WHO & Regionals [to 28 March 2015]

WHO & Regionals [to 28 March 2015]
:: Millions of Syrians endure deteriorating health crisis: WHO calls for increased funding
March 2015 – It is estimated that there are more than 1.3 million people in need of health assistance in Aleppo. Ahead of next week’s third International Humanitarian Pledging Conference for Syria in Kuwait, the WHO appeals for US$ 124 million to continue its support to health services in the Syrian Arab Republic.

:: Cyclone Pam delivers a devastating blow to health services in Vanuatu
25 March 2015 –WHO is responding to the health needs of those affected by Tropical Cyclone Pam – a storm which has been described as the strongest cyclone in the Pacific in more than a decade. To be able to respond to these crisis and provide emergency medical supplies and support to re-establishment of the health system WHO is requesting US$ 3 Million.
– WHO donor alert for Cyclone Pam

:: Global Alert and Response (GAR): Disease Outbreak News (DONs)
– 26 March 2015 Middle East respiratory syndrome coronavirus (MERS-CoV) – Saudi Arabia

:: The Weekly Epidemiological Record (WER) 27 March 2015, vol. 90, 12 (pp. 109–120) includes:
– Reducing mortality from emerging diseases
– Meningococcal disease control in countries of the African meningitis belt, 2014

:: WHO Regional Offices
WHO African Region AFRO
:: First Ebola Vaccine to Be Tested in Affected Communities One Year into Outbreak Ring Vaccination Starts in Coyah, Guinea 25 March 2015

:: Central African Republic: health emergency at a crossroads 25 March 2015

:: Message of the Regional Director on the occasion of World Tuberculosis Day 2015
WHO Region of the Americas PAHO
:: PAHO/WHO urges better detection and treatment of tuberculosis to “End TB” in the Americas (03/23/2015)

WHO South-East Asia Region SEARO
:: One year of polio-free certification 27 March 2015

:: World Water Day 2015: Water and Sustainable Development 22 March 2015

WHO European Region EURO
:: Europe leading the way in plain packaging legislation for tobacco products 26-03-2015

:: New WHO report shows that transparency and cooperation help to reduce high prices for new medicines 26-03-2015

:: Using price policies to promote healthier diets 23-03-2015

WHO Eastern Mediterranean Region EMRO
:: Millions of Syrians endure deteriorating health crisis: WHO calls for increased funding
Aleppo, Syria, 27 March, 2015 – Ahead of next week’s third International Humanitarian Pledging Conference for Syria in Kuwait, WHO appeals for US$ 124 million to continue its support to health services in the Syrian Arab Republic…

:: WHO and health partners respond to increased health needs as a result of conflict in Yemen
26 March 2015

WHO Western Pacific Region
:: Brunei Darussalam, Cambodia, Japan verified as achieving measles elimination
MANILA, 27 March 2015 – Brunei Darussalam, Cambodia and Japan have been verified as having achieved measles elimination by the Measles Regional Verification Commission. The three countries join Australia, Macao SAR (China), Mongolia and the Republic of Korea as countries and areas in the Western Pacific Region that have successfully eliminated measles

CDC/MMWR/ACIP Watch [to 28 March 2015]

CDC/MMWR/ACIP Watch [to 28 March 2015]

:: ACIP Presentation Slides: February 2015 Meeting
February 26, 2015

:: MMWR Weekly March 27, 2015 / Vol. 64 / No. 11
– Use of 9-Valent Human Papillomavirus (HPV) Vaccine: Updated HPV Vaccination Recommendations of the Advisory Committee on Immunization Practices
– Updated Recommendations for the Use of Typhoid Vaccine — Advisory Committee on Immunization Practices, United States, 2015

Sabin Vaccine Institute Watch [to 28 March 2015]

Sabin Vaccine Institute Watch [to 28 March 2015]

Dr. Gary Michelson Receives Albert B. Sabin Humanitarian Award
WASHINGTON, D.C. — March 25, 2015 — The Sabin Vaccine Institute (Sabin) will present the Albert B. Sabin Humanitarian Award to Gary Michelson, MD, a distinguished orthopedic spinal surgeon and inventor, in recognition of his extraordinary philanthropy and commitment toward the control and elimination of neglected tropical diseases (NTDs) through high-level advocacy and vaccine research and development. He will be honored today at a private event with Sabin’s executive leadership, Board of Trustees and key members of the scientific community in Houston, Texas.

