Opinions No more excuses. We have the tools to end the HIV/AIDS pandemic.

Washington Post
http://www.washingtonpost.com/
Accessed 9 January 2016

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Opinions
No more excuses. We have the tools to end the HIV/AIDS pandemic.
By Anthony S. Fauci January 8 at 7:51 PM
Anthony S. Fauci is director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.

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In the summer of 1981, the world became aware of a mysterious new disease that was seen initially among a relatively small group of gay men in the United States and was soon shown to be caused by the human immunodeficiency virus. Fast- forward more than 30 years, and the entire world is struggling with one of the most devastating pandemics in history. More than 70 million infections have occurred, predominantly among heterosexuals in the developing world, resulting in more than 30 million deaths. Despite these horrendous statistics, advances in HIV treatment and prevention have transformed the lives of those HIV-infected people who have access to health care, and have provided us with highly effective methods of preventing HIV infection.

So why does this global pandemic continue to rage? It is not that we lack the medical advances and interventions to end the pandemic. It is that our proven tools have not been implemented adequately or uniformly.

Combination anti-HIV therapy became available in the mid-1990s, and although the drug regimens were highly effective in suppressing the virus to below detectable levels and allowed patients to live relatively healthy lives, some questioned whether the cumulative toxicities of long-term drug therapy would negate the beneficial effects over time. Controlled clinical trials have since put that concern to rest by showing that the mostly manageable toxicities of anti-HIV therapy are much less harmful than continued HIV replication in the absence of therapy.

Next, a groundbreaking study demonstrated that treating HIV-infected individuals sooner rather than later dramatically diminished the likelihood that they would infect their sexual partners. The public- health benefit of treatment for the prevention of further transmission was clear.

Still, some argued that the health benefit to the infected person was unproven, putting clinicians in an unenviable position: They knew that infected individuals with uncontrolled virus could infect others, but they were unable to strongly recommend treatment for their patients. A study published last year put an end to this dilemma by showing that treating a person as soon as possible after diagnosis was much more beneficial than waiting until the person’s immune system showed damage. With these pivotal studies, there is now no excuse for delay; every person infected with HIV should be offered antiviral drugs upon diagnosis.

But doing so requires seeking out those at risk for infection and testing them; linking infected individuals to medical care; working to keep them in care; and providing anti-HIV drugs. It also requires careful attention to barriers to care such as poverty, substance abuse, and housing and food insecurity. Globally and domestically, we have not yet achieved this.

Most of this refers to those who are already HIV-infected. However, 2 million new infections occur globally each year, including 50,000 in the United States; the latter number has remained steady for almost two decades. The frustrating fact is that we know exactly who is infecting whom. Of the approximately 1.2 million people living with HIV in the United States, the 13 percent who do not know they are infected are responsible for transmitting about 30 percent of new infections per year. Even more striking, more than 60 percent of new HIV infections are transmitted by people who are aware they have HIV but who are not receiving appropriate care. Thus, if we identified all the infected people in the country and got them into continuous, effective care, including anti-HIV treatment, we could prevent more than 90 percent of new infections each year.

For uninfected, at-risk individuals, several modalities of prevention are available. An important recent advance comes from a series of clinical trials that convincingly demonstrated that regularly taking a single pill containing two anti-HIV drugs can reduce an individual’s risk of contracting HIV by more than 90 percent. Unfortunately, this prevention strategy — called pre-exposure prophylaxis, or PrEP — is vastly underutilized. The Centers for Disease Control and Prevention estimates that more than 1.2 million people in the United States are at substantial risk of HIV infection and could benefit from PrEP; however, less than 5 percent of these people are taking it. To make matters worse, one- third of primary- care doctors and nurses are unaware of PrEP and its potential health advantages. This must change.

Even in the absence of an effective HIV vaccine, which would be the final nail in the coffin of the pandemic, we have the tools to end the HIV/AIDS epidemic in the United States and globally. We can save the lives of infected individuals and prevent them from infecting others by getting them into treatment programs and maintaining them there. In addition, we can effectively prevent HIV infection in at-risk populations by a number of means, including the use of the highly effective PrEP.

It is often said that we were slow to recognize the seriousness of the emerging HIV pandemic during the early 1980s. At the time, our ability to fight its spread was meager. Today, we have the tools to end this modern-day plague. We must not squander the opportunity. History will judge us harshly if we do.

Vaccines and Global Health: The Week in Review 2 January 2016

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_2 January 2016

blog edition: comprised of the approx. 35+ entries posted below on 3 January 2016.

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 Policy
a program of the
– Division of Medical Ethics, NYU Medical School
– Children’s Hospital of Philadelphia Vaccine Education Center
Associate Faculty, Division of Medical Ethics, NYU Medical School

EBOLA/EVD [to 2 January 2016]

EBOLA/EVD [to 2 January 2016]
Public Health Emergency of International Concern (PHEIC); “Threat to international peace and security” (UN Security Council)

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Ebola Situation Report – 30 December 2015
SUMMARY
:: No confirmed cases of Ebola virus disease (EVD) were reported in the week to 27 December. On 29 December, WHO declared that human-to-human transmission of Ebola virus has ended in Guinea, after the completion of 42 days with zero cases since the last person confirmed to have EVD received a second consecutive negative blood test for Ebola virus RNA. Guinea has now entered a 90-day period of heightened surveillance.

:: Human-to-human transmission linked to the most recent cluster of cases in Liberia will be declared to have ended on 14 January 2016, 42 days after the 2 most-recent cases received a second consecutive negative test for Ebola virus, if no further cases are reported. In Sierra Leone, human-to-human transmission linked to the primary outbreak was declared to have ended on 7 November 2015. The country has now entered a 90-day period of enhanced surveillance scheduled to conclude on 5 February 2016.

:: The 8th meeting of the Emergency Committee convened by the WHO Director-General under the International Health Regulations (2005) regarding the EVD outbreak in West Africa took place by teleconference on 15 December 2015. Based on the advice of the Committee, the Director-General declared that the 2014–15 Ebola outbreak continues to constitute a Public Health Emergency of International Concern….

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WHO: End of Ebola transmission in Guinea
29 December 2015 — Today WHO declares the end of Ebola virus transmission in the Republic of Guinea. Forty-two days have passed since the last person confirmed to have Ebola virus disease tested negative for the second time. Guinea now enters a 90-day period of heightened surveillance to ensure that any new cases are identified quickly before they can spread to other people.
Read the news release from WHO African Region

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UNICEF [to 2 January 2016]
http://www.unicef.org/media/media_78364.html

UNICEF welcomes declaration of the end of Ebola outbreak in Guinea
CONAKRY, 29 December 2015 – Almost two years to the day when a toddler became the first victim of Ebola in West Africa, UNICEF welcomed the declaration that the outbreak has ended in Guinea, but cautioned that the thousands of children orphaned by the disease, as well as those who survived infection, will need continued support.

“While we mark this occasion, we must all remember that children were greatly impacted by Ebola. They were more likely to die if infected. Over 22,000 children lost one or both parents in Guinea, Liberia and Sierra Leone. They are traumatized and continue to be stigmatized in their neighbourhoods. For thousands of girls and boys, the outbreak does not end today. It will be with them throughout their lives. Let us commit to be with them too,” said Dr. Mohamed Ag Ayoya, UNICEF’s Representative in Guinea….

