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NY Times

WHO

Press release

Copenhagen, 11 July 2017

Ongoing measles outbreaks in the WHO European Region have caused 35 deaths in the past 12 months. The most recent fatality was a 6-year-old boy in Italy, where over 3300 measles cases and 2 deaths have occurred since June 2016. Several other countries have also reported outbreaks; according to national public health authorities, these have caused 31 deaths in Romania, 1 death in Germany and another in Portugal.

“Every death or disability caused by this vaccine-preventable disease is an unacceptable tragedy,” says Dr Zsuzsanna Jakab, WHO Regional Director for Europe. “We are very concerned that although a safe, effective and affordable vaccine is available, measles remains a leading cause of death among children worldwide, and unfortunately Europe is not spared. Working closely with health authorities in all European affected countries is our priority to control the outbreaks and maintain high vaccination coverage for all sections of the population.”

The Region has been progressing towards measles elimination. A total of 37 countries have interrupted endemic transmission, according to the assessment of the Regional Verification Commission for Measles and Rubella Elimination based on 2015 reporting. However, remaining pockets of low immunization coverage allow the highly contagious virus to spread among those who choose not to vaccinate, do not have equitable access to vaccines or cannot be protected through vaccination due to underlying health conditions.

In response, several countries are adopting measures, such as school-entry checks, to increase coverage rates for routine vaccinations against measles and other diseases. WHO recommends that every eligible child receive 2 doses of measles-containing vaccine. It also encourages adults who are not fully immunized, or who are not sure of their immunity status, to get vaccinated.

In line with the Regional Director’s call for intensified efforts, Romania conducted a nationwide campaign of enhanced routine immunization activities. Italy implemented outbreak control measures including notifying suspected cases, tracing contacts and offering post-exposure prophylaxis and vaccination.

On 21 June 2017 in Rome, Italy, experts from the WHO Regional Office for Europe contributed to a consultation with regional public health officials, representatives of the Italian Institute of Health (ISS), and measles and rubella laboratory officials. Together they decided on further strategies to improve vaccination coverage among adolescents, adults, vulnerable population groups and health-care workers. The range of identified activities includes strengthening disease surveillance and communication practices.

NY Times

EXECUTIVE SUMMARY

Final Document: Final_Report_of_the_Variola_Mishap-2017
In August of 2016, the National Institutes of Health (NIH) appointed a Blue Ribbon Panel to review the July 2014 discovery of six vials containing variola virus, the causative agent of smallpox, as well as over 300 other previously undiscovered biological samples on the NIH Bethesda, Maryland campus. The samples were found in an unsecured cold-storage room in a building occupied and managed by Food and Drug Administration (FDA) staff under NIH biosafety and biosecurity oversight.
The Panel includes a diverse group of seven external subject matter experts, and was constituted as a Working Group of the National Science Advisory Board for Biosecurity (NSABB), a federal advisory committee to the United States Government. The Panel began its work in August of 2016 and completed this final report in May of 2017. The Blue Ribbon Panel was charged with a number of tasks, including, 1) to determine how the smallpox virus vials came to be improperly stored and overlooked for years; 2) to identify any systemic issues that contributed to the lapse; and 3) to evaluate whether NIH had taken adequate corrective actions in response to this incident. It should be noted that this incident was one of several biosafety lapses involving federally regulated pathogens that occurred in the United States in 2014. These incidents caused considerable concern and led to substantial remedial activity throughout the United States Government.
Smallpox was a devastating, contagious disease that infected over 300 million people in the 20th century, killing up to 30% of those infected. It was declared eradicated by the World Health Organization in 1980, and by international agreement, the remaining acknowledged samples were to be placed under tight control and oversight in only two repositories: in the US, at the Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia and in Russia, now at The State Research Center of Virology and Biotechnology (VECTOR), Novosibirsk.
While there are now smallpox vaccines available in the U.S. should they be needed, routine vaccination of Americans ceased in the mid-1970’s. As a result, nearly half of the population is unvaccinated, and, because vaccine effectiveness wanes over time, nearly the entire US population is potentially vulnerable to infection. The finding of viable smallpox virus samples outside of the established repositories was totally unanticipated and required an appropriate response and a rethinking of laboratory biosafety and biosecurity policy at NIH.
The Blue Ribbon Panel evaluation benefited from several prior comprehensive investigations of the smallpox virus incident, including by the Federal Bureau of Investigation jointly with the CDC, by the Government Accountability Office, and by Congress. The FDA also conducted an internal review. The Blue Ribbon Panel examined relevant federal and biosafety policy, regulation and guidance documents, as well as the many administrative actions taken by NIH in response to the 2014 smallpox virus discovery. The Panel visited pertinent sites on the NIH

