Emerging Infectious Diseases
GAO calls for greater oversight of HHS research involving pandemic-capable pathogens
As called for under the CARES Act stimulus bill of 2020, the Government Accountability Office (GAO) conducted an investigation of the U.S. Department of Health and Human Services’ (HHS) oversight practices surrounding research into pandemic pathogens and found cause for concern. While such... Read More »
End of year government funding bill included public health measures from PREVENT Pandemics Act
As lawmakers process the passage of the government funding bill at the tail end of December 2022, U.S. Sen. Susan Collins (R-ME) announced that major portions of the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act) were included in its... Read More »
WHO, CDC declare Ugandan Ebola outbreak over
It was the worst Ebola outbreak Uganda had experienced in decades, but after 42 days – or two incubation periods – since the last case was reported, the World Health Organization (WHO), Uganda, and the Centers for Disease Control and Prevention (CDC) have declared the viral threat over. “I... Read More »
National Institutes of Health touts Home Test to Treat program
The National Institutes of Health (NIH) is touting the new Home Test to Treat program, a virtual community health intervention that provides free COVID-19 health services and treatments in selected communities. “At-home testing for COVID-19 is now widely available in the United States, as are... Read More »
CDC sticks COVID-19 test requirements on air passengers from China
Even as China reopens itself to travel following years of heavy restriction due to the COVID-19 pandemic, its citizens face a new roadblock from entry to the United States: a demand for negative COVID-19 tests for any flier. The restriction was announced by the Centers for Disease Control and... Read More »
HHS expands Tamiflu access for flu season
With flu season in full swing, the U.S. Department of Health and Human Services (HHS) announced this week that additional supplies of Tamiflu would be tapped to meet increased demand. Jurisdictions will manage any Tamiflu requests through the Strategic National Stockpile (SNS) in collaboration... Read More »
Randomized trials of three Ebola vaccine strategies for adults, children dub regimens safe
In two randomized, placebo-controlled trials of three Ebola vaccine administration regimens for adults and children, the Partnership for Research on Ebola Vaccination (PREVAC) recently published results concluding that all regimens were safe and effective. Vaccine candidates included Ad26.ZEBOV,... Read More »
NIH identifies new funding in support of Valley Fever vaccine research, development
Following up on a National Institute of Allergy and Infectious Diseases (NIAID) Notice of Special Interest from November that sought support for research into a Valley Fever vaccine, the National Institutes of Health (NIH) recently announced that additional funding avenues have been... Read More »
New Senate report criticizes significant failures in initial federal COVID-19 response, pandemic preparedness
Following a two-year investigation by U.S. Sen. Gary Peters (D-MI), chairman of the Senate Homeland Security and Governmental Affairs Committee, a new report detailed significant failures in the federal government’s initial response to the COVID-19 pandemic and overall preparedness. Released... Read More »
CEPI extends VBI Vaccines partnership for development of multivalent coronavirus vaccine
A partnership between VBI Vaccines Inc. and the Coalition for Epidemic Preparedness Innovations (CEPI) expanded this week with a new development agreement seeking the development of multivalent coronavirus shots for use against multiple coronavirus threats. Based on VBI’s proprietary enveloped... Read More »
NIAID awards more than $12M for development of antiviral therapeutics
As part of its Antiviral Program for Pandemics (APP), meant to accelerate the discovery, development, and manufacturing of antivirals, the National Institute of Allergy and Infectious Diseases (NIAID) recently awarded more than $12 million to three institutions for new therapies. These new... Read More »
First look at global vaccine market since COVID-19 shows development still lagging due to profit-over-health mindset
Capitalistic values continue to hinder vaccine development, according to the World Health Organization’s (WHO) first report on the global vaccine market since COVID-19, with prioritizes vaccines not being developed due to limited profit potential and limited access for lower-income countries... Read More »
Clinical data shows Pfizer, BioNTech Omicron BA.4/BA.5 booster offers higher protection in adults
Pfizer and BioNTech announced updates from a Phase 2/3 clinical trial of their bivalent booster for the COVID-19 variants Omicron BA.4/BA.5 last week, pointing to the 4-fold higher emergence of neutralizing antibody titers among treated adults older than 55, comparative to the original COVID-19... Read More »
