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BPL-1357 Universal Flu Vaccine
BPL-1357 Universal Flu Vaccine Description
BPL-1357 is a whole virus influenza vaccine candidate made up of four strains of non-infectious, chemically inactivated, low-pathogenicity avian flu virus. The vaccine candidate was developed by researchers at the National Institute of Allergy and Infectious Diseases (NIAID), a component of the U.S. National Institutes of Health (NIH). The intranasal formulation of BPL-1357 is currently in Phase Ib and II/III trials, designed to block virus transmission, and is also on track for U.S. FDA review by 2029.
BPL-1357 was studied in mice in September 2021, which showed that all mice receiving two doses of the BPL-1357 vaccine, delivered either intramuscularly or intranasally, survived subsequent exposure to lethal doses of each of six different influenza virus strains, including subtypes not included in the vaccine. Similar results were obtained in challenge experiments with ferrets vaccinated with BPL-1357.
“With the BPL-1357 vaccine, especially when given intranasally, we are attempting to induce a comprehensive immune response that closely mimics immunity gained following a natural influenza infection,” stated Matthew J. Memoli, M.D., on June 28, 2022. “This is very different than nearly all other vaccines for influenza or other respiratory viruses, which focus on inducing immunity to a single viral antigen and often do not induce mucosal immunity.”
The NIAID conducts and supports research at the NIH, throughout the USA, and worldwide.
BPL-1357 Vaccine Indication
This vaccine aims to provide broad-spectrum protection against multiple strains of pandemic-prone viruses. On January 17, 2023, Antiviral Research (Volume 210, 105505) published: The race toward a universal influenza vaccine: Front runners and the future directions.
BPL-1357 Vaccine News
May 1, 2025 - “Generation Gold Standard is a paradigm shift,” said NIH Director Dr. Jay Bhattacharya. “It extends vaccine protection beyond strain-specific limits and prepares for flu viral threats – not just today’s, but tomorrow’s as well – using traditional vaccine technology brought into the 21st century.”
June 28, 2022 - “Influenza vaccines that can provide long-lasting protection against a wide range of seasonal influenza viruses, as well as those with pandemic potential, would be invaluable public health tools,” said NIAID Director Anthony S. Fauci, M.D. “The scientific community is making progress on this pressing global health priority. The BPL-1357 candidate influenza vaccine being tested in this clinical trial performed very well in pre-clinical studies, and we look forward to learning how it performs in people.”
April 11, 2022 - Researchers at the NIH are investigating a new influenza vaccine that may offer protection against various flu strains. The study aims to gain a deeper understanding of the safety of this flu vaccine.
BPL-1357 Vaccine Clinical Trial
A Phase 1 trial began at the National Institutes of Health Clinical Center in Bethesda, Maryland. The placebo-controlled trial will test the safety of a candidate vaccine, BPL-1357, and its ability to prompt immune responses. The Complete Date is February 2025. Volunteers will be randomized into three groups in a 1:1:1 ratio and receive two doses of either placebo or vaccine, spaced 28 days apart. Group A participants receive BPL-1357 intramuscularly, along with an intranasal saline placebo. Group B will receive doses of the candidate vaccine intranasally, along with an intramuscular placebo. Volunteers in Group C receive a placebo administered intramuscularly and intranasally at both clinic visits. Neither the study clinicians nor the volunteers are aware of the group assignments. Volunteers must not have received any flu vaccination within the past eight weeks.
Additionally, they must agree to forgo seasonal flu vaccination for approximately two months after receiving the second dose of vaccine (or placebo). The study duration for each participant is approximately seven months. In addition to the two clinic visits to receive a vaccine (or placebo), volunteers will be asked to return to the clinic seven times to provide blood and nasal mucosal samples, which the investigators will use to detect and characterize immune responses.
A Phase II clinical trial to evaluate the efficacy and safety of the BPL-1357 vaccine in the setting of a healthy volunteer influenza human challenge study, sponsored and guided by NIAID but performed by UTMB’s research team. The primary hypothesis is that IM (intramuscular) and IN (intranasal) BPL-1357 will be safe and offer protection against mild-moderate influenza disease (MMID) caused by H1N1 influenza challenge compared to placebo. The primary objectives of this study are to measure the efficacy of BPL-1357, administered intramuscularly (IM) or intranasally (IN), in preventing MMID compared to placebo; and to assess the safety of BPL-1357, administered IM or IN in two doses 28 days apart, followed by viral challenge with H1N1. The challenge will be with a human 2015 seasonal-like H1N1 strain against which participants are likely to have partial immunity. The study population includes healthy male and female volunteers, aged 18 to 55 years. The 120 participants are divided into three study arms: placebo, intranasal vaccine, and intramuscular vaccine.
Manufacturer:
Reviewer:
Vaccine:
Availability:
N/A
Generic:
BPL-1357
Clinical Trial:
https://www.clinicaltrials.gov/ct2/results?cond=&term=NCT05027932&cntry=&state=&city=&dist=
Drug Class:
Whole virus vaccine
Clinical Trial Phase I:
Clinical Trial Phase II:
Condition:
Last Reviewed:
Thursday, May 1, 2025 - 12:35
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Manufacturer Country ID:
FDA First In Class:
Yes
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Mpox Outbreak
Mpox Outbreaks 2024
The World Health Organization (WHO) says mpox outbreaks linked to clade II began in 2017 and continues in 2024. The WHO's Global Strategic Preparedness and Response Plan for mpox, covering the six months from September 2024 to February 2025, was announced on August 26, 2024. The WHO Director-General declared a public health emergency of international concern (PHEIC) regarding mpox clade II outbreaks on July 23, 2022. The WHO announced the PHEIC ended on May 11, 2023. On August 14, 2024, the WHO Director-General determined that the upsurge of mpox clade 1 virus cases in the Democratic Republic of the Congo and a growing number of African countries constitutes a new PHEIC. The WHO published updated mpox FAQs on August 17, 2024. The WHO's Mpox External Situation Report #33 confirmed that it had received mpox case reports from 117 affected countries since May 2022. The WHO released a new framework for Enhancing Prevention and Control of mpox- 2024-2027 on May 24, 2024, for preventing and controlling future mpox outbreaks.
Mpox Virus Clades
According to the WHO, the natural reservoir of the zoonotic mpox virus (MPXV) remains unknown. There are two MPXV clades: clade I, previously known as the Congo Basin clade, and clade II, formerly the West African clade; clade II further has two subclades: clade IIa and clade IIb. A February 2023 study demonstrated that the clades exhibit highly significant differences in CAST/EiJ mice in the order clade I > clade IIa > clade IIb, similar to the severity of clinical disease in humans. Clade I outbreaks are deadlier (10%) than clade II outbreaks, says the WHO.
