Safety and Tolerability of a 13-Valent Pneumococcal Conjugated Vaccine Distributed in the Public Immunization Program of the Municipality of Campos dos Goytacazes, Rio de Janeiro, Brazil

Abstract

From september to december, 2010, we have assessed the frequency and occurrence of adverse events to Pneumo-coccal conjugated 13-valent vaccine (PCV-13) in the Public vaccination program of the municipality of Campos dos Goytacazes, State of Rio de Janeiro, the unique city in Brazil that has introduced this vaccine in it’s immunization schedule. This study analyzed 1001 toddlers who have received PCV-13 at 3, 5 and 7 months and a booster dose at 12 months. We observed a total of 514 local and systemic events in 303 subjects (30.2% of 1001 infants). The most reported systemic events were irritability (18.8%) and fever < 38.5°C (17.1%), followed by fever > or = 38.5°C (8.8%), loss of appetite (8.4%). Erythema (11.2%) and local pain (9.4%) were the most reported local events. Other events reported were diarrhea (6.2%), increased sleep (5.1%), edema and induration (4.8%), decreased sleep (4.3%), vomiting (1.4%), eruption (1.2%) urticaria (0.8%), prurience (0.8%), lymphadenopathy (0.2%) and hypersensitivity reaction (0.2%). There wasn’t any reported case of convulsion or Hospital admission. When stratified by each dose, irritability (systemic) and erythema (local) were the most common events reported at the first and fourth dose, although fever < 38.5°C (systemic) and pain (local) were the most common at second and third doses. Results were close to those encountered in product monograph. In our study, PCV-13 was secure in pneumococcal disease prevention and well tolerated

Cost-effectiveness analysis of routine pneumococcal vaccination in the UK: a comparison of the PHiD-CV vaccine and the PCV-13 vaccine using a Markov model

“…Hence, the model assumed an efficacy of 23.4% against X-ray-confirmed consolidated CAP (which usually requires hospitalisation) and 7.3% against clinically suspected CAP (commonly managed on an outpatient basis) for both vaccines, based on a clinical trial of PHiD-CV 12. These estimates are conservative, as postmarketing surveillance data from Brazil have shown a reduction of 40% and 30% in pneumonia hospitalisations with PHiD-CV65 and PCV-13,66 respectively.…”

“…These efficacy estimates, in line with expert validation and with data reported by Tregnaghi et al ,12 were applied to the respective serotypes, taking into account the frequency of these serotypes in causing AOM (see online supplementary table S5b in file 1). 66 67 A similar approach was used for NT Hi -related AOM. VE for both vaccines against AOM with TTP procedures was extrapolated using an exponential function based on the results of PCV-7 clinical trials68 69 and the relative ratio of overall AOM VE 70.…”