Threats
Moderna launches rolling FDA submission process to fully license COVID-19 vaccine for adults
After months of operating under the ongoing pandemic, Moderna, Inc. announced this week that it has initiated the Biologics License Application (BLA) process with the United States Food and Drug Administration (FDA) to gain full approval of its mRNA COVID-19 vaccine. This approval would make... Read More »
Biden’s budget blueprint ramps up HHS, CDC preparedness and response funding
President Joe Biden’s first budget proposal would authorize the largest funding increase in nearly two decades for the Centers for Disease Control and Prevention (CDC), going above and beyond funding the agency’s disease-focused work at the U.S. Department of Health and Human Services... Read More »
DHS announces cybersecurity requirements for critical pipeline owners, operators
The U.S. Department of Homeland Security’s Transportation Security Administration (TSA) announced a new security directive Thursday that will allow it to better identify, protect against and respond to threats to critical companies in the pipeline sector. The new directive requires critical... Read More »
CBP, Chamber of Commerce partnership targets counterfeit goods
U.S. Customs and Border Protection (CBP) announced last week that it has partnered with the U.S. Chamber of Commerce to foster enhanced information sharing and public outreach regarding counterfeit goods importation. A memorandum of understanding on information sharing has been established and... Read More »
DOD funds earmarked for nitrile gloves production
Renco Corporation has secured a $13.1 million contract via the Department of Defense (DOD) and the Department of Health and Human Services (HHS) to bolster domestic nitrile gloves production. Under the agreement, the initiative enables Renco to increase the production capacity of nitrile gloves... Read More »
Sanofi, GSK begin Phase 3 clinical study to chart safety, efficacy of COVID-19 vaccine candidate
Another COVID-19 vaccine may soon be on the way: Sanofi and GSK began enrollment for a phase three, global clinical study of their adjuvanted recombinant-protein vaccine candidate, with the anticipation it could be approved by the end of the year. Approval will, of course, depend on results, and... Read More »
WHO warns of need to distribute at least 2 billion COVID-19 vaccine doses through COVAX this year
According to the World Health Organization (WHO), the COVID-19 pandemic situation is stabilizing in nations with advanced vaccination programs, but it is surging in other, less equipped areas, demanding action lest the future become a repeat of present failures. WHO urges the distribution of 2... Read More »
Battelle, Ohio State and Northwestern collaborate to tackle COVID-19 infodemic in real time
A new collaborative effort between Battelle, a science and technology research and development firm headquartered in Columbus, Ohio; the Ohio State University; and Northwestern University hopes to combat the “infodemic” of false and misleading information online surrounding the COVID-19... Read More »
DOD, HHS establish acquisition support partnership
The Department of Defense (DoD) and Health and Human Services (HHS) have established a memorandum of understanding (MOU) to partner in defeating COVID-19 while preparing for future public health emergencies. The agreement establishes the framework of DoD continuing to support HHS with... Read More »
DOJ announces initiative to reduce violent crime
The U.S. Department of Justice (DOJ) is initiating an endeavor designed to address the rise of major violent crimes nationwide. “We renew our commitment to reducing violent crime and building strong communities where all Americans are safe,” Attorney General Merrick B. Garland said. “The... Read More »
Oxford University study of “mix and match” COVID-19 vaccines awarded $7.1M in CEPI funds
The Coalition for Epidemic Preparedness Innovations (CEPI) awarded $7.1 million grant funding to an Oxford University study assessing if COVID-19 vaccine regimens can be mixed. These funds will complement $3 million of funding already granted from the U.K. government and support from the... Read More »
FDA authorizes sotrovimab monoclonal antibody to treat mild to moderate COVID-19 cases
The U.S. Food and Drug Administration (FDA) added another tool to the fight against COVID-19 this week, granting emergency use authorization (EUA) to the monoclonal antibody therapy sotrovimab for use against mild to moderate COVID-19 cases in those 12 years and older. The EUA was granted to... Read More »
TSA preparing for increased passenger volume during summer travel season
Transportation Security Administration (TSA) officials said the agency is continuing to prepare for increased travel volumes in advance of the Memorial Day holiday weekend and summer months. “As we head into a summer where we hope to see a tremendous reemergence of domestic travel and the... Read More »
Curtiss-Wright Corporation secures naval defense contracts
Curtiss-Wright Corporation announced that it has secured a series of Navy contracts in excess of $130 million to aid naval defense platforms. The scope of work includes providing propulsion valves, pumps, and advanced instrumentation and control systems for the Navy’s Virginia-class... Read More »
NTI | bio virtually gathers global experts to address biotechnology risks, life sciences oversight
The nonprofit Nuclear Threat Initiative (NTI) | bio virtually convened an interdisciplinary group of experts and world leaders earlier this month to push for a global organization to reduce biotechnology risks, promote biosecurity and strengthen international oversight of life sciences... Read More »
Johns Hopkins Center for Health Security earns Rockefeller Foundation grant for COVID-19 response research
Thanks to a $400,000 grant from The Rockefeller Foundation, the Johns Hopkins Center for Health Security will document, evaluate and spread information on large-scale health successes among the COVID-19 response in low and middle-income nations over the past year. This information will be used... Read More »
A pandemic-free future requires public-private partnerships, government leadership
Academia and the private sector must be in a collaborative relationship with the United States government to invest in the research and development of technologies that will prevent a future pandemic, experts said on Wednesday during a webinar hosted by the Capitol Hill Steering Committee on... Read More »
