Pneumococcal

Prevnar 20 by Pfizer (Pneumococcal PCV)

Captured 2022-11-17
Document Highlights

Initial U.S. Approval: 2021

Prevnar 20 is a vaccine indicated for active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae… in adults 18 years of age and older.

Postmarketing Experience
– Anaphylactic/anaphylactoid reaction, including shock
– Angioneurotic edema, Erythema multiforme
– Lymphadenopathy localized to the region of the injection site
– Vaccination-site dermatitis, vaccination-site pruritus, vaccination-site urticaria

Each 0.5 mL dose of the vaccine is formulated to contain… polysorbate 80… and 125 μg aluminum as aluminum phosphate adjuvant.

Prevnar 20 has not been evaluated for the potential to cause carcinogenicity, genotoxicity, or impairment of male fertility.

Comments

Prevnar 20 was not tested for safety in a placebo-controlled clinical trial.

Why this is important.