Travel Vaccine Breaking News

The U.S. Administration for Strategic Preparedness and Response's Biomedical Advanced Research and Development Authority (BARDA) today awarded $10 million to Johnson & Johnson Innovation for a competition through project Blue Knight™.

"As the virus continues to evolve, we need new tools that keep pace with those changes," said Assistant Secretary for Preparedness and Response Dawn O'Connell in a press release on August 22, 2023.

This BARDA award is in alignment with 'Project NextGen' which focuses on advancing solutions aimed at addressing health security threats and improving preparedness,

Announced in May 2023, the U.S. Department of Health and Human Services Project NextGen is a $5 billion initiative led by BARDA in partnership with the National Institute of Allergy and Infectious Diseases, coordinates activities across the federal government and the private sector to advance innovative vaccines and therapeutics into clinical trials, regulatory review, and potential commercial availability for the American people.

Announced on May 11, 2023, the Blue Knight challenge offers current and alumni Blue Knight residents and their collaborators the opportunity to apply for the chance to receive funding to help them reach their critical developmental milestones.

Learn more about Blue Knight and hear from current companies at this Johnson & Johnson Innovation LLC link.

In the United States, the timing of seasonal respiratory syncytial virus (RSV) outbreaks throughout the country is generally reported between October - April most years.

The 2022–23 season it started later than in 2021–2022 but earlier than prepandemic seasons, suggesting a return toward normal seasonality.

Furthermore, the state of Florida is often a bell-weather state for RSV detections, as it is in 2023.

Florida’s RSV season is longer than the rest of the nation and has distinct regional patterns. For this reason, the state is segmented into five RSV regions, each with its own season. 

The Florida Department of Health recently announced RSV activity during week #33 had increasing detection and admission rates.

As of August 19, 2023, two RSV outbreaks were confirmed in Martin County, located north of Jupiter. Last week, one RSV outbreak occurred in Jacksonville, Florida.

In the U.S., RSV infections cause thousands of hospitalizations among young children and adults aged ≥65. The U.S. Centers for Disease Control and Prevention (CDC) RSV detection 5-week moving average graphs for each state are displayed at this link.

This RSV season, the U.S. government has approved RSV vaccines and monoclonal antibody therapeutics available in specific clinics and pharmacies as of August 22, 2023.

The CDC says people should speak with a healthcare provider if these new therapeutics are appropriate for their health. 

The U.S. Food and Drug Administration (FDA) today approved ABRYSVO™, the first vaccine approved for use in pregnant women to prevent lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV) in infants from birth through six months of age.

Abrysvo is approved for use at 32 through 36 weeks gestational age of pregnancy, says the FDA.

Previously, the FDA approved Pfizer Inc.'s Abrysvo in May 2023 to prevent LRTD caused by RSV in individuals 60 and older.

"RSV is a common cause of illness in children, and infants are among those at highest risk for severe disease, which can lead to hospitalization," said Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research, in a press release on August 21, 2023.

"This approval provides an option for healthcare providers and pregnant individuals to protect infants from this potentially life-threatening disease." 

Recently, the FDA approved Beyfortus™ for infants born during or entering their first RSV season and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

On July 17, 2023, Beyfortus became the first extended half-life monoclonal antibody offering passive immunization to prevent LRTI caused by RSV. 

RSV is a highly contagious virus that causes respiratory infections in individuals of all age groups, causing frequent outbreaks. Most individuals can be expected to be infected with RSV by the time they reach two years of age, says the FDA.

In most parts of the U.S., RSV circulation is seasonal, typically starting in Florida and peaking in the winter.

A study published by PLOS Medicine in July 2023 concluded RSV disease burden is high in the nearly 600 million children under five living in 121 low-income and middle-income countries. The peak age of community-based RSV incidence is 4.8 months.

CARsgen Therapeutics Holdings Limited today announced a collaboration agreement with Moderna Inc. to investigate CARsgen's investigational Claudin18.2 CAR T-cell product candidate (CT041) in combination with Moderna's investigational Claudin18.2 mRNA cancer vaccine.

CT041 (satricabtagene autoleucel) is CARsgen's autologous CAR T-cell product being investigated for potentially treating gastric, pancreatic, and other specified digestive system cancers.

It is currently in multiple ongoing clinical studies in China and North America.

"CT041 is the most advanced solid tumor CAR-T in development (pivotal phase II) and continues to show promise in treating gastric and pancreatic cancers. In our quest to make cancer curable, we are continuously exploring multiple modalities to eradicate tumors. Attacking tumors with CAR T-cell therapy in combination with a cancer vaccine could potentially provide greater clinical benefit to patients." said Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics Holdings Limited, in a press release on August 21, 2023.

Dr. Li added, "Moderna has clearly established itself as a scientific and commercial leader in mRNA-based vaccines and therapeutics, and we are pleased to partner with Moderna to explore a potential synergism between our innovative therapies."

