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Millions of vaccine records scoured for rare side effects

NCT ID NCT06743334

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Last updated Jul 10, 2026

Summary

This study uses a nationwide health database in South Korea to track the safety of the BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine in over 14 million people. Researchers will look for rare adverse events and severe COVID-19 outcomes after vaccination. The goal is to better understand the vaccine's real-world safety across different age groups.

What this could mean

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

Active substance
Tozinameran (BNT162b2) COVID-19 vaccine
What this could lead to
If successful, this study could provide a clearer picture of the vaccine's real-world safety profile, helping to guide public health decisions.
What could go wrong
This is an observational study using existing data, so it cannot prove cause and effect. Results may be influenced by factors like underlying health conditions or reporting biases.

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

14,302,529 people

The number who actually took part.

Started

Apr 2025

Finished

May 2025

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

Individuals who were vaccinated with at least one dose of Pfizer COVID-19 vaccine according to locally approved label in Republic of Korea from 27 February 2021 through 31 December 2023.

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. Primary Objectives 1-1. Measure of Occurrence Inclusion Criteria For the measure of occurrence, analytical populations will include following individuals, * Who meet the predefined criteria for each study population. * With enrollment in the national insurance during the observation period, as well as during the clean window prior to the start of the observation period. Exclusion Criteria For the measure of occurrence, analytical populations will exclude following individuals, * With diagnosis of AESI during the AESI-specific clean window; or * With diagnosis of AESI between first dose and second/third dose of primary series when analyzing for the second/third dose. 1-2. Measure of Association Inclusion Criteria For the measure of association, analytical populations will include following individuals, * Who meet the predefined criteria for each study population. * With enrollment in the national insurance during the observation period, as well as during the clean window prior to the start of the observation period; and * Who had incident AESI during the observation period. Exclusion Criteria For the measure of association, analytical populations will exclude following individuals, * Who do not have both risk and control window time. If an individual disenrolls, dies, or reaches the end of the study period during the risk window prior to accumulating any control window time, he/she will be excluded; or * With a diagnosis of AESI during the AESI-specific clean window. 2. Secondary Objective Inclusion Criteria For the secondary objective, the study populations will include following individuals, * Who meet the predefined criteria for each study population. Exclusion Criteria * None

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Conditions

The condition(s) this trial relates to.

COVID-19

As listed by the trial registrant

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

COVID-19 SARS-CoV 2

Contacts and locations

Locations

  • Pfizer

    Seoul, South Korea

More trials for these conditions

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