In May 2022, an outbreak of clade IIb MPXV was detected in the Canary Islands. Clade I MPXV community outbreaks occur regularly in Africa, in countries such as Cameroon, the Central African Republic, and the Democratic Republic of Congo (DRC). In 2024, the DRC reports a significant surge of mpox Clade 1 cases ever recorded. Before April 2023, no documented clade I MPXV cases were registered globally.
Mpox Outbreak United States
In the U.S., initial mpox virus clade IIb cases were detected in Boston, MA, in May 2022. The U.S. government declared an outbreak in August 2022. As of March 2024, the U.S. Centers for Disease Control and Prevention (CDC) reported 32,063 confirmed cases of mpox and 58 deaths in the U.S. On January 31, 2023, the U.S. HHS did not renew the public health emergency declaration for mpox. The mpox public health emergency in San Francisco, CA, ended on October 27, 2022, followed by New York in November 2022.
As of June 2024, the Los Angeles County Department of Public Health reported an increasing rate of mpox cases. From October 2023 to April 30, 2024, 42 states, the District of Columbia, and Puerto Rico reported 1,802 probable and confirmed mpox cases to the CDC. In 2024, mpox cases were reported in urban centers such as New York City, which confirmed 42 mpox cases from April 7, 2024, to May 4, 2024.
The ACIP presentation on October 25, 2023, reviewed mpox infections in Chicago, indicating an increase in mpox (18), particularly among previously JYNNEOS vaccinated persons. And in a CDC Morbidity and Mortality Weekly Report published on September 1, 2023, among 38 (73%) patients with no known exposure to a person with mpox, behaviors preceding illness included sexual activity (17; 45%), close face-to-face contact (14; 37%), attending large social gatherings (11; 29%), and being in occupational settings (10; 26%). The CDC published a Dispatch, Volume 29, Number 10—October 2023, confirming that 1.3% of reported mpox instances were in children and adolescents <18 years of age. The U.S. CDC Advisory Committee on Immunization Practices (ACIP) presented various mpox data on June 23, 2023.
Mpox Africa
The first human case of Mpox was identified in the Democratic Republic of Congo (DRC) in 1970. During 2016–2022, PCR testing confirmed 100 mpox cases among 302 suspected cases in the Central African Republic. In June 2024, the U.S. CDC issued a Level 2 Travel Health Advisory regarding the DRC's ongoing mpox outbreak. In March 2024, researchers reported 21,630 suspected MPXV Clade 1 cases and 1,003 deaths.
Mpox Europe
The European Centre for Disease Prevention and Control (ECDC). The ECDC reported on August 16, 2024, that the likelihood of infection with MPXV clade I for EU/EEA citizens traveling to or living in the affected areas and having close contact with affected communities is high, while the likelihood of infection is low when contacts with affected communities are avoided. The severity of the disease is expected to be low. On August 15, 2024, Sweden reported one travel-related mpox clade Ib case in an African visitor. Overall, the risk for these populations is moderate and low, respectively. The ECDC and WHO published a statement confirming that 26,703 mpox cases were identified from May 2022 to January 14, 2024, from 45 countries and areas throughout the European Region. Over the past four weeks, 138 cases of mpox have been identified from 11 countries and areas in Europe.
Mpox Pacific Region
China's National Health Commission (NHC) confirmed in a statement in September 2023 that it plans to manage mpox, Category B protocols, similar to other infectious diseases such as COVID-19, HIV, and rabies, after detecting 501 cases of viral infection in August 2023. These reported cases have been identified as clade IIb MPXV. The WHO situation report #27, published on August 14, 2023, identified sustained community transmission of mpox in China. Mpox cases increased to 491 on the Chinese mainland in July 2023, according to China's Center for Disease Control and Prevention (China CDC). That was an increase from 106 cases in June 2023. Since June 23, 2022, China has listed mpox as a second-class legal infectious disease. The WHO reported 106 mpox cases in Beijing in July 2023, plus recent infections in Taiwan and Hong Kong. The Hong Kong Special Administrative Region of the People's Republic of China recently recorded its fifth Mpox patient since September 2022. The Taiwan Centers for Disease Control and Prevention reported that 266 cases (250 local and 16 imported cases) have been diagnosed in Taiwan. As of August 7, a total of 77,809 mpox vaccination services have been completed in China.
A U.S. CDC study reported in July 2023 that asymptomatic mpox infections were likely underestimated in Japan and were comparable in magnitude to symptomatic infections. Japan's Ministry of Health, Labor and Welfare Health reported 169 mpox cases as of May 28, 2023, since the first domestic case in July 2022. On March 20, 2023, the Japanese Ministry of Health reported 13 men were confirmed to have a mpox infection. The Western Pacific Region reported additional mpox cases in early April 2023, driven by an outbreak of mpox affecting mainly men in Japan.
The Korean Herald reported that Korea's Centers for Disease Control and Prevention announced in April 2023 that it would raise the crisis alert level from 'Level 1' to 'Level 2 caution' following a mpox outbreak of about sixty cases.
Mpox United Kingdom
The U.K. Health Services Agency (UKHSA) began reporting mpox cases in March 2022, which accelerated in May 2022. The first smallpox specimen was identified during this outbreak through retrospective testing in the United Kingdom on March 7, 2022. From 2023 to March 2024, 160 cases of mpox have been reported in the UK. Of these, 153 were in England (68 cases were presumed to have acquired mpox in the UK, 58 were acquired outside the UK, and 27 are awaiting classification). The UKHSA published that the mpox clade of monkeypox predominantly circulating in the U.K. (Clade IIb, B.1 lineage) was no longer classified as a High Consequence of Infectious Disease. Before the recent outbreak, between 2018 and 2021, there were seven cases of mpox in the U.K. Of these; four were imported cases. There was no documented community transmission in previous outbreaks.
Mpox in Women
Eurosurveillance published a study on December 1, 2022, on mpox infections in 158 women. The average age of female patients was 34 years. The most likely transmission mechanism was close contact during sexual relationships.
Mpox Vaccines and Treatments
Various mpox vaccines (JYNNEOS®) and treatments (TPOXX) are authorized in 2024. Numerous research studies have clinically reviewed the mpox outbreak as of September 2023.
Reviewer:
Last Reviewed:
Monday, August 26, 2024 - 06:20
Description:
Mpox outbreaks in 2024 include Africa, the Americas, China, Europe
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Vaccine:
Typhoid Vaccines
Typhoid Vaccines
The U.S. Centers for Disease Control and Prevention (CDC) recommends typhoid conjugate vaccination (TCV) for individuals traveling to areas where typhoid fever is prevalent, such as South Asia, particularly India, Pakistan, and Bangladesh. As of 2025, the CDC says typhoid vaccines are not 100% effective. The World Health Organization (WHO) recommended in 2018 that the TCV is safe and effective. The WHO recommends three types of typhoid vaccines.
