Delving into the Latest Updates on Elasomeran with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine, mRNA vaccine

Synonyms

andusomeran, COVID-19 mRNA vaccine, COVID-19 Vaccine Moderna

+ [12]

Target

SARS-CoV-2 S protein

Action

inhibitors

Mechanism

SARS-CoV-2 S protein inhibitors(SARS-CoV-2 S protein inhibitors)

Therapeutic Areas

Infectious DiseasesRespiratory DiseasesOther Diseases

Active Indication

COVID-19 omicron variant infectionCOVID-19Influenza, Human+ [3]

Inactive Indication

ImmunosuppressionLung transplant rejection

Originator Organization

Moderna, Inc.

Active Organization

ModernaTX, Inc.

Moderna, Inc.Moderna Biotech Spain, S.L.

+ [2]

Inactive Organization

Takeda Pharmaceutical Co., Ltd.

License Organization

Takeda Pharmaceutical Co., Ltd.

Tabuk Pharmaceuticals Manufacturing Co.

Medison Pharma Ltd.

+ [5]

Drug Highest PhaseApproved

First Approval Date

Canada (23 Dec 2020),

COVID-19

RegulationPriority Review (United States), Fast Track (United States), Emergency Use Authorization (United States)

Login to view timeline

Structure/Sequence

Sequence Code 776927365

Source: *****

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

Login to view more data

100 Translational Medicine associated with Elasomeran

Login to view more data

100 Patents (Medical) associated with Elasomeran

Login to view more data

2,465

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.

876

News (Medical) associated with Elasomeran

11 Jul 2025

·www.biospace.com

Moderna Wins Full Approval for COVID-19 Shot for Higher-Risk Kids

iStock, Veronique D The approval of Moderna’s Spikevax for kids at higher risk of contracting the disease continues the company’s regulatory winning streak, which has also included nods for a next-gen COVID-19 vaccine and an RSV shot. The FDA granted full approval for Moderna ’s COVID-19 vaccine Spikevax for children aged 6 months through 11 years who are at higher risk of contracting the disease. Spikevax, which was previously only available to children under an emergency use authorization, is now approved for everyone 6 months through 64 years of age who are at increased risk of COVID-19, and all seniors 65 years and up. Moderna expects to make the updated Spikevax shot available ahead of the 2025-2026 respiratory virus season. The full approval, announced Thursday, continues a regulatory winning streak for Moderna—and comes even as health leaders show increased skepticism of the mRNA technology underlying the vaccine. Last month, Moderna secured two key approvals for its mRNA vaccine pipeline. The first was for its next-generation COVID-19 shot mNEXSPIKE , which is now cleared for older adults 65 and above, as well as people 12 through 64 years of age who have at least one underlying risk factor. The second was for its respiratory syncytial virus shot, mResvia , which secured a broader coverage including at-risk adults 18 through 59 years. Aside from regulatory wins, Moderna in June also reported that its flu vaccine mRNA-1010 cleared Phase III testing, outperforming a currently licensed standard-dose shot by 26.6% in adults 50 years and up. A spokesperson at the time confirmed to BioSpace that these data will contribute to Moderna’s plans to re biologics license application for its combo flu/COVID-19 vaccine mRNA-1083, but said the company “cannot share specifics on timeline right now.” Moderna in May voluntarily pulled its application for mRNA-1083 after consulting with the FDA. The company at the time did not reveal a specific reason for the withdrawal, announcing instead that it would resubmit the application following data from mRNA-1010. This plan “still stands,” a spokesperson told BioSpace on June 29, noting that Moderna still aims to share data from its vaccines with regulators “in due course.” Despite these wins for Moderna’s vaccine pipeline, high-level barriers remain, not least of which is the continued skepticism over mRNA technology from health authorities. Health Secretary Robert F. Kennedy Jr., for instance, said in a recent interview with former Fox News pundit Tucker Carlson that “there’s a lot of skepticism in this agency about mRNA vaccines, about mRNA technology . . . about whether it’s safe.” Meanwhile, at least one of the new members of the CDC’s Advisory Committee on Immunization Practices, Robert Malone, has previously testified before Congress to question the safety of mRNA vaccines.

