Korea launches Post-Market safety study of Pfizer's COVID vaccine
NCT ID NCT06613984
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study monitors the safety of the Comirnaty (Bretovameran) COVID-19 vaccine in 660 Korean participants aged 12 and older. Researchers will track side effects like injection site reactions and serious adverse events for up to 28 days after each dose. The goal is to identify any safety issues in real-world use after the vaccine was already approved.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Comirnaty (Bretovameran) COVID-19 vaccine
- What this could lead to
- If successful, this study will confirm the vaccine's safety in a real-world Korean population, supporting continued use.
- What could go wrong
- This is an observational safety study, not designed to test new efficacy. It may not detect rare or long-term side effects due to limited size and duration.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 660 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study population is Korean subjects who are eligible for "indications" specified in the approved label. \[INDICATIONS\] Active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and older.
- Ages
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12 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Korean subjects who are eligible for administration of Comirnaty Injection according to the locally authorized label * Subjects with evidence of a personally signed and dated informed consent/assent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study Exclusion Criteria: * Subjects who involved in the contraindications of use indicated in the locally authorized label * Subjects with a history of hypersensitivity to any ingredients of this product or this product * Any subjects (or a legally acceptable representative) who does not agree that Pfizer and companies working with Pfizer use his/her information
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Pfizer
Seoul, South Korea
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Other studies related to the condition(s) this trial covers.
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