Vaccine News

ImmunityBio, Inc. recently announced that the U.S. Food and Drug Administration (FDA) has granted Expanded Access authorization for the use of its Cancer BioShield™ platform, anchored by ANKTIVA®, to treat lymphopenia in adult patients with refractory or relapsed solid tumors independent of tumor type who have progressed after first-line standard-of-care treatment, chemotherapy, radiation, or immunotherapy.

On June 2, 2025, ImmunityBio stated 'while oncologists and patients have long had therapies such as EPOGEN® and NEUPOGEN® to manage chemotherapy- and radiation-induced anemia and neutropenia, no comparable option has been available for lymphopenia.'

To date no treatment exists for lymphopenia, a depletion of critical lymphocytes responsible for immunogenic cell death, specifically natural killer (NK) cells, killer CD8+ T cells and CD4+ with memory T cells.

Treatment-induced lymphopenia is a debilitating consequence of chemotherapy, radiation, specific immunotherapies, and steroids. This treatment-acquired immunodeficiency not only increases susceptibility to infections but also deprives the body’s immune system to fight residual or recurrent cancer, accelerating metastasis and disease progression, and contributing to early mortality.

Countless publications over the last two decades have reported lymphopenia as a highly predictive biomarker of poor prognosis across all tumor types.1-6 Despite its significant clinical impact, the pharmaceutical industry has largely overlooked lymphopenia as a disease in its own right, and no approved therapies have existed to directly address it, until the approval of ANKTIVA in the treatment of BCG-unresponsive bladder cancer with the mechanism of action of an IL-15 superagonist proliferating key lymphocytes.

Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio, commented in a related press release, “This FDA authorization allows all patients with solid tumors suffering from immune collapse following first-line therapy of chemo, radiation, or immunotherapy to access ANKTIVA."

"The survival benefit we observed at ASCO 2025 in 3rd to 6th line advanced metastatic pancreatic cancer confirms that restoring lymphocyte levels—rather than depleting them—can change the course of disease.”

As of June 4, 2025, ANKTIVA is available at participating cancer centers in the United States and other countries, such as the Kingdom of Saudi Arabia.

The Republic of Ecuador has been exposed to a wide range of zoonotic pathogens that have a significant impact on the population's health and the overall economy.

Recent disease outbreaks, such as yellow fever, rabies, hantavirus, and highly pathogenic avian influenza A(H5N1), have disrupted the health system of this South American country.

For example, the number of yellow fever cases reported in South America so far in 2025 represents a threefold increase compared to the cases reported in 2024.

Since the beginning of 2025 and as of early May, four confirmed fatal cases of yellow fever have been reported in Ecuador, from the provinces of Morona Santiago (one fatal case) and Zamora Chinchipe (three fatal cases).

These conditions led Ecuador to establish priority surveillance, prevention, and control strategies for potential outbreaks of animal-borne diseases.

In response to these conditions, with technical support from the Pan American Health Organization/World Health Organization, specialists from the Ecuador Ministry of Public Health, and others announced on June 2, 2025, they are working to prioritize zoonotic and emerging diseases to obtain a list that would provide the country with clarity in the implementation of surveillance and control tasks for these pathologies. 

To alert international visitors, the U.S. CDC has included Ecuador in various disease outbreak alerts. 

The CDC recommends yellow fever vaccination for travelers aged 9 months or older traveling to areas below 7,550 feet in elevation, east of the Andes Mountains, in the provinces of Morona-Santiago, Napo, Orellana, Pastaza, Sucumbíos, Tungurahua, and Zamora-Chinchipe.

As of June 3, 2025, the YF-Vax vaccine is generally not recommended for travel to areas with an elevation below 7,550 ft.

The vaccine is required for most travelers arriving from Brazil, the Democratic Republic of the Congo, or Uganda, including those with 12-hour airport transits or layovers in any of these countries. But not those arriving from the U.S.

Located on South America's Pacific Ocean, Ecuador also includes the Galápagos Province, about 600 miles west of the mainland.

This travel vaccine, along with others, is commercially offered at clinics and pharmacies in the U.S.

Since April 2024, the Ministry of Health (MOH) of the Republic of Costa Rica has reported an outbreak of Bordetella pertussis (whooping cough) in the Tibas district of San Jose, which has a population of over 70,000 residents.

As of June 2, 2025, the MOH remains on alert for whooping cough cases in local schools, which are primarily transmitted through respiratory droplets from coughing or sneezing, and have an incubation period ranging from 4 to 21 days.

