A Phase 3, Randomized, Modified Double-blind, Active-controlled, Parallel-group, 4-arm Study to Investigate the Mixed Vaccination Schedules of a 21-valent Pneumococcal Conjugate Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers

This study is a Phase 3, randomized, modified double-blind study which aims to measure whether the investigational pneumococcal conjugate vaccine PCV21 is safe and can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) when it is given after 1 dose, 2 doses, or 3 doses of a licensed 20-valent pneumococcal vaccine compared to when 20-valent pneumococcal vaccine is given as a complete series in infants aged from approximately 2 months (42 to 89 days).
The study duration per participant will be up to approximately 19 months. The study vaccines (either PCV21 or 20vPCV) will be administered at approximately 2, 4, 6 and 12 to 15 months of age (MoA). Routine pediatric vaccines will be given as per local recommendations.
There will be 6 study visits:
Visit (V)01, V02 separated from V01 by 60 days, V03 separated from V02 by 60 days, V04 separated from V03 by 30 days, V05 at 12 months of age until 15 months of age, V06 separated from V05 by 30 days.

Start Date27 Feb 2025

Sponsor / Collaborator

Sanofi

NCT06397768

/ TerminatedPhase 3

Phase III, Randomized, Single-blind, Placebo-controlled, Multi-center Study to Evaluate Non-interference of Concomitant Administration of Routine Pediatric Vaccines on the Antibody Response of an Investigational Live-attenuated Respiratory Syncytial Virus (RSV) Vaccine in Healthy Infants and Toddlers (CORAL)

This study is a Phase III, randomized, single-blind, placebo-controlled, multi-center study to be conducted in healthy infants and toddlers which will be enrolled at approximately 6 months of age (Cohort 1) and approximately 12 months of age (Cohort 2). The primary objective of the study will be to assess non-inferiority of the RSV infant and toddler (RSVt) vaccine antibody response when administered concomitantly with routine pediatric vaccines at 6 months of age (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine [Vaxelis® or Pentacel® and Recombivax HB®] Prevnar 20®, and RotaTeq®), and 12 months of age (M-M-R II, VARIVAX, and Prevnar 20 or per local country recommendations) compared to when administered non-concomitantly.

Start Date13 May 2024

Sponsor / Collaborator

Sanofi Pasteur SA

NCT05794230

/ CompletedPhase 3

Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in India and the Republic of South Africa

This open label randomized study will be conducted to evaluate and/or describe the immunogenicity and describe the safety of MenACYW conjugate vaccine when administered in infants and toddlers.
It will be conducted in India and the RSA in 2 cohorts:
* Cohort I: Infants and toddlers 6 months to 16 months of age (Cohort I)
* Cohort II: Infants and toddlers 6 weeks to 15 months of age (Cohort II) In Cohort I, eligible participants will be randomized in a 1:1 ratio to receive 2 intramuscular (IM) injections (1+1 vaccination schedule) of either MenACYW conjugate vaccine (Groups 1 and 3) or Menactra vaccine (Groups 2 and 4), co-administered with routine pediatric vaccines.
In Cohort II, eligible participants will be randomized in a 2:1 ratio to receive either 3 IM injections (2+1 vaccination schedule) of MenACYW conjugate vaccine co-administered with routine pediatric vaccines (Groups 5 and 7) or routine pediatric vaccines only (Groups 6 and 8).
The primary objectives of this study are:
* To demonstrate the non-inferiority of immunogenicity of 2 doses of MenACYW conjugate vaccine compared to 2 doses of Menactra® vaccine in infants and toddlers 6 months to 16 months of age (Cohort I) in terms of serum bactericidal assay using human complement (hSBA) seroprotection (titers ≥ 1:8) in India and the Republic of South Africa (RSA)
* To demonstrate the vaccine immune sufficiency of 3 doses of MenACYW conjugate vaccine in infants and toddlers 6 weeks to 15 months of age (Cohort II) in terms of hSBA seroprotection (titers ≥ 1:8) in India and the RSA
The secondary objectives of this study are:
* To describe the antibody titers to the meningococcal serogroups A, C, Y, and W:
* before and 30 days post primary series of MenACYW conjugate vaccine and before and 30 days post booster dose of MenACYW conjugate vaccine in infants and toddlers 6 weeks to 15 months of age (Cohort II) in India and the RSA when administered concomitantly with other age-recommended vaccines.
* before and after 30 days post each dose of MenACYW conjugate vaccine or Menactra vaccine in infants and toddlers 6 months to 16 months of age (Cohort I) in India and the RSA when administered concomitantly with other age-recommended vaccines.
* To describe the antibody responses against the antigens of the other age-recommended vaccines when administered concomitantly with MenACYW conjugate vaccine:
* in infants and toddlers 6 weeks to 15 months of age (Cohort II) in India and the RSA.
* in infants and toddlers 6 months to 16 months of age (Cohort I) in India and the RSA.
* To describe the safety profile of MenACYW conjugate vaccine and that of licensed Menactra vaccine in infants and toddlers 6 months to 16 months of age (Cohort I) in India and the RSA when administered concomitantly with other age-recommended vaccines.
* To describe the safety profile of MenACYW conjugate vaccine in infants and toddlers 6 weeks to 15 months of age (Cohort II) in India and the RSA when administered concomitantly with other age-recommended vaccines.
* To describe the safety profile of age-recommended vaccines:
* in infants 6 weeks to 15 months of age (Cohort II) in India and the RSA when administered concomitantly with MenACYW conjugate vaccine.
* in infants and toddlers 6 months to 16 months of age (Cohort I) in India and the RSA when administered concomitantly with MenACYW conjugate vaccine.
The duration of each participant's active participation in the study will be approximately 10 to 11 months for Cohort I and 13,5 to 14,5 months for Cohort II.

