Threats
HHS expands COVID-19 vaccine manufacturing capacity
The Department of Health and Human Services (HHS) officials said the agency has expanded its COVID-19 vaccine manufacturing capacity via the Center for Innovation in Advanced Development and Manufacturing (CIADM). The Texas A&M University System venue’s $265 million task order falls under an... Read More »
Late-stage trial of Moderna, NIAID COVID-19 vaccine gets underway
At sites across the United States, a phase 3 trial of the investigational vaccine mRNA-1273, jointly developed by Moderna, Inc. and the National Institute of Allergy and Infectious Diseases (NIAID) is set to enroll 30,000 volunteers for testing. Anyone 18 years of age and older, who does not... Read More »
DHS S&T seeking pandemic response, needs proposals
Department of Homeland Security (DHS) Science and Technology Directorate (S&T) personnel said the agency is seeking global proposals addressing pandemic response, as well as current and future needs. The Emerging Needs: Covid-19 Response & Future Mitigation topic call was introduced via the... Read More »
Emergent BioSolutions signs deal with AstraZeneca for manufacturing of its COVID-19 vaccine candidate
Emergent BioSolutions Inc. signed an agreement with AstraZeneca to provide contract development and manufacturing (CDMO) services for large-scale manufacturing of AstraZeneca’s COVID-19 vaccine candidate. The $174 million deal runs through 2021. It follows an $87 million contract in June for... Read More »
FDA greenlights LabCorp test that can diagnose COVID-19 in people without symptoms
A LabCorp COVID-19 diagnostic test became the first of its kind to gain a United States Food and Drug Administration (FDA) emergency use authorization (EUA) last week, for its potential to diagnose COVID-19 infections in those without symptoms. An EUA was also granted to allow its use in pooled... Read More »
Lawmakers laud CFATS extension
A group of lawmakers are espousing the benefits of extending the Chemical Facility Anti-Terrorism Standards (CFATS) program for three years, noting the action secures chemical facilities amid the COVID-19 pandemic. Sens. Gary Peters (D-MI), James Lankford (R-OK), Tom Carper (D-DE) and other... Read More »
EcoHealth Alliance study shows benefit of investing in disease outbreak mitigation
The investment to prevent the spread of infectious disease are well worth it compared to the costs associated with these outbreaks, a new analysis by published in Science by the nonprofit EcoHealth Alliance proclaims. While zoonotic disease outbreaks like the one that caused the COVID-19... Read More »
Hologic secures $7.6 million federal contract for production expansion of COVID-19 tests
Hologic will expand production of its custom sample collection and processing consumables used for COVID-19 tests as part of a $7.6 million investment from the United States Departments of Health and Human Services (HHS) and Defense (DoD). The contract is "undefinitized," meaning its terms and... Read More »
Pall Corp. nets $4.9 million contract with DoD for ventilator filters
The United States Department of Defense (DoD) awarded a $4.9 million contact to the Pall Corp. last week for efforts to expand the domestic industrial base capacity for medical ventilator filters. The COVID-19 pandemic has laid bare a critical need for ventilators in the U.S., but over the... Read More »
Senate passes cybersecurity bolstering measure
A group of lawmakers are espousing the benefits of the Senate’s recent passage of a FY 2021 National Defense Authorization Act (NDAA) amendment designed to bolster cybersecurity. Sens. Rob Portman (R-OH), Maggie Hassan (D-NH), John Cornyn (R-TX), and Gary Peters (D-MI) said the amendment... Read More »