On May 20, 2025, a case of whooping cough was confirmed in a teacher at a school in Golfito and a resident of the Corredores canton. There are now 14 confirmed cases in home isolation, in good general health, and receiving treatment and monitoring from the inter-institutional team.

Following the initial diagnosis, 79 direct contacts were identified, including 72 students, six teachers, and one cleaning staff member. Of these, 31 people presented symptoms.

The MOH recommends that the local population comply with the national vaccination schedule: the Pentavalent vaccine at 2, 4, 6, and 15 months, the Tetravalent vaccine at 4 years old, and the vaccine for pregnant women, indicated from the 20th week of pregnancy.

About 18 years ago, Costa Rico declared a whooping cough emergency and launched a nationwide vaccination program.

While the U.S. CDC advises individuals planning to visit Costa Rica in June 2025 to stay up to date with routine vaccinations, the agency also highlights the presence of Chikungunya and measles in Costa Rica.

These travel vaccines are commercially offered at clinics and pharmacies in the U.S. and should be administered about one month before departure abroad. 

Since being discovered in Lyme, Connecticut, decades ago, Lyme disease has expanded west in the United States, causing significant health risks to people when outdoors.

For example, the Michigan Department of Health and Human Services (MDHHS) recently confirmed Lyme disease is now the most common tick-borne disease in Michigan, and anaplasmosis is increasing across the state.

Lyme disease cases in Michigan have increased by 168% over the last five years.

Michigan recorded 1,215 cases in 2024, as compared to 452 cases in 2020.

Anaplasmosis cases in Michigan have increased by almost fivefold over the last five years, with 82 cases reported in 2024 compared to 17 in 2020.

"Preventing tick bites is the best way to prevent tick-borne diseases, including Lyme disease and anaplasmosis," said Dr. Natasha Bagdasarian, MDHHS's chief medical executive, in a media release on May 21, 2025.

"If you find a tick attached to your body, promptly remove it. Monitor your health, and if you experience fever, rash, muscle or joint aches, or other symptoms, or if you suspect a tick has been attached for more than 24 hours, consult with your medical provider."

As of June 2, 2025, the U.S. Food and Drug Administration has not approved a vaccine for the prevention of Lyme disease. However, an innovative vaccine candidate (VLA15) is progressing in late-stage clinical research.

VLA15 is a multivalent recombinant protein vaccine targeting Borrelia's outer surface protein A (OspA). It is designed for prophylactic, active immunization against Lyme disease. The first data readout of the Phase 3 clinical trial is expected by the end of 2025.

With the summer of 2025 cruise ship season getting underway, many passengers are seeking access to a norovirus preventive vaccine.

As of May 14, 2025, the U.S. CDC's Vessel Sanitation Program had reported 17 gastrointestinal (GI) illnesses on cruise ships this year, with over ten classified as norovirus outbreaks, and others still under investigation.

This CDC data compares with 18 GI outbreaks in all of 2024 and just 14 in 2023.

While norovirus vaccine research has been previously unsuccessful, one oral vaccine has published positive news.

Vaxart, Inc. recently announced the publication of complete data from a Phase 2b challenge study of its first-generation oral pill norovirus vaccine candidate. 

This study measured safety, efficacy against infection and symptomatic disease, as well as viral shedding.

Additionally, a machine learning analysis identified statistically significant correlates of protection, which will be incorporated into the development of Vaxart’s second-generation norovirus vaccine candidate.

“Challenge studies provide unique opportunities to identify correlates of protection that can be used to predict vaccine efficacy and support vaccine development,” said James F. Cummings, MD, Chief Medical Officer at Vaxart, in a press release.

“The application of machine learning approaches to the complete data from the Phase 2b challenge study of our first-generation oral pill norovirus vaccine candidate identified two such correlates, functional serum blocking antibody and fecal IgA."

"Evaluation of these endpoints will help inform our understanding and provide an early read on the potential efficacy profile of our second-generation norovirus vaccine candidate as it advances through clinical development."

The single-center, double-blinded Phase 2b challenge study enrolled 165 healthy adults, who were randomized 1:1 to receive Vaxart’s monovalent oral pill vaccine candidate targeting the norovirus GI.1 genotype or placebo. Four weeks after vaccination, subjects were challenged with GI.1 norovirus. The primary objective of the study was to determine the efficacy of the vaccine against norovirus infection and norovirus gastroenteritis (NVG) following gastrointestinal (GI) infection.1 NV challenge.

