally.
Funding
Sandoz International (a subsidiary of Novartis International).

Research in context
Evidence before this study
In 2016, we conducted a systematic review to identify published evaluations of pharmaceutical industry-led access programmes in low-income and middle-income countries and to assess the quality of the available evidence on the effect of these programmes. First, we developed a list of industry-led access programmes by reviewing the Health Partnerships Directory of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). Information from the directory was supplemented with information from reports published by the Access to Medicine Index and annual and corporate social responsibility reports for non-IFPMA companies. On May 1, 2016, we searched PubMed, Google Web, and Google Scholar for published evaluations of identified access programmes, using as search terms the name of the programme, the name of the company, the focus disease, and the focus countries. We did not set restrictions on the publication date of evaluations. We identified 120 access programmes that fit our criteria, seven of which had at least one published evaluation. We reviewed all of the published evaluations and assessed their quality using the GRADE system. None of the evaluations were rated as high quality and three were rated as moderate quality. We found no previous evaluations that used a randomised controlled trial design. None of the published evaluations provided clear evidence on the effect of a price reduction programme similar to Novartis Access.
Added value of this study
To our knowledge, this study is the first randomised controlled trial assessing the effect of a pharmaceutical industry-led access to medicines programme. We found that Novartis Access, a programme offering a portfolio of non-communicable disease medicines at a wholesale price of US$1 per treatment per month in Kenya, had little effect during its first year on the availability of medicines at facilities. Although the programme significantly increased the availability of amlodipine and metformin at health facilities, there was no effect on medicine prices or on availability at patient households. The study contributes to the public evidence base on strategies for improving access to non-communicable diseases medicines in low-income and middle-income countries. The study also contributes to ongoing discussions on the role of measurement and transparency in establishing accountability for private sector social programmes.
Implications of all the available evidence
Novartis Access is one of a growing number of pharmaceutical industry-led access programmes. Few of these programmes have been rigorously evaluated, and little is known about their effect or which strategies work best to improve access. This study suggests that offering a portfolio of medicines at a reduced price might not lead to immediate improvements in patient access. In order to build a more robust evidence base on this important topic and ensure accountability, rigorous measurement and transparent reporting should be adopted as a standard for pharmaceutical industry efforts to improve access to medicines globally. This study demonstrates that pharmaceutical companies can use robust, high-quality methods to evaluate their access programmes.

Lancet Global Health
Apr 2019  Volume 7Number 4e385-e532
http://www.thelancet.com/journals/langlo/issue/current

Comment
The ethical imperative to treat NCDs during research in Africa
Majaliwa Mzombwe, Bernard Desderius, Saidi Kapiga, Luke Smart, Robert Peck

Lancet Global Health
Apr 2019  Volume 7Number 4e385-e532
http://www.thelancet.com/journals/langlo/issue/current

Articles
Estimates of case-fatality ratios of measles in low-income and middle-income countries: a systematic review and modelling analysis
Allison Portnoy, Mark Jit, Matthew Ferrari, Matthew Hanson, Logan Brenzel, Stéphane Verguet
 

Lancet Infectious Diseases
Apr 2019  Volume 19Number 4p339-448, e109-e147
http://www.thelancet.com/journals/laninf/issue/current

Editorial
Trust issues
The Lancet Infectious Diseases
In November, 2017, we published an Editorial on measles vaccination, calling for strong interventions to curb preventable diseases. 18 months later, how have things changed? As reported in a news story in this issue, 229,000 cases of measles were reported in 2018, and 98 countries reported an increase in cases compared with 2017. Measles is a global health crisis and it is getting worse. Although the reasons vary by country, mistrust and misplaced reluctance to vaccinate, largely related to unfounded fears over safety, are important contributing factors from the Philippines to France, from Ukraine to the USA. WHO has named vaccine hesitancy as one of the top ten threats to global health in 2019.

Lack of trust is also central to another of the world’s major health emergencies: the Ebola virus disease outbreak in DR Congo. The epidemic is focused in the northeast of the country, where conflict, political tensions, and social grievances have instilled fear and suspicion in much of the local population. 40% of new cases so far this year have been in people who died in the community (ie, they hadn’t been to a treatment centre), and a large proportion of cases, particularly in Katwa and Butembo, cannot be linked to any other patients, suggesting that unknown chains of transmission exist. If patients are wary of seeking proper care, and if contact tracing cannot be done, the outbreak will not be stopped.

Mistrust has also manifested with more direct and violent consequences in DR Congo. Médecins Sans Frontières (MSF) has reported dozens of attacks on its workers in the region. In February, two treatment centres were attacked and burned down, forcing MSF to suspend its activities in Katwa and Butembo. Joanne Liu, the president of MSF, has been quoted as describing the atmosphere towards the response as “toxic”.

