6. December 2021
mRNA vaccines for protective vaccinations
To date, two mRNA vaccines have been approved for vaccination against covid-19 worldwide, including in the EU. Many more are in development, also against other diseases.
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The use of mRNA is becoming 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, 2021
Projects 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.
| Disease | Company or research institute | Name | Vaccine contains (if known) | Development status |
| Covid-19 | ||||
| Covid-19 | BioNTech / Pfizer (Germany / USA) | BNT162b2 (Comirnaty) | mRNA in lipid nanoparticles | approved in the EU |
| Covid-19 | Moderna (USA) | mRNA-1273 (Spikevax) | mRNA in lipid nanoparticles | approved in the EU |
| Covid-19 | Academy of Military Sciences / Walvax Biotechnology / Suzhou Abogen Biosciences (China) | ARCoV | mRNA | Phase III |
| Covid-19 | Arcturus Therapeutics (USA) | ARCT-154 | self-amplifying mRNA (optimized against different Variants of Concern) | Phase III; also being tested as a booster |
| Covid-19 | Gennova Biopharmaceuticals, a subsidiary of Emcure (India) | HGCO19 | self-amplifying mRNA | Phase III |
| Covid-19 | Moderna (USA) | mRNA-1273,211 | mRNA (bivalent: against Beta and Wuhan) | Phase II for booster vaccination |
| Covid-19 | Moderna (USA) | mRNA-1273.213 | mRNA (bivalent: against Beta and Delta | Phase II, for booster vaccination |
| Covid-19 | Arcturus Therapeutics (USA) | ARCT-021 | self-amplifying mRNA | Phase II |
| Covid-19 | Providence Therapeutics (Canada) and licensees Biological E (India), Everest Medicines (China) and VaxThera (Colombia). | PTX-COVID19-B | mRNA | Phase II and soon to be launched in the WHO Solidarity Trial Vaccines Phase III study. |
| Covid-19 | Daiichi Sankyo (Japan) | DS-5670a | mRNA | Phase II (Phase I part successfully completed) |
| Covid-19 | Moderna (USA) | mRNA-1283 | mRNA; processed in such a way that the vaccine is expected to be storable in ordinary freezers | Phase II |
| Covid-19 | Arcturus Therapeutics (USA) | ARCT-165 | Self-amplifying mRNA in lipid nanoparticles (optimized against different Variants of Concern). | Phase I/II; for booster vaccination |
| Covid-19 | Elixirgen Therapeutics (USA) (vaccine licensed to as yet unnamed company) | EXG-5003 | self-amplifying mRNA with the sequence for the receptor binding domain in the spike of SARS-CoV-2; applied intradermally | Phase I/II |
| Covid-19 | Imperial College London (UK) | LNP-nCoV saRNA | self-amplifying mRNA | phase I |
| Covid-19 | MRC/UVRI and LSHTM Uganda Research Unit (Uganda) | LNP-nCOV saRNA-02 Vaccine | mRNA | Phase I |
| Covid-19 | Chulalongkorn University (Thailand) | ChulaCov19 mRNA | mRNA | Phase I |
| Covid-19 | GSK (UK) | GSK4184258A (CoV2 SAM) | self-amplifying 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 and India (there in partnership with Gennova) |
| Covid-19 | China CDC / Tongji University / Stemirna (China) | k. A. | self-amplifying mRNA | Phase I |
| Covid-19 | Gritstone bio (USA) | GRT-R910 | self-amplifying mRNA for multiple antigens | Phase I |
| Covid-19 | Infectious Disease Research Institute (IDRI) / Amyris / Immunity Bio (all USA) | k. A. | "self-adjuvanting" mRNA in so-called "nanostructured lipid carrier" (NLC). Immunity Bio to take over production. | preclinical devel. |
| 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 | self-amplifying mRNA for multiple antigens in lipid nanoparticles | preclinical development |
| Covid-19 | baseclick (Germany) | BCV-193N | mRNA encoding nucleocapsid protein linked to a sugar molecule but without a lipid coat | preclinical development, phase I in preparation |
| Covid-19 | Sorrento Therapeutics (USA) | k. A. | mRNAs for different spike variants; for i.m. injection or needle-free application into a lymph node | preclinical development |
| Covid-19 | ST Pharm (South Korea) | tbd | mRNA in lipid nanoparticles (Genevant technology) | preclinical development |
| Covid-19 | Eyegene (South Korea) | EG Covid | mRNA in cationic liposomes and TLR4 agonist | preclinical development |
