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.

NCT06354998

/ CompletedPhase 3

Randomized, Observer-Blind, Active-Controlled, Clinical Trial to Assess the Immunogenicity of an Investigational mRNA-1273.815 COVID-19 Vaccine in Previously Vaccinated Adults

To evaluate immune responses of an Investigational mRNA-1273.815 vaccine against the Omicron subvariant strain (XBB.1.5) of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Start Date08 Apr 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]

100 Clinical Results associated with Elasomeran

100 Translational Medicine associated with Elasomeran

100 Patents (Medical) associated with Elasomeran

4,748

Literatures (Medical) associated with Elasomeran

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.

01 Jan 2025·LANCET INFECTIOUS DISEASES

Effect of timing of casirivimab and imdevimab administration relative to mRNA-1273 COVID-19 vaccination on vaccine-induced SARS-CoV-2 neutralising antibody responses: a prospective, open-label, phase 2, randomised controlled trial

Article

Author: Forleo-Neto, Eduardo ; Heirman, Ingeborg ; Trbovic, Caryn F ; Konis, George ; Patel, Aloki H ; Tomaras, Georgia D ; Baum, Alina ; Hellman, Caleb A ; Turner, Kenneth C ; Cohen, Kristen W ; Polakowski, Laura ; Gonzalez Ortiz, Ana M ; DiCioccio, A Thomas ; Hutter, Julia ; De Rosa, Stephen C ; Brackin, Taylor ; Thakur, Mazhar ; Hooper, Andrea T ; Williams, LaTonya D ; Hamilton, Jennifer D ; Ganguly, Samit ; Petro, Christopher D ; Faria, Lori ; Kowal, Bari ; Odeh, Ahmad J ; Musser, Bret ; Dakin, Paula ; Isa, Flonza ; Fakih, Faisal A ; Herman, Gary A ; Kyratsous, Christos A ; Rosenthal, Mark J ; Geba, Gregory P ; Kim, Yunji ; Meyer, Jonathan ; McElrath, M Juliana ; Yancopoulos, George D ; Olenchock, Benjamin A ; Marovich, Mary ; Irvin, Susan C

BACKGROUND:

Deeper insight is needed on how monoclonal antibodies (mAbs) affect vaccine-mediated immune responses when targeting the same protein. We describe the first prospective randomised trial designed to understand mAb-mediated alterations in vaccine-induced immune responses to SARS-CoV-2 spike protein epitopes.

METHODS:

This randomised, open-label, parallel-group study assessed the potential interaction of a mAb combination, casirivimab and imdevimab, with a vaccine, Moderna's mRNA-1273, in healthy SARS-CoV-2 immunologically naive, seronegative adults at six centres in the USA. Participants were randomly assigned (per prespecified randomisation ratios within enrolment waves) according to a computer-generated randomisation scheme, stratified by age (<65 years and ≥65 years), to various intravenous or subcutaneous doses of casirivimab and imdevimab before, after, or at the same time as mRNA-1273 or to mRNA-1273 only. The doses of casirivimab and imdevimab were chosen to mimic various time intervals between receipt of 1200 mg of the mAb and the first dose of a primary series with mRNA-1273. The primary endpoint was vaccine-induced 50% inhibitory dilution neutralising antibody titres to SARS-CoV-2 spike protein, 56 days after the first vaccination. Secondary endpoints included vaccine-induced total antibodies to SARS-CoV-2 antigens and incidence of treatment-emergent adverse events. Exploratory endpoints included blood-derived T-cell and B-cell responses. The per-protocol set was used for the analysis of the primary endpoint and included all randomly assigned participants who received both doses of the vaccine and completed the injection or infusion of casirivimab and imdevimab per protocol, had no evidence of SARS-CoV-2 infection in the past or in the 56 days after the first dose of vaccine, and did not receive any intervention outside of the study that could alter the immune response. Safety was assessed in the safety analysis set, which included all randomly assigned participants who had received one or more doses of mRNA-1273 or any study drug, and analysed based on treatment received. The study is registered with ClinicalTrials.gov, NCT04852978, and is complete.

