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Lyme Disease Outbreaks

Lyme Disease Outbreaks December 2025

Lyme disease (Lyme borreliosis) is a bacterial disease transmitted to humans through the bite of infected ticks. Lyme disease is common in Europe, the United Kingdom, and the United States, according to the World Health Organization (WHO). In 1977, the first 51 cases of Lyme arthritis were reported, and the Ixodes scapularis (black-legged) tick was linked to the discovery of the Lyme disease in Connecticut.

As of 2025, the U.S. Centers for Disease Control and Prevention (CDC) publishes the Tick Bite Data Tracker, which displays case data, and the CDC published a Lyme disease case map for the U.S. Seperately, the Pennsylvania Department of Health Tickborne Disease Dashboard shows Lyme disease cases peak in June through August. Wisconsin, Vermont, Rhode Island, New Jersey, New York, New Hampshire, Maine, Pennsylvania, and Connecticut were the leading states.

The Kay Hagan Tick Act (S.1657) requires the U.S. Department of Health and Human Services to develop a national strategy to address vector-borne diseases, including Tickborne diseases. The CDC reported on February 15, 2024, that Lyme disease cases, the most common vector-borne disease in the United States, increased by 69%, which is 1.7 times the annual average during 2017–2019 in the United States. In November 2024, a study determined that 50% of adult blacklegged ticks carry the bacteria that cause Lyme disease, while up to 25% of the younger (nymph) blacklegged ticks carry the bacteria.

Lyme Disease Outbreaks in the United Kingdom

In the UK, the Health Security Agency says Lyme disease-carrying ticks are most active in the spring and summer. Approximately 4% of ticks in England and Wales are infected with Lyme disease. Lyme Disease UK advises that if you find an embedded tick in your skin, remove it. The longer a tick is left to feed, the greater the chance that it will pass on any diseases it's carrying.

Lyme Disease Outbreaks in Europe

The World Health Organization Europe says the number of Lyme disease cases in Europe has increased steadily, with more than 360,000 cases reported over the last two decades. The highest-risk regions for future expanding tick colonization in Europe were France, Spain, Ukraine, Germany, Italy, Poland, Romania, and the UK.

A 2023 study found that, on average, 128,888 Lyme Disease cases are reported annually in Europe. The national Lyme disease incidence rates were highest in Estonia, Lithuania, Slovenia, and Switzerland (>100more than cases/100,000 Population per year), followed by France and Poland (40-80/100 cases per 000 Population per year), and Finland and Latvia (20-40/100 cases per 000 Population per year). At the subnational level, the highest LD incidence rates (more than 100/100,000 population per year) were observed in areas of Belgium, the Czech Republic, France, Germany, and Poland.

Lyme Disease Causes

Lyme disease is a Tickborne infection caused by a particular species of Borrelia spirochetes. Ticks transmit at least 20 different disease-causing bacteria, viruses, and parasites to people. The risk of contracting a Tickborne infection, including Lyme disease, is determined by the number of ticks in an area, the proportion of ticks that carry the bacteria, and human behavior, such as walking in areas infested with ticks. A study found that the overall risk of developing Lyme borreliosis after a tick bite was 2.2.6% (95% CI 1.4–5.1).

PrecisionVaccinations publishes Lyme disease vaccine news.

3 min read

Reviewer:

Robert Carlson, MD

Last Reviewed:

Wednesday, December 3, 2025 - 05:40

Description:

Lyme disease areas are located in the USA, Europe, and the United Kingdom.

Condition:

Lyme Disease

Anktiva BioShield Platform

Anktiva® (N-803) IL-15 Superagonist Vaccine BioShield Platform Availability, Clinical Trials, Dosage, Side Effects

ImmunityBio, Inc.'s BioShield platform, powered by Anktiva®, represents a paradigm shift in cancer care. Anktiva® (N-803) (nogapendekin alfa inbakicept-pmln) is a first-in-class interleukin-15 agonist IgG1 fusion complex consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. In March 2008, the National Cancer Institute selected IL-15 as a leading cytokine for cancer cure.

The fusion complex of Anktiva mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 through dendritic cells and driving the activation and proliferation of NK cells, resulting in the generation of memory killer T cells that retain immune memory against these tumor clones. The proliferation of the trifecta of these immune-killing cells and the activation of trained immune memory result in immunogenic cell death, inducing a state of equilibrium that leads to durable, complete responses. Anktiva has improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced anti-tumor activity compared to native, non-complexed IL-15 in vivo.

The Company's Cancer Moonshot program, QUILT clinical trials, was launched in January 2016. Anktiva is the backbone of ImmunityBio's Quantum Oncotherapeutics immunotherapy-based vaccine approach for treating multiple tumor types. Anktiva's triangle offense against cancer includes natural killer cells, T cells, and memory T cells. "We hypothesized that activation and proliferation of natural killer cells through IL-15 stimulation could rescue T cells after checkpoint failure, regardless of tumor type or location. As with non-muscle invasive bladder cancer, we believe that ANKTIVA enhanced the NK and T cell activity critical for targeting and killing cancer cells, which have entered the phase of tumor evasion and resistance," said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio, in a press release in April 2024. The Company is applying its science and platforms to treat cancers, including the development of potential cancer vaccines, immunotherapies, and cell therapies that significantly reduce or eliminate the need for standard high-dose chemotherapy.

On April 22, 2024, ImmunityBio announced that the U.S. Food and Drug Administration (FDA) had approved BLA 761336, Anktiva plus BCG, for treating patients with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. The U.S. FDA has approved Merck's TICE BCG and ImmunityBio's recombinant Bacillus Calmette-Guérin (BCG) vaccine for this therapy. The BCG vaccine is an approved combination therapy for treating adults with NMIBC carcinoma in situ, either alone or in combination with Ta/T1 papillary disease. On February 27, 2025, ImmunityBio announced that the FDA had granted Regenerative Medicine Advanced Therapy (RMAT) designation for Anktiva and CAR-NK (PD-L1 t-haNK) for the reversal of Lymphopenia in Patients Receiving Standard-of-Care Chemotherapy/Radiotherapy and in multiply relapsed, locally Advanced, or Metastatic Pancreatic Cancer.

On June 2, 2025, the FDA authorized expanded access to ANKTIVA to treat lymphopenia, a life-threatening immune deficiency induced by chemotherapy, radiotherapy, and immunotherapy, resulting in depletion of natural killer (NK) and CD4+ CD8+ T cells (lymphocytes). Expanded Access includes all patients with solid tumors who have failed first-line treatment on chemotherapy, radiotherapy, or immunotherapy and exhibit low Absolute Lymphocyte Counts (ALC <1,000/μL)

On July 4, 2025, the UK's Medicines and Healthcare products Regulatory Agency approved nogapendekin alfa inbakicept (Anktiva) for adults with BCG-unresponsive non-muscle-invasive bladder cancer, where the disease remains confined to the inner lining of the bladder and may include tumors. The approval was granted to Serum Life Science Europe GmbH. As of December 12, 2025, Anktiva has a Conditional Marketing Authorization by the European Union.

ImmunityBio is a vertically integrated biotechnology company based in Culver City, CA. It is developing next-generation therapies and vaccines that bolster the natural immune system to defeat cancers and infections. The Company's pipeline is based on broad immunotherapy and cell therapy platforms designed to attack cancer and infectious pathogens by orchestrating the innate and adaptive branches of the immune system. ImmunityBio's clinical pipeline comprises 27 clinical trials, 18 of which are in Phase 2 or 3 development. In December 2025, OncoDaily included Dr. Patrick Soon-Shiong among the 100 most influential people of the year.

Anktiva Plus BCG Therapy Bladder Cancer Indication

On December 16, 2025, ImmunityBio, Inc. announced treatment with ANKTIVA® plus BCG demonstrates efficacy at 12 and 36 months, including disease-free survival, disease-specific survival, long-term progression-free survival, and high cystectomy avoidance in patients with BCG-unresponsive high-grade papillary-only NMIBC. Published in The Journal of Urology's January 2026 print edition, the research findings also show tolerable safety consistent with BCG treatment alone, with 3% grade 3 and no grade 4 or 5 treatment-related adverse events.

On April 27, 2025, ImmunityBio presented updated clinical data highlighting the durability and impact of Anktiva in combination with BCG. The results demonstrated the most extended complete response duration and the highest cystectomy-avoidance rate among therapies studied in BCG-unresponsive NMIBC, including CIS with or without papillary disease and papillary-only disease without CIS. Sam S. Chang, M.D., Professor of Urology and Chief Surgical Officer of the Vanderbilt Ingram Cancer Center stated, "Our latest findings, including an 82% cystectomy avoidance rate, provide additional evidence that Anktiva can restore BCG activity and promote durable complete responses and, most importantly, help patients preserve their bladder for a prolonged duration from surgery in both CIS, as well as papillary without CIS disease."

