A Study to Learn About New COVD-19 RNA Vaccine Candidates for New Variants in Healthy Individuals

The purpose of this clinical protocol is to learn about the safety, tolerability, and immunogenicity of new BNT162b2 RNA-based vaccine candidates targeting new variants of SARS-CoV-2 in healthy people.

Substudy A:

• This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi XBB.1.5) given as a single 30 µg dose,

• in people who are 12 years of age and older,
• who previously received at least 3 doses of a US-authorized mRNA COVID-19 vaccine, with the most recent dose being an Omicron BA.4/BA.5-adapted bivalent vaccine received at least 150 days before the study vaccination (Visit 1).
• The study is about 6 months long for each participant.
• Participants will have at least 5 visits to the clinic.
• At each clinic visit a blood sample will be taken.
• At least 1 nasal swab will taken.

Substudy B:

• This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi XBB.1.5) given as a single 30 µg dose,

• in people who are 12 years of age and older,
• who are COVID-19 vaccine-naïve
• who have had any positive SARS-CoV-2 test result \>28 days before study vaccine administration.
• The study is about 6 months long for each participant.
• Participants will have at least 5 visits to the clinic.
• At each clinic visit a blood sample will be taken.
• At least 1 nasal swab will taken.

Substudy C:

• This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi JN.1) and BNT162b2 (Omi KP.2) given as a single 30 µg dose to:

• Cohort 1: people who are 18 years of age and older, who will receive BNT162b2 (Omi JN.1), and,
• Cohort 2: people who are 12 years of age and older, who will receive BNT162b2 (Omi JN.1), and,
• Cohort 3: people who are 18 years of age and older who will receive BNT162b2 (Omi KP.2).
• Participants may have never received a COVID-19 vaccine or, may have previously received COVID-19 vaccine(s), with the most recent dose received at least 150 days before the study vaccination (Visit 1).
• The study is about 6 months long for each participant.
• Participants will have at least 6 visits (Cohorts 1 and 3) or at least 5 visits (Cohort 2) to the clinic.
• At each clinic visit a blood sample will be taken.
• At least 1 nasal swab will taken.