A Multi-Centre, Prospective, Observational Post-Marketing Surveillance to Investigate the Long-Term Safety of SPIKEVAX BIVALENT and SPIKEVAX X Injection Under Routine Clinical Care in Korea

The main objective of the surveillance is to evaluate the incidence of the adverse events (AEs), and other safety related information in South-Korean population.

Start Date10 Mar 2023

Sponsor / Collaborator

ModernaTX, Inc.

NCT05658523

/ Active, not recruitingPhase 3

A Randomised Controlled Trial to Assess the Immunogenicity, Safety and Reactogenicity of a Bivalent mRNA Moderna COVID-19 Vaccine or a Protein-based Novavax COVID-19 Vaccine Given as a Fourth Dose in Healthy Adults in Australia

This is a double-blinded, randomised study to determine the safety, reactogenicity, and immunogenicity of a bivalent mRNA Moderna COVID-19 vaccine or a protein-based Novavax COVID-19 vaccine given as a fourth dose in healthy adults in Australia.

Start Date28 Feb 2023

Sponsor / Collaborator

Murdoch Childrens Research Institute

[+2]

NCT05383560

/ CompletedPhase 2IIT

Phase 2, Randomized, Observer-Blind, Investigator-Initiated, Collaborative Study to Evaluate the Safety and Immunogenicity of Omicron Variant-Matched Vaccine Booster in Adults

Under protocol versions 1.01-1.06: The five recently emerged SARS-CoV2 variants that were designated as VOCs are the Alpha variant, Beta variant, Gamma variant, Delta variant and the Omicron variant. The current dominant Omicron variant was designated a VOC by WHO on Nov 26, 2021, and was found to comprise 85% of reported variants in late January 2022. Studies have shown that the prevalent Omicron mutations in the S1 subunit RBD region and NTD region could dramatically change the antigenic features of the viral spike, leading to significantly reduced neutralization Omicron harbors 30 signature mutations (>50% prevalence) of which 15 are in the S1 subunit RBD region and 8 are in the S1 subunit NTD region. Omicron is a highly contagious variant with threatening immune evasion capabilities even despite robust immune response. Initial modeling showed the Omicron variant being 2.8 times more infectious than the Delta variant. While current vaccines are losing protection against Omicron with respect to infection and mild disease, there is still considerable protection from hospitalisation and severe COVID-19, especially after a booster dose. The International Coalition of Medicines Regulatory Authorities (ICMRA) COVID-19 Omicron Variant Workshop encouraged the international scientific community and vaccine developers to look at alternative approaches to monovalent vaccines. In ICMRA's view, companies should also explore the feasibility of developing bivalent or multivalent variant vaccines to determine if they offer advantages to monovalent vaccines. As advised by ICMRA, the investigated vaccine, mRNA-1273.214 is a bivalent vaccine containing the ancestral SARS-CoV-2 and the Omicron variant spike sequences that will be evaluated as a heterologous boost.
Under protocol version 1.07:The study will also investigate the safety, reactogenicity and immune response of the mRNA-1273.222 administered as a boost vaccine after primary series vaccination comprising 3 doses of an mRNA vaccine .
This study hypothesizes that the peak level of antibodies against SARS CoV-2, will be at two weeks after the first study dose is administered, which is similar to other recent findings (Anderson et al., 2022).2.2.1. The bivalent mRNA-1273.222 vaccine contains mRNA encoding for the spike protein of BA.4/BA.5 as well as mRNA encoding for the original (ancestral Wuhan-Hu-1) strain of the SARS-CoV-2 virus.

Start Date05 Sep 2022

Sponsor / Collaborator

Sheba Medical Center

[+1]

100 Clinical Results associated with Elasomeran/Imelasomeran

100 Translational Medicine associated with Elasomeran/Imelasomeran

100 Patents (Medical) associated with Elasomeran/Imelasomeran

146

Literatures (Medical) associated with Elasomeran/Imelasomeran

01 Dec 2024·eBioMedicine

Bivalent Omicron BA.1 vaccine booster increases memory B cell breadth and neutralising antibodies against emerging SARS-CoV-2 variants