European Medicines Agency Watch [to 28 March 2015]

European Medicines Agency Watch [to 28 March 2015]

Gardasil 9 offers wider protection against cancers caused by human papillomavirus (HPV)
Vaccine covers five more types of HPV than previously approved Gardasil vaccine
The European Medicines Agency (EMA) has recommended Gardasil 9 (human papillomavirus vaccine) for the prevention of diseases caused by nine types of human papillomavirus (HPV). This means that Gardasil 9 covers five more HPV types than Gardasil, one of two HPV vaccines available in the European Union (EU)…

…Gardasil 9 is recommended for use in boys and girls from nine years of age to protect against cervical cancer and pre-malignant cervical lesions, vulvar and vaginal cancers and pre-malignant vulvar and vaginal lesions, pre-malignant anal lesions and anal cancers and external genital warts covered by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58…
…The safety of Gardasil 9 was evaluated in more than 23,000 people in seven clinical trials. The assessment also took into account experience from the use of Gardasil, which has been authorised in the EU since 2006. The most commonly reported adverse reactions were injection site pain, swelling, redness, and headaches.

Gardasil 9 is administered in three separate injections, with the initial dose followed by additional injections given two and six months later. All three doses should be given within a one year period.

The company received scientific advice from the Committee for Medicinal Products for Human Use (CHMP) which pertained to clinical aspects of the company’s application.

The opinion adopted by the CHMP at its March 2015 meeting is an intermediary step on Gardasil 9’s path to patient access. The CHMP opinion will now be sent to the European Commission for the adoption of a decision on EU-wide marketing authorisation. Once a marketing authorisation has been granted, a decision about price and reimbursement will then take place at the level of each Member State considering the potential role/use of this vaccine in the context of the national health system of that country.


Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 March 2015
Five new medicines, including one orphan, recommended for approval
…One recommendation on extension of therapeutic indication
The Committee recommended an extension of indication for Tamiflu to include the treatment of influenza in infants below one year of age.


Regulatory information – EU recommendations for 2015/2016 seasonal flu vaccine composition
EMA annual recommendations are based on WHO observations
The European Medicines Agency has issued the European Union (EU) recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2015.

Trivalent vaccines for the 2015/2016 season should contain these three virus strains:
:: an A/California/7/2009 (H1N1)pdm09-like virus
:: an A/Switzerland/9715293/2013 (H3N2)-like virus
:: a B/Phuket/3073/2013-like virus

For quadrivalent vaccines with two influenza B viruses, a B/Brisbane/60/2008-like virus in addition to the strains mentioned above is considered appropriate.
Detailed recommendations including the specific virus strains recommended are available in a report from the Biologics Working Party (BWP) ad-hoc Influenza Working Group…

Industry Watch [to 28 March 2015]

Industry Watch [to 28 March 2015]
:: Sanofi Pasteur Announces FDA Approval of Quadracel DTaP-IPV Combination Vaccine for Children Aged 4-6
March 26, 2015
Approval allows children to receive a combination of two recommended vaccinations
SWIFTWATER, Pa., March 25, 2015 /PRNewswire/ — Sanofi Pasteur, the vaccines division of Sanofi, announced today that the U.S. Food and Drug Administration (FDA) has approved use of Quadracel™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis Absorbed and Inactivated Poliovirus; DTaP-IPV) vaccine for active immunization against diphtheria, tetanus, pertussis and poliomyelitis in children 4 through 6 years of age.

“The FDA approval of Quadracel vaccine provides health care providers with a new combination vaccine, potentially reducing the number of vaccine injections children aged 4 through 6 would need,” said David P. Greenberg, M.D., Vice President, U.S. Scientific and Medical Affairs, Sanofi Pasteur. “Our goal is to help remove barriers to timely immunization and we think this combination vaccine could help ensure children are getting vaccinated in line with current recommendations.”…

…This FDA approval is based on data from a pivotal multicenter, randomized, controlled, Phase III study designed to compare the safety and immunogenicity of Quadracel vaccine (DTaP-IPV) with DAPTACEL (DTaP) and IPOL (IPV) vaccines in children 4 through 6 years of age who were previously vaccinated with DAPTACEL and/or Pentacel (DTaP-IPV/Hib) vaccines. Results show Quadracel vaccine has similar safety and immunogenicity profiles as compared to those of separately administered DAPTACEL and IPOL vaccines…

UNICEF Watch [to 28 March 2015]

UNICEF Watch [to 28 March 2015]
:: Easier access to the most reliable and up-to-date stats on children through UNICEF’s revamped data websites

NEW YORK, 23 March 2015 – UNICEF has made all its data on health, nutrition, education, water and sanitation, child protection, and HIV/AIDS publicly available, in an easily searchable format which includes redesigned country profiles and a new data visualisation tool for the creation of charts, maps and graphs: UNICEF DATA AND ANALYTICS. All of which make UNICEF the most reliable and up-to-date source of statistics on women and children.