Start Date27 Mar 2023

Sponsor / Collaborator

Sanofi Pasteur SA

100 Clinical Results associated with Rotavirus vaccine,live(Merck & Co.)

100 Translational Medicine associated with Rotavirus vaccine,live(Merck & Co.)

100 Patents (Medical) associated with Rotavirus vaccine,live(Merck & Co.)

382

Literatures (Medical) associated with Rotavirus vaccine,live(Merck & Co.)

01 Jul 2026·EBioMedicine

Early-life gut microbiome composition and rotavirus vaccine-induced IgA responses in U.S. infants: a longitudinal cohort study

Article

Author: Sohn, Michael B ; Jiang, Baoming ; Caddy, Sarah L ; Castro-Melendez, Darline ; Velasquez-Portocarrero, Daniel ; Gill, Steven R ; O'Connor, Tom ; Laniewski, Nathan ; Brunner, Jessica ; Gill, Ann L ; Groff, Brandon ; Qiu, Xing ; Ras, Meghan ; Scheible, Kristin ; Ejiofor, Kelechi ; Narváez-Miranda, Janiret ; Beblavy, Robert ; Leger, Alena ; Macomber, Allison

BACKGROUND:

Rotavirus remains a leading cause of childhood mortality worldwide, despite the widespread introduction of oral rotavirus vaccines. Evidence linking the gut microbiome to vaccine response is inconsistent and limited in U.S.

POPULATIONS:

This study investigates the development of the infant gut microbiome and its association with immunogenicity following RotaTeq administration in U.S. infants.

METHODS:

We conducted a longitudinal analysis of infants in Rochester, New York, using 16S rRNA sequencing to assess microbiome composition at one (M1), sixth (M6), and twelfth (M12) months of age. Rotavirus-IgA serologies were measured at M6 and M12 to assess RotaTeq vaccine seroresponse. Clinical metadata were used to assess factors associated with microbial diversity and rotavirus-IgA titres over the first year of life. We examined associations between (1) M1 microbiome and M6 rotavirus-IgA; (2) M6 microbiome and M6 rotavirus-IgA; and (3) M6 microbiome and M12 rotavirus-IgA.

FINDINGS:

Higher gut microbial alpha diversity at M1 was associated with higher rotavirus-IgA titres at M6 (N = 47, β: 2·06, 95% CI: [0·31-3·99], p = 0·024). Alpha diversity at M6 was not associated with concurrent rotavirus-IgA responses (N = 56, β: 0·73, 95% CI: [-0·856, 2·313], p = 0·36) but was associated with higher rotavirus-IgA at M12 (N = 52, β: 1·47, 95% CI: [0·127, 2·805], p = 0·033). Rotavirus-IgA responses were associated with specific microbial taxa across timepoints, with both positive and negative associations observed.