One of the main challenges moving forward will be to rebuild and strengthen health systems, which were profoundly impacted by Ebola. In Guinea, vaccinations for children under one year dropped 30 per cent, all hospitalizations fell 54 per cent and assisted deliveries by a trained practitioner dropped 11 per cent between January and August 2014, according to the Government.

“Weak health systems fuelled the outbreak in all three countries. And, today, the system in Guinea is even weaker,” said Ayoya…

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World Health Organization to Review Merck’s Investigational Ebola Vaccine for Emergency Use Assessment and Listing
December 23, 2015
KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the application for Emergency Use Assessment and Listing (EUAL) for the company’s investigational Ebola Zaire vaccine, V920 (rVSV∆G-ZEBOV-GP, live attenuated), has been accepted for review by the World Health Organization (WHO).

“This application to the WHO is an important step toward enabling V920 to be used if a public health emergency of international concern were to be declared for the Ebola Zaire species prior to licensure of the vaccine candidate”

According to the WHO, the EUAL process is designed to expedite the availability of vaccines needed for public health emergencies such as another outbreak of Ebola. The procedure is intended to assist United Nations’ procurement agencies and Member States on the acceptability of using a vaccine candidate in an emergency-use setting. EUAL designation is not prequalification by WHO, but rather is a special procedure implemented when there is an outbreak of a disease with high rates of morbidity and/or mortality and a lack of treatment and/or prevention options. In such instances, WHO may recommend making a vaccine available for a limited time, while further clinical trial data are being gathered for formal regulatory agency review by a national regulatory authority.

“This application to the WHO is an important step toward enabling V920 to be used if a public health emergency of international concern were to be declared for the Ebola Zaire species prior to licensure of the vaccine candidate,” said Paula Annunziato, M.D., vice president for clinical research, Merck Research Laboratories.

The decision to grant V920 EUAL status will be based on data regarding quality, safety, and efficacy/effectiveness; as well as a risk/benefit analysis for emergency use. While EUAL designation allows for emergency use, the vaccine remains investigational and has not yet been licensed for commercial distribution.

For more information on the WHO’s EUAL process please visit: http://www.who.int/en/…

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WHO: Rebuilding resilient health systems in the aftermath of an outbreak
December 2015 — Recovering from Ebola requires getting essential health services back up and running in a safe and reliable way, and addressing the weaknesses of the system. WHO is supporting Guinea, Liberia and Sierra Leone on the road to recovery.

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Sierra Leone awards the Ebola fighters
23 December 2015 — The work of WHO Ebola fighters, many of whom have spent more than a year working to stop the outbreak, was recognized by His Excellency, the President of Sierra Leone this weekend in a special ceremony. All four recipients of the award have worked tirelessly along with WHO colleagues and thousands of others, both local and international, to bring this unprecedented outbreak under control.

POLIO [to 2 January 2016]

POLIO [to 2 January 2016]
Public Health Emergency of International Concern (PHEIC)

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GPEI Update: Polio this week as of 30 December 2015
http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx
:: Looking back at 2015, the programme has seen remarkable steps forward towards polio eradication. A wrap-up of the year shows fewer cases in fewer places than ever before. The report on the status of polio eradication to WHO’s Executive Board also summarizes the progress on the Polio Endgame Plan, and on Resolution WHA68.3, adopted by the World Health Assembly (WHA) in May 2015. The year to come will need strengthened momentum to build on these gains and deliver a polio-free world.
:: There are four months to go until the globally synchronized switch from the trivalent to bivalent oral polio vaccine. This will be an important milestone in achieving a polio-free world. Read more
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[No new cases identified in Country-level reports in this week’s Update]

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Circulating vaccine-derived poliovirus – Myanmar
WHO – Disease outbreak news
21 December 2015
The National IHR Focal Point of Myanmar has notified WHO of 2 cases of circulating vaccine-derived poliovirus type 2 (cVDPV2)….

National vaccination coverage is estimated to be 76% (WHO/UNICEF estimates, 2014). Vaccination coverage is lower among special risk populations. National surveillance indicator rates in Myanmar are good (2015 non-polio AFP rate: 1.8; 93% adequate stool collection percentage); however, subnational gaps persist…

Considering the globally synchronized withdrawal of type 2 OPV in April 2016 (through the switch from tOPV to bivalent OPV – bOPV), efforts are underway to ensure that transmission of any cVDPV2 is interrupted ahead of that date. Myanmar has developed a national switch plan which was endorsed by the Ministry of Health. The plan is to move from tOPV to bOPV on 29 April. Inactivated polio vaccine (IPV) was launched throughout the country on 3 December…

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Afghanistan polio worker killed by gunmen
Reuters (12/28) KANDAHAR, Afghanistan
Two gunmen on a motorbike shot and killed a female polio vaccination campaigner in Afghanistan on Monday and seriously wounded her granddaughter, officials said.

No group claimed responsibility for the attack but Islamists in some parts of the world believe campaigns against the crippling disease are a plot against Muslims or an attempt to spy on militants.

The pair, a woman and her teenaged granddaughter, were eradication-campaign volunteers, going house to house in the southern city of Kandahar when they were shot, said senior provincial health official Abdul Qayum Pukhla.

“Today was the last day of campaign and as the workers were leaving a house, the gunmen opened fire on them and fled,” Pukhla told Reuters…

WHO & Regionals [to 2 January 2016]

WHO & Regionals [to 2 January 2016]
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Ethical principles for protecting health workers during armed conflict and other emergencies
December 2015 — More than 600 health workers were killed and 958 injured in 32 countries during 2014. WHO has welcomed a statement of ethical principles for health workers that aims to ensure the impartiality and protection of medical personnel during armed conflicts and other emergencies.

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Research and development blueprint
December 2015 — WHO has convened a broad global coalition of experts to develop the blueprint and a platform for accelerated research and development to strengthen the emergency response. The blueprint will be presented to Member States at the next World Health Assembly in May 2016.

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Disease Outbreak News (DONs)
:: 22 December 2015 – Zika virus infection – Panama
:: 21 December 2015 – Zika virus infection – Honduras
:: 21 December 2015 – Zika virus infection – Cape Verde

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:: WHO Regional Offices
WHO African Region AFRO
:: End of Ebola transmission in Guinea
Geneva, 29 December 2015 – Today the World Health Organization (WHO) declares the end of Ebola virus transmission in the Republic of Guinea. Forty-two days have passed since the last person confirmed to have Ebola virus disease tested negative for the second time. Guinea now enters a 90-day period of heightened surveillance to ensure that any new cases are identified quickly before they can spread to other people.
:: Six World Health Organization staff in Sierra Leone honoured – 18 December 2015

WHO Region of the Americas PAHO
No new digest content identified.

WHO South-East Asia Region SEARO
No new digest content identified.

WHO European Region EURO
No new digest content identified.

WHO Eastern Mediterranean Region EMRO
:: WHO delivers medical aid for 1.2 million people in Taiz, Yemen, during ceasefire
24 December 2015, Sana’a, Yemen — The World Health Organization (WHO) has delivered more than 100 tonnes of medicines and medical supplies for more than one million beneficiaries in 8 districts of the Taiz governorate, where more than 3 million people, including 392 000 internally displaced persons, are in dire need of humanitarian assistance. The health supplies, which were delivered following the announcement of the ceasefire, consist of urgently needed oxygen cylinders, medicines and medical devices, including surgical supplies and equipment for the management of trauma cases.