Article

Author: Aggarwal, Anupriya ; Cunningham, Anthony L ; Stubis, Aija ; Bull, Rowena A ; Brilot, Fabienne ; Kelleher, Anthony ; Rockett, Rebecca ; Triccas, James A ; Lloyd, Andrew R ; Tedla, Nicodemus ; Shrestha, Lok Bahadur ; Fewings, Nicole L ; Tungatt, Katie ; Rodrigo, Chaturaka ; Britton, Warwick J ; Tangye, Stuart G ; Akerman, Anouschka ; Douglas, Mark W ; Turville, Stuart G ; Lee, Sharon ; Sandgren, Kerrie J ; Caterson, Ian D ; Fichter, Christina

BACKGROUNDCurrent literature informs us that bivalent vaccines will generate a broader serum neutralizing antibody response to multiple SARS-CoV-2 variants, but studies on how this breadth relates to the memory B cell (MBC) and T cell responses are sparse. This study compared breadth of neutralising antibody, and memory B and T cell responses to monovalent or a bivalent ancestral/Omicron BA.1 COVID-19 booster vaccine.METHODSAt baseline and 1-month post-booster, neutralisation activity and frequencies of receptor binding domain (RBD)-specific MBCs and Spike-specific memory T cells were measured against a panel of variants.FINDINGSBoth vaccines boosted neutralising antibodies to 5 variants - Wuhan-Hu-1, Delta, BA.1, BA.5 and JN.1, the latter of which had not yet emerged at the time of sample collection. The bivalent vaccine induced a significantly larger increase in nAb against BA.1 and JN.1. Both vaccines boosted RBD-specific MBC responses to Wuhan-Hu-1, Delta, BA.1 and BA.5 variants with a significantly greater increase for BA.1 in the bivalent group. The breadth of MBCs was significantly higher in those who received the bivalent boost and correlated with nAb breadth. Both vaccines significantly boosted Spike-specific T cell responses to the Wuhan-Hu-1 and BA.5 variants, but only the bivalent vaccine boosted BA.1 responses.INTERPRETATIONThese results suggest that the bivalent vaccine confers an advantage against future novel variants due to increased frequency of broadly reactive RBD-specific B cells.FUNDINGWork supported by NSW Health for the NSW Vaccine, Infection and Immunology Collaborative (VIIM).

01 Oct 2024·Vaccine

Effectiveness of COVID-19 bivalent vaccination against SARS-CoV-2 infection among residents of US nursing homes, November 2022 – March 2023

Article

Author: Wallace, Megan ; Gensheimer, Amber ; Wiegand, Ryan ; Patel, Arshiya ; Jernigan, John ; Baggs, James ; Franceschini, Thomas ; Hatfield, Kelly ; Reddy, Sujan ; Link-Gelles, Ruth

BACKGROUNDResidents of nursing homes remain an epidemiologically important population for COVID-19 prevention efforts, including vaccination. We aim to understand effectiveness of bivalent vaccination for preventing SARS-CoV-2 infections in this population.METHODSWe used a retrospective cohort of nursing home residents from November 1, 2022, through March 31, 2023, to identify new SARS-CoV-2 infections. A Cox proportional hazards model was used to estimate hazard ratios comparing residents with a bivalent vaccination compared with residents not up to date with vaccination recommendations. Vaccine effectiveness was estimated as (1 - Hazard Ratio) * 100.RESULTSAmong 6,916 residents residing in 76 nursing homes included in our cohort, 3,211 (46%) received a bivalent vaccine 7 or more days prior to censoring. Adjusted vaccine effectiveness against laboratory confirmed SARS-CoV-2 infection comparing receipt of a bivalent vaccine versus not up to date vaccine status was 29% (95% Confidence interval 18% to 39%). Vaccine effectiveness for receipt of a bivalent vaccine against residents who were unvaccinated or vaccinated more than a year prior was 32% (95% CI: 20% to 42%,) and was 25% compared with residents who were vaccinated with a monovalent vaccine in the past 61-365 days (95% CI:10% to 37%).CONCLUSIONSBivalent COVID-19 vaccines provided additional protection against SARS-CoV-2 infections in nursing home residents during our study time-period, compared to both no vaccination or vaccination more than a year ago and monovalent vaccination 60 - 365 days prior. Ensuring nursing home residents stay up to date with vaccine recommendations remains a critical tool for COVID-19 prevention efforts.