Typhoid Vaccine Efficacy
The October 2024 edition of the International Journal of Infectious Diseases published the findings from a study that calculated a 95.8% seroconversion rate after a single dose of TCV, and the decay in anti-Vi IgG titers at four years was approximately 75.6%, with 25.4% remaining seroconverted. Breakthrough infections were documented after a median of 3.4 years after vaccination. A study published in October 2024 concluded that a booster dose of TCV around the time of school entry might be needed for children vaccinated before the age of two to sustain protection against typhoid fever during the school years, when the risk is highest. The Lancet published a study in January 2024 that concluded a phase 3 randomized controlled clinical trial, also published in The Lancet, found that one dose of the conjugate typhoid vaccine had an estimated efficacy of 78.3% in children aged nine months to 12 years and remained strong over four years.
Typhoid Vaccine Types
There are three types of TCV: an injectable TCV, consisting of Vi polysaccharide antigen linked to a carrier protein licensed for children from 6 months of age and adults up to 45 years or 65 years of age; an injectable unconjugated polysaccharide vaccine based on the purified Vi antigen (known as Vi-PS vaccine); and an oral live attenuated Ty21a vaccine in capsule formulation for those over six years of age. In the United States, two typhoid fever vaccines are available - oral and Injectable.
Typhoid Vaccines Authorized
Two typhoid fever vaccines are available in the United States, and the WHO currently recommends three vaccines for controlling endemic and epidemic typhoid fever.
Bharat Biotech International's Typbar TCV is a vaccine containing polysaccharides of Salmonella typhi Ty2 conjugated to Tetanus Toxoid.
Sanofi Pasteur's Typhim VI is a sterile solution prepared from the purified polysaccharide capsule of Salmonella typhi (Ty 2 strain).
Emergent BioSolutions' Vivotif oral vaccine is indicated for immunization of adults and children over six years of age against disease caused by Salmonella Typhi.
SK bioscience SKYTyphoid™ is a polysaccharide-protein conjugate vaccine developed by conjugating the polysaccharide of typhoid bacteria, which acts as the antigen, to the diphtheria toxin protein (diphtheria toxoid), which acts as a carrier. SKYTyphoid achieved WHO qualification in 2024.
Typhoid Vaccine Acceleration Consortium
The Typhoid Vaccine Acceleration Consortium (TyVAC) is a partnership between the Center for Vaccine Development and Global Health at the University of Maryland School of Medicine, the Oxford Vaccine Group at the University of Oxford, and PATH, an international nonprofit organization. TyVAC aims to accelerate the introduction of new TCVs as part of an integrated approach to reduce the burden of typhoid in countries eligible for support from Gavi, the Vaccine Alliance. The Bill & Melinda Gates Foundation funds the TyVAC.
Typhoid Fever Vaccine News
September 3, 2025 - The Lancet published an article that concluded: Vaccination, along with water, sanitation, and hygiene measures, is a cornerstone of typhoid prevention.
February 23, 2024 - SK bioscience and IVI announced that SKYTyphoid, a third TCV, also achieved WHO PQ, which could increase the global supply.
May 12, 2023 - Malawi has launched a nationwide rollout of the newest typhoid vaccine for children under 15 years of age.
September 1, 2022 - The Lancet Global Health published a study titled " Safety and immunogenicity of a typhoid conjugate vaccine among children aged 9 months to 12 years in Malawi: a nested substudy of a double-blind, randomized controlled trial". Interpretation - This study provides evidence of TCV safety, tolerability, and immunogenicity up to 730–1035 days in Malawian children aged 9 months to 1 year.
September 16, 2021 - Study results: Typhoid conjugate vaccines are highly effective in African children. Children who received TCV were 84% less likely to contract typhoid during that period.
July 29, 2022 - Review of the Recent Advances in Typhoid Vaccine Development and Challenges Ahead.
Reviewer:
Last Reviewed:
Wednesday, September 17, 2025 - 12:05
Description:
Typhoid is a vaccine preventable disease.
Condition:
TPOXX (Tecovirimat) Antiviral
TPOXX® (Tecovirimat) Clinical Trials, Dosage, Efficacy, Side Effects
SIGA Technologies, Inc. TPOXX® (tecovirimat, ST-246®, TEPOXX), a novel small-molecule oral drug that inhibits the variola virus's and other poxviruses' viral maturation by preventing the formation of a secondary viral envelope (protein VP13) found on the surface of all orthopoxviruses. Without this envelope, viral particles remain inside the cell and cannot spread to and infect other cells. Tecovirimat is 77-82% bound to human plasma proteins. Tecovirimat is an inducer of cytochrome P450 (CYP) 3A and a weak inhibitor of CYP2C8 and CYP2C19. However, the effects are not expected to be clinically relevant for most substrates of those enzymes based on the magnitude of interactions and the duration of treatment of TPOXX.
Tecovirimat's efficacy for treating smallpox was established based on data from the U.S. Food and Drug Administration (FDA) Animal Rule and safety data from 359 healthy adults. TPOXX has been approved by the FDA, Canada, the U.K., and the European Medicines Agency (EMA) for the treatment of smallpox as of July 13, 2018. In January 2022, the EMA and the U.K. approved Tecovirimat with a broader label that covers the treatment of smallpox, mpox, cowpox, and complications from vaccination for smallpox. On May 30, 2022, the World Health Organization (WHO) confirmed that TPOXX was effective against mpox infections. On January 2, 2025, tecovirimat was approved in Japan for the treatment of orthopoxviruses.
On April 16, 2025, a study funded by the National Institute of Allergy and Infectious Diseases and others determined that tecovirimat did not reduce the number of days to lesion resolution in patients with mpox caused by clade I MPXV.
On December 10, 2024, the U.S. National Institutes of Health (NIH) announced tecovirimat did not reduce the time to lesion resolution or have an effect on pain among adults with mild to moderate clade II mpox and a low risk of developing severe disease, according to an interim data analysis from the international clinical trial called the Study of Tecovirimat for Mpox (STOMP). Given the lack of an efficacy signal, clinical trials have been discontinued. The STOMP findings are consistent with results reported in 2024 from a National Institute of Allergy and Infectious Diseases (NIAID)-cosponsored randomized controlled trial of tecovirimat among children and adults with clade I mpox in the Democratic Republic of the Congo. On August 15, 2024, the NIAID announced topline results from a preliminary analysis of the PALM 007 (Tecovirimat for Treatment of Monkeypox Virus) phase 2 clinical trial (NCT05559099). NIAID reported that the study did not meet its primary endpoint of a statistically significant improvement in time to lesion resolution within 28 days post-randomization for patients in the Democratic Republic of the Congo with mpox who were administered tecovirimat.