WHO Western Pacific Region
No new digest content identified.

CDC/ACIP [to 2 January 2016]

CDC/ACIP [to 2 January 2016]
http://www.cdc.gov/media/index.html

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First case of Zika virus reported
THURSDAY, DECEMBER 31, 2015
The Puerto Rico Department of Health reported today the first locally acquired case of Zika virus infection in Puerto Rico. Zika was confirmed in a resident of Puerto Rico…

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CDC Year in Review: What’s Next?
Dec 28, 2015, 11:41 ET
In a digital press kit released today, CDC reviews the most pressing public health challenges of 2015 and previews plans for 2016. CDC has made significant strides combatting some of the biggest threats to Americans’ health, including infectious and chronic diseases.

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Enhanced Entry Airport Screening for Ebola Modified for Travelers from Guinea to the United States
MONDAY, DECEMBER 28, 2015
On Dec. 29, 2015, the Centers for Disease Control and Prevention (CDC) and the Department of Homeland Security (DHS) will modify enhanced Ebola port-of-entry screening for travelers from Guinea.

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CDC To Play Key Role in National Multidrug-Resistant TB Plan – Media Statement
TUESDAY, DECEMBER 22, 2015

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Enhanced Entry Airport Screening for Ebola to End for Travelers from Sierra Leone to the United States – Media Statement
MONDAY, DECEMBER 21, 2015

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MMWR Weekly – January 1, 2016 / Nos. 50 & 51/ Volume (64)
http://www.cdc.gov/mmwr/index2015.html
:: Tuberculosis Contact Investigations — United States, 2003–2012
:: Fatal Bacterial Meningitis Possibly Associated with Substandard Ceftriaxone — Uganda, 2013

FACT SHEET: Obama Administration Releases National Action Plan for Combating Multidrug-Resistant Tuberculosis

FACT SHEET: Obama Administration Releases National Action Plan for Combating Multidrug-Resistant Tuberculosis
The White House
December 22, 2015
Today, the White House released a comprehensive plan that identifies critical actions to be taken by key Federal departments and agencies to combat the global rise of multidrug-resistant tuberculosis (MDR-TB). The National Action Plan for Combating Multidrug-Resistant Tuberculosis (hereafter referred to as the National Action Plan), developed by an interagency working group in response to Executive Order 13676: Combating Antibiotic-Resistant Bacteria and the National Action Plan for Combating Antibiotic Resistant Bacteria, identifies a set of targeted interventions that address the core domestic and global challenges posed by MDR-TB and extensively drug-resistant TB (XDR-TB). The recommended interventions represent the U.S. Government’s contributions to reversing the worldwide spread of MDR-TB and can help inform policy development processes around the world. The National Action Plan is an effort to articulate a comprehensive strategy, and to mobilize political will and additional financial and in-kind commitments from bilateral and multilateral donor partners, private-sector partners, and governments of all affected countries…

The National Action Plan is organized around three goals that aim to strengthen health-care services, public health, and academic and industrial research through collaborative action by the U.S. Government in partnership with other nations, organizations, and individuals:

Goal 1: Strengthen Domestic Capacity to Combat MDR-TB.
Each year in the United States, around 100 individuals are diagnosed with MDR-TB and health authorities must follow up with every patient to ensure appropriate treatment and to determine if others have been infected and require treatment or preventive services. Goal 1 activities will help prevent TB drug resistance by ensuring that all patients with TB disease are promptly detected and treated, and that people who have been in close contact with infectious TB patients are identified, monitored, and if necessary, treated. Although any transmission of TB is of public health importance, an outbreak sparked by an individual with undiagnosed MDR-TB or XDR-TB could have serious consequences due to the difficulty and costs associated with treating patients infected with these resistant strains.

Goal 2: Improve International Capacity and Collaboration to Combat MDR-TB.
The emergence of MDR-TB and XDR-TB not only results in significant loss of human life and economic damage, but has the potential to impede progress in mitigating the devastating effects of TB. Goal 2 describes efforts the United States will take to address the global threat of MDR-TB through strategic investments to broaden access to diagnosis and treatment by engaging providers from both the public and private sectors in the most affected communities, improving innovative health technologies and patient-centered approaches to care, and advancing diagnostic and treatment options.

Goal 3: Accelerate Basic and Applied Research and Development to Combat MDR-TB.
New products and innovations for the diagnosis, treatment, and prevention of TB are needed to accelerate control of TB and MDR-TB at home and abroad. Goal 3 activities will help with the development of rapid tests to diagnose TB and determine susceptibility to available drugs; novel therapies and drug regimens that could cure TB and MDR-TB within weeks, making it easier for patients to complete therapy and decreasing opportunities for the emergence of drug resistance; and new vaccines with the potential to prevent all forms of TB…

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AERAS [to 2 January 2016]
http://www.aeras.org/pressreleases
Aeras Applauds White House’s National Action Plan on Multidrug-Resistant Tuberculosis
Plan Points to the Importance of TB Vaccine R&D
Rockville, MD, December 22, 2015 – The White House plan to address drug-resistant tuberculosis (TB), The National Action Plan for Combating Multidrug-Resistant Tuberculosis, released today, is an important step in the U.S. government’s response to this deadly infectious disease…

“Treating MDR- and XDR-TB is expensive, takes years of therapy, and can cause serious side effects, including deafness, liver failure and psychosis, and has much higher failure rates,” said Ann Ginsberg, Aeras Chief Medical Officer. “Drug-resistant TB is an emerging threat to public health.”…

The National Action Plan includes a wide array of provisions aimed at putting in place programs to provide better diagnosis and treatment throughout the world. “It’s particularly important that the Plan acknowledges the need to fund R&D for improved TB drugs and diagnostics, and specifically points to the critical need for a new, effective vaccine, which could prevent all forms of drug-susceptible and drug-resistant TB,” said Dr. Ginsberg. “We urge the U.S. government to take action today by investing in TB R&D, including new TB vaccines, which are crucial to rid the world of TB.”

Dengvaxia® [dengue vaccine] receives regulatory approval in Brazil, Philippines

Dengvaxia® First Dengue Vaccine Approved in Brazil
– Global introduction of the first Dengue Vaccine gains further momentum with this third approval in a row in an endemic country –
– With 1.4 million dengue cases reported this year, Brazil stands to gain tremendous value from this new dengue prevention tool

Lyon, France – December 28, 2015 – Sanofi Pasteur, the vaccines division of Sanofi, announced today that Brazil has granted regulatory approval to Dengvaxia®, representing the third successful licensure of the dengue vaccine, which was also approved in Mexico and the Philippines earlier this month.

The Brazilian regulatory authorities ANVISA approved Dengvaxia®, tetravalent dengue vaccine, for the prevention of disease caused by all four dengue types in individuals from 9-45 years of age living in endemic areas.

Dengue continues to hit hard in Brazil with over 1.4 million Brazilians directly affected by the disease during this year’s outbreak season alone. Up to 70% of dengue cases in Brazil are reported in individuals 9 years and older, a highly mobile and socially active segment of the population who contributes to the spread of the disease within communities.

