The US Food and Drug Administration (FDA) today announced that it has granted emergency use authorization for Novavax's updated COVID-19 vaccine. 

Approval of the protein-based vaccine comes about a week after the FDA green-lighted the two updated mRNA vaccines—made by Moderna and Pfizer-BioNTech—which target the KP.2 variant. The Novavax vaccine targets JN.1, the parent of KP.2.

Novavax's updated vaccine is authorized for people ages 12 and older. 

A third COVID vaccine option

In a statement, Peter Marks, MD, PhD, who directs the FDA's Center for Biologics Evaluation and Research, said COVID vaccines continue to have a major positive impact on public health and that vaccination continues to be the most effective method for COVID prevention. "Today's authorization provides an additional COVID-19 vaccine option that meets the FDA's standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization."

Today's authorization provides an additional COVID-19 vaccine option that meets the FDA's standards.

The company has said the vaccine will be available in prefilled syringes and that it will promptly deliver it as soon as the FDA authorizes the vaccine. Its data suggest the JN.1 monovalent vaccine induces broad neutralization responses against JN.1 lineage viruses, including ones such as KP.2 and KP.3

The US Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) today confirmed another H5N1 avian flu outbreak in a dairy herd in New Mexico, the state’s first since the middle of April.

The outbreak pushes the nation's total confirmed outbreaks in dairy facilities to 194 in 13 states.

Though the pace of H5N1 outbreaks on dairy farms has slowed over the summer months, federal officials said at a briefing earlier this month that it was too soon to say if the virus was ebbing in cattle. They noted that cattle movement between states, which played a role in initial spread, picks back up in the fall due to greater demand for milk, partly due to schools resuming.

Suspected outbreaks in Central Valley

The California Department of Food and Agriculture yesterday announced that it is investigating the possible introduction of the virus into three dairy farms in the state’s Central Valley. It said samples have been sent for testing to California Animal Health and Food Safety laboratory. If positive, they will be considered "presumptive" and submitted to the USDA for confirmation.

In early June, WastewaterSCAN launched an H5 wastewater dashboard to help track undetected H5 spread, and, since then, traces of the virus have been found in nine states, seven of which have reported H5N1 outbreaks in dairy cows. California and Arkansas were the only two states with positive H5 wastewater findings that hadn't reported recent outbreaks on dairy or poultry farms.

California is the nation's top milk production state and accounts for one fifth of the nation's supply. The state has about 1,100 dairy farms, and herds in Tulare, Merced, and Stanislaus counties make up just more than half of the state's milk output.

As the United States heads into the Labor Day holiday weekend and with schools resuming, COVID-19 activity continues to rise in many areas, but it's showing early signs of decline in others, the Centers for Disease Control and Prevention (CDC) said today in its data updates.

Wastewater SARS-CoV-2 detections are still at the very high level and are highest in the South. Though levels are dropping in the West, they are rising in the South, Midwest, and Northeast, the CDC said.

Meanwhile, wastewater tracking from WastewaterSCAN shows that detections nationally are still at the high level, with no clear trend up or down over the past 3 weeks. The group, however, noted an upward trend in the Midwest. WastewaterSCAN is a national wastewater monitoring system based at Stanford University in partnership with Emory University.

KP.3.1.1 levels climb; hospitalizations elevated

In updated variant proportion estimates today, the CDC said the level of KP.3.1.1—a JN.1 offshoot thought to more easily evade immunity from earlier infection and vaccination—continues to rise sharply and is at 42.2%, up from 29.5% 2 weeks ago.

Among the CDC’s other COVID indicators, national test positivity is at 17%, down a hair since the previous week. Positivity is higher in Texas and surrounding states and in the lower Midwestern states than in other parts of the country. Emergency department visits declined from the previous week and are highest in parts of the South and Southeast.

Hospitalizations from COVID remain elevated, especially in seniors and in children younger than 2 years old, the CDC said in its weekly respiratory illness summary.

Deaths from COVID-19, though still low, rose last week and were at the highest level in Kentucky.

