A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Production Lots and Dose Levels of BNT162b2 Against COVID-19 in Healthy Participants

This is a Phase 3, randomized, observer-blind study in healthy individuals.

The study will evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 RNA vaccine candidate (BNT162b2):

• As a 30-microgram dose, administered from 1 of 4 manufacturing lots (batches)
• As a 20-microgram dose, administered from 1 of the manufacturing lots
• As a 2-dose (separated by 21 days) schedule
• In people 12 through 50 years of age

• SARS-CoV-2 Infection
• COVID-19

• Experimental: Arm 1
  30-microgram dose of US manufactured drug substance (Lot 1)
  Intervention: Biological: BNT162b2
• Experimental: Arm 2
  30-microgram dose of US manufactured drug substance (Lot 2)
  Intervention: Biological: BNT162b2
• Experimental: Arm 3
  30-microgram dose of US manufactured drug substance (Lot 3)
  Intervention: Biological: BNT162b2
• Experimental: Arm 4
  30-microgram dose of EU manufactured drug substance (Lot 4)
  Intervention: Biological: BNT162b2
• Experimental: Arm 5
  20-microgram dose of US manufactured drug substance (corresponding to Arm 1, 2 or 3 lot)
  Intervention: Biological: BNT162b2

Inclusion Criteria:

• Male or female participants between the ages of 12 and 50 years, inclusive, at randomization.
• Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
• Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
• Capable of giving personal signed informed consent/have parent(s)/legal guardian capable of giving signed informed consent.

Exclusion Criteria:

• Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
• Known infection with HIV, HCV, or HBV.
• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention.

• Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID 19.

  . Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.

• Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
• Women who are pregnant or breastfeeding.
• Previous vaccination with any coronavirus vaccine.
• Receipt of medications intended to prevent COVID-19.
• Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study.
• Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study.
• Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
• Previous participation in other studies involving study intervention containing lipid nanoparticles.
• Investigator site staff or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.