Dengvaxia® was shown to reduce dengue due to all four serotypes in two-thirds of the participants and prevent 8 out of 10 hospitalizations due to dengue and up to 93% of severe dengue cases.[1] …

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SANOFI PASTEUR’S DENGUE VACCINE APPROVED IN THE PHILIPPINES
– Dengvaxia®’s first approval in Asia reaffirms company’s vision for priority introduction of the dengue vaccine in endemic countries globally

Lyon, France – December 22, 2015 – Sanofi Pasteur, the vaccines division of Sanofi, announced today that the Philippines have granted marketing approval to Dengvaxia®, making it the first vaccine to be licensed for the prevention of dengue in Asia.

The Philippines’ Food and Drug Administration approved Dengvaxia®, tetravalent dengue vaccine, for the prevention of disease caused by all four dengue types in individuals from 9-45 years of age living in endemic areas.

“Approval of the first dengue vaccine in Asia, which bears 70% of global disease burden[1], is a major milestone in dengue prevention and public health,” notes Olivier Charmeil, President and CEO of Sanofi Pasteur. “Approval of Dengvaxia® in the Philippines, following closely the first approval in Mexico, is further evidence of Sanofi Pasteur’s long-standing commitment to introduce this innovative new vaccine first in countries where dengue is a major public health threat…

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Sabin Vaccine Institute
http://www.sabin.org/updates/pressreleases
Statement by the Dengue Vaccine Initiative on the Philippines Regulatory Approval of Sanofi Pasteur’s Dengue Vaccine, Dengvaxia
Wednesday, December 23, 2015
…The Dengue Vaccine Initiative (DVI) is encouraged by the growing momentum in global dengue prevention and control strategies. Together with Mexico’s approval of Dengvaxia® and Brazil’s recent authorization for a Phase III study of Instituto Butantan’s dengue vaccine candidate, DVI views the Philippines’ licensure as the latest development in an ongoing effort to deliver innovative, comprehensive dengue prevention and control strategies. The Philippines’ approval of Dengvaxia® also will help answer remaining questions about Dengvaxia®, including duration of protection, price, and impact on overall dengue virus transmission, especially in age groups not vaccinated…

Euvichol [OCV [Inactivated oral cholera single dose vial] receives WHO PQ

Euvichol [OCV [Inactivated oral cholera single dose vial] receives WHO PQ
Date of prequalification: 23 December 2015
Vaccine Trade Name: Euvichol
Vaccine Type: Inactivated oral cholera
Manufacturer: Eubiologics
Country of Manufacture: Republic of Korea
NRA of Record: Ministry of Food and Drug Safety
Product Description
Pharmaceutical form: liquid
Presentation: 1 dose vial
Route of administration: oral
Vaccine Vial Monitor: Type 30
Shelf life: 24 months at 2 – 8 °C
Secondary Packaging: carton of 10 vials with dimensions 9.0 x 3.5 x 3.5 cm
Cold Chain volume per dose (cm3): 11
Tertiary Packaging: insulated box in corrugated cardboard box with external dimensions 58 x 54 x 49.5 cm containing 240 cartons of 10 vials (2400 doses of vaccine)
preservative: none
Package insertpdf, 1.10Mb

MenAfriVac and the Struggle to Make Vaccines Affordable

MenAfriVac and the Struggle to Make Vaccines Affordable
Questions over the affordability of a breakthrough vaccine against meningitis highlight the need for a better understanding of funding and procurement.
Chatham House Expert Comment | 18 December 2015
Asha Herten-Crabb, Project Coordinator, Centre on Global Health Security
Abbas Omaar, Project Coordinator, Centre on Global Health Security

Since 2010, a revolutionary new vaccine has been introduced across several states in sub-Saharan Africa as a means of tackling deadly outbreaks of meningitis A – a longstanding threat to global health security in the region. The development of the vaccine MenAfriVac is a unique example of the triumphs that emerge from successful public-private partnerships and coordinated transfers of technology from high-income countries that have the capacity to develop such vaccines to low- and-middle income countries where manufacturing is possible at significantly reduced costs. The question now is whether a lack of willingness of governments to pay for this vaccine could keep it out of many countries where it is needed most.

The World Health Organization (WHO) estimates that every year more than 400 million people are at risk of bacterial meningitis epidemics across the ‘meningitis belt’ – an area spanning 26 countries from the eastern Horn of Africa to the coast of Senegal in the west. In 2009, a meningitis epidemic led to 80,000 reported cases and over 4,000 deaths in the meningitis belt but since 2010 one-off large-scale vaccination campaigns using MenAfriVac have resulted in no cases reported from the 16 implementing countries. But a recent study suggests that if countries make the wrong policy decisions regarding continued use of this vaccine, they could undermine and reverse these advances. It is essential therefore that the 10 remaining countries follow WHO advice (opens in new window) and roll out the initial one-off vaccination campaigns to avert the hundreds of deaths that are predicted each year, and that all 26 countries begin including the vaccine as part of routine childhood immunization programmes.

Although MenAfriVac has been ready for wide-scale roll out in the meningitis belt since 2010 and has proven effective in decreasing deaths and cutting healthcare costs, important questions remain about its affordability, despite it being available at less than $0.50 per dose. Through the concerted efforts of a consortium of experts and the support of private foundations, the Indian vaccine manufacturing company Serum Institute was able to produce the vaccine for use in these 26 countries at such a low cost. Yet several countries have delayed purchasing the vaccine for initial one-off mass vaccination campaigns in anticipation of provision of the vaccine by the Global Alliance on Vaccines and Immunizations (GAVI) (an international vaccine fund), and during the waiting period are seeing their children continue to die in meningitis outbreaks. And these delays have occurred while several of these same at-risk countries have amassed vast revenues through sales of oil and natural mineral reserves, revenues that have played a role in economic growth but are not being used to protect those at risk of meningitis.

If it is because $0.50 a dose is considered by these countries too high a price to pay, despite rises in GDP, then there is a need for more robust assessments of the market forces that guide purchasing behaviour and inform decision making before investing in research and development for preventative interventions, especially when vaccines such as MenAfriVac are so effective.

Recognizing the value of market research is one way of achieving this. Evaluating the will and purchase capacity of developing countries as part of the research that goes into vaccine development will help ensure that these countries are themselves eventually able to finance the procurement of new vaccines, and not depend on international donor agencies and funds. Conducting simple market surveys can facilitate this, as can the inclusion of national health ministries in early discussions with vaccine manufacturers. Cross-sector discussions of this nature create clarity and understanding about the needs, and means, of stakeholders that will either collectively share the successes of pioneering vaccines or will together face the challenges that come with poor prior planning and low market demand.

This is one of the reasons behind the UN’s focus on partnership creation, highlighted in the recently agreed Sustainable Development Goals. Such partnerships and collaborative efforts are as integral to developing vaccines and other goods at low cost as they are in ensuring that innovative funding mechanisms – such as those requiring receiving countries to provide matched funding – can eventually lead to sustainability of procurement. Ultimately, policy-makers and donors must learn to better assess and stimulate market conditions before investing in research and development of products that are to be affordable in the developing country market.

