Vaccines and Global Health: The Week in Review 28 April 2018

Vaccines and Global Health: The Week in Review is a weekly digest  summarizing news, events, announcements, peer-reviewed articles and research in the global vaccine ethics and policy space. Content is aggregated from key governmental, NGO, international organization and industry sources, key peer-reviewed journals, and other media channels. This summary proceeds from the broad base of themes and issues monitored by the Center for Vaccine Ethics & Policy in its work: it is not intended to be exhaustive in its coverage. You are viewing the blog version of our weekly digest, typically comprised of between 30 and 40 posts below all dated with the current issue date

.– Request an Email Summary: Vaccines and Global Health : The Week in Review is published as a single email summary, scheduled for release each Saturday evening before midnight (EDT in the U.S.). If you would like to receive the email version, please send your request to david.r.curry@centerforvaccineethicsandpolicy.org.

 pdf version A pdf of the current issue is available here: Vaccines and Global Health_The Week in Review_28 April 2018

– blog edition: comprised of the approx. 35+ entries posted below.

– Twitter:  Readers can also follow developments on twitter: @vaxethicspolicy.
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– Links:  We endeavor to test each link as we incorporate it into any post, but recognize that some links may become “stale” as publications and websites reorganize content over time. We apologize in advance for any links that may not be operative. We believe the contextual information in a given post should allow retrieval, but please contact us as above for assistance if necessary.

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David R. Curry, MS
Executive Director
Center for Vaccine Ethics and Poli

Dr. Paul Offit Receives 2018 Albert B. Sabin Gold Medal

Milestones :: Perspectives

Dr. Paul Offit Receives 2018 Albert B. Sabin Gold Medal

WASHINGTON, D.C. – April 24, 2018 – Tonight, the Sabin Vaccine Institute (Sabin) will honor Dr. Paul Offit with the 2018 Albert B. Sabin Gold Medal. Sabin will recognize Dr. Offit for his contributions as co-inventor of an oral rotavirus vaccine and his leadership as one of the United States’ most vocal and dedicated advocates for immunization…

…Dr. Offit’s contributions to protecting human health extend beyond the laboratory and for many years he has been a strong public advocate for childhood immunizations. Dr. Offit drives efforts to improve public understanding of vaccines through speaking engagements, media appearances and his books. Dr. Offit’s many books make science accessible to lay audiences worldwide, highlighting the history of immunization, tackling vaccine myths and reinforcing the message that science is not a matter of faith but a matter of fact.

“Paul’s contributions as a vaccinologist and advocate have improved the health of children in every corner of the world,” said Amy Finan, chief executive officer of the Sabin Vaccine Institute. “His scientific accomplishments are rivaled only by his impact as a dedicated advocate for immunization. Paul truly exemplifies Albert Sabin’s commitment to ensuring every child is protected from preventable disease. It is an honor to present Paul with this year’s Albert B. Sabin Gold Medal.”

“It’s an honor to join the distinguished ranks of Albert B. Sabin Gold Medal recipients,” said Dr. Offit. “Though our research may have focused on different diseases, we all share Dr. Sabin’s commitment to reducing human suffering. We have accomplished so much, discovering and introducing several vaccines that have reshaped the world as we know it, but vaccines will always be a victim of their own success. As once-common diseases disappear, it is increasingly important to stand as vaccine champions. I thank the Sabin Vaccine Institute for recognizing my research and advocacy with tonight’s award, and for its efforts to expand immunization globally.”…

 

Revised SAGE recommendation on use of dengue vaccine :: Sanofi Pasteur communication on SAGE recommendation about Dengvaxia® dengue vaccine

Milestones :: Perspectives

::::::

                           
Editor’s Note:
In last week’s edition, we published the full text of the initial report on the WHO SAGE meeting held 17-18 April 2018 in Geneva, including the revised SAGE recommendation on use of dengue vaccine [see link just below]. We should have also immediately explored whether Sanofi had made any response to this revised guidance and should have published any such response in tandem. We provide the full text of the Sanofi media release dated 19 April 2018 below.
 
Revised SAGE recommendation on use of dengue vaccine
19 April 2018
 
Sanofi Pasteur communication on SAGE recommendation about Dengvaxia® dengue vaccine
19th April 2018 – Today, the Strategic Advisory Group of Experts (SAGE) on Immunization communicated an updated recommendation on Dengvaxia® dengue vaccine to the World Health Organization (WHO).

:: The new SAGE recommendation confirms the public health value of Dengvaxia and its     potential to reduce the overall burden of dengue in high endemic populations.

