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12,000 koreans monitored for vaccine side effects over 6 years

NCT ID NCT05032976

Knowledge-focused Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is monitoring the safety of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) in 12,000 people in South Korea who received the vaccine as part of routine care. Researchers are tracking side effects like sore arms or fever within a week of each dose, as well as any other health issues that arise within a month. The goal is to gather real-world safety data from 2021 to 2027 to ensure the vaccine remains safe for the public.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BNT162b2 (Pfizer-BioNTech COVID-19 vaccine)
What this could lead to
If successful, this study will provide real-world safety data on the BNT162b2 vaccine in a large Korean population, helping confirm its safety profile.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may be influenced by other factors and may not apply to other populations.

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

About 12,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2022

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

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 subjects who received the BNT162b2 under an approved label for use in Korea in contracted study sites.

Ages

6 months and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show 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.

1\. Inclusion criteria Subjects must meet all of the following inclusion criteria to be eligible for inclusion in the study: 1. Korean subjects who are eligible for administration of BNT162b2 products (Including bivalent COVID-19 Vaccines for omicron) according to the locally approved and authorized label (indication, age criteria etc.) 2. Evidence of a personally signed and dated data privacy statement indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study - Data privacy statement signed by the subjects and parents or legal representative for subjects aged under 19 2\. Exclusion criteria Subjects meeting any of the following criteria will be excluded in the study 1. Subjects who involved in the contraindications of use indicated in the locally approved and authorized label 2. Subjects with a history of hypersensitivity to any ingredients of this product or this product

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Conditions

The condition(s) this trial relates to.

COVID-19 prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adverse effects COVID -19 SAFETY SARS-CoV-2 Vaccines

Contacts and locations

Locations

  • Pfizer

    Seoul, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.