BMC Infectious Diseases (Accessed 2 January 2016)

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 2 January 2016)

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Research article
Increases in absenteeism among health care workers in Hong Kong during influenza epidemics, 2004–2009
Acute respiratory infections (ARI) are a major cause of sickness absenteeism among health care workers (HCWs) and contribute significantly to overall productivity loss particularly during influenza epidemics. …
Dennis K. M. Ip, Eric H. Y. Lau, Yat Hung Tam, Hau Chi So, Benjamin J. Cowling and Henry K. H. Kwok
BMC Infectious Diseases 2015 15:586
Published on: 29 December 2015

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Research article
A novel approach to evaluating the UK childhood immunisation schedule: estimating the effective coverage vector across the entire vaccine programme
The availability of new vaccines can prompt policy makers to consider changes to the routine childhood immunisation programme in the UK. Alterations to one aspect of the schedule may have implications…
Sonya Crowe, Martin Utley, Guy Walker, Jasmina Panovska-Griffiths, Peter Grove and Christina Pagel
BMC Infectious Diseases 2015 15:585
Published on: 29 December 2015

BMC Public Health (Accessed 2 January 2016)

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 2 January 2016)

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Debate
Implementing a One Health approach to emerging infectious disease: reflections on the socio-political, ethical and legal dimensions
‘One Health’ represents a call for health researchers and practitioners at the human, animal and environmental interfaces to work together to mitigate the risks of emerging and re-emerging infectious diseases …
Chris Degeling, Jane Johnson, Ian Kerridge, Andrew Wilson, Michael Ward, Cameron Stewart and Gwendolyn Gilbert
BMC Public Health 2015 15:1307
Published on: 29 December 2015

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Research article
Girls’ explanations for being unvaccinated or under vaccinated against human papillomavirus: a content analysis of survey responses
In England HPV vaccination is offered to all girls age 12–13 years, free-at-the-point-of-receipt, mostly in schools. Coverage is good, but around 20 % of girls remain unvaccinated.
Alice S. Forster, Jo Waller, Harriet L. Bowyer and Laura A. V. Marlow
BMC Public Health 2015 15:1278
Published on: 22 December 2015

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Research article
Mapping how information about childhood vaccination is communicated in two regions of Cameroon: What is done and where are the gaps?
The ‘Communicate to vaccinate’ (COMMVAC) project builds research evidence for improving communication with parents and communities about childhood vaccinations in low- and middle-income countries.
Heather Ames, Diangha Mabel Njang, Claire Glenton, Atle Fretheim, Jessica Kaufman, Sophie Hill, Afiong Oku, Julie Cliff, Yuri Cartier, Xavier Bosch-Capblanch, Gabriel Rada, Artur Muloliwa, Angela Oyo-Ita and Simon Lewin
BMC Public Health 2015 15:1264
Published on: 21 December 2015

Understanding why low-risk patients accept vaccines: a socio-behavioral approach

BMC Research Notes
http://www.biomedcentral.com/bmcresnotes/content
(Accessed 2 January 2016)

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Research article
Understanding why low-risk patients accept vaccines: a socio-behavioral approach
Timothy L. Wiemken, Ruth M. Carrico, Robert R. Kelley, Laura E. Binford, Paula Peyrani, Kimbal D. Ford, Verna Welch and Julio A. Ramirez
BMC Research Notes 2015 8:813
Published on: 23 December 2015

Nobel prize for the artemisinin and ivermectin discoveries: a great boost towards elimination of the global infectious diseases of poverty

Infectious Diseases of Poverty
http://www.idpjournal.com/content
[Accessed 2 January 2016]

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Editorial
Nobel prize for the artemisinin and ivermectin discoveries: a great boost towards elimination of the global infectious diseases of poverty
Ernest Tambo, Emad Khater, Jun-Hu Chen, Robert Bergquist, Xiao-Nong Zhou Infectious Diseases of Poverty 2015, 4:58 (28 December 2015)
Abstract
The Millennium Development Goals (MDGs) made a marked transformation for neglected and vulnerable communities in the developing countries from the start, but infectious diseases of poverty (IDoPs) continue to inflict a disproportionate global public health burden with associated consequences, thereby contributing to the vicious cycle of poverty and inequity. However, the effectiveness and large-scale coverage of artemisinin combination therapy (ACT) have revolutionized malaria treatment just as the control of lymphatic filariasis (LF) and onchocerciasis have benefitted from harnessing the broad-spectrum effect of avermectin-based derivatives. The paradigm shift in therapeutic approach, effected by these two drugs and their impact on community-based interventions of parasitic diseases plaguing the endemic low- and middle-income countries (LIMCs), led to the Nobel Prize in Physiology or Medicine in 2015. However, the story would not be complete without mentioning praziquantel. The huge contribution of this drug in modernizing the control of schistosomiasis and also some intestinal helminth infections had already shifted the focus from control to potential elimination of this disease. Together, these new drugs have provided humankind with powerful new tools for the alleviation of infectious diseases that humans have lived with since time immemorial. These drugs all have broad-spectrum effects, yet they are very safe and can even be packaged together in various combinations. The strong effect on so many of the great infectious scourges in the developing countries has not only had a remarkable influence on many endemic diseases, but also contributed to improving the cost structure of healthcare. Significant benefits include improved quality of preventive and curative medicine, promotion of community-based interventions, universal health coverage and the fostering of global partnerships. The laudable progress and benefits achieved are indispensable in championing, strengthening and moving forward elimination of the IDoPs. However, there is an urgent need for further innovative, contextual and integrated approaches along with the advent of the Sustainable Development Goals (SDGs), replacing the MDGs in ensuring global health security, well-being and economic prosperity for all.

The Sustainable Development Goals: One-Health in the World’s Development Agenda

JAMA
December 22/29, 2015, Vol 314, No. 24
http://jama.jamanetwork.com/issue.aspx

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The Sustainable Development Goals: One-Health in the World’s Development Agenda
Lawrence O. Gostin, JD; Eric A. Friedman, JD
This Viewpoint discusses financial, political, and practical challenges to realizing the United Nations’ 2015 Sustainable Development Goals.

“We are resolved to free the human race from the tyranny of poverty and want to heal and secure our planet.”1 So pronounces the United Nations Sustainable Development Goals, adopted on September 25, 2015, succeeding the Millennium Development Goals. The Sustainable Development Goals embody a one-health strategy—healthy people living on a habitable planet…

The Lancet – Jan 02, 2016

The Lancet
Jan 02, 2016 Volume 387 Number 10013 p1-94
http://www.thelancet.com/journals/lancet/issue/current

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Editorial
Rights of refugees—collaboration is key
The Lancet
Summary
As a result of conflicts in countries such as Syria, Iraq, and Yemen, 1 million migrants have fled conflict areas and arrived at the borders of Europe in 2015. With more than 2 million refugees from Syria and roughly 230 000 refugees from other countries, Turkey has the largest population of refugees worldwide.

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Comment
Universal access to medicines
Louis W Niessen, Jahangir A M Khan
Published Online: 20 October 2015
Summary
Medicines account for 20–60% of health spending in low-income and middle-income countries, whereas in high-income countries the proportion is 18% or lower.1 Up to 90% of low-income populations purchase medicines through out-of-pocket payments, making medicines the largest household expenditure item after food.1 Strategies to make medicines more available and affordable are therefore crucial in increasing their use in low-income and middle-income countries, in which the burden of non-communicable diseases, in addition to awareness of the benefits of prevention and treatment, are increasing.

