12. June 2023
mRNA vaccines for protective vaccinations
To date, five mRNA vaccines have been approved for vaccination against covid-19 worldwide, two of them in the EU. Many more are in development, also against other diseases.
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The use of mRNA is emerging as a key pharmaceutical technology. It can be used in three different areas: for protective vaccinations against infectious diseases, for therapeutic vaccinations in cancer patients, and for mRNA therapeutics designed to achieve treatments without affecting the immune system.
mRNA drugs
The prospects for mRNA drugs were explained by vfa research spokesman Dr. Rolf Hömke in an Effecten Spiegel podcast on Oct. 02, 2021Projects
for mRNA-based vaccines against infectious diseases exist on four continents. Here is an overview. Here, Phase I to Phase III refers to testing with volunteers. Vaccines in preclinical development or in the research phase have not yet been tested with volunteers. Only new vaccines are listed, not virus variant-adapted versions of licensed vaccines.
| Disease | Company or research institute | Name | Vaccine contains (if known) | Development status |
| Lyme disease | ||||
| Lyme disease | Moderna (USA) | mRNA-1982 and mRNA-1975 | mRNA, specific against Borrelia burgderferi (1982) and four Borrelia species, among which are also common in Europe (1975), respectively | preclinical development |
| Covid-19 (and Covid-19/flu vaccines) | ||||
| Covid-19 | BioNTech / Pfizer (Germany / USA) | BNT162b2 (Comirnaty) | mRNA in lipid nanoparticles | approved in the EU; also in the form of two bivalent versions (original strain + BA.1; original strain + BA.4/5) |
| Covid-19 | Moderna (USA) | mRNA-1273 (Spikevax) | mRNA in lipid nanoparticles | approved in the EU; also in the form of two bivalent versions (original strain + BA.1; original strain + BA.4/5) |
| Covid-19 | Gennova Biopharmaceuticals, a subsidiary of Emcure (India) | HGCO19 | self-amplifying mRNA | approved in India. The extent to which this vaccine is based on the HDT-301 vaccine from former collaborator HDT Bio is the subject of a legal challenge. |
| Covid-19 | Academy of Military Sciences / Walvax Biotechnology / Suzhou Abogen Biosciences (China) | ARCoV | mRNA for section of spike protein (storable for several months at 2-8 degrees Celsius). | Approved in Indonesia; a version adapted to Omikron is in Phase I |
| Covid-19 | CSPC Pharmaceutical Group (China) | SYS6006 | mRNA | approved in China |
| Covid-19 | Daiichi Sankyo (Japan) | DS-5670 | mRNA | filed for approval in Japan following positive results as a booster in Phase III trial |
| Covid-19 | Arcturus Therapeutics (USA) in collaboration with CSL Seqirus (Australia) | ARCT-154 | self-amplifying mRNA (optimized against different Variants of Concern) | Phase III; also being tested as a booster |
| Covid-19 | AIM Vaccine (China) | LVRNA021 (bivalent Delta+Omicron BA.5) | Phase III | Phase III |
| Covid-19 | Stemirna Therapeutics (China) | SW-BIC-213 | mRNA | Phase III |
| Covid-19 | Moderna (USA) | mRNA-1283 | mRNA; processed in such a way that the vaccine is expected to be storable in ordinary freezers at 2 to 5 degrees Celsius | Phase III |
| Covid-19 | Providence Therapeutics (Canada) and licensees Biological E (India), Everest Medicines (China) and VaxThera (Colombia). | PTX-COVID19-B | mRNA | Phase II with positive results, also planned for testing in WHO Phase III Solidarity Trial Vaccines study |
| Covid-19 | Technovalia (Australia) and Chulalongkorn University (Thailand) | ChulaCov19 BNA159 | mRNA | Phase II |
| Covid-19 | BioNTech / Pfizer (Germany / USA) | BNT162b5 bivalent (WT/OMI BA.2) | mRNA in lipid nanoparticles for modified spike proteins of the original strain and of Omikron BA.2 | Phase II |