Secondary objectives were to assess the safety and tolerability of the vaccine candidate. The ability of the vaccine candidate to modify disease severity, the quantity and duration of norovirus shedding, and a set of immunogenicity parameters was also quantified. The primary efficacy endpoints were the proportion of participants showing evidence of NVG, a composite endpoint defined as meeting one or more definitions for acute gastroenteritis and a positive norovirus infection, and the norovirus infection itself.

Key findings from the study include the vaccine was immunogenic and protected against norovirus infection, with a 30% relative reduction for the vaccine group compared with placebo (p=0.003); The vaccine group had a lower incidence of norovirus gastroenteritis (21% relative reduction), but was not statistically different (p=0.178); The vaccine significantly increased serum IgA, IgG, norovirus-blocking antibodies, and antibody-secreting cells (p<0.001 for all endpoints). The vaccine stimulated mucosal-homing B cells and significantly increased norovirus-specific antibodies in saliva, nasal lining fluid, and the intestine.

Steven Lo, Chief Executive Officer of Vaxart, added, “The initiation of the Phase 1 clinical trial comparing our first- and second-generation norovirus vaccine candidates is a key step toward this important goal."

"The Phase 2 challenge study published today for our first-generation norovirus candidate supports our oral pill norovirus vaccine approach, and the preclinical data we have generated to date support our view that our second-generation candidate has the potential to provide improved immunogenicity and protection.”

As of May 30, 3035, the CDC has not recommended any norovirus vaccine.

During 2025, various measles outbreaks have been reported in North America. As of the end of May, the data from Canada and the United States have diverged.

In Canada, during week #20 (May 11 to 17, 2025), 354 new measles cases were reported. 

Throughout 2025, a total of 2,515 measles cases have been reported by nine Canadian jurisdictions: Alberta, British Columbia, Manitoba, the Northwest Territories, Nova Scotia, Ontario, Prince Edward Island, Quebec, and Saskatchewan. 

With Ontario reporting 1,848 cases, the vast majority of Canada's measles outbreak.

In the U.S., the Centers for Disease Control and Prevention (CDC) reported a total of 1,046 confirmed measles cases as of May 22, 2025, across 31 jurisdictions.

Of all states, Texas has been the unfortunate leader in 2025.

The Texas Department of State Health Services has reported 729 cases in West Texas and 24 other cases since late January 2025. The good news is that Texas has only reported one new measles case since May 23.

Globally, Ontario and Texas are not the only areas with measles outbreaks in 2025.

To notify international travelers of this ongoing health risk, the CDC reissued a Travel Health Advisory on May 28, 2025, identifying more than 50 countries that have reported measles cases.

The CDC recommends that international travelers be fully vaccinated against measles with the measles-mumps-rubella (MMR) vaccine, according to the CDC's measles vaccination recommendations for international travel. 

However, the CDC says, 'travelers unable to safely receive a measles-containing vaccine should talk to their clinician and consider postponing their trip.'

In the U.S., travel vaccine experts are staffed within many clinics and pharmacies to offer local vaccination recommendations.

Since early 2025, SARS-CoV-2 virus activity has been increasing globally, with the positivity rate reaching 11% in some countries. However, unlike in past years, activity is now very regional.

According to the World Health Organization (DON572) on May 28, 2025, this respiratory disease increase is primarily observed in countries in the Eastern Mediterranean, South-East Asia, and Western Pacific regions.  

This DON says recent increases in SARS-CoV-2 activity are broadly consistent with levels observed during the same period last year. But virus surveillance has been limited in 2025

Countries in the African Region, European Region, and the Region of the Americas are currently reporting low levels of SARS-CoV-2 activity with percent positivity from sentinel or systematic virological surveillance sites ranging from 2% to 3%. 

WHO advises all Member States to continue applying a risk-based, integrated approach to managing COVID-19, including vaccinations. Currently approved COVID-19 vaccines continue to protect against severe disease and death.

The WHO and its Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC) continue to regularly assess the impact of variants on the performance of COVID-19 vaccines to inform decisions on updates to vaccine composition.

In the latest recommendation published in mid-May 2025, the WHO TAG-COVAC advised that monovalent JN.1 or KP.2 remain appropriate COVID-19 vaccine antigens; monovalent LP.8.1 is a suitable alternative vaccine antigen.

An estimated 39.2 million individuals, across 90 reporting Member States, had received a dose in 2024. Uptake was notably higher among older adults, with coverage reaching 5.1% in the European Region and 3.6% in the Region of the Americas, compared to less than 0.5% in other regions.

In the United States, the COVID-19 vaccination policy was updated in May 2025.