Table 2.
Regulatory agency-approved mRNA vaccines
| Brand (Generic) name | Drug name | Originator company | Approval year | Regulatory agency | Disease | Delivery platform | Route | Target-based actions |
|---|---|---|---|---|---|---|---|---|
| Comirnaty (Tozinameran) | BNT-162b2 | BioNTech SE | 2020 | EMA | SARS-COV-2 | LNP | i.m. injection | COVID19 spike glycoprotein modulator |
| 2020 | HC | |||||||
| 2020 | MHRA | |||||||
| 2021 | FDA | |||||||
| Comirnaty Original/Omicron BA.4–5 (Tozinameran/Famtozinameran) | BNT-162b2 bivalent (WT/OMI BA.4/BA.5) | 2022 | EMA | SARS-COV-2 | LNP | i.m. injection | COVID19 spike glycoprotein modulator | |
| 2022 | HC | |||||||
| 2022 | MHRA | |||||||
| Spikevax (Elasomeran) | mRNA-1273 | Moderna | 2020 | HC | SARS-COV-2 | LNP | i.m. injection | COVID19 spike glycoprotein modulator |
| 2021 | EMA | |||||||
| 2021 | MHRA | |||||||
| 2022 | FDA | |||||||
| Spikevax Bivalent Original/Omicron BA.1 (Elasomeran/Imelasomeran) | mRNA-1273.214 | 2022 | EMA | SARS-COV-2 | LNP | i.m. injection | COVID19 spike glycoprotein modulator | |
| 2022 | MHRA | |||||||
| Spikevax Bivalent Original/Omicron BA.4–5 (Elasomeran/Davesomeran) | mRNA-1273 containing SARS-CoV-2 omicron-specific bivalent (BA.4/BA.5) | 2022 | EMA | SARS-COV-2 | LNP | i.m. injection | COVID19 spike glycoprotein modulator | |
| 2023 | SMC |
EMA European Medicines Agency, European Union, FDA Food and Drug Administration, United States, MHRA Medicines and Healthcare products Regulatory Agency, United Kingdom, HC Health Canada, Canada, SMC Swissmedic, Switzerland, LNP Lipid nanoparticles