Zika virus [to 12 March 2016]
Public Health Emergency of International Concern (PHEIC)
http://www.who.int/emergencies/zika-virus/en/
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WHO and experts prioritize vaccines, diagnostics and innovative vector control tools for Zika R&D
67 groups working on experimental products
Note for the media [Editor’s text bolding]
9 March 2016
After a three-day consultation on Zika research and development, international experts, convened by WHO, have agreed on top priorities to advance R&D for Zika medical products.
The following tools were prioritized as the most viable options to help fight the spread of Zika virus in the immediate future:
:: Multiplex tests for ‘flaviviruses’ (viruses related to Zika, such as dengue, chikungunya), in addition to more traditional tests;
:: protective vaccines based on killed virus (or other non-live) preparations for women of childbearing age; and
:: innovative vector control tools that reduce the mosquito population.
“Zika virus induces a mild and mostly harmless infection in the majority of patients,” indicated Dr Marie-Paule Kieny, Assistant Director-General in charge of R&D at WHO. “For that reason medicines to treat it seem less of a priority at this stage. The most pressing need is the development of diagnostic and preventive tools to address the current R&D gap and protect pregnant women and their babies.”
As of 2 March, 67 companies and research institutions were already working on a number of products (31 on diagnostics, 18 on vaccines, 8 on therapeutics, 10 on vector control), which are at various stages of early development. No vaccine or therapeutic has yet been tested on humans.
Vaccines
Experts agreed that the development of a vaccine is a major priority to respond to epidemics in the future. Vaccination of pregnant women and women of childbearing age is the main target, and pragmatic strategies will be needed to fast-track the development of a safe and effective product.
Work is underway for the development of an emergency vaccine target product profile. The target product profile will serve as a guide to consult and build consensus on regulatory requirements for Zika vaccine evaluation and registration. A draft target profile will be submitted to a public consultation in the coming weeks, with a view to having a final profile in May.
Diagnostics
Over 30 companies are working on or have developed potential diagnostic tests. There is general support for the development of a target product profile for a multiplex test that can diagnose dengue, chikungunya and Zika viruses. A first draft is ready and this too will undergo public consultation before finalization in mid-April.
WHO continues to encourage manufacturers to apply to the WHO Emergency Use, Assessment and Listing procedure for a quality and performance evaluation of their products…
:: Emergency use assessment and listing procedure for Zika virus disease
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WHO statement on the 2nd meeting of IHR Emergency Committee on Zika virus and observed increase in neurological disorders and neonatal malformations
WHO statement
8 March 2016
The second meeting of the Emergency Committee (EC) convened by the Director-General under the International Health Regulations (2005) (IHR 2005) regarding clusters of microcephaly cases and other neurological disorders in some areas affected by Zika virus was held by teleconference on 8 March 2016, from 13:00 to 16:45 Central European Time.
The WHO Secretariat briefed the Committee on action in implementing the Temporary Recommendations issued by the Director-General on 1 February 2016, and on clusters of microcephaly and Guillain-Barré Syndrome (GBS) that have had a temporal association with Zika virus transmission. The Committee was provided with additional data from observational, comparative and experimental studies on the possible causal association between Zika virus infection, microcephaly and GBS.
The following States Parties provided information on microcephaly, GBS and other neurological disorders occurring in the presence of Zika virus transmission: Brazil, Cabo Verde, Colombia, France, and the United States of America.
The Committee noted the new information from States Parties and academic institutions in terms of case reports, case series, 1 case control study (GBS) and 1 cohort study (microcephaly) on congenital abnormalities and neurologic disease in the presence of Zika virus infection. It reinforced the need for further work to generate additional evidence on this association and to understand any inconsistencies in data from countries. The Committee advised that the clusters of microcephaly cases and other neurological disorders continue to constitute a Public Health Emergency of International Concern (PHEIC), and that there is increasing evidence that there is a causal relationship with Zika virus.
The Committee provided the following advice to the Director-General for her consideration to address the PHEIC, in accordance with IHR (2005).
Microcephaly, other neurological disorders and Zika virus
:: Research into the relationship between new clusters of microcephaly, other neurological disorders, including GBS, and Zika virus, should be intensified.
:: Particular attention should be given to generating additional data on the genetic sequences and clinical effect of different Zika virus strains, studying the neuropathology of microcephaly, conducting additional case-control and cohort studies in other and more recently infected settings, and developing animal models for experimental studies.