A study by Chinese researchers indicates a global rise in Acinetobacter species carrying multiple carbapenem-resistance genes.

In a letter published yesterday in Clinical Microbiology and Infection, a team led by researchers from Zhejiang University School of Medicine said analysis of 30,713 Acinetobacter genomes from the National Center for Biotechnology Information Pathogen Detection Database revealed that 1,409 (5.1%) of 27,487 A baumannii isolates and 216 (6.7%) of 3,226 non-baumannii Acinetobacter spp. (nAB) isolates co-harbored at least two carbapenemases, with notable increases from 2018 through 2023. Multiple carbapenemase-positive Acinetobacter genomes were detected in 61 countries across six continents, with the highest prevalence found in the United States (33.7%), India (13.3%), and China (8.6%).

Carbapenem-resistant A baumannii is already considered an urgent public health threat by the World Health Organization and the US Centers for Disease Control and Prevention because it's so difficult to treat. Some studies have found mortality rates as high as 72% in patients with carbapenem-resistant A baumannii infections.

But among the 54 distinct combinations of double carbapenemases identified, the analysis also found the co-existence of metallo-beta-lactamase and tetracycline-inactivating genes, which confer resistance to many of the recently approved beta-lactam/beta-lactamase inhibitor combinations (such as ceftazidime/avibactam and meropenem/vaborbactam) and tigecycline, all of which have been considered potential treatments for carbapenem-resistant A baumannii infections. These combinations, the study authors said, further restrict the antibiotic treatment options for Acinetobacter infections.

Strains found in clinical settings, livestock, and the environment

While nearly all the A baumannii strains originated from clinical settings, 33.5% of the nAB strains were isolated from environmental or livestock sources, the researchers added.

"In summary, the prevalence of Acinetobacter species co-harboring multiple carbapenemases is increasing globally, and the emergence of novel combinations of carbapenemases and their coexistence with Tet(X) enzymes requires further investigation" they wrote. "Moreover, the global emergence of carbapenem-resistant Acinetobacter species in diverse sources emphasizes the critical importance for a One Health approach for the investigation and control of its spread."

A new report lays out the financial risks posed by antimicrobial resistance (AMR) and how investors might be able to mitigate them.

The health risks posed by drug-resistant pathogens are already well known. A 2022 study published in The Lancet estimated that AMR was directly responsible for 1.27 million deaths, and contributed to an additional 3.7 million deaths, in 2019. That's more than the number of deaths caused by HIV/AIDS, malaria, and many cancers.

But the report published this week by the Farm Animal Investment Risk & Return (FAIRR) initiative, the MSCI Sustainability Institute, and Investor Action on AMR highlights the significant financial costs. According to World Bank estimates, unchecked drug-resistance could cause annual gross domestic product losses ranging from US $1 trillion to $3.4 trillion by 2030, driven by increased human and veterinary healthcare costs, reduced productivity, and declines in global livestock production. Those losses could rise to $100 trillion by 2050 if the weak pipeline for new antibiotics continues to falter.

Incorporating an 'AMR lens' into investment decisions

But investors can play a role in addressing AMR by incorporating an "AMR lens" into investment decisions, the report suggests. This means identifying opportunities to invest in companies that are part of the solution to AMR and avoiding investments that exacerbate it. One clear area of opportunity is antibiotic research and development

"Investors can play a pivotal role in driving the research and development of new antibiotics, diagnostics, and alternative treatments," the report states. "By providing the necessary funding, investors can help accelerate the pace of innovation and commercialization of solutions."

Investors can play a pivotal role in driving the research and development of new antibiotics, diagnostics, and alternative treatments.

In addition, the report suggests that investors can work with companies in the livestock sector to encourage them to reduce inappropriate antibiotic use and adopt alternative treatment strategies, invest in global AMR surveillance systems that will help companies with global risk planning, and support healthcare companies that are using tools and databases to evaluate appropriate antibiotic use.

"By working collaboratively, investors can address existing gaps and promote sustainable practices," the report states. "Understanding the economic impact, integrating AMR into investment decisions, and supporting research and innovation are crucial."