Pfizer Inc ((PFE)) announced an update on their ongoing clinical study.
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Pfizer Inc. is conducting a study titled ‘Korea Comirnaty Post-marketing Surveillance’ to assess the safety of the BNT162b2 vaccine in routine clinical practice in Korea. The study aims to collect safety data from subjects who have received the vaccine, following the New Drug Re-Examination Guideline of the Ministry of Food and Drug Safety (MFDS). This study is significant as it helps ensure the ongoing safety of the vaccine in a real-world setting.
The study involves several biological interventions, including Tozinameran, Riltozinameran, Famtozinameran, and Raxtozinameran, targeting different age groups. These interventions are designed to provide protection against COVID-19 and its variants, with specific dosing schedules for each age group.
This observational study is prospective and cohort-based, focusing on collecting safety data through electronic diaries and case report forms. There is no randomization or masking involved, and the primary purpose is to monitor vaccine safety.
The study began on March 18, 2022, with an estimated completion date of March 4, 2027. The last update was submitted on July 31, 2025. These dates are crucial for tracking the study’s progress and ensuring timely data collection and analysis.
The market implications of this study are significant for Pfizer’s stock performance and investor sentiment, as positive safety data could enhance confidence in the vaccine’s continued use. This is particularly relevant in the competitive landscape of COVID-19 vaccines, where safety and efficacy are paramount.
The study is ongoing, with further details available on the ClinicalTrials portal.