A Phase 3b/4, Open-label Study to Assess the Immunogenicity of mRNA COVID-19 Variant-containing Vaccine Formulations in Previously Vaccinated Adults Aged ≥18 Years

The purpose of this study is to investigate the immunogenicity of mRNA COVID-19 variant-containing vaccine formulations against the vaccine matched variants and newly emerged variants of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in previously vaccinated adults.

Start Date09 Sep 2024

Sponsor / Collaborator

ModernaTX, Inc.

NCT05387317

/ WithdrawnPhase 3

A Randomised Controlled Trial to Assess the Immunogenicity, Safety & Reactogenicity of Standard Dose Versus Fractional Doses of COVID-19 Vaccines (Pfizer-BioNTech, AstraZeneca or Moderna) Given as a Booster Dose After Priming With Coronavac or AstraZeneca in Healthy Adults in Indonesia

This is a randomised controlled clinical trial to determine the reactogenicity and immunogenicity of booster doses of SARS-CoV-2 vaccines (Pfizer-BioNTech, AstraZeneca or Moderna) in adults who have previously received either AstraZeneca or Coronavac as their primary doses.
Both fractional and standard doses of Pfizer-BioNTech, AstraZeneca and Moderna will be tested.

Start Date01 Apr 2024

Sponsor / Collaborator

Murdoch Childrens Research Institute

[+4]

PACTR202212801139469

/ SuspendedPhase 2

A Phase 2/3, Randomized, Observer-Blind, Placebo-Controlled, Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273 SARS-CoV-2 Vaccine in Healthy Adolescents 12 to < 18 years of age

Start Date01 Aug 2023

Sponsor / Collaborator-

100 Clinical Results associated with Elasomeran

100 Translational Medicine associated with Elasomeran

100 Patents (Medical) associated with Elasomeran

2,562

Literatures (Medical) associated with Elasomeran

31 Dec 2025·Human Vaccines & Immunotherapeutics

Safety and immunogenicity of an mRNA-1273 vaccine booster in adolescents

Article

Author: Powell, Richard ; Boone, Gary ; Ali, Kashif ; Etokhana, Kenneth ; Clifford, Robert ; Figueroa, Amparo L. ; Miller, Jacqueline ; Rizzardi, Barbara ; Girard, Bethany ; Ampajwala, Madhavi ; Weiner, Leonard ; Slobod, Karen ; Kirstein, Judith ; Yeakey, Anne ; Carr, Quito ; Segall, Nathan ; Elfaki, Salma ; Fierro, Carlos ; Akinsola, Adebayo ; Xu, Wenqin ; Berman, Gary ; Chu, Laurence ; Ohnmacht, Richard ; Reyes-Acuna, Celia ; Turner, Mark ; Buynak, Robert ; Ruiz-de-Luzuriaga, Katherine ; Matherne, Paul ; Priddy, Frances ; Jeanfreau, Robert ; Das, Rituparna ; Deng, Weiping ; Griffin, Carl ; Adetona, Olutola

Safety, immunogenicity, and effectiveness of an mRNA-1273 50-μg booster were evaluated in adolescents (12-17 years), with and without pre-booster SARS-CoV-2 infection. Participants who had received the 2-dose mRNA-1273 100-µg primary series in the TeenCOVE trial (NCT04649151) were offered the mRNA-1273 50-μg booster. Primary objectives included safety and inference of effectiveness by establishing noninferiority of neutralizing antibody (nAb) responses after the booster compared with the nAb post-primary series of mRNA-1273 among young adults in COVE (NCT04470427). Binding antibody (bAb) responses against SARS-CoV-2 variants of interest and COVID-19 incidence after vaccination were also evaluated. Median boosting interval was 315 days. The mRNA-1273 booster was well-tolerated, with an acceptable safety profile. Relative to pre-booster, nAb geometric mean levels increased after the booster by 17.8-fold and 4.7-fold among pre-booster SARS-CoV-2-negative and -positive participants, respectively. Effectiveness was successfully inferred based on noninferiority of nAb levels from mRNA-1273 booster dose (Day 29) compared with nAb levels after mRNA-1273 primary series (Day 57) among young adults in COVE. Further, the booster increased bAb levels relative to pre-booster baseline against SARS-CoV-2 variants (alpha [B.1.1.7], beta [B.1.351], gamma [P.1], and delta [B.1.617.2]), regardless of pre-booster SARS-CoV-2 status. COVID-19 incidence (cases per 1000 person-months) was lower among boosted (0 cases) than non-boosted (95.766 cases) participants in January 2022, a peak period during the early omicron transmission. In summary, the mRNA-1273 50-μg booster induced robust nAb responses in previously vaccinated adolescents, regardless of SARS-CoV-2 serostatus. Effectiveness was successfully inferred and the booster was well-tolerated, with no new safety concerns identified.