DHS lifts Trusted Traveler Program ban for New York residents
The U.S. Department of Homeland Security will lift its ban on the Trusted Traveler Program (TTP) for New York residents. The ban, in place since February, was lifted after New York Gov. Andrew Cuomo and the state legislature amended the law that prevents sharing of information to federal law... Read More »
California pushes for 300 million more protective masks in state stockpile by fall
California seeks to bolster its strategic stockpile of protective masks to guarantee the shortcomings exposed by the COVID-19 outbreak never happen again, and as part of that, the state has signed a new contract with BYD North America for 420 million masks. That order includes 120 million N-95... Read More »
NTI says progress on protecting nuclear facilities wanes
Progress on protecting nuclear materials and facilities against theft and sabotage has slowed significantly over the past two years, the Nuclear Threat Initiativeʻs 2020 NTI Nuclear Security Index has found. The decline in the rate of improvement to national regulatory structures and the global... Read More »
Bill would establish coronavirus commission
A group of lawmakers have introduced a bill that would establish a coronavirus commission to examine the nation’s response to the pandemic. Sens. Bob Casey (D-PA), Dianne Feinstein (D-CA) and Amy Klobuchar (D-MN) recently joined 13 colleagues in presenting the National Commission on the... Read More »
Measure advocates domestic PPE manufacturing
A trio of lawmakers have introduced a measure they said decreases dependence on foreign countries for Personal Protective Equipment (PPE) for healthcare providers. Sens. Shelley Moore Capito (R-WV), Lindsey Graham (R-SC), and Mike Rounds (R-SD) said the U.S. MADE Act of 2020 lessens domestic... Read More »
NIH presses for 6 million daily COVID-19 testing capacity by year’s end
Scientists from the National Institutes of Health (NIH) published a framework in the New England Journal of Medicine this week for efforts to increase the number, quality and type of daily tests for SARS-CoV-2, the virus that causes COVID-19, to 6 million by the end of 2020. This has taken the... Read More »
Senate NDAA helps CISA warn critical infrastructure computer systems of cyberattacks
The U.S. Senate’s 2021 National Defense Authorization Act (NDAA) includes legislation that would help the Cybersecurity and Infrastructure Security Agency (CISA) warn the owners and operators of critical infrastructure computer systems that it is vulnerable to cyberattacks. The bill gives... Read More »
Bavarian Nordic to license AdaptVac’s coronavirus vaccine for 4 million euros
A new agreement reached between Bavarian Nordic A/S and AdaptVac for 4 million euros upfront will allow Bavarian to license AdaptVac’s capsid virus like particle (cVLP) technology for coronaviruses. Of particular note here is that the agreement gives Bavarian global commercialization rights to... Read More »
Officials laud Chemical Facility Anti-Terrorism Standards extension
The House of Representatives’ recent unanimous vote to extend the Chemical Facility Anti-Terrorism Standards program (CFATS) has garnered plaudits from lawmakers and chemical industry organizations. CFATS is the nation’s first regulatory program focusing specifically on security at high-risk... Read More »
Lawmakers tout NDAA House passage
A pair of lawmakers are espousing the benefits of the House of Representatives’ passage of the National Defense Authorization Act (NDAA) for FY21. Reps. Mac Thornberry (R-TX) and Adam Smith (D-WA), chairman of the House Armed Services Committee, offered statements regarding the... Read More »National Testing Implementation Forum to gather input on COVID-19 in the U.S.