BARDA invites Soligenix to submit contract proposal for thermostabilized Sudan Ebola, Marburg virus vaccines
Biopharmaceutical company Soligenix, Inc. recently received an invitation from the Biomedical Advanced Research and Development Authority (BARDA) to submit a contract proposal for millions of dollars in development support for single vial, thermostabilized subunit vaccines for the Sudan ebolavirus... Read More »
CEPI, SK bioscience collaboration seeks to address rapid Disease X response
Coalition for Epidemic Preparedness Innovations (CEPI) and SK bioscience personnel are touting a collaboration to facilitate rapid response to unknown pathogens with epidemic and pandemic potential or Disease X. The partnership agreement, in which CEPI is slated to provide up to $40 million in... Read More »
Merck, Bill & Melinda Gates Medical Research Institute to develop two tuberculosis antibiotics
Through a new licensing agreement between Merck and the Bill & Melinda Gates Medical Research Institute, two preclinical antibacterial candidates will be developed and evaluated for potential use in the treatment of tuberculosis (TB). “Tuberculosis is one of the world’s most significant... Read More »
BARDA, BioFire Defense partner on new molecular panel to test human coronaviruses
A new partnership united BioFire Defense, LLC, and the U.S. Biomedical Advanced Research and Development Authority (BARDA) last week under a contract to develop a pan-coronavirus test panel for known, novel, and emerging human coronaviruses. This panel, known as the BioFire Emerging CoV Panel,... Read More »
NIAID partners with Democratic Republic of the Congo for new trial of monkeypox antiviral TPOXX
Together, the Democratic Republic of the Congo (DRC) National Institute for Biomedical Research (INRB) and the United States National Institute of Allergy and Infectious Diseases (NIAID) are co-leading an evaluation trial of TPOXX, an antiviral drug for monkeypox. With this year’s worldwide... Read More »
BARDA, DIazyme Laboratories developing rapid test to measure neutralizing SARS-CoV-2 antibodies
Through a new partnership with Diazyme Laboratories, Inc., the Biomedical Advanced Research and Development Authority (BARDA) announced this week that efforts are underway to develop a fast, high-throughput, fully automated test to detect SARS-CoV-2 neutralizing antibodies. The focus is on... Read More »
HHS revises PREP Act declaration to increase number of people able to administer monkeypox vaccines
In order to expand the number of providers able to administer vaccines against monkeypox, smallpox, and other orthopoxviruses, the U.S. Department of Health and Human Services (HHS) this week amended its declaration of the Public Readiness and Emergency Preparedness (PREP) Act. HHS Secretary... Read More »
Bipartisan dozen in Congress urge FDA to pursue broad array of therapeutics for COVID-19 variants
In a letter to U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, M.D. last month, 12 members of Congress pressed the regulator to guarantee a variety of therapeutics to ready the nation for further COVID-19 variants. “We urge the FDA to ensure that the availability of... Read More »
Simplexa COVID-19 Direct becomes second COVID diagnostic test cleared by FDA
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 »
NIAID begins Phase 3 clinical trial to evaluate TPOXX monkeypox antiviral
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 »
Financial intermediary fund for pandemic prevention, preparedness and response launches with WHO, World Bank support
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 »
AmerisourceBergen wins nearly $20M HHS contract to improve deliveries of monkeypox vaccines, treatments
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 »
BARDA, Arcturus Therapeutics Holdings jointly developing self-amplifying mRNA-based flu vaccine
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 »
BARDA seeks opinions on new partnership model for medical countermeasures
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 »
HHS providing $11M to Michigan manufacturer for domestic monkeypox vaccine production
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 »
N95 supply no longer in shortage, FDA reports
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 »
Bipartisan Commission on Biodefense receives $5.2M Open Philanthropy grant for bio-preparation work
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 finishes FDA application for emergency use authorization of Omicron-specific COVID-19 booster vaccine
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 »
BARDA exercises contract option for additional smallpox treatments in early 2023
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 »
Whistleblowers prompt questions over COVID-19 vaccine mislabeling, unauthorized manufacturing
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 »
HHS-aided agreement between Bavarian Nordic and Michigan-based GRAM to create first fill and finish line for monkeypox vaccine
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 »