Vaccine News

ImmunityBio today announced that enrollment and initial follow-up have been completed for the safety portions of a phase 2b clinical trial that is studying an investigational cancer vaccine of a tri-valent combination of antigens delivered by a second-generation Adenovirus vector (Tri-Ad5 CEA/MUC1/brachyury) together with its IL-15 superagonist N-803 for participants with Lynch syndrome.

Each of the three vaccines in Tri-Ad5 targets different proteins associated with precancer and cancer cells.

The vaccine combination studies whether activating dendritic cells and training the immune system to recognize those proteins will destroy the precancer cells before the cancer occurs.

The IL-15 superagonist N-803 is designed to enhance the effects of the vaccines by increasing the proliferation and activation of natural killer and T cells, thereby increasing the potential for cancer prevention in study participants.

The study will include up to 186 participants when fully enrolled and is now open to the randomized controlled portion of the trial.

“We are pleased to be selected to participate in this important and innovative cancer prevention study, one that could provide insights into how the immune system could be harnessed to prevent cancer in individuals with hereditary risk,” said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio, in a press release on February 21, 2024.

“With an estimated 5 to 10 percent of cancers inherited, understanding mechanisms that might prevent or delay their onset could potentially change the prospects for tens of thousands of people annually.”

Lynch syndrome is associated with a genetic mutation present in an estimated one million Americans who are more likely to be diagnosed with cancer at a younger age and are at increased risk of developing multiple types of cancers during their lifetime.

ImmunityBio’s Tri-Ad5 Vaccines and N-803 are investigational and are not commercially approved. The safety and efficacy of these investigational agents have not been established by any Health Authority, including the U.S. FDA.

The National Cancer Institute sponsors this study.

While the respiratory virus season is likely past its peak, it is not over. Respiratory syncytial virus (RSV) outbreaks exist in a few hot spots.

According to the World Health Organization (WHO) Update N° 465, in countries with RSV surveillance, activity was stable or decreased in most reporting countries except in South Africa and New South Wales (Australia), where detections slightly increased in this reporting period.

As of February 19, 2024, RSV positivity was still high in Egypt, though it slightly dropped compared with the last report.

In the United States, the Centers for Disease Control and Prevention (CDC) reported on February 16, 2024, that RSV activity remained elevated but was decreasing nationally.

Other indicators, such as emergency department visits with diagnosed RSV and RSV test positivity, are also decreasing.

From a comparison perspective, the national RSV per capita hospitalization rate remains lower than the peak for last season, says the CDC.

Furthermore, the U.S. market has ample access to approved RSV adult vaccines. At this point in the season, 22% of adults 60 years and older have received an RSV vaccination. 

And a monoclonal antibody therapy (Beyfortus™) that delivers passive immunization to infants has become more available.

The Florida Department of Health in Broward County (DOH-Broward) confirmed on February 19, 2024, that it is investigating multiple cases of measles at the Manatee Bay Elementary School in Weston, Florida, located just north of Miami.

A CBS News Miami article reported a 5th measles case has been confirmed at this elementary school, which has an enrollment of about 1,100 students.

According to the Manatee Bay school district, about 11% of these students are not fully vaccinated against measles.

In its press release, DOH-Broward has notified local healthcare providers, stating that those who have received the entire series of MMR vaccines are 98% protected against this airborne virus.

Measles vaccines are generally offered at health clinics and pharmacies in Florida.

The ongoing mpox outbreak in the Democratic Republic of the Congo (DRC) has reached 22 out of 26 provinces, including the capital city of Kinshasa and a few other large cities.

As of February 8, 2024, the U.S. CDC reported the DRC had confirmed 12,569 suspect mpox cases and 581 deaths since January 2023.

Furthermore, the CDC's Level 2 Travel Advisory says casual contact is not likely to cause the disease to spread. However, travelers to impacted areas should seek medical care immediately if they develop unexplained skin rash, with or without fever and chills.