| Covid-19 | Eyegene (South Korea) | EG-COVID-102 | mRNA in cationic liposomes and TLR4 agonist | Phase I/IIa |
| Covid-19 | MRC/UVRI and LSHTM Uganda Research Unit (Uganda) | LNP-nCOV saRNA-02 Vaccine | mRNA | Phase I |
| Covid-19 | HDT Bio (USA) | HDT-301 | self-amplifying mRNA bound to "Lipid InOrganic Nanoparticles" (LION) | Phase I in South Korea and Brazil. In 2020, HDT Bio also entered into a collaboration with Gennova (India). Whether its vaccine HGCO19, approved in India in June 2022, is based on it is the subject of a legal dispute. |
| Covid-19 | Guangzhou RioBio | k. A. | mRNA | Phase I |
| Covid-19 | Gritstone bio (USA) | GRT-R910 | self-amplifying mRNA for multiple antigens | Phase I |
| Covid-19 | University of Melbourne (Australia) | MIPSCo-mRNA-RBD-1 | mRNA encoding the receptor binding domain of the spike; as part of a combination vaccine with the protein-based beta variant vaccine DoCo-Pro-RBD-1 + MF59®. | Phase I |
| Covid-19 | GSK / CureVac (UK / Germany) | CV0501 | mRNA vaccine with further developed RNA sequence, additionally modified nucleotides and adaptation to Omikron | Phase I |
| Covid-19 | Infectious Disease Research Institute (IDRI) / Amyris / Immunity Bio (all USA) | AAHI-SC2 and AAHI-SC3 | "self-adjuvanting" mRNA in so-called "nanostructured lipid carrier" (NLC). Immunity Bio is to take over production. | Phase I |
| Covid-19 / Influenza | Moderna (USA) | mRNA-1073 | mRNA in lipid nanoparticles encoding spike of SARS-CoV-2 (originating strain) and quadrivalent for hemagglutinin of four different influenza virus strains | Phase I/II |
| Covid-19 / Influenza / RSV | Moderna (USA) | mRNA-1230 | mRNA in lipid nanoparticles | Phase I |
| Covid-19 / Influenza | BioNTech / Pfizer (Germany / USA) | BNT162b2 + BNT161 | mRNA in lipid nanoparticles, quadrivalent with respect to influenza viruses (such as qIRV (22/23) ) and bivalent with respect to SARS-CoV-2 (originating strain and omicron BA.4/5 | Phase I |
| Covid-19 | BioNTech / Pfizer (Germany / USA) | BNT162b4 | mRNA in lipid nanoparticles encoding non-spike proteins of SARS-CoV-2 (specifically designed to enhance T-cell response) | Phase I (in combination with bivalent BA.4/5-adapted vaccine from the companies). |
| Covid-19 | RVAC (Singapore, USA, China) | RVM-V001 | mRNA | preclinical development; Phase I trial in preparation |
| Covid-19 | Sinopharm | k. A. | mRNA, adapted to Omikron variant | preclinical development(phase I filed) |
| Covid-19 | Selçuk Üniversitesi (Turkey) | k. A. | mRNA | preclinical development |
| Covid-19 | CanSino Biologics / Precision NanoSystems (China / USA) | k. A. | mRNA in lipid nanoparticles | preclinical development |
| Covid-19 | Fudan University / Shanghai JiaoTong University / RNACure Biopharma (China) | k. A. | mRNA (1. LNP-encapsulated mRNA cocktail encoding VLP; 2. LNP-encapsulated mRNA encoding RBD) | Preclinical devel. |
| Covid-19 | Centro Nacional Biotecnología (CNB-CSIC) (Spain). | k. A. | mRNAs derived from replication-incompetent SARS-CoV-2. | preclinical devel. |
| Covid-19 | University of Tokyo / Daiichi-Sankyo (Japan) | k. A. | mRNA in lipid nanoparticles | preclinical devel. |
| Covid-19 | BIOCAD (Russia) | k. A. | mRNA in liposomes | preclinical development |
| Covid-19 | RNAimmune (USA) | k. A. | mRNA | preclinical development |
| Covid-19 | FBRI SRC VB VECTOR, Rospotrebnadzor, Koltsovo (Russia) | k. A. | mRNA | preclinical devel. |
| Covid-19 | eTheRNA (Belgium) and ConserV Bioscience (UK) | k. A. | mRNA; for intranasal administration | preclinical devel. |
| Covid-19 | Greenlight Biosciences (USA) | k. A. | mRNA | preclinical development |
