Dosing officially began last week in a Phase 2 trial of Moderna’s COVID-19 Omicron variant-specific, bivalent booster vaccine candidate.
Known currently as mRNA-1273.214, the candidate combines another Omicron booster candidate with Moderna’s official COVID-19 vaccine, mRNA-1273.
"We are... Read More »
Researchers from the National Institute of Allergy and Infectious Diseases (NIAID) began a clinical trial this week investigating rare but potentially serious systemic allergic reactions to COVID-19 mRNA vaccines.
“People who experienced an allergic reaction after receiving a COVID-19 mRNA... Read More »
According to the Coalition for Epidemic Preparedness Innovations (CEPI), its effort to produce safe and effective vaccines within 100 days of an identified epidemic or pandemic threat has garnered $1.535 billion from world governments and organizations.
The 100 Days Mission is a five-year plan... Read More »
Joined by nine of his colleagues, U.S. Rep. Raja Krishnamoorthi (D-IL) wrote to House Appropriations Committee leaders this week requesting additional financial support for global vaccination efforts to end the COVID-19 pandemic and strengthen international relations.
The effort is, at least in... Read More »
In the most recent update to its malaria guidelines, the World Health Organization (WHO) recommended that the vaccine RTS,S/AS01 be used to prevent P. falciparum malaria among children living in areas of moderate to high transmission.
This represents the first time a vaccine for malaria was... Read More »
Efforts are underway to study the possibilities of oral smallpox treatment TPOXX as a post-exposure prophylactic (PEP), with the announcement of clinical trials by SIGA Technologies, Inc. last week.
These trials will support a U.S. Food and Drug Administration (FDA) label expansion for the drug,... Read More »
Triggered by a new case of avian flu in Iowa and cases of African Swine Fever in Haiti and the Dominican Republic, U.S. Sens. Joni Ernst (R-IA) and Raphael Warnock (D-GA) have introduced legislation to streamline funding for dogs used to detect animal diseases on cargo.
The National Detector Dog... Read More »
Reckoning with a world still navigating a pandemic and the changing diplomatic realities a war in Ukraine has wrought, United States Rep. Raja Krishnamoorthi (D-IL) this week called for increased COVID-19 aid abroad to counter Russian and Chinese influence.
“As Russian tanks roll into Ukraine... Read More »
U.S. Reps. Frank Pallone, Jr. (D-NJ) and Robert Scott (D-VA) introduced the No Surprises for COVID-19 Tests Act last week to close legislative loopholes and extend free COVID-19 testing.
COVID-19 tests were meant to be free and widely available as a result of the CARES Act, but some companies... Read More »
The Biomedical Advanced Research and Development Authority (BARDA) will continue long-standing partnerships with GlaxoSmithKline (GSK), Sanofi, and Seqirus to build up medical countermeasures to influenza pandemics and other public health emergencies.
For years, these partnerships and other... Read More »
With test data showing their COVID-19 vaccine’s capabilities to fight COVI-19 in regular or booster form, Sanofi and GSK announced this week that they intend to submit data as the foundation of regulatory authorization requests.
The Sanofi-GSK offering is a refrigerator temperature-stable,... Read More »
Nuclear Threat Initiative (NTI) and Munich Security Conference (MSC) personnel are espousing the benefits of a recently convened tabletop exercise to reduce high-consequence biological threats.
The effort involved uniting senior leaders from across government, industry, and civil society to... Read More »
Following an endorsement from the independent Data and Safety Monitoring Board this week, Moderna, Inc. officially began the third phase of trials for its mRNA Respiratory Syncytial Virus (RSC) vaccine candidate this week.
The safety greenlight was based on preliminary Phase 2 safety and... Read More »
A virtual event organized by the Coalition for Epidemic Preparedness Innovations (CEPI), the Johns Hopkins Center for Health Security, and the German Federal Ministry of Education and Research last week pulled in government officials and technical experts to address the best means of accelerating... Read More »
Seven senators last week urged the Biden administration to outline plans to develop more durable COVID-19 vaccines following a year of emerging variants that have tested the efficacy of current treatments.
Led by U.S. Sen. Tim Kaine (D-VA), a member of the Senate Health, Education, Labor, and... Read More »
The ReVector program – an anti-mosquito Defense Advanced Research Projects Agency (DARPA) creation undertaken at Stanford University – entered its next research phase this month, advancing to animal testing.
“Phase 1 of the program focused on identifying microbial or metabolic targets... Read More »
The United States Food and Drug Administration (FDA) granted breakthrough therapy designation to a Bavarian Nordic A/S vaccine candidate known as MVA-BN RSV this week, setting the preventative for RSV up for a hastened review and development cycle.
The vaccine’s focus, known as respiratory... Read More »
The COVID-19 monoclonal antibody treatment known as bebtelovimab was granted emergency use authorization (EUA) last week by the U.S. Food and Drug Administration (FDA), thanks to its displayed capabilities against the dominant Omicron variant.
Omicron has changed the field of the ongoing... Read More »
While monoclonal antibodies have made headway in some countries more than others, the World Health Organization (WHO), for the first time last week, offered prequalification to Roche’s tocilizumab treatment, smoothing the path to more widespread approval.
Prequalification guarantees that the... Read More »
With the Omicron variant of SARS-CoV-2 now dominating the pandemic’s reach, the U.S. Department of Health and Human Services (HHS) has sought ways to halt its effects, and as part of this effort, last week purchased 600,000 courses of a new monoclonal antibody.
This antibody, known as... Read More »
The National Institutes of Health (NIH) last week announced the allocation of $4.5 million across three grant awards to create collaborative research centers in the United States, focusing specifically on investigating treatments and vaccines specifically related to Valley Fever.
These centers... Read More »
Years into a global pandemic, the Access to COVID-19 Tools (ACT) Accelerator and affiliated world leaders have called for fair, shared-based financing of approximately $23 billion in 2022 to overcome inequalities in medical access, scale-up countermeasure efforts, and end the COVID-19... Read More »
Distribution of Merck and Ridgeback Biotherapeutics’ oral antiviral COVID-19 medicine molnupiravir reached a new milestone this week, with approximately 3.1 million courses provided to the United States government.
The companies are increasing access to the drug internationally, and according... Read More »
Phase 2 testing of a Lyme disease vaccine candidate, VLA15, produced strong immune responses, according to the newest data from Valneva SE and Pfizer inc, prompting preparations for a Phase 3 study in the third quarter of 2022.
The VLA15-221 trial produced stronger responses in adult... Read More »
The Biomedical Advanced Research and Development Authority (BARDA) awarded a contract to Detect, Inc. last week for the development of an over-the-counter test capable of detecting SARS-CoV-2, as well as influenza A and B, within 30 minutes.
This rapid diagnostic – the Detect COVID/Flu Test... Read More »
A combined legislative effort from U.S. Sens. Marco Rubio (R-FL) and Chris Coons (D-DE) brought the Agility in Manufacturing Preparedness Act (S.3553) to the Senate this week, offering a proposal of how to improve domestic biopharmaceutical manufacturing capabilities for public health... Read More »
The U.S. National Institute of Allergy and Infectious Diseases (NIAID) released a new Pandemic Preparedness Plan this week, directing its research efforts toward identifying pathogens with potential for significant spread among humans and those already known to be major threats.
Informed by a... Read More »
The National Institute of Allergy and Infectious Diseases (NIAID) awarded more than $4.5 million in total awards this week to support research into valley fever being conducted by the Universities of California-San Francisco, California-Los Angeles, and Texas-San Antonio.
That money will be... Read More »
The U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) will hold a virtual meeting on Feb. 15 to discuss the possibility of allowing Pfizer-BioNTech’s COVID-19 vaccine to be used on children as young as 6 months old.
The companies... Read More »
With the introduction of the Tracking Pathogens Act (S. 3534) this week, U.S. Sens. Tammy Baldwin (D-WI) and Bill Cassidy (R-LA) proposed the institution of national genomic sequence-based surveillance as a means of charting circulating pathogens, transmission patterns, and... Read More »
The U.S. Food and Drug Administration (FDA) awarded full approval to Moderna, Inc’s Spikevax vaccine for COVID-19 last week, greenlighting the mRNA vaccine for use without restriction on adults and making it the second COVID-19 vaccine to earn the measure.
Approval was based on endorsement of... Read More »
Citing data from six preclinical studies, Merck and Ridgeback Biotherapeutics last week announced that their oral antiviral COVID-19 medicine, molnupiravir, maintained efficacy against the widespread Omicron variant.
These in vitro lab studies were independently organized and conducted by... Read More »
Results of a multinational, Phase 3 National Institute of Allergy and Infectious Diseases (NIAID)-funded trial last week showed that combining remdesivir with anti-coronavirus hyperimmune intravenous immunoglobulin (HIVIG) fails to do more for COVID-19 hospitalized adults than remdesivir... Read More »
Moderna, Inc. dosed the first participant this week for its Phase 2 study of a COVID-19 booster vaccine tailored to the omicron variant, mRNA-1273.529, kicking off a two cohort trial that will span the United States.
In all, approximately 300 participants will be enrolled in each cohort. One... Read More »
Drawing from a $200 million program meant to stimulate the development of vaccines with broad betacoronavirus protection, the Coalition for Epidemic Preparedness Innovations (CEPI) announced a $16.9 million award this week for development efforts by BioNet.
BioNet, a French-Thai vaccine... Read More »