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Cedar Park Travel Vaccines

Cedar Park, Round Rock, Texas Travel Vaccination Services June 2025

Travel vaccination services are available at certified travel clinics and pharmacies in the greater Cedar Park (78613), Manor (78653), Pflugerville (78660), and Round Rock (78665), Texas, area. As of June 2025, travel vaccination appointments for yellow fever, measles, polio, and UTI can be requested at Vax-Before-Travel.

Measles Outbreak 2025

As of June 8, 2025, Williamson County has reported six measles cases in 2025. MMR vaccination services are offered at clinics and pharmacies in Texas.

Travel Vaccinations

Travel vaccines include but are not limited to the following vaccines:

Chikungunya - Two Chikungunya vaccines are expected to be available in 2025.

Cholera - Outbreaks are impacting over 20 countries in 2025. There is a global shortage of cholera vaccines.

Dengue - Both Dengvaxia and Qdenga vaccines are not available in the U.S. as of 2025.

Malaria - Two different malaria vaccines are available in Africa.

Measles - Vaccines are available in 2025.

Polio - Some international travelers are advised to receive polio IPV booster doses. The nOPV2 polio vaccine is not offered in the U.S.

Recurrent UTI vaccine - The Uromune vaccine is offered in various countries in 2025, but not in the USA or Canada.

Yellow Fever The YF-Vax vaccine is offered in the USA, while the Stamaril vaccine is offered internationally.

Yellow Fever Vaccine International Certificates

Known as 'yellow cards,' the International Certificates of Vaccination or Prophylaxis are available at certified yellow fever vaccination centers after a vaccination is completed.

Travel Vaccine News

Click here to read today's breaking travel vaccine news.

2 min read

Reviewer:

Holly Lutmer PharmD

Robert Carlson, MD

Last Reviewed:

Sunday, June 8, 2025 - 12:40

Description:

Travel vaccination services in Cedar Park, Pflugerville, and Round Rock Texas.

Travel:

Austin

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.

0 min read

Manufacturer:

SIGA

Reviewer:

Robert Carlson, MD

Vaccine:

TPOXX (Tecovirimat) Antiviral

VIS:

PDF

Availability:

U.S., Canada, Europe

Generic:

tecovirimat

Drug Class:

Small molecule medication

Clinical Trial Phase I:

Phase I Trial of an Investigational Small Pox Medication

Clinical Trial Phase II:

Study to Assess the Safety and Pharmacokinetics of TPOXX® When Administered Orally for 28 Days

Clinical Trial Phase III:

A5418:Study Of Tecovirimat For Human Monkeypox Virus (STOMP)

Clinical Trial Phase IV:

A Phase 4, Observational Field Study to Evaluate TPOXX in Patients With Smallpox

Lab Test:

CDC

Condition:

Smallpox

Monkeypox

Last Reviewed:

Saturday, April 19, 2025 - 06:50

Brand:

TPOXX

Abbreviation:

ST-246

CPT Code:

ChemSpider ID:

ChEMBL ID:

Accession Number:

Status:

Manufacturer Country ID:

FDA First In Class:

Yes

Side Effects:

Ingredients:

Countries:

UNII:

Rate Vaccine:

I9wMyxYx

Location tags:

United States of America

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.

5 min read

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

Last Reviewed:

Tuesday, June 10, 2025 - 06:00

Description:

Mpox vaccines are approved and offered in various countries in 2025

Vaccine:

JYNNEOS Smallpox Mpox Vaccine

Acute Hepatitis Children 2023

Acute Hepatitis in Children May 2023

The World Health Organization (WHO), the United Kingdom, Europe, Canada, and the U.S. Centers for Disease Control and Prevention (CDC) have reported acute liver inflammation infections of unknown etiology among children. Since the initial report in October 2021, the U.S. CDC has confirmed that 391 cases of an unknown cause are persons under investigation (PUI) in forty-four states, Puerto Rico, and Washington DC, as of April 12, 2023.

Among the reported PUIs in the U.S., about 90% required hospitalization, 6% needed a liver transplant, and 11 died. In addition, preliminary reports indicated that among PUIs receiving adenovirus testing, about 44% were positive. Although there have been previous reports of hepatitis in children with suppressed immune systems infected with adenovirus, adenovirus type 41 is not a common cause of hepatitis in otherwise healthy children. Some estimates suggest that 30-50% of hepatitis cases in children are from unknown causes. Of the pediatric patients with data regarding COVID-19 vaccination status, about 85% were unvaccinated.

Acute Hepatitis Cases 2023

Since its first identification in Scotland in 2022, and as of March 30, 2023, the following countries have reported over 1,000 pediatric patients with acute hepatitis: Austria, Argentina, Belgium, Brazil, Columbia, Cyrus, Denmark, England, France, Greece, Ireland, Italy, Japan, Latvia, Moldova, the Netherlands, Norway, Poland, Portugal, Scotland, Serbia, Singapore, Spain, Sweden, USA, Wales, and the United Kingdom.

Adeno-associated Virus Type 2 (AAV2) in Children

The journal Nature reported on March 30, 2023, a study used PCR testing, viral enrichment-based sequencing, and agnostic metagenomic sequencing to analyze samples from 16 HAdV-positive cases from October 1, 2021, to May 22, 2022, in parallel with 113 controls. In blood from 14 cases, adeno-associated virus 2 (AAV2) sequences were detected in 93% (13 of 14), compared to 4 (3.5%) of 113 controls (P<0.001) and to 0 of 30 patients with hepatitis of defined etiology (P<0.001). In controls, HAdV-41 was detected in blood from 9 (39.1%) of the 23 patients with acute gastroenteritis (without hepatitis), including 8 of 9 patients with positive stool HAdV testing, but co-infection with AAV2 was observed in only 3 (13.0%) of these 23 patients versus 93% of cases (P<0.001). Co-infections by Epstein-Barr virus, human herpesvirus 6, and/or enterovirus A71 were also detected in 12 (85.7%) of 14 cases, with higher herpesvirus detection in cases versus controls (P<0.001). Our findings suggest that the severity of the disease is related to co-infections involving AAV2 and one or more helper viruses.

Adenovirus Infections Children

Adenovirus has been the most frequently detected pathogen, noted in 193 (52%) of 368 cases in Europe, reported a study published by The Lancet Microbe on September 1, 2022. In children, adenoviruses most often cause infections in the respiratory system, but they also cause digestive tract infections. According to the CDC, there is no specific medical treatment for adenovirus infections, and antibiotics may not work on adenoviruses. Dr. Arun Kumarendu Singh, associated with AIIMS, Jodhpur, said, "Unlike COVID, children below ten are susceptible to Adenovirus. Among them, those below two years of age are more vulnerable," Singh told PTI over the phone on February 21, 2023.