| Covid-19 | IDIBAPS Hospital Clínic of Barcelona / Hipra (Spain) | k. A. | mRNA | preclinical development |
| Covid-19 | Cell Tech Pharmed (Iran) | k. A. | mRNA | preclinical development |
| Covid-19 | Globe Biotech (Bangladesh) | BANCOVID | D614G variant LNP-encapsulated mRNA | preclinical development |
| Covid-19 | CEA / INSERM (France) (CEA = commissariat à l'énergie atomique) | NanoCov2-Vac | encapsulated mRNA | preclinical development |
| Covid-19 | Ziphius Vaccines and Ghent University (Belgium / Belgium) | ZIP-1642 | two self-amplifying mRNAs, for the receptor binding domain of the spike protein and the nucleocapsid protein, in lipid nanoparticles | Preclinical development; positive results published |
| Covid-19 | baseclick (Germany) | BCV-193N | mRNA encoding the nucleocapsid protein, linked to a sugar molecule, but without a lipid envelope | preclinical development, phase I in preparation |
| Covid-19 | Sorrento Therapeutics (USA) | MultiValent STI mRNA vaccine | mRNAs for different spike variants; for i.m. injection or needle-free application into a lymph node | preclinical development (with positive results) |
| Covid-19 | ST Pharm (South Korea) | tbd | mRNA in lipid nanoparticles (Genevant technology) | preclinical development |
| Covid-19 | Capricor (USA) | tbd | mRNA, exosome-based processing | preclinical development |
| Covid-19 | Longuide (China) | tbd | mRNA in nanoparticles | preclinical development |
| Covid-19 | Enesi Pharma (UK) / Imperial College London (UK) | tbd | self-amplifying mRNA (from Imperial College London) and ImplaVax technology and Polyplex DNA/RNA stabilization (from Enesi); vaccine to be stable at temperatures up to 40 degrees Celsius | preclinical development |
| Covid-19 | Phylex BioSciences (USA) | tbd | mRNA (bivalent: encodes receptor binding domain of delta and omicron variant spike proteins) | preclinical development |
| Covid-19 | Tonix Pharmaceuticals and Kansas State University (both USA) | TNX-3700 | mRNA encoding the spike protein; formulation with zinc nanoparticles instead of lipid nanoparticles, which may keep the vaccine stable under lower cooling conditions | preclinical development |
| Covid-19 | mCureX (South Korea) (subsidiary of OliX Pharmaceuticals) / Samyang Holdings (South Korea) / GC Pharma | tbd | mRNA | Research phase |
| Covid-19 | Helix Nanotechnologies (USA) | tbd | mRNA | Research phase |
| Covid-19 | Afrigen Biologics and Vaccines (South Africa) | tbd | mRNA (mimicked Moderna vaccine) in nanoparticles (developed in collaboration with Curapath [Spain and USA]) | Research phase |
| Covid-19 | SK Bioscience (South Korea) | tbd | mRNA | Research phase or preclinical development |
| Covid-19 and other beta-coronavirus infections | BioNet (France - Thailand(1) / University of Pennsylvania, Univ. of North Carolina and Univ. of California-Davis (USA) / Chulalongkorn University (Thailand) / International Vaccine Institute (South Korea) | mRNA | with mRNA for different proteins from SARS-CoV-2; should protect against infections with all beta-coronaviruses, which include SARS-CoV-2 and MERS-CoV, including different variants. The project is funded by CEPI; in return, the consortium has pledged to provide easy access to the vaccine for poorer countries if successful. | probably laboratory stage |
| Covid-19 and other beta-coronavirus infections. | Ethris (Germany) and DIOSynVax (UK) | ETH 50 | mRNA in lipid nanoparticles | probably laboratory stage; sponsored by CEPI |
| Covid-19 | CSL (Australia) | saRNA (technology licensed from Arcturus [USA]) | Research phase | |
| Chlamydial infections | ||||
| Chlamydial infections | Ziphius Vaccines (Belgium) | ZIP-008 | self-amplifying mRNA | preclinical devel. |