| Covid-19 | Capricor (USA) | tbd | mRNA, exosome-based processing | preclinical development |
| Covid-19 | Daiichi Sankyo and University of Munich | tbd | mRNA in nanocarrier system optimized for lymphocyte activation | 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 the Moderna vaccine) | Research phase |
| 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 |
| Chlamydia infections | ||||
| Chlamydia infections | Ziphius Vaccines (Belgium) | tbd | 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) | Phase III |
| Genital herpes (infection with HSV-2) | ||||
| Genital Herpes | BioNTech | tbd | mRNA | preclinical development |
| Genital Herpes | Moderna | mRNA-1608 | mRNA | Research phase or preclinical devel. |
| Influenza | ||||
| Influenza, seasonal | Moderna (USA) | mRNA-1010 | mRNAs (quadrivalent: A H1N1, A H3N2, B Yamagata, B Victoria) | Phase II |
| Influenza | Sanofi Pasteur and Translate Bio (France / USA) | SP0273 | mRNA for hemagglutinin of A/H3N2 in lipid nanoparticles; two different formulations | Phase I |
| Avian influenza H7N9 | Moderna (USA) | mRNA-1851 | mRNA, monovalent against virus strain H7N9 | Phase I |
| Influenza | Pfizer (in collaboration with BioNTech) (USA) | BNT161 | self-amplifying mRNA; initially monovalent, later multivalent | Phase I in the USA |
| Influenza | CureVac (Germany) / GSK (UK) | CVSQIV | mRNA (second generation) | Phase I |
| Influenza | Arcturus (USA) | LUNAR-FLU | mRNA in "Lipid-enabled and Unlocked Nucleomonomer Agent". | preclinical development |
| Flu | Stemirna (China) | k. A. | mRNA | preclinical devel. |
| Flu | Seqirus (Australia) | k. A. | self-amplifying mRNA | preclinical development |
| Universal influenza vaccine | CureVac / Bill & Melinda Gates Foundation | k. A. | mRNA | Research phase |
| Shingles | ||||
| Shingles | BioNTech / Pfizer | k. A. | mRNA | Preclinical development |
| Shingles | Moderna | mRNA-1468 | mRNA | Research phase or preclinical development |
| Hepatitis C | ||||
| Hepatitis C | Ziphius Vaccines (Belgium) | tbd | self-amplifying mRNA | preclinical devel. |
| 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 |
| HIV infection | Moderna / National Institutes of Health (USA / USA) | mRNA-1574 | mRNA | preclinical development |
| HIV infection | BioNTech / B&M Gates Foundation (Germany / USA) | tbd | mRNA | Target identification |
| HPV infection | ||||
| HPV infection | Ziphius Vaccines (Belgium) | tbd | self-amplifying mRNA | preclinical development |
| HPV infections | Stemirna (China) | tbd | mRNA | Research phase or preclinical devel. |
| Lassa fever, yellow fever | ||||
| Lassa fever, yellow fever | CureVac / CEPI (Germany) | k. A. | mRNA | preclinical devel. |
| Malaria | ||||
| Malaria | CureVac / Bill & Melinda Gates Foundation | tbd | mRNA | Research phase |
| Malaria | BioNTech (Germany) / kENUP Foundation ("eradicateMalaria" initiative), supported by WHO and Africa Centers for Disease Control and Prevention (Africa CDC) | tbd | mRNA | Fundamental work with the goal of starting clinical trials by the end of 2022. |
| Malaria | eTheRNA (Belgium) | tbd | mRNA | Discovery/lead 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 | preclinical devel. |
| Pfeiffer's glandular fever and latent Epstein-Barr virus (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 (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 | Moderna (USA) | mRNA-1345 | mRNA | Phase II for adults, Phase I for children |
| see also combination vaccine from Moderna under "Metapneumovirus infection | ||||
| RSV infections | CureVac (Germany) | k. A. | mRNA | preclinical devel. |
| RSV infections | Ziphius Vaccines (Belgium) | tbd | self-amplifying mRNA | preclinical devel. |
| Rabies | ||||
| Rabies | CureVac (Germany) | CV7202 | mRNA in lipid nanoparticles | Phase I |
| Tuberculosis | ||||
| Tuberculosis | Stemirna (China) | k. A. | mRNA | preclinical devel. |
| Tuberculosis | BioNTech / B&M Gates Foundation (Germany / USA) | tbd | mRNA | Target identification |
| Zika | ||||
| Zika | Moderna (USA) | mRNA-1893 | mRNA | Phase II |
(1) Member of the Developing Country Vaccine Manufacturing Network (DCVMN)
Sources: WHO + company websites
