Mar 22 · Apexxnar is approved by the MHRA for active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older [18]
Feb 22 · Approved in the EU for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older [17].
Dec 21 · Committee for Medicinal Products for Human Use of EMA has issued a positive opinion to recommend the granting of a marketing authorization for Pfizer’s Pneumococcal 20-valent Conjugate Vaccine for the prevention of invasive disease and pneumonia caused by 20 Streptococcus pneumoniae (pneumococcus) serotypes in adults ages 18 years and older. Trade name in the EU to be: APEXXNAR [16]
Jun 21 · Prevnar 20 includes capsular polysaccharide conjugates for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) already included in Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine). The vaccine also contains capsular polysaccharide conjugates for seven additional serotypes (8, 10A, 11A, 12F, 15B, 22F and 33F) that cause invasive pneumococcal disease (IPD), and have been associated with high case-fatality rates, antibiotic resistance, and/or meningitis [16].
Jun 21 · Approved for use in adults in the US. Development for use in children is ongoing with application expected late 2022 [15]
Feb 21 · EMA has accepted for review the MAA for 20-valent pneumococcal conjugate vaccine for prevention of invasive disease and pneumonia caused by S. pneumoniae serotypes in adults [14].
Dec 20 · Granted priority review in US with target action date of June 2021 [11].
Oct 20 · Pfizer announces intention to submit MAA to EMA for Pneumococcal infections (In adults, Prevention) in Q1 2021. [13]
Sep 20 · Granted a breakthrough therapy designation for the prevention of pneumococcal infections in infants, children, and adolescents. [12]
May 20 · PIII adult clinical trials (NCT03760146, NCT03828617, and NCT03835975) evaluating the vaccine for prevention of invasive disease and pneumococcal pneumonia now completed [10].
Sep 19 · Enrolment in PIII trials in adults now complete and Pfizer plans to file in the US for adults by the end of 2020 [8].
Sep 19 · PIII studies in children are planned following data from the 4th dose becoming available.[7]
Sep 18 · Granted breakthrough therapy designation in the US for adults [1]
Oct 17 · Granted fast track designation in the US for adults [1]
May 17 · Granted fast track designation in the US for paediatrics [1]