NEJM

“…….Results

A total of 966 EBOV antibody–positive survivors and 2350 antibody-negative close contacts (controls) were enrolled, and 90% of these participants were followed for 12 months. At enrollment (median time to baseline visit, 358 days after symptom onset), six symptoms were reported significantly more often among survivors than among controls: urinary frequency (14.7% vs. 3.4%), headache (47.6% vs. 35.6%), fatigue (18.4% vs. 6.3%), muscle pain (23.1% vs. 10.1%), memory loss (29.2% vs. 4.8%), and joint pain (47.5% vs. 17.5%). On examination, more survivors than controls had abnormal abdominal, chest, neurologic, and musculoskeletal findings and uveitis. Other than uveitis (prevalence at enrollment, 26.4% vs. 12.1%; at year 1, 33.3% vs. 15.4%), the prevalence of these conditions declined during follow-up in both groups. The incidence of most symptoms, neurologic findings, and uveitis was greater among survivors than among controls. EBOV RNA was detected in semen samples from 30% of the survivors tested, with a maximum time from illness to detection of 40 months…….”

March 7, 2019
N Engl J Med 2019; 380:924-934
DOI: 10.1056/NEJMoa1805435

NYT

“…..While the motive behind the transit center packages is still unknown, London has been target of terrorism many times over the last 15 years.  On July 7, 2005, suicide bombers killed 52 subway and bus travelers in London. In 2017, there were various deadly attacks on pedestrians on  Westminster Bridge, on London Bridge and near the Finsbury Park Mosque. And a bomb that partially exploded on a commuter train that year burned 23 people.….”

https://www.youtube.com/watch?v=uMlaeJdrNzU

NYT

“……The calamity in Genoa is now the subject of a criminal inquiry, with 21 people under investigation, including nine employees of Autostrade and three officials from the Ministry of Infrastructure and Transport. The authorities are sorting through years of email exchanges and documents, plus the contents of a few dozen mobile phones, to try to determine who is to blame.….”

https://www.youtube.com/watch?v=vc_E3lTzMGY

NYT

“……On Sunday afternoon, sirens wailed and cellphones erupted with about 12 minutes of notice that a funnel cloud had dropped from a foreboding Alabama sky and was bound for Beauregard.

In forecasting, double-digit lead time is considered an extraordinary scientific feat, and officials said the warning was issued as soon as there was data available. But in a place with widespread poverty and few places to hide, the urgent forecast could not save everyone who did not have time to find safe shelter. Others simply disregarded the warning…….”

USA Today

‘….”We are currently facing both a border security and humanitarian crisis along our southwest border,” Customs and Border Protection Commissioner Kevin McAleenan told reporters.

During the five-month period ended Feb. 28, Border Patrol officers apprehended some 268,000 migrants who entered the United States without legal authorization. More than 76,000 entered in February alone…..’

FDA

FDA takes new steps to protect food products from deliberate attacks

March 5, 2019

Media Inquiries

  Lindsay Haake
  301-796-3007

“The U.S. has one of the safest food supplies in the world. However, to keep it safe we must recognize that our foods can be vulnerable – not just from unintended contamination, but from those who would do us harm. We’ve taken steps to minimize the risk of an intentional attack on our food supply, and today we’re advancing new steps to help manufacturers implement additional activities that can help identify and mitigate the risk of intentional food adulteration. To secure these goals, in 2016 we put forth a rule outlining smart, risk-based steps food production facilities must implement to help protect our foods from acts of intentional adulteration. This is a serious issue that warrants serious attention and is why today we’re taking some additional steps to help ensure food facilities will implement the rule as effectively as possible,” said FDA Commissioner Scott Gottlieb, M.D. “When it comes to modernizing our approach to food safety, our core aim is to shift the FDA’s focus from reacting to food safety problems to preventing them from occurring in the first place. To help secure this goal when it comes to the risk of intentional adulteration and acts of terrorism, today we’re providing additional draft guidance to help producers implement the rule’s protective standards, identify their biggest risks, and mitigate these risks from those who might try to use food products to cause deliberate harm to American consumers.”