INTERPRETATION:

In a healthy U.S. infant cohort, early-life gut microbiome diversity and composition were associated with rotavirus-IgA responses following RotaTeq vaccination. This study advances understanding of microbiome-vaccine interactions in high-income settings.

FUNDING:

Office of the Director of the National Institutes of Health, National Institute of Mental Health of the National Institutes of Health, and the National Center for Advancing Translational Sciences of the National Institutes of Health.

01 Jun 2026·VACCINE

Does an off-label two-dose RotaTeq vaccine schedule translate into a higher incidence of rotavirus hospital admissions compared to the approved three-dose RotaTeq schedule? A Canadian immunization research network study

Article

Author: Grewal, Ramandip ; MacDonald, Shannon E ; Naveed, Zaeema ; Miron, Éliane ; Swayze, Sarah ; Naus, Monika ; Fortin, Élise ; Sadarangani, Manish ; Quach, Caroline ; Janjua, Naveed Z ; Wilson, Sarah E ; Kiely, Marilou ; Brousseau, Nicholas

BACKGROUND:

Rotavirus (RV) vaccination programs were implemented between 2011 and 2012 in Canada and have considerably reduced the burden of RV disease. In September 2018, the province of Quebec implemented a reduced-dose RotaTeq vaccination schedule (two doses). Other provinces, such as British Columbia and Ontario, continued to use the approved three-dose schedule for this product. Our aim was to determine whether using a reduced-dose RotaTeq schedule was associated with an increased burden of RV disease.

METHODS:

This quasi-experimental study spanned from September 2006 to March 2023. The main analysis focused on children aged 6-23 months in Quebec, Ontario, and British Columbia. Data were retrieved from administrative databases using diagnosis-specific ICD-10 codes. A difference-in-differences approach using Poisson regression was used to compare admission rates for rotavirus-associated acute gastroenteritis (RV-AGE) and for any acute gastroenteritis (AGE) before and after the implementation of a reduced-dose RotaTeq vaccination schedule in Quebec.

FINDINGS:

A total of 3875 RV-AGE and 36,568 AGE hospital admissions were identified. Across the three provinces, the rates of admission for RV-AGE and AGE were 87% and 56% lower, respectively, after vaccine program introduction as compared to before. After the implementation of the reduced-dose RotaTeq vaccination schedule in Quebec, between September 2018 and August 2020, only 19 RV-AGE hospital admissions were identified among children between 6 and 23 months of age in the three provinces. In Quebec, the reduced schedule was not associated with a statistically significant increase in RV-AGE admissions (rate ratio = 2.32; 95%CI = 0.80-6.69), or for AGE admissions in general (rate ratio = 1.02; 95%CI = 0.91-1.14), compared to temporal trends in the other two provinces.

INTERPRETATION:

This study provides reassuring evidence regarding the use of a two-dose RotaTeq schedule in a high-income country with relatively high vaccination coverage and reaffirms the substantial impact of RV vaccination introduction at a population level.

01 Apr 2026·VACCINE

Low uptake rotavirus vaccine: A study of vaccine effectiveness against rotavirus-related hospitalization based on electronic health records, Slovenia, 2019–2023

Article

Author: Danis, Kostas ; Učakar, Veronika ; Mrzel, Maja

BACKGROUND:

In Slovenia, coverage of rotavirus vaccines (Rotarix (RV1) and RotaTeq (RV5)) remains low, and the vaccines are not included in the National Vaccination Programme (NVP). We aimed to estimate vaccine effectiveness (VE) against rotavirus-related hospitalization among children aged 6 weeks to 5 years to inform national vaccination policy.

METHODS:

We linked Slovenian population registry with vaccination, surveillance, and hospitalization databases for 2019-2023 birth cohorts. We defined fully vaccinated as those receiving all recommended doses with the last dose ≥14 days before the end date (disease onset or hospitalization date, death, or study end) and partially vaccinated those receiving ≥1 dose ≥14 days before the end date. We estimated VE using quasi-Poisson regression, adjusting for age, healthcare access, socioeconomic status, and calendar time, with person-time at risk included as an offset. We also examined the relationship between full vaccination coverage and hospitalization rates across municipalities using Pearson's correlation coefficient.

