Novavax applies for FDA nod for its updated COVID vaccine

News brief

Novavax announced last week that it has submitted amendment to the US Food and Drug Administration (FDA) for an emergency use authorization (EUA) for its updated COVID vaccine targeting the JN.1 variant.

covid vaccine items — *Troy Saunders, APG News / Flickr cc*

The vaccine is the only protein-based option and contains the Matrix M adjuvant. It is indicated for use in people ages 12 and older. Novavax said its submission aligns with guidance from the FDA, the European Medicines Agency, and the World Health Organization.

The company said it will have vaccine doses ready to distribute in the middle of July and is preparing to promptly deliver it as prefilled syringes as soon as the FDA authorizes it and the Centers for Disease Control and Prevention recommends it.

Broad immune response

In its statement, Novavax said nonclinical data suggest its JN.1 monovalent vaccine induces broad neutralization responses against JN.1 lineage viruses, including ones such as KP.2 and KP.3 that have the FLiRT (F456L and R346T) and FLuQE (F456L and Q493E) mutations.

John Jacobs, MBA, Novavax president and CEO, said, "Novavax is committed to having a protein-based COVID-19 option available at the start of the vaccination season, which is critical because research suggests that providing vaccine choice, along with healthcare provider recommendations, may help improve vaccination rates."

Antibiotics, resistant bacteria found on ocean surface

News brief

Mary Van Beusekom, MS

Antibiotics found in the top oceanic surface layer can contribute to antimicrobial resistance and have negative ecologic effects, according to research presented late last week at the annual meeting of the American Society for Microbiology (ASM) in Atlanta.

Scientists evaluated the susceptibility and resistance of marine bacteria to the antibiotics ofloxacin, clindamycin, clarithromycin, and novobiocin on bacterial diversity in the sea surface microlayer in Jade Bay in the southern North Sea in Germany, the ASM press release said.

58% to 100% of bacteria resistant

A total of 70% of marine bacteria were resistant to ofloxacin, 95% to clindamycin, 58% to clarithromycin, and 100% to novobiocin. Novobiocin was most highly concentrated in the sea samples.

The researchers found more bacteria in samples taken from the sea surface microlayer than in the water below, even when they added different amounts of the antibiotic ciprofloxacin to the samples. The number of bacteria in the samples fell as ciprofloxacin concentration rose, but over time the bacteria proliferated when levels of ciprofloxacin were high, which the team said shows growing resistance.

Our results emphasize the collective effort needed to reduce the potential ecological effects of introducing antibiotics into coastal waters, because antibiotics may accumulate more in the sea surface microlayer, affect the bacteria diversity, and lead to the adaptation of marine bacteria to antibiotics.

Adenike Adenaya, PhD

At high ciprofloxacin concentrations, 97 bacterial strains belonging to more than 14 bacterial classifications were identified. Fifty-seven (59%) of those strains can infect humans, particularly those with weakened immune systems, the researchers said.

In addition to the four studied antibiotics, lincomycin, tylosin, erythromycin, trimethoprim, sulfamethoxazole, roxithromycin, and chloramphenicol were also collected from the sea surface microlayer. Only a few were found at deeper levels.

"Our results emphasize the collective effort needed to reduce the potential ecological effects of introducing antibiotics into coastal waters, because antibiotics may accumulate more in the sea surface microlayer, affect the bacteria diversity, and lead to the adaptation of marine bacteria to antibiotics," Adenike Adenaya, PhD, of Carl von Ossietzky Universitat in Oldenburg, Germany, said in the release.

CWD detected for first time in Trinity County, Texas

News brief

Mary Van Beusekom, MS

White-tailed deer — Chad Horwedel / Flickr

Trinity County joins the ranks of chronic wasting disease (CWD)-affected counties in Texas after a detection at a deer-breeding facility, the Texas Parks and Wildlife Department (TPWD) reported late last week.

The 2-year-old white-tailed doe tested positive during required CWD postmortem surveillance at the facility, a finding confirmed by the National Veterinary Services Laboratory in Ames, Iowa. Trinity County is located in eastern Texas; TPWD didn't provide the city.

"CWD has an incubation period that can span years, so the first indication of the disease in a herd is often found through routine surveillance testing rather than observed clinical signs," the press release said. "TAHC [Texas Animal Health Commission] and TPWD remind all deer breeders of requirements to report mortalities within seven days of detection and submit CWD test samples within seven days of collection."

First found in Texas in 2012

CWD, a neurologic disease caused by misfolded proteins called prions, affects cervids such as deer, elk, moose, and reindeer. The disease poses an ongoing threat to cervids because it can spread from animal to animal and through environmental contamination.

It isn't known to infect humans, but officials recommend not eating meat from a sick animal and using precautions when field-dressing or butchering cervids.

"In Texas, the disease was first discovered in 2012 in free-ranging mule deer along a remote area of the Hueco Mountains near the Texas-New Mexico border," TPWD wrote. "CWD has since been detected in Texas captive and free-ranging cervids, including white-tailed deer, mule deer, red deer, and elk."

Study shows 12% long-COVID prevalence following Omicron infection

News brief

Stephanie Soucheray, MA

A new report in Emerging Infectious Diseases reveals an 11.8% prevalence of long COVID during the Omicron BA.5 wave in Japan, based on outcomes seen among 25,911 adults 20 years and older.

Japan experienced the seventh wave of COVID-19 in July 2022, caused by the Omicron subvariant BA.5 lineage, the authors said.

"The Omicron variant tends to cause less severe acute symptoms and has a similar or lower risk for post–COVID-19 condition than the previous variant," the authors wrote. "Longer sequelae and risks for post–COVID-19 condition in persons infected with the Omicron variant compared with noninfected populations remain unknown."

The study was based on adults 20 to 69 years of age who had confirmed SARS-CoV-2 infection during July to August 2022 and answered a survey about the presence of 26 symptoms roughly 6 months following their Omicron infection. Cases were matched with controls, and any symptoms were ranked on severity and impact on daily activities.

Cough most frequent persistent symptom

The percentage of post–COVID-19 condition for cases was 11.8%, and the percentage of persistent symptoms among controls was 5.5%. According to the authors, the most frequent post–COVID-19 condition was cough (3.7%), followed by difficulty concentrating (3.1%), hair loss (2.8%), fatigue (2.4%), and brain fog (2.2%).

The odds ratio (OR) of any persistent symptoms for cases versus controls was 2.33 (95% confidence interval, 2.05 to 2.64).

Among the cases, female sex, underlying medical conditions, and severity of acute COVID-19 were associated with having post–COVID-19 condition.

"Among the cases, female sex, underlying medical conditions, and severity of acute COVID-19 were associated with having post–COVID-19 condition. We recommend a longer follow-up study of the effects on daily life and socioeconomic status after infection during the Omicron-dominant wave," the authors concluded.