The importance of community engagement to build trust was well recognised in the aftermath of the west Africa Ebola epidemic, but the difficulties of the DR Congo outbreak have led to the use of coercion against patients and their contacts, and a reliance on police and UN peacekeepers for security has further alienated the local population. MSF has criticised the use of coercion in DR Congo, and in an interview with STAT, Liu has said that “using police to force people into complying with health measures is not only unethical, it’s totally counterproductive“. WHO is taking a different tack: on March 9, it announced that it had sought further support from UN and local police forces to protect treatment centres, despite recognising the importance of “maintaining the neutrality of the response”.

As for trust in measles vaccination, a Danish study of more than 650,000 children once again confirms that measles, mumps, and rubella (MMR) vaccination is not associated with autism. But while the findings are welcome, the paper will not change the beliefs of anti-vaccination advocates. The safety of MMR was already well established before this study—a shortage of reliable scientific evidence is not the problem. And in countries such as the USA, the dangers of not vaccinating have been shown repeatedly, most recently in an outbreak of measles among mainly unvaccinated children in Washington and Oregon, as reported in our March issue. Rather, it is the abundance of misinformation and distrust of authority that must be addressed. Social media companies such as YouTube and Facebook have made changes to begin to stem the tide of misleading claims, but the impact of these initiatives remains to be seen.

An anti-vaxxer in California, USA, for example, is vastly different from someone potentially exposed to Ebola in rural DR Congo. Yet there are similarities in their mistrust. A belief that vaccines cause autism or that Ebola is a government ploy likely has as much to do with wider grievances and distrust of authority as with the specifics of the scientific evidence and education. Part of the problem is that a lack of faith in government, the health-care system, and pharmaceutical companies is not always irrational. In DR Congo, the postponement of elections in the regions affected by Ebola has been considered to be motivated more by politics than by public health (the region is a stronghold for opposition to the ruling party). The poverty and conflict in the region have long been neglected. In the USA, the country is plagued by prescription opioid misuse fuelled by aggressive pharmaceutical marketing, the people of Flint, MI, have been without safe drinking water for 3 years, and the most basic drugs are often unaffordable because of profit-driven health care. Little wonder that some individuals question the authorities’ desire to prioritise their wellbeing. It is impossible to build trust while at the same time abusing it.

Lancet Infectious Diseases
Apr 2019  Volume 19Number 4p339-448, e109-e147
http://www.thelancet.com/journals/laninf/issue/current

Articles
The global burden of typhoid and paratyphoid fevers: a systematic analysis for the Global Burden of Disease Study 2017
GBD 2017 Typhoid and Paratyphoid Collaborators

Lancet Infectious Diseases
Apr 2019  Volume 19Number 4p339-448, e109-e147
http://www.thelancet.com/journals/laninf/issue/current

Articles
Maternal pertussis vaccination and its effects on the immune response of infants aged up to 12 months in the Netherlands: an open-label, parallel, randomised controlled trial
Daan Barug, Inge Pronk,  arlies A van Houten, Florens G A Versteegh, Mirjam J Knol, Jan van de Kassteele, Guy A M Berbers, Elisabeth A M Sanders, Nynke Y Rots

Lancet Infectious Diseases
Apr 2019  Volume 19Number 4p339-448, e109-e147
http://www.thelancet.com/journals/laninf/issue/current

Immunogenicity and safety of measles-rubella vaccine co-administered with attenuated Japanese encephalitis SA 14–14–2 vaccine in infants aged 8 months in China: a non-inferiority randomised controlled trial
Yan Li, et al.

Lancet Infectious Diseases
Apr 2019  Volume 19Number 4p339-448, e109-e147
http://www.thelancet.com/journals/laninf/issue/current

Review
The efficacy, effectiveness, and immunogenicity of influenza vaccines in Africa: a systematic review
Benjamin B Lindsey, Edwin P Armitage, Beate Kampmann, Thushan I de Silva

Lancet Infectious Diseases
Apr 2019  Volume 19Number 4p339-448, e109-e147
http://www.thelancet.com/journals/laninf/issue/current

Review
Maternal immunisation to improve the health of HIV-exposed infants
Angela M Bengtson, Alan M Sanfilippo, Brenna L Hughes, David A Savitz

Nature 
Volume 567 Issue 7749, 28 March 2019
http://www.nature.com/nature/current_issue.html

Editorial | 22 March 2019
Building trust is essential to combat the Ebola outbreak
Researchers can do more to contain the escalating public-health crisis in the Democratic Republic of the Congo.