PLoS Medicine (Accessed 2 January 2016)

PLoS Medicine
http://www.plosmedicine.org/
(Accessed 2 January 2016)

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Progress in Medicine: Experts Take Stock
The PLOS Medicine Editors , Andrew Beck, Ewan Birney, Manuel Graeber, James Tumwine, Phillipa Hay, Hyeong Sik Ahn, Anushka Patel, Philipp du Cros, Lorenz von Seidlein, Nick Wareham, Nicola Low
Editorial | published 29 Dec 2015 | PLOS Medicine
10.1371/journal.pmed.1001933
Introduction
For the 2015 end-of-the-year editorial, PLOS Medicine asked 11 researchers and clinicians spanning a range of specialties to comment on the state of their field and what they expect or hope to see next year. From cardiovascular diseases and diabetes to cancer to infectious diseases, from new research and technologies to clinical practice, and from training to health policy and strategy, our contributors had plenty to say. Here’s to a healthy 2016!

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Public Health and International Partnerships in the Democratic People’s Republic of Korea
John Grundy, Beverley-Ann Biggs, David B. Hipgrave
Policy Forum | published 29 Dec 2015 | PLOS Medicine
10.1371/journal.pmed.1001929
Summary Points
:: The health system in the Democratic People’s Republic of Korea (DPRK) is suitable for high public health program coverage, with a wide facility network and high staff-population ratios.
:: Economic difficulties, natural disasters, and poor resourcing of the health sector in the 1990s had catastrophic impacts on public health and system functioning, leading to sharp declines in vaccination coverage.
:: With considerable international support, diphtheria, tetanus, and pertussis (DTP) vaccine coverage has risen from 37% in 1997 to 96% in 2013. Major challenges related to immunization services and the health sector more generally have been reduced.
:: This recovery demonstrates the potential for international partners to support DPRK’s national health agencies and improve public health programming, notwithstanding tensions in international relations and challenging domestic conditions.
:: Sustained collaboration is required to improve population health and health services in DPRK. This has regional and global public health implications and may influence ongoing political tensions.

Pregnancy Outcomes after a Mass Vaccination Campaign with an Oral Cholera Vaccine in Guinea: A Retrospective Cohort Study

PLoS Neglected Tropical Diseases
http://www.plosntds.org/
(Accessed 2 January 2016)

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Quantifying Poverty as a Driver of Ebola Transmission
Mosoka P. Fallah, Laura A. Skrip, Shai Gertler, Dan Yamin, Alison P. Galvani
Research Article | published 31 Dec 2015 | PLOS Neglected Tropical Diseases
10.1371/journal.pntd.0004260

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Pregnancy Outcomes after a Mass Vaccination Campaign with an Oral Cholera Vaccine in Guinea: A Retrospective Cohort Study
Lise Grout, Isabel Martinez-Pino, Iza Ciglenecki, Sakoba Keita, Alpha Amadou Diallo, Balla Traore, Daloka Delamou, Oumar Toure, Sarala Nicholas, Barbara Rusch, Nelly Staderini, Micaela Serafini, Rebecca F. Grais, Francisco J. Luquero
Research Article | published 29 Dec 2015 | PLOS Neglected Tropical Diseases
10.1371/journal.pntd.0004274

Access to Routine Immunization: A Comparative Analysis of Supply-Side Disparities between Northern and Southern Nigeria

PLoS One
http://www.plosone.org/
[Accessed 2 January 2016]

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Access to Routine Immunization: A Comparative Analysis of Supply-Side Disparities between Northern and Southern Nigeria
Ejemai Eboreime, Seye Abimbola, Fiammetta Bozzani
Research Article | published 21 Dec 2015 | PLOS ONE
Abstract
Background
The available data on routine immunization in Nigeria show a disparity in coverage between Northern and Southern Nigeria, with the former performing worse. The effect of socio-cultural differences on health-seeking behaviour has been identified in the literature as the main cause of the disparity. Our study analyses the role of supply-side determinants, particularly access to services, in causing these disparities.
Methods
Using routine government data, we compared supply-side determinants of access in two Northern states with two Southern states. The states were identified using criteria-based purposive selection such that the comparisons were made between a low-coverage state in the South and a low-coverage state in the North as well as between a high-coverage state in the South and a high-coverage state in the North.
Results
Human resources and commodities at routine immunization service delivery points were generally insufficient for service delivery in both geographical regions. While disparities were evident between individual states irrespective of regional location, compared to the South, residents in Northern Nigeria were more likely to have vaccination service delivery points located within a 5km radius of their settlements.
Conclusion
Our findings suggest that regional supply-side disparities are not apparent, reinforcing the earlier reported socio-cultural explanations for disparities in routine immunization service uptake between Northern and Southern Nigeria. Nonetheless, improving routine immunisation coverage services require that there are available human resources and that health facilities are equitably distributed.
10.1371/journal.pone.0144876

The Relationship between Health Literacy and Health Disparities: A Systematic Review

PLoS One
http://www.plosone.org/
[Accessed 2 January 2016]

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The Relationship between Health Literacy and Health Disparities: A Systematic Review
Sarah Mantwill, Silvia Monestel-Umaña, Peter J. Schulz
Research Article | published 23 Dec 2015 | PLOS ONE
10.1371/journal.pone.0145455
Abstract
Objectives
Health literacy is commonly associated with many of the antecedents of health disparities. Yet the precise nature of the relationship between health literacy and disparities remains unclear. A systematic review was conducted to better understand in how far the relationship between health literacy and health disparities has been systematically studied and which potential relationships and pathways have been identified.
Methods
Five databases, including PubMed/MEDLINE and CINAHL, were searched for peer-reviewed studies. Publications were included in the review when they (1) included a valid measure of health literacy, (2) explicitly conceived a health disparity as related to a social disparity, such as race/ethnicity or education and (3) when results were presented by comparing two or more groups afflicted by a social disparity investigating the effect of health literacy on health outcomes. Two reviewers evaluated each study for inclusion and abstracted relevant information. Findings were ordered according to the disparities identified and the role of health literacy in explaining them.
Results
36 studies were included in the final synthesis. Most of the studies investigated racial/ethnic disparities, followed by some few studies that systematically investigated educational disparities. Some evidence was found on the mediating function of health literacy on self-rated health status across racial/ethnic and educational disparities, as well as on the potential effect of health literacy and numeracy on reducing racial/ethnic disparities in medication adherence and understanding of medication intake.
Conclusion
Overall the evidence on the relationship between health literacy and disparities is still mixed and fairly limited. Studies largely varied with regard to health(-related) outcomes under investigation and the health literacy assessments used. Further, many studies lacked a specific description of the nature of the disparity that was explored and a clear account of possible pathways tested.

