Emerging Infectious Diseases
After being backed by the Biomedical Advanced Research and Development Authority (BARDA) under public-private partnerships, the office recently announced that Simplexa COVID-19 Direct became the second standalone COVID-19 diagnostic cleared by the Food and Drug Administration (FDA).
In so doing,... Read More »
The AIDS Clinical Trials Group began enrolling more than 500 adults and children for a Phase 3 clinical trial of the antiviral tecovirimat (TPOXX) for use against monkeypox, the National Institute of Allergy and Infectious Diseases (NIAID) announced this week.
“Monkeypox can be an extremely... Read More »
Looking to get ahead of future health concerns, a new financial intermediary fund (FIF) was officially launched last week by the FIF Governing Board, which was recently created with support from G20 members and other nations, along with a positive vote from the World Bank Board of... Read More »
The U.S. Department of Health and Human Services recently awarded AmerisourceBergen a $19.8 million contract to improve the delivery of monkeypox vaccines and treatments.
AmerisourceBergen was specifically tasked with expanding distribution capacity and weekly shipments. The company will... Read More »
The Biomedical Advanced Research and Development Authority (BARDA) announced a new partnership with Arcturus Therapeutics Holdings, Inc. this week, which seeks to create a self-amplifying messenger RNA (samRNA) vaccine for use against pandemic influenza.
This, the partners believe, would allow... Read More »
Turning to the public, the Biomedical Advanced Research and Development Authority (BARDA) released a Sources Sought Notice (SSN) this week to gather input on an idea for a new Rapid Response Partnership Vehicle meant to be the guiding model for health security acquisitions.
Its development could... Read More »
Grand River Aseptic Manufacturing (GRAM) of Grand Rapids, Mich., secured its place as the first face of domestic manufacturing for the JYNNEOS smallpox and monkeypox vaccine this week, thanks to an award of approximately $11 million in support from the United States Department of Health and Human... Read More »
The U.S. Food and Drug Administration (FDA) officially removed N95 respirators from its list of medical device shortages, deeming the personal protective equipment (PPE) in sufficient supply now after supply chain issues that roiled much of the COVID-19 pandemic.
While the agency will continue... Read More »
The Bipartisan Commission on Biodefense announced Tuesday that it had received a $5.2 million grant from Open Philanthropy to strengthen efforts to improve preparation for biological incidents, ranging from pandemics and zoonotic diseases to biological terrorism and warfare.
The private... Read More »
Moderna, Inc. announced this week that it has finished its submission to the United States Food and Drug Administration (FDA) seeking emergency use authorization (EUA) for its BA.4/BA.5 Omicron-focused bivalent COVID-19 booster vaccine.
The candidate, or mRNA-1273.222, would be formulated as a... Read More »
Amid a monkeypox outbreak that continues to grow internationally, the Biomedical Advanced Research and Development Authority (BARDA) exercised an option on an existing contract this week to acquire additional intravenous (IV) doses of the TPOXX smallpox treatment.
TPOXX is a U.S. Food and Drug... Read More »
In a letter to leadership at the U.S. Department of Defense (DoD), the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC), U.S. Sen. Ron Johnson (R-WI) revealed nine whistleblowers had disclosed concerns of mislabeling and unauthorized manufacturing of... Read More »
Bavarian Nordic reached an agreement last week with pharmaceutical contract manufacturer Grand River Aseptic Manufacturing (GRAM), making arrangements backed by the U.S. Department of Health and Human Services (HHS) to create the first U.S. fill and finish line for the JYNNEOS vaccine.
JYNNEOS... Read More »
During some COVID-19 surges, U.S. hospitals were hampered in terms of staff, supplies, or space to care for patients that exceeded their normal operating capacity, though health care coalitions helped fill some gaps.
According to the Government Accountability Office (GAO), a review of eight... Read More »
With no signs the monkeypox health emergency is set to lessen, a group of 14 U.S. senators wrote to congressional leadership this week in search of additional funding for a public health response in any future legislative package.
“Monkeypox is a serious threat to public health, and we need to... Read More »
Roche Diagnostics announced a new test for its line-up this week to offer additional means for decision-making and treatment options surrounding SARS-CoV-2, particularly in at-risk patient groups.
The Elecsys IGRA SARS-CoV-2 test focuses on the T-cell response to offer a potentially better... Read More »
A collection of 14 U.S. senators wrote to Senate Majority Leader Charles Schumer (D-NY) and Minority Leader Mitch McConnell (R-KY) last week to request funding for the monkeypox outbreak response be included in any upcoming legislative package.
Designated a Public Health Emergency (PHE) earlier... Read More »
Responding to the ongoing monkeypox outbreak worldwide, the Biomedical Advanced Research and Development Authority (BARDA) last week exercised procurement options for SIGA Technologies, Inc.’s intravenous TPOXX treatments of smallpox.