| Cytomegalovirus infection (CMV infection) | ||||
| CMV infection | Moderna (USA) | mRNA-1647 | six mRNAs (five encode the pentamer complex, one encodes gB) | in phase III with females aged 16-40; in phase I/II with adolescents of both sexes |
| Dengue | ||||
| Dengue | Ziphius Vaccines (Belgium) | ZIP-019 | mRNA | preclinical devel. |
| Genital herpes (infection with HSV-2) | ||||
| Genital Herpes | BioNTech | BNT163 | mRNA | Phase I study since 12/2022 |
| Genital Herpes | Moderna | mRNA-1608 | mRNA | preclinical development |
| Influenza [see also Covid 19 / Influenza]. | ||||
| Influenza | Pfizer (in collaboration with BioNTech) (USA) | qIRV (22/23) | quadrivalent vaccine with modRNA encoding antigens of the virus strains recommended by WHO for the northern hemisphere for 2022/23 | Phase III in the USA |
| Influenza, seasonal | Moderna (USA) | mRNA-1010 | mRNAs (quadrivalent: A H1N1, A H3N2, B Yamagata, B Victoria) | Phase III |
| Influenza | Sanofi Pasteur and Translate Bio (France / USA) | SP0273 | mRNA for hemagglutinin of A/H3N2 in lipid nanoparticles; two different formulations | Phase I |
| Influenza | CureVac (Germany) / GSK (UK) | Flu-SV mRNA | mRNA, modified, monovalent | Phase I |
| Flu | CureVac (Germany) / GSK (UK) | tbd | mRNA, modified, tetravalent | Phase I |
| Influenza, seasonal | Moderna (USA) | mRNA-1020 and mRNA-1030 | Two vaccines with eight mRNAs (each for hemagglutinin and neuraminidase from the four WHO-selected influenza virus strains) undergoing comparative testing. | Phase II |
| Influenza | Moderna (USA) | mRNA-1011 and mRNA-1012 | Two vaccines with more than eight mRNAs (each for hemagglutinin and neuraminidase from the four WHO-selected influenza virus strains plus one or two additional hemagglutinins from other strains) | Phase II |
| Influenza | Pfizer (USA) | PF-07852352 influenza saRNA 1, PF-07836391 influenza saRNA, PF-07836394 influenza saRNA, PF-07836395 influenza saRNA, PF-07836396 influenza saRNA, PF-07867246 influenza saRNA. | Vaccines with self-amplifying RNAs encoding antigens of influenza viruses | Phase I in the USA |
| Influenza (seasonal) | Arcturus (USA) and CSL Behring | LUNAR-FLU | mRNA in Lipid-enabled and Unlocked Nucleomonomer Agent | preclinical development |
| Influenza (pandemic) | Arcturus (USA) | LUNAR-FLU | mRNA in Lipid-enabled and Unlocked Nucleomonomer Agent | preclinical development (funded by BARDA) |
| Influenza | Stemirna Therapeutics (China) | k. A. | mRNA | preclinical development |
| Influenza | CSL Seqirus (Australia) | k. A. | Self-amplifying mRNA, bicistronic (i.e., coding sequences for the proteins hemagglutinin and neuraminidase in the same mRNA). | preclinical development |
| Universal influenza vaccine | University of Pennsylvania (USA) | k. A. | mRNA encoding the hemagglutinin proteins of all 20 known influenza A and B subtypes | pre-clinical development |
| Universal influenza vaccine | CureVac / Bill & Melinda Gates Foundation | k. A. | mRNA | Research phase |
| Shingles | ||||
| Shingles | BioNTech / Pfizer | BNT167 | mRNA | Phase I/II since February 2023 |
| Shingles | Moderna | mRNA-1468 | mRNA | Phase I |
| Shingles | Stemirna (China) | tbd | mRNA | preclinical development |
| HIV infections | ||||
| HIV infection | Moderna / International AIDS Vaccine Initiative (IAVI) (USA/USA) | mRNA-1644 / mRNA-1644v2 core (vaccines to be used sequentially [prime-boost concept]) | mRNA (for the first vaccine eOD-GT8 60mer; for the second core-g28v2 60mer) | Phase I in Rwanda and South Africa |
| HIV infection | Moderna (USA) / IAVI / BMGF / NIAID et al. | mRNA-1574 | mRNA | Phase I |
| HIV infection | BioNTech / B&M Gates Foundation (Germany / USA) | tbd | mRNA | Target identification |