New Strains Intended for the Production of Inactivated Polio Vaccine at Low-Containment After Eradication

PLoS Pathogens
http://journals.plos.org/plospathogens/
(Accessed 2 January 2016)

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New Strains Intended for the Production of Inactivated Polio Vaccine at Low-Containment After Eradication
Sarah Knowlson, John Burlison, Elaine Giles, Helen Fox, Andrew J. Macadam, Philip D. Minor
Research Article | published 31 Dec 2015 | PLOS Pathogens
10.1371/journal.ppat.1005316
Abstract
Poliomyelitis has nearly been eradicated through the efforts of the World Health Organization’s Global Eradication Initiative raising questions on containment of the virus after it has been eliminated in the wild. Most manufacture of inactivated polio vaccines currently requires the growth of large amounts of highly virulent poliovirus, and release from a production facility after eradication could be disastrous; WHO have therefore recommended the use of the attenuated Sabin strains for production as a safer option although it is recognised that they can revert to a transmissible paralytic form. We have exploited the understanding of the molecular virology of the Sabin vaccine strains to design viruses that are extremely genetically stable and hyperattenuated. The viruses are based on the type 3 Sabin vaccine strain and have been genetically modified in domain V of the 5’ non-coding region by changing base pairs to produce a cassette into which capsid regions of other serotypes have been introduced. The viruses give satisfactory yields of antigenically and immunogenically correct viruses in culture, are without measurable neurovirulence and fail to infect non-human primates under conditions where the Sabin strains will do so.
Author Summary
New polio vaccines will be needed to safeguard global eradication: Sabin strains are known to evolve to fill the niche left by wild-strains so their long-term use is incompatible with eradication; most current inactivated vaccine is made from wild polioviruses so that production presents a significant biosecurity risk. We have developed new strains for Inactivated Polio Vaccine (IPV) production with negligible risk to the human population should they escape. Sabin’s live-attenuated vaccines are variants of wild strains selected by the use of unnatural cell substrates, hosts and growth conditions. Unsurprisingly these variants evolve back towards wild-type properties during replication in, and transmission between, their natural hosts. An understanding of the molecular basis of these pathways led us to design novel vaccine strains that are very highly attenuated and arguably cannot replicate in people and whose opportunities for reversion during replication in cell culture are severely restricted. At the same time, the strains can feasibly be produced on a large-scale and they are as immunogenic as current IPV. These attributes allow for safe vaccine production in the post-eradication world.

Unfilled Vials – Vaccine Development Priorities

Science
1 January 2016 vol 351, issue 6268, pages 1-100
http://www.sciencemag.org/current.dtl

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Feature
Unfilled Vials
Jon Cohen
Vaccines that appear scientifically feasible often move through development slowly because they have little commercial potential and thus have trouble attracting serious investments. Just such a situation held back R&D on Ebola vaccines, one of which quickly proved its worth in a real-world trial held in Guinea last year. In the wake of that success, a growing number of researchers and public health advocates are lobbying to find new money and strategies to develop vaccines that could thwart both outbreak diseases like chikungunya and Marburg to endemic afflictions like paratyphoid fever and schistosomiasis. In response to a survey designed by Science, 50 vaccine experts ranked 10 vaccine-vulnerable diseases in order of development priority based on needs and the likelihood that they would work.

Interventions to increase the uptake of seasonal influenza vaccination among pregnant women: A systematic review

Vaccine
Volume 34, Issue 1, Pages 1-186 (2 January 2016)
http://www.sciencedirect.com/science/journal/0264410X/34/1
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Interventions to increase the uptake of seasonal influenza vaccination among pregnant women: A systematic review
Review Article
Pages 20-32
Valerie W.Y. Wong, Kris Y.W. Lok, Marie Tarrant
Abstract
Background
Pregnant women and their infants under 6 months of age infected with influenza have a high risk of serious morbidity and mortality. Influenza vaccine during pregnancy offers 3-for-1 benefits to pregnant women, fetuses and newborn infants. Current vaccination uptake rates during pregnancy, however, are often lower than other high-risk groups and the general population.
Methods
We systematically reviewed evidence on the effectiveness of interventions to improve influenza vaccination coverage in pregnant women. Risk differences (RDs) were calculated from the included studies.
Results
Eleven studies were included in the review, of which four were randomized controlled trials (RCTs). Three cohort studies assessed provider-focused interventions while four RCTs and one cohort study evaluated pregnant women-focused interventions. Two cohort studies and a prospective intervention study assessed the effectiveness of bundled interventions. No study solely assessed the effectiveness of interventions to enhance access to influenza vaccination. One moderate quality RCT showed that an influenza pamphlet, with or without a verbalized benefit statement, improved the vaccination rate (RD = 0.26; RD = 0.39). The other reviewed RCTs showed discordant results, with RDs ranging from −0.15 to 0.03. Although all observational studies significantly improved vaccination rates (RDs ranged from 0.03 to 0.44), the quality of the evidence varied.
Conclusions
There is a lack of effective interventions to increase the influenza vaccination rate in pregnant women. Based on the existing research, we recommend that clinicians provide influenza pamphlets to pregnant women with a verbalized statement about the benefits of influenza vaccine to newborns. Further high-quality RCTs are needed to develop successful maternal influenza vaccination programs. Increased clarity in reporting the content of interventions would help to improve the comparability and generalizability of the published studies.

Perceptions of Hong Kong Chinese women toward influenza vaccination during pregnancy

Vaccine
Volume 34, Issue 1, Pages 1-186 (2 January 2016)
http://www.sciencedirect.com/science/journal/0264410X/34/1
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Perceptions of Hong Kong Chinese women toward influenza vaccination during pregnancy
Original Research Article
Pages 33-40
Carol Y.S. Yuen, Joan E. Dodgson, Marie Tarrant
Abstract
Introduction
Pregnant women are the highest priority group for seasonal influenza vaccination. However, their vaccination uptake remains suboptimal. The purpose of this study is to explore Hong Kong women’s perceptions of the threat of influenza infection during pregnancy, the risks and benefits of influenza vaccination, and their decision-making processes.
Methods
We used a qualitative descriptive design and recruited women who had just given births to a live infant from April to June 2011. Participants were recruited from a large teaching hospital in Hong Kong and were interviewed in the immediate postpartum period.
Results
A total of 32 postpartum women were interviewed, and two had been vaccinated during pregnancy. Following thematic analysis, three themes emerged: perceived risk of influenza infection, perceived risk of influenza vaccine, and decision-making cues. Overall, participants held negative impressions about influenza vaccination during pregnancy, and they underestimated the threat of influenza to themselves and their fetus. They were also confused about the safety and efficacy of the influenza vaccine and the differences between preventive strategies and treatment for influenza. Most participants reported that their health care providers (HCPs) did not offer or recommend vaccination. Because of negative media reports about vaccination, participants were hesitant to receive the vaccine. Motivating forces for vaccine acceptance were a perceived high prevalence of circulating influenza during their pregnancy and HCP recommendations and reassurances that the vaccination was safe, effective, and beneficial for the fetus.
Conclusion
Vaccination promotion strategies need to focus on encouraging HCPs to take the initiative to discuss vaccination with their pregnant clients and provide accurate and unbiased information about the risks of influenza and the benefits of vaccination.