The U.S. Food and Drug Administration today released a revised draft guidance, “Mitigation Strategies to Protect Food Against Intentional Adulteration: Guidance for Industry,” to support compliance with the intentional adulteration (IA) rule set forth under the FDA Food Safety Modernization Act (FSMA).

The IA rule is designed to address hazards that may be intentionally introduced to foods, including by acts of terrorism, with the intent to cause widespread harm to public health. Unlike the other FSMA rules that address specific foods or hazards, the IA rule requires certain facilities – both domestic facilities and foreign facilities that export to the U.S. – to develop and implement food defense plans that assesses their potential vulnerabilities to such acts of deliberate contamination.

The draft guidance issued today outlines two, flexible methods for how facilities can conduct vulnerability assessments to identify their areas of highest risk and provides information about requirements for education and training. This installment of the draft guidance includes all of the information in the first installment, including information on the Key Activity Type method to conduct vulnerability assessments, mitigation strategies, and food defense monitoring procedures, released in June 2018.

In the near future, the FDA also intends to provide a third installment of this draft guidance that will include additional information on corrective actions, verification, records maintenance, reanalysis requirements, and how to calculate small and very small business sizes in order to determine what requirements of the rule are applicable. When finalized, this draft guidance is intended to be a resource that will help the food industry implement the IA rule’s provisions in a flexible and cost-effective manner. For more information on this guidance, as well as instructions on how to submit comments, please visit FDA.gov.

FDA

March 2019

Contains Nonbinding Recommendations

Draft-Not for Implementation

The FDA Food Safety Modernization Act (FSMA) added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) several new sections that reference intentional adulteration.  For example, section 418 of the FD&C Act (21 U.S.C. 350g) addresses intentional adulteration in the context of facilities that manufacture, process, pack, or hold food, and that are required to register under section 415 (21 U.S.C. 350d).  Section 420 of the FD&C Act (21 U.S.C. 350i) addresses intentional adulteration in the context of high-risk foods and exempts farms except for farms that produce milk [2].

We implemented these intentional adulteration provisions through a rule entitled “Mitigation Strategies to Protect Food Against Intentional Adulteration” (IA rule).We published the final rule in the Federal Register of May 27, 2016.  (81 FR 34166).

The rule, which includes the requirements for food defense measures against intentional adulteration, and related requirements, can be found in 21 CFR part 121, as shown in Table 1.

Table 1. Subparts Established in 21 CFR Part 121

As shown in Table 2 below, the amount of time we are allowing you to comply with the IA rule depends on your particular business.

Table 2. Compliance Dates for IA Rule Based on Size of Business

The IA rule applies to the owner, operator, or agent in charge of a domestic or foreign food facility that manufactures/processes, packs, or holds food for consumption in the United States and is required to register under section 415 of the FD&C Act, unless one of the exemptions provided in 21 CFR 121.5 applies.  (21 CFR 121.1).

Acts of intentional adulteration may take several forms: acts intended to cause wide scale public health harm, such as acts of terrorism focused on the food supply; acts of disgruntled employees, consumers, or competitors; and economically motivated adulteration (EMA).  Acts intended to cause wide scale public health harm are associated with intent to cause significant human morbidity and mortality. The other forms are typically not intended to cause wide scale public health harm, although some public health harm may occur because of the adulteration.  For example, acts of disgruntled employees, consumers, and competitors are generally intended to attack the reputation of a company, and EMA is intended to obtain economic gain.  In the spectrum of risk associated with intentional adulteration of food, attacks intended to cause wide scale public health harm to humans are ranked as the highest risk.  Therefore, the IA rule is focused on addressing those acts and not acts of disgruntled employees, consumers, or competitors, or acts of EMA [3].

This document is directed to those persons who are subject to the Intentional Adulteration (IA) requirements of 21 CFR part 121 (you).  Identifying significant vulnerabilities at your facility and implementing mitigation strategies and mitigation strategy management components enables you to apply a proactive and systematic approach to your food defense program to protect your food from intentional adulteration intended to cause wide scale public health harm.