Circovirus in Human Hepatitis

The U.S. CDC reported that in March 2022, a 61-year-old woman in France who had received a heart-lung transplant sought treatment for chronic hepatitis, mainly characterized by increased liver enzymes. After ruling out common etiologies, we used metagenomic next-generation sequencing to analyze a liver biopsy sample and identified an unknown species of circovirus, tentatively named human circovirus 1 (HCirV-1). We found no other viral or bacterial sequences. HCirV-1 shared 70% amino acid identity with the closest known viral sequences. The viral genome was undetectable in blood samples from 2017–2019, then became detectable at low levels in September 2020 and peaked at very high titers (1010 genome copies/mL) in January 2022. In March 2022, we found >108 genome copies/g or mL in the liver and blood, concomitant with hepatic cytolysis. In addition, we detected HCirV-1 transcripts in 2% of hepatocytes, demonstrating viral replication and supporting the role of HCirV-1 in liver damage.

Hepatitis Vaccines

Hepatitis vaccine news is posted at this link.

Acute Hepatitis Children News

May 1, 2023 - Inactivated Enterovirus Type 71 Vaccine Inlive® has been authorized for children in Indonesia

March 31, 2023 - The Conversation published an article that suggests strongly that AAV2, HAdV F41, and the immune response to one or both of the identified viruses underlie the cases of hepatitis seen around the world.

March 30, 2023 - @HelenBranswell Tweeted new studies found the presence of adeno-associated virus 2 (AAV2) in the blood and liver tissues of a number of affected children. They also identified the presence of adenoviruses or herpes viruses.

January 23, 2023 - The Institut Pasteur scientists identified a previously unknown species of circovirus, provisionally named human circovirus 1 (HCirV-1). In March 2022, they found >108 genome copies/g or mL in the liver and blood, concomitant with hepatic cytolysis. Furthermore, we detected HCirV-1 transcripts in 2% of hepatocytes, demonstrating viral replication and supporting the role of HCirV-1 in liver damage.

December 4, 2022 - The peer-review journal Vaccines published a study: Vaccine-Related Autoimmune Hepatitis: Emerging Association with SARS-CoV-2 Vaccination or Coincidence? Early diagnosis is mandatory and should be considered in patients with acute or chronic hepatitis after SARS-CoV-2 vaccination, especially those with pre-existing liver disease.

September 6, 2022 - Local media in Spain reported there had been (48) pediatric cases of unknown hepatitis-like illness in 2022, with (3) liver transplants and (2) related fatalities.

September 1, 2022 - The Lancet Microbe published New guidance for researching acute hepatitis in children. So far, adenovirus has been the most frequently detected pathogen, noted in 193 (52%) of 368 cases in Europe.

August 18, 2022 - The NEJM published an ORIGINAL ARTICLE: A Case Series of Children with Acute Hepatitis and Human Adenovirus Infection. CONCLUSIONS: Human adenovirus viremia was present in the majority of children with acute hepatitis of unknown cause admitted to Children's of Alabama from October 2021 to February 2022, but whether human adenovirus was causative remains unclear. Sequencing results suggest that if human adenovirus was causative, this was not an outbreak driven by a single strain. A related Editorial added: Many other viruses, some quite commonly encountered during childhood, are hepatotropic and, in a minority of patients, may cause illness that can escalate in severity. In these cases, liver damage manifests as elevations in serum levels of liver enzymes.

August 5, 2022 - The AP reported Spain's health ministry had reported 46 cases, including three children who needed liver transplants. Of these three, two patients died.

July 29, 2022 - This ECDC/WHO report provides an overview of the cases of hepatitis of unknown origin in children aged 16 years and below reported to ECDC and the WHO Regional Office for Europe for the period up to 28 July 2022, including the 27 countries of the European Union and the additional three countries of the European Economic Area. Since the first alert launched by the UK on 5 April 2022, cases of hepatitis of unknown etiology in children have been reported from multiple countries worldwide, it is unclear whether all cases identified following the alert are part of an actual increase compared to the baseline rate of hepatitis of unknown etiology in children.

July 28, 2022 - The UK Health Security Agency confirmed 270 cases of sudden onset hepatitis in children aged ten and younger. Of these children, 15 have received a liver transplant; none has died. The rate at which new cases are reported has now declined. And the UKHSA published Technical Briefing #4: Investigation into acute hepatitis of unknown etiology in children in England. Adenovirus (64%) remains the most frequently detected potential pathogen in the U.K.'s 270 confirmed cases. And the SARS-CoV-2 virus had been detected in 17%.

July 25, 2022 - MIT Tech Review published: We're starting to understand the mysterious surge of hepatitis in children.

July 1, 2022 - The peer-review journal Nature published: Sudden onset hepatitis in children. The UKHSA has triggered a special Comprehensive Clinical Characterisation Collaboration (ISARIC4C) in response to unexplained hepatitis in children in the UK.

June 28, 2022 - Science.org reported 'a WHO team led by infectious disease physician Philippa Easterbrook this week aims to launch a survey of hepatologists at pediatric liver units and intensive care units around the globe, asking for case counts and data from the prepandemic era as well as from recent months.'

June 24, 2022 - The U.S. CDC published a Morbidity and Mortality Weekly Report - Interim Analysis of Acute Hepatitis of Unknown Etiology in Children. The investigation is ongoing; further clinical data are needed to understand the cause of these (296) cases and to assess the potential association with Adenovirus.

June 24, 2022 - The WHO published - Severe acute hepatitis of unknown etiology in children - Multi-country - The risk at the global level is currently assessed as moderate, considering the etiology of this severe acute hepatitis remains unknown and is being investigated.

June 21, 2022 - The Pan American Health Organization announced new guidance for regional laboratories to contribute to investigating the causes of hepatitis of unknown origin in children. "While this is a severe disease in children and is a cause of concern, its occurrence remains rare," commented Ruben Mayorga at the PAHO. He stressed, however, that it is important to "continue to monitor the situation and investigate probable cases."

June 20, 2022 - Prof Rela and his India-based team were recognized as South Asia's most extensive Paediatric liver transplant program, having performed over 500+ pediatric liver transplantations. "Liver transplantation in children was unheard of and has seen many families suffer. And now, to see how this is made available to the neediest, I must thank the Government of Tamil Nadu for their relentless support."