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campus, and interviewed those who had knowledge of or responsibility for the response. The Panel assessed that the incident has been now adequately evaluated and documented. Some questions remain, however, including the identity of the original owner of the samples and how they may have come to be in the cold-storage room. Unless further new information surfaces to solve this mystery, it is unlikely to be resolved, due to the passage of time. In addition, storage of the samples likely occurred before the Select Agents Program was established, at a time when biosafety standards were very different from today.
The Blue Ribbon Panel identified several key factors that contributed to the smallpox virus incident: There was a lack of individual responsibility for infectious materials in the FDA occupied space where the vials were found. There were also numerous missed opportunities to find the samples prior to 2014, particularly in the 1980’s when all smallpox virus samples were required to be either destroyed or sent to CDC, and again in 2003 when laws governing the possession of regulated pathogens, called “select agents,” were implemented. In addition, a lack of policies for dealing with abandoned research materials and for regular inventory of potentially hazardous biological materials were major contributors to the occurrence of this incident.
The panel assessed the response to the incident as appropriate and thorough, with excellent inter-agency cooperation (including the FBI) to manage a highly unusual situation. However, the Panel noted several specific problematic issues relating to the immediate response after discovery of the smallpox virus and other samples. In particular, the Panel determined that given the potentially hazardous nature of the abandoned samples, there are significant concerns about how they were packaged and transferred between buildings on the NIH campus. Following the discovery by an FDA official, it was decided by NIH that the samples should be immediately transferred to a secure high-containment Biosafety Level 3 laboratory. The samples, in their original boxes, were packaged into a larger cardboard box, and then handcarried to the secure NIH laboratory. No negative consequences occurred — there were no infections or injuries — but packaging and transport of the samples were conducted in ways that presented both biosafety and security risks. Other concerns identified by the panel included inadequate chain-of-custody and logging of events directly after the discovery of the vials, and the use of cardboard in cold-storage rooms. Although secondary to the issues associated with this event, cardboard containers can contribute to mold and unsanitary conditions.
The Panel assessed efforts pursued by NIH following the incident that were intended to improve biosafety and biosecurity procedures and minimize the likelihood of such occurrences in the future. It was determined that most of the factors and causative issues have been addressed by NIH’s subsequent efforts and policy revisions and are detailed in the report. However, there are several remaining issues requiring attention.

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The Blue Ribbon Panel offers to NIH the following observations and recommendations. First, with regard to specific, detailed steps NIH should take to remedy remaining gaps in biosafety policies and procedures, the BRP recommends:  Revise several specific biosafety policies and procedures, as detailed in the report.  Rapidly finish the on-going space audit to ensure responsibility and oversight of all research materials is assigned to individuals by name, and updated as required by personnel changes.  Ensure that any shared research space arrangements have clear written agreements with responsibilities well defined.  The BRP noted that NIH policies and procedures use terms that are not in general use; such as “High consequence pathogens,” “and “potentially infectious materials. These categories need to be defined carefully or eliminated when not clearly necessary.