On July 2, 2024, Taylor and Francis Online published a Plain Language Review. It reported that N-803 plus BCG eliminated NMIBC in all nine BCG-naïve participants in NCT02138734 (Phase 1/2 study) and NCT03022825 (Phase 2/3 study), and the effects were long-lasting. Participants remained NMIBC-free for 8.3 to 9.2 years. On November 19, 2024, ImmunityBio announced that 100 patients with BCG-unresponsive NMIBC and CIS have been treated with ANKTIVA in combination with BCG, achieving a 71% complete response (CR) rate. In these responders, the range of durable responses extended to Companynths.

The Company stated that while BCG vaccination is an effective treatment for many patients, it doesn't work for an estimated 40% of NMIBC cases. Patients with intermediate or high-risk NMIBC typically receive a treatment of transurethral resection of the bladder tumor (TURBT) followed by BCG intravesical instillation. However, cancer will recur in 30% to 40% of patients with NMIBC despite adequate treatment with BCG. Moreover, even among those in whom a complete response is achieved with BCG, up to 50% see their cancer return. The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by influencing the development, maintenance, and function of critical immune cells—namely, natural killer (NK) cells and CD8+ killer T cells—that target and kill cancer cells.

Bladder cancer was the 9th most commonly diagnosed cancer in 2022. In the U.S., the American Cancer Society estimates there will be 83,190 new cases and 16,840 deaths from bladder cancer in 2024.

Anktiva Plus BCG Vaccine Mechanism of Action

Anktiva's mechanism of action involves the direct, specific stimulation of CD8+ T cells and Natural Killer (NK) cells through beta-gamma T-cell receptor binding, thereby generating memory T cells while avoiding stimulation of T-regulatory cells (Tregs). 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 IL-15 superagonist N-803 acts synergistically with Bacille CaCalmette-Guérin (BCG). As a result, n-803 has improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced anti-tumor activity compared to native, non-complexed IL-15 in vivo.

The superagonist N-803 has been studied in over 700 patients across multiple Phase 1 and 2 clinical trials for liquid and solid tumors. In addition to the NMIBC study, it is currently being investigated in trials for pancreatic cancer, non-small cell lung cancer (NSCLC), non-Hodgkin lymphoma, and HIV. On November 10, 2022, the journal NEJM Evidence published its conclusion from a phase 2/3 study: In patients with BCG-unresponsive bladder carcinoma in situ and papillary NMIBC treated with BCG and the novel agent NAI, CRs were achieved with the persistence of effect, cystectomy avoidance, and 100% bladder cancer–specific survival at 24 months. Given the observed strong efficacy and favorable adverse event (AE) profile, as well as the mode of administration, N-803 represents a significant advance in treatment options compared to existing therapies for BCG-unresponsive CIS and Papillary NMIBC, as these researchers wrote in 2022. On December 27, 2022, an editorial from urological cancer experts from Memorial Sloan Kettering Cancer Center stated: "The efficacy and minimal toxicity of this combination represents a major advance for the care of patients with BCG-unresponsive NMIBC, and the authors should be congratulated. In addition, this promising combination offers a potential alternative to cystectomy and may allow us to move beyond single-arm studies toward randomized phase 3 trials against other novel therapies."

In February 2024, the Company announced that the journal Urology Practice had published findings from the Patient-Reported Outcomes (PROs) of participants in the phase 2/3 QUILT 3.032 study. These PROs support the positive interim results from the study published in NEJM Evidence, in which 71% of patients in cohort A with CIS, with or without Ta/T1 disease, achieved a complete response. The finding of relative stability in global health and physical function during the study is similar to that reported by others for BCG monotherapy. This suggests that the novel combination is as tolerable as treatment with BCG alone.

Anktiva Plus BCG Vaccine Dosage

For dosage induction, 400 mcg of Anktiva is administered intravesically with BCG vaccine once weekly for 6 weeks. A second induction course may be administered if the complete response is not achieved at month 3. For maintenance, 400 mcg of Antiva is administered intravesically with BCG once a week for three weeks at months 4, 7, 10, 13, and 19. Additional maintenance instillations with BCG may be required for patients with an ongoing complete response at month 25 and later.

U.S. FDA Review Anktiva Plus BCG Vaccine

The U.S. FDA approved Anktiva on April 22, 2024. On October 23, 2023, ImmunityBio announced that it had resubmitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Anktiva. Recent study results support the BLA, including the pivotal Phase II/III, open-label, single-arm, multicenter QUILT-3.032 clinical study published in NEJM Evidence in November 2022. Anktiva has received both FDA Breakthrough Therapy and Fast Track designations for treating BCG-unresponsive NMIBC CIS and a Fast Track designation for BCG-unresponsive NMIBC papillary and BCG-naïve NMIBC CIS.

Anktiva Plus BCG Papillary Disease Indication

In Company 2025, the Company submitted a supplemental Biologics License Application (sBLA) for the use of Anktiva® plus Bacillus Calmette-Guérin (BCG) in BCG-unresponsive NMIBC for the indication of papillary disease. The data submitted to the FDA included efficacy results demonstrating durable complete remissions in patients with BCG-unresponsive NMIBC papillary disease. In 88% and 82% of subjects, the probability of avoiding surgical removal of the bladder was achieved for 2 and 3 years following Anktiva plus BCG, respectively. The mortality and morbidity associated with a radical total cystectomy are high, and this long-term bladder-sparing therapy has the potential to provide a significant benefit and quality of life to patients suffering from BCG-unresponsive papillary disease. In a pivotal study published in NEJM Evidence, BCG plus Anktiva resulted in disease-free survival (DFS) rates of 55%, 51%, and 48% at 12, 18, and 24 months, respectively, in participants with papillary non-muscle-invasive bladder cancer (NMIBC). In addition, patients receiving the novel treatment achieved a 93% avoidance of cystectomy (surgical removal of the bladder) with a median follow-up of 20.7 months.

Anktiva Long COVID Indication

ImmunityBio announced on August 19, 2025, the opening of a new Phase 2 clinical study to assess the BioShield™ platform in 40 individuals in California, anchored by ANKTIVA®, in patients with long COVID. This condition comprises a broad range of symptoms. The new study, COVID-4.019-Long, aims to evaluate the safety of ANKTIVA when administered subcutaneously in participants with long COVID. The secondary objective is to assess the effect of ANKTIVA on absolute lymphocyte count. Exploratory objectives include evaluation of ANKTIVA's ability to improve post-COVID natural killer cell and CD8+ T cell counts, and assessment of the immunological function of NK cells and CD8+ T cells. The safety and tolerability of ANKTIVA for long COVID is also being assessed in a separate Phase 2 study conducted at the University of California, San Francisco. ImmunityBio supports both studies.

Anktiva Plus BCG Vaccine Availability

As of August 20, 2025, Anktiva plus BCG Vaccine is approved in the UK and the United States and is available at various clinical sites and cancer centers in the U.S. On August 11, 2025, the Company announced that the Michael E. DeBakey Department of Veterans Affairs (VA) Medical Center had recently become the first VA hospital in the Houston, Texas, region and one of the first in the U.S. to provide treatment with ANKTIVA® to a veteran with bladder cancer. On May 27, 2025, ImmunityBio announced that a multi-party collaboration will introduce the Cancer BioShield platform to Saudi Arabia and the broader Middle East.

In September 2024, ImmunityBio announced that more than 100 million medical lives are covered by medical reimbursement policies that include ANKTIVA reimbursement eligibility. In May 2024, it was added to the National Comprehensive Cancer Network guidelines. On June 20, 2024, ImmunityBio, Inc. announced the initial treatment of multiple patients in the U.S. with ANKTIVA. According to an X post by @DrPatSoonShiong, the initial 1,000 doses of ANKTIVA were shipped on Company2024. The Company previously announced that the ANKTIVA Drug Substance had been completed and released, accompanied by two-year storage stability data sufficient for 170,000 doses.

Anktiva Availability Europe

ImmunityBio confirmed on January 27, 2025, that the filing process for regulatory approval of Anktiva for the Treatment of Patients with BCG-unresponsive non-muscle-invasive bladder cancer (carcinoma in situ) in the European Union (EU) has commenced. The filing will include 30 countries, including 27 in the EU and three in the European Economic Area.

