History

https://www.youtube.com/watch?v=DiP2whQmv0k

At A Glance

WC

WHO

“The Ministry of Health (MoH), WHO and partners continue to respond to the Ebola virus disease (EVD) outbreak in the Democratic Republic of the Congo, and remain confident that the outbreak can be contained, despite ongoing challenges. During the reporting period (27 November – 3 December 2018), 31 new confirmed cases and one new probable case were detected. The cases were reported from eight health zones in North Kivu Province: Beni (n=8), Katwa (n=8), Vuhovi (n=3), Kalunguta (n=2), Butembo (n=1), Masereka (n=1), Mutwanga (n=1) and Mabalako (n=1), as well as Komanda Health Zone (n=7) in Ituri Province. A total of 27 deaths occurred during the reporting period.
As of 3 December 2018, a total of 453 EVD cases, including 405 confirmed and 48 probable cases (Table 1), have been reported from 14 health zones in the two neighbouring provinces of North Kivu and Ituri (Figure 2). The health zones of Komanda, Masereka and Mabalako have reported one new confirmed case each, respectively 61 days, 48 days and 56 days after confirmation of previously confirmed cases, and investigations are ongoing regarding links and travel history from other areas to these cases. Over the last 21 days (13 November to 3 December 2018), 110 confirmed and probable cases were reported from 11 health zones. The majority were reported from Beni (n=35), Katwa (n=34), Kalunguta (n=15) and Butembo (n=10). The other affected health zones were Komanda, Kyondo, Mabalako, Masereka, Mutwanga, Oicha and Vuhovi. Of the 453 cases, 268 died (case fatality rate 59%), including 220 among confirmed cases. Females account for 59% of all confirmed and probable cases. Two health workers were among the new confirmed cases, bringing the total number of health workers infected to 44, including 12 deaths.
As of 3 December 2018, 144 confirmed cases have recovered and been discharged from Ebola Treatment Centres (ETCs). On this day, 114 patients were hospitalised in transit centres and ETCs, of which 35 were laboratory confirmed and are receiving compassionate therapy under the monitored emergency use of unregistered and experimental interventions (MEURI) guidelines…..”

History

“…..In West Virginia’s Marion County, an explosion in a network of mines owned by the Fairmont Coal Company in Monongah kills 361 coal miners. It was the worst mining disaster in American history……”

History

The flow chart below provides a summary of the process for Emergency Use Authorization (EUA) issuance.

Description of chart:

Issuance of an EUA by the FDA Commissioner requires several steps under section 564 of the FD&C Act. First, one of the four following determinations must be in place:

1. The Department of Defense (DoD) Secretary issues a determination of military emergency or significant potential for military emergency
2. The Department of Homeland Security (DHS) Secretary issues a determination of domestic emergency or significant potential for domestic emergency.
3. The Department of Health and Human Services (HHS) Secretary issues a determination of public health emergency or significant potential for public health emergency
4. The DHS Secretary issues a material threat determination

After one of the above four determinations is in place, the HHS Secretary can issue a declaration that circumstances exist to justify issuing the EUA.  This declaration is specific to EUAs and is not linked to other types of emergency declarations.

The FDA Commissioner, in consultation with the HHS Assistant Secretary for Preparedness and Response (ASPR), Centers for Disease Control and Prevention (CDC), and the National Institutes of Health (NIH), can then issue the EUA, if criteria for issuance under the statute are met.  FDA publishes public notice of each EUA that is issued in the Federal Register.

The last step in the process is termination of declaration and EUA, if appropriate and needed.

FDA

The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies.

Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives.

Section 564 of the FD&C Act was amended by the Project Bioshield Act of 2004 and the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), which was enacted in March 2013

Current EUAs

The tables below provide information on current EUAs:

• Anthrax: Doxycycline Mass Dispensing EUA Information and National Postal Model Anthrax EUA Information
• Ebola Virus EUA Information
• Enterovirus D68 (EV-D68) EUA Information
• French Freeze Dried Plasma Information
• H7N9 Influenza EUA Information
• Middle East Respiratory Syndrome Coronavirus (MERS-CoV) EUA Information
• Nerve Agent EUA Information
• Zika Virus EUA Information

History

BBC

“……There have been no reports of injuries or damage in the French overseas territory, officials say.

Earlier, residents had been urged to go to shelters, following the 7.5 magnitude quake close to New Caledonia…..”