June 17, 2022 - Since the last ECDC surveillance bulletin, 48 new cases have been reported from eight countries (Austria (one), Greece (three), Ireland (one), Italy (two), the Netherlands (one), Spain (one), Sweden (one), and the United Kingdom (38).

June 17, 2022 - The UKHSA published - Research and analysis: Investigation into acute hepatitis of unknown etiology in children in England: case update.

June 16, 2022 - The U.S. CDC's National Center for Immunization and Respiratory Diseases published a 'Technical Report: Acute Hepatitis of Unknown Cause.'

June 14, 2022 - The U.S. CDC published an early MMWR - Trends in Acute Hepatitis of Unspecified Etiology and Adenovirus Stool Testing Results in Children — U.S., 2017–2022.

June 14, 2022 - The U.S. CDC reported, 'Analyses of four data sources did not indicate recent increases in hepatitis-associated emergency department visits or hospitalizations, liver transplants, or adenovirus types 40/41 percent positivity among U.S. children compared with pre–COVID-19 pandemic levels.' The findings in this CDC report are subject to at least seven limitations.

June 11, 2022 - Portugal's Directorate-General for Health (DGS) recently advised that children with symptoms suggestive of acute hepatitis should urgently attend a hospital.

June 10, 2022 - A study from Tel Aviv University: Long COVID-19 Liver Manifestation in Children. We report five pediatric patients who recovered from COVID-19 and later presented with liver injury. After a thorough workup that excluded other known etiologies, we report two patterns of potentially long COVID-19 liver manifestations in children with common clinical, radiological, and histopathological characteristics.

June 7, 2022 - The World Hepatitis Summit 2022 urges action to eliminate viral hepatitis as unexplained hepatitis cases in children increases globally.

June 2, 2022 - The journal Nature published: A multiancestry genome-wide association study of unexplained chronic ALT elevation as a proxy for nonalcoholic fatty liver disease with histological and radiological validation. Our approach to integrating cALT, histology, and imaging reveals new insights into a genetic liability to NAFLD.

May 31, 2022 - Revive Therapeutics Ltd. announced that in light of the growing cases of acute hepatitis in children, the Company would advance its drug pipeline for inflammatory liver disorders, including Bucillamine in the prevention of ischemia-reperfusion injury during liver transplantation and Cannabidiol for autoimmune hepatitis.

May 27, 2022 - Japan's Ministry of health, labor, and welfare announced the 31st case of acute hepatitis in children of unknown etiology.

May 20, 2022 - Public Health Scotland confirmed that 26 cases of sudden onset hepatitis (liver inflammation) in children aged ten and under had been identified in Scotland since January 2022.

May 20, 2022 - The UKHSA published Technical Briefing document #3 on investigating acute hepatitis cases of unknown etiology in children in England.

May 17, 2022 - The BMJ published an Editorial: Acute hepatitis of unknown origin in children: 'Many leads but few clear answers.'

May 16, 2022 - NanoViricides, Inc. has initiated a program to screen its library of broad-spectrum antiviral nanoviricides against human Adenovirus 41 Type F (hAd41-F), believed to be strongly associated with the occurrence of severe hepatitis syndrome in some children, causing liver transplants as well as fatalities in large percentages of cases.

May 16, 2022 - Isabella Eckerle, co-Head of the Centre for Emerging Viral Diseases at the Geneva University Hospitals, said the possibility of acute hepatitis in children following COVID-19 infection could not be ruled out.

May 13, 2022 - The Lancet published: Severe acute hepatitis in children: investigate SARS-CoV-2 superantigens. 'We suggest that children with acute hepatitis be investigated for SARS-CoV-2 persistence in stool, T-cell receptor skewing, and IFN-γ upregulation because this could provide evidence of a SARS-CoV-2 superantigen mechanism in an adenovirus-41F-sensitised host. If evidence of superantigen-mediated immune activation is found, immunomodulatory therapies should be considered in children with severe acute hepatitis.'

May 12, 2022 - The Lancet published: Explaining unexplained hepatitis in children.

May 11, 2022 - The U.S. CDC issued Health Alert Network Health Update CDCHAN-00465 with information about an epidemiologic investigation of pediatric cases of hepatitis of unknown etiology in the U.S. Where possible, clinical specimens should be tested locally to ensure timely results for patient care. Nucleic acid amplification testing, such as polymerase chain reaction, is preferred for adenovirus detection (currently unavailable for FFPE liver biopsy or native liver explant). In addition, testing whole blood by PCR is more sensitive and preferred over testing plasma by PCR.

May 9, 2022 - Indonesia identified 15 cases of acute hepatitis of unknown origin after reporting three pediatric fatalities.

May 6, 2022 - Staff from the U.S. CDC conducted a telebriefing where Dr. Jay Butler, the deputy director of infectious diseases, commented, 'these pediatric cases have been reported since October 2021, with initial cases confirmed in Alabama. Of the 109 diagnosed children, 90% were hospitalized, 14% required liver transplants, five children have died, with some children are still hospitalized.

April 29, 2022 - The CDC reported: The Alabama cluster review: cases began Oct. 1, 2021, with no geographical or epidemiological links between the children who were <= age 5; Adenovirus was detected in all children, with type 41 detected in five specimens; three patients developed acute liver failure, two of whom were treated with cidofovir (off-label use) and steroids, and underwent liver transplantation; at admission, eight patients had scleral icterus, seven had hepatomegaly, six had jaundice, and one had encephalopathy.

April 29, 2022 - Garcetin Madrid reported that in Spain, between January 2022 and April 29, 2022, twenty-two acute hepatitis-like cases have been detected with no epidemiological link. A total of 8 have been in the Community of Madrid. In one case, it has been possible to determine through genomic sequencing that the Adenovirus is type 2.

April 26, 2022 - The Romanian Ministry of Health announced a 5-year-old child from the Bucharest-Ilfov area was admitted to a specialized hospital on April 4, 2022, for severe acute hepatitis.

April 20, 2022 - The Journal of Virology published: SARS-CoV-2 vaccination can elicit a CD8 T-cell dominant hepatitis. In this case report, we show that highly activated T cells accumulate and are evenly distributed in the different areas of the liver in a patient with liver inflammation following SARS-CoV-2 vaccination. Moreover, within these liver-infiltrating T cells, we observed an enrichment of T cells reactive to SARS-CoV-2, suggesting that these vaccine-induced cells can contribute to liver inflammation. Autoimmune-hepatitis-like disease after vaccination against SARS-CoV-2 is now recognized as a rare adverse event not identified in early trials. The widespread use of the vaccine with the administration of hundreds of millions of doses worldwide also raises questions of causality vs. coincidence.