RESULTS:

Among 89,994 children, 4% were partially, and 25% fully vaccinated. A total of 1272 rotavirus hospitalizations occurred, 94% among unvaccinated children. VE against hospitalization was 84% (95% CI: 73%-91%) for full and 81% (95% CI: 42%-94%) for partial vaccination. VE was 85% (95% CI: 74%-91%) for RV1 and 78% (95% CI: -29%-96%) for RV5. VE was 73% (95% CI: 30%-89%) among children aged <11 months and 88% (95% CI: 76%-94%) among those aged 11 to 23 months, with sustained high effectiveness through 5 years of age (84%, 95% CI: 63%-93%). We observed a negative correlation between full vaccination coverage and hospitalization rates across municipalities (r = -0.155, p = 0.024).

CONCLUSION:

Both full and partial rotavirus vaccination significantly reduced rotavirus-related hospitalizations among children in Slovenia. These findings support efforts to improve vaccine uptake and consideration of rotavirus vaccination inclusion in the NVP to reduce disease burden.

News (Medical) associated with Rotavirus vaccine,live(Merck & Co.)

07 Jul 2026

·www.biospace.com

ARS Pharmaceuticals Announces CEO Succession

Richard Lowenthal, Chief Executive Officer, Transitioning following More than a Decade of Leadership Since Co-Founding the Company Donn Casale, President, Appointed Chief Executive Officer and Director SAN DIEGO, July 07, 2026 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect against allergic reactions that could lead to anaphylaxis, today announced a CEO succession, in which co-founder and CEO Richard Lowenthal will no longer serve as an employee and officer of the company effective July 6, 2026. The Board has appointed Donn Casale, currently President, as CEO and Director effective July 7, 2026. “Since co-founding ARS Pharma in 2015, Rich was integral to guiding the company from development to establishing neffy ® as a leading treatment for adults and children with Type 1 allergic reactions, including anaphylaxis, and we are grateful for his many contributions,” said Pratik Shah, chairman of the Board of Directors. “As we look ahead, Donn is a seasoned business leader with deep operational and financial acumen, and proven commercial track record, particularly in growing adoption and share in large, consumer-driven markets. We are confident that he has the right background and experience to drive the company through its next phase, growing the neffy franchise and positioning ARS Pharma for both near and long-term value-creation.” Mr. Casale brings more than 25 years of biopharmaceutical business and commercial leadership, with a track record of scaling innovative products in large, patient-driven healthcare markets. Prior to ARS Pharma, he served as Chief Commercial Officer at Dynavax Technologies, where he built the U.S. commercial infrastructure and helped scale the hepatitis B vaccine HEPLISAV-B® from launch to more than $300 million in annualized revenue and over 50% U.S. market share, positioning the company for Sanofi’s $2.2 billion acquisition. Before Dynavax, Mr. Casale held leadership positions in marketing and sales operations at Depomed, supporting the commercialization of GRALISE® and NUCYNTA®. Earlier in his career, he spent 14 years at Merck in progressive roles across sales, marketing, and corporate strategy, contributing to the successful launches of ZOSTAVAX®, GARDASIL®, ROTATEQ®, and PROQUAD®. “I am excited by the opportunity to lead ARS Pharma through its next evolution,” said Mr. Casale. “ neffy is a transformational product for patients, backed by a foundational intranasal technology platform, and I am confident in our ability to grow its impact in the years to come. I’m grateful for the foundation Rich and the Board have built, and I look forward to working alongside our team to increase access, accelerate adoption, and expand the reach of ARS Pharma, delivering on the promise that our treatments can have on patients worldwide.” About neffy ® neffy is a nasal spray used for emergency treatment of allergic reactions including anaphylaxis, in adults and children who weigh 33 lbs. or greater. INDICATION AND IMPORTANT SAFETY INFORMATION FOR neffy (epinephrine nasal spray) INDICATION neffy is indicated for emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 33 lbs. or greater. IMPORTANT SAFETY INFORMATION neffy contains epinephrine, a medicine used to treat allergic emergencies (anaphylaxis). Anaphylaxis can be life-threatening, can happen in minutes, and can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise, or other unknown causes. Always carry two neffy nasal sprays with you because you may not know when anaphylaxis may happen and because you may need a second dose of neffy if symptoms continue or come back. Each neffy contains a single dose of epinephrine. neffy is for use in the nose only. Use neffy right away, as soon as you notice symptoms of an allergic reaction. If symptoms continue or get worse after the first dose of neffy , a second dose is needed. If needed, administer a second dose using a new neffy in the same nostril starting 5 minutes after the first dose. Get emergency medical help for further treatment of the allergic emergency (anaphylaxis), if needed after using neffy . Tell your healthcare provider if you have underlying structural or anatomical nasal conditions, about all the medicines you take, and about all your medical conditions, especially if you have heart problems, kidney problems, low potassium in your blood, Parkinson's disease, thyroid problems, high blood pressure, diabetes, are pregnant or plan to become pregnant, or plan to breastfeed. Tell your healthcare provider if you take or use other nasal sprays or water pills (diuretics) or if you take medicines to