As of September 17, 2024, the U.S. Centers for Disease Control and Prevention (CDC) recommends tecovirimat as the first-line antiviral treatment for severe mpox or for individuals with mpox who are at risk for severe disease. Tecovirimat is FDA-approved only for the treatment of smallpox in adults and children. Using tecovirimat to treat other orthopoxvirus infections, including mpox, is unapproved. On June 9, 2023, the CDC recommended that postexposure prophylaxis be considered for all household members, including children and infants, when mpox is diagnosed. However, the safety and efficacy of TPOXX for treating mpox have not been established. The CDC published Guidance for Tecovirimat Use Under Expanded Access Investigational New Drug Protocol on September 15, 2022. The CDC/FDA expanded TPOXX access via the Investigational New Drug Protocol. Its use follows Informed Consent. The FDA suggested that the broad use of TPOXX could promote resistance and render the drug ineffective for some patients. The CDC hosted a COCA call on October 6, 2022, and presented a situational update for Clinicians about severe mpox virus infections. The CDC Health Alert Network (HAN) issued CDCHAN-00481 on November 17, 2022, providing clinicians and public health officials with information on managing mpox in patients requiring therapeutics. TPOXX treatment for mpox is available through voluntary participation in https://www.stomptpoxx.org/stompsites, sponsored by the U.S. NIH.
Tecovirimat - NDC Code(s): 50072-200-42. DrugBank Accession Number: DB12020. UNII: F925RR824R. ATC code: J05AX24. KEGG: D09390, as monohydrate: D11557. ChEMBL: ChEMBL1257073. Formula: C19H15F3N2O3. ND No. 116,039, CDC IRB No. 6402.
SIGA Technologies, Inc. (NASDAQ: SIGA) is a commercial-stage pharmaceutical company based in New York (31 East 62nd Street, 10065).
TPOXX Sales And Deliveries
SIGA established a network with over 20 partners across discovery, pre-clinical, clinical, manufacturing, and supply chains that supported the development of TPOXX and the successful delivery of approximately $200 million of courses to the U.S. Strategic National Stockpile (SNS). On July 22, 2024, the U.S. Department of Health and Human Services exercised a procurement option to deliver approximately $113 million of oral TPOXX treatment courses.
On June 17, 2024, SIGA announced an agreement to expand access to TPOXX to the member states in the Association of Southeast Asian Nations. On April 1, 2024, SIGA Technologies announced that it had entered into an amendment to its international promotion agreement with Meridian Medical Technologies, Inc. Effective June 1, 2024, SIGA will drive international promotion activities for oral TPOXX, while maintaining its contractual relationship with Meridian to ensure continuity for key customer relationships.
In 2023, SIGA had $131 million in product sales, including approximately $98 million of fourth quarter product sales of oral TPOXX to the U.S. SNS, roughly $11 million of product sales of oral TPOXX to the U.S. DoD, of which approximately $6 million was recognized in the fourth quarter; and approximately $21 million of international sales, of which roughly $12 million was recognized in the fourth quarter. In the first two months of 2024, the Company delivered an additional approximately $15 million of oral TPOXX to the U.S. SNS, substantially completing the oral TPOXX order received in July 2023, as well as offered an additional roughly $7 million of oral TPOXX to European countries and Canada.
On August 9, 2022, SIGA Technologies announced the exercise of procurement options under its 75A50118C00019 (19C) contract with the U.S. Department of Health and Human Services (HHS) to deliver intravenous (IV) formulations of TPOXX treatment courses, valued at approximately $26 million. Product deliveries of IV TPOXX in connection with these contract options are targeted for 2023. September 29, 2022, SIGA Technologies announced that the U.S. DoD awarded a new contract for the procurement of $10.7 million of oral TPOXX (Contract number: W911SR22C0051), of which $5.1 million of oral TPOXX is targeted for delivery in 2022. The remainder is subject to an option at the sole discretion of the DoD. This contract follows an award made earlier this year for the procurement of $7.4 million of oral TPOXX (Contract Number: W911SR22C0032), under which all products are expected to be delivered in 2022.
In September 2018, SIGA signed a contract with the U.S. Biomedical Advanced Research and Development Authority (BARDA) for additional procurement and development related to oral and intravenous formulations of TPOXX. SIGA has also collaborated with the Department of Defence (DoD) Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND) to develop the post-exposure prophylaxis (PEP) indication for TPOXX. The DoD has drafted an Expanded Access Protocol (EAP) for TPOXX, which can be used for post-exposure prophylaxis (PEP) purposes for certain DoD-affiliated personnel. In addition, oral TPOXX is supplied to the Canadian Department of National Defence and the Public Health Agency of Canada for stockpiling as an essential countermeasure.
TPOXX Mpox Effectiveness and Breakthrough Infections
Data from 15 clinical trials of oral TPOXX in over 800 healthy volunteers, including a pivotal repeat-dose phase 1 pharmacokinetics (PK) trial involving 20 healthy volunteers conducted in Japan. These studies showed no drug-related serious adverse events and quantifiable PK within efficacious dose ranges.
A small study published in January 2024 suggested that early tecovirimat initiation may hasten subjective symptomatic improvement in people with severe mpox. However, more extensive randomized trials are needed to evaluate this finding. The Antimicrobial Agents Chemotherapy journal published a letter on June 20, 2023, identifying Tecovirimat Resistance-Associated Mutations in Human Monkeypox Virus in Los Angeles County. This analysis detected TPOXX resistance-related HIV status.
The U.S. CDC published "Notes from the Field" on April 28, 2023, describing patients in New York City who were diagnosed with mpox and also developed new lesions after completing tecovirimat treatment, suggesting that post-treatment lesions may occur more commonly than previously reported by the CDC. In addition, the CDC reported on September 9, 2022, among 317 patients with available outcome information, 230 (72.6%) recovered with or without sequelae by or before completion of the post-treatment assessment; 87 (27.4%) patients were reported by clinicians to be not yet recovered, 78 of whom had not yet completed the standard 14-day tecovirimat treatment course. The CDC's MMWR was published on September 9, 2022. At the post-treatment follow-up visit, it was confirmed that three (2.2%) of 137 persons with available information had developed new lesions, compared with 25 (13.1%) who had developed new lesions during the first week of treatment. Most (119, 89.5%) patients reported that all lesions were crusted and healing with a new layer of skin under the scab following treatment.