| HPV infection | ||||
| HPV infection | Stemirna Therapeutics (China) | tbd | mRNA | Research stage or preclinical development. |
| Lassa fever, yellow fever | ||||
| Lassa fever, yellow fever | CureVac / CEPI (Germany) | k. A. | mRNA | preclinical devel. |
| Lyme borreliosis see Lyme disease | ||||
| Malaria | ||||
| Malaria | BioNTech (Germany) / kENUP foundation ("eradicateMalaria" initiative), supported by WHO and Africa Centers for Disease Control and Prevention (Africa CDC) | BNT165b1 | mRNA encoding specific regions of the circumsporozoite protein (CSP). | Phase I since December 2022, following basic work. |
| Malaria | CureVac / Bill & Melinda Gates Foundation | tbd | mRNA | Research phase |
| Malaria | eTheRNA (Belgium) | tbd | mRNA | Discovery/Lead Phase |
| Malaria | Stemirna (China) | tbd | mRNA | early preclinical devel. |
| MERS (MERS-CoV infection) | ||||
| MERS | Stemirna Therapeutics (China) | tbd | mRNA | Research phase |
| Metapneumovirus infection (hMPV infection) | ||||
| Metapneumovirus or parainfluenza virus type 3 (PIV3) infection, pediatric | Moderna (USA) | mRNA-1653 | mRNA | Phase I |
| Infection with metapneumovirus or respiratory syncytial virus (RSV), pediatric | Moderna (USA) | mRNA-1365 | mRNA | preclinical development |
| Nipah | ||||
| Nipah | Moderna (USA) | mRNA-1215 | mRNA | Phase I |
| M-Pox | ||||
| M-Pox | Stemirna (China) | tbd | mRNA | early preclinical development |
| Norovirus infections | ||||
| Norovirus infections | Moderna (USA) | mRNA-1405 and mRNA-1403 | mRNA, pentavalent (1405) and trivalent (1403), respectively | preclin. Development |
| Pfeiffer's glandular fever and latent Epstein-Barr virus infection (EBV infection) | ||||
| Epstein-Barr virus infection | Moderna (USA) | mRNA-1189 | mRNA | Phase I |
| Epstein-Barr virus infection | Moderna (USA) | mRNA-1195 | mRNA | preclinical development |
| Epstein-Barr virus infection | Stemirna Therapeutics (China) | tbd | mRNA | Research phase or preclinical devel. |
| Rotavirus infections | ||||
| Rotavirus Infections | CureVac / Bill & Melinda Gates Foundation | tbd | mRNA | Research phase |
| RSV infection (caused by respiratory syncytial virus) | ||||
| RSV infection | Sanofi | RSV mRNA LNP CL-0059 and LNP CL-0137, respectively | mRNA in two different lipid nanoparticle formulations | Phase I/II |
| RSV infection | Moderna (USA) | mRNA-1345 | mRNA | Phase III for older adults completed, Phase I for children |
| see also combination vaccine from Moderna under "Metapneumovirus infection | ||||
| RSV infections | CureVac (Germany) | k. A. | mRNA | preclinical devel. |
| RSV infections | Stemirna (China) | k. A. | mRNA | preclinical devel. |
| RSV infections | AIM Vaccine (China) | k. A. | mRNA | preclinical development |
| Rabies | ||||
| Rabies | CureVac (Germany) | CV7202 | mRNA in lipid nanoparticles | Phase I |
| Rabies | Stemirna (China) | tbd | mRNA | preclinical development |
| Rabies | Providence Therapeutics (Canada) and Everest Medicines (China) | tbd | mRNA | preclinical development |
| Rabies | AIM Vaccine (China) | tbd | mRNA | preclinical development |
| Tuberculosis | ||||
| Tuberculosis | BioNTech / B&M Gates Foundation (Germany / USA) | BNT-164 | mRNA | Phase I since 04/2023 |
| Tuberculosis | Stemirna Therapeutics (China) | k. A. | mRNA | preclinical development |
| West Nile virus infections | ||||
| West Nile virus infections | Fraunhofer IZI (Germany) | tbd | mRNA | Research phase or preclinical development |
| Zika | ||||
| Zika | Moderna (USA) | mRNA-1893 | mRNA | Phase II |
(1) )Member of the Developing Country Vaccine Manufacturing Network (DCVMN)
Sources: WHO + company websites