treat depression, abnormal heart beats, Parkinson's disease, heart disease, thyroid disease, medicines used in labor, and medicines to treat allergies. neffy and other medications may affect each other, causing side effects. neffy may affect the way other medicines work, and other medicines may affect how neffy works. neffy may cause serious side effects. If you have certain medical conditions or take certain medicines, your condition may get worse, or you may have more or longer lasting side effects when you use neffy . Common side effects of neffy include: nasal discomfort, headache, throat irritation, chest and nasal congestion, feeling overly excited, nervous or anxious, nose bleed, nose pain, sneezing, runny nose, dry nose or throat, tingling sensation, including in the nose, feeling tired, dizziness, nausea, and vomiting. Tell your healthcare provider if you have any side effects that bother you or that do not go away after using neffy . These are not all of the possible side effects of neffy . Call your healthcare provider for medical advice about side effects. To report side effects, contact ARS Pharmaceuticals Operations, Inc. at 1-877-MY-NEFFY (877-696-3339) or the FDA at 1-800-FDA-1088 or . Please see the full Prescribing Information and Patient Information for neffy . About Type I Allergic Reactions Including Anaphylaxis Type I allergic reactions are serious and potentially life-threatening events that can occur within minutes of exposure to an allergen and require immediate treatment with epinephrine, the only FDA-approved medication for these reactions. While epinephrine auto-injectors have been shown to be highly effective, there are well published limitations that result in many patients and caregivers delaying or not administering treatment in an emergency situation. These limitations include fear of the needle, lack of portability, needle-related safety concerns, lack of reliability, and complexity of the devices. There are approximately 40 million people in the United States who experience Type I allergic reactions. Of this group, over the last three years, approximately 20 million people have been diagnosed and treated for severe Type I allergic reactions that may lead to anaphylaxis, but (in 2023, for example) only 3.2 million filled their active epinephrine auto-injector prescription, and of those, only half consistently carry their prescribed auto-injector. Even if patients or caregivers carry an auto-injector, more than half either delay or do not administer the device when needed in an emergency. About ARS Pharmaceuticals, Inc. ARS Pharma is a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients against allergic reactions that could lead to anaphylaxis. The Company is commercializing neffy ® (trade name EUR neffy ® in the EU and UK and 优敏速 ® in China), an epinephrine nasal spray indicated in the U.S. for emergency treatment of Type I allergic reactions, including anaphylaxis, in adult patients and pediatric patients who weigh 33 lbs. or greater, and in the EU for emergency treatment of allergic reactions (anaphylaxis) due to insect stings or bites, foods, medicinal products, and other allergens as well as idiopathic or exercise induced anaphylaxis in adults and children who weigh 15 kg or greater. For more information, visit . Forward-Looking Statements Statements in this press release that are not purely historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to: the belief that ARS Pharma is well-positioned to drive meaningful market share growth; expectations regarding prescription renewals and demand generally; ARS Pharma’s plans to increase access to, accelerate adoption of, and expand the reach of ARS Pharma and of neffy ; and other statements that are not historical fact. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “anticipate,” “believe,” “can,” “could,” “expect,” “if,” “may,” “on track,” “potential,” “plan,” “will,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon ARS Pharma’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation: risks associated with transitions of members of the senior management team; potential safety and other complications from neffy ; the ability to maintain regulatory approval for neffy in its currently approved indications; the scope, progress and expansion of developing and commercializing neffy ; the risk that personnel costs will be higher than anticipated; the scope, progress and expansion of developing our intranasal epinephrine technology; clinical trial results; the potential for governments and payors to delay, limit or deny coverage for neffy ; the size and growth of the market for neffy and the rate and degree of market acceptance thereof vis-à-vis intramuscular injectable products; ARS Pharma’s ability to protect its intellectual property position; and the impact of government laws, regulations and policies. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption 'Risk Factors' in ARS Pharma's Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission ('SEC'), and as updated by the 'Risk Factors' in ARS Pharma's Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed with the SEC on May 15, 2026 . These documents can also be accessed on ARS Pharma’s website at by clicking on the link “ Financials & Filings ” under the “Investors & Media” tab. The forward-looking statements included in this press release are made only as of the date hereof. ARS Pharma assumes no obligation and does not intend to update these forward-looking statements, except as required by law. For more information, visit , and follow us on LinkedIn and X . Investor Contact: Monique Allaire, THRUST monique@thrustsc.com Media Contact: Nabeelah Khan nabeelahk@ars-pharma.com