Phase 2 study shows Emergent BioSolutions’ chikungunya vaccine candidate can protect for two years
A phase two clinical study of the Emergent BioSolutions, Inc. chikungunya virus vaccine candidate has been shown to spur antibodies, reflecting a persistent immune response for two years, after just a single dose. There is currently no vaccine to prevent or treat chikungunya virus infection,... Read More »
Biden administration increases FEMA funding in advance of hurricane season
In advance of what is predicted to be another busy hurricane season, the Biden administration has allocated $1 billion to the Federal Emergency Management Agency (FEMA) for pre-disaster mitigation resources to prepare for extreme weather events and other disasters. Meeting with homeland... Read More »
CEPI, SK bioscience expand vaccine development partnership
Coalition for Epidemic Preparedness Innovations (CEPI) officials said the organization has expanded its partnership with SK bioscience to develop a vaccine to combat SARS-CoV-2 and variants of concern. The agreement calls for CEPI to earmark up to $173.4 million for SK bioscience's to COVID-19... Read More »
Twenty union, stakeholder organizations offer PPE bill support
The AFL-CIO, the Service Employees International Union (SEIU), and the United States Footwear Manufacturers Association are among 20 union and stakeholder organizations supporting the Make PPE in America Act. The unions and stakeholder organizations recently forwarded correspondence to Majority... Read More »
Moderna COVID-19 vaccine shown effective in 12 to 17 years olds in Phase 2/3 study
Plans are underway to submit the Moderna, Inc. COVID-19 vaccine to regulators in early June to expand its use, following positive results from a Phase 2/3 study that distributed the vaccine among adolescents aged 12 to 17 years old. The vaccine, known as mRNA-1273, met its primary immunogenicity... Read More »
WHO teams up with Switzerland to launch BioHub for sharing, storing and analyzing pathogens globally
As part of a new Memorandum of Understanding between the World Health Organization (WHO) and the Swiss Confederation, the first facility in the WHO BioHub System was agreed to this week. Such facilities, first announced in November 2020, will serve as centers for reception, sequencing, storage,... Read More »
U.S. Chamber call on government to act on cyberthreats
The U.S. Chamber of Commerce is calling on the federal government to step up and take decisive action against the threat of cyberattacks. Calling cyberthreats an assault on the government and the economy, the Chamber urged Congress and the rest of the federal government to use all means... Read More »
DHS, South Korea collaboration targets aviation security
Department of Homeland Security (DHS) Science and Technology Directorate (S&T) officials said the agency has partnered with South Korea to conduct a civil aviation security technology field demonstration. DHS personnel said the agreement with the Ministry of Land, Infrastructure and Transport of... Read More »
CBP, partners initiate Free and Secure Trade for Commercial Vehicles project
Customs and Border Protection (CBP) personnel said the agency has partnered with a pair of entities to facilitate commercial truck processing at the World Trade Bridge in Laredo, Texas. The CBP said the General Services Administration (GSA) and the City of Laredo have agreed to the collaboration... Read More »
House Energy and Commerce Committee Republicans seek classified DHS briefings on COVID-19 origins
In a letter to Homeland Security Secretary Alejandro Mayorkas written last week, Republican House Energy and Commerce Committee leaders requested two classified briefings on the origins of COVID-19 and any work conducted therein. “[W]e strongly support a comprehensive investigation into the... Read More »
Samsung Biologics to assist with fill-finish manufacturing of Moderna’s COVID-19 vaccine
Under a new agreement announced last week, Samsung Biologics will bolster the global supply of mRNA-1273, Moderna, Inc.’s COVID-19 vaccine, by providing large-scale, commercial fill-finish manufacturing. Technology transfer began upon execution of the deal so that Samsung Biologics could... Read More »
GAO: How Congress should ensure BioWatch replacement
The U.S. Government Accountability Office (GAO) on Friday issued risk mitigation steps that the U.S. Department of Homeland Security (DHS) should consider during its acquisition of a new system to replace BioWatch, the federal government’s current biodetection system for detecting aerosolized... Read More »
U.S. Sens. Tester, Hoeven introduce anti-drug bill
U.S Sens. Jon Tester (D-MT) and John Hoeven (R-ND) introduced Thursday a bill to boost critical resources to help law enforcement officials in the war on drugs. The Assisting Narcotics and Trafficking Officers in Interdicting (ANTI) Drugs Act would increase resources for the High Intensity Drug... Read More »
TSA selects Los Angeles International Airport as drone detection test site
The U.S. Transportation Security Administration (TSA) has selected Los Angeles International Airport (LAX) to join Miami International Airport as a drone detection test site. The technology would be used to aid in detecting, tracking, and identifying (DTI) drones, which are also known as... Read More »
Bill seeks to bolster wildfire protection
U.S. Reps. Kurt Schrader (D-OR), Kim Schrier (D-WA), and Mike Simpson (R-ID) recently introduced a measure they said is designed to protect communities from the catastrophic impact of wildfires. The National Prescribed Fire Act of 2021 would invest in hazardous fuels management by increasing the... Read More »
CEPI appoints former Assistant Secretary for Preparedness and Response as newest U.S. director
The Coalition for Epidemic Preparedness Innovations (CEPI) made a major change at the top last week, with the appointment of former Assistant Secretary for Preparedness and Response (ASPR) Dr. Nicole Lurie as its United States director. Lurie has already been guiding CEPI’s emergency response... Read More »
Senators reintroduce Medical Supplies for Pandemics Act to improve supply manufacturing, rebuild Strategic National Stockpile
With the reintroduction of the Medical Supplies for Pandemics Act in the Senate last week, U.S. Sens. Thom Tillis (R-NC) and Michael Bennet (D-CO) sought to more tightly link the federal government and medical product distributors to strengthen domestic manufacturing and refill the Strategic... Read More »