Anktiva Access to BCG Vaccines

In the second quarter of 2025, the Serum Institute of India will become an alternative source of BCG vaccines, including TUBERVAC. On May 2, 2024, ImmunityBio, Inc. announced an exclusive arrangement with the Serum Institute of India (SII) to supply the Company with BCG vaccines. The agreement encompasses the manufacturing of standard BCG (sBCG), which is currently approved for use outside the United States, as well as a next-generation recombinant BCG (iBCG) that is undergoing clinical trials. BCG has been modified with two genetic modifications to enhance immunogenicity and safety, resulting in iBCG. It is intended for use with Anktiva for currently approved and potential future indications, pending regulatory approval. The companies plan to accelerate the ongoing Phase 2 clinical trials of iBCG in Europe, which have demonstrated safety advantages over sBCG and enhanced immunogenicity in driving both CD8+ and CD4 T cells. ImmunityBio plans to submit this protocol to the U.S. Food and Drug Administration (FDA) and global regulatory bodies in mid-2024.

ANKTIVA® and CAR-NK Regenerative Medicine Advanced Therapy Designation

The U.S. FDA's Regenerative Medicine Advanced Therapy designation in February 2025 follows clinical data showing correlations between Absolute Lymphocyte Count (ALC) and significant overall survival in QUILT trials across multiple tumor types, including third-line or more advanced metastatic pancreatic cancer, checkpoint-relapsed non-small cell lung cancer (NSCLC), and supportive data from healthy volunteers. The reversal of lymphopenia by ImmunityBio's IL-15 superagonist is consistent with the mechanism of action of ANKTIVA, which demonstrates the proliferation and activation of NK cells, CD4+ T cells, CD8+ T cells, and memory T cells, without upregulation of suppressive T regulatory cells, as approved in the ANCompanyabel. The Company intends to submit an FDA BLA for the indication of reversing lymphopenia in patients receiving standard-of-care chemotherapy and/or radiation, as well as for the treatment of locally advanced or metastatic pancreatic cancer, which includes the first-in-class CAR-NK (PD-L1 t-haNK).

On August 13, 2025, ImmunityBio announced early findings from its QUILT-106 Phase I trial, showing highly promising complete responses in the first two patients treated to date with late-stage Waldenstrom macroglobulinemia, using its CD19 CAR-NK natural killer cell therapy.

Anktiva Plus Checkpoint Inhibitor Therapy Non-Small Cell Lung Cancer Indication

Non-small cell lung cancer (NSCLC) accounts for about 80% to 85% of all lung cancer diagnoses (230,000). The development of checkpoint inhibitors in NSCLC has been revolutionary, doubling the median overall survival in some settings; however, patient responses may be short-lived, with late responses and/or progression after achieving an initial response.

On September 9, 2024, the phase 2b study of ANKTIVA in combination with the checkpoint inhibitors KEYTRUDA or OPDIVO in multiple tumor types, including NSCLC who failed CPI, showed long-term overall survival of 57% (49/86) and 34% (29/86) at 12 and 18 months, respectively, exceeding the current standard of care. Based on the results of the QUILT 3.055 study and other trials involving ANKTIVA with checkpoint inhibitors, ImmunityBio is opening Phase 3 trials of ANKTIVA plus KEYTRUDA or OPDIVO in 1st and 2nd-line NSCLC.

On April 25, 2024, ImmunityBio announced positive overall survival results in the QUILT 3.055 study of 2nd- and 3rd-line Non-small cell lung cancer (NSCLC) patients who progressed after checkpoint inhibitor therapy (pembrolizumab, nivolumab, or atezolizumab) and standard-of-care chemotherapy. The study's results reinforce ImmunityBio's belief in the unique mechanism of action of ANKTIVA (N-803, or nogapendekin alfa inbakicept-pmln) and its potential efficacy as a next-generation immunotherapy across multiple solid and liquid tumor types.

Anktiva Endometrial Cancer Indication

ImmunityBio, Inc. announced on August 6, 2024, the opening of the QUILT 502 clinical trial to study ANKTIVA® together with the investigational AdHER2DC vaccine (autologous dendritic cells transduced with HER2-expressing adenovirus) in individuals with HER2-expressing endometrial cancer. This trial will evaluate ANKTIVA as a replacement for the short-term activity of checkpoint inhibitor immunotherapies, with long-term effectiveness. The Phase1/2 interventional study will enroll 60 participants with HER2-positive endometrial cancer, who will also receive pembrolizumab and lenvatinib, two FDA-approved drugs for endometrial cancer. The study is expected to be completed in 2026.

Ankylosing Spondylitis Indication

ImmunityBio partnered with the NCI in February 2024 to study the use of ANKTIVA in cases of Lynch syndrome. This genetic condition is linked with a significantly increased incidence of cancers, particularly colon cancer.

Cancer BioShield™ Platform Lymphopenia Indication

On June 2, 2025, ImmunityBio announced that the U.S. FDA had 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.

BCG Naïve Trial Global Expansion

ImmunityBio continues to add U.S. sites to the BCG-naïve trial (QUILT-2.005) and to enroll patients in the study; the Company has received regulatory approval to begin patient enrollment in QUILT-2.005 in India. The Company plans to submit an application to the South African regulatory authorities in Q3 2024 to initiate the QUILT-2.005 trial in that country.

Anktiva Plus BCG Therapy Side Effects

Anktiva's most common adverse reactions (occurring in≥15% of patients) include laboratory test abnormalities, such as increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills, and pyrexia. Pregnancy: May cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.

Tri-Ad5 Vaccine Combination With N-803

On April 25, 2023, ImmunityBio, Inc. announced the opening of a phase 2b clinical trial to study its investigational Tri-Ad5 vaccine combination (Adenovirus 5 CEA/MUC1/brachyury) together with its IL-15 superagonist N-803 for people with a hereditary condition known as Lynch syndrome to prevent colorectal and other cancers in study participants.

Bladder Cancer Patient Treatment Costs

The annual projected cost of bladder cancer treatment is over $2 billion. The cost profile varies substantially across the different stages of the disease. The average price per patient ranged from $19,521 (stage 0a) to $169,533 (metastatic disease).

Anktiva plus BCG Vaccine Price

In 2024, Anktiva will be priced at $35,800 per dose. On January 1, 2025, the Healthcare Common Procedure Coding System J-code assigned by the Centers for Medicare & Medicaid Services for ANKTIVA® became effective. Healthcare providers may now use the permanent J-code, J9028 (Injection, nogapendekin alfa inbakicept-pmln, for intravesical use, one microgram) when submitting claims for ANKTIVA.

Anktiva Plus BCG Vaccine Payment Options

The ImmunityBio CARE™ program is designed to help patients access ImmunityBio's innovative treatment. Since its launch in May 2024, ANKTIVA has become accessible to patients through commercial and government insurance programs, including the VA, DoD, and Medicare. In April 2025, the Company also announced that it had submitted an EAP to the FDA to make ANKTIVA available for the treatment of lymphopenia. Lymphopenia is characterized by the loss of natural killer cells and T cells, which are essential for fighting cancer.

ImmunityBio Investments

In January 2024, the Company announced an aggregate capital raise of $850 million in 2023, comprising $320 million from institutional investors and $530 million from the Founder, Dr. Patrick Soon-Shiong. In April 2024, the Company confirmed a $100 million non-dilutive cash infusion following Anktiva's FDA approval, bringing its cash on hand to approximately $240 million for the launch of Anktiva in NMIBC. On ApCompany2025, the Company announced a securities purchase agreement with an investor.

ImmunityBio Revenues

In the second quarter of 2025, ImmunityBio reported $26.4 million in revenue, representing a 60% increase from $16.5 million in the first quarter of 2025. This growth reflects continued commercial traction of ANKTIVA + BCG in BCG-unresponsive non-muscle invasive bladder cancer with CIS with or without Papillary tumors. ImmunityBio announced on April 15 that the Company earned net product revenue of approximately $16.5 million during the three months ended March 31, 2025, representing a 129% increase over the $7.2 million in net revenue earned during the fourth quarter of 2024.

Anktiva News

August 11, 2025 - Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio, commented in a press release, "Drs. Jones' and Taylor's leadership and commitment to innovation are exactly what's needed to expand access to transformative treatments like ANKTIVA across the VA system. This milestone at DeBakey underscores the real-world impact of our mission."

July 25, 2025 - The 1H 2025 sales of $42.9 million represent a 246% increase in unit volume during the first two quarters of 2025 since the J-code approval versus the last two quarters of 2024.

