mRNA-based Vaccines

Form: Injectable suspension

Strength: 30 µg and 100 µg

Reference Brands: Comirnaty, Spikevax(US)

Category: Vaccines

mRNA-based vaccines, such as Pfizer-BioNTech’s Comirnaty and Moderna’s Spikevax, are approved in both the US and EU, supported by dossiers demonstrating safety, efficacy, and manufacturing quality in compliance with GMP and IVDR standards. In the US, FDA approval involves rigorous clinical trials, while in the EU, CE marking certifies conformity with in vitro diagnostic regulations. These vaccines undergo validation, stability testing, and quality audits, with comprehensive documentation including safety profiles, clinical trial data, and manufacturing processes. For licensing procedures, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Ensuring regulatory compliance guarantees safe, effective COVID-19 protection globally, supporting public health efforts.