Travel Vaccine Breaking News

Many people are looking forward to Spring 2024, but the respiratory season still affects children's health in the United States.

On March 8, 2024, the U.S. CDC published an updated national outlook on respiratory diseases. According to the report, influenza percent positivity has remained stable compared to the previous week, but there have been flu outbreaks in some areas of the country.

In addition, last week, ten children died from influenza.

As of week #9 of 2024, the CDC has identified 103 influenza-associated pediatric deaths using underlying cause-of-death codes J09–J18. During the 2022-2023 flu season, 182 children died from influenza infections.

The vaccination status of these children was not disclosed.

The CDC continues to recommend a seasonal flu shot for anyone older than six months and suggests speaking with a doctor, nurse, or pharmacist about flu shot options (egg, cell, nasal) in March 2024.

Since the Respiratory Syncytial Virus (RSV) season began in the United States in Florida last year and peaked over the winter months, pregnant women have had two immunization options available to protect their future infants.

In August 2023, the CDC recommended Beyfortus™ (Nirsevimab-alip), a single-dose, long-acting monoclonal antibody offering passive immunization, to protect infants aged <8 months against RSV-associated lower respiratory tract infection in their first RSV season.

The other option is maternal vaccination.

On March 7, 2023, the U.S. CDC's Morbidity and Mortality Weekly Report offered encouraging news.

The CDC confirmed that Beyfortus was 90% (95% CI = 75%–96%) effective against RSV-associated hospitalization in infants in their first RSV season.

However, Beyfortus's effectiveness is expected to decrease after receipt because of antibody decay.

In clinical trials, nirsevimab remained highly efficacious against RSV-associated lower respiratory tract infection in infants through 150 days, consistent with an extended half-life of 63–73 days.

This early estimate supports the current CDC recommendation for the prevention of severe RSV disease in infants.

As of January 2024, among females with an infant <8 months, 40.5% reported that their infant received nirsevimab. An additional 21.7% said that they plan to get nirsevimab for their infant.

The European Centre for Disease Prevention and Control (ECDC) today reported a significant surge in sexually transmitted infections (STIs) across Europe.

The latest Annual Epidemiological Reports on STIs in the European Union/European Economic Area (EU/EEA), published on March 7, 2024, reveal a sharp increase in reported STI cases in 2022 compared to the previous year.

Gonorrhea cases rose by a staggering 48%, syphilis by 34%, and chlamydia by 16%. This is a concerning trend that requires immediate action to prevent further escalation, wrote the ECDC.

ECDC Director Andrea Ammon expressed deep concern over the rising STI rates in a press release: "Addressing the substantial increases in STI cases demands urgent attention and concerted efforts."

"Testing, treatment, and prevention lie at the heart of any long-term strategy."

While no approved vaccines for these STIs exist, the United Kingdom (U.K.) has launched an innovative immunization program targeting gonorrhea.

In 2023, the U.K.'s JCVI considered the evidence presented regarding program cost-effectiveness and likely impact on gonorrhea epidemiology.

The committee agreed that a targeted program should be initiated using the 4CMenB vaccine (Bexsero®) to prevent gonorrhea in those at most significant risk of infection.

It is essential for individuals offered vaccination to understand that real-world studies have estimated that the 4CMenB vaccine is effective against gonorrhea between 32.7% and 42%.

Therefore, although vaccination would be expected to reduce the chance of becoming infected with gonorrhea, it would not eliminate the possibility.

Vaccinated individuals could expect to have some reduction in their own risk of contracting gonorrhea.

However, the JVCI wrote that the main benefit of a vaccination program is expected to be at the community level, with a significant reduction in the overall number of cases.

AstraZeneca today announced plans to invest £650 million in the United Kingdom (UK), helping boost the UK's Life Sciences sector and grow the economy.

On March 6, 2024, AstraZeneca confirmed it intends to invest £450 million to research, develop, and manufacture vaccines in Speke, Liverpool. The facility will be operationally net zero, with power supplied from renewable energy sources.

A further £200 million investment announced to expand AstraZeneca's presence in Cambridge, employing potentially 1,000 people.

In a government press release, AstraZeneca Chief Executive Officer Sir Pascal Soriot said, "AstraZeneca's planned investment would enhance the UK's pandemic preparedness and demonstrate our ongoing confidence in UK life sciences."

"We will continue to support the UK in driving innovation and patient access, building on the strong foundations which have been put in place."

AstraZeneca's investment decision is contingent upon mutual agreement with the UK Government and third parties, and successful completion of regulatory processes. Any final commitment is not solely subject to AstraZeneca's discretion.

Currently, AstraZeneca produces vaccines targeting influenza and RSV.

African countries with the highest burden of malaria have vowed to take bold action to end deaths from this mosquito-transmitted disease.

The African region is home to countries reporting approximately 70% of malaria outbreaks: Burkina Faso, Cameroon, the Democratic Republic of the Congo, Ghana, Mali, Mozambique, Niger, Nigeria, Sudan, Uganda, and Tanzania. 

The Health Ministers have committed to addressing the threat of malaria in the African region, which accounts for a staggering 95% of malaria deaths worldwide.