01 Oct 2024·The Lancet Infectious Diseases

Immunogenicity of a booster dose of a bivalent (Asp614Gly and omicron BA.4/5 variant) self-amplifying mRNA SARS-CoV-2 booster vaccine versus the BNT162b2 omicron BA.4/5 mRNA vaccine: a randomised phase 3 trial

Article

Author: Smolenov, Igor ; Otsuki, Mako ; Iwama, Yasuhiro ; Ishida, Natsuki ; Kurosawa, Toru ; van Boxmeer, Josephine ; Minamida, Takeshi ; Kumagai, Yuji ; Walson, Judd L ; Okura, Iori ; Okada, Yusuke ; Yagi, Yukihiro ; Zhang, Ye

BACKGROUNDWe previously showed that ARCT-154, a self-amplifying mRNA COVID-19 vaccine, had improved immunogenicity and antibody persistence compared with conventional mRNA or adenovirus vector vaccines. In this study, we compared ARCT-2301, a bivalent self-amplifying mRNA vaccine (Asp614Gly and omicron BA.4/5 variant), with the bivalent Comirnaty omicron BA.4-5 vaccine, to determine whether this improved response persisted in bivalent formulations against different SARS-CoV-2 variants.METHODSThis randomised, multicentre, phase 3, observer-masked, active-controlled comparative study was done at nine hospitals in Japan. Eligible participants were healthy Japanese adults, aged at least 18 years, who had previously received a full immunisation series of three to five doses of mRNA COVID-19 vaccines (Comirnaty or Spikevax [Moderna]), with the last dose received at least 3 months before screening for this trial. Participants were randomly assigned (1:1) to either ARCT-2301 or Comirnaty BA.4-5 mRNA vaccine using interactive computer-generated randomisation with a block size of four. Randomisation was stratified by gender (men vs women), age group (<65 years vs ≥65 years), type of vaccine used for last vaccination (bivalent omicron BA.1 vs bivalent omicron BA.4/5), and time since last COVID-19 vaccination (<5 months vs ≥5 months). ARCT-2301 was supplied in vials containing 100 μg lyophilised mRNA, 50 μg mRNA each coding for the full-length spike proteins of the ancestral Asp614Gly SARS-CoV-2 strain and omicron BA.4/5 variant. Immediately before use, each vial was reconstituted with 10 mL saline. The comparator original omicron BA.4/5 mRNA vaccine (Comirnaty BA.4-5) was supplied in ready-to-use vials containing a single dose of 30 μg mRNA in 0·3 mL volume. Both vaccines were administered by intramuscular injection in the deltoid of the non-dominant arm. The primary outcome of the study was to show non-inferiority of immunogenicity of ARCT-2301 versus Comirnaty BA.4-5 at day 29 as neutralising antibody geometric mean titres (GMT) and seroresponse rates against omicron BA.4/5. Primary analyses were done in a per-protocol manner. The trial is registered with the Japan Registry for Clinical Trials, jRCT2031230340.FINDINGSBetween Sept 29 and Nov 18, 2023, we enrolled 930 participants (451 men and 479 women) to receive a booster dose of ARCT-2301 (n=465) or Comirnaty BA.4-5 (n=465). The primary immunogenicity outcome to show that the antibody response at day 29 against omicron BA.4/5 elicited by ARCT-2301 was non-inferior to that elicited with Comirnaty BA.4-5 was achieved, both by GMT ratio (1·49, 95% CI 1·26-1·76) and difference in seroresponse rate (7·2%, 95% CI 0·6-13·7). Furthermore, the differences in antibody response between the groups showed superiority for ARCT-2301 against Wuhan-Hu-1 using both criteria, with a GMT ratio of 1·45 (95% CI 1·28-1·63) and a difference in seroresponse rate of 12·5% (95% CI 5·9-19·0), and omicron XBB.1.5, with a GMT ratio of 1·63 (95% CI 1·36-1·94) and a seroresponse rate difference of 16·7% (95% CI 10·1-23·2). Both vaccines were well-tolerated with mainly mild, transient solicited adverse events and no causally related severe or serious adverse events.INTERPRETATIONBoosting mRNA-immunised adults with ARCT-2301 induced superior immunogenicity compared with Comirnaty BA.4-5 against both Wuhan-Hu-1 and omicron BA.4/5 variant COVID-19, and elicited a higher response against omicron XBB.1.5. Both vaccines had similar tolerability profiles. Self-amplifying mRNA vaccines could provide a substantial contribution to pandemic preparedness and response, inducing robust immune responses with a lower dose of mRNA to allow wider and more equitable distribution.FUNDINGJapanese Ministry of Health, Labour, and Welfare and Meiji Seika Pharma.