:: For dengue-endemic countries that would like to use Dengvaxia as part of their integrated dengue control and prevention strategy, SAGE recommends as a preferred option pre-vaccination screening in which only previously dengue infected individuals are vaccinated. As will be made clear in forthcoming published documents from SAGE, current available sero-tests or Rapid Diagnostic Tests (RDT) could be considered in high transmission settings until better tests are available. We maintain our efforts to develop a dengue RDT that can reliably assess prior dengue infection as an aid to vaccination.

:: SAGE also acknowledges the public health value of vaccinating without pre-vaccination screening in very high endemic settings (80% seroprevalence at 9 years of age).

This guidance from the SAGE will help to inform an updated World Health Organization position on the vaccine expected to be published in the coming months. The WHO’s mandate is to promote global public health, and their positions on new vaccines provide guidance to countries to make decision on public program implementation, based on their specific disease burden and epidemiology.

The SAGE updated their recommendation on the vaccine taking into account the results of a supplementary analysis of clinical data on the vaccine, for which findings were communicated publically last year by Sanofi.

These new data1, which were finalized and shared by Sanofi at the end of November 2017 and submitted to a peer-reviewed medical journal, contribute to the scientific understanding of how this vaccine can be used optimally in dengue prevention efforts at individual and population levels. They show that for people 9 years of age or older who had a dengue infection prior to vaccination, which includes most of the people living in high transmission areas2, the vaccine provides sustained protective benefit up to 5 years after the first injection which highlights the public health value of the vaccine in high endemic settings. These findings also represent the first clinical evidence that the vaccine’s long-term safety profile in individuals 9 years and older differs according to prior dengue infection exposure. Sanofi has proposed a label update for the vaccine that takes these new findings into account. The label update is currently under review or has been accepted already by some of the regulatory agencies in the countries where the vaccine is either approved today or under regulatory consideration.

We are confident in Dengvaxia’s safety and its proven potential to reduce dengue disease burden in endemic countries. As we previously communicated in November, in our new analysis, the risk and severity of cases in vaccinated individuals not previously infected with dengue was similar to those observed in unvaccinated individuals previously infected. Over five years, in vaccinated individuals not previously infected this increased risk was of 0.2% for vaccinated vs unvaccinated individuals. The severe dengue symptoms observed were a temperature over 38°C for 2 days or more coupled with symptoms such as bruising and abnormal laboratory findings. All fully recovered after symptomatic treatment.

At Sanofi, we have worked to provide an innovative vaccine against dengue in spite of the challenges posed by this complex infection. Dengue can be caused by 4 distinct dengue viruses capable of making a person sick up to four times in a lifetime. Most dengue infections are ‘silent’ which means people have dengue but do not feel ill. However, in rare cases, dengue can be severe, leading to a range of clinical symptoms that require hospital treatment and can deteriorate into a life-threatening form of the disease called dengue hemorrhagic fever. Severe dengue can occur at any of the four infections yet, for reasons not fully understood by the scientific community, secondary dengue infections lead more often to severe dengue than a first infection with the virus3. Therefore, prevention of subsequent dengue infections has the potential to significantly reduce the human suffering, as well as the economic impact caused by dengue every year4.

Dengue continues to represent a significant public health challenge for countries where almost half the world’s population lives today. An estimated 390 million dengue infections are reported annually; about 100 million of which cause overt illness2. Dengue is spread by mosquitoes that bite during the daytime which contributes to rapid spread of the disease during the rainy season and can often result in overburdened community healthcare services and societal disruption and anxiety.

The global strategy for dengue prevention and control was adopted by the WHO member states in 2012 aiming to reduce the mortality associated with dengue by 50% and the morbidity or illness caused by dengue by 25% by the Year 2020. To achieve this goal, the WHO recommends that countries adopt an integrated approach to dengue infection prevention and disease management5.

Sanofi shares the same goal as the WHO and endemic countries to significantly reduce global dengue burden. The WHO recognizes the important role of vaccination together with vector control, robust disease surveillance and proper medical management in addressing dengue burden.  Appropriate introduction of Dengvaxia as part of such an integrated approach has the potential to significantly reduce overall dengue burden, particularly leading to lower impact of severe dengue on human lives and healthcare expenditures in highly endemic countries. Sanofi continues our long-term commitment to global dengue burden reduction. We developed the first approved vaccine to fight this complex infection and we will continue to work with the international public health community and endemic countries, to ensure the best usage of the vaccine to increase protection for populations at risk of subsequent dengue infections, potentially more debilitating.

