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PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines)
Protocol C4591001

participant in this vaccine study than individuals with other chronic stable medical
conditions.

• All participants with chronic stable HIV disease will be included in the
reactogenicity subset (see Section 8.2.2).

Updates as part of protocol amendment 7:

• The minimum age for inclusion in Phase 3 is lowered to 12 years, therefore
allowing the inclusion of participants 12 to 15 years of age.

• For individuals 12 to 15 years of age, the immune responses in this age group may
be higher and reactogenicity is expected to be similar to younger adults 18 to 25
years of age. Inclusion of individuals 12 to 15 years of age was based upon a
satisfactory blinded safety profile in participants 18 to 25 years of age.

• All participants 12 to 15 years of age will be included in the reactogenicity subset
(see Section 8.2.2).

More detailed information about the known and expected benefits and risks and reasonably
expected AEs of BNT162 RNA-based COVID-19 vaccines may be found in the IB, which is
the SRSD for this study.

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