31 Dec 2025·ANNALS OF MEDICINE

Neutralizing antibodies against SARS-CoV-2 of vaccinated healthcare workers in Taiwan

Article

Author: Syu, Guan-Da ; Kuo, Kuang-Che ; Weng, Ken-Pen ; Kuo, Ho-Chang ; Priyambodo, Seto ; Liu, Shih-Feng

BACKGROUND:

Vaccination is one of the best ways to control the SARS-CoV-2 outbreak. In Taiwan, healthcare workers were prioritized for vaccination, but the effectiveness of these vaccines for them remains unclear. Thus, it's essential to examine their neutralizing antibodies after prime-boost vaccinations.

METHODS:

In this prospective observational study, 514 healthcare workers from Chang Gung Memorial hospitals in Taiwan were included between 19 March 2021 and 21 August 2021. The two doses of COVID-19 vaccines were either a match or a mixing of AZD1222 and mRNA-1273, e.g. AZD1222 + AZD1222 (n = 406), mRNA-1273 + mRNA-1273 (n = 62), and AZD1222 + mRNA-1273 (n = 46). Blood specimens were drawn after two doses of vaccines, defined as post-vaccine days [median 34.00 days and interquartile range (IQR) 29.00-42.00 days], and examined for the neutralizing antibodies via SARS-CoV-2 neutralization kits. The results were analyzed as a percentage of inhibition based on the negative control.

RESULTS:

After 2 vaccination doses, subjects with AZD1222 + mRNA-1273 (median 97.15%, IQR 96.06-98.06%) and mRNA-1273 + mRNA-1273 (median 97.47%, IQR 96.75-97.89%) exhibited higher neutralizing antibodies than those receiving AZD1222 + AZD1222 vaccines (median 71.28%, IQR 49.39-89.70%) (the percentage was referred to inhibition of surrogate virus). The post-vaccination days negatively impacted the neutralizing antibodies, except for the mRNA-1273 + mRNA-1273 group. The presence of fever, headache, and myalgia after the second dosage was reflected in the higher neutralizing antibodies (median of no fever 76.00% vs. fever 97.00%, p < 0.0001; median of no headache 76.00% vs. headache 95.00%, p < 0.0001; median of no myalgia 75.50% vs. myalgia 96.00%, p < 0.0001). The subjects with underlying diseases, including hypertension and cancer showed lower neutralizing antibodies (median of no hypertension 81.00% vs. hypertension 56.00%, p = 0.0029; median of no cancer 81.00% vs. cancer 56.00%, p = 0.0143).

CONCLUSION:

Heterologous prime-boost vaccines (AZD1222 + mRNA-1273) and two doses of mRNA vaccines are recommended. For future directions, we need to investigate the effectiveness of the vaccination against new SARS-CoV-2 variants.

01 Dec 2025·IMMUNOLOGIC RESEARCH

QuantiFERON SARS-CoV-2 assay for the evaluation of cellular immunity after immunization with mRNA SARS-CoV-2 vaccines: a systematic review and meta-analysis