April 21, 2022 - The U.S. CDC published Health Advisory #CDCHAN-00462 - Recommendations for Adenovirus Testing and Reporting of Children with Acute Hepatitis of Unknown Etiology. A possible association between pediatric hepatitis and adenovirus 41 infection is under investigation.

April 20, 2022 - A peer-reviewed Research Article by the Journal of Hepatology: SARS-CoV-2 vaccination can elicit a CD8 T-cell dominant hepatitis. Conclusions - COVID-19 vaccination can elicit a distinct T cell-dominant immune-mediated hepatitis with a unique pathomechanism associated with vaccination-induced antigen-specific tissue-resident immunity requiring systemic immunosuppression.

April 18, 2022 - The Alabama Department of Public Health recently announced it is investigating an increase in hepatitis in nine young children in Alabama, with a potential association with Adenovirus 41.

April 14, 2022 - The number of children presenting acutely with abnormal liver function tests in March 2022 to the Royal Hospital for Children, Glasgow, were compared with those in March 2019 as well as March 2020 and 2021, confirming higher-than-expected numbers in 2022 among children under five years of age. Furthermore, the number presented in March 2022 exceeded the total number expected for Scotland over one year.

December 27, 2021 - The journal Immunology published: New-onset autoimmune phenomena post-COVID-19 vaccination, which summarized the emerging evidence about autoimmune manifestations occurring in response to certain COVID-19 vaccines.

March 12, 2019 - Adenovirus in solid organ transplant recipients: Guidelines from the American Society of Transplantation Infectious Diseases Community of PracticeProspective randomized clinical trials do not support the use of antiviral therapy. However, most transplant centers consider intravenous cidofovir the standard practice for treating severe, progressive, or disseminated adenovirus disease. In addition, intravenous immunoglobulin may be beneficial, primarily in a select group of patients with hypogammaglobulinemia.

October 6, 2017 - U.S. CDC MMWR: Human Adenovirus (41) Surveillance — the United States, 2003–2016.

August 4, 2017 - Epidemic Keratoconjunctivitis Outbreak Associated with Human Adenovirus Type 8 — U.S. Virgin Islands, June–November 2016.

June 2017 - The American Journal of Surgical Pathology: Adenovirus Hepatitis - Clinicopathologic Analysis of 12 Consecutive Cases From a Single Institution.

January 2007 - Treatment of Adenovirus Disease in Stem Cell Transplant Recipients with Cidofovir. In conclusion, early treatment of AdV disease with cidofovir inhibits viral replication in vivo and reduces mortality in allogeneic SCT recipients compared with historical data.

August 1996 - U.S. NIH - Adenovirus 41 replication: cell-related differences in viral gene transcription.

August 1994 - This paper used various approaches to characterize the two proteins and determine whether both fibers were expressed in infected cells and viral particles. DNA sequencing of the subgroup F human adenovirus serotype 41 (TAK, Ad41) fiber gene revealed the presence of two adjacent open reading frames encoding information for proteins with molecular weights of 60.6 kDa and 41.4 kDa (Pieniazek et al.; Nucleic Acids Res. 18: p. 1901, 1990).

Adenovirus Vaccines

There is an adenovector vaccine available for most U.S. military personnel. In addition, the U.S. Department of Defense recommends it for military recruits entering basic training. It may also be recommended for other military personnel at high risk for adenovirus infection. Initially approved by the U.S. FDA in 2011, the Johnson & Johnson (Barr Labs, Inc.) adenovirus vaccine contains live adenovirus Type 4 and Type 7. The vaccine (BL 125296) comes as two tablets, taken orally, and should be swallowed whole, not chewed or crushed. The safety and effectiveness of Adenovirus Type 4 and Type 7 Vaccine in immunocompromised individuals have not been evaluated. In Canada, the Adenovirus Vaccine (W6369-19A009/A) was approved in 2018.

Autoimmune Hepatitis

Autoimmune hepatitis (AIH) can occur in individuals where environmental factors trigger an immune-mediated reaction against hepatocytes. Vaccines are a very rare cause of AIH. There are two clinically relevant types of AIH, including type 1 and type 2. Type 1 AIH, also referred to as the classic type, is typically diagnosed in adulthood, whereas type 2 is diagnosed during childhood. Both types are treated similarly; however, type 2 AIH can be more severe and difficult to control.

Nonalcoholic Steatohepatitis

Nonalcoholic fatty liver disease (NAFLD) is a condition in which fat builds up in your liver. The more severe form of NAFLD is called nonalcoholic steatohepatitis (NASH). NASH causes the liver to swell and become damaged. NAFLD is one of the most common forms of chronic liver disease in children and adolescents, possibly related to environmental and genetic reasons.

17 min read

Reviewer:

Holly Lutmer PharmD

Robert Carlson, MD

Last Reviewed:

Monday, May 1, 2023 - 07:35

Description:

Children acute liver inflammation infections of unknown etiology among reported in May 2023.

Condition:

Hepatitis

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.

0 min read

Manufacturer:

Janssen

Reviewer:

Robert Carlson, MD

Vaccine:

Janssen Ad26. RSV. preF Vaccine

Generic:

Ad26.RSV.preF

Drug Class:

Vaccine

Clinical Trial Phase I:

A Study to Evaluate the Safety, Tolerability and Immunogenicity of an Investigational RSV Vaccine Candidate (Ad26.RSV.preF) in A

Clinical Trial Phase II:

A Study of an Ad26.RSV.preF-based Regimen in the Prevention of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirme

Clinical Trial Phase III:

A Study of an Ad26.RSV. preF-based Vaccine in Adults Aged 18 to 59 Years, Including Adults at High Risk for Severe RSV Infection

Condition:

Respiratory Syncytial Virus (RSV)

Last Reviewed:

Monday, August 1, 2022 - 15:15

Status:

Candidate

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.

0 min read

Manufacturer:

Biogen

Reviewer:

Robert Carlson, MD

Vaccine:

Aduhelm Monoclonal Antibody

Drug Class:

mAB

Clinical Trial Phase I:

Single and Multiple Ascending Dose Study of Aducanumab (BIIB037) in Japanese Participants With Alzheimer's Disease (PROPEL)

Clinical Trial Phase III:

A Study to Evaluate Safety and Tolerability of Aducanumab in Participants With Alzheimer's Disease Who Had Previously Participat

Condition:

Alzheimer’s Disease

Last Reviewed:

Saturday, August 19, 2023 - 05:40

Brand:

Aduhelm

Status:

Approved

Manufacturer Country ID:

Countries:

USA

Shingles Vaccines

Shingles (Herpes Zoster) Vaccines 2025

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 according to the updated 2025 schedules. The European Medicines Agency (EMA) approves various shingles vaccines in over 30 countries. As of 2025, the shingles vaccination market exceeds $2 billion in annual revenue.