FINDINGS:

Between April 29, 2021, and Nov 21, 2022, 807 participants were assessed for eligibility and 295 were randomly assigned. 293 participants were included in the safety analysis set and 260 were included in the per-protocol set. All vaccinated participants developed neutralising antibodies to SARS-CoV-2, with median titres above the published protective threshold (100 IU/mL) against the SARS-CoV-2 D614G variant (considered a reference strain at the time the initial COVID-19 vaccines were developed). Titres were decreased up to 4-fold (median titres 280-450 IU/mL for casirivimab and imdevimab vs 1160 IU/mL for vaccine only on day 56) when casirivimab and imdevimab was given 85 days or less before vaccination (150-1200 mg intravenously) or co-administered subcutaneously (600 mg or 1200 mg) with vaccination. Minimal reduction in neutralisation titres was observed in the 48 mg and 12 mg intravenous groups, corresponding to receipt of casirivimab and imdevimab 113 days and 169 days, respectively, before vaccination, and when administering the vaccine 6 days before the mAb. Across all groups, mAbs had a minimal effect on vaccine-induced total antibodies and T-cell responses to the spike protein. Casirivimab and imdevimab plus mRNA-1273 was generally well tolerated; a slight increase in treatment-emergent adverse events was observed in the casirivimab and imdevimab plus vaccine groups versus the vaccine-only group.

INTERPRETATION:

Casirivimab and imdevimab administration before or at the time of COVID-19 vaccination reduced the elicitation of SARS-CoV-2 neutralising antibodies, but minimal effect was observed when vaccination occurred before mAb administration. Although the clinical significance of this decrease in neutralisation is unclear, this evidence suggests that further investigation of potential interactions could be warranted before concurrent clinical use of mAbs and vaccines targeting the same viral proteins as their main modes of action for the prevention or treatment of infectious diseases.

FUNDING:

Regeneron Pharmaceuticals and F Hoffmann-La Roche.

217

News (Medical) associated with Elasomeran

18 Oct 2024

·www.pharmaceutical-technology.com

mRNA licensing agreements surge 800% amid GSK lawsuits

COVID-19 mRNA vaccines have sparked interest in the potential of mRNA technology, but they have also put producers at the centre of licensing lawsuits. Credit: wacomka / Shutterstock. mRNA-based innovator pharmaceuticals have experienced a massive increase in licensing agreement deal values following success with the technology in Covid-19 vaccines, which helped to curtail the pandemic. Data and analytics provider GlobalData identified an 800% increase in deal values between 2019 and 2024 so far and has noted that key companies are continuing to invest heavily in the development of mRNA-based pharmaceuticals. GlobalData is Pharamceutical Technology’s parent company. However, recent lawsuits filed by GSK against mRNA vaccine producers Pfizer , BioNTech and most recently (15 October) Moderna , have put the licensing of mRNA-based pharmaceuticals in the spotlight. In its lawsuit, GSK has alleged the use of its technology without proper licenses. GSK is suing Moderna in two lawsuits regarding its mRNA vaccines: Spikevax for Covid-19 and mResvia for RSV. The British pharma giant alleges that Moderna ignored patents relating to lipid nanoparticles used in mRNA vaccine formulation technology. See Also: FDA approves AbbVie’s VYALEV for advanced Parkinson’s treatment Glaukos eyes FDA approval for ocular therapy after Phase III win It follows a similar lawsuit against Pfizer and BioNTech filed in April in which GSK alleges the companies were in violation of five patents relating to mRNA vaccine technology. Pfizer/BioNTech’s Covid-19 vaccine, known as Comirnaty, was approved by the FDA in August 2021 and was the first mRNA vaccine to enter the global market. It was followed by the approval of Moderna’s Spikevax in January 2022, although an emergency use authorization (EUA) had made Moderna’s vaccine available earlier. Ophelia Chan, business fundamentals senior analyst at GlobalData, has pointed to Covid-19 vaccines as a turning point for the mRNA sector. “The Covid-19 pandemic highlighted the key advantages of mRNA technology in vaccine development, including rapid production, precise immune targeting and streamlined manufacturing factors that drove the success of mRNA-based Covid-19 vaccines,” she said. mRNA Covid-19 vaccine sales declined significantly in 2023 compared to 2022. However, GlobalData reported that 2023 still saw Moderna’s Spikevax generate around $18.4bn in global revenue , while Pfizer and BioNTech’s Comirnaty generated around $42.4bn. Considering the reasons behind the jump in licensing deal values, Chan added: “Licensing agreement deal values for mRNA-based pharmaceuticals have doubled since 2023 , reaching $3.8bn as major players like GSK and Bristol Myers Squibb invest in mRNA therapeutics to address unmet medical needs.” In April, Bristol Myers Squibb entered into a multi-year, $1.87bn strategic collaboration with Repertoire Immune Medicines looking to develop mRNA-based tolerising vaccines. Meanwhile, GSK and Curevac contributed to the jump in licensing value in July, with a new licensing agreement worth up to $1.57bn. Beyond licensing, GlobalData also expects the sector to see growth across mRNA sales, predicting that the global sales of innovator mRNA-based drugs will rise from $22bn in 2023 to $26.2bn in 2030.