1 http://www.who.int/immunization/diseases/dengue/q_and_a_dengue_vaccine_dengvaxia_use/en/
2

World Health Organization.  Dengue and severe dengue. Fact sheet No 117.  www.who.int/mediacentre/factsheets.fs117 updated April 2017.  Last accessed May 2017
3

Mizumoto, K., Ejima, K., Yamamoto, T. & Nishiura, H. On the risk of severe dengue during secondary infection: a systematic review coupled with mathematical modeling. J. Vector Borne Dis. 51, 153–164 (2014)
4
http://www.who.int/immunization/sage/meetings/2016/april/1_Background_Paper_Dengue_Vaccines_2016_03_17.pdf
5

World Health Organization. Dengue guidelines for diagnosis, treatment, prevention and control. WHO/HTM/NTD/DEN/2009.1.http://whqlibdoc.who.int/publications/2009/9789241547871_eng.pdf

EMA launches public consultation on revised guideline on clinical evaluation of vaccines

Milestones :: Perspectives

EMA launches public consultation on revised guideline on clinical evaluation of vaccines

26/04/2018
Updated rules for clinical development of vaccines
The European Medicines Agency (EMA) has released a revised guideline on the clinical evaluation of vaccines for a six-month public consultation.
Stakeholders are invited to send their comments by 30 October 2018 to vwp@ema.europa.eu using the template provided in the guideline.
Vaccination is one of the greatest breakthroughs in modern medicine. According to the World Health Organization (WHO), immunisation saves an estimated two to three million lives every year and protects against many dangerous diseases, including, for example, cervical cancer, diphtheria, hepatitis B, measles, mumps, pertussis (whooping cough), and tetanus. Additionally, vaccines can help limit the spread of antibiotic resistance as vaccination is a very effective way to stop people and animals getting infected, thereby preventing the need for antibiotics.
Vaccines undergo a rigorous scientific review to ensure that they are safe and effective. The updated guideline introduces additional safeguards for European Union citizens and ensures that the evaluation is in line with the most up-to-date scientific knowledge and technological developments.
EMA’s draft guideline includes specific considerations for clinical trials with vaccines in special populations, such as pregnant women or the elderly.
The revised version of the guideline also adds considerations to priming and boosting strategies, including the option of heterologous prime-boost, which entails administration of one type of vaccine first followed by a different type of vaccine for the same pathogen later. The need to develop vaccine for pathogens that may cause future epidemics and for which conducting clinical trials outside of outbreaks might be problematic, is also addressed.
Once the revised guideline is adopted by the Committee for Medicinal Products for Human Use (CHMP), the current guideline on the clinical evaluation of new vaccines and the Annex on summaries of product characteristics (SmPCs) for vaccines will no longer apply.

Vaccination in humanitarian emergencies

Milestones :: Perspectives

Vaccination in humanitarian emergencies

Humanitarian emergencies, regardless of type and cause, have a number of common risk factors for communicable diseases inextricably linked to excess risk of morbidity and mortality which can come from vaccine–preventable diseases.

Vaccine-preventable disease outbreaks occurring in humanitarian emergencies highlighted the need for a comprehensive and evidence-based decision-making framework for vaccination in humanitarian emergencies. In 2013, “Vaccination in acute humanitarian emergencies: a framework for decision making” was developed by the World Health Organization (WHO). The ultimate aim of the framework is to assist the user to thoughtfully, deliberately, ethically, and rationally determine whether or not the delivery of one or more vaccines to specific target populations during the acute phase of an emergency would result in an overall saving of lives, a reduction in the population burden of disease, and generally more favourable outcomes than would otherwise be the case.

Revised and extended guidance/content
Through a series of consultations with partners in 2016 the revised and extended guidance is now available:
:: Vaccination in acute humanitarian emergencies: a framework for decision making
:: Vaccination in humanitarian emergencies implementation guide
:: Country case studies pdf, 240kb

eTool
An eTool based on the framework for decision making has been developed. The intended audience for the eTool includes UNICEF and WHO staff, government and partner agencies who are expected to work together to reach a decision regarding the need and strategies of implementing one or more vaccines in a given humanitarian emergency.
:: Download Mac version  zip, 69.27Mb
:: Download Windows version  zip, 67.03Mb
:: Instructions on installing the tool  pdf, 321kb

eLearning course
An eLearning course has been developed in collaboration with UNICEF, it is intended to provide a methodology and tools to immunization programme managers for vaccination during humanitarian emergencies. It takes 2 – 2.5 hours to complete this course. A certificate is available following the successful completion of all five modules.
:: UNICEF site for eLearning

Humanitarian Mechanism
A “Humanitarian Mechanism” has been developed by WHO, UNICEF, Médecins Sans Frontières, and Save the Children to enable civil society organizations, governments and UN agencies to quickly procure affordable vaccine supplies on behalf of populations facing humanitarian emergencies and who do not have such access. The mechanism is available for use as of 1 May 2017.
:: Accessing Affordable and Timely Supply of Vaccines for use in Humanitarian Emergencies: the Humanitarian Mechanism pdf, 126kb

UNICEF – Twelve things you didn’t know about immunization

Milestones :: Perspectives

UNICEF – Twelve things you didn’t know about immunization

Reaching every child: Nearly 13 million children went unvaccinated in 2016

Vaccines keep children alive and healthy by protecting them against disease. Yet in 2016, an estimated 1.4 million children under five died from vaccine-preventable diseases. Approximately one-fourth of deaths among children under 5 were from¬ pneumonia, diarrhoea and measles, and could have been mostly prevented by vaccines. Globally 1 in 7 children – over 19 million – missed out on routine vaccines, including 13 million who have never been vaccinated, putting them and their communities at risk of disease and death. Low immunization coverage compromises gains in all other areas of health for mothers and children. The poorest, most vulnerable children who need immunization the most continue to be the least likely to get it.

UNICEF and its partners are working to ensure that the lives of all children are protected. But, if vaccination is not prioritized, some of the most marginalized children will miss out on their right to benefit from immunization, which could mean the difference between life and death.

Despite these challenges, vaccines are protecting more children than ever before. Behind their phenomenal success lies the hard work of health workers who go from village-to-village to vaccinate children, even though they encounter fear and suspicion.
“Last year, it is estimated that vaccines saved the lives of as many as 3 million children. That’s 3 million future doctors, teachers, artists, community leaders, mothers and fathers alive today thanks to millions of frontline health workers who walk for hundreds of miles to remote locations, through jungles and across seas to reach every child,” said Robin Nandy, UNICEF’s Chief of Immunization. “We continue to work with governments on the ground, including in places affected by conflict, in support of these unsung heroes who take on this extremely dangerous work to save lives.”

Twelve key facts on vaccines today

  1. Two-thirds of unvaccinated children live in fragile countries or those affected by conflict. Between 2010 and 2016, Syria saw the sharpest decline in vaccinated children, with coverage* falling by 38 percentage points over this period. Second is Ukraine where coverage decreased by 33 percentage points.
  1. A number of countries have seen a significant increase in the number of vaccinated children since 2010, driving most of the gains in immunization coverage this decade, including India, Ethiopia, Democratic Republic of the Congo, Bangladesh, Philippines, Mexico, United Republic of Tanzania, Vietnam, Turkey and Sudan. In India, the number of unvaccinated children** reduced by 45 per cent, from 5.3 million in 2010 to 2.9 million in 2016.
  1. As of 2016, six countries accounted for half of the world’s unimmunized children*: Nigeria (18%); India (15%); Pakistan (7%); Indonesia (5%); Ethiopia (4%); and Democratic Republic of the Congo (3%).
  1. The top 10 countries where vaccination coverage*, in percentage points, has increased between 2010 and 2016 are Palau (29%), Malta (21%), Democratic Republic of the Congo (19%), Comoros (17%), Azerbaijan (16%), Ethiopia (16%), Timor-Leste (13%), Barbados (11%), Costa Rica (9%) and India (9%).
  1. In 2017, Yemen witnessed one of the worst cholera epidemics on record with over a million suspected cases, almost 29 per cent of them among are children under five. Around 5.2 million people received two doses of the oral cholera vaccine in South Sudan, Somalia, Mozambique, Malawi, Sierra Leone, Philippines, Nigeria, Chad, Haiti, Cameroon, Zambia and Bangladesh during cholera outbreaks or as part of preventive campaigns.
  1. Diphtheria, a disease that is only rarely seen thanks to immunization, is making a come-back. In response to an outbreak among Rohingya refugees – in which three out of four people affected were children – UNICEF supported several large vaccination campaigns in southern Bangladesh, reaching close to half a million children.
  1. In 1988, there were 350,000 cases of polio a year. Since then, over 2.5 billion children have been vaccinated against the disease. Today, the world is closer than ever to eradicating polio, with only 22 cases in two countries last year. More than 400 million children will be vaccinated this year.
  1. The lives of an estimated 20 million children have been saved through measles immunization between 2000 and 2016.
  1. A billion people will be vaccinated against Yellow fever in Africa by 2026 – almost half of them children under 15 years of age. Since 2001, the production of the yellow fever vaccine has quadrupled from 20 million to 80 million doses annually, and is expected to increase in the coming years.
  1. As of 2016, an estimated 86 per cent of children less than one year of age were fully vaccinated against diphtheria, tetanus and pertussis, compared to 52 per cent some 30 years ago.
  1. In 2017, UNICEF procured 2.4 billion vaccine doses worth $1.3 billion, reaching 45 per cent of the world’s children.

 

  1. Thanks to vaccines, maternal and neonatal tetanus, which is extremely deadly amongst newborns, has been eliminated in all but 15 countries. Ethiopia, Haiti and Philippines eliminated the disease in 2017.