Shingles Vaccines Approved

Shingrix—GSK's Shingrix is a non-live, adjuvanted recombinant shingles vaccine (zoster) containing the varicella-zoster virus glycoprotein E antigen and the AS01B adjuvant system, a proprietary adjuvant containing QS-21 and MPL with 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 2025

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 be beneficial for reducing the burden of cardiovascular disease in the general population.

0 min read

Reviewer:

Robert Carlson, MD

Vaccine:

Shingles Vaccines

VIS:

PDF

Availability:

Worldwide

Drug Class:

Vaccine

Find Price:

Discounts

Lab Test:

CDC

Condition:

Shingles

Last Reviewed:

Thursday, December 11, 2025 - 16:35

Status:

Approved

Kosher:

Yes

Halal:

Yes

Ingredients:

Countries:

Location tags:

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.

0 min read

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

Vaccine:

Lyme Disease Vaccines

Availability:

N/A

Drug Class:

Vaccine

Condition:

Lyme Disease

Last Reviewed:

Monday, March 3, 2025 - 06:10

Status:

Countries:

Location tags:

United States of America

Alzheimer’s Disease Vaccines

Alzheimer's Disease Vaccine and Monoclonal Antibody 2024

As of June 14, 2024, the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), Japan, and the United Kingdom's NHS have not authorized preventive Alzheimer's disease (AD) vaccines or approved therapeutics for bipolar disorder (BD), major depressive disorder (MDD) and post-traumatic stress disorder (PTSD). In the United States, the CDC says about 4% of people over 65 years of age have Dementia. Recently, monoclonal antibody intravenous infusion therapies (Leqembi® and Aduhelm®) have been approved in the U.S. and Japan to treat, not prevent, early AD, a degenerative brain disease.

Alzheimer's Vaccine Candidates 2024

AADvac1 is a therapeutic vaccine candidate for Alzheimer's disease that targets misfolded tau protein, a common denominator of neurofibrillary pathology.

ACI-35.030 is a first-in-class AD vaccine candidate designed to generate a specific antibody response against pTau proteins in the brain. AC Immune is collaborating with Janssen Pharmaceuticals, Inc. Recent results show that ACI-35.030 treatment rapidly leads to the strong and durable induction of antibodies specific for pathological forms of Tau, such as pTau and its aggregated form, ePHF. In addition, the ACI-35.030-induced antibody response was sustained and could be periodically boosted over 72 weeks.

Alzamend Neuro, Inc.'s AL001 novel lithium-delivery system can potentially deliver the benefits of marketed lithium salts while mitigating or avoiding currently experienced toxicities associated with lithium. AL001 is designed to distribute lithium in the brain, resulting in lower exposure to other body organs and an improved safety profile compared to currently marketed lithium salts. Alzamend Neuro announced in October 2023 the receipt of a "Study May Proceed" letter from the U.S. FDA for the initiation of study AL001-BD01, a Phase IIA clinical study of AL001 for BD type 1. On March 22, 2023, the Company announced the completion of the clinical portion of its Phase IIA multiple ascending dose study. On November 20, 2023, the Company announced a receipt of a "Study May Proceed" letter from the FDA for the initiation of study AL001-MDD01, a Phase IIA clinical study of AL001 for treating patients with MDD. On December 11, 2023, the Company received a "Study May Proceed" letter from the FDA for the initiation of study AL001-PTSD01, a Phase IIA clinical study of AL001 for treating patients with PTSD. On May 9, 2024, the Company announced a stock offering for $25,000,000.

Alzinova AB's ALZ101 is an active, therapeutic oligomer-specific vaccine candidate that stimulates the production of antibodies against the toxic Aβ oligomers. The first-in-human Phase 1b study in patients with early AD was initiated in 2021. Alzamend is also pursuing AL001 for the treatment of bipolar disorder and PTSD. Topline data for the analysis is anticipated in the second half of 2023. In addition, the Company partnered with the Miller School of Medicine and the Interdisciplinary Stem Cell Institute at the University of Miami in Florida for its Phase I/IIA clinical trial of ALZN002.

Araclon Biotech's ABvac40 is an active vaccine against the Aβ40 peptide for treating patients with early-stage Alzheimer's disease. On October 25, 2023, the Company reported a phase 2 trial met primary endpoints, confirming the vaccine's safety, tolerability, and robust immune response against the Aβ40 peptide in early-stage Alzheimer's patients. ABvac40 treatment slowed disease progression up to 38% compared with placebo as measured by the Mini-Mental State Examination score.

Alzheimer's Monoclonal Antibody Treatments

Aduhelm™ is an amyloid beta-directed antibody injection of 100 mg/mL for intravenous use indicated to treat AD and was approved by the FDA on July 8, 2021. The FDA issued approval to Biogen and Eisai Co., Ltd.

Leqembi™ gained U.S. FDA traditional approval for treating AD l on July 6, 2023. The approval of Leqembi (BAN2401, lecanemab-irmb) was granted to Eisai R&D Management Co., Ltd. On September 25, 2023, Japan issued a similar authorization, as did China on January 9, 2024.

Eli Lilly's donanemab (Kisunla™) was approved in July 2024 for a broad population of people diagnosed with mild cognitive impairment due to Alzheimer’s. The total cost of Kisunla will vary by patient based on when they complete treatment. A JAMA Original Investigation published positive study results in 2023.

Gantenerumab is a fully human IgG1 antibody that binds with subnanomolar affinity to a conformational epitope on Aβ fibrils. It encompasses both N-terminal and central amino acids of Aβ. A November 2023 study found that Gantenerumab led to a lower amyloid plaque burden among persons with early AD than placebo at 116 weeks. Still, it was not associated with slower clinical decline. (GRADUATE I and II; NCT03444870 and NCT03443973. In 2021, Gantenerumab was granted U.S. FDA Breakthrough Therapy Designation in Alzheimer's Disease.

ACI-24.060 is an amyloid-beta (Abeta) antibody produced by AC Immune SA and derived from the Company's SupraAntigen® platform. The FDA awarded Fast Track destination on June 27, 2023. On May 13, 2024, AC Immune and Takeda announced a partnership.

