Pfizer-BioNTech COVID-19 Vaccine Effectiveness Study - Kaiser Permanente Southern California

Description

The primary objective of this study is to determine the vaccine effectiveness of 2 doses of Pfizer-BioNTech BNT162b2 vaccine against COVID-19-associated hospitalization. There will be a large retrospective database study using two parallel study designs: a test-negative case-control design and a retrospective cohort design. VE estimates by various strata and strain type will be conducted.

Conditions

COVID-19

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Study Overview

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Study Details

Study overview

The primary objective of this study is to determine the vaccine effectiveness of 2 doses of Pfizer-BioNTech BNT162b2 vaccine against COVID-19-associated hospitalization. There will be a large retrospective database study using two parallel study designs: a test-negative case-control design and a retrospective cohort design. VE estimates by various strata and strain type will be conducted.

Vaccine Effectiveness Study of Pfizer-BNT Vaccines - Kaiser Permanente Southern California

Pfizer-BioNTech COVID-19 Vaccine Effectiveness Study - Kaiser Permanente Southern California

Condition
COVID-19
Intervention / Treatment

-

Contacts and Locations

Pasadena

Kaiser Permanente Southern California, Pasadena, California, United States, 91101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * KPSC membership for a minimum of 1 year prior to index date, allowing a 30-day gap in membership to allow for delays in renewal. Participants \<1 year did not have a membership requirement.≥6 months of age as of index date
  • * Admitted to the hospital or had an encounter in the ED, UC, or OP setting with a diagnosis of acute respiratory infection (ARI; defined based on International Classification of Diseases (ICD) codes listed in Appendix Table 1) after 25 September 2023
  • * Received a SARS-CoV-2 PCR or rapid antigen test
  • * Individuals who received a non-Pfizer-BioNTech XBB.1.5-adapted monovalent vaccine
  • * Individuals with an index event \<14 days after vaccination with Pfizer-BioNTech XBB.1.5-adapted monovalent vaccine
  • * Individuals receiving a mRNA bivalent BA4.5 booster ≤ 8 weeks (≤ 56 days) since receiving last wild type dose
  • * Individuals with \<28 days between a second and subsequent wild type dose
  • * Individuals receiving a XBB.1.5-adapted monovalent vaccine ≤ 8 weeks (≤ 56 days) since receiving a mRNA bivalent BA4.5 booster
  • * Individuals receiving oral COVID-19 antiviral OP treatments within 30 days of index event (will be excluded for primary analysis, but included in sensitivity analyses)

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Pfizer,

Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

2025-06-15