Executive ChangeVaccineAcquisition

08 Apr 2026

·endpoints.news

Merck adjusts its vaccine supply deal in China; Soleno withdraws EU application

Plus, news about Novavax, ReAlta and AtaiBeckley: Merck adjusts China vaccine supply deal: The company and its distribution partner Zhifei have tweaked their agreement as Merck continues to grapple with lower demand for its HPV vaccine Gardasil in China. The new deal no longer specifies a baseline procurement volume for Merck’s vaccines, but instead allows the companies to determine supply plans “based on anticipated market demand and actual vaccination uptake,” according to a translated regulatory filing from Zhifei. Merck supplies three products to Zhifei: Gardasil, its rotavirus vaccine RotaTeq, and the pneumococcal vaccine Pneumovax 23. — Nicole DeFeudis Soleno withdraws EU application: A day after saying it was selling to Neurocrine Biosciences for $2.9 billion, Soleno Therapeutics revealed in an SEC filing that it pulled its approval application for Vykat XR in Europe, where it expected a decision later this year in the rare genetic condition known as Prader-Willi syndrome. Neurocrine CEO Kyle Gano had hinted at this the day before, telling analysts his company had no plans to commercialize the drug in Europe. — Kyle LaHucik Large Novavax shareholder still displeased: Shah Capital, which holds about 9% of the Maryland vaccine maker, penned a letter to the company’s board Wednesday to share its continued annoyance with Novavax’s performance and its lack of confidence in the board nominees. The shareholder called for a sale of Novavax in October. In the Wednesday letter, founder and chief investment officer Himanshu Shah said the firm intends to vote against the reelection of Novavax’s board nominees and against the executive compensation package at this year’s annual meeting. Shah concluded with an ask for “a like-minded strategic long-term investor taking 10-20% ownership position to reshape Novavax entirely.” — Kyle LaHucik ReAlta Life Sciences gets $40M: The Virginia biotech got the funding for its experimental treatment for hypoxic ischemic encephalopathy, in which there’s little oxygen and blood flowing to the brain around birth. The company’s peptide, called pegtarazimod, is in Phase 2 testing. ReAlta has now raised $150 million total and recently got a new CEO , the former Coya Therapeutics leader Howard Berman. — Kyle LaHucik AtaiBeckley shares more depression data: The biotech’s psychedelic candidate, called BPL-003, produced an antidepressant response in almost 67% of patients with treatment-resistant depression who were taking a stable dose of an SSRI. The patients were enrolled in AtaiBeckley’s open-label Phase 2a study. The company reported success for its controlled Phase 2b trial of BPL-003 last year. The drug is set to enter Phase 3 in the second quarter. — Ayisha Sharma

