News Scan for Jan 30, 2018

Saudi MERS case
;
US food safety agreement
;
New antimicrobials
;
Wolbachia mosquitoes
;
Suspected RVF in South Sudan
;
Global health cuts

Saudi Arabia reports 1 new MERS case, death

Yesterday the Saudi Arabian Ministry of Health (MOH) reported a new case of MERS-CoV and announced the death of a previously reported MERS patient.

A 40-year-old Saudi woman from Riyadh is in stable condition after presenting with symptoms of MERS-CoV (Middle East respiratory syndrome coronavirus). The woman's source of infection is listed as "primary," meaning it's unlikely she contracted the disease from another person.

The MOH also said that a 50-year-old male expatriate from Al Qunfudhah, reported as having MERS on Jan 27, has died. That patient had direct contact with camels and preexisting disease.

The latest reports raise Saudi Arabia's total since the virus was first detected in humans in 2012 to 1,785, which includes 727 deaths. Eleven people are currently being treated for their infections.
Jan 29 MOH
report

 

USDA and FDA sign new agreement on food safety, other activities

The US Department of Agriculture (USDA) and Food and Drug Administration (FDA) signed a formal agreement today that increases collaboration and efficiency on produce safety and biotechnology activities between the two agencies.

"Today, Commissioner [Scott] Gottlieb and I signed a formal agreement to promote coordination and the streamlining of capacities and obligations on shared concerns and jurisdiction," said US Agriculture Secretary Sonny Perdue in a press release from the FDA.

Notably, the agreement will see the two agencies working together on the Food Safety Modernization Act (FSMA), which aims to prevent foodborne illness. Under the new agreement, both agencies are tasked with working together to investigate foodborne illness outbreaks. Currently  the USDA oversees the safety of most meat, poultry, catfish and certain egg products while the FDA oversees dairy, seafood, produce and packaged foods.

In the release, the FDA said the interagency collaboration will "use government resources more efficiently to protect public health."

The agreementalso commits the two agencies to identify efficiencies in their approaches to regulate biotechnology as outlined in the 2016 National Strategy for Modernizing the Regulatory System for Biotechnology Products and the 2017 Task Force on Agricultural and Rural Prosperity Report.
Jan 30 FDA
statement

 

FDA offers guidance on new antimicrobials under GAIN Act

The FDA yesterday published guidance for industry on the implementation of the Generating Antibiotic Incentives Now (GAIN) Act, detailing policies and procedures related to the designation of a qualified antimicrobial under the 2012 law.

GAIN offers incentives for the development of antibacterial and antifungal drugs to treat serious infections, including those that are life-threatening. The primary incentive to pharmaceutical companies is a 5-year exclusivity extension for drug products that have been designated and approved as a qualified infectious disease product (QIDP). A QIDP can also receive FDA fast-track status.

Yesterday's guidance states, "For a drug product to be designated a QIDP, the sponsor is required to demonstrate that the drug is an 'antibacterial or antifungal drug for human use intended to treat serious or life-threatening infections.' A sponsor requesting a QIDP designation may also include documentation that the product is intended to treat an 'antibacterial or antifungal resistant pathogen, including novel or emerging infectious pathogens' or a qualifying pathogen as part of the designation request; however, such documentation is not required."

The FDA said it will respond to QIDP designation requests within 60 days of submission.
Jan 29 FDA guidance

 

Wolbachia mosquitos released in Miami to help combat Zika

Late last week, Miami-Dade County announced the launch of the Mosquito Mate program, which introduced Wolbachia-treated male mosquitoes throughout the city of South Miami.

The Mosquito Mate program is designed to reduce the number of Aedes aegypti mosquitoes in southern Florida, where the insects have transmitted Zika virus locally since 2016.

Wolbachia is a naturally occurring bacterium that renders mosquitoes infertile and unable to transmit diseases.

The Wolbachia mosquitoes do not bite or feed on blood and are incapable of transmitting pathogens that cause human disease. When they mate with female Ae aegypti, Wolbachia-treated mosquitoes produce eggs that do not hatch, reducing mosquito numbers and breaking vector-borne transmission cycles. The phenomenon, called cytoplasmic incompatibility, has been demonstrated successfully in labs.
Jan 26 Mosquito Mate announcement
Jan 3 Miami-Dade County
announcement

 

More cases reported in South Sudan's suspected RVF outbreak

In an ongoing investigation into a suspected Rift Valley fever (RVF) outbreak in South Sudan, seven new possible cases were reported last week, the World Health Organization (WHO) Regional Office for Africa said in its latest weekly outbreak and health emergency bulletin.

The new suspected cases are all from Yirol East County, the same area where a cluster of three severe hemorrhagic illness cases were initially reported from in late December. As of Jan 26, two of the most recent suspected case-patients are still hospitalized.

According to the latest report, 20 cases have been reported: 3 confirmed, 3 probable cases in people who died but had links to confirmed cases, 4 ruled out based on testing, and 10 with test results pending at the Uganda Viral Research Institute. Also, serological testing is under way on many of the samples.

The WHO said close monitoring of South Sudan's suspected RVF outbreak continues, and support for investigations is needed, especially regarding animal deaths in Yirol East County, where the suspected human cases have occurred. Though findings suggest that RVF is the cause, more substantial lab confirmation is needed, it added.
Jan 29 WHO report
Jan 23 CIDRAP News scan "More suspected RVF cases in South Sudan and 1 in Senegal"

 

Global health groups express concern over CDC cuts

A group of nongovernmental organizations involved in global health yesterday sent a letter to the newly sworn-in US Department of Health and Human Services (HHS) Secretary Alex Azar raising concerns about recent reports that the Centers for Disease Control and Prevention (CDC) will dramatically scale back work in 39 of 49 countries.

News of the cuts appeared in a Jan 19 Wall Street Journal story, which said the cutbacks are related to the expiration in fiscal year 2019 of a 5-year supplemental funding package meant to support the Ebola response. The organizations that signed the letter include the Global Health Council, Next Generation Global Health Security Network, Global Health Security Agenda Consortium, and Global Health Technologies Coalition, umbrella groups that represent more than 200 organizations and companies.

In their letter, the groups said the country programs are essential to the US defense and form critical links to preventing, detecting, and responding to disease outbreaks. They added that they were alarmed by news of the cuts, especially given that President Trump has voiced support for wider initiatives that bolster the nation's health and prosperity. "This infrastructure is critical to protecting against devastating, destabilizing, and debilitating disease threats—whether naturally occurring or deliberate," they wrote.

They also noted that cuts would hurt the CDC's ability to gather vital health information about emerging disease threats from the relationships and real-time surveillance ties they have fostered in the countries. "US investments in global health security and deployed CDC personnel are making America safer today."

Complacency after epidemics wind down and the funding cuts that typically follow create a cycle of a more costly response to future outbreaks when preparedness gains aren't maintained and improved, they warned, urging policymakers to dedicate steady funding for global health security.
Jan 29 letter to HHS Secretary Azar
Jan 19 Wall Street Journal report

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