Announcements

Announcements
 
 
BMGF – Gates Foundation  [to 28 April 2018]
http://www.gatesfoundation.org/Media-Center/Press-Releases
APRIL 23, 2018
Global Financing Facility Replenishment Event to Be Co-hosted by Governments of Norway and Burkina Faso, World Bank Group, and Bill & Melinda Gates Foundation
Event in Oslo in November aims to urgently raise funds to save the lives of 38 million women, children and adolescents in 50 countries
OSLO, NORWAY, April 23, 2018 – Every year in 50 countries across the world, more than 5 million mothers and children die from preventable causes, and countries lose billions of dollars to poor health and nutrition. The estimated annual financing shortfall is about US$33 billion on a global level. To end preventable maternal, newborn and child deaths by 2030, countries are acting now to fill the funding gap by investing in the Global Financing Facility (GFF).
The Governments of Norway and Burkina Faso, the World Bank Group, and the Bill & Melinda Gates Foundation announced today that they will co-host the GFF replenishment event on November 6, 2018, in Oslo, Norway. The Government of Norway, one of the initiators of and largest investors in the GFF, will also host a conference focused on development finance, in partnership with the GFF, on November 5, 2018, the day before the GFF replenishment event…

 
CEPI – Coalition for Epidemic Preparedness Innovations  [to 28 April 2018]
http://cepi.net/
Governance
Overview of CEPI Board and Scientific Advisory Committee members

EDCTP    [to 28 April 2018]
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
25 April 2018
A growing malaria R&D portfolio: grants and calls 2014-2018
The fight against malaria requires a concerted effort of many and various partners. EDCTP wholeheartedly supports the fight for a world free of malaria that goes back more than 100 years. To end malaria much effort through a combination of…

European Medicines Agency  [to 28 April 2018]
http://www.ema.europa.eu/ema/
27/04/2018
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 April 2018
Three medicines recommended for approval
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended three medicines for approval at its April 2018 meeting.
The CHMP recommended granting a marketing authorisation for Biktarvy (bictegravir / emtricitabine / tenofovir alafenamide), for the treatment of HIV-1 infection.
One hybrid medicine, Dzuveo (sufentanil) received a positive opinion for the treatment of pain. Hybrid applications rely in part on the results of pre-clinical tests and clinical trials for a reference product and in part on new data.
The Committee recommended for approval the generic medicine Carmustine Obvius (carmustine), for the treatment brain tumours, non-Hodgkin’s lymphoma and Hodgkin’s disease…

26/04/2018
Updated rules for clinical development of vaccines
EMA launches public consultation on revised guideline on clinical evaluation of vaccines …
[See Milestones/Perspectives above for more detail]

25/04/2018
Ten years promoting high-quality scientific research in paediatric medicines
Registration opens for workshop of the European Network of Paediatric Research at EMA (Enpr-EMA), 7–8 June 2018 … \

23/04/2018
European Immunization Week 2018: Statement of Guido Rasi, Executive Director, European Medicines Agency
Protected together, #VaccinesWork
Vaccines matter for each of us: yearly, they prevent 2.7 million people from contracting measles, one million from getting whooping cough and two million babies from getting tetanus.
They eradicated smallpox. They stopped polio, a dreadful disease affecting millions of children, in almost all countries in the world.
Despite these hard facts, many Europeans are hesitant when it comes to immunising themselves or their children.
Between 2016 and 2017, data from the European Centre for Disease Prevention and Control (ECDC) show that the number of people affected by measles more than tripled in the European Union (EU). Of these, 86% were not vaccinated. Since the beginning of 2017, 50 people have died from this disease, although it can be easily prevented through vaccination.
Some parents are actively choosing not to vaccinate their child. This has consequences both for the individuals and for public health. In some communities, vaccination coverage has dropped below 95%, the rate needed to shield the population.
This poses serious risks to vulnerable groups, such as very small babies, people with an immune disorder or people who receive treatment against cancer. They cannot be vaccinated themselves, but are protected when people they come in contact with are vaccinated.
By deciding not to use vaccination, people put themselves, their children and those around them at risk.
Our job at the European Medicines Agency (EMA) is to ensure that only vaccines that are safe and effective are used in the EU. EMA has strict rules for the authorisation of vaccines across Europe. Once they are in use, EMA continuously monitors their safety, so any adverse effects can be promptly detected, investigated and managed.
Immunisation keeps you safe, but at the same time it is a responsibility towards those close to you.
EMA therefore supports European Immunization Week .
We have produced a video together with the community of patients, consumers, doctors, nurses and pharmacists we work with across the EU, who took the time to explain why vaccination matters. Let’s listen to them and reflect.

