Table 1.
Summary of the included medicinal products
| Product name | Treatment/vaccine | Studies contributing to the main efficacy and safety data sets | Efficacy population | Safety population | SmPC | EPAR | Additional information |
| remdesivir | Treatment | NIAID-ACTT(1) GS-US 540 5776 (adaptive trial); GS-US-540–5773 (phase III); GS-US-540–5774 (phase III); CO-US-540–5758 (phase III) |
All subjects in the adaptive trial | All subjects in the phase III trials | * | † | Confidential—MAA dossiers |
| dexamethasone | Treatment | RECOVERY adaptive platform trial | All subjects | All subjects | ‡ | § | Public—EMA website |
| BNT162b2 mRNA (BioNTech/Pfizer) | Vaccine | C4951001 (phase I/II/III) | Subjects without evidence of infection before vaccination phase I/II/III | All subjects in the phase II/III study | ¶ | ** | Public—EMA website |
| mRNA-1273 (Moderna) | Vaccine | mRNA-1273-P301 (phase III) | Subjects in the phase III study 14 days after the second injection in the PP set | All subjects in the phase III study | †† | ‡‡ | Public—EMA website |
| ChAdOx1-S (AstraZeneca) | Vaccine | Study COV001 (phase I/II); Study COV002 (phase II/III); Study COV003 (phase II/III); Study COV005 (phase I/II) |
Subjects receiving SD/SD in both phase II/III studies | All subjects in all studies | §§ | ¶¶ | Confidential—MAA dossiers |
| Ad26.COV2-S (Janssen) | Vaccine | VAC31518COV3001 (phase III) | Subjects in the PP set of the phase III study | All subjects in the phase III study | *** | ††† | Confidential—MAA dossiers |
*https://www.ema.europa.eu/en/documents/product-information/veklury-epar-product-information_en.pdf.
¶https://www.ema.europa.eu/en/documents/product-information/comirnaty-epar-product-information_en.pdf.
EMA, European Medicines Agency; EPAR, European Public Assessment Report; MAA, marketing authorisation application; PP, per protocol; SmPC, Summary of Product Characteristics.