Delving into the Latest Updates on mRNA COVID-19 Vaccine(LiveRNA Therapeutics Inc.) with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine, mRNA vaccine

Synonyms

mRNA COVID-19 Vaccine(AIM Vaccine), SARS-CoV-2 mRNA Vaccine, mRNA新冠疫苗（艾美疫苗）

+ [2]

Target

SARS-CoV-2 S protein

Mechanism

SARS-CoV-2 S protein inhibitors(Coronavirus spike glycoprotein inhibitors)

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

COVID-19

Inactive Indication-

Originator Organization

LiveRNA Therapeutics Inc.

Active Organization

AIM Vaccine Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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Author: Graz, Myriam Bickle ; Madec, Yoann ; Bromley, Rebecca L ; Panchaud, Alice ; Favre, Guillaume ; Blume, Carolin ; Baud, David ; Bromley, Rebecca L. ; Daire, Charlotte ; Radan, Anda-Petronela ; Surbek, Daniel ; Winterfeld, Ursula ; Bickle Graz, Myriam ; Kalimeris, Stylianos ; Schneider, Juliane ; Raio, Luigi ; Bluett-Duncan, Matthew ; Maisonneuve, Emeline ; Pomar, Léo

OBJECTIVES:

Data are lacking regarding the long-term consequences of SARS-CoV-2 and COVID-19 mRNA vaccine on infants exposed in utero. We aimed to evaluate the neurodevelopment of infants exposed prenatally to SARS-CoV-2 or mRNA-COVID-19 vaccine during pregnancy at 12 months after birth.

METHODS:

Infants born to mothers exposed to SARS-CoV-2 or mRNA-COVID-19 vaccine during pregnancy, or unexposed to either the virus or the vaccine were enrolled from 2021 to 2023. Infants with prenatal exposure to the virus or vaccine were compared with infants without prenatal exposure to the virus and/or vaccine. Parents received a neurodevelopmental questionnaire (ages and stages questionnaire third edition) at 12 months after birth assessing five subdomains: communication, gross motor, fine motor, problem-solving, and personal social development. A low score was defined as <2 standard deviations below the normative mean in at least one of the subdomains.

RESULTS:

A total of 330 infants were included (76 in the SARS-CoV-2 group, 153 in the mRNA-COVID-19 vaccine group, and 101 in the reference group). In utero exposure to the SARS-CoV-2 or mRNA-COVID-19 vaccine was not associated with an increased risk of a low score for at least one subdomain compared with the reference group. The crude ORs were 1.16 (95% CI, 0.59-2.28) and 1.04 (95% CI, 0.58-1.86), respectively. Results remained consistent in the multivariate analysis, showing no increased risk of a low score for at least one subdomain for infants exposed to the SARS-CoV-2 or mRNA-COVID-19 vaccine, compared with the reference group. The adjusted ORs were 1.74 (95% CI, 0.76-3.99) and 0.76 (95% CI, 0.39-1.49), respectively.

DISCUSSION:

In utero exposure to SARS-CoV-2 or mRNA-COVID-19 vaccine was not associated with an increased risk of a low score for at least one ages and stages questionnaire third edition subdomain at 12 months after birth. Additional studies are needed to confirm our results, especially longer-term evaluation of infant development.

01 Jan 2025·JOURNAL OF INFECTION AND CHEMOTHERAPY

SARS-CoV-2 mRNA vaccine-related myocarditis and pericarditis: An analysis of the Japanese Adverse Drug Event Report database

Article

Author: Takada, Keisuke ; Igarashi, Yuki ; Okamoto, Yuko ; Samura, Masaru ; Tanikawa, Koji ; Enoki, Yuki ; Taguchi, Kazuaki ; Matsumoto, Kazuaki

BACKGROUND:

The association between severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) mRNA vaccines and myocarditis/pericarditis in the Japanese population has not been systematically investigated. This study was aimed at clarifying the association between SARS-CoV-2 mRNA vaccines (BNT162b2 and mRNA-1273) and myocarditis/pericarditis as well as influencing factors by using the Japanese Adverse Drug Event Report database.