May 27, 2025 - His Excellency Khalid A. AlFalih, Minister of Investment, Saudi Arabia, commented: "This partnership reflects the Kingdom's commitment to positioning itself as a global hub in the biotechnology sector in advanced therapeutics. Through this collaboration, we will localize cutting-edge technologies, build biomanufacturing capabilities, and enhance our national biotechnology infrastructure and human capabilities in alignment with the objectives of the National Biotech Strategy."

April 8, 2025 - The Company entered into a securities purchase agreement for a potential investment of up to $90 million.

February 27, 2025 - "The Founder applied for RMAT designation for ANKTIVA combined with NK cells in the initial 2017 IND. With the clinical results of the QUILT trials across multiple tumor types from 2017 to 2024, validating the hypothesis that high-dose chemotherapy and radiation induce lymphopenia and can be reversed by ANKTIVA together with off-the-shelf CAR-NK cells, resulting in prolongation of overall survival, and enabling ImmunityBio to reapply for RMAT in 2025," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific & Medical Officer of ImmunityBio, in a press release.

February 6, 2025 - Patrick Soon-Shiong, MD, shares key updates in the development of Anktiva.

November 12, 2024 - "The response from the urologists and clinical practices about the utility of ANKTIVA in NMIBC CIS has been gratifying. ImmunityBio's clinical trial in BCG naïve NMIBC is enrolling well, and clinical sites have been expanded from the U.S. to multiple global locations. In the urology space, initial clinical trials of ANKTIVA are being designed for high-risk prostate cancer," said Dr. Patrick Soon-Shiong, Executive Chairman and Global Chief Scientific & Medical Officer of ImmunityBio.

September 9, 2024 - Patrick Soon-Shiong, M.D., Executive Chairman, Founder, and Global Chief Scientific and Medical Officer at ImmunityBio, commented, "Based on this study, the ResQ studies have been activated as randomized Phase 3 trials in both 1st- and 2nd-line NSCLC by combining ANKTIVA with pembrolizumab or nivolumab versus standard of care. The current results presented at the World Congress on Lung Cancer confirm that by activating the body's natural immune system and proliferating natural killer cells, killer T cells, and memory T cells, this IL-15 superagonist boosts, or rescues, the checkpoint inhibitor, likely by reactivating MHC1 expression on the tumor. We are excited about the potential of converting an MHC-ve cold tumor to an MHC+ve hot tumor and evolving the field of immunotherapy beyond T cells."

September 8, 2024 - John Wrangle, M.D., MPH, Associate Professor, Medical University of South Carolina, presented an oral presentation of the data at the World Congress on Lung Cancer in San Diego in the session titled "Novel Immunotherapy Strategies and Combinations."

August 12, 2024 - "We are encouraged by the keen interest that physicians are showing in ANKTIVA as a treatment option for their patients with non-muscle invasive bladder cancer with carcinoma in situ (CIS), as well as by our conversations with payers as we see them adding our approved product into their policies," said Richard Adcock, President and CEO of ImmunityBio.

June 20, 2024 - Richard Adcock, President and CEO of ImmunityBio, stated, "We look forward to ANKTIVA reaching an increasing number of eligible NMIBC patients and for our science to deliver even more therapies from our pipeline."

May 2, 2024 - "We are pleased to partner with the Serum Institute of India so that the power of its large-scale, world-class GMP manufacturing capacity can be used to address the issue of BCG shortage, which affects thousands of bladder cancer patients annually," said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio.

April 25, 2024 - The Company announced positive overall survival results of ANKTIVA combined with checkpoint inhibitors in NSCLC from the completed QUILT 3.055 trial.

April 22, 2024 - "The FDA's approval of ANKTIVA marks our launch of a next-generation immunotherapy beyond checkpoint inhibitors," said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio.

February 5, 2024 - "Many current therapies for bladder cancer slow disease progression but can cause debilitating side effects," commented Principal Investigator Karim Chamie, M.D., Associate Professor of Urology at UCLA, in a press release. "The QUILT 3.032 Quality of Life study data suggest that many patients not only have a durable response but also report no decline in physical function, which is very important for these patients."

January 2, 2024 - "This transaction raises significant capital for the Company to support important growth plans, yet with limited equity dilution and with a cap on total payments tied to the initial investment," said Richard Adcock, Chief Executive Officer and President of ImmunityBio.

October 26, 2023 - "We are pleased that the FDA has accepted ImmunityBio's resubmission of the BLA as a complete response, following our productive interactions leading up to the resubmission," said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio.

February 16, 2023—ImmunityBio, Inc. announced that it had executed financing expected to result in gross proceeds at closing of approximately $50 million before deducting any offering-related expenses, subject to customary closing conditions. The warrants could result in additional gross proceeds of up to $60 million if fully exercised.

November 10, 2022 - NEJM Evidence has published results from the QUILT 3.032 phase 2/3 clinical trial studying N-803 plus BCG in adults with NMIBC CIS with or without Ta/T1 papillary disease.

July 28, 2022 - The U.S. FDA accepted a BLA from ImmunityBio, Inc. for review.

February 2022 - Data presented at the ASCO Genitourinary Cancers Symposium showed a complete response in 59 of 83 patients, with a 1% complete response rate (95% CI: 0.6, 1.8) and a median duration of complete response of 24.1 months. In patients who responded to the investigational therapy, the probability of avoiding bladder cancer and cystectomy progression at 24 months exceeded 90%. In addition, the combination of Anktiva and BCG had a well-tolerated profile, with 0% treatment-related severe adverse events (SAEs), 0% immune-related adverse events (irAEs), and 100% bladder cancer-specific overall survival at 24 months.

January 2019 - ScienceDirect published a Brief Correspondence: Prognostic Implications of the U.S. FDA-defined BCG-unresponsive Disease.

N-803 plus BCG Vaccine Clinical Trials

As of August 12, 2024, ImmunityBio continues to add U.S. sites to the BCG-naïve trial (QUILT-2.005) and to enroll patients in the study. The Company has received regulatory approval to begin patient enrollment in QUILT-2.005 in India, and the necessary medicines have been successfully imported into the country for use in the trial. A Companyally, the Company plans to submit an application to the South African regulatory authorities in Q3 2024 to initiate the QUILT-2.005 trial in that country.

N-803 is currently being evaluated in adult patients in two clinical trials for non-muscle-invasive bladder cancer (NMIBC). QUILT-2.005 is investigating the use of N-803 in combination with BCG for patients with BCG-naïve non-muscle-invasive bladder cancer (NMIBC); QUILT-3.032 is studying N-803 in combination with BCG in patients with BCG-unresponsive NMIBC, CIS, and Papillary Disease. QUILT 3.032 Registrational Trial of IL-15 Superagonist N-803 Plus BCG in Patients with Bladder Cancer - results presentation.

In February 2024 - The ongoing phase 2/3 open-label multicenter registrational study QUILT 3.032 (NCT03022825) is evaluating the safety and efficacy of the investigational interleukin-15 superagonist N-803 (also known as Anktiva® and nogapendekin alfa in Aricept, NAI) in combination with standard therapy for NMIBC, bacillus CaCalmette-GuérinBCG), in patients who failed or in whom cancer returned after BCG monotherapy, and thus were diagnosed as BCG-unresponsive. Durability, cystectomy avoidance, progression-free survival, disease-specific survival (DSS), and overall survival are secondary endpoints for cohort A. Cohort C was discontinued per the study design due to a low response rate with N-803 monotherapy.

In 2022, an open-label, multicenter Phase 3 study (QUILT 3.032) of intravesical BCG plus N-803 in patients with BCG-unresponsive high-grade non-muscle-invasive bladder cancer (NMIBC), including those with carcinoma in situ (CIS) and Papillary disease, was reported (NCT03022825). Results: Cohort A (CIS) Efficacy: Fully enrolled n = 81 with a 20.9-month median follow-up. CR rate 72% (95% CI: 60.5%, 81.1%) with a median duration for 3-month responders of 24.1 months and a 60% probability of maintaining this CR for ≥ 18 months (95% CI: 43.1%, 73.5%). The 12-month cystectomy-free rate is 89% (95% CI: 80.1%, 94.6%), with a 100% cancer-specific survival rate at 24 months. Cohort B (Papillary) Efficacy: To date, 73 patients have enrolled with a median follow-up of 17.3 months. The primary endpoint was met, with a disease-free rate of 57% (95% CI: 43.7%, 68.5%) at 12 months and 53% (95% CI: 38.8%, 64.8%) at 18 months. The 12-month cystectomy-free rate is 95% (95% CI: 84.7%, 98.3%), with a 98% cancer-specific survival rate at 24 months. Combined Efficacy: In the combined group (n = 154) of BCG-unresponsive NMIBC, with a 19.3 months median follow-up, the 12-month cystectomy-free rate was 92% (95% CI: 85.5%, 95.3%), and the 24 months OS is 94% (95% CI: 86.9%, 97.1%) with 99.5% cancer-specific overall survival. Combined Safety: There were 0% treatment-related SAEs and 0% immune-related SAEs, with 4/ 154 (3%) ≥ TR Grade 3 AEs. 0% treatment-related deaths have occurred as of the Sept 2021 analysis date.