Review

Author: Michos, Athanasios ; Kourlaba, Georgia ; Dourdouna, Maria-Myrto

A systematic review and meta-analysis were performed to evaluate the virus-specific T-cell response after COVID-19 mRNA vaccination, using the QuantiFERON SARS-CoV-2 interferon-γ release assay. A search was conducted (June 8, 2023) in the PUBMED, SCOPUS, and medRxiv databases, to identify studies reporting the QuantiFERON SARS-CoV-2 (Starter (two antigen tubes) or Starter + Extended Pack (three antigen tubes), cut-off ≥ 0.15 IU/mL) positivity rate (PR) in immunocompetent adults, following the administration of two or three COVID-19 mRNA vaccine doses. Study quality was evaluated with the Critical Appraisal Skills Programme Tool. A meta-analysis was conducted using a random-effects model. Heterogeneity and publication bias were assessed. Eleven eligible studies (with 5-73 vaccinated immunocompetent participants) were identified. For COVID-19-naïve participants, ≤ 3 months after the second dose, the pooled PR (random-effects model) was 86 (95% confidence interval (95% CI) 78-95%). Comparing the Starter vs. the Starter + Extended Pack, a significant difference in PRs was detected (80.6% vs. 100% p-value < 0.001). At 3-6 and >6 months after the second dose and ≥ 3 months after the third dose, the pooled PRs were 59% (95% CI 45-72%), 79% (95% CI 66-92%), and 66% (95% CI 50-82%), respectively. For convalescent participants, ≥ 6 months after the third dose, the pooled PR was 81% (95% CI 67-95%). Limitations include heterogeneity and a small number of studies, at some timepoints. In conclusion, following the second or third COVID-19 mRNA vaccine dose, QuantiFERON SARS-CoV-2 detected positive responses in a certain percentage of the vaccinees, possibly because of waning immunity, reduced assay sensitivity, or lack of T-cell response induction in some vaccinees. The detection of positive responses was higher when the Starter + Extended Pack was used. PROSPERO Registration Number: CRD42023431315.