News (Medical) associated with Elasomeran/Imelasomeran

17 Feb 2023

·www.biospace.com

Health Canada Authorizes Moderna's Omicron-Targeting Bivalent COVID-19 Vaccine in Children & Adolescents (6-17 Years)

The recommendation is based on clinical data for Moderna's bivalent Omicron-targeting COVID-19 vaccine, mRNA.1273.214 Moderna's bivalent Omicron-targeting COVID-19 vaccines (mRNA.1273.214 (BA.1) & mRNA.1273.222 (BA.4/5)) are currently authorized for use in individuals 18 years of age and older in Canada Both bivalents have been shown to trigger a superior antibody response compared to a booster dose of mRNA-1273, the Company's prototype vaccine, against Omicron (BA.4/5) in Phase 2/3 clinical trials CAMBRIDGE, MA / ACCESSWIRE / February 17, 2023 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that Health Canada has authorized the use of its Omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.214 (Spikevax Bivalent Original/Omicron) in children and adolescents 6 to 17 years of age. The authorizations are based on a 25 μg booster dose for children ages 6 to 11 years old and a 50 μg booster dose for adolescents 12 to 17 years old, each following a completed primary series of any of the authorized COVID-19 vaccines or a previous booster. "The authorization of a booster dose of mRNA-1273.214 in children and adolescents is a critical step to broaden protection against the Omicron family of variants, and the emergence of new variants of concern in Canada," said Stéphane Bancel, Chief Executive Officer of Moderna. "This decision highlights the effectiveness and safety of our vaccine in this important age group." The pediatric and adolescent authorization is based on clinical trial booster data for Moderna's original vaccine, Spikevax, which was administered to over a thousand participants in each cohort. The application described data from a 25 μg booster dose administered to children ages 6 to 11 years old and a 50 μg booster dose for adolescents 12 to 17 years old, following a completed primary series of the Moderna COVID-19 vaccine. In addition, the application included clinical trial data from a Phase 2/3 studying mRNA-1273.214. "We are pleased with Health Canada's authorization of our bivalent booster for children and adolescents and our continued collaboration to provide boosters to help protect all Canadians from current and future COVID-19 variants of concern, especially as this virus continues to circulate across the country and around the world," said Shehzad Iqbal, Country Medical Director of Moderna Canada. In November 2022, Moderna announced that its bivalent Omicron-targeting booster candidates (mRNA-1273.214 and mRNA-1273.222) trigger a superior antibody response compared to a booster dose of mRNA-1273, the Company's prototype vaccine, against Omicron (BA.4/BA.5) in Phase 2/3 clinical trials. Both bivalent vaccines also met non-inferiority immunogenicity criteria to the original strain. About Moderna In 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic. Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past eight years. To learn more, visit . 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 regarding: the Company's development of bivalent vaccine candidates against COVID-19 (mRNA-1273.222 and mRNA-1273.214); the ability of mRNA-1273.214 to protect children against COVID-19; the ability of mRNA-1273.214 and mRNA-1273.222 to induce higher neutralizing antibody titers against Omicron variants in adults than the Company's vaccine candidate against the ancestral strain of SARS-CoV-2 (mRNA-1273); and authorization of mRNA-1273.214 in Canada for administration in children and adolescents ages 6-17 by Health 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 those other risks and uncertainties described under the heading "Risk Factors" in Moderna's most recent Annual Report on Form 10-K and the Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, each filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at . 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, Corporate Communications Luke.Mirceawillats@modernatx.com Canada Media: Sacha Kennedy Director, Communications & Media Relations, Canada sacha.kennedy@modernatx.com Investors: Lavina Talukdar Senior Vice President & Head of Investor Relations 617-209-5834 Lavina.Talukdar@modernatx.com SOURCE: Moderna, Inc. View source version on accesswire.com:

VaccinemRNAEmergency Use AuthorizationClinical StudyClinical Result

30 Aug 2022

·www.biospace.com

Therapeutic Goods Administration Provisionally Approves Moderna’s Omicron-Containing Bivalent Booster Candidate, MRNA-1273.214, For Australia