This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

Download the Draft Guidance for Industry

[1] This guidance has been prepared by the Office of Analytics and Outreach, Food Defense and Emergency Coordination Staff, in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration.

[2] The IA rule did not include any requirements for farms that produce milk. As such, farms that produce milk are not covered under this draft guidance.

[3] As we noted in the final rule, the protections required by the rule will help minimize the likelihood of success of a disgruntled employee, consumer, or competitor who attempts an act of intentional adulteration at an actionable process step—even if that act is not intended to cause wide scale public health harm. (81 FR at 34183).

Asharq Al-Awsat

“……Twenty public figures were targeted in this horrifying terrorist plot, including 10 prominent politicians, seven journalists and activists in syndicates and human rights, they continued.

Moreover, they said that the terrorist groups have shifted their tactics after security measures against them have limited their activity.

For years, they have relied on armed attacks, but they are now forced to resort to poisoning their victims, said the security agencies…..”

Types of Anthrax(https://www.cdc.gov/anthrax/basics/types/index.html)

FEMA Daily Ops

Current Situation: Multiple tornadoes touched down Sunday afternoon/evening in AL and GA. NWS confirmed an EF-4 tornado in Lee County, AL. Hundreds of homes and multiple public buildings have been damaged and dozens of transportation routes have been impacted in eastern AL and western GA.

Impacts:

• Food, Water and Shelter
• • Shelters: (ARC Midnight shelter count, 6:00 a.m. EST) ₒ AL: 2 open w/ 12 occupants ₒ GA: 2 open w/ 17 occupants Health and Medical
• • Fatalities/Injuries: ₒ AL: 23 confirmed fatalities; approx. 30 people missing (Region IV SPOTREP) ₒ GA: No reported fatalities
• Energy: Minimal power outages across the impacted area (EAGLE-I, as of 6:45 a.m. EST)*
• Transportation
• • AL: Multiple aircraft and hangars damaged at airport in Barbour County; several roads reported impassable in Lee County
• State and Local Response:
• • AL EOC at Partial Activation; Governor extended a State of Emergency
• • Governor requested Expedited Major Disaster Declaration
• • GA EOC at Partial Activation; Governor declaring a State of Emergency
• • Damage assessments with state/local officials ongoing
• FEMA Region IV Response:
• • RWC at Steady State, continues to monitor
• • IMAT-1 deployed to AL EOC
• • IMAT-2 demobilized from GA and is Partially Mission Capable
• • LNO deployed to AL; LNO demobilized from GA

FDA

The flu vaccine you get at your doctor’s office or pharmacy is the year-round work of highly skilled microbiologists, epidemiologists, physicians and other public health experts.

Sound complicated? It is.

The U.S. Food and Drug Administration (FDA) and the U.S. Department of Health and Human Services (HHS) are working toward developing new and better technologies for producing flu vaccines. As new strains of flu viruses emerge, the FDA works in close coordination with sister agencies, such as the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH), encouraging manufacturers to develop vaccines that will successfully protect us from influenza disease, which can be a very serious illness.

The more diverse the influenza vaccine supply, the better we can respond to flu public health emergencies in a timely manner. All U.S. licensed flu vaccines have been evaluated and determined to be safe and effective by the FDA.

There is often more than one type of influenza virus circulating each season, so influenza vaccines are formulated to target three or four of the most likely influenza viruses of the season: two influenza A types (H1N1 and H3N2) and one (trivalent vaccine formulation) or two (quadrivalent vaccine formulation) types of influenza B.

Influenza Vaccines and How They Are Made

Influenza (flu) vaccine works by triggering your immune system to produce antibodies that help the body prevent the flu.

Most of the U.S. influenza vaccine supply is made using an egg-based production process. In this method of making influenza vaccines, manufacturers use fertilized eggs to grow flu viruses. After about six months of laboratory work and manufacturing, those viruses are incorporated into that season’s flu vaccine. While this method produces safe and effective vaccines, FDA, HHS, and manufacturers have been working on different technologies to increase the influenza vaccine supply, making sure to still maintain safety and effectiveness. Some technologies have the potential to produce these vaccines faster and less labor-intensively.