799

News (Medical) associated with Elasomeran

07 Apr 2025

·investors.modernatx.com

Moderna to Showcase Extensive Infectious Disease Research at ESCMID 2025

CAMBRIDGE, MA / ACCESS Newswire / April 7, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the Company will present research across multiple infectious disease areas, including COVID-19, influenza, respiratory syncytial virus (RSV), cytomegalovirus (CMV), norovirus, and mpox, at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Global Congress in Vienna, Austria, from April 11-15, 2025. Moderna will present twelve scientific presentations at the ESCMID 2025 Global Congress, including three oral presentations, one e-poster presentation, and eight poster presentations, highlighting the breadth of its research in respiratory and emerging infectious diseases. COVID-19 Immunogenicity of JN.1- and KP.2-encoding mRNA COVID-19 vaccines against JN.1 SARS-CoV-2 sublineages in adult participants - Oral Presentation Presenter: Frances Priddy Session: Advances in vaccine effectiveness for viral respiratory infections Date: April 12 | Time & Location: 11:00 (Hall 9) Relative vaccine efficacy of a SARS-CoV-2 spike receptor-binding and N-terminal domain COVID-19 vaccine versus mRNA-1273: subgroup analyses - Oral Presentation Presenter: Spyros Chalkias Session: Vaccines and prophylaxis against respiratory viral infections Date: April 13 | Time & Location: 11:00 (Hall 9) Clinical evaluation of a SARS-CoV-2 spike receptor-binding and N-terminal domain COVID-19 vaccine - Poster Presentation Presenter: Spyros Chalkias Session: COVID-19 Date: April 12 | Time & Location: 12:00 (Poster Hall) Immunogenicity and safety of a SARS-CoV-2 N-terminal domain and receptor-binding domain monovalent XBB.1.5 vaccine in Japanese participants aged ≥12 years - Poster Presentation Presenter: Christina Grassi Session: COVID-19 Date: April 12 | Time & Location: 12:00 (Poster Hall) Immunogenicity of JN.1- and KP.2-encoding mRNA COVID-19 vaccines against JN.1 SARS-CoV-2 sublineages in adult participants - Oral Presentation Presenter: Frances Priddy Session: Advances in vaccine effectiveness for viral respiratory infections Date: April 12 | Time & Location: 11:00 (Hall 9) Relative vaccine efficacy of a SARS-CoV-2 spike receptor-binding and N-terminal domain COVID-19 vaccine versus mRNA-1273: subgroup analyses - Oral Presentation Presenter: Spyros Chalkias Session: Vaccines and prophylaxis against respiratory viral infections Date: April 13 | Time & Location: 11:00 (Hall 9) Clinical evaluation of a SARS-CoV-2 spike receptor-binding and N-terminal domain COVID-19 vaccine - Poster Presentation Presenter: Spyros Chalkias Session: COVID-19 Date: April 12 | Time & Location: 12:00 (Poster Hall) Immunogenicity and safety of a SARS-CoV-2 N-terminal domain and receptor-binding domain monovalent XBB.1.5 vaccine in Japanese participants aged ≥12 years - Poster Presentation Presenter: Christina Grassi Session: COVID-19 Date: April 12 | Time & Location: 12:00 (Poster Hall) RSV Six-month Immunogenicity of mRNA-1345 RSV Vaccine in Adults Aged ≥60 Years - E-Poster Presentation Presenter: Mihir Desai Session: On the frontiers of vaccine-driven prevention Date: April 12 | Time & Location: 08:30 (Arena 1) Safety and immunogenicity of mRNA-1345 revaccination at 24 months in adults ≥60 years - Poster Presentation Presenter: Mihir Desai Session: Clinical Trials Date: April 15 | Time & Location: 12:00 (Poster Hall) Burden of chronic medical conditions that are risk factors for severe RSV among adults aged 18-59 years in the United States - Poster Presentation Presenter: Clarisse Demont Session: Influenza and respiratory viruses Date: April 12 | Time & Location: 12:00 (Poster Hall) Association of virology swab positivity in adults aged ≥40 years with Computerized Medical Record Reported Acute Respiratory Infection (ARI) Subgroups: Observational Study of ARI (ObservatARI) - Poster Presentation Presenter: Simon De Lusignan Session: Influenza and respiratory viruses Date: April 12 | Time & Location: 12:00 (Poster Hall) Six-month Immunogenicity of mRNA-1345 RSV Vaccine in Adults Aged ≥60 Years - E-Poster Presentation Presenter: Mihir Desai Session: On the frontiers of vaccine-driven prevention Date: April 12 | Time & Location: 08:30 (Arena 1) Safety and immunogenicity of mRNA-1345 revaccination at 24 months in adults ≥60 years - Poster Presentation Presenter: Mihir Desai Session: Clinical Trials Date: April 15 | Time & Location: 12:00 (Poster Hall) Burden of chronic medical conditions that are risk factors for severe RSV among adults aged 18-59 years in the United States - Poster Presentation Presenter: Clarisse Demont Session: Influenza and respiratory viruses Date: April 12 | Time & Location: 12:00 (Poster Hall) Association of virology swab positivity in adults aged ≥40 years with Computerized Medical Record Reported Acute Respiratory Infection (ARI) Subgroups: Observational Study of ARI (ObservatARI) - Poster Presentation Presenter: Simon De Lusignan Session: Influenza and respiratory viruses Date: April 12 | Time & Location: 12:00 (Poster Hall) Mpox Safety and immunogenicity of mRNA mpox vaccine candidate mRNA-1769: Interim analysis results from a Phase 1/2 Trial - Oral Presentation Presenter: Hiwot Hiruy Session: Novel vaccines in clinical development Date: April 14 | Time & Location: 17:30 (Hall 3) Safety and immunogenicity of mRNA mpox vaccine candidate mRNA-1769: Interim analysis results from a Phase 1/2 Trial - Oral Presentation Presenter: Hiwot Hiruy Session: Novel vaccines in clinical development Date: April 14 | Time & Location: 17:30 (Hall 3) Cytomegalovirus Long-term safety and immunogenicity of cytomegalovirus mRNA-1647 vaccine in healthy adults: 36-month results from a phase 2 extension trial - Poster Presentation Presenter: Ben Lorenz Session: Clinical Trials Date: April 15 | Time & Location: 12:00 (Poster Hall) Long-term safety and immunogenicity of cytomegalovirus mRNA-1647 vaccine in healthy adults: 36-month results from a phase 2 extension trial - Poster Presentation Presenter: Ben Lorenz Session: Clinical Trials Date: April 15 | Time & Location: 12:00 (Poster Hall) Influenza Six-month persistence and safety of mRNA-based influenza or multicomponent influenza/COVID-19 vaccines versus licensed comparators in adults aged ≥18 years - Poster Presentation Presenter: Mieke Soens Session: Influenza and respiratory viruses Date: April 12 | Time & Location: 12:00 (Poster Hall) Six-month persistence and safety of mRNA-based influenza or multicomponent influenza/COVID-19 vaccines versus licensed comparators in adults aged ≥18 years - Poster Presentation Presenter: Mieke Soens Session: Influenza and respiratory viruses Date: April 12 | Time & Location: 12:00 (Poster Hall) Norovirus Incidence and severity of sporadic, medically attended norovirus infection in the United States, 2023-2024 - Poster Presentation Presenter: Mark A. Schmidt Session: Viral epidemiology - general, prevalence studies, molecular and genomic epidemiology Date: April 12 | Time & Location: 12:00 (Poster Hall) Incidence and severity of sporadic, medically attended norovirus infection in the United States, 2023-2024 - Poster Presentation Presenter: Mark A. Schmidt Session: Viral epidemiology - general, prevalence studies, molecular and genomic epidemiology Date: April 12 | Time & Location: 12:00 (Poster Hall) About Moderna Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines. Moderna's mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the potential for Moderna's vaccine candidates to alleviate disease outcomes. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and in subsequent filings made by Moderna with the U.S. Securities and Exchange Commission, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release. Moderna Contacts Media: Luke Mircea-Willats Senior Director, International Communications Luke.Mirceawillats@modernatx.com Investors: Lavina Talukdar Senior Vice President & Head of Investor Relations +1 617-209-5834 Lavina.Talukdar@modernatx.com SOURCE: Moderna Inc.