VaccineDrug ApprovalPhase 3mRNA

10 Jul 2025

·endpoints.news

Moderna wins FDA approval for Covid shot in at-risk kids; Makary, Prasad defend vaccine framework

The FDA on Thursday approved Moderna’s Covid-19 shot for kids six months through 11 years old who are at higher risk of severe disease, the latest move that fits the agency’s new vaccine framework. The decision expands full approval of Spikevax to younger children ahead of the upcoming respiratory season. The vaccine was previously available for this age group under emergency use authorization. It’s now fully approved for all adults 65 and older and at-risk individuals six months through 64. “We appreciate the FDA’s diligent scientific review and approval of Spikevax for pediatric populations at increased risk for Covid-19 disease,” Moderna CEO Stéphane Bancel said in a release. The approval is also the latest in a series of FDA green lights for Moderna vaccines despite concerns from top health officials about mRNA technology. In the past six weeks, Moderna also won FDA approval for its next-generation Covid vaccine, mNexspike , and an expanded label for its RSV vaccine to cover adults 18 to 59 at higher risk of severe illness. When asked in a recent interview with Tucker Carlson whether he was satisfied that the mRNA vaccines were safe, HHS chief Robert F. Kennedy Jr. said he wasn’t. “I would say there’s a lot of skepticism in this agency about mRNA vaccines, about mRNA technology, about the status of it now, about whether it’s safe,” he said. FDA Commissioner Marty Makary and CBER Director Vinay Prasad announced in May that new Covid vaccine approvals would be limited to adults 65 and older and at-risk younger people. Companies would be strongly recommended to run post-marketing, placebo-controlled studies in adults 50-64 to try and expand those labels to healthy people younger than 65. Makary and Prasad defended that framework in response to criticism from clinicians and researchers published in a top medical journal on Wednesday. In a response to letters to the editor published in the New England Journal of Medicine , the two officials reiterated that the agency no longer believes the benefits of Covid-19 vaccination outweigh the risks in younger healthy adults. They also addressed more regulatory action if the newly-required post-marketing studies are delayed or fail. “If postmarketing commitments are not completed or if the findings are negative, the FDA may take additional actions in this space,” they said. The officials also rejected an argument laid out by two researchers that vaccination reduces the risk of long Covid, an umbrella term for people who have experienced a post-infection chronic illness. Survey data from CDC researchers published in December found that 8.4% adults in the US reported ever having a post-Covid condition. “Absent substantial evidence, the FDA has never permitted manufacturers to make claims about transmission or long Covid in the package inserts of Covid-19 vaccines,” Makary and Prasad wrote.

VaccineDrug ApprovalmRNAEmergency Use Authorization

10 Jul 2025

·firstwordpharma.com

Moderna's COVID-19 shot gets full approval for children as young as 6 months

The FDA on Thursday approved Moderna's flagship mRNA-based COVID-19 vaccine for children aged 6 months to 11 years old who are at increased risk for disease, marking the third consecutive month that the biotech has scored a green light for one of its infectious disease programmes.Previously, Spikevax was available to paediatric populations under an emergency use authorization (EUA) granted in 2022, though that designation was not limited to at-risk individuals. Meanwhile, Moderna said it expects to have its updated Spikevax vaccine available for the 2025-2026 respiratory virus season. Shares in the company ticked up about 4.5% on the news Thursday.Vaccine ups and downsThe regulatory decision follows a May approval for Moderna's next-generation COVID-19 vaccine, mNEXSPIKE (mRNA-1283), though that jab is restricted to adults 65 and older, or those between the ages of 12 and 64 who are at high risk for severe disease.And in June, the label for Moderna's mRNA-based respiratory syncytial virus (RSV) vaccine mRESVIA (mRNA-1345) was expanded to include individuals 18-59 years of age who are at increased risk of disease. It was initially cleared last year for adults aged 60 years and older.The company also stands to benefit from broader guidelines from the Centers for Disease Control and Prevention (CDC) recommending RSV vaccinations for adults ages 50 to 59 who face a higher risk of severe illness. While seemingly on a hot streak for its portfolio, Moderna is also facing down an uncertain regulatory landscape in the US for vaccines (see – Vital Signs: Moderna starts sweating vaccine climate at the 'new FDA').Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., as well as several new members of the CDC's vaccine advisory committee, have cast doubt on the safety of mRNA vaccines. In May, HHS cancelled over $760 million in funding previously awarded to Moderna for the development of vaccines for pre-pandemic influenzas, including bird flu. A department spokesperson said that "continued investment in Moderna’s H5N1 mRNA vaccine was not scientifically or ethically justifiable," adding that "mRNA technology remains under-tested."The company has already hit one setback for its combination COVID-19/flu shot, and going forward, any future COVID-19 boosters from Moderna will have to undergo placebo-controlled testing to reach healthy individuals under the age of 65.

VaccineDrug ApprovalmRNA

100 Deals associated with Elasomeran

Login to view more data

External Link

KEGG	Wiki	ATC	Drug Bank
-	Elasomeran	J07	DB15654

R&D Status

Approved

10 top approved records.

Login

to view more data

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.