Mass vaccination with a two-dose oral cholera vaccine in a long-standing refugee camp, Thailand

Vaccine
Volume 34, Issue 1, Pages 1-186 (2 January 2016)
http://www.sciencedirect.com/science/journal/0264410X/34/1
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Mass vaccination with a two-dose oral cholera vaccine in a long-standing refugee camp, Thailand
Original Research Article
Pages 128-133
Christina R. Phares, Kashmira Date, Philippe Travers, Carole Déglise, Nuttapong Wongjindanon, Luis Ortega, Ponchanok Rattanadilok Na Bhuket
Abstract
Background
During 2005–2012, surveillance in Maela refugee camp, Thailand, identified four cholera outbreaks, with rates up to 10.7 cases per 1000 refugees. In 2013, the Thailand Ministry of Public Health sponsored a two-dose oral cholera vaccine (OCV) campaign for the approximately 46,000 refugees living in Maela.
Methods
We enumerated the target population (refugees living in Maela who are ≥1 year old and not pregnant) in a census three months before the campaign and issued barcoded OCV cards to each individual. We conducted the campaign using a fixed-post strategy during two eight-day rounds plus one two-day round for persons who had missed their second dose and recorded vaccine status for each individual. To identify factors associated with no vaccination (versus at least one dose) and those associated with adverse events following immunization (AEFI), we used separate marginal log-binomial regression models with robust variance estimates to account for household clustering.
Results
A total of 63,057 OCV doses were administered to a target population of 43,485 refugees. An estimated 35,399 (81%) refugees received at least one dose and 27,658 (64%) received two doses. A total of 993 additional doses (1.5%) were wasted including 297 that were spat out. Only 0.05% of refugees, mostly children, could not be vaccinated due to repeated spitting. Characteristics associated with no vaccination (versus at least one dose) included age ≥15 years (versus 1–14 years), Karen ethnicity (versus any other ethnicity) and, only among adults 15–64 years old, male sex. Passive surveillance identified 84 refugees who experienced 108 AEFI including three serious but coincidental events. The most frequent AEFI were nausea (49%), dizziness (38%), and fever (30%). Overall, AEFI were more prevalent among young children and older adults.
Conclusions
Our results suggest that mass vaccination in refugee camps with a two-dose OCV is readily achievable and AEFI are few.

Promoting Tdap immunization in pregnancy: Associations between maternal perceptions and vaccination rates

Vaccine
Volume 34, Issue 1, Pages 1-186 (2 January 2016)
http://www.sciencedirect.com/science/journal/0264410X/34/1
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Promoting Tdap immunization in pregnancy: Associations between maternal perceptions and vaccination rates
Original Research Article
Pages 179-186
Nalin Payakachat, Kristie B. Hadden, Denise Ragland
Abstract
Objective
Tdap vaccine uptake among US pregnant women is low despite current recommendations. This study evaluated if a Tdap vaccine information statement (VIS) affected overall perception, vaccination intention, and components of a health behavior model associated with Tdap vaccination rates.
Methods
A randomized, prospective study was conducted among pregnant women receiving care at two women’s clinics in May–August 2014. Verbally consented participants were randomized to receive either the standard CDC Tdap VIS (sVIS) or a modified version (mVIS) before completing the first multi-part survey (T1). After T1, participants read their assigned VIS then completed the second part (T2). A 2015 chart review identified vaccinated participants. A health behavior model was hypothesized using the Reasoned Action Approach and Health Belief Model. Logistic regression, path analysis, and chi-square tests were used in the analysis.
Results
279 surveys were analyzed. Average age of the participants was 26.4 years (SD = 5.7) with average gestational age of 25.9 weeks (SD = 9.2). 13% self-reported receiving Tdap vaccine prior to the survey. Overall perception scores significantly increased (3.1–3.4, p < 0.001) after VIS review. A chart review showed that 131 (47%) received the vaccine post study. There was no significant difference in vaccination rates between the sVIS and mVIS groups (45% vs. 49%). Perceived benefits (B = 0.315) and self-efficacy (B = 0.197) were positively associated with the overall perception (T1), while perceived barriers (B = −0.191) were negatively associated with the overall perception (T1). Social norms (B = 0.230), self-efficacy (B = 0.213), and perceived benefits (B = 0.117) were positively associated with vaccination intention (T1). The vaccination intention (T2) was positively associated with participants’ decision to receive Tdap vaccine (B = 0.223).
Conclusion
A VIS improved overall perception of the Tdap vaccine. Vaccination intention was a predictor of Tdap vaccination. It is crucial to provide information about immunization benefits to promote maternal Tdap vaccination.

Malaria Vaccines 2015 — Special Issue of “Vaccine”

Vaccine
Volume 33, Issue 52, Pages 7423-7558 (22 December 2015)
http://www.sciencedirect.com/science/journal/0264410X/33/52

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Malaria Vaccines 2015
Edited by Robert W. Sauerwein and Thomas L. Richie

Editorial
Malaria vaccines getting close to clinical reality
R.W. Sauerwein, T.L. Richie
[This issue includes sections on Vaccine Candidates, Efficacy Trials, Early Clinical Pipeline, Challenges and Opportunities, and Applications]

Nearing Triumph Over Ebola – NY Times Op-Ed

New York Times
http://www.nytimes.com/
Accessed 2 January 2016
The Opinion Pages | Editorial
Nearing Triumph Over Ebola
By THE EDITORIAL BOARD
DEC. 30, 2015
Guinea had every reason to celebrate Tuesday. The country where the West African Ebola epidemic began had been declared free of virus transmission. That in effect meant that the three countries hardest hit by the disease — Guinea, Liberia and Sierra Leone — had broken the chain of infections that took 11,300 lives, jumped borders and spread panic around the world.

The announcement did not mean that the virus had fully surrendered, and indeed Liberia has twice declared the chain broken only to see the virus mysteriously reappear, and must wait until mid-January for an all-clear. Moreover, there is considerable work still to be done to ensure that the global health apparatus — in particular the World Health Organization — will be far better prepared to attack the next epidemic more quickly and effectively.

For the moment, however, largely ending the transmission of a disease for which there was no vaccine and no effective treatment when the epidemic was detected in March 2014 was a major triumph for the emergency workers and medical teams, many from international organizations like Doctors Without Borders, who risked their lives to battle and finally defeat the Ebola virus. It also provided a moment to recall the suffering of those who lost their lives to the terrible infection and of the millions of their relatives, neighbors and countrymen who endured fear, deprivation and grief as the virus spread through their cities and towns.

As Liberia’s ordeal suggests, vigilance must continue. There is growing evidence that the virus can survive in recovered Ebola victims, apparently in the eyes or the testes, and then reappear when resistance is lowered. Ebola survivors have also been found to suffer various aftereffects, including hearing loss, lethargy and depression. All this must be watched and studied, and an effective vaccine developed.

Meanwhile, it is essential that the W.H.O., a United Nations agency, reform its policies for reacting to a disease outbreak. It was five months late in identifying Ebola as a global health emergency, and did so two months after Doctors Without Borders warned that the disease was out of control.

Two groups of health experts, one independent and one convened by the W.H.O., have recommended various reforms the agency must undertake. Most important among these is that it ensure that it is not influenced by politics, such as pressure from officials to play down an outbreak that may affect tourism or trade, in raising international alarms. Dr. Margaret Chan, the director general of the W.H.O., has already announced some changes and has vowed to carry out other recommendations.

Stopping the Ebola virus, despite the late start and the huge challenge of working in countries with woefully poor health systems, was an example of what the world can do once it acknowledges an emergency and provides the resources needed to save lives. The entire experience is also a clear warning of the need for significantly better preparations and procedures next time.