They signed a declaration on March 6, 2024.... “No one shall die from malaria”... committing to providing decisive leadership and increased domestic funding for malaria control.

In 2022, $4.1 billion was available for malaria response.

“This declaration reflects our shared commitment as nations and partners to protect our people from the devastating consequences of malaria. We will work together to ensure that this commitment is translated into action and impact,” said Hon Manaouda Malachie, Minister for Health of Cameroon, in a WHO press release.

This commitment will ensure the fight against malaria is sustained and equitable, leaving no one behind.

Globally, the number of malaria cases in 2022 reached 249 million.

Malaria is now a vaccine-preventable disease.

The World Health Organization recommended the Mosquirix™ malaria vaccine in 2021. In 2023, the R21 / Matrix-M™ vaccine was WHO-approved for use in certain countries.

 As of March 6, 2024, the U.S. Food and Drug Administration had not approved either malaria vaccine.

ImmunityBio has announced that the combination of N-803 and natural killer cells can potentially reduce viral load in people living with human immunodeficiency virus (HIV), per the Phase 1 pilot study data.

Results from this study were published in The Journal of Infectious Diseases in January 2024; researchers at the University of Minnesota Medical School gave six HIV-positive individuals infusions of healthy NK cells from close relatives, along with N-803, to boost NK cell activity. All participants in this Phase 1 study experienced a significant reduction in infection levels following treatment with N-803.

The approach was well tolerated, with no unexpected adverse events.

N-803 is a novel investigational IL-15 superagonist complex with an IL-15 mutant (IL-15N72D) bound to an IL-15 receptor α/IgG1 Fc fusion protein. Its proposed mechanism of action is direct specific stimulation of CD8+ T cells and NK cells through beta gamma T-cell receptor binding with the generation of memory T-cells while avoiding T-reg stimulation.

N-803 is designed to have improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced anti-tumor activity compared to native, non-complexed IL-15 in vivo.

The use of N-803 is investigational. Safety and efficacy have not been established by any Health Authority or Agency, including the U.S. FDA.

Tim Schacker, MD, senior author of this paper, and colleagues are planning a follow-on study with additional participants to investigate these immunotherapies in HIV-infected individuals further.

“Antiretroviral therapies have had a profound impact on society, making it possible for those living with HIV to live longer lives with better outcomes. However, these therapies are not a cure, and still place a significant burden on people living with HIV and the healthcare system,” said Patrick Soon-Shiong, M.D., Chairman and Global Chief Scientific and Medical Officer at ImmunityBio, in a press release on March 5, 2024.

“These data preliminarily validate what we know about the benefit of enhancing NK cell function and the potential utility of N-803 in infectious diseases.”

In addition to this study, three other clinical trials are underway involving N-803 in HIV Cure-related strategies.

Two Phase 1 clinical trials are investigating N-803 in combination with bNAbs in HIV-infected individuals (ACTG A5386, NCT04340596: and NCT05245292 at the Rockefeller University), and a Phase 2 study is also underway to investigate the effect of combining N-803 with ART during acute HIV infection, sponsored by the Thai Red Cross and the U.S. Military HIV Research Program. To learn more about these studies, please visit our website.

HIV affects tens of millions globally and currently has no known cure. HIV can disable NK cells—a frontline defense against viral infections—making it difficult to clear the infection.

One current strategy for curing HIV is known as the “kick and kill” approach. N-803 is under evaluation using this strategy, given the molecule’s ability to activate viral transcription in CD4+ T cells (“kick”) and boost CD8+ and NK cells, crucial for identifying and eliminating infected cells (“kill”), directing them to viral reservoirs.

ImmunityBio’s IL-15 superagonist N-803 (also called Anktiva® and nogapendekin alfa inbakicept)

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of the natural killer (NK) and T cells.

N-803 is currently being evaluated in adult patients in two clinical NMIBC trials. QUILT-2.005 is investigating the use of N-803 in combination with BCG for patients with BCG-naïve NMIBC; QUILT-3.032 is studying N-803 in combination with BCG in patients with BCG-unresponsive NMIBC CIS and Papillary Disease.

PhotonPharma, a biotechnology company that aims to revolutionize cancer treatment, announced today that it has received clearance from the U.S. Food and Drug Administration to proceed with its Phase I clinical study for the treatment of Stage III/IV ovarian cancer.

The company will use Innocell™, its groundbreaking investigational autologous cell-based vaccine therapy, for this purpose. The vaccine therapy will be manufactured at City of Hope's Los Angeles campus.

This therapy is based on the use of inactivated tumor cells prepared with a proprietary process that involves UV light and riboflavin.

These cells are isolated from a patient's tumor and inactivated and then used in a treatment that is designed to stimulate the patient's immune system to fight cancer.

Alan Rudolph, the CEO of PhotonPharma, expressed his enthusiasm about this development in a press release on March 5, 2024, stating, "We are thrilled to have reached this pivotal moment in our journey toward providing a novel treatment option for patients facing advanced ovarian cancer."

PhotonPharma anticipates initiating patient enrollment for this study shortly to profile the therapeutic potential of this innovative autologous vaccine therapy.