For example, more recent approvals include influenza vaccines that do not use an egg-based production process for manufacturing. In addition, quadrivalent vaccines, which protect against two influenza A strains and two influenza B strains, have been available for several years. Quadrivalent vaccines provide protection against the two lineages of influenza B strains, both of which circulate each flu season. This is important, particularly for preschool and school-age children who get Influenza B more often than adults do. Influenza B also causes more complications and fatalities in children than adults.

In addition, the FDA has approved a high-dose and an adjuvanted vaccine specifically for people ages 65 and older, who typically bear the greatest burden of severe influenza disease and account for most of influenza-related hospitalizations and deaths. Adjuvants are incorporated into some vaccine formulations to enhance the immune response of the vaccinated individual.

Making the Flu Vaccine: A Year-Round Effort

The job of producing a new vaccine for the next flu season starts well before the current flu season ends. For the FDA, it’s a year-round initiative.

The composition of vaccines for the prevention of other infectious diseases stays the same year after year. In contrast, flu viruses are constantly evolving. And the flu viruses that circulate causing disease in people, often change from one year to another. So, every year, there is a need for a new flu vaccine. To that end, FDA, World Health Organization (WHO), CDC, and other partners collaborate by collecting and reviewing data on the circulating strains of influenza from around the world to identify those likely to cause the most illness in the upcoming flu season.

In late February/early March — well before the new flu season begins — an FDA advisory committee reviews data about which flu viruses have caused disease in the past year, how the viruses are changing, and disease trends so they can recommend the three or four flu strains to include in the trivalent and quadrivalent influenza vaccines for the U.S in the upcoming flu season.

Once the strains are selected, vaccine manufacturers begin the manufacturing process to include the newly selected flu strains in their FDA-approved vaccines. The different flu virus strains are combined to formulate the vaccine into standard dosages. The vaccine is then filled into vials, syringes and, for the nasal vaccine, sprayers. Both egg-based and non-egg-based manufacturing methods for FDA-approved flu vaccines require high-tech processes and manufacturing facilities that have been inspected by the FDA. Vaccine manufacturers must submit applications to the FDA to include the new flu strains in their FDA-approved vaccines.

In its own laboratories, the FDA also produces materials that are critical for making the vaccine. These include generating candidate vaccine virus strains suitable for further vaccine manufacture and producing the critical potency reagents, which are materials needed to test the vaccines for potency and identity (to ensure standardization) before the FDA approves the new formulation of the approved seasonal influenza vaccines for U.S. distribution.

The FDA is also responsible for ensuring that released lots of influenza vaccines meet appropriate standards. Each vaccine undergoes quality control tests, including testing for sterility. Manufacturers submit the results of their testing, along with sample vials from each lot to the FDA for “lot release.” The FDA typically begins releasing lots of flu vaccines in late summer. Lot release can continue into early fall. Once lots are released, manufacturers distribute the vaccine throughout the United States for use by the public.

Flu seasons and severity are unpredictable. Annual vaccination is the best way to prevent the flu for people ages 6 months and older.

An annual immunization with flu vaccine is the most effective and safest way for most of us to reduce our risk of getting the flu and spreading it to others. When more people get vaccinated, it is less likely that the flu viruses will spread through a community, making us all healthier.

Updated: March 1, 2019

WHO

Between 12 and 18 February 2019, the National IHR Focal Point of Oman reported eight additional cases of Middle East respiratory syndrome coronavirus (MERS-CoV) infection. Four cases were reported from South Sharquia governorate, and four cases were reported from North Batinah governorate where a MERS-CoV cluster was recently identified. Details of the additional eight cases can be found in the attached excel sheet.

• MERS-CoV cases reported from 12 through 18 February 2019
  xlsx, 17kb

Since 27 January 2019, a total of 13 MERS cases were reported from Oman, including nine from North Batinah (five cases were previously reported in the Disease outbreak News 11 February 2019) and four from South Sharquia.

• MERS-CoV Disease outbreak news 11 February 2019

An investigation into the exposure history to known risk factors in the 14 days prior to symptom onset in all eight cases is currently ongoing.