VaccineClinical ResultPhase 2mRNA

31 Mar 2025

·investors.modernatx.com

Moderna Receives Australian Therapeutic Goods Administration Approval for RSV Vaccine for Older Adults

CAMBRIDGE, MA / ACCESS Newswire / March 31, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the Australian Therapeutic Goods Administration (TGA) has granted approval for mRESVIA® (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to prevent lower respiratory tract disease caused by RSV infection in adults aged 60 years and older.1 mRESVIA's approval marks a significant milestone as it is the first mRNA vaccine in Australia approved for use against a disease beyond COVID-19. "We are pleased to receive regulatory approval for mRESVIA in Australia following the TGA's decision," said Stéphane Bancel, Chief Executive Officer of Moderna. "This approval underscores our commitment to protecting older adults from RSV-related respiratory diseases. We look forward to supplying mRESVIA from our Melbourne facility to older Australians vulnerable to RSV in the future." RSV is a highly contagious respiratory virus that causes a substantial burden of disease, particularly in older adults. In the 2024 Australian winter period, RSV laboratory-notified cases in adults aged 65 and older were nearly two-thirds the number of influenza cases in the same age group.2 90% of RSV-related deaths reported nationally occurred in those aged 60 years and older, underscoring its potential for severe impact on older Australians.2 The approval is based on positive data from the Phase 3 clinical trial ConquerRSV, a randomized, placebo-controlled, observer-blind, case-driven clinical study conducted in approximately 37,000 adults aged 60 years or older in 22 countries. About mRESVIA (Respiratory Syncytial Virus Vaccine) mRNA-1345 is an RSV vaccine that consists of an mRNA sequence encoding a stabilized prefusion F glycoprotein. The F glycoprotein is expressed on the surface of the virus and is required for infection by helping the virus to enter host cells. The prefusion conformation of the F protein is a significant target of potent neutralizing antibodies and is highly conserved across both RSV-A and RSV-B subtypes. To date, Moderna has received marketing authorizations for its RSV vaccine in the United States, the European Union, Canada, Qatar, the United Arab Emirates, Taiwan, and the United Kingdom and has submitted regulatory applications in other markets worldwide. About Moderna Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines. Moderna's mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the Australian Therapeutic Goods Administration (TGA) granting approval for mRESVIA® (mRNA-1345); the potential for mRESVIA to reduce disease burden from RSV; and Moderna's pending marketing authorization applications for mRNA-1345. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and in subsequent filings made by Moderna with the U.S. Securities and Exchange Commission, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release. Moderna Contacts International Media: Luke Mircea-Willats Senior Director, International Communications Luke.Mirceawillats@modernatx.com Australia Media: Jemimah Brennan Director, Communications & Corporate Affairs, Australia jemimah.brennan@modernatx.com Investors: Lavina Talukdar Senior Vice President & Head of Investor Relations +1 617-209-5834 Lavina.Talukdar@modernatx.com References Australian Register of Therapeutic Goods (ARTG) Information - https://www.tga.gov.au/resources/artg/411450 Australian Respiratory Surveillance Report 11 - 29 July to 11 August 2024, https://www.health.gov.au/resources/publications/australian-respiratory-surveillance-report-11-12-august-to-25-august-2024 accessed 7 March 2025. SOURCE: Moderna, Inc.