0 min read

Manufacturer:

ImmunityBio

Reviewer:

Robert Carlson, MD

Vaccine:

Anktiva BioShield Platform

VIS:

PDF

Availability:

US FDA May 2024, UK July 2025

Generic:

N-803 plus BCG Vaccine

Clinical Trial:

https://immunitybio.com/bladder-cancer/

Drug Class:

Vaccine

Clinical Trial Phase I:

BCG in Combination With ALT-803

Clinical Trial Phase II:

Phase 2 multi-cohort study of N803 (IL-15 superagonist) in combination with checkpoint inhibitors

Clinical Trial Phase III:

QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in

Condition:

Bladder Cancer

Availability Link:

FDA Approved BLA 761336

Last Reviewed:

Monday, December 22, 2025 - 08:10

Brand:

Anktiva

Abbreviation:

nogapendekin alfa inbakicept

CPT Code:

J9028

Status:

Approved

Manufacturer Country ID:

FDA First In Class:

Yes

Side Effects:

Ingredients:

Countries:

Location tags:

United States of America

Saudi Arabia

England

Europe

0 min read

The U.S. Department of State reissued its Level 4: Do Not Travel advisory for the Republic of Iraq. As of January 3, 2023, this travel alert indicates significant civil unrest and Mission Iraq’s limited capacity to support U.S. citizens.

Furthermore, U.S. citizens in Iraq face high risks to their safety and security.

Due to risks to civil aviation operating in the Baghdad Flight Information Region, the U.S. Federal Aviation Administration (FAA) has extended its Special Federal Aviation Regulation for an additional two years, prohibiting certain flights at altitudes below 32,000 feet.

Because of security concerns, U.S. government personnel in Baghdad are instructed not to use Baghdad International Airport.

U.S. citizens should consult the FAA Prohibitions, Restrictions, and Notices website for more information.

For local assistance, the U.S. Embassy in Baghdad is located at Al-Kindi Street, International Zone, Baghdad, Iraq.

From a health perspective, the U.S. CDC publishes travel vaccine recommendations at this link.

Image:

Image Caption:

U.S. Dept of State

Live Blog Update Author:

Don Hackett

Location Tags:

Baghdad

0 min read

In response to a significant measles outbreak at the end of 2022, the state government of Maharashtra confirmed it would continue vaccinating children with a measles vaccine.

On January 3, 2023, the IndianExpress reported as many as 4.74 lakh young children were identified to receive an additional dose of vaccine against measles.

The first phase of the immunization program was completed in late December, and the second phase is scheduled to begin on January 15, 2023.

Maharashtra is a highly populated state located on the Deccan plateau in the western peninsular part of the subcontinent.

Maharashtra has seven domestic airports located in Mumbai, Pune, Nagpur, Aurangabad, Kolhapur, Juhu, and Nanded.

And it has four international airports, with Mumbai International Airport being one of the busiest airports in India.

According to the U.S. Centers for Disease Control and Prevention, the country of India reported the most measles patients in 2022.

Other measles outbreak news 2023 is posted at Vax-Before-Travel.com/Measles.

Vaccine Treats:

Measles

Image:

Image Caption:

Google Maps

Live Blog Update Author:

Staff Review

Location Tags:

Mumbai

Vaccine:

Priorix MMR Vaccine

0 min read

Evaxion Biotech A/S today announced that the U.S. Food and Drug Administration ("FDA") determined that the Company may proceed with its Phase 2b clinical trial of EVX-01.

The study (EVX-01 plus Pembrolizumab 25 MG/ML) was first initiated in Australia in September 2022.

EVX-01 is a peptide-based cancer therapy intended for the first-line treatment of various metastatic and unresectable melanoma.

In November 2022, the Company submitted an Investigational New Drug Application ("IND") along with a Fast Track designation application to the FDA for a

On December 22, 2022, the FDA issued approval for the Company to proceed with its Phase 2b clinical trial of EVX-01 in combination with KEYTRUDA® for treating patients with metastatic melanoma.

"Receiving a green light from the FDA is a tremendous boost for our personalized cancer vaccine program. EVX-01 is already actively enrolling patients in Australia, and the FDA approval expands our ability to move forward quickly with our lead program in malignant melanoma," commented Erik Heegaard, Chief Medical Officer at Evaxion, in a press release on January 3, 2022.

"Moreover, the FDA is a universally recognized national authority, and its endorsement is an important step towards demonstrating a clinically meaningful benefit of our first personalized cancer vaccine,"

The Phase 2b study will be conducted at clinical sites across the U.S., Europe, and Australia. It is carried out in collaboration with Merck, supplying its PD-1 inhibitor KEYTRUDA®.

The U.S. NIH says melanoma is the third most common cutaneous malignancy after basal cell carcinoma and squamous cell carcinoma.

The treatment modalities currently used for metastatic melanoma include surgery, immunotherapy, targeted therapy, and chemotherapy.

The treatment paradigm of metastatic melanoma has changed dramatically within the last few years with the advent of immune checkpoint inhibitors and targeted therapy, says the NIH.

Evaxion Biotech A/S is a clinical-stage biotech company developing AI-powered immunotherapies.

Vaccine Treats:

Skin Cancer

Image:

Image Caption:

by Gerd Altmann

Live Blog Update Author:

Staff Review

Location Tags:

Copenhagen

0 min read

The U.S. Centers for Disease Control and Prevention (CDC) recently announced that beginning early January 5, 2023, there are new requirements for air passengers two years of age and older traveling to the U.S. from China, Hong Kong, or Macau.

And these requirements apply to those traveling from Seoul, Toronto, and Vancouver who have been in China, Hong Kong, or Macau to the U.S. in the past ten days.

The CDC's Alert - Level 2, Practice Enhanced Precautions, issued on December 28, 2022, says to reconsider travel to China, Hong Kong, and Macau due to the rapid increase in COVID-19 cases and limited healthcare resources.

These changes are created to China ending its Zero-COVID policy in late December 2022.

In addition to COVID-19 vaccinations, the CDC suggests various travel vaccines before revisiting China.

Previously, the U.S. Department of State revised its Level 3: Reconsider Travel on December 22, 2022.

This travel advisory says mainland Peoples Republic of China visitors should prepare to be tested for COVID-19 and to quarantine at a government-designated location upon arrival.

U.S. citizens in China can visit a local embassy for assistance, such as the U.S. Embassy in Beijing, located ta No. 55 An Jia Lou Road, Chaoyang District, Beijing 100600, China.

Vaccine Treats:

COVID-19

Image:

Image Caption:

U.S. Dept. of State

Live Blog Update Author:

Don Hackett

Location Tags:

Macau

Vaccine:

CoronaVac COVID-19 Vaccine (Sinovac)

Polio Outbreaks

Poliovirus Outbreaks September 2025

The World Health Organization (WHO) confirmed during the 42nd meeting of the IHR Emergency Committee for Polio in June 2025 that the spread of the poliovirus remained a Public Health Emergency of International Concern (PHEIC) and updated its polio outbreak map. As of September 2025, the Global Polio Eradication Initiative (GPEI) confirmed that various countries had reported cases of wild poliovirus type 1 (WPV1), circulating vaccine-derived poliovirus type 2 (cVDPV2), vaccine-derived poliovirus type 2 (VDPV2), and circulating vaccine-derived poliovirus type 1 (cVDPV1).

The U.S. Centers for Disease Control and Prevention (CDC) reissued a Global Polio Alert—Level 2, Practice Enhanced Precautions Travel Health Notice on August 4, 2025, regarding polio outbreaks and poliovirus detections in 41 countries. The CDC published an MMWR on March 6, 2025, confirming that the Nigeria virus lineage had been detected in wastewater samples in 16 cities across five European countries. On October 17, 2024, the CDC announced (MMWR Vol. 73 , No. 41) that from January 2023 to June 2024, 74 cVDPV outbreaks were detected in 39 countries, with 672 confirmed cases of acute flaccid paralysis (AFP) identified in 27 countries. Less than 1% of wild poliovirus infections result in Acute Flaccid Paralysis (AFP). In 2024, the GPEI reported 243 cases of AFP worldwide.