License out/inVaccinemRNADrug ApprovalPatent Infringement

17 Sep 2024

·investors.modernatx.com

Moderna Receives Health Canada Approval For Updated COVID-19 Vaccine Targeting KP.2 Variant Of SARS-COV-2 For Ages Six Months And Older

SPIKEVAX® is the first updated COVID-19 vaccine authorized in Canada for 2024-2025, offering a timely solution to help protect Canadians this fall and winter season. Moderna will promptly begin delivery of updated COVID-19 vaccines to the Public Health Agency of Canada, so there is robust supply available in time for provincial and territorial vaccination campaigns. CAMBRIDGE, MA / ACCESSWIRE / September 17, 2024 / Moderna Inc (Nasdaq:MRNA) today announced that Health Canada has authorized its updated COVID-19 vaccine, SPIKEVAX® KP.2 variant, to help prevent COVID-19 in individuals six months of age and older. Moderna's updated COVID-19 vaccine targets the KP.2 sub-lineage of SARS-CoV-2. With vaccines ready, Moderna will begin delivery of updated doses to the Public Health Agency of Canada, ensuring supply is available in time for provincial and territorial vaccination campaigns. "As we face another critical season in the fight against COVID-19, we remain steadfast in our dedication to delivering innovative solutions that help protect communities," said Stéphane Bancel, CEO of Moderna. "The authorization of our updated COVID-19 vaccine by Health Canada ensures that Canadians have timely access to the latest vaccines, helping them to stay protected during the upcoming fall and winter months." Receiving the most recently updated COVID-19 vaccine is expected to provide a better immune response against circulating COVID-19 strains compared to earlier vaccines. It is especially important for those at increased risk for COVID-19 infection or severe COVID-19 illness.1 "With the recent increase in COVID-19-infections,2 staying up to date with your COVID-19 vaccination remains one of the best ways to help protect yourself from severe illness," said Dr. Shehzad Iqbal, Country Medical Director, Moderna Canada. "Canadians are encouraged to speak to their healthcare providers about receiving an updated 2024-2025 COVID-19 vaccine alongside a flu shot this fall." Health Canada's approval is based on a combination of manufacturing and pre-clinical data, as well as previous clinical, non-clinical, and real-world evidence supporting the efficacy and safety of Moderna's COVID-19 mRNA vaccines. Highlights for Fall 2024-2025 KP.2 Variant Updated Vaccine: The updated vaccine is based on consultations with the Public Health Agency of Canada that the preferred composition for the 2024-2025 updated COVID-19 vaccine is a monovalent KP.2. SPIKEVAX®will be available in one presentation, allowing adult and pediatric doses to be drawn from the same multidose vial. The National Advisory Committee on Immunization (NACI) recommends that anyone not vaccinated or without a known COVID-19 infection in the past three months may receive an updated dose, with a focus on safeguarding vulnerable individuals.1 The updated vaccine is based on consultations with the Public Health Agency of Canada that the preferred composition for the 2024-2025 updated COVID-19 vaccine is a monovalent KP.2. SPIKEVAX®will be available in one presentation, allowing adult and pediatric doses to be drawn from the same multidose vial. The National Advisory Committee on Immunization (NACI) recommends that anyone not vaccinated or without a known COVID-19 infection in the past three months may receive an updated dose, with a focus on safeguarding vulnerable individuals.1 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 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. Moderna 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 approval of Moderna's updated KP.2-targeting COVID-19 vaccine by Health Canada; the ability of Moderna's updated COVID-19 vaccine to induce an immune response and provide protection against circulating SARS-CoV-2 variants; and Moderna's ability to supply its COVID-19 vaccine to the Public Health Agency of Canada. 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, 2023 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: International media Luke Mircea-Willats Senior Director, International Communications Luke.mirceawillats@modernatx.com Moderna Canada Sacha Kennedy Director, Communications and Media sacha.kennedy@modernatx.com Investors: Lavina Talukdar Senior Vice President & Head of Investor Relations +1 617-209-5834 Lavina.Talukdar@modernatx.com 1 Summary of NACI statement of May 3, 2024: Guidance on the use of COVID-19 vaccines during the fall of 2024. Available at: https://www.canada.ca/en/public-health/services/publications/vaccines-immunization/national-advisory-committee-immunization-summary-guidance-covid-19-vaccines-fall-2024.html Accessed August 27, 2024. 2 COVID-19 epidemiology update: Summary: https://health-infobase.canada.ca/covid-19/ Accessed September 3, 2024. SOURCE: Moderna, Inc.