METHODS:

Reporting odds ratios (RORs) and 95 % confidence intervals (95 % CIs) for the association between the vaccines and myocarditis/pericarditis were calculated using data from the database (April 2004-December 2023). Age, sex, onset time, and outcomes in symptomatic patients were evaluated.

RESULTS:

The total number of reports was 880,999 (myocarditis: 1846; pericarditis: 761). The adverse events associated with the vaccines included myocarditis (919 cases) and pericarditis (321 cases), with the ROR [95 % CIs] being significant for both (myocarditis: 30.51 [27.82-33.45], pericarditis: 21.99 [19.03-25.40]). Furthermore, the ROR [95 % CIs] of BNT162b2 and mRNA-1273 were 15.64 [14.15-17.28] and 54.23 [48.13-61.10], respectively, for myocarditis, and 15.78 [13.52-18.42] and 27.03 [21.58-33.87], respectively, for pericarditis. Furthermore, most cases were ≤30 years or male. The period from vaccination to onset was ≤8 days, corresponding to early failure type based on analysis using the Weibull distribution. Outcomes were recovery or remission for most cases; however, they were severe or caused death in some cases.

CONCLUSION:

In the Japanese population, SARS-CoV-2 mRNA vaccination was significantly associated with the onset of myocarditis/pericarditis. The influencing factors included age of ≤30 years and male. Furthermore, although most adverse events occurred early after vaccination, overall outcomes were good.

01 Jan 2025·JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY

Monocytic reactive oxygen species-induced T cell apoptosis impairs cellular immune response to SARS-CoV-2 mRNA vaccine

Article

Author: André, Sonia ; Kundura, Lucy ; Vincent, Thierry ; Soundaramourty, Calayselvy ; Hamrouni, Emna ; Lozano, Claire ; Estaquier, Jérôme ; Corbeau, Pierre ; Picard, Morgane ; Tran, Tu-Anh ; Gimenez, Sandrine

BACKGROUND:

We have recently shown that, during acute severe COVID-19, SARS-CoV-2 spike protein (S) induces a cascade of events resulting in T cell apoptosis. Indeed, by neutralizing the protease activity of its receptor, ACE2, S induces an increase in circulating Angiotensin II (AngII), resulting in monocytic release of reactive oxygen species (ROS) and programmed T cell death.

OBJECTIVE:

Here, we tested whether SARS-CoV-2 mRNA vaccines, known to cause the circulation of the vaccine antigen, S-protein receptor binding domain (RBD), might trigger the same cascade.

METHODS:

To this aim, we used ELISA to quantify the presence of RBD and AngII in participants' peripheral blood as well as the presence of interferon-γ in the supernatant of peripheral blood mononuclear cells (PBMCs) exposed to S. Monocytic ROS production, T cell apoptosis, and S-induced T lymphocyte proliferation were measured by flow cytometry, and DNA damage by immunofluorescence.

RESULTS:

In most vaccinees, we observed the presence of circulating RBD peaking on Day 14, and linked to an increase in AngII plasma levels with a peak on Day 28. This increase correlated with i) the ability of monocytes to produce ROS and to induce ROS-mediated DNA damage in neighboring cells, including PBMCs, ii) CD4⁺ and CD8⁺ T lymphocyte apoptosis, and iii) a poor response to S in vitro from both CD4⁺ and CD8⁺ T cells.

CLINICAL IMPLICATIONS:

We observed the same cascade of events triggered by the vaccinal antigen as by SARS-CoV-2 infection. This cascade may account for the suboptimal efficiency of mRNA SARS-CoV-2 vaccines in preventing the infection, the limited vaccine memory, and certain side-effects. In this model, AngII receptor antagonists and/or antioxidants might improve the performance of the SARS-CoV-2 vaccine.

2

News (Medical) associated with mRNA COVID-19 Vaccine(LiveRNA Therapeutics Inc.)