:: Research on the natural history of Zika virus infection should be expedited, including on the rates of asymptomatic infection, the implications of asymptomatic infection, particularly with respect to pregnancy, and the persistence of virus excretion.
:: Retrospective and prospective studies of the rates of microcephaly and other neurological disorders should be conducted in other areas known to have had Zika virus transmission but where such clusters were not observed.
:: Research should continue to explore the possibility of other causative factors or co-factors for the observed clusters of microcephaly and other neurological disorders.
:: To facilitate this research and ensure the most rapid results:
:::: surveillance for microcephaly and GBS should be standardized and enhanced, particularly in areas of known Zika virus transmission and areas at risk,
:::: work should begin on the development of a potential case definition for ‘congenital Zika infection’,
:::: clinical, virologic and epidemiologic data related to the increased rates of microcephaly and/or GBS, and Zika virus transmission, should be rapidly shared with the World Health Organization to facilitate international understanding of the these events, to guide international support for control efforts, and to prioritize further research and product development.
Surveillance
:: Surveillance for and notification of Zika virus infection should be enhanced with the dissemination of standard case definitions and diagnostics to areas of transmission and at-risk areas; newly infected areas should undertake the vector control measures outlined below.
Vector control
:: Vector surveillance, including the determination of mosquito vector species and their sensitivity to insecticides, should be enhanced to strengthen risk assessments and vector control measures.
:: Vector control measures and appropriate personal protective measures should be aggressively promoted and implemented to reduce the risk of exposure to Zika virus.
:: Countries should strengthen vector control measures in the long term and the Director-General of WHO should explore the use of IHR mechanisms, and consider bringing this to a forthcoming World Health Assembly, as means to better engage countries on this issue.
Risk communication
:: Risk communication should be enhanced in countries with Zika virus transmission to address population concerns, enhance community engagement, improve reporting, and ensure application of vector control and personal protective measures.
:: These measures should be based on an appropriate assessment of public perception, knowledge and information; the impact of risk communication measures should be rigorously evaluated to guide their adaptation and improve their impact.
:: Attention should be given to ensuring women of childbearing age and particularly pregnant women have the necessary information and materials to reduce risk of exposure.
:: Information on the risk of sexual transmission, and measures to reduce that risk, should be available to people living in and returning from areas of reported Zika virus transmission.
Clinical care
:: Pregnant women who have been exposed to Zika virus should be counselled and followed for birth outcomes based on the best available information and national practice and policies,
:: In areas of known Zika virus transmission, health services should be prepared for potential increases in neurological syndromes and/or congenital malformations.
Travel measures
:: There should be no general restrictions on travel or trade with countries, areas and/or territories with Zika virus transmission.
:: Pregnant women should be advised not travel to areas of ongoing Zika virus outbreaks; pregnant women whose sexual partners live in or travel to areas with Zika virus outbreaks should ensure safe sexual practices or abstain from sex for the duration of their pregnancy.
:: Travellers to areas with Zika virus outbreaks should be provided with up to date advice on potential risks and appropriate measures to reduce the possibility of exposure to mosquito bites and, upon return, should take appropriate measures, including safe sex, to reduce the risk of onward transmission.
:: The World Health Organization should regularly update its guidance on travel with evolving information on the nature and duration of risks associated with Zika virus infection.
:: Standard WHO recommendations regarding vector control at airports should be implemented in keeping with the IHR (2005). Countries should consider the disinsection of aircraft.
Research & product development
:: The development of new diagnostics for Zika virus infection should be prioritized to facilitate surveillance and control measures, and especially the management of pregnancy.
:: Research, development and evaluation of novel vector control measures should be pursued with particular urgency.
:: Research and development efforts should also be intensified for Zika virus vaccines and therapeutics in the medium term.
Based on this advice the Director-General declared the continuation of the Public Health Emergency of International Concern (PHEIC). The Director-General endorsed the Committee’s advice and issued them as Temporary Recommendations under IHR (2005). The Director-General thanked the Committee Members and Advisors for their advice.
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Zika virus, Microcephaly and Guillain-Barré syndrome – 10 March 2016
WHO Situation Report: Read the full situation report
Summary
:: The second meeting of the Emergency Committee was convened by the Director-General under the International Health Regulations (2005) on 8 March 2016. The Committee advised that the clusters of microcephaly cases and other neurological disorders in some areas affected by Zika virus continue to constitute a Public Health Emergency of International Concern, and that there is increasing evidence that there is a causal relationship with Zika virus.
:: Between 1 January 2007 and 9 March 2016, a total of 52 countries and territories have reported autochthonous (local) transmission or indication of transmission of Zika virus (41 since 1 January 2015). The Philippines is the latest to report autochthonous transmission of Zika virus. Five of these countries and territories reported a Zika virus outbreak that is now over. In addition, three countries have reported locally acquired infection in the absence of any known mosquito vectors, probably through sexual transmission.
:: The geographical distribution of Zika virus has steadily widened since the virus was first detected in the Americas in 2014. Autochthonous Zika virus transmission has been reported in 31 countries and territories of this region.
:: So far an increase in microcephaly and other neonatal malformations has only been reported in Brazil and French Polynesia, although two cases linked to a stay in Brazil were detected in the United States of America and Slovenia. Reported cases of microcephaly and/or congenital malformation in Colombia are under investigation.
:: In the context of Zika virus circulation, nine countries or territories have reported an increased incidence of Guillain-Barré syndrome (GBS) and/or laboratory confirmation of a Zika virus infection among GBS cases.
:: A recently published cohort study in Brazil shows an increased risk of microcephaly and other congenital abnormalities associated with a Zika virus infection during pregnancy and provides further information to support the possible causal relationship between Zika virus and microcephaly and other congenital abnormalities.
:: The global prevention and control strategy launched by WHO as a Strategic Response Framework encompasses surveillance, response activities and research, and this situation report is organized under those headings.
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Disease Outbreak News (DONs)
:: 7 March 2016 – Guillain-Barré syndrome – France – French Polynesia
:: 7 March 2016 – Zika virus infection – Argentina and France
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Guidance for health workers
:: Protecting the health and safety of workers in emergency vector control of Aedes mosquitoes
11 March 2016
:: Monitoring and managing insecticide resistance
8 March 2016
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Zika Open
[Bulletin of the World Health Organization]
:: All papers available here
No new papers posted.
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CDC/ACIP [to 12 March 2016]
http://www.cdc.gov/media/index.html
FRIDAY, MARCH 11, 2016
CDC’s revised travel notices estimate Zika risk using elevation information
Mosquitoes linked to Zika virus not likely in areas above 6,500 feet (2,000 meters)
CDC travel alerts for destinations where Zika is spreading will now include recommendations specific to travel at elevations above and below 6,500 feet (2,000 meters). As a result of these changes, CDC’s regional notices have been revised to destination-specific notices.
Starting in January 2016, CDC issued level 2 travel health notices for several countries where local vector-borne transmission of Zika virus infection has been reported. Local vector-borne transmission means that mosquitoes in an area are infected with Zika virus and are spreading it to people. Specific areas with Zika are often difficult to determine and are likely to change over time. As more information becomes available, travel notices are updated.
CDC today released 37 destination-specific Zika travel notices; for destinations with areas above 6,500 feet, the notices include elevation maps and additional information about the risk of Zika virus infection at these elevations. CDC recently examined historical reports of the mosquito species linked to Zika and dengue virus, which is spread by the same mosquito, and found that reports of both mosquitoes and dengue were rare for locations above 6,500 feet.
These new maps show, for each country, the areas above and below 6,500 feet. The maps are intended to help travelers determine if the location(s) they plan to visit are above the elevation at which the mosquitos are likely to be found. Travelers whose itineraries are limited to areas above 6,500 feet are at minimal risk of getting Zika from a mosquito…
FRIDAY, MARCH 11, 2016
Transcript for CDC Telebriefing: Updates on Zika response efforts
Audio recording[MP3, 3.10 MB]
THURSDAY, MARCH 10, 2016
Updates on Zika response efforts
CDC Director Tom Frieden traveled to Puerto Rico March 7-9 to assess firsthand CDC’s support for the Zika response.
WEDNESDAY, MARCH 9, 2016
CDC adds 1 destination to interim travel guidance related to Zika virus
CDC is working with other public health officials to monitor for ongoing Zika virus? transmission. Today, CDC added the following destination to the Zika virus travel notices: New Caledonia.
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MMWR March 11, 2016 / Vol. 65 / No. 9
:: Increase in Reported Prevalence of Microcephaly in Infants Born to Women Living in Areas with Confirmed Zika Virus Transmission During the First Trimester of Pregnancy — Brazil, 2015
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FDA [to 12 March 2016]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Posted: 3/11/2016
Questions and Answers Regarding – Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus: Guidance for Industry (PDF – 310KB)