Emerging Infectious Diseases
With data from its Phase 3 COVE study showing a COVID-19 vaccine with 93 percent effectiveness, Moderna, Inc. has officially filed for a biologics license application (BLA) to the United States Food and Drug Administration (FDA) that would lead to full licensure.
It’s an important step, which... Read More »
Through publication of data in Vaccine, this week Soligenix showcased the capabilities of its filovirus vaccine platform to formulate and provide heat stabilization for multiple antigen combinations of vaccine candidates: monovalent, bivalent, and trivalent.
The single-vial platform project was... Read More »
A 210-person Phase 2 clinical trial for the COVID-19 vaccine candidate, ABNCoV2, began this week to determine its potential as a booster vaccine for those who have either caught the disease previously or been otherwise vaccinated.
Licensed by Bavarian Nordic A/S and developed by AdaptVac, the... Read More »
Results of a Phase 3 clinical trial have shown that AstraZeneca’s antibody combination for COVID-19, AZD7442, cuts the risk of symptomatic COVID-19 cases by 77 percent for at least three months.
That is dependent on the treatment being taken prior to infection. However, the antibodies used in... Read More »
With the formation of a new Scientific Advisory Group for the Origins of Novel Pathogens (SAGO), the World Health Organization (WHO) is calling for experts to lend their knowledge on the origins of pathogens with wide-reaching potential.
This multidisciplinary group will consist of up to 25... Read More »
The United States Food and Drug Administration (FDA) on Monday granted full approval to Pfizer-BioNTech’s COVID-19 vaccine for use among patients 16 years and older, making it the first of the disease’s vaccines to cross beyond conditional use.
Since Dec. 11, 2020, the mRNA-based vaccine had... Read More »
U.S. Rep. Mark Pocan (D-WI) introduced legislation Wednesday that seeks to divert a small percentage of military spending towards global vaccination efforts, vaccinating potentially an additional 30 percent of the world’s low-income population within a year.
The COVID Defense Act would... Read More »
According to preclinical data produced by Soligenix, Inc. this week, positive, effective results have been demonstrated by multiple filovirus vaccine candidates.
In collaboration with the University of Hawaiʻi at Mānoa, Soligenix’s vaccines proved capable against three potentially deadly... Read More »
Utilizing initial funding from the American Rescue Plan, the U.S. Centers for Disease Control and Prevention (CDC) unveiled plans this week for a new Center for Forecasting and Outbreak Analytics, focused on forecasts of disease outbreaks and analytics for public health.
The new center will be... Read More »
The National Institutes of Health (NIH) announced this week that it will award approximately $53 million in annual funding across the next five years to 10 research organizations currently pursuing HIV cure research.
“June marked the 40th anniversary of the first reported U.S. cases of what... Read More »
As part of a new agreement with Gritstone bio, Inc., the Coalition for Epidemic Preparedness Innovations (CEPI) will provide up to $20.6 million to support the development of a new, self-amplifying mRNA vaccine candidate for the growing number of COVID-19 variants.
These funds will cover a... Read More »
The World Health Organization (WHO) is asking for $7.7 billion in funding for the Rapid ACT-Accelerator Delta Response (RADAR) to help stop the Delta variant and bring about an end to the COVID-19 pandemic.
The funding would allow for increased testing and better surveillance to detect and... Read More »
A preclinical study conducted on non-human primates and published this week showed potential in a second-generation mRNA COVID-19 vaccine candidate, CV2CoV, created by the joint efforts of biopharmaceutical companies CureVac N.V. and GSK.
Among cynomolgus macaques, the new candidate -- an... Read More »
With diagnostic testing as important as ever in the battle to contain COVID-19, researchers from various institutions under the umbrella of the National Institutes of Health (NIH) have banded together to create a new sample preparation method for detecting SARS-CoV-2.
The collaboration has... Read More »
Area Port of Memphis Customs and Border Protection (CBP) personnel said the agency routinely seizes low-quality, counterfeit COVID-19 vaccination cards.
This fiscal year, Memphis has initiated 121 seizures totaling 3,017 of the fake vaccination cards. The cards regularly contain typographical... Read More »
The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) last week authorized the use of third COVID-19 vaccine doses from Pfizer Inc. and Moderna Inc. for patients with compromised immune systems.
The decision follows months of build-up surrounding... Read More »
The specialty vaccine firm Valneva SE has initiated a Phase 3 trial for its COVID-19 vaccine candidate, VLA2001.
VLA2001-304 seeks to generate data in the elderly and is designed to potentially enable variant-bridging through immune-comparability. Study data is slated to complement ongoing... Read More »
According to a new manuscript published in Science last week, the majority of people given Moderna Inc.’s COVID-19 vaccine maintained antibodies not just against SARS-CoV-2, but against many of its variants of concern, for six months after a second dose.