Moderna is developing an investigational off-the-shelf mRNA cancer vaccine that encodes for the Claudin18.2 protein, a tumor-associated antigen.

The collaboration contemplates conducting preclinical studies and a phase I clinical trial to evaluate CT041 in combination with Moderna's Claudin18.2 mRNA cancer vaccine.

"We are pleased to partner with CARsgen to explore the potential synergy of CAR-T with an investigational mRNA cancer vaccine that encodes for the Claudin18.2 protein. Claudin18.2 is a promising therapeutic target to potentially treat multiple cancer types with high unmet medical need. We continue to deliver on the promise of mRNA science to create a new generation of transformative medicines in oncology," added Dr. Lin Guey, Chief Scientific Officer of External Research Ventures, Moderna.

CARsgen is a biopharmaceutical company with operations in China, and the U.S. focused on innovative CAR T-cell therapies for treating hematologic malignancies and solid tumors.

The Transportation Security Administration (TSA) recently announced that it was expanding TSA PreCheck® with Telos Corporation at ten airports in the U.S.

Telos began enrolling its first applicants during trial periods in Annapolis, Md., Chantilly, Va., Ashburn, Va., and Las Vegas. 

Since TSA first launched the TSA PreCheck application program for low-risk travelers in December 2013, active membership in the program has grown to more than 15 million passengers.

About 99% of TSA PreCheck® passengers wait less than 10 minutes at 200 airports.

“TSA PreCheck is a trusted traveler program that improves overall aviation security and provides time and convenience benefits to its members,” said TSA Administrator David Pekoske in a press release on August 15, 2023.

“This expansion of enrollment providers will increase the network of locations where applicants may go to complete their TSA PreCheck membership.”

Moving forward, TSA PreCheck members may renew their memberships online with Telos or IDEMIA (TSA PreCheck’s original enrollment provider), regardless of who they enrolled with initially.

As of August 20, 2023, TSA reported airport screening activity had regained volumes last seen in 2019.

Gavi today reported the Republic of Kenya is innovating to help every eligible child get four malaria vaccine doses in 2023.

As of August 18, 2023, about 96.5% of eligible children in Vihiga County in Kenya have received at least one RTS,S vaccine dose.

However, only 30% of eligible children in Vihiga are yet to complete the four-dose regimen that maximizes the WHO-approved malaria vaccine's effectiveness.

Part of the so-called "Lake-endemic region" in Kenya, a particularly mosquito-plagued set of districts abutting Lake Victoria, Vihiga has been offering malaria vaccinations since 2019.

The positive impact of malaria vaccination is already being measured.

More than a million Gavi-supported RTS,S (Mosquirix™) vaccine doses have been administered to some 400,000 children across the Lake-endemic counties, and Dr Abdourahmane Diallo, WHO Kenya Representative, confirms that those jabs, in concert with other malaria-control measures, have led to a demonstrable decline in case" .

The U.S. CDC Kenya"s Amy Herman-Roloff quantifies that decline at 50%.

The precise burden of malaria in sub-Saharan Africa has remained elusive, wrote researchers in an article published by the journal BMC Medicine.

Infection with Plasmodium falciparum is a frequent event for individuals living in stable transmission areas in Afric. Not all new infections cause illness in partdue tof acquired immunity, says the CDC.

In Africa, two malaria vaccines have been in use during 2023.

In addition to malaria, the CDC included Kenya in a recent polio outbreak travel advisory. When visiting polio outbreak areas, the CDC recommends travelers ensure they have been fully immunized. 

The U.S. CDC published a Morbidity and Mortality Weekly Report (MMWR) today that concluded all adults at risk for mpox should receive Bavarian Nordic JYNNEOS® (MVA-BN) vaccine, irrespective of childhood smallpox vaccination status.

Immunologic studies have demonstrated some long-term immunologic memory from childhood smallpox vaccination that is cross-protective against mpox. Still, such immunity might have waned by May 2022, when the global outbreak began.

On August 18, 2023, the MMWR disclosed although persons aged >50 years likely received a childhood smallpox vaccination, they might have more comorbidities and a higher risk for severe mpox than those aged ≤50. 

This study found among 29,984 adults with mpox, those aged >50 years had higher prevalences of immunocompromising conditions and HIV and lower prevalence of symptoms than younger people.

Among 1,020 adults aged >50 with vaccination data, prevalences of pruritus, constitutional symptoms, and hospitalization were lower among those who received the JYNNEOS vaccine than those who had not.

This finding underscores the importance that persons at risk for mpox, particularly adults aged >50 years, receive the recommended JYNNEOS vaccination. JYNNEOS vaccination is recommended for all adults at risk for mpox irrespective of receipt of childhood smallpox vaccination, wrote these researchers.

The JYNNEOS vaccination services remain available in most health clinics and pharmacies in U.S. cities, London, and in various other locations.

It's unknown how long JYNNEOS protection last or if protection might decrease over time, says the CDC. 

On August 3, 2023, the U.S. government ordered an additional $120 million worth of JYNNEOS vaccines.