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Source: http://www.cidrap.umn.edu/news-persp...an-apr-24-2018
News Scan for Apr 24, 2018
US stockpile management; Lassa fever in Nigeria; Meningitis B vaccine progress
Filed Under:
Lassa fever; Pandemic Influenza; Bioterrorism; Business Preparedness; VHF; Meningitis; Public Health
Lawmakers air pros, cons of shifting stockpile oversight to ASPR
The Trump administration plan to shift oversight of the nation's Strategic National Stockpile (SNS) and its $575 million budget from the Centers for Disease Control and Prevention (CDC) to the Department of Health and Human Services (HHS) Assistant Secretary for Preparedness and Response (ASPR) is set to occur in October, but some observers worry that the plan could impede deployment when supplies are needed and that decisions to acquire products might become more politicized, the Washington Post reported today.
Administration officials have said the change is being made to streamline operations, but lawmakers raised concerns about the impending change at an Apr 18 oversight hearing on HHS biodefense activities before the House Subcommittee on Labor, Health and Human Services, Education, and Related Agencies. According to the report, currently ASPR awards contracts to companies that develop and make medicines and the CDC purchases and replenishes the materials. However, when the change takes place, ASPR will both chose and purchase the products.
According to the Post, some public health officials and bipartisan members of Congress raised concerns about how the change might affect the complex interplay between the federal government and the groups that distribute SNS materials: state and local health departments.
Other experts quoted in the story, however, said consolidating the purchasing and maintenance of the SNS at ASPR makes sense and could boost its ability push for more funding.
Apr 24 Washington Post story
Apr 18 House oversight hearing materials
Nigeria's Lassa fever outbreak shows more signs of slowing
In its latest Lassa fever outbreak update, Nigeria's Centre for Disease Control (NCDC) reported one new confirmed case, the lowest weekly total since January.
From Jan 1 to Apr 22, the NCDC has confirmed 416 Lassa fever cases, along with 105 deaths. The case-fatality rate is 25.2 %. Aside from the new case, which appears to involve a health worker infected at a private facility in Edo state, the total includes two retrospective cases from the same state. So far, 37 healthcare workers from eight states have been sickened in the outbreak.
Only three people are still hospitalized for treatment, which the NCDC said is the lowest since the outbreak began.
The World Health Organization (WHO) Regional Office for Africa said today in a weekly disease and health emergencies update that although the general trend with Lassa fever in Nigeria is encouraging, the peak transmission season isn't over, so authorities should stay vigilant.
Lassa fever is endemic in Nigeria, and though it is mainly transmitted by rats, human spread can occur from contact with infected bodily fluids.
Apr 22 NCDC report
Apr 22 WHO report
Pfizer gets FDA priority review for meningococcal B vaccine in young kids
Pfizer announced yesterday that the US Food and Drug Administration (FDA) has approved its request for breakthrough therapy designation for its meningococcal group B vaccine (Trumenba) in children ages 1 though 9 years, a way of granting priority review if early clinical trials signal that the therapy may offer substantial benefits over existing treatments for patients with serious?including life-threatening?medical conditions.
In a press release, Pfizer said that when the FDA approved Trumenba as the first meningococcal B vaccine in October 2014, it required the company to assess the safety and effectiveness in children as young as 1 year. The company has completed phase 2 studies in this age-group, and that data supported its request for breakthrough therapy designation. Trumenba had previously received breakthrough therapy designation for preventing Neisseria meningitidis meningococcal B illness in children and young adults ages 10 through 25 years.
Luis Jodar, PhD, chief medical and scientific affairs officer in Pfizer's vaccine development unit, said despite occurrence of invasive serogroup B disease in children ages 1 through 9, there is no vaccine licensed in the United States for the age-group. "We look forward to working closely with the FDA toward our goal to extend the range of individuals who may benefit from immunization with Trumenba," he added.
In 2017, the FDA expanded the approval of Trumenba to include children as young as 10 based on a three-dose schedule, but the vaccine can be administered as a two- or three-dose schedule based on exposure risk. Pfizer said a study to confirm the effectiveness of a two-dose schedule is ongoing.
