Nirsevimab publications: Key publications, HARMONIE publication & NIRSE-GAL-study
Key Nirsevimab publications
Ph2b
Single-Dose Nirsevimab for Prevention of
RSV in Preterm Infants
Griffin MP et al, N Engl J Med. 2020 Jul
30;383(5):415-425.
Medley
Safety of Nirsevimab for RSV in Infants with
Heart or Lung Disease or Prematurity
Domachowske J et al. N Engl J Med. 2022
Mar 3;386(9):892-894.
Melody
Nirsevimab for Prevention of RSV in
Healthy Late-Preterm and Term Infants
Hammitt LL et al.. N Engl J Med. 2022 Mar
3;386(9):837-846.
doi:
Pooled Analysis
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
Simões EAF et al. Lancet Child Adolesc
Health. 2023 Mar;7(3):180-189.
Nirsevimab Melody All subjects
Nirsevimab for Prevention of RSV in Term
and Late-Preterm Infants
Muller WJ et al. N Engl J Med. 2023 Apr
20;388(16):1533-1534.
doi: 10.1056/NEJMc2214773
Nirsevimab Microneutralization
Durability of neutralizing RSV antibodies
following nirsevimab administration and
elicitation of the natural immune response
to RSV infection in infants
Wilkins D et al. Nat Med. 2023 Apr 24.
HARMONIE publication
https://www.nejm.org/doi/pdf/10.1056/NEJMoa2309189
The primary end point of this study was hospitalization for RSV-associated lower respiratory tract infection, defined as hospital admission and an RSV-positive test result. A key secondary end point was very severe RSV-associated lower respiratory tract infection, defined as hospitalization for RSV-associated lower respiratory tract infection with an oxygen saturation of less than 90% and the need for supplemental oxygen.
Nirsevimab for Prevention of
Hospitalizations Due to RSV in
Infants Research summary
Nirsevimab for preventing RSV
Hospitalizations in Infants Video
NIRSE-GAL-study
NIRSE-GAL study: evolution of Immunization Coverage with Nirsevimab (nirsegal.es)
Galicia has conducted a study entitled ‘Evaluation of the effectiveness and impact of Nirsevimab in Galicia’. The NIRSE-GAL study evaluates the impact of the inclusion of nirsevimab in the Galician immunization schedule on the prevention of RSV infections in children.
The primary objective of the study is to evaluate the effectiveness of nirsevimab on hospitalization for RSV related to lower respiratory track infections (LRTI) during the RSV season (which starts on October 1st and ends on March 1st) in 3 groups of children: Infants born during RSV season, infants younger than 6 months at the start of RSV season and high-risk children younger than 24 months at the start of RSV season. Results are presented as reports on a weekly basis.
Report on immunization with
nirsevimab in Galicia
Press release on the impact of
nirsevimab
RSV immunization has reduced 77%
emergency room visits for babies under 6
months. Access the press release via:
https://canalsalut.gencat.cat/ca/inici/no