Polio Cases in the Americas

The WHO / Pan American Health Organization (PAHO) issued an Epidemiological Update (Year 39, 51-52) - Poliomyelitis in the Americas Region and reported AFP Surveillance in 2024. The PAHO/WHO reminds Member States that the risk of the emergence of a cVDPV1 or circulating vaccine-derived poliovirus type 3 (cVDPV3) has increased due to low vaccination coverage. In addition, the PAHO/WHO reports a continuing risk of importing a WPV1 or VDPV, mainly cVDPV2. cVDPV2 cases peaked in 2020, with over 1,000 cases of paralysis in 24 countries. As of January 2025, the PAHO reported 1,856 AFP cases in 2024.

Polio in the United States

The United States was added to a list identified with polio in 2022. The CDC reported (Volume 30, Number 11—November 2024) that wastewater surveillance for poliovirus identified ongoing transmission of poliovirus in Rockland County and adjacent New York counties in 2022. In June 2022, a case of paralytic polio caused by VDPV2 was identified in an unvaccinated adult in Rockland County, New York. In addition, poliovirus type 2, genetically linked to the VDPV2 isolated from the patient, was detected in wastewater samples from Rockland and several surrounding counties, indicating community transmission. This case was the first known case of paralytic polio in the U.S. since 2013 and the first documented instance of community transmission of poliovirus in the U.S. since 2005. The New York State Department of Health (NYSDOH) confirmed the presence of poliovirus in wastewater in March 2023 and October 2024. The CDC states that the detection of poliovirus in wastewater cannot be used to determine the total number of infected individuals in a community or the proportion of the infected population. The minimum number of infected individuals that can be reliably detected through wastewater testing is not known.

The International Health Regulations classify the U.S. as a country or state infected with cVDPV2, with or without evidence of local transmission. Therefore, the U.S. is subject to Temporary Recommendations issued by the International Health Regulations Emergency Committee on Polio Eradication.

Afghanistan Polio Outbreak

Afghanistan is affected by the ongoing endemic transmission of wild poliovirus. In 2024, 25 WPV1 cases were reported. In 2023, 18 WPV1-positive environmental samples were reported. According to the Ministry of Health, Afghanistan detected its initial human polio case in May 2023. As of June 2, 2023, local media reported four confirmed cases of polio in the province of Nangarhar. Two polio patients were confirmed in 2022, four in 2021, and 56 in 2020.

Africa Polio Outbreaks

Kenya's Ministry of Health announced on October 1, 2024, that five polio cases have been confirmed, and one positive environmental surveillance sample has been taken in Kamukunji Sub-County, Nairobi. In June 2024, Somalia launched a significant polio vaccination campaign for children. On May 24, 2024, Angola reported AFP and environmental detections. On May 14, 2024, the closure of the WPV1 outbreaks in Malawi and Mozambique was announced. Over 100 million vaccine doses have been administered in the areas most at risk. Zimbabwe is inoculating more than 4 million children against polio in February 2024, following the detection of three cases caused by a rare mutation of the weakened virus in oral vaccines.

Australia Poliovirus Detections

On December 2, 2024, Australia's poliovirus surveillance program detected vaccine-derived poliovirus in pre-treated sewage from the Western Treatment Plant in Melbourne. This detection is likely linked to an individual who received a live polio vaccine and shed the virus in Victoria. Australia remains polio-free, as there has not been a detection of wild-type poliovirus.

South-East Asia Polio Outbreaks

Singapore reported one polio case in February 2025. Indonesia reported four instances of cVDPV2 from October 2022 to February 2023. In late December 2023, the Indonesian Ministry of Health notified WHO of two new confirmed cases of cVDPV2. Despite Indonesia having a strong capacity to respond to poliovirus outbreaks and West Java having a moderate to strong outbreak response capacity to interrupt transmission, the population remains highly susceptible to poliovirus type 2 after switching from trivalent to bivalent OPV. The ongoing polio outbreak in Indonesia poses a high risk at the national level, a moderate regional threat, and a low global risk as of 2024. The GPEI published a report of the Indonesia Polio Outbreak Response Assessment – July 2023. BMC Public Health published in March 2021 - Scaling up public health interventions: a case study of the polio immunization program in Indonesia.

Europe Polio Outbreaks

This Eureopen CDC dashboard provides an overview of the global poliovirus situation in April 2025. The European Centre for Disease Prevention and Control (ECDC) published an interactive map in 2025 displaying countries currently confirming polio or poliovirus cases. From September through December 2024, vaccine-derived poliovirus type 2 (VDPV2) was detected in wastewater systems of 14 cities in five European countries. The isolated VDPV2 viruses are linked to a lineage (NIE-ZAS-1) first detected in Nigeria in July 2020. Poliovirus has been detected in Germany, Finland, Poland, and Spain. Poland's health ministry confirmed that a sample of municipal sewage collected in Win 2024 Warsaw in 2024 revealed the presence of poliovirus type 2. The last poliovirus cases in Poland were recorded in 1982 and 1984. Finland's Institute for Health and Welfare identified VDPV2 in wastewater samples from Tampere in 2024. The WHO declared the European Region polio-free in 2002.

India Polio Outbreaks

The World Health Organization declared India polio-free in 2014. National Immunization Days are held twice a year across India, and the government aims to administer two drops of OPV to every child under five, as reported by The Times of India in 2023. Polio vaccination campaigns for children are expected to continue in 2024.

Israel Polio Outbreaks

The Global Polio Eradication Initiative reported on August 4, 2025, that Israel confirmed six environmental samples of circulating vaccine-derived poliovirus type 1 (cVDPV1), five from Jerusalem and one from Center. On April 24, 2025, the Ministry of Health's Central Virus Laboratory in Israel detected poliovirus in an environmental sample in the Jerusalem area. In March 2025, Israel discontinued offering the live attenuated polio vaccine (oral). It now provides the IPV. As of March 2023, four VDPV3-positive polio cases in children were confirmed. On February 27, 2023, the Israeli Ministry of Health issued an official alert describing a local case of Acute Flaccid Paralysis (AFP). As of April 15, 2022, a total of seven VDPV3-positive cases were confirmed. A cluster of VDPV3 was previously detected in environmental samples from Jerusalem and Bethlehem city, collected between September 2021 and January 2022.

Gaza Strip Polio Outbreak

In February 2025, the WHO confirmed a polio case that had occurred in August 2024. New environmental samples from Deir al Balah and Khan Younis, collected in December 2024 and January 2025, confirm the transmission of poliovirus, genetically linked to the poliovirus detected in the Gaza Strip in July 2024.

Pakistan Polio Outbreaks

In 2025, 3 WPV1 cases were reported. In 2024, 73 WPV1 cases were confirmed, and numerous WPV1-positive environmental samples were reported this year. Of these, 27 were from Balochistan, 22 from Khyber Pakhtunkhwa, 22 from Sindh, and one from Punjab and Islamabad. In 2022, 20 WPV1 cases and 20 paralyzed children were reported in the southern KP province.

South America Poliovirus Detections

The Pan American Health Organization (PAHO) published an alert on October 14, 2024, confirming the detection of circulating vaccine-derived poliovirus type 3 (cVDPV3) in wastewater samples collected in Cayenne, French Guiana. Additional testing identified positive samples collected in Remire-Montjoly and Saint-Georges-de-l'Oyapock. In 2024, the PAHO identified Argentina, Haiti, and Peru as at very high risk for the reintroduction of polio. In 2024, the PAHO reported that 176 virus isolation test results were pending in the Americas.

Spain Poliovirus

In Spain, circulating vaccine-derived poliovirus type 2 (cVDPV2) was isolated from a single positive sample collected in Barcelona for the first time in September 2024.

United Kingdom Poliovirus

In December 2024, one cVDPV2-positive environmental sample was collected in London. Five cVDPV2-positive environmental samples were collected in November 2024 from Yorkshire and the Humber, the South East, and London in the U.K. The UKHSA National Polio Guidelines outline public health actions to be taken when a cVDPV2 is detected in environmental samples. In May 2022, six positive samples were reported following the isolation of VDPV2 from ecological samples in London. U.K. public health authorities continue to intensify surveillance efforts, including for potential cases of paralysis, offering an additional dose of inactivated polio vaccine to all children across London.

Polio Vaccines

As of April 2025, various polio vaccines are available worldwide. Due to the high vaccination rate (93%), the CDC reports very few cases of polio. According to the CDC, the IPV has been the only vaccine in the U.S. since 2000. The New York City Health Department and the CDC recommend that adults who received polio vaccines as children receive a one-time lifetime IPV booster dose if traveling to an area with poliovirus transmission.