Those treatments, valued at approximately $26 million,... Read More »
As the monkeypox virus continues to spread and health officials warn that vaccine supply is not meeting demand, the United States Food and Drug Administration (FDA) this week granted an emergency use authorization (EUA) to intradermal injections of Bavarian Nordic’s JYNNEOS vaccine.
The... Read More »
Pfizer Inc. and Valneva SE this week started a Phase 3 clinical study -- Vaccine Against Lyme for Outdoor Recreationists (VALOR) -- to study the efficacy, safety and immunogenicity of a Lyme disease vaccine candidate known as VLA15.
Currently, VLA15 is the only Lyme disease vaccine undergoing... Read More »
As more states and localities declare emergencies over the growing monkeypox outbreak, President Joe Biden this week formed an official White House national monkeypox team from other agencies to guide federal response.
Helming the team will be FEMA’s Regional Administrator for the American... Read More »
In letters dispatched to the U.S. Government Accountability Office (GAO) and the Department of Homeland Security (DHS), House Homeland Security Committee leaders have pressed for details of the federal government’s preparations for and response to the ongoing monkeypox outbreak.
Committee... Read More »
New legislation up for consideration in the U.S. House would revamp the Department of Homeland Security’s efforts on weapons of mass destruction (WMDs) by modernizing its Countering WMD office and formalizing and expanding its Office of Health Security.
The Health Security and Countering... Read More »
For use later this year, the U.S. Departments of Health and Human Services (HHS) and Defense (DoD) announced last week that they had bought 66 million doses of a Moderna bivalent COVID-19 vaccine booster candidate.
“We must stay vigilant in our fight against COVID-19 and continue to expand... Read More »
Following inspection and approval of a Bavarian Nordic manufacturing facility overseas, the U.S. Department of Health and Human Services (HHS) announced last week that it now has access to – and plans to allocate – another 786,000 doses of the company’s JYNNEOS monkeypox vaccine nationwide.... Read More »
San Francisco declared monkeypox a local public health emergency last week as New York state designated the disease an imminent threat.
In both cases, such designations will help focus preparedness and response efforts to rising cases of monkeypox. That same disease was declared a public health... Read More »
Monkeypox vaccine production is about to experience a significant surge following the U.S. Food and Drug Administration’s (FDA) approval this week of a supplement to the Bavarian Nordic JYNNEOS vaccine and its fill-and-finish capabilities.
Through an expedited inspection and approval process,... Read More »
More than 100 members of Congress, backed by more than 100 organizations, sent a letter to the Biden administration this week, urging additional funding for sexual health clinics dealing with the expanding monkeypox outbreak.
Signatories of the letter, led by U.S. Reps. Jerrold Nadler (D-NY) and... Read More »
As an international monkeypox outbreak continues to grow in scope, U.S. Sens. Dianne Feinstein (D-CA), Jeff Merkley (D-OR), and 20 colleagues last week dispatched a letter to the U.S. Department of Health and Human Services and the Centers for Disease Control and Prevention (CDC) calling for... Read More »
As concerns about the monkeypox outbreak worldwide continued to grow, the U.S. Department of Health and Human Services (HHS) responded last week with an order for another 2.5 million doses of Bavarian Nordic’s JYNNEOS monkeypox vaccine to fill the Strategic National Stockpile (SNS).
While the... Read More »
Beginning last week, Aegis Sciences began testing for monkeypox at its laboratories in Nashville, Tenn., adding potential capacity for up to 10,000 tests per week to the Center for Disease Control and Prevention’s (CDC) national Laboratory Response Network (LRN).
To achieve this, Aegis will... Read More »
A major provision of the recently passed National Defense Authorization Act (NDAA, or H.R. 7900) – which advanced from the House by a vote of 329-101 last week – addresses commercial wildlife markets and illegal wildlife trafficking.
An amendment to the act from U.S. Reps. Mike Quigley... Read More »
Bolstering the number of options for use against SARS-CoV-2, the United States Food and Drug Administration (FDA) issued an emergency use authorization (EUA) this week for the Novavax COVID-19 Vaccine, Adjuvanted.
This authorization greenlit the vaccine for use on those at least 18 years old and... Read More »
While the general focus has been on the immediate effects of the COVID-19 pandemic, the outbreak also reversed years of progress in the fight against antimicrobial resistance (AR), according to the Centers for Disease Control and Prevention (CDC).
In a report released this week – "COVID-19:... Read More »
Nipah virus became the newest target of the National Institute of Allergy and Infectious Diseases (NIAID) this week, with the launch of a phase 1 clinical trial to evaluate an investigational vaccine from Moderna, Inc. and NIAID’s own Vaccine Research Center.
This potential vaccine was built... Read More »