ADvantage Therapeutics, Inc. announced that the UK's MHRA had granted AD04™ an Innovation Passport for treating AD under the Innovative Licensing and Access Pathway on April 5, 2023. Authorities in Poland, Bulgaria, and Slovakia approved its Clinical Trial Application on June 20, 2023, to conduct a clinical trial with AD04. The Company believes AD04™ may function as an immunomodulator, stimulating and/or regulating the immune system to reduce AD pathology. Rather than being limited to a specific aspect of AD pathology, such as amyloid beta or tau, AD04™ may restore the expression of genes in lipid metabolism, improve phagocytosis, and reduce inflammation. On November 27, 2023, the Company announced the first patient enrolled in AD04's European Phase 2b clinical trial.

ProMIS therapeutic product candidate PMN310 is a monoclonal therapeutic antibody designed to treat AD, consisting of an AβO conformational peptide epitope conjugated to KLH as a carrier protein to provide T cell help, elicited robust and sustained antibody responses with either alum or QS-21 as the adjuvants.

UB-311 is a synthetic, peptide-based active immunotherapy candidate targeting toxic forms of aggregated beta-amyloid in the brain to treat and prevent Alzheimer's disease. Phase 1, Phase 2a, and Phase 2a long-term extension trials have shown UB-311 to be well tolerated in mild-to-moderate AD patients over three years of repeat dosing, with a safety profile comparable to placebo and no cases of amyloid-related imaging abnormalities-edema in the Phase 2a trial. It was granted U.S. FDA Fast Track status.

Alzheimer's Treatments

Eli Lilly and Company presented an interim analysis from a phase 1 study of LY3372993 on March 31, 2023. Remternetug (LY3372993) is an IgG1 monoclonal antibody directed at the pyroglutamate modification of the third amino acid of the amyloid-beta peptide that is present only in brain amyloid plaques. This antibody demonstrated rapid and robust amyloid plaque reduction in participants with AD. The safety, tolerability, and pharmacokinetic/pharmacodynamic data support the ongoing Phase 3 trial (NCT05463731)

Alzamend Neuro, Inc.'s AL001 is a patented ionic cocrystal technology that delivers a therapeutic combination of lithium, proline, and salicylate to treat Alzheimer's and other neurodegenerative diseases and psychiatric disorders. ALZN002 immunotherapy is intended to treat patients diagnosed with Alzheimer's by inducing their antibodies. These are targeted to remove the Aβ1‑42 protein, reducing the deposition of amyloid plaque in the brain and thereby reducing the progression of disease-associated clinical signs and symptoms. The Company partnered with Biorasi as its contract research organization.

Prothena Corporation's PRX012 is a next-generation, high-binding potency antibody designed to enable subcutaneous dosing on a patient-friendly, convenient administration schedule, potentially providing greater accessibility for AD patients and caregivers. Accordingly, the U.S. FDA granted Fast Track Designation on April 26, 2022.

Synaptogenix, Inc.'s Bryostatin-1 is targeting Alzheimer's disease. The paper "Advanced Alzheimer's Disease Patients Show Safe, Significant, and Persistent Benefit in 6-Month Bryostatin Trial" concluded that the Bryostatin-treated MMSE 10-14 patients showed no significant cognitive decline throughout the 10-month trial. In contrast, the placebo patients declined by -12.8 SIB points.

BCG Vaccination and Dementia

An Original Investigation led by investigators at Massachusetts General Hospital and Brigham and Women's Hospital was published by The JAMA Network on May 19, 2023, concluding that BCG vaccination was associated with a lower rate and risk of Alzheimer's disease and related Dementia. In a risks analysis, the BCG vaccine was associated with a lower risk of Alzheimer's disease and related dementias (ADRD) (5-year risk difference, −0.011; 95% CI, −0.019 to −0.003) and a decreased risk of death in patients without an earlier diagnosis of ADRD (5-year risk difference, −0.056; 95% CI, −0.075 to −0.037).

Alzheimer's Testing

Researchers at Karolinska Institutet announced on April 12, 2023, that a type of sugar molecule in the blood is associated with the level of Tau. This protein plays a critical role in the development of severe Dementia. Therefore, bisecting N-acetylglucosamine and Tau are valuable blood biomarkers for predicting AD. The U.S. FDA permitted marketing on May 4, 2022, for Fujirebio Diagnostics, Inc. Lumipulse G β-Amyloid Ratio (1-42/1-40) in vitro diagnostic test intended to be used in adult patients aged 55 years and older, presenting with cognitive impairment who are being evaluated for AD and other causes of cognitive decline.

On December 27, 2022, a new study, Brain-derived Tau: a novel blood-based biomarker for Alzheimer's disease-type neurodegeneration, presented a novel blood test that assessed brain-derived Tau-detected Alzheimer' s-related neurodegeneration and differentiated Alzheimer's from other neurodegenerative diseases. Furthermore, this innovative test outperformed total Tau and, unlike neurofilament light, showed specificity to Alzheimer's disease-type neurodegeneration. Thus, brain-derived Tau demonstrates the potential to complete the AT(N) scheme in blood and will be used in evaluating.

Note: This webpage aggregates and edits content and manually curates it for mobile readers. Healthcare providers fact-check all content.

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Reviewer:

Robert Carlson, MD

Danielle Reiter RN

Holly Lutmer PharmD

Vaccine:

Alzheimer’s Disease Vaccines

Drug Class:

Vaccine

Lab Test:

CDC

Condition:

Alzheimer’s Disease

Last Reviewed:

Monday, July 1, 2024 - 07:30

Status:

Candidate

Countries:

U.S. - mAb treatment

AREXVY RSV Vaccine

AREXVY™ RSV Vaccine Clinical Trials, Dosage, Efficacy, Indication, Side Effects

GlaxoSmithKline Biologicals plc (GSK) AREXVY™ recombinant, AS01E adjuvanted, single-dose RSV vaccine contains a recombinant subunit pre-fusion respiratory syncytial virus (RSV) glycoprotein antigen (RSVPreF3) combined with GSK's proprietary AS01 adjuvant. The antigen plus adjuvant combination helps overcome the natural decline in immunity that contributes to the challenge of protecting people from RSV disease. AREXVY contains Agenus' proprietary QS-21 STIMULON™ within its AS01 adjuvant, which has already demonstrated positive immune responses and a favorable safety profile. QS-21 Stimulon improves a vaccine's effectiveness by inducing strong antibody and cell-mediated immune responses. It also plays a crucial role in boosting immune response in older adults who often experience age-related decline in immunity.

On May 3, 2023, the U.S. Food and Drug Administration (FDA) approved Arexvy to prevent LRVD caused by RSV in individuals 60 and older in the U.S. (PRESCRIBING INFORMATION, Package Insert). On June 7, 2024, the FDA approved Arexvy for adults aged 50 through 59 who are at increased risk of RSV. As of October 2024, about 9 million people in the U.S. have been vaccinated with Arexvy. GSK says Arexvy is the only RSV vaccine with efficacy and safety data available through three full seasons, including in people at increased risk.

The European Medicines Agency (EMA) recommended marketing authorization in the European Union (EU) on April 26, 2023, for Arexvy for active immunization to protect adults aged 60 years and older against LRTD caused by RSV. The European Commission authorized Arexvy on June 7, 2023. The U.K.'s Medicines and Healthcare products Regulatory Agency authorized Arexvy on July 10, 2023, followed by Canada on August 4, 2023. On January 29, 2023, the EMA accepted the company's regulatory application to expand the use of Arexvy to adults aged 50-59 at increased risk for RSV disease. The EMA's Committee for Human Medicines (CHMP) issued a positive opinion for individuals aged 50-59 at increased risk of RSV disease on July 29, 2024.

On November 5, 2024, AREXVY was approved in Canada for the prevention of LRTD caused by RSV. As of January 2025, the U.S. CDC says RSV vaccines are recommended for all adults ages 75 and older and adults ages 60 – 74 who are at increased risk for severe RSV. The RSV vaccine is not currently an annual vaccine. If you have received an RSV vaccine, you should not get another RSV vaccine in 2025. On April 16, 2025, the Advisory Committee on Immunization Practices (ACIP) voted in favor of recommending the use of AREXVY in adults aged 50-59 who are at increased risk for severe RSV disease.

GlaxoSmithKline plc (LSE/NYSE: GSK) is located in Brentford, West London, England, and is a science-led global healthcare company. For further information, please visit www.gsk.com/about-us. AREXVY trademark was issued on November 15, 2022.

AREXVY Indication

Arexvy has been approved for certain adults.

AREXVY Immunocompromised Persons

A Research Letter published by the JAMA Network on December 30, 2024, indicated AREXVY (RSVA-AS01E ) produced better results in immunocompromised persons.

AREXVY Efficacy

Phase 3 clinical trial results indicate that after a single dose of GSK’s RSV vaccine, cumulative efficacy over three full RSV seasons was clinically meaningful at 62.9% against RSV-LRTD (97.5% CI, 46.7-74.8, 48 of 12,468 vs 215 of 12,498) and 67.4% against severe RSV-LRTD (95% CI, 42.4-82.7, 15 of 12,468 vs 75 of 12,498) compared to placebo. In the third season, the vaccine’s efficacy was 48.0% against RSV-LRTD (95% CI, 8.7-72.0, 16 of 4,988 vs 61 of 10,031).

AREXVY Coadministration With Shingrix

GSK plc announced on September 18, 2024, that a Phase 3 clinical trial (NCT05966090) met the primary endpoint of non-inferior immune response when administering RSVPreF3 OA and Shingrix vaccines compared with separate vaccinations.

AREXVY Coadministration of Influenza Vaccines

Available data on the immunogenicity of coadministration of RSV vaccines and other vaccines are currently limited, says the U.S. CDC. Administering an RSV vaccine with other vaccines might increase local or systemic reactogenicity, and RSV and influenza antibody titers were somewhat lower with coadministration; however, the clinical significance of this is unknown. GSK presented acceptable coadministration with influenza vaccine data to the U.S. FDA on March 1, 2023.

AREXVY Vaccine U.S. CDC ACIP Review

The U.S. CDC Advisory Committee on Immunization Practices (ACIP) conducted a review of RSV vaccines on April 16, 2025.

And on October 24, 2024. On June 26, 2024, including these presentations, on October 25, 2023. Camille Kotton, MD, presented an overview, Monica E. Patton, MD, presented the epidemiology of RSV hospitalizations in adults, and Amadea Britton, MD, MS, presented ACIP Adult RSV Work Group Considerations. On July 21, 2023, the CDC's Morbidity and Mortality Weekly Report confirmed the efficacy of 1 dose of the GSK vaccine in preventing symptomatic, laboratory-confirmed RSV-associated LRTD was 82.6% (96.95% CI = 57.9%–94.1%) during the first RSV season and 56.1% (95% CI = 28.2%–74.4%) during the second season. Efficacy of 1 dose over two seasons was 74.5% (97.5% CI = 60.0%–84.5%) in preventing RSV-associated LRTD and 77.5% (95% CI = 57.9%–89.0%) in preventing medically attended RSV-associated LRTD. Leonard Friedland, M.D. Vice President, Scientific Affairs and Public Health, GSK, presented updated data. The ACIP committee voted to recommend Arexvy for preventing RSV disease in adults aged 60 and older with shared clinical decision-making. The committee recommendations mean that over 55 million older adults in the U.S. could have access to RSV vaccination for the first time. On February 23, 2023, presentations included Ismael R. Ortega-Sanchez, Ph.D., presented - Economics of Vaccinating U.S. Adults ≥60 years old against RSV; Evidence to Recommendations Framework. On October 20, 2022, Bishoy Rizkalla, GSK Global Medical Affairs, presented an update to the CDC's vaccine committee.

AREXVY U.S. FDA Review

The FDA conducted a Vaccines and Related Biological Products Advisory Committee (VRBPAC) AREXVY review meeting for (STN 125775/0) on March 1, 2023. The FDA published the Briefing Document, GSK SPONSOR BRIEFING DOCUMENT, and Errata to the GSK Briefing Document. The committee voted unanimously (100%) that the data supported the effectiveness of the vaccine and 10-2 that the data supported the safety of the RSV vaccine. On November 2, 2022, GSK announced that the FDA had accepted a Biologics License Application (BLA) (STN 125775/0) and granted a Priority Review for the RSVPreF3 OA vaccine candidate.

AREXVY Availability 2025

As of April 2025, Arexvy was available in major retail pharmacies in the U.S. and is recommended in Europe, Malaysia, the United Kingdom, Quebec, Canada, Australia, and various countries.

AREXVY Dosage

Prescribing information was posted on May 3, 2023. Recent in-house results from a parallel Phase III trial, AReSVi 004, showed that in participants aged 60 years and above, one dose of the RSV OA investigational vaccine induced strong humoral and cellular immune responses that remained above pre-vaccination levels up to at least the six-month post-vaccination readout time point.