From 2012 through 18 February 2019, a total of 2357 laboratory-confirmed cases of MERS, along with 820 associated deaths, have been reported to WHO globally. The first reported MERS infection in Oman was reported in 2013. Since then, a total of 24 cases and seven deaths have been reported.

The global number reflects the total number of laboratory-confirmed cases reported to WHO under IHR to date. The total number of deaths includes the deaths that WHO is aware of to date through follow-up with affected member states.

Public Health response

Whole genome sequencing of available human specimens of patients is being conducted. As of 21 February, all identified contacts (family and health workers) of confirmed MERS patients have been screened, including 69 contacts from North Batinah patients and 57 contacts from South Sharqiyah patients. Tracing and follow-up of these contacts is ongoing by the Ministry of Health for 14 days from the last date of exposure as per WHO and national guidelines for MERS-CoV. All contacts have been sampled and have tested negative for MERS-CoV by RT-PCR.

The Ministry of Agriculture has conducted an investigation of dromedaries at the farms of one of the patients. Results of this investigation are pending.

The Ministry of Health has strengthened infection prevention and control measures in emergency departments, especially in triaging areas. Health education and awareness materials were produced and disseminated to health care staff, patients and visitors.

Family members of MERS-CoV infected patients have been contacted and advised about the virus and on measures to ensure personal protection to prevent infection. Efforts in improving public health awareness among the general public has been strengthened through greater messaging in the media.

WHO risk assessment

Infection with MERS-CoV can cause severe disease resulting in high morbidity and mortality. Humans are infected with MERS-CoV from direct or indirect contact with infected dromedary camels. MERS-CoV has demonstrated the ability to transmit between humans, especially from close unprotected contact with infected patients. So far, the observed non-sustained human-to-human transmission has occurred mainly in health care settings.

The notification of these additional cases does not change WHO’s overall risk assessment of MERS-CoV. WHO expects that additional cases of MERS infection will be reported from the Middle East, and that cases will continue to be exported to other countries by individuals who might acquire the infection after exposure to dromedary camels, animal products (e.g. consumption of camel’s raw milk), or humans (e.g. in a health care setting). WHO continues to monitor the epidemiological situation and conducts risk assessment based on the latest available information.

WHO advice

Based on the current situation and available information, WHO encourages all Member States to continue their surveillance for acute respiratory infections and to carefully review any unusual patterns.

Infection prevention and control measures are critical to prevent the possible spread of MERS-CoV between people in health care facilities. It is not always possible to identify patients with MERS-CoV infection early because like other respiratory infections, the early symptoms of MERS are non-specific. Therefore, healthcare workers should always apply standard precautions consistently with all patients, regardless of their diagnosis. Droplet precautions should be added to the standard precautions when providing care to patients with symptoms of acute respiratory infection; contact precautions and eye protection should be added when caring for probable or confirmed cases of MERS infection; airborne precautions should be applied when performing aerosol generating procedures.

Early identification, case management and isolation, together with appropriate infection prevention and control measures can prevent human-to-human transmission of MERS-CoV.

WHO recommends that comprehensive identification, follow up and testing of all contacts of MERS patients be conducted, if feasible, regardless of the development of symptoms since approximately 20% of all reported MERS infections have been reported as mild or asymptomatic. The role of asymptomatic MERS infection in transmission is not well understood. However, reports of transmission from an asymptomatic MERS infected patient to another individual have been documented.

MERS causes more severe disease in people with underlying chronic medical conditions such as diabetes, renal failure, chronic lung disease, and immunocompromised persons. Therefore, these people should avoid close contact with dromedary camels when visiting farms, markets, or barn areas where the virus is known to be potentially circulating. General hygiene measures, such as regular hand washing before and after touching animals and avoiding contact with sick animals, should be adhered to.

Food hygiene practices should be observed. People should avoid drinking raw camel milk or camel urine, and refrain from eating meat that has not been properly cooked.

WHO does not advise special screening at points of entry with regards to this event, and does not currently recommend the application of any travel or trade restrictions at this time.