VaccineDrug ApprovalmRNA

13 Sep 2024

·www.pharmaceutical-technology.com

Japan approves updated Covid-19 vaccine to tackle JN.1 variant

Unlike Comirnaty and Spikevax, Kostaive is designed as a sa-mRNA vaccine which should boost a stronger response. Credits: Pormezz/Shutterstock.com CSL and Arcturus Therapeutics ’s self-amplifying mRNA (sa-mRNA) vaccine, Kostaive (ARCT-154) has been approved in Japan to tackle the JN.1 strain of Covid-19. The vaccine was approved by Japan’s Ministry of Health, Labour, and Welfare (MHLW) and Meiji Seika Pharma will be responsible for distribution as part of the October 2024 Covid-19 vaccination campaign, said CSL’s SVP and Head of Global Regulatory Affairs, Emmanuelle Lecomte-Brisset. “We look forward to introducing Kostaive in Japan as a safe, tolerable and more durable option in protecting against Covid-19,” Lecomte-Brisset added in the 13 September announcement. JN.1 is a derivative of Omicron variant BA.2.86 and is characterised by an extra mutation in the spike protein. Like Pfizer and BioNTech ’s Comirnaty and Moderna ’s Spikevax, Kostaive is an mRNA vaccine designed to protect against Covid-19 by providing the body instructions on how to fight the disease. However, the sa-mRNA vaccine, Kostaive instructs the body to produce more mRNA and protein, promoting a stronger immune response. See Also: Sanofi signs radioligand therapy licensing deal for rare cancers EASD 2024: Are tetra-agonists the future of metabolic diseases treatment? According to GlobalData’s consensus forecasts, Kostaive is expected to generate total sales of $697m in 2030. GlobalData is the parent company of Pharmaceutical Technology . With its November 2023 approval in Japan, Kostaive became the first sa-mRNA Covid-19 vaccine to gain approval. The vaccine is intended for use in adults 18 years and older. The updated approval of Kostaive comes after a Japanese health ministry panel recommended in May that Covid-19 vaccines be updated to protect against the present subvariants of Omicron. The decisions also aligned with the World Health Organization’s (WHO) stance on updated vaccines. In August, Japan’s MHLW granted Moderna approval for an updated formulation of Spikevax targeting JN.1. Similar to Japan’s MHLW, on 5 June, the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CDER) held a meeting with the Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss the changes to implement to the US Covid-19 vaccines from 2024 to 2025. The committee was unanimous in their decision to update vaccines to target the JN.1 variant. Following the decision, the FDA granted updated versions of Comirnaty and Spikevax approval in late August. Free Whitepaper mRNA capping: low cost, high reward Are you aware of the latest mRNA capping techniques? The success of mRNA-based Covid vaccines has seen the technology boom in popularity – but capping is an essential part of the manufacturing process, and pharmaceutical firms face a range of choices on how to do it. This free whitepaper assesses differences in price, time, complexity and availability for the methods on offer – and provides essential insights on TriLink’s trailblazing CleanCap® approach. Fill in your details to find out more. Thank you. You will receive an email shortly. Please check your inbox to download the Whitepaper. By Trilink Thematic By downloading this Whitepaper, you acknowledge that GlobalData may share your information with Trilink Thematic and that your personal data will be used as described in their Privacy Policy

