nirsevimab

12/28/2023 - "Very severe RSV-associated lower respiratory tract infection occurred in 5 infants (0.1%) in the nirsevimab group and in 19 (0.5%) in the standard-care group, which represented a nirsevimab efficacy of 75.7% (95% CI, 32.8 to 92.9; P = 0.004). "
03/07/2024 - "In phase 3 clinical trials, nirsevimab efficacy against RSV-associated lower respiratory tract infection with hospitalization was 81% (95% CI = 62%-90%) through 150 days after receipt; post-introduction effectiveness has not been assessed in the United States. "
12/28/2023 - "The efficacy of nirsevimab against hospitalization for RSV-associated lower respiratory tract infection was 89.6% (adjusted 95% CI, 58.8 to 98.7; multiplicity-adjusted P<0.001) in France, 74.2% (adjusted 95% CI, 27.9 to 92.5; multiplicity-adjusted P = 0.006) in Germany, and 83.4% (adjusted 95% CI, 34.3 to 97.6; multiplicity-adjusted P = 0.003) in the United Kingdom. "
12/28/2023 - "Eleven infants (0.3%) in the nirsevimab group and 60 (1.5%) in the standard-care group were hospitalized for RSV-associated lower respiratory tract infection, which corresponded to a nirsevimab efficacy of 83.2% (95% confidence interval [CI], 67.8 to 92.0; P<0.001). "
01/01/2022 - "Medically attended RSV-associated lower respiratory tract infection occurred in 12 infants (1.2%) in the nirsevimab group and in 25 infants (5.0%) in the placebo group; these findings correspond to an efficacy of 74.5% (95% confidence interval [CI], 49.6 to 87.1; P<0.001) for nirsevimab. "

01/01/2023 - "Nirsevimab (formerly MEDI8897) is a highly potent, long-acting, human, recombinant mAb that received approval for the prevention of RSV infection in newborns and infants during their first RSV season from the EMA and the UK's Medicines and Healthcare products Regulatory Agency in November 2022 based on positive results in Phase 2b and 3 clinical trials. "
05/01/2024 - "This study explores the economically justifiable price of nirsevimab for preventing RSV infection in Colombia's children under 1 year of age. "
04/08/2024 - "Author Correction: Molecular and phenotypic characteristics of RSV infections in infants during two nirsevimab randomized clinical trials."
01/01/2023 - "Molecular and phenotypic characteristics of RSV infections in infants during two nirsevimab randomized clinical trials."
01/01/2023 - "The use of nirsevimab to prevent RSV infections and hospitalization shows its promising potential, but studies on its cost-effectiveness are lacking. "

03/01/2024 - "Major updates for pediatric clinicians include recommendations for XBB monovalent COVID-19 immunization for the 2023-2024 respiratory season, the recently licensed pentavalent meningococcal conjugate vaccine and mpox vaccination in high-risk young adults, and discussion regarding the parallel strategies of protection against RSV disease in infants via maternal immunization during pregnancy or direct prophylaxis of infants with nirsevimab."
12/14/2023 - "Major updates for pediatric clinicians include recommendations for XBB monovalent COVID-19 immunization for the 2023-2024 respiratory season, the recently licensed pentavalent MenABCWY meningococcal vaccine and mpox vaccination in high-risk young adults and discussion regarding the parallel strategies of protection against RSV disease in infants via maternal immunization during pregnancy or direct prophylaxis of infants with nirsevimab."
11/01/2023 - "Major updates for pediatric clinicians include a new recommendation for the monoclonal antibody nirsevimab for prevention of RSV disease in all infants, recommendations regarding use of 20-valent pneumococcal conjugate vaccine, and discussion of potential forthcoming changes to meningococcal and COVID-19 vaccination recommendations."

04/01/2024 - "Four landmark randomized controlled trials, the first published in July 2020, have documented the efficacy and safety of nirsevimab in healthy late-preterm and term infants, healthy preterm infants, and high-risk preterm infants and those with congenital heart disease. "
05/01/2024 - "Congenital heart disease (CHD) and chronic lung disease (CLD) did not significantly impact nirsevimab PK. "
02/01/2024 - "Recommendations of the Spanish Society of Pediatric Cardiology and Congenital Heart Diseases for the prevention of respiratory syncytial virus infections with nirsevimab in pediatric cardiology."
01/01/2023 - "Efficacy of nirsevimab against respiratory syncytial virus lower respiratory tract infections in preterm and term infants, and pharmacokinetic extrapolation to infants with congenital heart disease and chronic lung disease: a pooled analysis of randomised controlled trials."
01/01/2023 - "Among infants with chronic lung disease, congenital heart disease, or extreme preterm birth in MEDLEY, nirsevimab serum exposures were similar to those found in the pooled data; exposures were above the target in more than 80% of the overall MEDLEY trial population (94%), including infants with chronic lung disease (94%) or congenital heart disease (80%) and those born extremely preterm (94%). "

12/01/2023 - "Nirsevimab has demonstrated an efficacy of 76.8% (95% CI, 49.4 to 89.4) in preventing lower respiratory infection 150 days after vaccination, decreasing the risk of ICU admission by 90.1% (95% CI: 16.4-98.8). "
01/01/2023 - "Passive immunization with nirsevimab protects infants from severe RSV disease without impairing the immune response to natural infection."
02/26/2024 - "No increase in medically attended RSV lower respiratory tract infections or evidence of antibody-dependent enhancement of infection or disease severity was found for nirsevimab vs placebo recipients. "
01/01/2023 - "Data analysis showed that among infants, nirsevimab given before the RSV season significantly reduced the risk of medically attended RSV-related infection (RR: 0.26; 95% CI: 0.18-0.38) and the risk of hospitalization due to RSV infection (RR: 0.24; 95% CI: 0.13-0.47). "
01/01/2022 - "The authors introduce RSV and surface viral proteins involved in infection, then discuss the development and achievements of nirsevimab in clinical trials concluding with expert opinion. "