Zika virus [to 13 February 2016]
Public Health Emergency of International Concern (PHEIC)
http://www.who.int/emergencies/zika-virus/en/

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Situation report: Zika and potential complications – 12 February 2016
http://www.who.int/emergencies/zika-virus/situation-report/en/
Summary
:: WHO has called for a coordinated and multisectoral response through an inter-agency Strategic Response Framework focusing on response, surveillance and research.

:: 39 countries have reported locally acquired circulation of the virus since January 2007. Geographical distribution of the virus has steadily expanded.

:: Six countries (Brazil, French Polynesia, El Salvador, Venezuela, Colombia and Suriname) have reported an increase in the incidence of cases of microcephaly and/or Guillain-Barré syndrome (GBS) in conjunction with an outbreak of the Zika virus. Puerto Rico and Martinique have reported cases of GBS associated with Zika virus infection without an increase of incidence. No scientific evidence to date confirms a link between Zika virus and microcephaly or GBS.

:: Women’s reproductive health has been thrust into the limelight with the spread of the Zika virus. The latest evidence suggests that Zika virus infection during pregnancy may be linked to microcephaly in newborn babies.

:: WHO advice on travel to Zika-affected countries includes advice for pregnant women as well as women who are trying to become pregnant and their sexual partners.
Read the full situation report

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Zika Open
[Bulletin of the World Health Organization]
EDITORIAL
Data sharing in public health emergencies: a call to researchers
– Christopher Dye, Kidist Bartolomeos, Vasee Moorthy, Marie Paule Kieny
Posted: 4 February 2016 http://dx.doi.org/10.2471/BLT.16.170860
…The deficiencies with existing data-sharing mechanisms, which were highlighted during the 2013–16 Ebola epidemic in west Africa, have brought the question of data access to the forefront of the global health agenda.2 In September 2015, agreement was reached on the need for open sharing of data and results, especially in public health emergencies.3 Subsequently, following published expressions of support by its members, the International Committee of Medical Journal Editors (ICMJE) have explicitly confirmed that pre-publication dissemination of information critical to public health will not prejudice journal publication in the context of a public health emergency declared by WHO.4 While efforts so far have focused on results from clinical trials, and on making full accompanying data sets available at the time of publication, there are further opportunities to expand access to information from observational studies, operational research, routine surveillance and the monitoring of disease control programmes.

To improve timely access to data in the context of a public health emergency, the Bulletin of the World Health Organization will implement a new data sharing and reporting protocol. The protocol is established specifically to address the data gap that exists in responding to the current Zika virus epidemic and, in the first instance, will apply only to articles submitted in the context of this outbreak…
…Given the number and complexity of unanswered questions on the mechanisms and consequences of Zika infection and associated disease, our goal is to encourage all researchers to share their data as quickly and widely as possible. With this protocol for immediate online posting, we are providing another means to achieve immediate global access to relevant data. Researchers can thus share their data while meeting their need to retain authorship, achieve precedence, and put their research on public record. We are pleased to announce that the first paper to which this protocol applies is now available online.7
:: New Papers available here

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WHO involvement in Zika R&D
8 February 2016
WHO is currently mapping existing R&D for Zika in order to prioritize medical products and approaches that should be fast-tracked into development. These will be reviewed by expert advisory committees as soon as possible. As of today, most research that could be useful for Zika has been carried out on other flaviviruses – such as dengue or yellow fever.

Diagnostics are a top urgency in order to ascertain the presence of the Zika virus as opposed to other similar diseases caused by flaviviruses with mosquito vectors. Very few test are available. A call to interested companies and other groups was issued on 5 February to submit potential products to the WHO ‘Emergency Assessment and Listing’ procedure. This procedure, once a product has been accepted, guarantees acceptable levels of quality and performance and allows UN agencies, NGOs and countries to procure the product with confidence.

There are at least 12 groups working on Zika vaccines; all are in the early stages of development and availability of licensed products could take a few years.

Some studies are being carried out on prophylactic therapeutics that would work in the same way as prophylaxis for malaria. Fogging followed by the controlled release of genetically modified mosquitoes may be worth considering for halting the spread of Zika.

WHO is also working on:
:: Establishing regulatory support networks to fast-track approval of clinical trials in countries
:: Advocacy on timely samples and data sharing among groups undertaking R&D studies on Zika, to ensure the best science is brought to bear on research and development.

WHO’s R&D efforts on Zika are part of the overall work on a roadmap – the R&D Blueprint – for better R&D preparedness based on the experience of the R&D work carried out during the West-Africa Ebola outbreak. The roadmap will enable roll-out of an emergency R&D response as early and as efficiently as possible for emerging diseases for which there are no, or few, countermeasures. In December 2015, WHO held a consultation to identify a short-list of pathogens to be prioritized immediately for R&D preparedness. Zika was identified as a serious risk, needing further action as soon as possible.

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WHO: Disease Outbreak News (DONs) [Zika]
:: 12 February 2016 – Zika virus infection – United States of America
:: 12 February 2016 – Microcephaly – United States of America
:: 12 February 2016 – Guillain-Barré syndrome – Colombia and Venezuela
:: 8 February 2016 – Guillain-Barré syndrome – Brazil
:: 8 February 2016 – Guillain-Barré syndrome – France – Martinique
:: 8 February 2016 – Zika virus infection – Maldives
:: 8 February 2016 – Zika virus infection – Region of the Americas

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WHO: Women in the context of microcephaly and Zika virus disease
Online Q&A
10 February 2016
The risk of babies born with microcephaly has raised understandable concerns among women including those who are pregnant or planning to become pregnant. There are many unknowns regarding the possible causes of microcephaly. Until we have more answers, there are ways that women can protect themselves from Zika infection.

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CDC/ACIP [to 13 February 2016]
http://www.cdc.gov/media/index.html
http://www.cdc.gov/vaccines/acip/
MONDAY, FEBRUARY 8, 2016
CDC Emergency Operations Center moves to highest level of activation for Zika response
To further enhance its response to the Zika virus outbreak, CDC’s Emergency Operations Center is moving to a Level 1 activation—reflecting the agency’s assessment of the need for an accelerated preparedness to bring together experts to focus intently and work efficiently in anticipation of local Zika virus transmission by mosquitoes in the Continental U.S…

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IOM
Research Priorities to Inform Public Health and Medical Practice for Domestic Zika Virus: A Workshop
February 16, 2016 (8:30 AM EST/US)
Open Meeting
Activity Description
At the request of the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary of Preparedness and Response (ASPR), the National Academies of Sciences, Engineering, and Medicine will host a one-day public workshop on February 16, 2016 to explore potential research priorities arising as a result of the emergence of Zika virus in the United States…

…There is an urgent need for additional research to better characterize the Zika virus, especially those issues related to means of transmission and infection during pregnancy. Additional epidemiologic, entomologic, and virology research of the Zika virus under real-world conditions could provide a more robust evidence base to inform medical and public health efforts to protect those at-risk. Such research could also provide much needed answers to questions about health risks and appropriate public health and medical interventions.

This workshop will bring together key stakeholders and experts to discuss the research priorities needed to inform medical and public health practice that can be implemented under real world conditions to better understand the true risk that Zika virus poses to the public in the U.S. and adequate prevention efforts and interventions to mitigate that risk.

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The White House [U.S.] [to 13 February 2016]
https://www.whitehouse.gov/briefing-room/statements-and-releases
Selected Statements and Releases
FACT SHEET: Preparing for and Responding to the Zika Virus at Home and Abroad
February 08, 2016
Since late last year, the Administration has been aggressively working to combat Zika, a virus primarily spread by mosquitoes that has recently been linked to birth defects and other concerning health outcomes. The Federal Government has been monitoring the Zika virus and working with our domestic and international public health partners to alert healthcare providers and the public about Zika; provide public health laboratories with diagnostic tests; and detect and report cases both domestically and internationally.

The Administration is taking every appropriate measure to protect the American people, and today announced that it is asking Congress for more than $1.8 billion in emergency funding to enhance our ongoing efforts to prepare for and respond to the Zika virus, both domestically and internationally. The Administration will submit a formal request to Congress shortly…
…The requested resources will build on our ongoing preparedness efforts and will support essential strategies to combat this virus, such as rapidly expanding mosquito control programs; accelerating vaccine research and diagnostic development; enabling the testing and procurement of vaccines and diagnostics; educating health care providers, pregnant women and their partners; improving epidemiology and expanding laboratory and diagnostic testing capacity; improving health services and supports for low-income pregnant women, and enhancing the ability of Zika-affected countries to better combat mosquitoes and control transmission…

[Funding request excerpts; Editor’s text bolding]
Department of Health and Human Services – $1.48 billion
Centers for Disease Control and Prevention – $828 million. The request includes funding to support prevention and response strategies through the following activities:
:: Support Zika virus readiness and response capacity in States and territories with mosquito populations that are known to transmit Zika virus, with a priority focus on areas with ongoing Zika transmission;
:: Enhance mosquito control programs through enhanced laboratory, epidemiology and surveillance capacity in at-risk areas to reduce the opportunities for Zika transmission;
:: Establish rapid response teams to limit potential clusters of Zika virus in the United States;
:: Improve laboratory capacity and infrastructure to test for Zika virus and other infectious diseases;
:: Implement surveillance efforts to track Zika virus in communities and in mosquitoes;
:: Deploy targeted prevention and education strategies with key populations, including pregnant women, their partners, and health care professionals;
:: Expand the CDC Pregnancy Risk Assessment Monitoring System, improve Guillain Barré syndrome tracking, and ensure the ability of birth defect registries across the country to detect risks related to Zika;
:: Increase research into the link between Zika virus infections and the birth defect microcephaly and measure changes in incidence rates over time;
:: Enhance international capacity for virus surveillance, expand the Field Epidemiology Training program, laboratory testing, health care provider training, and vector surveillance and control in countries at highest risk of Zika virus outbreaks; and
:: Improve diagnostics for Zika virus, including advanced methods to refine tests, and support advanced developments for vector control.

Centers for Medicare and Medicaid Services – $250 million
The request seeks a temporary one-year increase in Puerto Rico’s Medicaid Federal Medical Assistance Percentage (FMAP) to provide an estimated $250 million in additional Federal assistance to support health services for pregnant women at risk of infection or diagnosed with Zika virus and for children with microcephaly, and other health care costs…

Vaccine Research and Diagnostic Development & Procurement – $200 million
The request includes $200 million for research, rapid advanced development and commercialization of new vaccines and diagnostic tests for Zika virus. It includes funding for the National Institutes of Health to build upon existing resources and work to develop a vaccine for Zika virus and the chikungunya virus, which is spread by the same type of mosquito. Funding will accelerate this work and improve scientific understanding of the disease to inform the development of additional tools to combat it. The request also includes resources for the Food and Drug Administration to support Zika virus medical product development including the next generation diagnostic devices.

Other HHS Response Activities – $210 million
The request includes funding to establish a new Urgent and Emerging Threat Fund to address Zika virus and other outbreaks. This funding would be available to support emerging needs related to Zika, including additional support to States for emerging public health response needs should mosquito populations known to be potential Zika carriers migrate to additional States…

U.S. Agency for International Development – $335 million
The request includes investments to support affected countries’ ability to control mosquitoes and the transmission of the virus; support maternal health; expand public education on prevention and response; and create new incentives for the development of vaccines and diagnostics. The request would also provide flexibility in the use of remaining USAID Ebola funds. Activities would focus particularly on South America, Central America, the Caribbean…

U.S. Department of State – $41 million
The funding request includes support for U.S. citizens in affected countries, medical support for State Department employees in affected countries, public diplomacy, communications, and other operations activities. State would also support the World Health Organization and its regional arm, the Pan American Health Organization (PAHO), to minimize the Zika threat in affected countries while reducing the risk of further spreading the virus. These resources will support critical public health actions underway, including preparedness, surveillance, data collection, and risk communication. Activities would also include support for UNICEF’s Zika response efforts in Brazil; activities to bolster diagnostic capabilities through deployment of equipment and specialized training.

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European Medicines Agency [to 13 February 2016]
http://www.ema.europa.eu/
08/02/2016
EMA sets up task force on Zika virus
European experts to provide support to global response on the emerging epidemic
The European Medicines Agency (EMA) has established a task force of European experts with specialised knowledge in vaccines, infectious diseases and other relevant expertise to contribute to the global response to the threat of the Zika virus infection. This group will be available to give advice on any scientific and regulatory matters for the research and development of medicines or vaccines against the virus…

…The Agency is encouraging medicines developers to contact EMA if they have any promising projects in this area. EMA will also proactively reach out to companies already planning to work on investigational vaccines and offer scientific and regulatory advice. EMA will review any new information as soon as it becomes available to support the response to this widening public health crisis.

During a health emergency such as the Zika virus outbreak, EMA works closely with European bodies, including the European Commission and the European Centre for Disease Prevention and Control (ECDC) and with international partners such as WHO and other international regulators from affected countries…

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Sabin Vaccine Institute [to 13 February 2016]
http://www.sabin.org/updates/ressreleases
Monday, February 8, 2016
Statement on the World Health Organization’s Declaration of a Public Health Emergency International Concern for Zika Virus
…The Sabin Vaccine Institute supports the WHO decision to declare the recent outbreak of Zika virus a global health emergency. We believe the highly infectious nature of Zika’s growing outbreak, coupled with its possible link to birth defects and other neurological conditions, warrants urgent collaboration among global health partners to accelerate the development of a sustainable measure against Zika — a vaccine.
To facilitate an efficient and effective response, the global health community must strengthen access to scientific evidence and close knowledge gaps in regions most affected by Zika, building information flows among stakeholders.
Global health advocates must also strengthen vector control initiatives and reinforce public awareness of techniques to prevent mosquito bites, currently the most protective measure available. Practices such as the use of insecticides, eliminating standing water and decreasing skin exposure in areas where the Aedes mosquito has been found should be prioritized and articulated extensively.
Lastly, disseminating previous lessons learned from fighting similar diseases, such as dengue fever, will be instrumental to quickly responding to Zika, assessing the potential for developing a vaccine, keeping communities and international agencies informed and building an integrated response against Zika.