Apr 23 Pfizer press release
News Scan for Apr 24, 2018
US stockpile management; Lassa fever in Nigeria; Meningitis B vaccine progress
Filed Under:
Lassa fever; Pandemic Influenza; Bioterrorism; Business Preparedness; VHF; Meningitis; Public Health
Lawmakers air pros, cons of shifting stockpile oversight to ASPR
The Trump administration plan to shift oversight of the nation's Strategic National Stockpile (SNS) and its $575 million budget from the Centers for Disease Control and Prevention (CDC) to the Department of Health and Human Services (HHS) Assistant Secretary for Preparedness and Response (ASPR) is set to occur in October, but some observers worry that the plan could impede deployment when supplies are needed and that decisions to acquire products might become more politicized, the Washington Post reported today.
Administration officials have said the change is being made to streamline operations, but lawmakers raised concerns about the impending change at an Apr 18 oversight hearing on HHS biodefense activities before the House Subcommittee on Labor, Health and Human Services, Education, and Related Agencies. According to the report, currently ASPR awards contracts to companies that develop and make medicines and the CDC purchases and replenishes the materials. However, when the change takes place, ASPR will both chose and purchase the products.
According to the Post, some public health officials and bipartisan members of Congress raised concerns about how the change might affect the complex interplay between the federal government and the groups that distribute SNS materials: state and local health departments.
Other experts quoted in the story, however, said consolidating the purchasing and maintenance of the SNS at ASPR makes sense and could boost its ability push for more funding.
Apr 24 Washington Post story
Apr 18 House oversight hearing materials
Nigeria's Lassa fever outbreak shows more signs of slowing
In its latest Lassa fever outbreak update, Nigeria's Centre for Disease Control (NCDC) reported one new confirmed case, the lowest weekly total since January.
From Jan 1 to Apr 22, the NCDC has confirmed 416 Lassa fever cases, along with 105 deaths. The case-fatality rate is 25.2 %. Aside from the new case, which appears to involve a health worker infected at a private facility in Edo state, the total includes two retrospective cases from the same state. So far, 37 healthcare workers from eight states have been sickened in the outbreak.
Only three people are still hospitalized for treatment, which the NCDC said is the lowest since the outbreak began.
The World Health Organization (WHO) Regional Office for Africa said today in a weekly disease and health emergencies update that although the general trend with Lassa fever in Nigeria is encouraging, the peak transmission season isn't over, so authorities should stay vigilant.
Lassa fever is endemic in Nigeria, and though it is mainly transmitted by rats, human spread can occur from contact with infected bodily fluids.
Apr 22 NCDC report
Apr 22 WHO report
Pfizer gets FDA priority review for meningococcal B vaccine in young kids
Pfizer announced yesterday that the US Food and Drug Administration (FDA) has approved its request for breakthrough therapy designation for its meningococcal group B vaccine (Trumenba) in children ages 1 though 9 years, a way of granting priority review if early clinical trials signal that the therapy may offer substantial benefits over existing treatments for patients with serious?including life-threatening?medical conditions.
In a press release, Pfizer said that when the FDA approved Trumenba as the first meningococcal B vaccine in October 2014, it required the company to assess the safety and effectiveness in children as young as 1 year. The company has completed phase 2 studies in this age-group, and that data supported its request for breakthrough therapy designation. Trumenba had previously received breakthrough therapy designation for preventing Neisseria meningitidis meningococcal B illness in children and young adults ages 10 through 25 years.
Luis Jodar, PhD, chief medical and scientific affairs officer in Pfizer's vaccine development unit, said despite occurrence of invasive serogroup B disease in children ages 1 through 9, there is no vaccine licensed in the United States for the age-group. "We look forward to working closely with the FDA toward our goal to extend the range of individuals who may benefit from immunization with Trumenba," he added.
In 2017, the FDA expanded the approval of Trumenba to include children as young as 10 based on a three-dose schedule, but the vaccine can be administered as a two- or three-dose schedule based on exposure risk. Pfizer said a study to confirm the effectiveness of a two-dose schedule is ongoing.
Apr 23 Pfizer press release