9 min read

Reviewer:

Robert Carlson, MD

Last Reviewed:

Tuesday, September 2, 2025 - 09:35

Description:

Poliovirus detections continue in 2025. Polio is a vaccine preventable disease according to the U.S. CDC, WHO, and European Medicines Agency.

Condition:

Polio

Malaria Outbreaks

Malaria Outbreaks September 2025

According to the World Health Organization (WHO) Malaria Report 2024, eleven out of 83 malaria-endemic countries had the highest rates of infections and deaths in 2023. According to the WHO, despite an annual expenditure of $4 billion, malaria deaths and cases have not shown substantial change over the last decade. The WHO African Region bears the heaviest burden of malaria disease. The WHO's malaria report estimated 263 million malaria cases and 597,000 related fatalities worldwide in 2023. This data represents about 11 million more cases than in 2022.

On World Malaria Day 2025, the WHO calls for revitalized efforts at all levels, from global policy to community action, to accelerate progress towards malaria elimination. Malaria infections are often misdiagnosed; however, commercial lab testing services can detect malaria infections. As of June 2025, the WHO Guidelines for Malaria include updated recommendations for malaria vaccines, primaquine, and tafenoquine. The WHO recommends the use of malaria vaccines for the prevention of P. falciparum malaria in children living in malaria-endemic areas, such as Africa.

The Institute for Health Metrics and Evaluation publishes estimates of malaria-related mortality. The Atlasvisualdelamalaria.org is a project of the iO Foundation, which published malaria information in 2025.

Malaria Cases in the United States 2025

The U.S. Centers for Disease Control and Prevention (CDC) says millions of residents travel to countries where Malaria is present. As of week 14, ending April 5, 2025, the CDC confirmed 545 malaria cases in the United States, with New York City and Maryland leading the way. During 2024, the CDC confirmed 436 cases.

The CDC published MMWR Volume 30, Number 7—July 2024, Research Letter, which reported that about ten Plasmodium vivax malaria cases were confirmed at an institution in Los Angeles, California, in 2023. The CDC published a Report on September 8, 2023, confirming eight cases of autochthonous Malaria were reported by state health departments in Florida (Sarasota, seven) and Texas (one) in Cameron County from May 18 to July 17, 2023. On October 24, 2024, the CDC reported (73(42);946–949) nine local malaria cases from May to August 2023, followed by a 10th case of locally acquired Malaria diagnosed in Arkansas. On August 6, 2023, Maryland reported one local case of Malaria.

In March 2025, Florida reported eight cases of travel-related Malaria. As of December 2023, Florida Health reported over 71 cases of Malaria related to international travel. In 2003, 8 cases of locally acquired P. vivax malaria were identified in Palm Beach County, FL. The Texas Department of State Health Services (DSHS), Amira Bashadi, MPH, reported on February 16, 2024, that from 2013 to 2022, 1,239 cases of Malaria were reported in Texas. In 2022, there were 166 malaria cases in Texas. Of these, the majority (98%) were acquired from international travelers from Africa, Asia, and South America.

In 2019, 2,048 malaria cases, most associated with travel to 85 countries where Malaria remains endemic, were reported to the CDC.

Malaria Outbreaks in Africa

The WHO reports that four African countries are responsible for over 50% of all malaria deaths worldwide: Nigeria (31.3%), the Democratic Republic of the Congo (12.6%), the United Republic of Tanzania (4.1%), and Niger (3.9%).

Malaria Outbreaks in the Region of the Americas

In 2024, the Pan American Health Organization (PAHO) estimated that 41 million people live in 21 areas where the risk of infection by mosquito-carrying Malaria is considered moderate to high. Eighteen countries, including one territory in the Americas, are currently at risk of Malaria. Countries in the Region of the Americas reported 505,000 malaria cases in 2023, a 5% increase from 2022, when the PAHO reported 481,788 cases and approximately 92 deaths, and in 2023, around 520,000 cases and 120 deaths were reported.

In the Region Americas, during the construction of the Panama Canal, approximately 30,000 people lost their lives to infectious diseases common in the tropical environment, Malaria. Panama reported a total of 15,109 malaria cases in 2024, up from 11,659 cases in 2023.

The Argentine Republic Ministry of Health confirmed local malaria transmission in Santa Elena Town and Cristo Rey Village in the Cayo District in April 2025. In December 2023, the Costa Rica Health Surveillance Directorate of the Ministry of Health announced an increased risk of Malaria in Costa Rica, especially in coastal zones. Costa Rica reported over 544 malaria cases in 2022 and 406 locally acquired malaria cases in 2021. The CDC issued various outbreak alerts for malaria-endemic countries, including Costa Rica.

In 2023, the WHO certified Paraguay, Argentina, and El Salvador as malaria-free in 2018, 2019, and 2021, respectively. Additionally, the WHO certified Belize malaria-free on June 21, 2023.

The Trinidad and Tobago Ministry of Health reported eight cases of Malaria in 2025.

A study published by the Royal Society on February 15, 2023, indicates malaria-carrying mosquitoes are gaining an average of 6.5 meters (21 feet) of elevation per year, and the southern limits of their ranges are moving by 4.7 kilometers (nearly 3 miles) from the equator per year.

Malaria Outbreaks in Australia

Australia was certified by the World Health Organization (WHO) as malaria-free in 1981. However, the re-establishment of malaria and local transmission in Australia has occurred.

Malaria Outbreaks in China

China was declared malaria-free by the World Health Organization in 2021, and no indigenous cases of Malaria have been reported since 2016. In China, the malaria burden was reduced from 30 million cases per year in the 1940s to zero indigenous cases in 2017.

Malaria Outbreaks in Europe

As of April 2024, malaria-carrying mosquitoes have been detected in Greece (since 2021) and along Italy's southeastern coast. The European CDC published the Surveillance Atlas, which reported travel-associated malaria cases in Europe from 2018 to 2022.

Malaria Outbreaks in India

In 2022, 50 people died of Malaria across India. However, this was a drastic decrease from 2014, when 562 deaths were attributed to Malaria. The National Framework for Malaria Elimination in India (2016-2030) was launched in 2016, followed by the National Strategic Plan (2017-2022). According to the WMR 2019, India represents 3% of the global malaria burden.

Malaria Mexico

On November 7, 2023, The Lancet published an article titled "The U.S.–Mexico border and falciparum malaria." The U.S. CDC recommends that travelers to certain areas of Mexico take prescription medicine to prevent Malaria. Depending on your medication, you must start taking this medicine multiple days before, during, and after your trip.

Malaria in South Korea

In April 2025, South Korean military personnel were treated for malaria infections. In 2024, the Korea Disease Control and Prevention Agency issued a nationwide malaria alert. According to the Korea Disease Control and Prevention Agency, over 719 malaria cases were confirmed from January to mid-October 2023. This is the first time the annual number of malaria cases has topped 700 since 2011.

Malaria United Kingdom

Provisional UKHSA data indicate that imported malaria cases decreased to 1,812 in 2024, down from 2,106 in 2023. Most malaria cases were reported during peak summer travel months between July and October, and in the London area.

Malaria

Malaria is a curable disease caused by four species of protozoan parasites of the genus Plasmodium: P. falciparum, P. vivax, P. malariae, and P. ovale, and is transmitted to people by Anopheles mosquitoes.

Zoonotic Avian Malaria Outbreaks

Zoonotic forms of Malaria have been documented as causes of human infections and some deaths, especially P. knowlesi, a parasite of Old World (Eastern Hemisphere) monkeys in Southeast Asia. Avian Malaria is a disease caused by a species of protozoan parasites (Plasmodium) that infect birds. It has caused mortalities in captive penguins worldwide. A study published in 2021 concluded that penguins' susceptibility, translocation across institutions, and the wide distribution of avian Malaria make this disease a constant threat.

Malaria Vaccines 2025

Malaria vaccine information is posted on Vax-Before-Travel as of 2025.

7 min read

Reviewer:

Robert Carlson, MD

Last Reviewed:

Monday, September 1, 2025 - 14:25

Description:

Malaria is vaccine preventable disease caused by parasites transmitted to people by infected mosquitoes.

