CDC/ACIP [to 20 May 2017]

CDC/ACIP [to 20 May 2017]
http://www.cdc.gov/media/index.html
Updated Recommendations for Use of MenB-FHbp Serogroup B Meningococcal Vaccine — Advisory Committee on Immunization Practices, 2016
If vaccinating with MenB-FHbp – including during serogroup B meningococcal disease outbreaks – ACIP recommends that three doses of MenB-FHbp be administered at 0, 1–2, and 6 months for people at increased risk of meningococcal disease. ACIP recommends that two doses of MenB-FHbp should be administered at 0 and 6 months when given to healthy adolescents who are not at increased risk for meningococcal disease. Recommendations regarding use of MenB-4C vaccine (Bexsero) are unchanged. Either MenB vaccine can be used when indicated; however, they are not interchangeable and the same product must be used for all doses in a series. Two serogroup B meningococcal (MenB) vaccines are currently licensed for use among people aged 10–25 years in the United States: MenB-FHbp (trade name, Trumenba) and MenB-4C (trade name, Bexsero). Changes to the dosage and administration of MenB-FHbp vaccines were recently approved by FDA to include both a three-dose series (administered at 0, 1–2, and 6 months) and a two-dose series (administered at 0 and 6 months). For people at increased risk for meningococcal disease and for use during serogroup B meningococcal disease outbreaks, ACIP recommends that three doses of MenB-FHbp be administered at 0, 1–2, and 6 months. When given to healthy adolescents who are not at increased risk for meningococcal disease, ACIP recommends that 2 doses of MenB-FHbp should be administered at 0 and 6 months.

Gavi [to 20 May 2017]

Gavi [to 20 May 2017]
http://www.gavi.org/library/news/press-releases/
13 May 2017
India’s most vulnerable children to get access to new vaccine against pneumonia
Pneumococcal vaccine will reach 2.1 million children in the first year.
Geneva, 13 May 2017 – For the first time, millions of children in India will receive protection for free against the leading cause of pneumonia – which kills more children under the age of five than any other infectious disease in the world – thanks to the launch of the pneumococcal conjugate vaccine (PCV).

PCV is being introduced to India’s Universal Immunization Program (UIP) with support from Gavi, the Vaccine Alliance, a move that will help to reduce the number of under-five pneumonia deaths in India, the highest in the world.

Currently, almost 200,000 children under five die from pneumonia in India each year. Until now PCV, a relatively new vaccine, has only been made available in the private market, putting it beyond the reach of most of the population. With this phased introduction, nearly 2.1 million children in Himachal Pradesh, Bihar and Uttar Pradesh will be vaccinated with PCV. This coverage will be expanded across the entire country in the coming years.

“This is a huge milestone because it means that, for the first time, India’s most vulnerable children will be protected against one of India’s most deadly diseases,” said Gavi CEO Seth Berkley. “India is not only the largest Gavi-supported country, but it also has the single largest number of under-immunised children in the world. This vaccine will save many lives.”…

 

UNICEF [to 20 May 2017]

UNICEF  [to 20 May 2017]
https://www.unicef.org/media/media_94367.html
17 May 2017
Five-fold increase in number of refugee and migrant children traveling alone since 2010 – UNICEF
NEW YORK, 17 May 2017 – The global number of refugee and migrant children moving alone has reached a record high, increasing nearly five-fold since 2010, UNICEF said today in a new report. At least 300,000 unaccompanied and separated children were recorded in some 80 countries in the combined years of 2015 and 2016, up from 66,000 in 2010 and 2011.

UNICEF joins tech giants in artificial intelligence group
New York, 17 May 2017 – UNICEF joins the Partnership on Artificial Intelligence (AI) founded by Amazon, Apple, Google/DeepMind, Facebook, IBM and Microsoft.

At least one in four children live in poverty in the Middle East and North Africa
RABAT, 15 May 2017 – According to a recent UNICEF analysis covering 11 countries in the Middle East and North Africa[1], poverty continues to impact at least 29 million children – one in four children in the region. These children are deprived of the minimum requirements in two or more of the most basic life necessities including basic education, decent housing, nutritious food, quality health care, safe water, sanitation and access to information.

 

Announcements: AIDS

IAVI – International AIDS Vaccine Initiative   [to 20 May 2017]
https://www.iavi.org/
May 18, 2017
Canadian Researcher Wins Grant to Explore Promising HIV Vaccine Candidate
Canadian Institutes of Health Research funds Gary Kobinger to develop HIV vaccine in partnership with IAVI.
The Canadian Institutes of Health Research (CIHR) has awarded a new CA$3.99 million grant to Dr. Gary Kobinger of Université Laval for work on a vaccine to prevent HIV infection.

