Pfizer’s Use of Real-World Evidence (RWE) to Support Comirnaty COVID-19 Vaccine

Pfizer, in collaboration with BioNTech, leveraged RWE to support the continued effectiveness and safety of their COVID-19 vaccine, Comirnaty, beyond the initial controlled clinical trials. With millions of people vaccinated globally, the company utilized real-world data to monitor the vaccine’s performance.

RWE Utilization
Pfizer conducted studies using data from electronic health records (EHRs), insurance claims, and national health databases. These studies provided evidence that the vaccine was effective in reducing severe outcomes, such as hospitalization and death, even against emerging variants like Delta and Omicron.

Impact
The RWE gathered from these studies was used to inform healthcare providers, regulators, and the public, reinforcing the vaccine’s efficacy and safety in real-world settings. This data also supported the vaccine’s authorization for broader age groups and booster doses.

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