TPOXX, Mpox, and HIV
JAMA Internal Medicine published a study on January 8, 2024, demonstrating that people with HIV (PWH) who received tecovirimat within seven days of mpox symptom onset were 13 times less likely to progress to severe mpox disease compared with those who were treated after seven days or who did not receive tecovirimat. These researchers wrote that the findings of this study support the use of tecovirimat in all people with HIV (PWH) as soon as mpox is suspected. In a U.S. NIH-funded retrospective study published on May 2, 2023, a cohort of New York City patients treated with tecovirimat for severe mpox, HIV status did not appear to affect treatment outcomes. As of March 3, 2023, the STOMP Trial is evaluating the use of TPOXX in the HIV community.
TPOXX Tecovirimat Resistance
On November 19, 2023, the U.S. CDC's Emerging Infectious Diseases - Volume 29, Number 12—December 2023 - confirmed that the MPXV F13L gene homologue encodes the target of tecovirimat, and single amino acid changes in F13 are known to cause resistance to tecovirimat. Genomic sequencing identified 11 mutations previously reported to cause resistance, as well as 13 novel mutations. The resistant phenotype was determined using a viral cytopathic effect assay. We tested 124 isolates from 68 patients; 96 isolates from 46 patients were found to have a resistant phenotype. Most resistant isolates were associated with severely immunocompromised mpox patients on multiple courses of tecovirimat treatment. In contrast, most isolates identified by routine surveillance of patients not treated with tecovirimat remained sensitive.
This Annals of Internal Medicine report (July 2023) - Tecovirimat Resistance in an Immunocompromised Patient With Mpox and Prolonged Viral Shedding - confirms the potential rapid selection of a resistant mutant virus during tecovirimat monotherapy, and we believe this report is the first to study this phenomenon longitudinally. A variant (VP37 N267D) with substantiated tecovirimat resistance was selected within the standard 2-week treatment.
TPOXX Ingredients
Tecovirimat Formula: C19H15F3N2O3; ChemSpider ID: 17281586; ChEMBL Id: 1257073; PubChem CID: 16124688; Monoisotopic mass376.103485 Da. The capsules include the inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C Blue #1, FD&C Red #3, FD&C Yellow #6, and titanium dioxide.
TPOXX For Children
The U.S. CDC's MMWR on June 9, 2023 - Notes from the Field: Exposures to Mpox Among Cases in Children Aged ≤12 Years — United States, September 25–December 31, 2022- When caring for the child with mpox, postexposure prophylaxis should be considered for all members of the household. On August 4, 2022, the CDC confirmed that no clinical studies had been conducted in pediatric populations regarding the use of TPOXX.
TPOXX For Women
On May 18, 2023, the CDC confirmed a lack of sufficient data on TPOXX in women. However, on January 6, 2023, a CDC Morbidity and Mortality Weekly Report disclosed that four pregnant women were hospitalized for mpox and administered tecovirimat, which was tolerated with no adverse reactions.
TPOXX Side Effects
The JAMA Network published a Research Letter on August 22, 2022: Compassionate Use of Tecovirimat for Treating Monkeypox Infection. In this preliminary, limited study, oral tecovirimat was well tolerated by all patients with mpox infection, with minimal adverse effects. The safety of TPOXX was evaluated in three clinical trials in 359 healthy adult subjects aged 18-79 years. Of the subjects who received at least one 600 mg dose of TPOXX, 59% were female, 69% were White, 28% were Black/African American, 1% were Asian, and 12% were Hispanic or Latino. Ten percent of the study participants were aged 65 or older. Of these 359 subjects, 336 received at least 23 of 28 doses of 600 mg TPOXX twice daily for 14 days. The most frequently reported adverse reactions were headaches and nausea. Adverse reactions occurred in at least 2% of the subjects in the TPOXX treatment group. In addition, co-administration of repaglinide and tecovirimat may cause mild to moderate hypoglycemia.
TPOXX Drug Interactions
Significant interactions have been reported in healthy adults with co-administration of repaglinide (hypoglycemia) and midazolam (decreased effectiveness of midazolam).
TPOXX Price
The U.S. CDC confirmed on August 18, 2022, that healthcare providers could provide tecovirimat (TPOXX) treatment to patients with mpox under EA-IND. The drug is currently offered at no cost. Contact the CDC Emergency Operations Center (770-488-7100) for clinical consultation on patient cases. NYC providers who want to prescribe tecovirimat and adhere to the IND protocol can email [email protected] for information on free delivery to patients or request supplies for a pharmacy at their facility.
TPOXX News
January 2, 2025 - SIGA Technologies received regulatory approval in Japan for treating smallpox, mpox, and cowpox, as well as complications following smallpox vaccination in adults and pediatric patients weighing at least 13 kg.
March 13, 2024 - "In 2023, SIGA had approximately $131 million in product revenues and approximately $84 million of pre-tax operating income," stated Diem Nguyen, Chief Executive Officer. "These financial results represent a significant increase over the 2022 financial results; product revenues increased 51% over the corresponding 2022 amount, and pre-tax operating income increased 96% over the corresponding 2022 amount.
April 28, 2023—The U.S. CDC published Notes from the Field: Post-treatment Lesions After Tecovirimat Treatment for Mpox—New York City, August–September 2022. New lesions appeared a median of 13 days after completion of Tecovirimat treatment (range = 2–30 days). In eight patients, the provider rated post-treatment lesions as less severe than initial lesions (median severity score = 3 [range = 3–7]).
February 2, 2023 - Special Report: Overview of the regulatory approval of tecovirimat intravenous formulation for treating smallpox: potential impact on smallpox outbreak response capabilities, and future tecovirimat development potential.
September 6, 2022—The HHS Administration for Strategic Preparedness and Response awarded AmerisourceBergen a distribution contract valued at $19.8 million to expand MPXV treatment access.
August 25, 2022 - The Swiss government health agency (SwissMedic) intends to purchase 500 units of the TPOXX antiviral.
July 15, 2022 - SIGA Technologies announced a collaboration with KaliVir Immunotherapeutics to make TPOXX® available for use with KaliVir's novel oncolytic vaccinia immunotherapy platform, including multiple proprietary genetic modifications that can be combined to generate a unique oncolytic virus that has been optimized for systemic delivery and anti-tumor immune stimulation.
May 19, 2022 - SIGA Technologies, Inc. announced that the U.S. FDA approved the IV formulation of TPOXX for treating smallpox.
January 10, 2022 - SIGA Technologies, Inc. announced that the EMA approved SIGA's Marketing Authorisation Application for oral tecovirimat. The EMA approval includes labeling for oral tecovirimat, indicating its use to treat smallpox, mpox, cowpox, and vaccinia complications following vaccination against smallpox.