09 Jun 2021

·news.pedaily.cn

丽凡达生物回购横琴天使基金股权，天使基金让利近亿元

近日，艾美疫苗股份有限公司完成对珠海丽凡达生物技术公司（简称丽凡达公司）收购，对其控股50.1546%。鉴于丽凡达创始团队向天使基金提出回购需求，为支持丽凡达公司完善公司治理、实现更大发展，横琴天使投资基金适时启动退出工作，按照横琴天使投资基金产业扶持政策，丽凡达公司创始团队以天使基金投资款的2.5倍，作价回购天使基金所持股权，区天使投资基金让利金额近1亿元。后续，丽凡达公司将留在横琴长期稳定发展。丽凡达公司为横琴金融投资集团于2019年以投资方式引进的致力于mRNA技术研发的高端医疗类科创项目。主要研发管线包括人用和兽用狂犬疫苗、生殖激素项目、罕见病蛋白补充项目、难治性实体瘤项目等。2020年初，新冠肺炎疫情发生后，该公司发挥其研发技术优势，迅速启动新冠病毒mRNA疫苗的研发，在短时间内完成候选疫苗设计、小试生产和动物模型实验，并成功获得NMPA临床批件，为国内新冠疫苗mRNA技术路线的*者。丽凡达公司自落地横琴发展以来，横琴金投集团着力为其提供全方位支持。在公司成立初期，横琴金投集团通过横琴天使投资基金为其提供数百万元天使投资，带动社会资本近2000万元支持其发展，助力丽凡达公司起好步、开好局；在其新冠疫苗研发进入关键阶段、资金需求加大时，横琴金投集团及时为其提供近1500万元贷款资金支持，为其对接市场投资机构提供帮助，协助其与社会资本开展谈判，保障其研发和运营持续推进。在本次新一轮融资中，丽凡达公司以较高估值获得社会资本大比例融资，为支持其完善公司治理和持续稳健发展，兑现天使基金让利承诺，大幅度让利公司创始人近1亿元，较好地履行了国有投资公司对区内科创项目“扶上马、再送一程”的担当与使命。横琴新区天使投资基金首期规模3.5亿元，由横琴新区政府投资基金和横琴金投集团各按50%比例出资，重点投资落地在横琴的初创期科创项目，通过聚合政府资源、国企资源和市场力量，扶持优质产业项目在横琴发展壮大。为鼓励引导科创项目落地横琴发展，天使基金管理办法对科创项目实施大力度的优惠让利政策，同时为落地横琴的被投项目提供场地租赁、工商注册、补贴申报、人才招聘、融资对接等一站式服务，助力科创项目在横琴快速发展。天使基金运营三年来，累计投资引进了30多个科创项目，得益于横琴作为国家重大战略平台所拥有优良投资环境和公司完善的投后服务，没有出现失败项目，超过一半的项目获得新一轮融资，部分项目估值超60倍，在横琴实现快速发展。

01 Jun 2021

·en.aimbio.com

AIM Vaccine completed acquisition of Lifanda to accelerate deployment of mRNA COVID-19 Vaccine

On May 31, AIM Vaccine Co., Ltd completed acquisition of Zhuhai Lifanda Biology Co., Ltd, holding 50.1546% of its shares. Lifanda Biology is one of 3 enterprises obtained clinical approval of mRNA COVID-19 vaccine. Such acquisition serves as the integration between manufacturing enterprise and R&D company, which has accelerated R&D and production layout of AIM Vaccine for mRNA vaccine as well as industrialization of technologies of Lifanda Biology on mRNA. This has promoted production and marketing of mRNA COVID-19 vaccine in China. mRNA COVID-19 vaccine as developed by Lifanda Biology obtained Approval Form of Clinical Trial as approved and issued by National Medical Products Administration in March of this year for formal clinical test as scheduled. Since formal input for R&D of mRNA products in 2017, Lifanda Biology has established its own mRNA production and drug delivery technical platform, and has successfully applied numerous patents of invention for drug design, production and delivery of preparations.