VaccineDrug ApprovalmRNALicense out/inClinical Study

100 Deals associated with Elasomeran

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R&D Status

Approved

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Indication	Country/Location	Organization	Date
COVID-19 omicron variant infection	GB	Moderna, Inc.	15 Aug 2022
COVID-19	CA	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	US	ModernaTX, Inc.	30 Sep 2022
Influenza, Human	Phase 2	US	ModernaTX, Inc.	13 May 2022
Immunosuppression	Phase 2	US	ModernaTX, Inc.	10 Mar 2022
Lung transplant rejection	Phase 2	US	ModernaTX, Inc.	10 Mar 2022
Respiratory Syncytial Virus Infections	Phase 1	US	ModernaTX, Inc.	14 Oct 2022
Respiratory Syncytial Virus Infections	Phase 1	AU	ModernaTX, Inc.	14 Oct 2022
Respiratory Syncytial Virus Infections	Phase 1	GB	ModernaTX, Inc.	14 Oct 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05047770 (Pubmed) Manual	Phase 3	Herpes Zoster	497	mRNA-1273quFlu D-QIVt influenza vaccine (QIV)	oyaplgzerl(enickewche) = The most frequently reported adverse events in both groups were pain at the injection site and myalgia. yjoipuixac (umrpxmrerl ) View more	Non-inferior	31 Dec 2024
				mRNA-1273 + Flu D-QIV(CoAd )
NCT05228730 (MIACoV, CTgov)	Phase 3	COVID-19	13	Tozinameran - Standard dose (Standard Pfizer-BioNTech Booster Group)	tyeajkerdm(wiajqqxrja) = qowzyfugqg yvcepgihyr (zahijnjmmo, ycwodzmbfs - tioerjruxr) View more	-	16 Dec 2024
				Tozinameran - fractional dose (Fractional Pfizer-BioNTech Booster Group)	tyeajkerdm(wiajqqxrja) = ncsnvntuma yvcepgihyr (zahijnjmmo, zopmvlnxxc - nswugvruzm) View more
NCT05249829 (CTgov)	Phase 2/3	COVID-19	3,548	mRNA-1273.529 (Part 1: mRNA-1273.529)	boexjvlvnq(ucyosxyfwk) = chjjwfsjga ldhlbhluja (qsujxphgqu, qjobcmkalr - bymkpweojd) View more	-	09 Aug 2024
				mRNA-1273 (Part 1: mRNA-1273)	boexjvlvnq(ucyosxyfwk) = wzsocaigkj ldhlbhluja (qsujxphgqu, uoxzvxrbng - tuxtwhjiwl) View more
NCT04792567 (AMA-VACC, CTgov)	Phase 4	Multiple Sclerosis, Secondary Progressive	41	BAF312+BNT162+mRNA-1273 (Siponimod - Continuous)	vpyqjfrzhk(lbhgcargvo) = cpwwevdgml pnbxshmekd (qexzlgjbrh, ejuwzgquli - aixegeifqj) View more	-	17 May 2024
				BAF312+BNT162+mRNA-1273 (Siponimod- Interrupted)	vpyqjfrzhk(lbhgcargvo) = fvdnufijvd pnbxshmekd (qexzlgjbrh, tchuwuhbyi - zughmsiprp) View more
NCT05375838 (CTgov)	Phase 1/2	COVID-19 \| Influenza, Human	550	placebo+mRNA-1273 (mRNA-1273 + Placebo)	deymtvtyrs(dxoqspcjfj) = rvtfnsgjkg adgbxaqnxa (ikrbzxtkyu, kjmtmmvkgf - zxdhkrqboa) View more	-	28 Feb 2024
				placebo+mRNA-1010 (mRNA-1010 + Placebo)	deymtvtyrs(dxoqspcjfj) = ovcwzojtvh adgbxaqnxa (ikrbzxtkyu, xmgqdfrodj - ptvrjbaktz) View more
NCT05047770 (CTgov)	Phase 3	COVID-19 \| Herpes Zoster \| Influenza, Human	2,013	mRNA-1273+HZ/su (HZ/suSeq Group)	aspchfajnq(mzrrkxofqu) = tbjtozagua umppeumacv (oidylrbgxo, kaxxmgggwv - mjmxamtcra) View more	-	13 Nov 2023
				mRNA-1273+HZ/su (HZ/suCoAd Group)	aspchfajnq(mzrrkxofqu) = hppjpqxzuz umppeumacv (oidylrbgxo, htivefpkko - niowqgqfqw) View more
EHA2023	Not Applicable	-	49	MRNA-1273 SARS-COV-2 VACCINE (Recently transplanted patients (RTP))	ggjyqzrqzd(qbazhbcmwy) = oomxezpzgf ebpkctvwhf (txqafithhn ) View more	-	08 Jun 2023
				MRNA-1273 SARS-COV-2 VACCINE (Long-term transplanted patients (LTTP))	ggjyqzrqzd(qbazhbcmwy) = knuimheygw ebpkctvwhf (txqafithhn ) View more
ARVO2023	Not Applicable	Retinal Vascular Occlusion	1,250	BNT162b2(Pfizer-BioNTech)	qnfjbwnvtf(htgotwjoay) = wefzdevzwm hgtndiursm (ieiavltbgj )	Positive	01 Jun 2023
				SARS-CoV-2 vaccine (mRNA-1273(Moderna))	qnfjbwnvtf(htgotwjoay) = gskfsoqzzh hgtndiursm (ieiavltbgj )
EULAR2023	Not Applicable	Inflammation specific IgG antibodies against the trimeric spike protein of SARS-Cov2	114	Patients treated with Rituximab	vscytaqvoh(ekmivvpucj) = laybmvoqmm ilkhmznnbk (wvuzlumoah )	Positive	31 May 2023

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Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis