According to the CAPVAXIVE (PCV21) package insert, in pre-licensing clinical trials, the most commonly reported side effects following vaccination included injection site pain, redness and swelling, muscle pain, headache, and fatigue. Serious adverse events considered related to CAPVAXIVE that were reported during the clinical trials included an acute allergic reaction with bronchospasms occurring within 30 minutes of vaccine administration, and injection site cellulitis requiring hospitalization that occurred within 6 days of vaccination.
In clinical trials, six deaths were reported among CAPVAXIVE (PCV21) vaccine recipients, and three among those who received the comparator vaccine. The causes of death among persons who received CAPVAXIVE included sepsis, septic shock, myocardial infarction, hepatic cirrhosis, hepatic encephalopathy, cerebrovascular accident, and victim of homicide. Among individuals in the comparator group who died, deaths were reported as abdominal abscess, cardiac arrest, and road traffic accident. None of the deaths were considered by clinical trial investigators to be related to vaccination.
All pre-licensing clinical safety trials of PCV21 compared the vaccine to other licensed pneumococcal vaccines (PPSV23, PCV20, and PCV15). One clinical trial examined the use of CAPVAXIVE given at the same time as the quadrivalent flu vaccine (FLUZONE Quadrivalent) when compared to the same vaccines given one month apart. According to the manufacturer, adverse reactions were similar between both groups.
The PCV21 package insert does not contain information on post-marketing safety of the vaccine.
