News Scan for Sep 03, 2019

Baloxavir pediatric trial
;
Smallpox vaccine stockpile contract
;
Liberia Lassa emergency
;
H5N1 in Nepalese poultry

Genentech reports promising findings for baloxavir flu treatment in children

Genentech, part of the Roche Group, yesterday announced promising phase 3 trial findings for the use of one-dose baloxavir marboxil (Xofluza) to safely treat flu in children, according to results presented on Sep 1 during the Options X Congress in Singapore.

Baloxavir, developed in Japan, is the newest novel flu treatment since oseltamivir and zanamivir and was approved by the US Food and Drug Administration (FDA) in October 2018 for use in patients ages 12 years and older.

The recent global trial was designed to assess tolerability and effectiveness in healthy children ages 1 through 11 years old, Genentech said in a press release. The one-dose treatment was administered as an oral suspension, and researchers evaluated patients up to study day 29.

Regarding adverse events, findings were consistent with baloxavir's known safety profile. Of kids in the trial who received baloxavir, 46.1% had at least one treatment-related adverse event compared to 53.4% of those in the oseltamivir arm. Efficacy findings were similar to that of oseltamivir. And similar to findings in adults and adolescents, baloxavir shortened flu virus shedding by more than 2 days compared to oseltamivir. The median time was 24.2 hours compared to 75.8 hours. The time to alleviation of flu symptoms was a median 138.1 hours for baloxavir, compared to 150 hours for oseltamivir.

Sandra Horning, MD, chief medical officer and health of global product development for Genentech, said in the statement that each year one in three children develop flu, and their less mature immune systems mean they are slower to fight infection and are more susceptible to complications. "We are committed to developing new, more convenient treatment options for children with the flu and look forward to sharing these data with global health authorities."

Researchers are currently conducting phase 3 trials in other populations including children younger than 1 year and people hospitalized with severe flu. Teams are also assessing the drug for prophylactic use.
Sep 2 Genentech press release

 

Emergent BioSolutions awarded contract for stockpile smallpox vaccine

Emergent BioSolutions today announced that it was awarded a contract worth about $2 billion over the next 10 years to deliver the ACAM200 smallpox vaccine to the US government's Strategic National Stockpile.

In a statement, the company said the contract was awarded by the US Department of Health and Human Services' Assistant Secretary for Preparedness and Response (ASPR), and that  the number of doses depends on timing and tiered-pricing terms that are subject to ASPR discretion. ACAM2000 is the only vaccine licensed by the FDA for active immunization against smallpox for those at high risk for infection.

In early 2018, Emergent BioSolutions received a contract worth $26 million to supply the smallpox vaccine complications therapy vaccinia immune globulin intravenous (VIGIV) to the US government.

For the ACAM2000 vaccine, the contract consists of a 1-year base period of performance, worth about $170 million, and 9 option years. The company said it expects to deliver the majority of the doses to the SNS under the base year by the end of 2019. The multiple-year contract is designed to replace the current vaccine stockpile and comes at the end of a 10-year $425 million contract to establish domestic manufacturing and procurement. The one-dose vaccine is the primary vaccine the government would use in the event of a smallpox emergency.
Sep 3 Emergent BioSolutions press release
Mar 2, 2018, CIDRAP News scan "
Emergent awarded $26 million for vaccinia immune globulin treatment"

 

Liberia declares Lassa health emergency

Liberia health officials yesterday declared a health emergency due to a Lassa fever outbreak that has affected four counties and resulted in 21 deaths so far this year, according to media reports.

At a media briefing, Francis Kateh, MD, the country's chief medical officer, said officials are worried about infections in health workers and that a lab technician is also among the people who have died, Xinhua, China's state news agency, reported yesterday.

Affected counties include Nimba, Grand Bassa, Bong, and Grand Cru. Officials said another cause for concern is that cases are expending outside an area already identified as the "Lassa belt".

The World Health Organization (WHO) regional office for Africa said in its weekly outbreaks and health emergencies report that Liberia has recorded 34 cases as of Aug 25, 25 of them confirmed and 9 of them fatal. It notes that there are 92 suspected cases, 21 of those fatal. It said the three most recent cases were from Bong County, including that of the lab technician, whose exposure is under investigation.

In West Africa, Lassa virus—which can cause a viral hemorrhagic illness in humans—is typically spread by contact with urine or feces of African soft-furred rats. The virus can spread from person to person through contact with body fluids. The virus sickens about 100,000 to 300,000 people in Africa each year, about 5,000 of them fatally. No vaccine is available, though global health groups have prioritized the disease for vaccine development.
Sep 2 Xinhua story


H5N1 avian flu outbreak reported at Nepalese poultry farm

Nepal's agriculture ministry yesterday reported a highly pathogenic H5N1 avian influenza outbreak at a farm in Koshi zone in the eastern part of the country, according to a notification from the World Organization for Animal Health (OIE).

The outbreak began on Aug 19 at a facility housing mixed poultry, including turkeys, backyard chickens, ducks, and quail of different ages. The virus killed 195 of 417 susceptible birds. Authorities culled the remaining 222 birds. The team also destroyed feed ingredients. The event was declared as resolved yesterday.

Nepal's last H5N1 outbreak, which struck backyard birds in Bagmati zone, was reported in June.
Sep 2 OIE report on H5N1 in Nepal

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