A new program -- the National Testing Implementation Forum -- announced by the United States Department of Health and Human Services (HHS) this week will gather input from private stakeholders across the U.S. to inform federal testing and diagnostics efforts for SARS-CoV-2, the virus that causes... Read More »
CEPI’s call for COVID-19 vaccine proposals seeks doses capable of 12-18 month turnaround
The Coalition for Epidemic Preparedness (CEPI) has extended a call for proposals on COVID-19 vaccines until September, pushing for licensure, efficacy and safety in quick order: a timeframe of just 12-18 months. The coalition is working to guarantee that manufacturing capabilities and capacities... Read More »
Justice Department charges two Chinese hackers with stealing US research
A federal grand jury in Spokane, Wash., indicted two hackers from the People’s Republic of China for alleged cyberattacks on hundreds of computer systems of companies, governments, non-governmental organizations, and individuals in the United States and abroad. Officials alleged the global... Read More »
U.S. strikes $1.95 billion deal with Pfizer, BioNTech for COVID-19 vaccine candidate
Up to 600 million doses of a vaccine candidate produced by Pfizer Inc. and BioNTech could be acquired by the United States government under a deal penned this week. All of this would be conditional on the vaccine’s successful manufacture and either Emergency Use Authorization or licensure... Read More »
Reps. Langevin, Gallagher applaud inclusion of cyberspace recommendations in NDAA
U.S. Reps. Jim Langevin (D-RI) and Mike Gallagher (R-WI), commissioners of the Cyberspace Solarium, applauded the inclusion of budget amendments to the 2021 National Defense Authorization Act (NDAA) that implement recommendations from the Solarium Commission’s report. The Cyberspace Solarium... Read More »
GOP lawmakers urge action by Trump administration against hackers
Republican committee leaders in the U.S. House of Representatives are urging the Trump administration to impose consequences on China-linked hackers who have targeted U.S. institutions, including sanctions. “We applaud your administration’s work to ramp up the investigation and prosecution... Read More »
Bill addresses counterfeit medical products
Sens. Mike Enzi (R-WY) and Maggie Hassan (D-NH) introduced Monday legislation targeting potentially harmful counterfeit medical products while also protecting patients from such dangers. The Safeguarding Therapeutics Act would empower the Food and Drug Administration (FDA) to seize and destroy... Read More »
GSK, CureVac to collaborate on up to five mRNA-based vaccines and antibodies for infectious diseases
CureVac and GlaxoSmithKline plc (GSK) have signed an agreement to work together on the research, development, manufacturing, and marketing of as many as five mRNA-based vaccines and monoclonal antibodies for use against infectious diseases. By collaborating, CureVac gains access to GSK’s mRNA... Read More »
Oxford-developed coronavirus vaccine shows strong immune responses, no safety concerns
A coronavirus vaccine developed by Oxford University produced strong immune responses in a phase 1/2 trial of 1,077 people, scientists from the Jenner Institute and Oxford Vaccine Group reported this week, possibly heralding a safe and effective candidate. The findings of the UK trial, which... Read More »
COVID-19 vaccine race is on: Biopharma companies on fast-track to deliver product by 2021
Several biopharmaceutical companies are working in unprecedented fashion to develop, manufacture and deliver a safe and effective vaccine to combat COVID-19 as soon as is humanly possible. Executives from five companies developing COVID-19 vaccine candidates — AstraZeneca, Pfizer, Johnson &... Read More »
U.S. needs to unite and restructure to meet disaster demands, emergency management panelists warn
The United States was just as dangerously unprepared to combat a coronavirus pandemic in 2020 as it was back in 2015, former U.S. Sen. Joe Lieberman noted in the opening remarks of the Bipartisan Commission on Biodefense’s virtual meeting on Tuesday, setting the tone for a critical examination of... Read More »
FDA reissues EUA for Quest Diagnostic’s COVID-19 test
The U.S. Food and Drug Administration (FDA) reissued an emergency use authorization (EUA) to Quest Diagnostics for its COVID-19 test. The Quest test is the first COVID-19 diagnostic test to be authorized for use with pooled samples containing up to four individual swab specimens collected under... Read More »
Senators urge Congressional leaders to include funding for COVID-19 vaccine infrastructure
A group of U.S. Senators recently called on Congress to provide at least $5.6 billion in federal funding to support the COVID-19 vaccine infrastructure. The funding -- needed to boost the country’s vaccine supply and distribution system -- should be included in the next coronavirus relief... Read More »
Sen. Gardner advocates cybersecurity enhancement efforts
Sen. Cory Gardner (R-CO) forwarded correspondence last week to Federal Bureau of Investigation (FBI) and Cybersecurity and Infrastructure Security Agency (CISA) personnel, urging efforts to bolster cybersecurity infrastructure against Russia and China threats. Gardner maintains the advocacy... Read More »