The two-dose vaccine has been... Read More »
The more than 25,000 healthcare workers employed by the U.S. Department of Health and Human Services (HHS) will need to be vaccinated against COVID-19, adding it to a list of requirements that include influenza and other routine vaccinations.
“Our number one goal is the health and safety of... Read More »
Members of Congress this summer ramped up bipartisan efforts with the introduction of at least eight bills that seek to help the United States prepare for and respond to pandemics and other public health emergencies.
Most recently, the Disease X Act, S. 2640, proposed on Aug. 5 by U.S. Sens.... Read More »
Groups of medical experts this week proposed a standardized definition for defining and evaluating placental SARS-CoV-2 infections to optimize both clinical care and new research, as well as the pursuit of COVID-19 vaccinations for pregnant individuals.
The first came from a panel of experts... Read More »
Regulatory approval was granted for two new clinical trials of INO-4800 in China this week, allowing its creator INOVIO and its partners Advaccine Biopharmaceuticals Suzhou Co. Ltd. and Sinovac Biotechnology to investigate the safety, tolerability, and immunogenicity of different... Read More »
A new partnership announced last week between Integrum Scientific and the Coalition for Epidemic Preparedness Innovations (CEPI) will advance progress toward a Rift Valley fever (RVF) vaccine by developing an international antibody standard and validation of new assays.
From now until September... Read More »
BARDA’s Division of Research Innovation and Ventures (DRIVe) announced Thursday that it will partner with US Biologic Inc. to develop an oral vaccine for two strains of the influenza virus.
Part of BARDA DRIVe’s Beyond the Needle program, the partnership’s goal is to make vaccines and... Read More »
A Phase Three trial of Valneva SE’s chikungunya vaccine candidate, VLA1553, met with major success, according to topline results released last week that showed it induced protective neutralizing antibody titers in 98.5 percent of subjects after a single vaccination.
The trial involved 4,115... Read More »
U.S. Sen. Tammy Baldwin (D-WI) introduced legislation last week that would allocate $2 billion to the Biomedical Advanced Research and Development Authority (BARDA).
The Disease X Act would provide $2 billion over the next four years -- $500 million per year, beginning in 2022 -- for BARDA to... Read More »
Biotechnology company INOVIO dosed its first participant in a Phase 2 trial of a DNA vaccine for Middle East Respiratory Syndrome (MERS).
MERS, another coronavirus disease, is far deadlier than COVID-19, with a kill rate of approximately 34 percent. Fortunately, though, its transmission rate has... Read More »
A cocktail of casirivimab and imdevimab known as REGEN-COV, produced by Regeneron Pharmaceuticals, Inc., cut the risk of symptomatic infections by 81 percent in a Phase 3 trial of more than 1,500 people, according to a new publication in the New England Journal of Medicine.
Even better,... Read More »
REGEN-COV was confirmed for continued use against COVID-19 cases deemed at high risk for progression to hospitalization or death last week, with the extension of its Emergency Use Authorization by the United States Food and Drug Administration (FDA).
The therapeutic is a monoclonal antibody... Read More »
Faced with a disease that tends to hit suddenly, erratically, and with extremely lethal effects, the Coalition for Epidemic Preparedness Innovations (CEPI) announced last week that it will provide up to $188,000 to support Universiti Malaya (UM) research into the Nipah virus.
UM, based in... Read More »
This year marks the fifth anniversary of the founding of Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), a global non-profit partnership dedicated to funding and supporting the development of new products to counter antibiotic-resistant bacteria.
According to... Read More »
The Food and Drug Administration (FDA) is permitting Emergent BioSolutions Inc. to resume manufacturing the Johnson & Johnson COVID-19 Janssen vaccine at its Bayview facility in Baltimore, according to the multinational biopharmaceutical company.
“We are proud to be resuming production of... Read More »
State funding for public health departments has dropped by 16 percent since 2010, and these same departments have lost a quarter of their workforce in the last decade.
How can the United States adequately prepare for the next pandemic when the public health infrastructure is woefully... Read More »
In a first for virus detection, the company Opteev this week launched a plug-in airborne virus detector known as ViraWarn to scan for COVID-19, flu, and other virus particles in the air indoors and then warn those who might be affected.
Meant as prevention rather than confirmation of infection,... Read More »
What is already the largest ever Lassa fever assessment study will expand to reach Benin, Guinea, Liberia, and Sierra Leone, thanks to an additional $10.3 million from the Coalition for Epidemic Preparedness Innovation (CEPI).
“There have been a number of positive developments in the Lassa... Read More »