Phase 2VaccineClinical Result

07 Apr 2026

·www.fiercepharma.com

With Gardasil demand shortfall in China, Merck and Zhifei adjust their partnership

With demand plummetting in China for Merck's HPV vaccine Gardasil, the New Jersey company has adjusted its distribution deal with its partner in the country, Zhifei. The plummeting demand for Merck & Co.’s HPV vaccine Gardasil in China has forced the New Jersey drugmaker to rework its arrangement with its partner in the country, Chongqing Zhifei Biological Products.The companies have agreed to remove minimum purchase commitments and use a rolling, demand-based supply model for the three Merck vaccines that Zhifei distributes in China. In addition to Gardasil, Zhifei distributes rotavirus shot, RotaTeq, and pneumococcal vaccine Pneumovax 23.The adjustment of the arrangement between the companies enhances their ability “to respond to market fluctuations in a synergistic manner, while simultaneously alleviating” Zhifei’s operational pressures and mitigating its risks, the Chongqing-based company explained in a regulatory filing.The companies were operating under a multiyear deal, which specified a total procurement commitment of 97.9 billion Chinese yuan ($14.2 billion), running from 2023 to 2026. The new arrangement will run until the end of 2028. Zhifei, which was established in 1995, has been Merck’s distribution partner since 2011.The first trace of a demand shortfall for Gardasil in China came in 2024, when Merck reported a decline in vaccine sales, which reached the market in 2014. After a 3% decline in sales for Gardasil in 2024, the shortfall hit with full force in 2025, as its sales plummeted from $8.6 billion to $5.2 billion, for a 39% drop-off, with Merck blaming competition in China for cheaper alternatives.For China specifically, Zhifei reported that its total procurement of all Merck vaccines had fallen sharply from 34.8 billion yuan in 2023 to below 2.2 billion yuan last year, compared with a minimum procurement amount of 26 billion yuan set for Gardasil alone under the original deal between the two companies. The changing vaccine landscape in China also forced Zhifei to adjust its distribution deal with GSK in 2024, as the companies agreed to an extension of their partnership but at reduced volumes. Zhifei has felt the pinch, with its revenue peaking in 2023 at $7.4 billion before falling by more than 50% each of the last two years.

VaccineLicense out/in

100 Deals associated with Rotavirus vaccine,live(Merck & Co.)

External Link

KEGG	Wiki	ATC	Drug Bank
D10211	Rotavirus vaccine,live(Merck & Co.)	J07BH02	DB10276

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Rotavirus Infections	European Union	Merck Sharp & Dohme BV	26 Jun 2006
Rotavirus Infections	Iceland	Merck Sharp & Dohme BV	26 Jun 2006
Rotavirus Infections	Liechtenstein	Merck Sharp & Dohme BV	26 Jun 2006
Rotavirus Infections	Norway	Merck Sharp & Dohme BV	26 Jun 2006
Viral gastroenteritis due to Rotavirus	United States	Merck Sharp & Dohme LLC	03 Feb 2006

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Gastroenteritis	Phase 3	-	Merck Sharp & Dohme LLC	01 Oct 2005
Short Bowel Syndrome	Phase 1	United States	Merck Sharp & Dohme Corp.	01 Jul 2009

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04481191 (V260-074, CTgov)	Phase 3	-	400	IPV+RotaTeq (V260) (Concomitant RotaTeq and IPV)	bxqxtonfrs = fvkkglosnp xwxyiutmaj (kdnjcpzzpn, igpbevaogf - glabtyjomv) View more	-	17 Feb 2023
				IPV+RotaTeq (V260) (Staggered RotaTeq and IPV)	bxqxtonfrs = eevidqyjfi xwxyiutmaj (kdnjcpzzpn, hftomzltyw - mmyyovbbqp) View more
NCT02847026 (Pubmed) Manual	Phase 4	Rotavirus Infections	1,144	RotaTeq	vsvcjbmdmx(idfadxxawo) = qjlzwkzcgn rpoteudblb (wsziaqhvow ) View more	Positive	09 Aug 2022
				Rotarix	vsvcjbmdmx(idfadxxawo) = sahvxmksnb rpoteudblb (wsziaqhvow ) View more
NCT02062385 (Pubmed \| Vaccine)	Phase 3	-	4,040	Pentavalent rotavirus vaccine (RV5)	swvmbqrssm(fyqgkxnngm) = sgunhnfcpf kyhrhigmgy (kwvygsdzab )	-	22 Mar 2019
				Placebo	swvmbqrssm(fyqgkxnngm) = kxqzdlrxcu kyhrhigmgy (kwvygsdzab )
NCT02542462 (CTgov)	Phase 4	Rotavirus Infections \| Intussusception	144	Rotarix®, (Rotarix® Alone)	jobpvzbtzt = yqikcukdcr ovftafepmj (ahkylvnxqu, bgidgcszyy - vjpsolybhm) View more	-	12 Jul 2018
				routine vaccines+Rotarix® (Rotarix®,With Other Routine Vaccines)	jobpvzbtzt = lgwsywhrdh ovftafepmj (ahkylvnxqu, jhqwwbufgj - jnxlmvhwba) View more
NCT00443846 (V260-016, CTgov)	Phase 3	Rotavirus Infections	247	RotaTeq®+NeisVac-C® (Group 1: Concomitant Administration)	bzougmvekz = bppwfkghws cmydlnpptw (scovnloown, wzltyjrvjb - vqvnxqkxvf) View more	-	20 Jun 2018
				RotaTeq®+NeisVac-C® (Group 2: Sequential Administration)	bzougmvekz = ldjzengmbv cmydlnpptw (scovnloown, bcqzjnspvs - wtmslughxi) View more
NCT02062385 (V260-024, Pubmed \| Vaccine) Manual	Phase 3	Viral gastroenteritis due to Rotavirus	4,040	RV5	bgtrhffppe(ueczzcjaps) = noubmmqhwc ujakavwkuc (lcxiialvqb ) View more	Positive	13 Oct 2017
				Placebo	bgtrhffppe(ueczzcjaps) = kqojlbpvfc ujakavwkuc (lcxiialvqb ) View more
NCT01960725 (CTgov)	Phase 4	Gastroenteritis \| Diarrhea	66	RV5 (Pentavalent Rotavirus Vaccine) (Group A: Standard Dosing)	dodsynbpog(itagrthdzh) = oqcsggssaq hulfmsufiv (xeycmlgzft, rbgboorthp - fykilxykrj) View more	-	21 Apr 2017
				RV5 vaccine (Group B: Alternate Dosing)	dodsynbpog(itagrthdzh) = mtktpkjofk hulfmsufiv (xeycmlgzft, pyocylcwhb - xfycroixeb) View more
NCT00880698 (Pubmed \| AIDS)	Phase 2	-	202	Pentavalent rotavirus vaccine (RV5)	jtypacmtip(rqdmiwkeqp) = dwxamexwlj tqhtzxhihy (tqtqollmxa )	-	02 Jan 2017
				Placebo	jtypacmtip(rqdmiwkeqp) = bxxskqceor tqhtzxhihy (tqtqollmxa )
NCT02062385 (V260-024, CTgov)	Phase 3	Viral gastroenteritis due to Rotavirus	4,040	DTaP+OPV+V260 (V260 With Concomitant EPI)	cqgxhryste = qzlvbmzvor lpuriiplrn (fvawgdixmi, eogppxykig - pfrrslpokd) View more	-	04 Apr 2016
				DTaP+OPV (Placebo With Concomitant EPI)	cqgxhryste = ynpysjejhq lpuriiplrn (fvawgdixmi, cqvnsoeclc - yltedbmakn) View more
NCT01926015 (V260-060, CTgov)	Phase 4	Diphtheria \| Rotavirus Infections \| Whooping Cough ... View more	192	RotaTeq™ (V260)+DTP-IPV (Concomitant RotaTeq™ and DTP-IPV)	yitjnvwvyl = amhglepfdc hxbaaggbyq (vushrlhphn, lvyggqggzw - wivkczrpwq) View more	-	09 Apr 2015
				RotaTeq™ (V260)+DTP-IPV (Staggered RotaTeq™ and DTP-IPV)	yitjnvwvyl = gpscvelzgd hxbaaggbyq (vushrlhphn, soxtqtfmgm - ckzqgzbxjk) View more

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