Australia becomes among the first countries in the world to approve the use of a next-generation bivalent COVID-19 vaccine mRNA-1273.214, an Omicron-containing bivalent vaccine, has demonstrated significantly higher antibody titers against all tested variants, including Omicron BA.1 and BA.4/5 subvariants Moderna expects to supply mRNA-1273.214 to Australia in September CAMBRIDGE, MA / ACCESSWIRE / August 30, 2022 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the Therapeutic Goods Administration (TGA) in Australia has granted provisional approval for its Omicron-containing bivalent booster vaccine, mRNA-1273.214 (Spikevax Bivalent Original/Omicron) as a booster dose for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. Spikevax Bivalent Original/Omicron is a next-generation bivalent vaccine that contains 25 µg of mRNA-1273 (Spikevax) and 25 µg of a vaccine candidate targeting the Omicron variant of concern (BA.1). "We are delighted to receive provisional approval from the TGA for our next-generation bivalent vaccine, mRNA-1273.214. Australia becomes one of the first countries in the world to approve an Omicron-containing vaccine, highlighting its continued stewardship in the fight against COVID-19," said Arpa Garay, Chief Commercial Officer at Moderna. "This is a vital step in helping to keep the Australian people safe from the ongoing threat that COVID-19 represents to global public health." The decision from the TGA is based on clinical trial data from a phase 2/3 trial, in which mRNA-1273.214 met all primary endpoints, including superior neutralizing antibody response against Omicron (BA.1) when compared to a 50 µg booster dose of mRNA-1273 in previously uninfected participants. A booster dose of mRNA-1273.214 increased neutralizing geometric mean titers (GMT) against Omicron approximately 8-fold above baseline levels. In addition, mRNA-1273.214 elicited potent neutralizing antibody responses against the Omicron subvariants BA.4 and BA.5 compared to the currently authorized booster (mRNA-1273) regardless of prior infection status or age. mRNA-1273.214's reactogenicity and safety pro consistent with the currently authorized Spikevax (mRNA-1273) booster. "I am incredibly proud to see our nation reach this critical step in providing access to this new vaccine. mRNA-1273.214 has demonstrated a superior neutralizing antibody response against Omicron (BA.1) and subvariants (BA.4/BA.5) as compared to mRNA-1273, in addition to having the potential for superior durability of protection," said Michael Azrak, General Manager of Moderna for Australia and New Zealand. Moderna will continue to work with the Commonwealth of Australia on the implementation of this important vaccine for Australians with the aim of supplying product in September. Moderna has received approval for mRNA-1273.214 in the UK and Switzerland and has completed regulatory submissions for the next-generation vaccine worldwide. Authorized use Spikevax bivalent Original/Omicron is indicated as a booster dose for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. About Moderna In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both ground-breaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most-effective vaccines against the COVID-19 pandemic. Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit . 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 regarding: the provisional approval of mRNA-1273.214 in Australia by the TGA, the Company's development of mRNA-1273.214; the ability of mRNA-1273.214 to induce higher neutralizing antibody titers against Omicron subvariants BA.4 and BA.5 than the Company's vaccine candidate against the ancestral strain of SARS-CoV-2 (mRNA-1273); and the safety, efficacy, and tolerability of mRNA-1273.214 in adults ages 18 and above. 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 those other 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, 2021 and Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2022, each filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at . 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 Director, Corporate Communications Luke.Mirceawillats@modernatx.com Investors: Lavina Talukdar Senior Vice President & Head of Investor Relations 617-209-5834 Lavina.Talukdar@modernatx.com SOURCE: Moderna, Inc. View source version on accesswire.com:

VaccineAntibodymRNA

15 Aug 2022

·www.pmlive.com

Moderna’s Omicron booster receives MHRA approval

Moderna’s COVID-19 booster vaccine has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA). The booster dose can be used in adults aged 18 years and over to protect against contracting COVID-19. The MHRA’s authorisation is based on data from a phase 2/3 trial, which showed that mRNA- 1273.214 met all primary endpoints. The trial showed a booster dose of mRNA-1273.214 increased neutralising geometric mean titres (GMT) against Omicron approximately eight times above baseline levels. The booster dose also provided potent neutralising antibody responses against the Omicron subvariants BA.4 and BA.5 when compared against the currently authorised booster – mRNA-1273 – regardless of age or prior infection status. Commenting on the decision, Stéphane Bancel, chief executive officer of Moderna, said: “We are delighted with the MHRA’s authorisation of Spikevax Bivalent Original/Omicron, our next- generation COVID-19 vaccine. This represents the first authorisation of an Omicron-containing bivalent vaccine, further highlighting the dedication and leadership of the UK public health authorities in helping to end the COVID-19 pandemic.” He added: “mRNA- 1273.214 has consistently shown superior breadth of immune response over mRNA-1273 in clinical trials. This bivalent vaccine has an important role to play in protecting people in the UK from COVID-19 as we enter the winter months.” The conditional authorisation is for mRNA-1273.214 – Spikevax Bivalent Original/Omicron – an Omicron-containing bivalent. The Spikevax Bivalent Original/Omicron is a next-generation bivalent vaccine, containing mRNA-1273 – Spikevax – and a vaccine candidate targeting the Omicron subvariant of concern, BA.1. The company is currently working with the Vaccines Taskforce, the UK Health Security Agency and the NHS to make the Spikevax Bivalent Original/Omicron vaccine available in the UK. Moderna has completed regulatory submissions for mRNA-1273.214 in the EU, Australia and Canada and anticipates further authorisations over the next few weeks.

VaccineAntibodymRNA

100 Deals associated with Elasomeran/Imelasomeran

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Indication	Country/Location	Organization	Date
COVID-19	JP	Moderna Japan Co. Ltd.	21 May 2021

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 3	US	Moderna, Inc.	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESC2022	Not Applicable	Heart Failure	-	BNT162B2 mRNA vaccine	(vqlmokgxcu) = mokwcridla vnczomhbhz (ahiglgabzo, 2.1 - 2.4) View more	Positive	26 Aug 2022
				mRNA-1273 vaccine	(vqlmokgxcu) = vdpwdpmmgq vnczomhbhz (ahiglgabzo, 2.4 - 2.7) View more
ASCO2022	Not Applicable	Neoplasms	93	mRNA-1273 vaccine	xsslxktfrk(sojninyoud) = cbbkqeykrq axhdwjqwfa (cmfpwfqfam )	-	02 Jun 2022
EHA2022	Not Applicable	Chronic Lymphocytic Leukemia \| Multiple Myeloma	-	BNT162b2 mRNA vaccine	hlkcnjcfhs(ntkuaoxjko) = drddpdkdln xhdcatwwge (awftweethz )	-	12 May 2022
				mRNA-1273 vaccine	hlkcnjcfhs(ntkuaoxjko) = rffnokhmlp xhdcatwwge (awftweethz )
MO862 (ERA2022)	Not Applicable	-	66	mRNA-1273 vaccine	gfcdbqgowd(wtezoqlahk) = veqzxbuhjl hngfvlstbr (fpgfaiexgg, 0.7 - >1632)	Positive	03 May 2022
MO180 (ERA2022)	Not Applicable	Hemodialysis complication	126	mRNA-1273 vaccine	(nrvrxqmwes) = oczujscyzu zizaqcmiwi (vooufljayk ) View more	Positive	03 May 2022
MO975 (ERA2022)	Not Applicable	Renal transplant rejection	-	mRNA-1273 vaccine	awdjhiavib(xlbrqrcwwg) = wznhmnycxq ztzkrjyasg (llybtxfjtb ) View more	Positive	03 May 2022
mRNA-1273 (ASN2021)	Not Applicable	Nephrosis, Lipoid IgG antibody \| tacrolimus	1	mRNA-1273 vaccine	(rlhmjekbah) = developed NS and AKI following the mRNA-1273 vaccine ofyozygwdb (prbbplkcqc ) View more	Positive	27 Oct 2021
				Prednisone
mRNA-1273 (ASN2021)	Not Applicable	-	-	mRNA-1273 vaccine	(khxzwwafcu) = ksslqfazhi cwuzerwljn (diliuxungl, 93.3% - 97.9)	Positive	27 Oct 2021
ASN2021	Not Applicable	Renal transplant rejection serum creatinine \| proteinuria \| anti-RBD antibodies ... View more	58	mRNA-BNT162b2 vaccine	zvpuyglzbm(myhtvfzkei) = There were no severe adverse events or deaths during follow-up vzwuyhvcvy (ycwzuitqkb )	Positive	27 Oct 2021
				mRNA-1273 vaccine

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