Phase 3Drug ApprovalVaccinemRNAClinical Result

17 Mar 2025

·www.fiercebiotech.com

Curevo rounds up $110M to challenge GSK’s Shringrix, nabs Moncef Slaoui to lead board

A midstage study found that Curevo\'s candidate elicited a 100% vaccine response rate compared to 97.9% for GSK\'s Shingrix. \n In its effort to rival GSK’s shingles vaccine Shingrix, Curevo Vaccine has circled up $110 million and recruited two former GSK leaders to its board.The biotech’s series B was led by new investor Medicxi, a European biotech VC with vaccine companies such as Vaxcyte and ViceBio already in its portfolio, according to a March 17 release. Other new Curevo backers include OrbiMed, Sanofi Ventures and HBM Healthcare Investments.Existing investors RA Capital Management, Janus Henderson Investors and Adjuvant Capital participated in the round, along with founding investor GC Biopharma.The Seattle-based biotech will inject the money into a phase 2 extension program for amezosvatein, a non-mRNA adjuvanted sub-unit vaccine designed to prevent shingles. The extension builds off midstage results that found the candidate elicited a 100% vaccine response rate compared to 97.9% for GSK\'s Shingrix, along with being linked to lower rates of solicited local and systemic adverse events. The extended program will include 640 more participants in efforts to finalize dose selection for phase 3.The extension trial is slated to launch in mid-2025, Curevo CEO George Simeon said in the release.The small biotech plans to go head-to-head with Shingrix with an assist from some former GSK execs, one being Operation Warp Speed’s chief scientific advisor Moncef Slaoui, Ph.D. Before advising the federal government during the COVID-19 pandemic, Slaoui served as vaccine head at GSK and contributed to the creation of several new vaccines—including Shingrix—during his almost 30 years with the Big Pharma. Now, he’ll serve as chair of Curevo’s board of directors.“I have been collaborating with the Curevo team for several weeks now,” Slaoui said in a company statement. “I’m very excited to work with them to help perfect shingles vaccination, adding good tolerability to the exceptional efficacy achieved by the current vaccine. The data so far show Curevo’s adjuvant technology has the attributes to succeed in this endeavor.”The vaccine biotech has also landed Tal Zaks, M.D., Ph.D., to serve on its board on behalf of OrbiMed. Zaks served as Moderna’s chief medical officer for more than six years, overseeing the development of the company\'s mRNA vaccine Spikevax against COVID-19 during part of that time. Before that, he had held senior drug development roles at GSK and Sanofi. Curevo’s mission is to develop varicella zoster virus (VZV) vaccines that boost tolerability and efficacy, with amezosvatein also being tested in an early-stage chickenpox study for children.The series B financing nearly doubles Curevo’s $60 million series A raised in August 2022 and it still tops the round after $26 million was tacked on in November of the same year.

VaccinePhase 2mRNAExecutive Change

100 Deals associated with Elasomeran

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
COVID-19 omicron variant infection	United Kingdom	Moderna, Inc.	15 Aug 2022
COVID-19	Canada	Moderna, Inc.	23 Dec 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Severe Acute Respiratory Syndrome	Phase 2	United States	ModernaTX, Inc.	30 Sep 2022
Influenza, Human	Phase 2	United States	ModernaTX, Inc.	13 May 2022
Immunosuppression	Phase 2	United States	ModernaTX, Inc.	10 Mar 2022
Lung transplant rejection	Phase 2	United States	ModernaTX, Inc.	10 Mar 2022
Cytomegalovirus Infections	Phase 1	United States	ModernaTX, Inc.	24 May 2022
Respiratory Syncytial Virus Infections	Phase 1	United States	ModernaTX, Inc.	24 May 2022

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05280158 (CTgov)	Phase 1/2	Lung transplant rejection \| Immunosuppression	19	mRNA-1273 (Moderna COVID-19 vaccine) (Standard-dose)	mpwuhtlbix = qpbamyzslv jgwzmtdiyh (upxgpdeerq, nywogmdysb - btaeywtfeg) View more	-	26 Mar 2025
				mRNA-1273 (Moderna COVID-19 vaccine) (Mid-Dose)	mpwuhtlbix = zxpbrnyptb jgwzmtdiyh (upxgpdeerq, xddelfarcc - qwactvjjqp) View more
NCT05022329 (BOOST KIDNEY, CTgov)	Phase 2/3	COVID-19 \| Chronic kidney disease, Stage V \| Chronic Kidney Diseases	273	BNT162b2 (Third Dose BNT162b2)	wbvptjclcr(bmqyeaizqy) = ypmzndhwpi mnazzjvdin (svllephzox, 0.334) View more	-	19 Feb 2025
				mRNA-1273 (Moderna) (Third Dose mRNA-1273)	wbvptjclcr(bmqyeaizqy) = svwyxcqege mnazzjvdin (svllephzox, 0.169) View more
NCT05047770 (Pubmed) Manual	Phase 3	Herpes Zoster	497	mRNA-1273quFlu D-QIVt influenza vaccine (QIV)	cwefheeuoi(jhlwojagoz) = The most frequently reported adverse events in both groups were pain at the injection site and myalgia. jeymkzeijb (awiefdoowc ) View more	Non-inferior	31 Dec 2024
				mRNA-1273 + Flu D-QIV(CoAd )
NCT05228730 (MIACoV, CTgov)	Phase 3	COVID-19	13	Tozinameran (Standard Pfizer-BioNTech Booster Group)	dlybwmyuvd(lvadnawfgt) = mjdxuvmqch ndgfsyxwjo (oqrjluutrv, svkcyjueau - zlheyrkqcw) View more	-	16 Dec 2024
				Tozinameran - fractional dose (Fractional Pfizer-BioNTech Booster Group)	dlybwmyuvd(lvadnawfgt) = ompdcettsw ndgfsyxwjo (oqrjluutrv, vlstqulhzp - ktmqpdddyo) View more
NCT05249829 (CTgov)	Phase 2/3	COVID-19	3,548	mRNA-1273.529 (Part 1: mRNA-1273.529)	nhsqmuoysa(tvocddhbel) = frsdwtxtjm fzeotirpkx (pquhoxafoj, wowobjjquz - oehlyybyaj) View more	-	09 Aug 2024
				mRNA-1273 (Part 1: mRNA-1273)	nhsqmuoysa(tvocddhbel) = jzdsubmets fzeotirpkx (pquhoxafoj, eslclucgya - plzouitauw) View more
NCT04792567 (AMA-VACC, CTgov)	Phase 4	Multiple Sclerosis, Secondary Progressive	41	BAF312+BNT162+mRNA-1273 (Siponimod - Continuous)	cluzgelvan = weplasxrcu yzhzxdpzhk (nivtwyvdff, ijrncrcxkf - olblaksbsr) View more	-	17 May 2024
				BAF312+BNT162+mRNA-1273 (Siponimod- Interrupted)	cluzgelvan = ajehoqsfma yzhzxdpzhk (nivtwyvdff, tdpuezryke - tuenjhplai) View more
NCT05375838 (CTgov)	Phase 1/2	COVID-19 \| Influenza, Human	550	placebo+mRNA-1273 (mRNA-1273 + Placebo)	lzvagwhhtp = fwpdiwamfx oetpogqkqu (nocmjmbjxi, ejbebrhyyo - vamiameygd) View more	-	28 Feb 2024
				placebo+mRNA-1010 (mRNA-1010 + Placebo)	lzvagwhhtp = iubsoiisut oetpogqkqu (nocmjmbjxi, owyvwygyrv - avotjxzayk) View more
EHA2023	Not Applicable	-	49	MRNA-1273 SARS-COV-2 VACCINE (Recently transplanted patients (RTP))	cmwvibazfd(qmtogyndof) = dncocnltfs udjumicflh (afyleblgpv ) View more	-	08 Jun 2023
				MRNA-1273 SARS-COV-2 VACCINE (Long-term transplanted patients (LTTP))	cmwvibazfd(qmtogyndof) = vnoouhahtv udjumicflh (afyleblgpv ) View more
ARVO2023	Not Applicable	Retinal Vascular Occlusion	1,250	BNT162b2(Pfizer-BioNTech)	jhowxfmbsf(vxxaoiwnfc) = lrnoxbzyaa ebafyuguaq (hqoptnezbf )	Positive	01 Jun 2023
				SARS-CoV-2 vaccine (mRNA-1273(Moderna))	jhowxfmbsf(vxxaoiwnfc) = mviwipjexx ebafyuguaq (hqoptnezbf )

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