Login

to view more data

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

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05160766 (EU-COVAT-1 \| EU-COVAT-1_AGED, CTgov)	Phase 2	COVID-19	323	Comirnaty (BNT162b2 (Part A))	aorgezjfrh = slmpkupfus gujmkibnaz (mkfevqnbor, snqipxdkih - ilqihbqptm) View more	-	20 May 2025
				Spikevax (mRNA-1273 (Part A))	aorgezjfrh = schvlermop gujmkibnaz (mkfevqnbor, laskbsaupc - mivcfrtngk) View more
NCT05280158 (CTgov)	Phase 1/2	Lung transplant rejection \| Immunosuppression	19	mRNA-1273 (Moderna COVID-19 vaccine) (Standard-dose)	hwqpsmwwqd = cquvukptvi tavsffxlkq (wkvuywsieo, xljezmpvvp - obpthbioxq) View more	-	26 Mar 2025
				mRNA-1273 (Moderna COVID-19 vaccine) (Mid-Dose)	hwqpsmwwqd = ljeqwadxxp tavsffxlkq (wkvuywsieo, wgljxfgcln - oevskbkfht) View more
NCT05022329 (BOOST KIDNEY, CTgov)	Phase 2/3	COVID-19 \| Chronic kidney disease, Stage V \| Chronic Kidney Diseases	273	BNT162b2 (Third Dose BNT162b2)	wfzihmmuuz(hqnsjlyrdy) = ogsuosqzpx frxcfgyaxb (bjcpykhaiw, 0.334) View more	-	19 Feb 2025
				mRNA-1273 (Moderna) (Third Dose mRNA-1273)	wfzihmmuuz(hqnsjlyrdy) = kcevsofift frxcfgyaxb (bjcpykhaiw, 0.169) View more
NCT05047770 (Pubmed) Manual	Phase 3	Herpes Zoster	497	mRNA-1273quFlu D-QIVt influenza vaccine (QIV)	xhdcvikzeo(pazodaexfq) = The most frequently reported adverse events in both groups were pain at the injection site and myalgia. vnveihboqh (xnpwxslmgy ) 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)	hqneslniso(vatftcfble) = uaaetylahj mqytacxmup (vcbthtitgf, xzmeecfhjd - kjflqxxhvr) View more	-	16 Dec 2024
				Tozinameran - fractional dose (Fractional Pfizer-BioNTech Booster Group)	hqneslniso(vatftcfble) = rctgfsepda mqytacxmup (vcbthtitgf, qoemiynrxv - kznsnphfgv) View more
NCT05249829 (CTgov)	Phase 2/3	COVID-19	3,548	mRNA-1273.529 (Part 1: mRNA-1273.529)	nkzldsrmbj(wvbubgzgbs) = snpcuhzdei zyapmqgeno (ymkxmdqtrj, nptbdwlhuo - ckyidmeuud) View more	-	09 Aug 2024
				mRNA-1273 (Part 1: mRNA-1273)	nkzldsrmbj(wvbubgzgbs) = erepzniwlc zyapmqgeno (ymkxmdqtrj, raphsflvpe - argxmcuppz) View more
NCT05375838 (CTgov)	Phase 1/2	COVID-19 \| Influenza, Human	550	placebo+mRNA-1273 (mRNA-1273 + Placebo)	jggkoiiida = tvgxxtnubo zdsefootce (wqxougoimb, pxjvsfucvy - ahtwwehnhf) View more	-	28 Feb 2024
				placebo+mRNA-1010 (mRNA-1010 + Placebo)	jggkoiiida = cxmbmwlaar zdsefootce (wqxougoimb, hczgzvtiuy - hikqbncxjf) View more
EHA2023	Not Applicable	-	49	MRNA-1273 SARS-COV-2 VACCINE (Recently transplanted patients (RTP))	tzcfkphzyl(rgqfazxoyc) = hbfgguoviu vluzljchef (busohpwmnj ) View more	-	08 Jun 2023
				MRNA-1273 SARS-COV-2 VACCINE (Long-term transplanted patients (LTTP))	tzcfkphzyl(rgqfazxoyc) = gwccsogibw vluzljchef (busohpwmnj ) View more
ARVO2023	Not Applicable	Retinal Vascular Occlusion	1,250	BNT162b2(Pfizer-BioNTech)	bbdnentchd(ylwkimzqgj) = fgirfftgrq rbmwnxlzuq (mzpylvhfgd )	Positive	01 Jun 2023
				SARS-CoV-2 vaccine (mRNA-1273(Moderna))	bbdnentchd(ylwkimzqgj) = wqncqmkkpb rbmwnxlzuq (mzpylvhfgd )