July 29, 2021 - SIGA Technologies, Inc. announced that it has partnered with Oxford University in the U.K. to provide TPOXX® (tecovirimat) under an expanded access protocol to treat individuals affected by mpox in the Central African Republic.
July 13, 2018 - The U.S. FDA approved TPOXX (tecovirimat), the first drug with an indication for the treatment of smallpox. The FDA granted this application Fast Track and Priority Review designations, and TPOXX also received an Orphan Drug designation.
TPOXX Clinical Trials
The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, is sponsoring the Study of Tecovirimat for Human Mpox Virus (STOMP). The STOMP trial assesses whether tecovirimat is safe and effective for treating mpox in people with the disease.
A Phase 3 clinical trial evaluating the antiviral tecovirimat, also known as TPOXX, began enrolling adults and children with monkeypox infection in the United States on September 9, 2022. Study investigators aim to register more than 500 people from clinical research sites nationwide. Interested volunteers can visit the ACTG website (clinical trial A5418) for more information. The National Institute of Allergy and Infectious Diseases sponsors the trialThe first study compares the enrolled participants' immune response to the Jynneos smallpox vaccines to the immune response to Jynneos while on TPOXX treatment. In addition, the study is designed to determine if TPOXX interferes with developing an effective immune response to the vaccine. A second clinical study, also expected to commence in 2022, will look at creating an expanded safety dataset to support 28-day dosing of TPOXX for the post-exposure prophylaxis indication compared with the currently approved 14 days for treatment of smallpox indication.
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U.S., Canada, Europe
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tecovirimat
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Small molecule medication
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Saturday, April 19, 2025 - 06:50
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TPOXX
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ST-246
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Yes
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Mpox Vaccines
Mpox Vaccines June 2025
The World Health Organization (WHO) announced in June 2025 that the mpox upsurge continues to meet the WHO criteria of a public health emergency of international concern. The Strategic Advisory Group of Experts on Immunization, along with other health agencies, has recommended vaccination against mpox disease and publishes the Emergency Use Listing of mpox vaccines. As of June 10, 2025, four vaccines are in use to protect people against mpox. According to the WHO, travelers who may be at risk, as assessed by their healthcare provider, may wish to consider mpox vaccination. However, mass vaccination is not recommended.
The United States Food and Drug Administration (FDA) Approved the JYNNEOS® (MVA-BN, IMVANEX®, IMVAMUNE®) Smallpox and Mpox Vaccine on September 24, 2019. The U.S. began offering Bavarian Nordic's JYNNEOS to healthcare staff in Boston on May 24, 2022, and then to consumers throughout the U.S.
Japan's K.M. Biologics' LC16 "KMB" freeze-dried smallpox vaccine has been approved by Japan's Ministry of Health, Labor, and Welfare, as well as by other countries, for the prevention of mpox disease. A review published by John D. Grabenstein and Adam Hacker summarizes the human and pivotal animal data establishing the safety and efficacy of LC16m8.
The ACAM2000 live vaccinia virus vaccine is authorized to prevent mpox and smallpox infections in various countries, including the United States. The saf ty profile of the ACAM2000 vaccination includes side effects and risks.
The State Research Center of Virology and Biotechnology Vector Laboratories produces the OrthopoxVac vaccine.
Mpox Vaccine Candidates
The Sinopharm mpox vaccine candidate clinical trial was approved in China in September 2024. The Bei ing Institute of Biological Products Co., Ltd. (BIBP), also known as Sinopharm, confirmed that China's drug authority has granted permission to launch an mpox vaccine based on replication-defective mpox viruses that cannot spread but can confer immunity to a person. China classified mpox as a Class B infectious disease in 2022.
Moderna Inc.'s mpox vaccine candidate mRNA-1769 prevented severe disease and reduced virus levels in monkeys. The results of a preclinical study were published in Cell on September 4, 2024. A study published in December 2024 concluded, 'A single vaccination provided considerable protection, enhanced by boosting, for at least 4 months. Protective immunity was related to the amount of mRNA inoculated, which correlated with neutralizing antibody levels. Furthermore, immunocompetent and immunodeficient mice lacking mature B and T cells that received serum from mRNA-immunized macaques before or after the VACV challenge were protected.'
Tonix Pharmaceuticals Holding Corp. confirmed the development of X-801 as a vaccine candidate targeting mpox. As of September 2024, Tonix has completed non-human primate studies showing protection from the Clade 1 mpox virus. Seth Leerman, M.D., Chief Executive Officer of Tonix, stated, "In animal studies, TNX-801 has shown single-dose protection against a lethal challenge of Clade I monkeypox virus administered by the intratracheal route." TNX-801 is an attenuated live-virus vaccine based on synthesized horsepox that has been shown to provide single-dose immune protection against a monkeypox challenge with better tolerability than 20th-century vaccinia live-virus vaccines in animals. On August 26, 2024, Tonix partnered with Bilthoven Biologicals on vaccine development.
The Institute of India, Reliance Life Sciences, and Dr. Reddy's Laboratories are among the firms collaborating to produce a vaccine for the MPXV in India. The Indian Council of Medical Research (ICMR) initiated this in collaboration on July 27, 2022, for the development of in-vitro diagnostic kits and vaccine candidates against the MPox virus.
Emergex Vaccines Holding Limited announced on October 18, 2022, that it has formulated and confirmed the synthesis and assembly of a CD8+ T cell Adaptive Vaccine for smallpox and mpox, comprised predominantly of early "eclipse phase" antigens.
EpiVax, Inc.'s "Epitope-Driven Vaccine" is a smallpox vaccine candidate predicted to be highly effective against mpox. The development of VennVax, a DNA-prime, peptide-boost multi-T-cell epitope poxvirus vaccine, was funded by the U.S. National Institutes of Health (SBIR grant #R43AI058376).
The Hopoxvac vaccine, developed by the Vektor laboratory, was registered in 2022.
A study published on March 26, 2025, found that co-immunization with Mix-12 and MPX-EPs provides complete protection against MPXV challenge. Overall, these results suggest a practical approach to enhancing the immune protection of mRNA vaccines through the specific coordination of humoral and cellular immune responses.
Mpox Treatment
In June 2025, this living guideline from WHO incorporates new evidence to dynamically update recommendations for clinical management and IPC for mpox infection. The Africa CDC announced in January 2025 that brincidofovir, an antiviral treatment for mpox infection from Emergent BioSolutions, had launched a clinical trial.
