According to the PCV20 package insert, in pre-licensing clinical trials, the most commonly reported side effects following vaccination in children 15 months of age and younger who received four doses of the vaccine included irritability, injection site pain, redness and swelling, drowsiness, decreased appetite, and fever. Within six months of the fourth dose of PCV20, 4.5 percent of children reported at least one or more serious adverse events, compared with 3.7 percent of children who received four doses of PCV13. Two children who received PCV20 experienced febrile seizures, with one considered serious. Both were considered to be possibly related to vaccination. One child experienced injection site hypersensitivity within 30 minutes of vaccination with receipt of each of the first three PCV20 vaccine doses that resolved on the same day. No reaction was reported post dose four of PCV20 in this child.
In children aged 15 months through 17 years who received a single vaccine dose, the most commonly reported side effects included irritability, injection site pain, swelling, and redness, decreased appetite, headache, fatigue and muscle pain, drowsiness, and fever.
The most common adverse reactions reported among adults 18 years and older included injection site pain and swelling, muscle and joint pain, headache, and fatigue. Within six months of PCV20 administration, 1.5 percent of adults reported experiencing a serious adverse event, compared to 1.8 percent of adults who received PCV13 vaccine or other control vaccine. According to the package insert, rates between the groups were comparable, and no serious adverse events were considered to have a causal relationship to PCV20.
All pre-licensing clinical safety trials of PCV20 compared the vaccine to PCV13 and/or PPSV23. Adults 65 years of age and older who received PCV20 at the same time as the quadrivalent flu vaccine experienced higher rates of systemic reactions (fever, muscle or joint pain, headache and fatigue) within seven days of administration when compared to individuals who received PCV20 and quadrivalent flu vaccine on separate occasions.
The PCV20 package insert does not contain information on post-marketing safety of the vaccine but rather it lists adverse events reported following PCV13 vaccine administration. These adverse events include cyanosis (bluish or grayish coloring of the skin, lips or nails), apnea, hypotonia, and pallor in children, swelling of lymph nodes, vaccine injection site swelling, itching, and redness, anaphylaxis including shock, angioneurotic edema, and erythema multiforme.