The CDC says people in the United States who have already had a mpox infection or are fully vaccinated with the JYNNEOS® (MVA-BN®, IMVAMUNE®) vaccine should be protected against the type of mpox cade spreading in DRC.

JYNNEOS is a 2-dose vaccine; people need both doses for the best protection against mpox. The second dose should be given four weeks after the first dose.

 In the U.S., some large cities offer JYNNEOS for free. It may be available at the health department, public health clinics, hospitals, or pharmacies.

The World Health Organization (WHO) Mpox External Situation Report #31 confirmed on December 22, 2023, that it has received mpox case reports from 115 affected countries since May 2022. Based on the data reported, the mpox outbreak will continue in most WHO regions in 2024.

During the global measles outbreak of 2024, the UK Health Security Agency (UKHSA) announced yesterday that there has been a potential slowing of measles cases in England.

On February 15, 2024, the UKHSA reported that since October 2023, England has confirmed 521 measles cases. There were 252 in January and 50 so far in February 2024.

From a location perspective, 69% (358 of 521) of these cases have been in the West Midlands, 14% in London, and 7% in Yorkshire and The Humber. The remaining cases were reported in other regions of England.

Across the West Midlands, the population centers of Birmingham (1.1 million) and Coventry (350,000) are located.

Dr Vanessa Saliba, UKHSA Consultant Epidemiologist, commented in a press statement, "As expected, due to worryingly low MMR vaccine uptake in some areas across England."

"We are now seeing clusters of cases in other (England) regions."

There are two different brands of MMR vaccine available in the UK. These are called Priorix and MMRVaxPro.

The UKHSA stated the data published in this epidemiological overview is currently provisional, with the number of cases for the most recent months likely to increase.

The U.S. Centers for Disease Control and Prevention (CDC) has released an update for Week #6 of the 2024 flu season.

As of February 16, 2024, the overall national percent positivity for influenza has remained stable.

However, there has been a slight decrease in percent positivity for influenza A and a slight increase in percent positivity for influenza B. This change has been primarily driven by U.S. regions 3, 5, and 7 activity.

CDC estimates that there have been at least 16,000 deaths from influenza so far this season.

During Week 6, eight influenza-associated pediatric deaths were reported, bringing the 2023-2024 flu season total to 82.

During the last flu season, there were 182 pediatric influenza-related deaths.

The CDC added vaccination can still provide benefits this season. Everyone six months and older can get an annual flu vaccine at a local pharmacy if influenza viruses spread.

As of early February 2024, about 156 million flu shots had been distributed.

Following the end of the recent pandemic, many travelers explored new destinations in 2023. However, over 667,000 cholera cases and 4,000 deaths were reported last year.

In countries experiencing cholera outbreaks, international travelers protected themselves with safe and effective vaccines.

Since the beginning of 2023, there have been 24 reactive cholera vaccination campaigns implemented in 12 countries.

But, there is a global shortage of cholera vaccines. From January 2023 to January 2024, 76 million oral cholera vaccines (OCV) were requested by 14 countries, while only 38 million doses were available.

The World Health Organization (WHO) has three pre-qualified OCVs: Dukoral®, Shanchol™, and Euvichol®.

One of these OCV manufacturers reported a 72% increase in revenues today.

On February 15, 2024, Valneva SE reported its revenue for 2023. Last year, sales of Valneav's DUKORAL® vaccine amounted to €29.8 million (US32 million), a significant increase from the €17.3 million recorded in 2022.

This significant increase can be attributed to the recovery of the private travel markets and price hikes. However, the company says that foreign currency fluctuations caused a reduction of €0.9 million in DUKORAL® sales.

In a press release, Peter Bühler, Valneva's Chief Financial Officer, commented, "In 2023, Valneva successfully executed key strategic objectives despite a difficult economic environment.... we are entering 2024 in a good financial position to support our commercial and R&D objectives."

In the United States, access to cholera vaccines is limited.