AREXVY Safety Data

On January 7, 2025, the FDA required and approved safety labeling changes to the Prescribing Information, which include a new warning about the risk of Guillain-Barré syndrome. GSK announced in October 2024 that the safety and reactogenicity data were consistent with those from the Phase III program. In Season 1, the vaccine was generally well-tolerated. The most frequently observed adverse events were pain at the injection site, fatigue, myalgia, headache, and arthralgia within four days of vaccination. Data to the U.S. FDA on March 1, 2023, indicating limited safety data following vaccination in multiple studies. The EMA confirmed on April 26, 2023, the most common side effects reported were headache, tiredness, muscle pain, joint pain, and injection site pain.

AREXVY Maternal Vaccine Candidate

Arexvy is not approved for use in individuals under 60 years of age. In a clinical study that enrolled pregnant individuals who received an investigational unadjuvanted RSV vaccine containing the same RSVPreF3 antigen as AREXVY, an increase in preterm births was observed compared to pregnant individuals who received a placebo (sucrose reconstituted with saline). In the vaccine and placebo groups, 6.81% and 4.95% of preterm births were reported, respectively. The maternal RSV candidate vaccine was tested in three doses compared with a placebo in 502 healthy, non-pregnant women, with monthly visits at Days 8, 31, and 91 post-immunization. The data show that compared with the base, the investigational vaccine rapidly boosted the pre-existing immunity at all doses, leading to high levels of protective neutralizing antibodies. On Day 8, a 14-fold increase in RSV-A and RSV-B neutralizing antibody titers was observed. As of May 27, 2023, this product was on hold.

AREXVY Cost

GSK plc announced on August 17, 2023, that Arexvy costs will be covered by most U.S. Medicare and commercial insurance plans under the Inflation Reduction Act, and patients with Medicare Part D will pay no out-of-pocket expenses. As part of the Affordable Care Act, AREXVY may be covered for commercially insured patients at no cost when administered in-network.

AREXVY Vaccine News

April 16, 2025 - Tony Wood, Chief Scientific Officer, GSK commented: “We are pleased with ACIP's recommendation to expand the benefits of RSV immunization to more than 13 million adults aged 50-59 who are at increased risk for the severe consequences of this virus. RSV can have a significant impact for those with underlying medical conditions. We look forward to helping protect more people with RSV vaccination.”

October 24, 2024 - Tony Wood, Chief Scientific Officer, GSK, said in a press release, “We’re committed to working with health authorities and regulators to help adults at increased risk of RSV disease benefit from vaccination.”

October 8, 2024 - Tony Wood, Chief Scientific Officer, GSK, said: “We are excited by these new data, which show that a single dose of AREXVY could help protect millions of older adults at risk of RSV disease over three seasons, benefiting public health."

September 18, 2024 - Len Friedland, MD, Vice President of Scientific Affairs and Public Health, GSK, said in a press release, "We are excited to share data on the co‑administration of our RSV and shingles vaccines."

June 7, 2024 - Tony Wood, Chief Scientific Officer, GSK, said: “Today's approval reflects the importance of broadening the benefits of RSV immunization to adults aged 50-59 who are at increased risk. For those with underlying medical conditions, RSV can have serious consequences, so we are proud to be the first to help protect them from RSV-LRTD.”

April 26, 2023 - The EMA recommended a marketing authorization in the European Union for Arexvy.

June 10, 2022 - GSK plc announced positive headline results from a pre-specified efficacy interim analysis of the AReSVi 006 phase III trial. The interim analysis indicates the primary endpoint was exceeded, with no unexpected safety concerns observed.

November 23, 2020 - GlaxoSmithKline plc announced that patient dosing had begun in phase 3 clinical program investigating the safety and efficacy of its RSV candidate vaccine for maternal immunization (GSK3888550A) following the presentation of positive phase 1/2 safety, reactogenicity, and immunogenicity data last month

RSV OA Vaccine Clinical Trials

The GSK RSVPreF3 RSV vaccine has been involved in various clinical studies.

GSK announced positive phase III trial results for its RSV vaccine, demonstrating an overall vaccine efficacy of 82.6% (96.95% CI, 57.9–94.1, 7 of 12,466 vs. 40 of 12,494) against RSV lower respiratory tract disease (RSV-LRTD), meeting the AReSVi 006's primary endpoint. On February 16, 2023, the NEJM published an ORIGINAL ARTICLE: Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults. Findings: A single dose of the RSVPreF3 OA vaccine had an acceptable safety profile in a phase 3 study and prevented RSV-related acute respiratory infection and lower respiratory tract disease and severe RSV-LRTD in adults 60 years of age or older, regardless of RSV subtype and the presence of the underlying coexisting condition. GSK funded the AReSVi-006 ClinicalTrials.gov NCT04886596.

On October 25, 2023, GSK announced preliminary results from a phase III clinical trial showing that the primary endpoints had been met, with non-inferior immune responses observed in adults aged 50-59 compared to adults aged 60 and older. Adults aged 50 and above with certain underlying medical conditions are at increased risk for RSV disease. GSK is on track to being the first company to submit data in this population to regulators, with decisions on potential label expansion expected in 2024.

The AReSVi-006 (Adult Respiratory Syncytial Virus) phase III trial is a randomized, placebo-controlled, observer-blind, multi-country demonstrating the efficacyGSK's single dose of GSK's adjuvanted RSVPreF3 OA investigational vaccine in adults aged 60 years and above. Approximately 25,000 participants from 17 countries were enrolled. AReSVi 006 is a phase III trial. Last Update Posted: June 30, 2022.

Results: 24,966 participants received one dose of the RSVPreF3 OA vaccine (12,467 participants) or placebo (12,499). Over a median follow-up of 6.7 months, vaccine efficacy against RT-PCR–confirmed RSV-related lower respiratory tract disease was 82.6% (96.95% confidence interval [CI], 57.9 to 94.1), with 7 cases (1.0 per 1000 participant-years) in the vaccine group and 40 patients (5.8 per 1000 participant-years) in the placebo group. Vaccine efficacy was 94.1% (95% CI, 62.4 to 99.9) against severe RSV-related lower respiratory tract disease (assessed based on clinical signs or by the investigator) and 71.7% (95% CI, 56.2 to 82.3) against RSV-related acute respiratory infection. Vaccine efficacy was similar against the RSV A and B subtypes (for RSV-related lower respiratory tract disease: 84.6% and 80.9%, respectively; for RSV-related acute respiratory infection: 71.9% and 70.6%, respectively). In addition, high vaccine efficacy was observed in various age groups in participants with coexisting conditions. The RSVPreF3 OA vaccine was more reactogenic than the placebo, but most adverse events for which reports were solicited were transient, with mild-to-moderate severity. The incidences of serious adverse events and potential immune-mediated diseases were similar in the two groups.

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