Emerging Infectious Diseases
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 »
With new and aggressive strains of COVID-19 continuing to emerge, such as the omicron subvariants BA.4/5, Moderna, Inc. has continued developing new means to counter them, including its booster candidate mRNA-1273.214, which recently delivered promising results.
One month after administration... Read More »
On Friday, the U.S. Department of Health and Human Services (HHS) announced it had secured 3.2 million doses of the COVID-19 vaccine, Novavax.
Working in collaboration with the U.S. Department of Defense (DOD), HHS said it acquired the doses as a way to provide additional protection options for... Read More »
States and jurisdictions will begin receiving another 144,000 doses of the Bavarian Nordic JYNNEOS vaccine from the Strategic National Stockpile (SNS) this week as the U.S. Department of Health and Human Services (HHS) pivots to focus more heavily on monkeypox.
As of July 8, the Centers for... Read More »
New recommendations meant to overhaul U.S. research oversight for enhanced potential pandemic pathogens (ePPPs) and life sciences dual-use efforts were submitted last week by a 34-member group of scientists, public health experts, and policy researchers.
These recommendations were submitted by... Read More »
Responding to the more than 450 cases of monkeypox reported in the United States as of July 1, the U.S. Department of Health and Human Services (HHS) ordered another 2.5 million doses of Bavarian Nordic’s JYNNEOS vaccine for smallpox and monkeypox.
The case count held at 459 at the end of... Read More »
A group of lawmakers recently forwarded correspondence to the Centers for Medicare and Medicaid Services (CMS), advocating support for a CMS proposal encouraging hospitals to buy domestically-produced masks.
U.S. Sens. Mark Warner (D-VA) and Tammy Baldwin (D-WI) joined six colleagues in sending... Read More »
The efforts of an interdisciplinary research team funded by the National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx) Tech program have yielded a quick, cost-effective new means of detecting and identifying known variants and subvariants of SARS-CoV-2.
The results of the... Read More »
The U.S. Department of Health and Human Services (HHS) recently detailed an agreement to purchase 105 million doses of Pfizer’s COVID-19 vaccine for a fall vaccination campaign.
HHS collaborated with the U.S. Department of Defense on the $3.2 billion contract that includes a combination of... Read More »
Inoculations began this week at the National Institutes of Health Clinical Center in Bethesda, Maryland, for up to 100 participants in a phase 1 trial of novel universal flu vaccine candidate BPL-1357.
Testing will be conducted at this site alone and will focus on volunteers between 18 and 55... Read More »
Late-stage biopharmaceutical company Soligenix, Inc. announced last week that it has created and tested a bivalent filovirus vaccine that offered 100 percent protection to non-human primate test subjects against the lethal Marburg and Ebola viruses.
"Filoviruses such as Zaire ebolavirus, Sudan... Read More »
Working through the Centers for Disease Control and Prevention (CDC), the U.S. Department of Health and Human Services (HHS) began shipping monkeypox tests to five commercial lab companies this week.
It aims to boost the nation’s monkeypox testing capacity at large, with assistance from Aegis... Read More »
A new partnership arranged between SC Johnson and the Global Fund this week will focus on resource development for malaria, one of the world’s oldest and deadliest diseases.
Together, the pair intend to push for social impact in some of the places malaria has proven most stubborn: Burundi, the... Read More »
Roche broke new ground with its cobas SARS-CoV-2 Duo, which this week received U.S. Food and Drug Administration (FDA) emergency use authorization (EUA) to become the first PCR test capable of simultaneously detecting COVID-19 and quantitatively measuring viral load levels.
“The test’s... Read More »
In two trials of a new Sanofi-GSK COVID-19 booster vaccine, strong immune responses were offered to previously vaccinated adults, and solid protection was offered against variants of concern, according to the company’s latest data.
This booster is modeled on the Beta variant antigen,... Read More »
Responding to an increase in global cases of monkeypox, the U.S. Biomedical Advanced Research and Development Authority (BARDA) purchased an additional 500,000 doses of the liquid-frozen JYNNEOS vaccine, a Bavarian Nordic A/S product.
JYNNEOS holds the unique position of being the only U.S. Food... Read More »
Moderna, Inc. revealed clinical data on its Omicron-containing bivalent COVID booster candidate, mRNA-1273.214, this week, showing that one-month post-administration, a 50 µg dose of the booster provided a superior neutralizing antibody response compared to its predecessor... Read More »
After considering data from a Phase 3 clinical trial of approximately 30,000 participants, the U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted to recommend the Novavax COVID-19 vaccine gain Emergency Use Authorization... Read More »
Following a World Health Organization (WHO) global research consultation, more than 500 experts emphasized that expedited studies, strengthened collaboration from researchers in endemic countries, public health responses, and new clinical studies are needed to address monkeypox.
Monkeypox has... Read More »
Amid some nervousness over a monkeypox outbreak this year, Bavarian Nordic A/S announced that it has a new supply contract for its smallpox vaccine meant to help those at risk of monkeypox in the short or medium term.
The country to benefit from that contract remains unidentified at this time.... Read More »
Beginning with $20 million this year, the United States Department of Health and Human Services (HHS) will commit up to $300 million to support antimicrobial resistant (AMR) infection research conducted through the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) over... Read More »
Beginning in 2023 and 2024, Bavarian Nordic A/S will, for the first time, manufacture and invoice a freeze-dried version of its JYNNEOS smallpox vaccine to the U.S. government.
The announcement followed a decision by the Biomedical Advanced Research and Development Authority (BARDA) to exercise... Read More »
Through awards amounting to approximately $577 million, the National Institute of Allergy and Infectious Diseases (NIAID) is working to create nine Antiviral Drug Discovery (AViDD) Centers for Pathogens of Pandemic Concern, working to develop innovative drugs.
“The COVID-19 pandemic has... Read More »
In an expansion of its efforts against COVID-19, AstraZeneca announced a new agreement this week with RQ Biotechnology Ltd. that will see it acquire the worldwide license to develop, manufacture, and commercialize monoclonal antibodies against SARS-CoV-2.
Developed by the U.K.-based RQ... Read More »
Broadening testing capabilities and achieving a long-term goal, the U.S. Food and Drug Administration (FDA) this week authorized the first COVID-19 test also capable of detecting flu and the respiratory syncytial virus (RSV) without requiring a prescription.
The multifunctional test, the... Read More »
According to a peer-reviewed analysis from scientists at the Johns Hopkins Center for Health Security and Ugandan colleagues, Uganda’s preparedness efforts during the 2018-2020 Ebola virus disease (EVD) outbreaks in the neighboring Democratic Republic of Congo showed the potential value of... Read More »
At the second Global COVID-19 Summit last week, governments, including the United States, pledged to provide $3.2 billion in additional funds for COVID-19 and other pandemic preparedness needs and committed to expanding and accelerating testing and vaccine access.
This year’s summit was led by... Read More »