This three-year grant supports a scientific collaboration between Kobinger and the Design and Development Lab, a state-of-the-art research facility in Brooklyn, New York, operated by the International AIDS Vaccine Initiative (IAVI). Led by Kobinger and IAVI’s Dr. Chris Parks, the respective Canadian and U.S. research teams aim to improve upon a promising HIV vaccine candidate designed by Parks, with the goal of advancing the candidate to clinical testing in human volunteers.

“We are encouraged by this support of Gary Kobinger’s work and the prospects of his collaboration with IAVI’s Design and Development Lab,” said Mark Feinberg, IAVI CEO. “The innovative work of the Kobinger lab provides a great illustration of how creative and insightful science can advance the global response to emerging infectious diseases, and exemplifies ways in which the benefits of research progress in one disease area can be translated to another, in this case, from an understanding of how to develop an effective Ebola vaccine to the ongoing search for an AIDS vaccine.”

Using a modified animal virus called Vesicular Stomatitis Virus (VSV) that does not cause disease in humans, the IAVI vaccine candidate delivers copies of a protein taken from HIV’s surface. Once inside the body, the protein stimulates protective immune defenses against HIV infection. Studies in animals to date have yielded encouraging results.

Kobinger’s team will further modify the IAVI candidate vaccine for greater efficacy and clinical testing. An expert in the Ebola virus, Kobinger helped develop the Ebola (rVSV-ZEBOV) vaccine, which to date has proven the most effective at preventing Ebola infection, and which also uses a VSV backbone…
 
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NIH  [to 20 May 2017]
http://www.nih.gov/news-events/news-releases
May 18, 2017
NIH statement on HIV Vaccine Awareness Day – 2017
— Anthony S. Fauci, M.D., Director, NIAID and Carl W. Dieffenbach, Ph.D., Director, Division of AIDS, NIAID.
Much progress has been made in HIV/AIDS research since the disease was first recognized in 1981. Today, lifesaving antiretroviral therapies allow those living with HIV to enjoy longer, healthier lives — an outcome that once seemed unattainable. Research supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has proven that when antiretroviral therapy durably keeps HIV at undetectable levels, the risk that the treated individual will sexually transmit the virus to an HIV-negative partner is negligible. When implemented in communities, treatment as prevention is remarkably successful at preventing the spread of HIV infection. Pre-exposure prophylaxis, or PrEP, is another prevention strategy in which HIV-negative people take one pill a day to reduce their risk of acquiring the virus. This intervention is highly effective when individuals adhere to the drug regimen.

While these and other prevention tools have the power to dramatically decrease the incidence of HIV infection, a safe and effective vaccine would be transformative. More than two million new HIV infections occurred worldwide in 2015 alone, and this rate of infection has declined only slightly since 2010. A new National Institutes of Health-funded modeling study (link is external) suggests that a 50-percent effective preventative vaccine could reduce the number of people living with HIV by 36 percent globally over a period of 15 years. Together with the other medical and behavioral prevention modalities that have been proven to decrease the risk of acquiring HIV, a vaccine could change the epidemic’s trajectory, dramatically reducing the number of people who become infected with HIV.

Developing a safe and effective HIV vaccine is one of the most formidable challenges facing scientists today. HIV mutates rapidly, evading immune responses and thwarting the attempts of scientists to develop an effective vaccine. Only a minority of individuals living with HIV develop broadly neutralizing antibodies, a powerful type of antibody that can fight an array of HIV strains by binding to key sites on the virus. In those individuals who do develop such antibodies, they generally appear only after several years of infection, when the virus has already gained a strong foothold in the body.

Despite these challenges, scientists are working to develop a vaccine that may reduce the spread of HIV. On World AIDS Day 2016, NIAID and its partners launched HVTN 702, a phase 2b/3 HIV vaccine efficacy trial. This trial is the first HIV vaccine efficacy study to launch in 7 years, and is currently enrolling 5,400 men and women in South Africa between the ages of 18 and 35. This study will test an experimental vaccine regimen to see if it can extend and amplify the modest success of the vaccine candidate tested in RV144, a clinical trial in Thailand that showed a modest degree of efficacy in 2009.

Another component of the HIV vaccine research effort focuses on inducing the immune system to make the kind of broadly neutralizing antibodies that may protect people from HIV. The NIAID Vaccine Research Center and several NIAID grantees are at the vanguard of this effort.
Two multinational clinical trials testing an investigational anti-HIV broadly neutralizing antibody for preventing HIV infection began last year. Known as the AMP Studies, for antibody-mediated prevention, the trials will test whether giving people a broadly neutralizing HIV antibody as an intravenous infusion every 8 weeks is safe, tolerable and effective at preventing HIV infection among the study participants. With a projected enrollment of 4,200 men and women across three continents, the trials are designed to answer fundamental scientific questions for the fields of HIV prevention and vaccine research.

While the pursuit of a safe and effective HIV vaccine is challenging, this prevention strategy holds lifesaving potential and is NIAID’s highest priority for AIDS research. On this HIV Vaccine Awareness Day, we recognize and thank the thousands of HIV vaccine clinical trial volunteers, researchers, health professionals, activists and others who work together with us toward this goal.

May 18, 2017
Antibodies from Ebola survivor protect mice and ferrets against related viruses
— NIAID-funded study could lead to broad, versatile treatments for many different Ebolaviruses.

FDA-approved drug helps treat rare immunologic disease, study finds
May 17, 2017 — NIH co-funded clinical trial tested alternative treatment for eosinophilic syndrome.

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UNAIDS  [to 20 May 2017]
http://www.unaids.org/
Selected Press Releases & Updates
Update
Myanmar launches new HIV strategic plan
The Ministry of Health and Sports of Myanmar launched the country’s latest five-year HIV plan on 17 May. The plan provides a road map on how to Fast-Track the national HIV response…
 
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PhRMA    [to 20 May 2017]
http://www.phrma.org/press-room
May 15, 2017
ICYMI: New study shows medicines advance life expectancy for HIV patients
… A new study from the Antiretroviral Therapy Cohort Collaboration (ART-CC) found that HIV patients in Europe and North America treated with a combination of three or more antiretroviral therapy (ART) medicines can achieve the same life expectancy of people without HIV. ART-CC estimates that a 20-year-old patient who began treatment with ART between 2008 and 2010 could now live to age 78 – the same life expectancy for the general U.S. population.
In a recent article in STAT, reflecting on the new research, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, commented on the study: “We’re just getting better at what we do….We have better drugs… People are adhering better because they know these drugs really work.”…

Announcements

European Vaccine Initiative  [to 20 May 2017]
http://www.euvaccine.eu/news-events
18 May 2017
Workshop on universal influenza vaccines
The EDUFLUVAC partners, as part of their work programme on the development of a broadly reactive influenza vaccine, are planning a workshop in close collaboration with the FLUTCORE and UNISEC consortia entitled: “Four years of European research on the development of universal influenza vaccines: what have we learnt and how can we move forward?”.
The workshop will be held in Brussels, Belgium on 12-14 June 2017…
 
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IFPMA   [to 20 May 2017]
http://www.ifpma.org/resources/news-releases/
18 May 2017
New Alliance to Drive and Measure Industry Progress to Curb Antimicrobial Resistance
:: New Industry Alliance brings together research-based pharmaceutical companies, generics, biotech and diagnostic companies, to drive and measure industry progress to curb antimicrobial resistance.
:: The AMR Industry Alliance will ensure that signatories collectively deliver on the commitments made in the Declaration (January 2016) and the Roadmap (September 2016) and will measure industry’s progress in the fight against AMR.
:: The Alliance will develop a reporting mechanism to track progress, identify gaps and set targets for the future. Its progress reports will also help to assess what are the key hurdles impeding actions outside of industry’s sole control on reducing antimicrobial resistance and facilitate collaboration between the public and private sector.
 
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Wellcome Trust  [to 20 May 2017]
https://wellcome.ac.uk/news
Opinion / Published: 19 May 2017
Drug-resistant infections: the clock is ticking
This week marks a year since the publication of the International Review on Antimicrobial Resistance (opens in a new tab), a review led by Lord Jim O’Neill and supported by Wellcome and the UK Department of Health.
It set out a plan for governments to tackle the growing problem of drug-resistant infections.
Writing in The Guardian today, Ed Whiting, Wellcome’s Head of Policy and Chief of Staff, looks at what has happened since the review’s publication and explains why without action on antibiotics, medicine will return to the dark ages (opens in a new tab).
 
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FDA [to 20 May 2017]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
What’s New for Biologics
:: May 16, 2017 Approval Letter – MMR II (PDF – 55KB)  Posted: 5/17/2016
:: Meeting Transcript for the Public Workshop: Emerging Tick-Borne Diseases and Blood Safety (PDF – 429KB)  Posted: 5/16/2017
::  May 16, 2017 Approval Letter – PROQUAD (PDF – 56KB) Posted: 5/16/2017
 
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European Medicines Agency  [to 20 May 2017]
http://www.ema.europa.eu/ema/
19/05/2017
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 May 2017
Eleven medicines recommended for approval, including one advanced therapy medicine
 
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Global Fund [to 20 May 2017]
http://www.theglobalfund.org/en/news/?topic=&type=NEWS;&country=
News
Global Fund Rates Highly in Australian Aid Review
15 May 2017
The Global Fund scored a top rating for its effective investment of donor money to respond to HIV, tuberculosis and malaria in a newly released Multilateral Performance Assessment published in the Performance of Australian Aid Report by the Department of Foreign Affairs and Trade.  The assessment confirmed the Global Fund as a strong, results-driven partner, giving consistent ratings of 5 out of 6 across its six criteria.
 
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PATH  [to 20 May 2017]
http://www.path.org/news/index.php
Announcement | May 18, 2017
PATH joins world leaders in defining global health and development priorities at 70th World Health Assembly
PATH leaders are slated to deliver remarks at Assembly Committee meetings and to lend their expertise to several events on the formal agenda, as well as key side events covering issues including research and development, global health security, noncommunicable diseases, access to essential medicines and health technologies, and planning for polio eradication.
 
Announcement | May 17, 2017
PATH statement on the Ebola outbreak in the Democratic Republic of the Congo
[See Ebola/EVD above for full statement]
 
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Reports/Research/Analysis/Commentary/Conferences/Meetings/Book Watch/Tenders

Reports/Research/Analysis/Commentary/Conferences/Meetings/Book Watch/Tenders

Vaccines and Global Health: The Week in Review has expanded its coverage of new reports, books, research and analysis published independent of the journal channel covered in Journal Watch below. Our interests span immunization and vaccines, as well as global public health, health governance, and associated themes. If you would like to suggest content to be included in this service, please contact David Curry at: david.r.curry@centerforvaccineethicsandpolicy.org

IVI   [to 20 May 2017]
http://www.ivi.int/
May 15, 2017
World must join forces to prevent infectious diseases
Op-ed by Dr. Jerome Kim, Director General, IVI
The Dong-A Ilbo (Business Section)
Imagine a world where the emergence of Ebola was rapidly terminated by vaccines that had been developed and stockpiled in anticipation of a crisis. Over 11,000 lives lost and 6 billion dollars later, a year after the Ebola outbreak started, we had the first hint of an effective vaccine.  Bill Gates, Co-chair of the Bill and Melinda Gates Foundation, notes, “Ebola and Zika showed that the world is tragically unprepared to detect local outbreaks and respond quickly enough to prevent them from becoming global pandemics. Without investments in research and development, the world will remain unequipped when we face the next threat.”

The launch of a global coalition that will support development of new vaccines for emerging infectious diseases, was announced at the World Economic Forum in Davos, Switzerland in January. The Coalition for Epidemic Preparedness Innovations (CEPI) has already raised almost half of the $1billion it needs for its first five years. The governments of Germany, Japan and Norway joined forces with the Bill & Melinda Gates Foundation and the Wellcome Trust to make an initial investment of US $460 million. India is considering a major investment. The coalition would welcome other leading scientific countries including Korea to join this partnership, and benefit from it.

There is an already precedent of successful global public-private partnerships that have developed new vaccines, laboratory tests and drugs for global health. As independent Gates Foundation funded projects, organizations like the Foundation for Innovative New Diagnostics (FIND), International Vaccine Institute (IVI), and the Medicines for Malaria Venture (MMV) have work with Korean companies to make products for global health – new tests for rapid diagnosis of infectious diseases, a new vaccine against the disease called cholera, or a medication that works against malaria. In a similar way, but targeting those epidemic diseases that threaten us all, CEPI will be proactive, collective defense through vaccine development, and stockpiling.

CEPI is already receiving proposals from researchers and companies around the world to support the development of vaccines for the initial set of emerging diseases: MERS, Lassa fever and Nipah. Companies can be incentivized for the development of outbreak vaccines and to offset their investments with CEPI funding. Korean biotechnology companies, large and small, have an opportunity, and the Korean government’s plans for the future growth and development of the vaccines industry could be leveraged against CEPI’s funding.

After MERS, and the recent outbreaks of avian influenza and hoof-and-mouth disease, Korea knows the human and economic cost of epidemic disease (animal and human).  The US National Academy of Sciences estimated that the average yearly cost of pandemic disease in the 21st century was 60 billion US dollars.  Against this cost to the global society, GAVI, the Vaccine Alliance estimates that vaccines provide a return on investment (ROI) of 16:1, in other words, 16 dollars of benefit for every dollar spent!.

Infectious diseases do not respect borders. These are potentially lingering problems for Korea but they are also global problems and can be more efficiently addressed collectively by the world. CEPI’s funders commit to the collaborative identification and prioritization of threats, the development of vaccine solutions, and the stockpiling of vaccines against the inevitable outbreaks. To meet these goals, CEPI will need significant additional investment. Korea as the current chair of the Global Health Security Agenda should show leadership by funding CEPI and challenging other nations to do the same.

 

Journal Watch

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