Problems that go unmeasured often go unsolved. Consistent, credible data about children, their families and their communities are critical to the improvement of children’s lives and indispensable to the realisation of their rights.

UNICEF’s data provide a fuller picture than ever before of the situation of children across the globe. The data tells intricate and detailed stories about where and how children are born and cared for, how they grow, learn, work and connect with others, and how they make their way in the world.

U.S. White House: Our Plan to Combat and Prevent Antibiotic-Resistant Bacteria

U.S. White House: Our Plan to Combat and Prevent Antibiotic-Resistant Bacteria
Secretary Sylvia Mathews Burwell, Secretary Tom Vilsack, Secretary Ash Carter
March 27, 2015
Antibiotics save millions of lives every year. Today, however, the emergence of drug resistance in bacteria is undermining the effectiveness of current antibiotics and our ability to treat and prevent disease. The Centers for Disease Control and Prevention (CDC) estimates that drug-resistant bacteria cause two million illnesses and approximately 23,000 deaths each year in the United States alone. Antibiotic resistance also limits our ability to perform a range of modern medical procedures, such as chemotherapy, surgery, and organ transplants. That’s why fighting antibiotic resistance is a national priority.

Over the past year, the Administration has taken important steps to address the threat of antibiotic resistance. In September 2014, the President issued Executive Order (EO) 13676: Combating Antibiotic-Resistant Bacteria, which outlines steps for implementing the National Strategy on Combating Antibiotic-Resistant Bacteria and addressing the policy recommendations of the President’s Council of Advisors on Science and Technology (PCAST)’s report on Combating Antibiotic Resistance. Furthermore, the President’s FY 2016 Budget released earlier this year proposed nearly doubling the amount of Federal funding for combating and preventing antibiotic resistance to more than $1.2 billion.

Combating and preventing antibiotic resistance, however, will be a long-term effort. That’s why, today, the Administration is releasing the National Action Plan for Combating Antibiotic Resistant Bacteria (NAP).

The NAP outlines a whole-of-government approach over the next five years targeted at addressing this threat:
1. Slow the emergence of resistant bacteria and prevent the spread of resistant infections
The judicious use of antibiotics in health care and agriculture settings is essential to combating the rise in antibiotic resistance. We can help slow the emergence of resistant bacteria by being smarter about prescribing practices across all human and animal health care settings, and by continuing to eliminate the use of medically-important antibiotics for growth promotion in animals.

2. Strengthen national “One-Health” surveillance efforts
A “One-Health” approach to disease surveillance will improve detection and control of antibiotic resistance by integrating data from multiple monitoring networks, and by providing high-quality information, such as detailed genomic data, necessary to tracking resistant bacteria in diverse settings in a timely fashion.

3. Advance development and use of rapid and innovative diagnostic tests
The development of rapid “point-of-need” diagnostic tests could significantly reduce unnecessary antibiotic use by allowing health care providers to distinguish between viral and bacterial infections, and identify bacterial drug susceptibilities during a single health care visit making it easier for providers to recommend appropriate, targeted treatment.

4. Accelerate basic and applied research and development
New antibiotics and alternative treatments for both humans and animals are critical to maintaining our capacity to treat and prevent disease. This involves supporting and streamlining the drug development process, as well as increasing the number of candidate drugs at all stages of the development pipeline. Additionally, boosting basic research to better understand the ecology of antibiotic resistance will help us develop effective mitigation strategies.

5. Improve international collaboration and capacities
Antibiotic resistance is a global problem that requires global solutions. The United States will engage with foreign ministries and institutions to strengthen national and international capacities to detect, monitor, analyze, and report antibiotic resistance; provide resources and incentives to spur the development of therapeutics and diagnostics for use in humans and animals; and strengthen regional networks and global partnerships that help prevent and control the emergence and spread of resistance.

The NAP is a comprehensive effort that will require the coordinated and complementary efforts of individuals and groups around the world, including public- and private-sector partners, health care providers, health care leaders, veterinarians, agriculture industry leaders, manufacturers, policymakers, and patients. Working together, we can turn the tide against the rise in antibiotic resistance and make the world a healthier and safer place for the next generation.


National Action Plan for Combating Antibiotic Resistant Bacteria (NAP)
The White House, Washington
March 2015 :: 63 pages
Pdf: https://www.whitehouse.gov/sites/default/files/docs/national_action_plan_for_combating_antibotic-resistant_bacteria.pdf

Vision: The United States will work domestically and internationally to prevent, detect, and control illness and death related to infections caused by antibiotic-resistant bacteria by
implementing measures to mitigate the emergence and spread of antibiotic-resistance and ensuring the continued availability of therapeutics for the treatment of bacterial infections.