Mpox Virus Disease
Monkeypox is a zoonotic virus that is transmitted from one person to another through physical contact with lesions, body fluids, respiratory droplets, and contaminated materials. The virus causes monkeypox disease, a member of the Orthopoxvirus genus in the family Poxviridae. According to the WHO, the monkeypox virus has two distinct genetic clades: the Congo Basin and the West African clade.
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Last Reviewed:
Tuesday, June 10, 2025 - 06:00
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Mpox vaccines are approved and offered in various countries in 2025
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Janssen Ad26. RSV. preF Vaccine
Janssen Ad26. RSV. preF Vaccine Description for 2022
Janssen Ad26. RSV. preF Vaccine uses its innovative vaccine technology platform®. This technology is based on the development and production of adenoviral vectors (for transfer of hereditary material) which can activate the immune system to stimulate immunity against the virus.
According to the CDC, Respiratory Syncytial Virus Infection (RSV) was discovered in 1956 and has since been recognized as one of the most common causes of childhood illness. It causes annual outbreaks of respiratory illnesses in all age groups. In most regions of the United States, RSV usually circulates during fall, winter, and spring, but the timing and severity of RSV season in a given community can vary from year to year.
Although most children will be infected by RSV within the first year of life, adults are also susceptible to the virus. Usually, the illness is mild however some adults may have severe symptoms consistent with a lower respiratory tract infection, such as pneumonia.
Janssen Ad26. RSV. preF Vaccine has been tested in several clinical trials with older adults. Positive results from the Phase 2b CYPRESS study have led to the initiation of a Phase 3 EVERGREEN study.
Janssen Ad26. RSV. preF Vaccine Indication
Janssen Ad26. RSV. preF Vaccine candidate is indicated to prevent illness from RSV.
Janssen Ad26. RSV. preF Vaccine News 2021- 2022
September 29, 2021 - "Positive data from our first RSV vaccine efficacy study and the initiation of the Phase 3 EVERGREEN study are crucial milestones in the clinical development of our investigational RSV adult vaccine, which has the potential to safely and effectively prevent lower respiratory tract disease caused by RSV in older adults," says Penny Heaton, M.D., Global Therapeutic Area Head, Vaccines, Janssen Research & Development, LLC.
January 5, 2021 - The Journal of Infectious Diseases published the results of a Phase 2 study. Ad26.RSV.preF demonstrated protection from RSV infection through immunization in a human challenge model and, therefore could potentially protect against natural RSV infection and disease.
Janssen Ad26. RSV. preF Vaccine Clinical Trials
Janssen Ad26. RSV. preF Vaccine has been studied in many clinical trials.
A phase 3 trial is in the process of recruiting 1,113 adults 18 to 59 years of age who are healthy or at risk for severe Respiratory Syncytial Virus (RSV) disease, compared to adults 65 years and above.
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Ad26.RSV.preF
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Monday, August 1, 2022 - 15:15
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Aduhelm Monoclonal Antibody
Aduhelm
Aduhelm (Aducanumab) is a human, IgG1 monoclonal antibody (mAb) directed against aggregated soluble and insoluble forms of Aβ1. It is expressed in a Chinese hamster ovary cell line. Aduhelm is an amyloid beta-directed antibody indicated to treat Alzheimer’s disease. Aduhelm is approved under the accelerated approval pathway, which provides patients with a serious disease earlier access to drugs when there is an expectation of clinical benefit despite some uncertainty about the clinical benefit.
U.S. Food and Drug Administration (FDA) accelerated approval is based upon the drug’s effect on a surrogate endpoint — an endpoint that reflects the effect of the drug on an essential aspect of the disease — where the drug’s effect on the surrogate endpoint is expected, but not established, to predict clinical benefit. In the case of Aduhelm, the surrogate endpoint is the reduction of amyloid beta plaque. The accelerated approval pathway requires the company to verify clinical benefits in a post-approval trial. Aduhelm is the first novel therapy approved for Alzheimer’s disease since 2003.
On July 8, 2021, the FDA issued approval to Biogen and Eisai Co., Ltd.
Aduhelm Indication
Aduhelm is administered intravenously monthly. Injection of 100 mg/mL for intravenous use indicated to treat AD
Aduhelm News
June 7, 2023 - The U.S. Food and Drug Administration approved Aduhelm (aducanumab) for treating AD.
January 11, 2022 - Biogen released a statement regarding the Draft National Coverage Determination. The current draft decision denies nearly all Medicare beneficiaries from accessing Aduhelm.
September 1, 2016 - Nature reported in patients with prodromal or mild AD, one year of monthly intravenous infusions of aducanumab reduces brain Aβ in a dose- and time-dependent manner.
Aduhelm Clinical Trials
The clinical trials for Aduhelm were the first to show that a reduction in these plaques—a hallmark finding in the brain of patients with Alzheimer’s—is expected to reduce the clinical decline of this devastating form of dementia.
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mAB
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Saturday, August 19, 2023 - 05:40
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Aduhelm
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Shingles Vaccines
Shingles (Herpes Zoster) Vaccines 2026
Herpes Zoster, also known as shingles, is a vaccine-preventable disease caused by the varicella-zoster virus (VZV), which also causes chickenpox, according to the U.S. Centers for Disease Control and Prevention (CDC). The U.S. Food and Drug Administration (FDA) approved shingles vaccines for use in accordance with the updated 2025 schedules. The European Medicines Agency (EMA) approves various shingles vaccines in over 30 countries. As of 2026, the shingles vaccination market exceeds $2 billion in annual revenue.
Shingles Vaccines Approved
Shingrix—GSK's Shingrix is a non-live, adjuvanted recombinant shingles (zoster) vaccine containing the varicella-zoster virus glycoprotein E antigen and the AS01B adjuvant system, a proprietary formulation containing QS-21 and MPL in liposomes.
Zostavax is Merck's live, attenuated varicella-zoster virus (a weakened form of the chickenpox virus) vaccine. According to the U.S. CDC, the zoster vaccine can be administered concurrently with all other live and inactivated vaccines, including those routinely recommended for people 60 or older.
SK bioscience's SKYZoster™ is a live varicella-zoster virus vaccine that attenuates the virus. SKYZoster was approved in South Korea by the Ministry of Food and Drug Safety in September 2017.
SINOVAC's live attenuated varicella vaccine, a WHO-prequalified Chinese varicella vaccine, was successfully delivered to the Republic of Türkiye in 2023 and is registered in Lebanon and Kenya.