VaccineAcquisitionmRNADrug ApprovalClinical Study

100 Deals associated with mRNA COVID-19 Vaccine(LiveRNA Therapeutics Inc.)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 3	CN	AIM Vaccine Co., Ltd.	08 Apr 2022

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASN2022	Not Applicable	Maintenance	-	SARS-CoV-2 mRNA Vaccines (One dose)	kqvpphaiwl(zrlugrrbha) = wsefqwheoo tsnejvtcyp (lzezahhblb, 97 - 100) View more	Positive	05 Nov 2022
				SARS-CoV-2 mRNA Vaccines (Two doses)	kqvpphaiwl(zrlugrrbha) = xzltukoewm tsnejvtcyp (lzezahhblb, 47 - 76) View more
ASN2022	Not Applicable	Glomerulosclerosis, Focal Segmental	-	Moderna mRNA COVID-19 vaccine	gueodkxmxa(vpxaukjgmi) = ixlgwhpfrr epeyrqcvsa (xooiuausur ) View more	-	04 Nov 2022
ASN2022	Not Applicable	Hemodialysis complication	-	mRNA COVID-19 Vaccine (mRNA-1273 (Moderna))	hsetghptuj(erdwpssuje) = ijbknvlaci cwpaqzxres (mgxwptkfsp )	Positive	03 Nov 2022
				BNT-162b2 (Pfizer)	hsetghptuj(erdwpssuje) = avmqatnwri cwpaqzxres (mgxwptkfsp )
PSUN36 (ENDO2022)	Not Applicable	Thyroiditis, Subacute	1	Pfizer-BioNTech mRNA COVID-19 vaccine	lpotoflhlr(ycrmtiqced) = ntaklyoczk gzhifmaixt (jidfczlaif )	Positive	01 Nov 2022
				Moderna mRNA COVID-19 vaccine	hvuepynxnd(uplfffvaid) = luyptavmuv hjuxvtoing (rqngvuaptm )
CovaXiMS study (ECTRIMS2022)	Not Applicable	Multiple Sclerosis	1,881	pwMS on fingolimod	nitevyazux(zolwvrfbve) = lveqryxrvw vrowipexft (zcpmvukewo )	-	12 Oct 2022
				pwMS on other DMTs	nitevyazux(zolwvrfbve) = rlpxgyeskc vrowipexft (zcpmvukewo )
EADV2022	Not Applicable	COVID-19	-	Moderna (1273 vaccine)	ouzpvvwobv(motytfdbng) = Seven patients developed herpes zoster 2-5 days after the first vaccine dose, five patients 3-21 days after the second dose and three patients 6-14 days after the third vaccine dose. All patients who exhibited herpes zoster either after the 1st or the 2nd vaccine dose, received the following dose without any adverse reactions or complications. Oral treatment with valacyclovir (1.000mg 1x3/day) for 5-7 days in all patients led to a complete resolution of the symptoms and the rash within 9-14 days. All patients have presently completed a 3-4.5-month follow-up without any evidence of herpes zoster complications and/or recurrences. wlbjysokbe (ageaukoliv )	-	07 Sep 2022
NCT05352867 (NEWS) Manual	Phase 2	COVID-19	-	LVRNA009 (成人中剂量组)	yoxheogxpq(kphnodqfbm) = 整体上与疫苗接种有关的不良反应以1级为主，无相关的严重不良事件（SAE）或特殊关注的不良事件，疫苗安全风险低 mbmliowkot (ibvfuvkwlr )	Positive	24 Aug 2022
				LVRNA009 (成人高剂量组)
EASL2022	Not Applicable	Liver transplant rejection	181	2-dose mRNA vaccine	xsqlhlfnft(qatdynkgch) = jmrtxttfzf yowrxzebmi (kcbdwuoyfh )	-	25 Jun 2022
				3rd dose mRNA vaccine	xsqlhlfnft(qatdynkgch) = hgkkgwyuqp yowrxzebmi (kcbdwuoyfh )
MO970 (ERA2022)	Not Applicable	-	83	2 doses of mRNA vaccine	bxfchccsvi(vlzfijulpr) = cokyktwdif yberfqcgrq (yndhdbtoiv, 34 - 350) View more	Positive	03 May 2022
				3 doses of mRNA vaccine	bxfchccsvi(vlzfijulpr) = pxsesairpd yberfqcgrq (yndhdbtoiv, 205 - 2415) View more
ASN2021	Not Applicable	Glomerulonephritis	-	Moderna vaccine	mprmplqgau(jlyrtapess) = axowsinibz wsacmgthby (tngsifflsj ) View more	-	27 Oct 2021
				Pfizer vaccine	mprmplqgau(jlyrtapess) = lyrnnnkvoy wsacmgthby (tngsifflsj ) View more