 
European Vaccine Initiative  [to 28 April 2018]
http://www.euvaccine.eu/news-events
25 April 2018
World Malaria Day 2018: EVI calls for further stepping up investments
European Vaccine Initiative reports positive clinical trial results for two malaria vaccines and calls for further increase in…
 
 
FDA [to 28 April 2018]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
What’s New for Biologics
Maternal vaccination with pertussis vaccine containing only one immunity-stimulating component provides protection against disease in baboon model
Posted: 4/26/2018

IVAC  [to 28 April 2018]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Latest Updates
April 24-30th: Share messages from IVAC’s World Immunization Week 2018 Social Media Toolkit
 
 
MSF/Médecins Sans Frontières  [to 28 April 2018]
http://www.doctorswithoutborders.org/news-stories/press/press-releases
Press release
MSF: USTR Special 301 Report Calls Out Countries for Protecting Public Health
NEW YORK, APRIL 27, 2018—The Office of the United States Trade Representative (USTR) released its annual “Special 301 Report” today, which reviews countries based on their intellectual property (IP) rights protection and enforcement. Countries that are deemed by the U.S. to not protect IP strongly enough are placed on this watch list.

 
NIH  [to 28 April 2018]
http://www.nih.gov/news-events/news-releases
April 25, 2018
Anti-HIV drug combination does not increase preterm birth risk, study suggests
— NIH-funded study could allay concerns about regimens containing TDF.

NIH statement on World Malaria Day 2018
April 25, 2018 — NIH reaffirms its commitment to conduct and support innovative scientific research needed to end malaria.

Sabin Vaccine Institute  [to 28 April 2018]
http://www.sabin.org/updates/pressreleases
April 27, 2018
Statement on New Universal Flu Vaccine Development Grand Challenge
The new $12 million Ending the Pandemic Threat: A Grand Challenge for Universal Influenza Vaccine Development from the Bill & Melinda Gates Foundation and Lucy and Larry Page is an important and necessary step toward finding a game-changing solution to end the threat of flu, according to experts at the Sabin Vaccine Institute (Sabin), a leading advocate for expanding vaccine access and uptake across the world. This challenge invites researchers from any discipline to submit innovative ideas for safe, effective, affordable flu vaccines.
Sabin Vaccine Institute has 25 years of experience catalyzing vaccine innovation through collaboration and partnerships. Bruce Gellin, M.D., M.P.H., Sabin’s president of Global Immunization and lead on influenza efforts, welcomed today’s announcement with the following statement:
“The Grand Challenge is a strong example of how we can invigorate influenza research and stimulate interest to accelerate the development of a long-lasting, universal flu vaccine. The Gates Foundation and Page Family are right to encourage innovative approaches by the world’s best thinkers across a variety of disciplines— beyond the traditional flu community…

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.
[See Milestones, Perspectives above for more detail]
 

UNAIDS [to 28 April 2018]
http://www.unaids.org/en
27 April 2018
Reaching people who inject drugs with HIV services in Finland

Urgent work ahead for Start Free Stay Free AIDS Free

26 April 2018
The injustices faced by transgender women in Peru

Mobile phones provide massive potential to move towards e-health systems
Read

25 April 2018
UNAIDS ambassadors speak out to stop discrimination
Read

Egyptian medical students meet to address stigma and discrimination in health-care settings
Read

UNICEF  [to 28 April 2018]
https://www.unicef.org/media/
Selected Press Releases
17 April 2018
Ten things you didn’t know about malaria
New York, 25 April 2018 – Every two minutes, a child dies of malaria .
Malaria is a preventable and treatable disease that remains, in many regions of the world, a major public health problem . Ninety-one countries currently experience ongoing malaria transmission. Almost half the world’s population – about 3.2 billion people – are at risk of malaria. In 2016 alone, 216 million new cases of malaria were reported, and approximately 445,000 people died of the disease – most of them children.

Twelve things you didn’t know about immunization
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.
[See Milestones, Perspectives above for full text]

 
Vaccine Confidence Project  [to 28 April 2018]
http://www.vaccineconfidence.org/
26 Apr, 2018
Rise in vaccine hesitancy related to pursuit of purity
Heidi Larson
Immunization Week 24-30 April 2018   “Protected Together”
Interview published in HORIZON — The rise of alternative health practices and a quest for purity can partly explain the falling confidence in vaccines which is driving outbreaks of preventable diseases such as measles
 

Vaccine Education Center – Children’s Hospital of Philadelphia  [to 28 April 2018]
http://www.chop.edu/centers-programs/vaccine-education-center
April 2018
Newsletter – Vaccine Update for Providers
The March webinar, Current Issues in Vaccines, is available online for viewing. During the event, Dr. Offit discussed the following topics:
:: Novel hepatitis B vaccine: ACIP recommendations
:: : Updates on vaccine efficacy and disease burden
:: HPV: Updates on vaccine safety and long-term efficacy
:: Meningococcal disease: Revised data on risk for college students

Wellcome Trust  [to 28 April 2018]
https://wellcome.ac.uk/news
Q&A / Published: 23 April 2018
Why do we need vaccines?
Vaccines are one of our most effective health interventions, but are often misunderstood. In this Q&A, we explain what they are, how they work and why they are important.

 
The Wistar Institute   [to 28 April 2018]
https://www.wistar.org/news/press-releases
Press Release   Apr. 27 2018
Wistar and Ben Franklin Technology Partners of Southeastern Pa. Forge Collaboration to Accelerate Technology Commercialization
Wistar and Ben Franklin Technology Partners of Southeastern Pennsylvania, a nonprofit conglomerate of partners providing direct/seed funding, mentorship and networks to strengthen enterprise development, have signed a Memorandum of Understanding (MoU) to accelerate the advancement of early-stage life sciences start-ups coming out of Wistar…

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DCVMN – Developing Country Vaccine Manufacturers Network  [to 28 April 2018]
http://www.dcvmn.org/
28 April 2018
Regional workshop: Optimization of vaccines’ manufacturing, containers and testing for global supply
7 May 2018 to 10 May 2018
Hyderabad / India
 
PhRMA    [to 28 April 2018]
http://www.phrma.org/press-room
April 27, 2018
PhRMA Welcomes 2018 Special 301 Report
Applauds Administration for Combatting Discriminatory Pricing and Intellectual Property Barriers Abroad
Washington, D.C.— The Pharmaceutical Research and Manufacturers of America (PhRMA) welcomed the 2018 Special 301 Report, including a new section devoted to pharmaceutical market access barriers, released today by U.S. Trade Representative (USTR) Robert Lighthizer. The Report highlights serious threats America’s biopharmaceutical innovators face in countries around the world, including with trading partners like Canada, Japan, Colombia and others…
PhRMA’s Special 301 submission asked USTR to name Korea, Canada and Malaysia Priority Foreign Countries, a designation reserved for economies with the most onerous and egregious intellectual property or market access practices that have the greatest impact on U.S. products. Earlier this year, USTR secured a commitment under the U.S.–Korea Free Trade Agreement (KORUS) that Korea will end some discriminatory pricing and reimbursement policies. USTR today downgraded Canada from the Watch List to the Priority Watch List and committed to an Out-of-Cycle review of Malaysia’s intellectual property system.
The USTR report also places a priority on solving longstanding problems in India, Indonesia, Chile and other countries, and heading off emerging threats in Colombia and Saudi Arabia…

Industry Watch    [to 28 April 2018]
:: Zoetis to Expand Animal Vaccine Research and Manufacturing in Suzhou, China
April 26, 2018
   Company begins construction of state-of-the-art vaccine manufacturing and research and development facilities in Suzhou to support growth
   Operations to focus on development and manufacturing of vaccines for pigs, cattle and fish and companion animals tailored to the animal health needs of China

:: Pfizer Granted FDA Breakthrough Therapy Designation for TRUMENBA® (Meningococcal Group B Vaccine) for the Prevention of Invasive Meningococcal B Disease in Children Ages 1 to 9 Years
April 23, 2018