Shingles Vaccine Candidates
Curevo Vaccine's Amezosvatein (CRV-101) is an adjuvanted subunit shingles vaccine candidate designed to maximize cellular-mediated immunity (CMI) protection by combining the gE protein antigen with our proprietary adjuvant. On January 7, 2024, Curevo announced positive data from a Phase 2 trial of Amezosvatein, head-to-head versus Shingrix, in participants aged 50 and older. There were zero confirmed cases of herpes zoster (shingles) among participants in the amezosvatein arm. On October 16, 2024, the Company announced that Amezosvatein met all primary endpoints in the randomized, active-controlled, and observer-blind Phase 2 trial. On January 13, 2025, the Company announced positive updated immunogenicity and safety data from its 876-patient Phase 2 trial of amezosvatein (CRV-101) compared to Shingrix in participants aged 50 years and older. Based upon these results, Curevo will advance amezosvatein into global Phase 3 trials in 2025. On March 17, 2025, Curevo Vaccine announced the closing of a $110 million Series B round to advance the development of amezosvatein.
BioNTech SE initiated a randomized, controlled, dose-selection Phase 1/2 clinical trial of BNT167 in February 2023. The trial evaluates the safety, tolerability, and immunogenicity of mRNA vaccine candidates against shingles.
Jiangsu Recbio Technology Co., Ltd. announced on December 29, 2023, that REC610 is equipped with a novel adjuvant BFA01 independently developed by the Company, which can promote the production of high levels of VZV glycoprotein E (gE)-specific CD4+T cells and antibodies. On December 19, 2022, it received approval from the Philippines FDA to conduct a randomized, observer-blinded, phase I clinical trial. The Interim Analysis results published on December 29, 2023, showed that REC610 demonstrated an overall favorable safety and tolerability profile in healthy participants aged 40 and above after two vaccination doses. REC610 induced strong gE-specific humoral and cellular immune responses, evident after the first vaccination and peaked 30 days after the second vaccination.
Immorna announced on January 9, 2023, that the U.S. FDA cleared its investigational new drug application to conduct a Phase 1 multi-center study of JCXH-105, a self-replicating RNA vaccine against Shingles. Additionally, on May 30, 2023, the Company announced that the first subject had been dosed in its First-In-Human (FIH) Phase 1 multi-center study of JCXH-105.
Dynavax's Z-1018 is an investigational vaccine candidate being developed to prevent shingles in adults aged 50 and older. In the fourth quarter of 2024, the Company completed enrollment in the phase 1/2 trial, and Dynavax anticipates reporting top-line immunogenicity and safety data in the third quarter of 2025.
Shingles Vaccination and Dementia
On April 23, 2025, a study published in JAMA found evidence that herpes zoster vaccination reduces the risk of dementia, a finding more likely to be causal than the associations reported in existing correlational evidence. On April 2, 2025, Nature published a study - A natural experiment on the effect of herpes zoster vaccination on dementia - that provides evidence of a dementia-preventing or dementia-delaying effect from zoster vaccination that is less vulnerable to confounding and bias than the existing associational evidence. The journal BMC Public Health published results from a study on October 2, 2023. The study concluded that the zoster vaccine for the prevention of shingles/herpes zoster and the influenza vaccine to prevent influenza were associated with a diminished risk of dementia, with the zoster association appearing more pronounced. A non-peer-reviewed study published on May 25, 2023, reported that shingles vaccinations were associated with a 19.9% lower risk of dementia.
Shingles Vaccination and Cardiovascular Events
A study published in the European Heart Journal in May 2025 shows a 23% lower risk of cardiovascular events in recipients of the shingles vaccine in the 8 years following vaccination. These findings suggest that live zoster vaccination may help reduce the burden of cardiovascular disease in the general population.
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Worldwide
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Vaccine
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Thursday, January 22, 2026 - 12:35
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Yes
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Lyme Disease Vaccines
Lyme Disease Vaccine Candidates
Lyme disease vaccine research includes early-stage discovery and novel vaccine formulations, including tick saliva-based approaches. In addition, the U.S. National Institutes of Health (NIH) published a Strategic Plan for Tickborne Disease Research that prioritizes vaccines needed to prevent diseases. As of March 2025, the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the United Kingdom have not approved a preventive Lyme disease vaccine. The only human Lyme disease vaccine marketed in the U.S. was LYMERix®, which was discontinued in 2002.
According to IMARC, the Lyme disease market was worth $594 million in 2023. Over the next decade, it is expected to exceed $1 billion by 2034, exhibiting a growth rate of 6.45%.
Lyme Disease Vaccine Candidates 2025
VLA15, a multivalent Lyme Disease vaccine candidate produced by Pfizer Inc. and Valneva SE, targets Borrelia's outer surface protein A and conducts late-stage clinical trials.
Moderna Inc. is advancing a seven-valent approach with two Lyme disease vaccine candidates that will be developed in parallel. mRNA-1982 is designed to elicit antibodies specific for Borrelia burgdorferi, which causes almost all Lyme disease in the U.S. mRNA-1975 is designed to elicit antibodies specific for the four major Borrelia species causing disease in the U.S. and Europe.
TP-05 is a novel investigative oral therapeutic that could potentially prevent Lyme disease. It is an oral systemic formulation of lotilaner, a well-characterized anti-parasitic agent that selectively inhibits parasite-specific GABA-CI channels.
The National School of Tropical Medicine at Baylor College of Medicine and Texas Children's Hospital's Center for Vaccine Development received an $860,000 grant from the U.S. Department of Defense to develop a recombinant protein vaccine for Lyme disease. The Congressional Director of Medical Research Programs supports this work through the DoD Tick-borne Disease Research Program. W81XWH-20-1-0913.
Penn Medicine's Lyme disease vaccine candidate uses mRNA-LNP platform technology pioneered at Penn. After a single immunization, the OspA mRNA-LNP vaccine induced superior humoral and cell-mediated immune responses in mice. These potent immune responses resulted in protection against bacterial infection.
CyanVac's intranasal parainfluenza virus 5 (PIV5)-based vaccine for Lyme Disease was found in a study to induce protection against a multi-strain Borrelia burgdorferi tick challenge in mice. The Lyme disease project was a collaboration between CyanVac and Immuno Technologies, Inc. and was supported by the National Institute of Allergy and Infectious Disease.
Lyme Disease Diagnostics
Many tick-borne infections are misdiagnosed because their nonspecific symptoms mirror other illnesses. In addition, several Borrelia sub-species and strains exist, and researchers continue to discover new species.
Lyme Disease Overview
According to the U.S. NIH, Borreliosis is an infectious disease caused by spiral-shaped bacteria known as Borreliae, often carried by ticks. The species of Borreliae known to cause disease in humans are split into the following two groups: B. burgdorferi sensu lato, which causes Lyme disease, and Relapsing Fever Borrelia, which causes Tick-borne Relapsing Fever.
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Monday, March 3, 2025 - 06:10
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