Second, regarding more general approaches to improving biosafety and biosecurity at NIH, the BRP considers the following to be important considerations:

 Effective and complete implementation of current policies, procedures, guidance and practices on an on-going basis over time will be critical to ensuring safety and security surrounding pathogen research at NIH.  The importance of leadership at the highest levels and continuous efforts to develop and maintain a culture of safety and responsibility among research staff cannot be overemphasized.  There would be significant benefits to having consistent biosafety and biosecurity policies across the Department of Health Human Services (HHS) and the entire USG; ideally, insofar as possible, these should be harmonized with efforts by governments and international institutions as well. The BRP recommends continuing on-going efforts to address these issues.  Response plans coordinated and exercised with agencies outside of HHS, including the Federal Bureau of Investigation, the Environmental Protection Agency and others, as needed, remain important.  The variola virus incident illustrates how changes in infectious disease epidemiology and biosafety practices over time can radically alter a situation from “standard lab practice” to a potential major public health event.
The Blue Ribbon Panel concludes its effort with the observation that the smallpox virus incident illustrates how biosafety practices and laboratory management need to be continually evaluated. There was a time that research with smallpox virus could be conducted in relatively routine containment settings because the virus presented no extraordinary danger to the US population, as most everyone was vaccinated. As other infectious diseases are eradicated or controlled in the future, similar situations to the events of 2014 may arise — for example, with polio virus, which is currently close to eradication. Research samples and collections not

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previously considered a significant biosecurity concern, need to be routinely re-evaluated to ensure proper biosafety and handling so that public health and safety are not compromised.

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FEMA

The National Preparedness System is intended to be used by the whole community. The intended audience for this page is individuals, families, communities, the private and nonprofit sectors, faith-based organizations, and local, state, tribal, territorial, insular area, and Federal governments. If you have any questions, please contact the National Integration Center at FEMA-NIC@fema.dhs.gov.

Introduction
Every day, we take steps to keep our nation safe and ensure that we thrive after disasters occur. Whether we face risks related to earthquakes, cyber attacks or chemical spills, our goal is shared: safety and resilience.

The National Preparedness System outlines an organized process for everyone in the whole community to move forward with their preparedness activities and achieve the National Preparedness Goal.

The National Preparedness System has six parts:

Identifying and Assessing Risk. This part involves collecting historical and recent data on existing, potential and perceived threats and hazards. The results of these risk assessments form the basis for the remaining steps.

Estimating Capability Requirements. Next, you can determine the specific capabilities and activities to best address those risks. Some capabilities may already exist and some may need to be built or improved. FEMA provides a list of core capabilities related to protection, prevention, mitigation, response and recovery, the five mission areas of preparedness. To see a full list of the core capabilities, including details about each one, visit our Core Capabilities page on this site.

Building and Sustaining Capabilities. This involves figuring out the best way to use limited resources to build capabilities. You can use the risk assessment to prioritize resources to address the highest probability or highest consequence threats.

Planning to Deliver Capabilities. Because preparedness efforts involve and affect the whole community, it’s important that you coordinate your plans with other organizations. This includes all parts of the whole community: individuals, businesses, nonprofits, community and faith-based groups, and all levels of government.

Validating Capabilities. Now it’s time to see if your activities are working as intended. Participating in exercises, simulations or other activities helps you identify gaps in your plans and capabilities. It also helps you see progress toward meeting preparedness goals. Please visit the National Exercise Division for more information.

Reviewing and Updating. It is important to regularly review and update all capabilities, resources and plans. Risks and resources evolve—and so should your preparedness efforts.

Specific Tools and Resources
Depending on your role in the community, you may be in need of specific tools and resources to help you through the cycle of the National Preparedness System. We’ve listed a few below, along with links for more information.

Threat and Hazard Identification and Risk Assessment (THIRA). Guidance for conducting a THIRA at all levels of government can be found in Comprehensive Preparedness Guide (CPG) 201: Second Edition.
Operations Plans. Guidance for creating these plans can be found in Comprehensive Preparedness Guide (CPG) 101: Second Edition.
National Incident Management System. The National Incident Management System (NIMS) provides a systematic, proactive approach to guide organizations in managing all types of incidents. Information about NIMS – including supporting tools and materials – can be found on the NIMS web page.
National Planning System. The National Planning System provides a unified approach and common terminology to support the implementation of the National Preparedness System through plans that support an all threats and hazards approach to preparedness. These plans—whether strategic, operational, or tactical—enable the whole community to build, sustain, and deliver the core capabilities identified in the National Preparedness Goal.
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