Condition:

Malaria

BNT165 Malaria Vaccine

BNT165 Malaria Vaccine 2023

BioNTech SE is developing the first Messenger RNA (mRNA)-based vaccine candidate for Malaria prevention. BNT165b1 is a vaccine that expresses certain parts of the circumsporozoite protein (CSP). This vaccine candidate is based on a novel multi-antigen vaccine approach. BioNTech is evaluating a set of mRNA-encoded antigens of the malaria-causing parasite Plasmodium falciparum (P. falciparum) to help select the multi-antigen vaccine candidate to proceed to planned later-stage trials.

In December 2022, BioNTech initiated a Phase 1 clinical trial of BNT165b1 to evaluate the safety, tolerability, and exploratory immunogenicity of the vaccine candidate. A data update is expected in 2H 2023. The Estimated Study Completion Date is September 2024.

Biopharmaceutical New Technologies (BioNTech) is a next-generation immunotherapy company located in Mainz, Germany, pioneering novel therapies for cancer and other serious diseases.

BNT165 Indication

Malaria is a life-threatening disease caused by parasites transmitted to people through the bites of infected female Anopheles mosquitoes. The World Health Organization (WHO) estimated on December 8, 2022, that there were over 247 million cases of Malaria and 619,000 associated deaths in 2021. The WHO African Region was home to 95% of malaria cases and 96% of malaria deaths. Children under 5 accounted for about 80% of all malaria deaths in the Region.

BNT165 Vaccine News

December 23, 2022 - BioNTech announced the initiation of a first-in-human Phase 1 study with BNT165b1, the first candidate from the Company’s BNT165 program, to develop a multi-antigen malaria vaccine candidate. “The trial initiation is an important milestone in our efforts to help address diseases with high unmet medical need. Our objective is to develop a vaccine that can help to prevent Malaria and reduce mortality. Over the next few months, we aim to evaluate different antigens with scientific rigor to identify the optimal candidate,” said Prof. Özlem Türeci, M.D., Chief Medical Officer and Co-Founder of BioNTech.

July 26, 2021 - BioNTech announced the launch of its Malaria project, which aims to develop a well-tolerated and highly effective Malaria vaccine and implement sustainable vaccine supply solutions on the African continent.

BNT165 Clinical Trial

Clinical trial NCT05581641 has not begun recruiting as of December 23, 2022. BioNTech’s placebo-controlled, observer-blinded Phase 1 dose escalation trial is expected to enroll approximately 60 healthy volunteers with no history of previous or current malaria infection throughout several sites in the United States. BNT165b1 will be evaluated at three dose levels.

0 min read

Manufacturer:

BioNTech

Reviewer:

Robert Carlson, MD

Vaccine:

BNT165 Malaria Vaccine

Availability:

N/A

Generic:

BNT165

Drug Class:

mRNA vaccine

Clinical Trial Phase I:

Investigational RNA-based Vaccine Against Malaria

Condition:

Malaria

Last Reviewed:

Monday, March 27, 2023 - 14:55

Status:

Candidate

Manufacturer Country ID:

FDA First In Class:

Yes

BNT163 Herpes Vaccine

BNT163 Herpes Vaccine Clinical Trials, Dosage, Indication, Side Effects

BioNTech SE's BNT163 herpes simplex virus (HSV) vaccine candidate is under development to prevent genital lesions caused by Herpes Simplex Virus-2 (HSV-2) and potentially Herpes Simplex Virus-1 (HSV-1). Based on the Company's Messenger RNA (mRNA) platform, BNT163 encodes three HSV-2 glycoproteins to help prevent HSV-2 cellular entry and spread, as well as to counteract the immunosuppressive properties of HSV-2. BNT163 is an anti-viral ribonucleic acid (RNA) vaccine candidate from BioNTech's infectious disease mRNA vaccine collaboration with the Perelman School of Medicine at the University of Pennsylvania (Penn) in Philadelphia to enter the clinic. The program is Part of BioNTech's strategy to address diseases with a high unmet medical need.

Announced on December 21, 2022, BioNTech's placebo-controlled, observer-blinded, dose-escalation Phase 1 clinical trial is expected to enroll around 308 healthy volunteers aged 18 to 55 without current or history of symptomatic genital herpes infections in the U.S. The first subject was dosed on December 21, 2022. The study comprises a first-dose escalation part, focusing on safety evaluations and assessing the optimal dose-response across various dose levels. The trial's second Part is designed to expand the safety characterization of the selected BNT163 dosing for a more comprehensive assessment of the impact of pre-existing immunity to HSV-1 and -2 on safety and BNT163-induced immune responses. The ClinicalTrials.gov Identifier is NCT05432583, with an estimated study completion date of October 2026.

Currently, available HSV therapies only reduce the severity and frequency of symptoms, says the U.S. Centers for Disease Control and Prevention (CDC). As of 2025, the U.S. Food and Drug Administration (FDA) and other agencies have not authorized any herpes vaccine.

Based in Mainz, Germany, Biopharmaceutical New Technologies (BioNTech SE) (Nasdaq: BNTX) is a next-generation immunotherapy company pioneering novel therapies for cancer and other serious diseases.

BNT163 Indication

HSV-1 and HSV-2 viruses cause two highly prevalent viral infections, according to the World Health Organization (WHO). Both viruses are highly contagious and can also be transmitted during childbirth. As neurotropic and neuroinvasive viruses, HSV-1 and -2 persist in the body by hiding from the immune system in the cell bodies of neurons, where they reside lifelong and thus cannot be eradicated with current treatments. Once acquired, HSV persists lifelong in the body with recurring symptomatic outbreaks. HSV-1 is mainly transmitted by oral contact and causes lesions around the mouth, but in some cases, it also leads to genital infections and respective lesions.

HSV-2 is a sexually transmitted disease that causes genital herpes. Therefore, infections with HSV-2 further increase the risk of acquiring and transmitting HIV infections. According to the WHO, approximately 500 million people globally are estimated to be affected by genital infections caused by HSV-2, with painful genital lesions, an increased risk for meningitis, and high levels of emotional distress. Moreover, HSV-2 infection increases the risk of acquiring HIV infection by approximately threefold. In addition, co-infections with both HIV and HSV-2 increase the likelihood of transmitting HIV to others, says the WHO.

BioNTech - University of Pennsylvania

In 2018, Penn and BioNTech entered into a research collaboration and license agreement to develop novel mRNA vaccine candidates for the prevention and treatment of various infectious diseases. As a result, the Perelman School of Medicine at the University of Pennsylvania has licensed some intellectual property related to the BNT163 vaccine candidate to BioNTech. Additionally, the University receives sponsored research funding from BioNTech, associated with the preclinical development of the BNT163 vaccine candidate. As inventors of specific intellectual property related to the BNT163 vaccine candidate, some of the scientists involved in the preclinical development of the vaccine and Penn may receive additional financial benefits under the BioNTech license in the future. The Penn (BNT163-01) research study is being conducted to determine the optimal dose of the investigational vaccine, BNT163, and to assess its safety and tolerability.

BNT163 Herpes Vaccine News

February 23, 2023 - Herpes Vaccines Focus on mRNA.

December 21, 2022 - "This program is part of our strategy to help address diseases with a high unmet medical need and of global health relevance by combining our new technologies, such as mRNA, and our expertise in immune engineering," said Prof. Özlem Türeci, M.D., Chief Medical Officer and Co-Founder of BioNTech, in a press release. "BNT163 is based on three non-infectious mRNA-encoded HSV-2 glycoproteins. We aim to induce a broad immune response against multiple antivirus antigens and mobilize various immune effectors to support virus neutralization and clearance."

November 5, 2018 - BioNTech AG, a rapidly growing biotechnology company focused on the development of immunotherapies for the precise and individualized treatment of cancer and prevention of infectious diseases, and the University of Pennsylvania (Penn), Philadelphia, USA, today announced that they have entered into a strategic research collaboration. The exclusive, multi-year partnership aims to develop novel nucleoside-modified mRNA vaccine candidates for the prevention and treatment of various infectious diseases.

BNT163 Herpes Vaccine Clinical Trials

Phase 1 study: ClinicalTrials.gov Identifier: NCT05432583 - This exploratory trial will have two parts. While Part A will focus on safety evaluations, vaccine-induced immune responses, specifically neutralizing antibodies, will also be analyzed to assess whether there is a dose-response relationship. The trial will expand the safety characterization for a BNT163 dose selected based on Part A data and enable a more comprehensive assessment of the impact of pre-existing immunity to HSV-1 and -2 on the safety and BNT163-induced immune responses after one selected (higher) dose of BNT163 than could be done during the dose escalation performed in Part A.

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Manufacturer:

BioNTech SE

Reviewer:

Robert Carlson, MD

Vaccine:

BNT163 Herpes Vaccine

Availability:

N/A

Generic:

BNT163

Drug Class: